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The Burrill Report: (September 7, 2010): DOJ Seeks Stay in Stem Cell Ruling (.MP3,19.55 Mb)
The U.S. Department of Justice has filed an appeal to the recent preliminary injunction issued by a federal district court judge that halted federal funding of human embryonic stem cell research. At issue is Judge Royce Lamberth’s broad interpretation of the Dickey-Wicker Amendment, which prohibits the U.S. government from funding research in which a human embryo is destroyed. We spoke to Ken Taymor, executive director of the Berkeley Center for Law, Business and Economy about the judge’s ruling, the Justice Department’s request for a stay, and the legal and legislative fights ahead.
The Burrill Report (August 30, 2010): Legislators Weigh Goals of Personalized Medicine Bill (.MP3,16.13 Mb)
When Barack Obama was a junior senator from Illinois he introduced legislation designed to foster the development of personalized medicine. New versions of that bill have followed, but never managed to get out of committee. The latest one, introduced in May, now faces the added dynamic of an emerging controvery over direct-to-consumer genetic tests. We spoke to Dan Vorhaus, editor Genomics Law Report and an attorney with Robinson, Bradshaw & Hinson about the legislative efforts, what this latest version of the bill seeks to accomplish, and whether there’s a future for direct-to-consumer genetic tests.
The Burrill Report (August 23, 2010): Drug Recalls Soar (.MP3,8.35 Mb)
Drug recalls listed by the U.S. Food and Drug Administration hit a record 1,742 in 2009, according to a new report from The Gold Sheet. That shattered the previous record of 464 set in 2000, according to the publication, which has tracked drug recalls since 1988. We spoke to Bowman Cox, managing editor for The Gold Sheet, about the trend, whether it reflects a new posture at the FDA under the Obama administration, and how legislation in the works could give the agency new powers to institute recalls.
The Burrill Report (August 16, 2010): FDA Readies Overhaul of Key Medical Device Regulations (.MP3,14.98 Mb)
The U.S. Food and Drug Administration is in the process of overhauling a critical set of regulations relating to the introduction of new medical devices. The agency says the proposed changes have the goals of fostering innovation while better assuring the safety and efficacy of new devices. Medical device makers, though, are concerned about the FDA adding to their regulatory burden without making meaningful improvements in patient safety. We spoke to Carmelina Allis, former assistant chief counsel for enforcement at the FDA and an attorney with Hyman, Phelps & McNamara, about the proposed changes, how far they reach, and why there’s concern that they fall short of balancing the differing goals of encouraging innovation while improving safety.
The Burrill Report (August 9, 2011): FDA Gives Geron Green Light for Stem Cell Trial (.MP3,10.82 Mb)
The U.S. Food and Drug Administration has given a green light to Geron to proceed with the first trial of a human embryonic stem cell derived therapy in humans. The decision sets into motion a study that had been placed on hold in 2009 over safety concerns after data in a preclinical study of the therapy showed some rats that had received the cells developed cysts. We spoke to Bernie Siegel, executive director of the Genetics Policy Institute, about the significance of the trial, whether too much will be read into its results, and other recent developments in the world of stem cells.
The Burrill Report (August 2, 2010): The IPO Market Sizzles - In China (.MP3,8.73 Mb)
Wondering if the IPO window is open? Well there’s no doubt about it if you are talking about the IPO market in China. The life sciences sector has raised $6.1 billion through initial public offerings in the past 12 months, far outpacing the activity in the United States. And, despite the collapse of Charles River's $1.6 billion acquisition of Wuxi, M&A activity is growing. We spoke to Greg Scott, president and founder of the consulting firm ChinaBio and publisher of ChinaBio Today about the thriving IPO market for life sciences companies there, how that’s evolved over the past year and what the outlook is moving forward.
The Burrill Report (July 26, 2010): Investors Weigh Biotech Results (.MP3,10.45 Mb)
Earnings season is well underway with Gilead, Genzyme, Biogen Idec, and Roche all having reported their second quarter results. The numbers have been a mixed bag and there are some big questions overhanging key players in the industry. Some investors are looking beyond the quarter, but what they see isn’t always encouraging. We spoke to Adam Feuerstein, senior columnist for The Street.com, about how the second quarter numbers are shaping up, what red flags may be out there, and how investors are looking at the results these days.
The Burrill Report (July 19, 2010): Can PhRMA's New CEO Repair the Industry's Image? (.MP3,12.33 Mb)
The Pharmaceutical Research and Manufacturers of America named John Castellani as president and CEO replacing Billy Tauzin, who stepped down from the post earlier this year and remains a senior advisor to the trade group. Castellani, who headed the Business Roundtable, comes at a difficult time for the industry. Its reputation with the public is suffering, its relationships in Congress are strained, and headlines over drug safety plague it as it readies for a legislative fight to renew the Prescription Drug User Fee Act. We spoke to Ian Spatz, former vice president of global health policy at Merck and founder of the Rock Creek Policy Group, about a recent In Vivo blog he penned in which he offered his advice to PhRMA’s new CEO, why repairing the industry’s reputation should be Castellani’s top priority, and why the industry remains unloved by the public at large.
The Burrill Report (July 12, 2010): Will Investors Hang on to Biotech (.MP3,10.89 Mb)
As 2010 took shape, the worst seemed to be behind us and the year was looking as if it would be a good one for the biotech sector. Lately, though, things seem to have turned a tad sour. A downturn in the general market and growing concerns among investors have weighed heavily on the industry. The good news is that companies have been successful at raising money. But while a dozen companies have managed to go public since last summer, their performance has been disappointing and investors’ seem to have little appetite for biotech IPOs. As The Burrill Report gets ready to release it July issue with a wrap-up of the first half of the year, we spoke to Editor Peter Winter about what’s happened during 2010, the dealmaking activity to date, and what it's going to take to kick-start the industry in the second half of the year.
The Burrill Report (July 5, 2010) Supreme Court Decision Allows Diagnostics Makers to Dodge a Bullet (.MP3,9.81 Mb)
The U.S. Supreme Court has upheld a Federal Court of Appeals ruling in Bilski v. Kappos, a case that raised fundamental questions about what can and cannot be patented. The case centered on whether a method for hedging risk in commodities trading is patentable, but threatened to upend the molecular diagnostics business in the process. Though the justices upheld the lower court’s ruling, it left open the ability for companies to get so-called business method patents. We spoke to Ken Chahine, a visiting professor of law at the University of Utah, about what the decision did and didn’t say, what other cases are in the works that may provide the clarity some hoped the Bilski decision would provide, and why the biotechnology industry is cheering.
The Burrill Report (June 28, 2010): FDA Faces Challenges Monitoring the Growing Number of Clinical Trials Conducted Overseas (.MP3,9.68 Mb)
A new report from the inspector general of the U.S. Department of Health and Human Services finds 80 percent of products approved by the U.S. Food and Drug Administration relied in part on foreign clinical trials. The report also found the agency inspected far fewer of these trial sites than trial sites in the United States and often didn’t even know about the trials until long after they were concluded. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest about the FDA’s oversight of these trials, the trends that are driving the growth in drug and device makers looking overseas for trial sites, and what steps should be taken to address the issue.
The Burrill Report (June 21, 2010): FDA Moves Toward Regulating Direct-to-Consumer Genetic Tests (.MP3,13.59 Mb)
The U.S. Food and Drug Administration is taking steps to regulate direct-to-consumer genetic tests. The agency recently sent letter to 23andMe, Navigenics, deCODE Genetics, Knome, and Illumina stating that they are marketing medical devices without the necessary review and approval from the agency. The action follows last month’s controversy over Pathway Genomics aborted attempts to sell its test kits through the retail drugstore chain Walgreens. We spoke to Daniel Vorhaus, an attorney with Robinson, Bradshaw & Hinson and Editor of the Genomics Law Report, about the FDA letters, how these companies are responding to the agency, and what it all means to the future of the genetic testing industry.
The Burrill Report (June 14, 2010): Amgen's 15-Year Effort to Build a Blockbuster (.MP3,14.8 Mb)
Amgen’s denosumab, its treatment for osteoporosis, has won approval in both Europe and the United States. Marketed under the name Prolia, analysts forecast sales will approach $1 billion in 2011 and EvaluatePharma thinks that could grow to $5.3 billion by 2016. We spoke to Dave Lacey, senior vice president and head of research for Amgen, about the long road travelled to bring Prolia to market, why the discovery and development of new drugs like it remains so difficult, and what other interesting therapies might be working their way through Amgen’s deep pipeline.
Amgen’s denosumab, its treatment for osteoporosis, has won approval in both Europe and the United States. Marketed under the name Prolia, analysts forecast sales will approach $1 billion in 2011 and EvaluatePharma thinks that could grow to $5.3 billion by 2016. We spoke to Dave Lacey, senior vice president and head of research for Amgen, about the long road travelled to bring Prolia to market, why the discovery and development of new drugs like it remains so difficult, and what other interesting therapies might be working their way through Amgen’s deep pipeline.The Burrill Report (June 7, 2010): Bridging The Gap on Discovery and Development (.MP3,11.79 Mb)
Bridging the gulf from discovery across what’s become known as the valley of death, remains a problem not only for biopharmaceutical companies, but also for patients in need of new therapies to address unmet medical needs. At a time when raising money for early-stage drug discovery and development remains a challenge, the pharmaceutical industry has been slashing its own R&D spending and increasingly looking beyond its own walls for promising new drugs. We spoke to Paul Laikand, chief business officer for the Sanford-Burnham Medical Research Institute, about how the institute is seeking to establish collaborations with industry, what it's done to exploit the resources it's built, and the unique role independent research institutes can play in addressing the need for translational research.
Bridging the gulf from discovery across what’s become known as the valley of death, remains a problem not only for biopharmaceutical companies, but also for patients in need of new therapies to address unmet medical needs. At a time when raising money for early-stage drug discovery and development remains a challenge, the pharmaceutical industry has been slashing its own R&D spending and increasingly looking beyond its own walls for promising new drugs. We spoke to Paul Laikand, chief business officer for the Sanford-Burnham Medical Research Institute, about how the institute is seeking to establish collaborations with industry, what it's done to exploit the resources it's built, and the unique role independent research institutes can play in addressing the need for translational research.The Burrill Report (June 1, 2010): Does the Industry Get Its Money's Worth from Drug Review Fees (.MP3,9.63 Mb)
The U.S. Food and Drug Administration has sought to address its lack of resources and accelerate the speed with which it reviews applications for new drugs and biologics through fees imposed on the pharmaceutical and biotechnology companies whose products it reviews. The fourth incarnation of the so-called Prescription Drug User Fee Act or PDUFA, which first passed in 1992, expires at the end of September 2012. Its reauthorization is moving toward the top of the industry’s policy agenda. PDUFA fees have more than doubled since fiscal 2007 to $667 million and now account for two-thirds of the total spent on human drug reviews. Recent data suggest that despite improvements credited to PDUFA, performance under the program has been slipping. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA, about reauthorization of the act, how to view the agency’s performance, and whether the industry is getting the intended benefits from the fees it pays.
The U.S. Food and Drug Administration has sought to address its lack of resources and accelerate the speed with which it reviews applications for new drugs and biologics through fees imposed on the pharmaceutical and biotechnology companies whose products it reviews. The fourth incarnation of the so-called Prescription Drug User Fee Act or PDUFA, which first passed in 1992, expires at the end of September 2012. Its reauthorization is moving toward the top of the industry’s policy agenda. PDUFA fees have more than doubled since fiscal 2007 to $667 million and now account for two-thirds of the total spent on human drug reviews. Recent data suggest that despite improvements credited to PDUFA, performance under the program has been slipping. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA, about reauthorization of the act, how to view the agency’s performance, and whether the industry is getting the intended benefits from the fees it pays.The Burrill Report (May 24, 2010): Transforming the Life Sciences Labor Force (.MP3,12.04 Mb)
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As the economy emerges from what’s been described as the longest and deepest downturn since the Great Depression, work is returning to the life sciences, just not jobs in the conventional sense. Instead, some say companies are balancing their needs to bolster their ranks while controlling labor costs through the use of contingent workers. While such efforts are not new, some argue that the life sciences industry is starting to tap into a growing pool of highly skilled workers. They say that we are witnessing the start of a major transformation in the way the industry works with specialized teams of workers assembled for specific projects and then disbanded. We spoke to Alan Edwards, science product leader for the Americas Products Group of temporary staffing firm Kelly Services, about this trend, how the workforce is changing, and why life sciences companies may be well suited for working in this way.
As the economy emerges from what’s been described as the longest and deepest downturn since the Great Depression, work is returning to the life sciences, just not jobs in the conventional sense. Instead, some say companies are balancing their needs to bolster their ranks while controlling labor costs through the use of contingent workers. While such efforts are not new, some argue that the life sciences industry is starting to tap into a growing pool of highly skilled workers. They say that we are witnessing the start of a major transformation in the way the industry works with specialized teams of workers assembled for specific projects and then disbanded. We spoke to Alan Edwards, science product leader for the Americas Products Group of temporary staffing firm Kelly Services, about this trend, how the workforce is changing, and why life sciences companies may be well suited for working in this way. The Burrill Report (May 17, 2010): Sanofi Looks Outside Its Own Walls for Innovation (.MP3,9.69 Mb)
Sanofi-Aventis is searching for an edge. Like other big pharmas, the company is increasingly looking outside its own walls for breakthrough ideas. At the BIO International Convention in Chicago at the start of May, the Paris-Based pharmaceutical company announced it had joined the Massachusetts Life Sciences Center’s Corporate Consortium Program. The Center, a quasi-public agency, is charged with implementing a ten-year, $1 billion Life Sciences Initiative for the state. Under the agreement, Sanofi is paying $500,000 for a two-year, non-voting membership. The funds will be used in the center’s Accelerator Program, which makes loans to early-stage Massachusetts life sciences companies performing translational science and research. What Sanofi gets in return is an early peek at these promising companies and their technologies. We spoke to Paul Chew, U.S. chief medical officer for Sanofi, about the agreement, changes to the company’s R&D structure, and why Big Pharma is increasingly looking beyond its own walls for innovation.
Sanofi-Aventis is searching for an edge. Like other big pharmas, the company is increasingly looking outside its own walls for breakthrough ideas. At the BIO International Convention in Chicago at the start of May, the Paris-Based pharmaceutical company announced it had joined the Massachusetts Life Sciences Center’s Corporate Consortium Program. The Center, a quasi-public agency, is charged with implementing a ten-year, $1 billion Life Sciences Initiative for the state. Under the agreement, Sanofi is paying $500,000 for a two-year, non-voting membership. The funds will be used in the center’s Accelerator Program, which makes loans to early-stage Massachusetts life sciences companies performing translational science and research. What Sanofi gets in return is an early peek at these promising companies and their technologies. We spoke to Paul Chew, U.S. chief medical officer for Sanofi, about the agreement, changes to the company’s R&D structure, and why Big Pharma is increasingly looking beyond its own walls for innovation. The Burrill Report (May 10, 2010): Let's Make a Deal (.MP3,11.96 Mb)
The BIO International Convention that just concluded in Chicago can be described in many ways. On one hand it was a gathering of nearly 15,000 industry leaders looking to discuss evolving business models, ongoing policy issues, and the changing financial landscape. On the other hand, it was a bit like a continuous speed dating session spread over four days, an oversized convention facility, a few dozen hotels, as well as busses, bars, and parties. This week we’re departing from our usual format to give our listeners a taste of the convention with the voices from a few of the folks we met during our stay in the Windy City. What you’ll hear is a diverse group of people who are excited by innovative ideas, optimistic about the future, and ready to find partners with which to work.
The BIO International Convention that just concluded in Chicago can be described in many ways. On one hand it was a gathering of nearly 15,000 industry leaders looking to discuss evolving business models, ongoing policy issues, and the changing financial landscape. On the other hand, it was a bit like a continuous speed dating session spread over four days, an oversized convention facility, a few dozen hotels, as well as busses, bars, and parties. This week we’re departing from our usual format to give our listeners a taste of the convention with the voices from a few of the folks we met during our stay in the Windy City. What you’ll hear is a diverse group of people who are excited by innovative ideas, optimistic about the future, and ready to find partners with which to work.The Burrill Report (May 3, 2010): Biotech's Recurring Lesson-Take the Money When You Can (.MP3,11.5 Mb)
As the biotechnology industry gathers in Chicago this week for its largest annual convention, it finds itself in a vastly improved state from a year ago. Once again, to the surprise of many, biotech companies have proved to be more resilient than thought. Through a combination of cost-cutting, creative financing, and a willingness to accept deals on less favorable terms, many companies have managed to live to fight another day. We spoke to Glen Giovannetti, global biotechnology leader for Ernst & Young, about the company’s latest report on the industry, the growing divide between biotech’s haves and have nots, and what companies will need to do to raise money and be successful in the current environment.
As the biotechnology industry gathers in Chicago this week for its largest annual convention, it finds itself in a vastly improved state from a year ago. Once again, to the surprise of many, biotech companies have proved to be more resilient than thought. Through a combination of cost-cutting, creative financing, and a willingness to accept deals on less favorable terms, many companies have managed to live to fight another day. We spoke to Glen Giovannetti, global biotechnology leader for Ernst & Young, about the company’s latest report on the industry, the growing divide between biotech’s haves and have nots, and what companies will need to do to raise money and be successful in the current environment.The Burrill Report (April 26, 2010): Stemming a Crisis in Cancer Clinical Trials (.MP3,14.51 Mb)
The National Cancer Institute’s Clinical Trials Cooperative Group Program involves more than 3,100 institutions and 14,000 investigators who enroll more than 25,000 patients in clinical trials each year. But a new report from the Institute of Medicine finds the Cooperative Group Program is at a critical juncture as it has grown into a complex, cumbersome, and inefficient system. We spoke to John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center and chair of the Institute of Medicine committee that wrote the report. We discussed the crisis in cancer clinical trials, the challenges the Clinical Trials Cooperative Group faces, and what needs to be done to accelerate the translation of new discoveries into therapies that benefit patients with cancer.
The National Cancer Institute’s Clinical Trials Cooperative Group Program involves more than 3,100 institutions and 14,000 investigators who enroll more than 25,000 patients in clinical trials each year. But a new report from the Institute of Medicine finds the Cooperative Group Program is at a critical juncture as it has grown into a complex, cumbersome, and inefficient system. We spoke to John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center and chair of the Institute of Medicine committee that wrote the report. We discussed the crisis in cancer clinical trials, the challenges the Clinical Trials Cooperative Group faces, and what needs to be done to accelerate the translation of new discoveries into therapies that benefit patients with cancer. The Burrill Report (April 19, 2010): Healthcare Reform Delivers a Bonanza for Biotechs (.MP3,8.22 Mb)
During the debate over healthcare reform much of the biotechnology industry focused on what kind of damage, if any, the legislation would deliver. But tucked away in the massive bill was a little noticed provision that could provide a big boost to small companies. The Therapeutic Discovery Project Credit set aside $1 billion to provide a 50 percent tax credit to companies for qualified investments made in 2009 and 2010. We spoke to David Green, U.S. Life Sciences Tax leader for Deloitte, about the new credit, what it will mean to smaller biotechs, and what companies will need to do to claim their share.
During the debate over healthcare reform much of the biotechnology industry focused on what kind of damage, if any, the legislation would deliver. But tucked away in the massive bill was a little noticed provision that could provide a big boost to small companies. The Therapeutic Discovery Project Credit set aside $1 billion to provide a 50 percent tax credit to companies for qualified investments made in 2009 and 2010. We spoke to David Green, U.S. Life Sciences Tax leader for Deloitte, about the new credit, what it will mean to smaller biotechs, and what companies will need to do to claim their share.The Burrill Report (April 12, 2010): BIO Readies To Address Big Issues in the City of Big Shoulders (.MP3,9.53 Mb)
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When the biotechnology industry gathers in Chicago this year for the BIO International Convention, its largest annual meeting, the mood will be quite different from a year ago. Healthcare reform legislation has since passed, the economy continues to improve, and stability has returned to financial markets. We spoke to Jim Greenwood, president and CEO of the Biotechnology Industry Organization, about this year’s conference, how the industry is addressing some of the ongoing challenges it faces, and what will be on the top of the agenda for those in attendance.
When the biotechnology industry gathers in Chicago this year for the BIO International Convention, its largest annual meeting, the mood will be quite different from a year ago. Healthcare reform legislation has since passed, the economy continues to improve, and stability has returned to financial markets. We spoke to Jim Greenwood, president and CEO of the Biotechnology Industry Organization, about this year’s conference, how the industry is addressing some of the ongoing challenges it faces, and what will be on the top of the agenda for those in attendance. The Burrill Report: (April 5, 2010): Biotech Companies Weigh Implications of Judge's Gene Patents Ruling (.MP3,12.45 Mb)
On March 29, a federal judge invalidated seven Myriad Genetics and University of Utah Research Foundation patents relating to two genes linked to breast and ovarian cancer in a decision that surprised patent attorneys. If upheld on appeal, it could alter the landscape for thousands of other gene patents held by biotechnology and diagnostics companies. We spoke to Ken Chahine, a visiting professor of law at the University of Utah about the decision, what it means to the industry, and whether companies that rely on such patents will need to rethink their business models.
On March 29, a federal judge invalidated seven Myriad Genetics and University of Utah Research Foundation patents relating to two genes linked to breast and ovarian cancer in a decision that surprised patent attorneys. If upheld on appeal, it could alter the landscape for thousands of other gene patents held by biotechnology and diagnostics companies. We spoke to Ken Chahine, a visiting professor of law at the University of Utah about the decision, what it means to the industry, and whether companies that rely on such patents will need to rethink their business models.
The Burrill Report (March 29, 2010): Healthcare Reform Opens the Door to Copycat Biologics (.MP3,7.84 Mb)
When President Obama signed healthcare reform legislation it contained a provision that opens the doorway to biosimilars—copycat versions of biologics that are no longer protected by patents. The legislation was viewed as a big victory for the biotech industry because it provides for a 12-year period of protection from biosimilar competition for these expensive therapies, but big questions remain as to how the U.S. Food and Drug Administration will construct a pathway for biosimilar approvals. We spoke to Erika Lietzan, a partner with Covington & Burling in the lawfirm’s food and drug group and government affairs group. She discussed the significance of the legislation, the challenges ahead for the FDA, and what points of controversy remain to be resolved.
When President Obama signed healthcare reform legislation it contained a provision that opens the doorway to biosimilars—copycat versions of biologics that are no longer protected by patents. The legislation was viewed as a big victory for the biotech industry because it provides for a 12-year period of protection from biosimilar competition for these expensive therapies, but big questions remain as to how the U.S. Food and Drug Administration will construct a pathway for biosimilar approvals. We spoke to Erika Lietzan, a partner with Covington & Burling in the lawfirm’s food and drug group and government affairs group. She discussed the significance of the legislation, the challenges ahead for the FDA, and what points of controversy remain to be resolved.The Burrill Report (March 22, 2010): Appraising Progress in the War on Cancer (.MP3,10.21 Mb)
It’s been nearly 40 years since Richard Nixon signed the National Cancer Act and launched what has become known as “the war on cancer.” But since that time, despite massive investment in research, cancer has remained one of the leading causes of death in the United States. Susan Gapstur, an epidemiologist with the American Cancer Society, authored a commentary in the cancer-themed March 17 issue of JAMA. We talked to Gapstur about what progress has been made on the war on cancer, the tension between the high cost of new treatments and the benefits they provide, and whether or not we need a better metaphor than war for the ongoing efforts to prevent and halt the disease.
It’s been nearly 40 years since Richard Nixon signed the National Cancer Act and launched what has become known as “the war on cancer.” But since that time, despite massive investment in research, cancer has remained one of the leading causes of death in the United States. Susan Gapstur, an epidemiologist with the American Cancer Society, authored a commentary in the cancer-themed March 17 issue of JAMA. We talked to Gapstur about what progress has been made on the war on cancer, the tension between the high cost of new treatments and the benefits they provide, and whether or not we need a better metaphor than war for the ongoing efforts to prevent and halt the disease. The Burrill Report (March 15, 2010): Convergence of Technologies Transforms Healthcare (.MP3,7.49 Mb)
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The convergence of technologies such as mobile phones, wireless monitors, and the Internet, have begun to forever change healthcare. Coupled with the increasing ability to identify people who carry genes that put them at risk for certain conditions, we are witnessing the start of a consumer digital health revolution that promises to change the way doctor diagnose, treat, and interact with patients. We spoke to Eric Topol, chief medical officer of the West Wireless Health Institute, about how the convergence of technologies is empowering patients, attacking the high cost of chronic diseases by allowing doctors to intervene before problems become serious, and making the long-sought promise of personalized medicine a reality.
The convergence of technologies such as mobile phones, wireless monitors, and the Internet, have begun to forever change healthcare. Coupled with the increasing ability to identify people who carry genes that put them at risk for certain conditions, we are witnessing the start of a consumer digital health revolution that promises to change the way doctor diagnose, treat, and interact with patients. We spoke to Eric Topol, chief medical officer of the West Wireless Health Institute, about how the convergence of technologies is empowering patients, attacking the high cost of chronic diseases by allowing doctors to intervene before problems become serious, and making the long-sought promise of personalized medicine a reality.The Burrill Report (March 8, 2010): Consumer Group Sues Over Health Insurance Increases (.MP3,10.81 Mb)
Anthem Blue Cross, California’s biggest for profit health insurance company, has been on the hot seat lately. Its plan to raise premiums on policies for individuals by as much as 39 percent landed the CEO of its parent company, Wellpoint, in front of a Congressional committee and reignighted efforts in Washington to pass healthcare reform legislation. Now the advocacy group ConsumerWatchdog has filed a class-action lawsuit against Anthem over the rate increases saying they violate California law. We spoke to Jerry Flanagan, healthcare policy director for ConsumerWatchdog, about his group’s lawsuit, what Anthem’s actions mean for reform, and why the proposed healthcare legislation wouldn’t have prevented Anthem from instituting the rate increases in the first place.
Anthem Blue Cross, California’s biggest for profit health insurance company, has been on the hot seat lately. Its plan to raise premiums on policies for individuals by as much as 39 percent landed the CEO of its parent company, Wellpoint, in front of a Congressional committee and reignighted efforts in Washington to pass healthcare reform legislation. Now the advocacy group ConsumerWatchdog has filed a class-action lawsuit against Anthem over the rate increases saying they violate California law. We spoke to Jerry Flanagan, healthcare policy director for ConsumerWatchdog, about his group’s lawsuit, what Anthem’s actions mean for reform, and why the proposed healthcare legislation wouldn’t have prevented Anthem from instituting the rate increases in the first place. A Battle Brews for Control of Genzyme (.MP3,8.71 Mb)
In 2009, Genzyme stumbled as a viral contamination halted production at a key manufacturing plant, caused drug shortages for the company, and eventually financial disappointment to its investors. The missteps have left the smell of blood in the water and now activist investor Carl Ichan is seeking to win four board seats and wrest control of the company from its CEO Henri Termeer. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about Ichan’s efforts, what it means for Termeer and Genzyme, and how other biotechs that have fallen in the investor’s grasp have fared.
In 2009, Genzyme stumbled as a viral contamination halted production at a key manufacturing plant, caused drug shortages for the company, and eventually financial disappointment to its investors. The missteps have left the smell of blood in the water and now activist investor Carl Ichan is seeking to win four board seats and wrest control of the company from its CEO Henri Termeer. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about Ichan’s efforts, what it means for Termeer and Genzyme, and how other biotechs that have fallen in the investor’s grasp have fared.The Burrill Report: (February 22, 2010): Why Biotech Is Worried About The Fight Over Gene Patents (.MP3,10.38 Mb)
It would have seemed that the question over whether or not genes could be patented was settled long ago, but ongoing legal battles and a report earlier this month from an advisory committee to the U.S. Secretary of Health and Human Services threaten, in the words of one industry group, to “unravel” the foundation of life science innovation in this country. Opponents say gene patents impede critical research and make important new diagnostics unnecessarily expensive, but industry argues they fuel innovation and bring important breakthroughs to patients. We spoke to Ken Chahine, visiting professor of law at the University of Utah about the recent report, the ongoing legal battles, and what’s at stake for the biotech industry, as well as patients.
It would have seemed that the question over whether or not genes could be patented was settled long ago, but ongoing legal battles and a report earlier this month from an advisory committee to the U.S. Secretary of Health and Human Services threaten, in the words of one industry group, to “unravel” the foundation of life science innovation in this country. Opponents say gene patents impede critical research and make important new diagnostics unnecessarily expensive, but industry argues they fuel innovation and bring important breakthroughs to patients. We spoke to Ken Chahine, visiting professor of law at the University of Utah about the recent report, the ongoing legal battles, and what’s at stake for the biotech industry, as well as patients. The Burrill Report (February 15, 2010): Why Pharmaceutical Companies Need To Rethink Their Business Models (.MP3,10.43 Mb)
Pharmaceutical companies will need to rethink their strategies as the world in which they operate undergoes dramatic changes. Patients, armed with unprecedented access to information, are being transformed from passive participants to superconsumers of healthcare services. Drugmakers will need to rethink not only how they approach them, but how to forge partnerships with nontraditional healthcare players that are helping to usher in this new era from telecommunications carriers to information technology device makers. We spoke to Carolyn Buck Luce, global pharmaceutical sector leader for Ernst & Young, about these changes, how pharmaceutical companies will need to alter their business models, and whether or not drugmakers are ready for what lies ahead.
Pharmaceutical companies will need to rethink their strategies as the world in which they operate undergoes dramatic changes. Patients, armed with unprecedented access to information, are being transformed from passive participants to superconsumers of healthcare services. Drugmakers will need to rethink not only how they approach them, but how to forge partnerships with nontraditional healthcare players that are helping to usher in this new era from telecommunications carriers to information technology device makers. We spoke to Carolyn Buck Luce, global pharmaceutical sector leader for Ernst & Young, about these changes, how pharmaceutical companies will need to alter their business models, and whether or not drugmakers are ready for what lies ahead.The Burrill Report (February 8, 2010): Why GINA Can Be Problematic in the Workplace (.MP3,8.15 Mb)
A policy approved by The University of Akron last summer – before the Genetic Information Non-Discrimination Act took effect – required criminal background checks for nearly all prospective employees, including the possible collection of DNA samples. The policy was retracted following a public outcry, but it left uncertainty about how GINA applies to employers’ law enforcement efforts. Shawneequa Callier, a post doctoral fellow at the Center for Genetic Research, Ethics, and Law in the Bioethics Department at Case Western Reserve University co-authored an essay on the controversy in the latest Hastings Center Report. We spoke to Callier about the UA case, how it played out against the implementation of GINA and why enforcement of the new law can be problematic.
A policy approved by The University of Akron last summer – before the Genetic Information Non-Discrimination Act took effect – required criminal background checks for nearly all prospective employees, including the possible collection of DNA samples. The policy was retracted following a public outcry, but it left uncertainty about how GINA applies to employers’ law enforcement efforts. Shawneequa Callier, a post doctoral fellow at the Center for Genetic Research, Ethics, and Law in the Bioethics Department at Case Western Reserve University co-authored an essay on the controversy in the latest Hastings Center Report. We spoke to Callier about the UA case, how it played out against the implementation of GINA and why enforcement of the new law can be problematic. The Burrill Report (February 1, 2010): With Healthcare Reform Uncertain, BIO's Policy Fights Remain (.MP3,9.31 Mb)
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As President Barack Obama delivered his State of the Union Address, healthcare reform legislation, as one Senator described, was on life support. The Democrats, losing their supermajority in the Senate, say they are not ready to pull the plug on the bill, but as of now the path forward is unclear. We spoke to Jim Greenwood, president and CEO of the Biotechnology Industry Organization, about the uncertainty surrounding healthcare reform, what it means for such issues as follow-on biologics, and what the industry’s policy agenda looks like for 2010.
As President Barack Obama delivered his State of the Union Address, healthcare reform legislation, as one Senator described, was on life support. The Democrats, losing their supermajority in the Senate, say they are not ready to pull the plug on the bill, but as of now the path forward is unclear. We spoke to Jim Greenwood, president and CEO of the Biotechnology Industry Organization, about the uncertainty surrounding healthcare reform, what it means for such issues as follow-on biologics, and what the industry’s policy agenda looks like for 2010. The Burrill Report (January 25, 2010): Where Healthcare Reform Goes After Massachusetts (.MP3,11.33 Mb)
Not long ago it seemed healthcare reform legislation was sure to be signed, sealed and delivered in time for President Obama’s State of the Union address. But the dramatic upset in Massachusetts that has resulted in Republican Scott Brown winning the seat held by long-time healthcare reform advocate Ted Kennedy has thrown the Democrats plan on its head as Brown represents the 41st vote for the Republicans, which gives them the ability to shut down the legislation. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest about where the Democrats went wrong, what Brown’s election means for healthcare reform and where we go from here.
Not long ago it seemed healthcare reform legislation was sure to be signed, sealed and delivered in time for President Obama’s State of the Union address. But the dramatic upset in Massachusetts that has resulted in Republican Scott Brown winning the seat held by long-time healthcare reform advocate Ted Kennedy has thrown the Democrats plan on its head as Brown represents the 41st vote for the Republicans, which gives them the ability to shut down the legislation. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest about where the Democrats went wrong, what Brown’s election means for healthcare reform and where we go from here.The Burrill Report: (January 18. 2010): Biotechs Adjust to the New Normal (.MP3,16.34 Mb)
Chris Starr has lived through biotech windows, cycles, and bubbles. An industry veteran, today he is CEO and co-founder of Raptor Pharmaceuticals, which works on improving existing drugs through its targeting platform and formulation expertise. Like many executives, Starr has had to prioritize his pipeline and find ways to raise money during tough times. We talked to Starr about the changing environment for biotechs, how he’s adapted, and as times improve, whether or not there’s a new normal.
Chris Starr has lived through biotech windows, cycles, and bubbles. An industry veteran, today he is CEO and co-founder of Raptor Pharmaceuticals, which works on improving existing drugs through its targeting platform and formulation expertise. Like many executives, Starr has had to prioritize his pipeline and find ways to raise money during tough times. We talked to Starr about the changing environment for biotechs, how he’s adapted, and as times improve, whether or not there’s a new normal.The Burrill Report (January 11, 2010): New drug approvals improve in 2009 as more biologics get the green light (.MP3,11.84 Mb)
The U.S. Food and Drug Administration approved 26 new drugs in 2009, besting 2008 by a hair, according to Washington Analysis, which provides research to institutional investors. The number of new approvals for small molecule drugs actually fell slightly, while the number of new biologics approved grew. We spoke to Ira Loss, senior health policy analyst with Washington Analysis, about the numbers, whether they reflect a push by Big Pharma into biologics, and whether the FDA under a new administration is faring any better.
The Burrill Report: (January 4, 2010): Will the Biotech Industry See Its Own Shadow at JPMorgan? (.MP3,9.42 Mb)
The biotechnology industry is gearing up for the annual JPMorgan Healthcare conference, the key annual meeting that kicks off the New Year for the industry. Last year the dismal economy cast a long shadow at the normally upbeat conference, but much has changed since then. We spoke to the Adam Feuerstein, Senior Columnist TheStreet.com about how far the industry has come during the past year, what he’ll be looking for at this year’s conference and whether or not biotech executives will be in a celebratory mood once again.
The Burrill Report (December 28, 2009): Life Science Companies Brace For Big Changes (.MP3,12.25 Mb)
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As the new year begins, pharmaceutical and biotechnology companies are preparing for big changes. Healthcare reform, constrained capital markets, and a shifting regulatory environment all spell new challenges for the industry. We continue with the second part of our year-end conversation with G. Steven Burrill, CEO of Burrill & Company and the publisher of The Burrill Report, with a look ahead to 2010 and beyond, what companies are doing to adapt to the changing environment, and whether or not the worst is over.
The Burrill Report (December 18, 2009): Making Sense of a Tumultuous Year (.MP3,12.06 Mb)
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As 2009 began, a legislative battle around healthcare reform and a troubled economic environment stood ready to set the stage for the year. But a series of jaw-dropping acquisitions, robust partnering activity and a pick up in venture capital made the year a big one on the financing front. In the first part of a two-part interview G. Steven Burrill, CEO of Burrill & Company and the publisher of The Burrill Report, discusses the events of 2009, how the pharmaceutical and biotechnology industry adapted to a changing environment, and the meaning behind the numbers.
As 2009 began, a legislative battle around healthcare reform and a troubled economic environment stood ready to set the stage for the year. But a series of jaw-dropping acquisitions, robust partnering activity and a pick up in venture capital made the year a big one on the financing front. In the first part of a two-part interview G. Steven Burrill, CEO of Burrill & Company and the publisher of The Burrill Report, discusses the events of 2009, how the pharmaceutical and biotechnology industry adapted to a changing environment, and the meaning behind the numbers. The Burrill Report (December 10, 2009): Life Science Execs Enjoy Rising Pay Despite Economic Downturn (.MP3,9.72 Mb)
For the first time in 10 years, top executives at technology companies saw their 2009 total cash compensation target drop slightly, but comparable executives at life sciences firms experienced an average increase of 3.5 percent in total cash compensation year over year, according to a study of private businesses from the executive search firm J. Robert Scott and Ernst & Young. Among the more than 200 emerging, private life sciences firms surveyed, CEOs attained an average base salary of $273,000, up 3.2 percent from 2008. CEOs at these life sciences firms, however, received average bonuses of $48,000 in 2008 or 44 percent of their target bonus, down from 73 percent in 2007. We spoke to Erik Lundh, managing director with the executive search firm J. Robert Scott, about the findings in the report, why life science executives were better insulated from the economic downturn than their high-tech counterparts and what pressures companies may feel to retain talent as the economy turns.
For the first time in 10 years, top executives at technology companies saw their 2009 total cash compensation target drop slightly, but comparable executives at life sciences firms experienced an average increase of 3.5 percent in total cash compensation year over year, according to a study of private businesses from the executive search firm J. Robert Scott and Ernst & Young. Among the more than 200 emerging, private life sciences firms surveyed, CEOs attained an average base salary of $273,000, up 3.2 percent from 2008. CEOs at these life sciences firms, however, received average bonuses of $48,000 in 2008 or 44 percent of their target bonus, down from 73 percent in 2007. We spoke to Erik Lundh, managing director with the executive search firm J. Robert Scott, about the findings in the report, why life science executives were better insulated from the economic downturn than their high-tech counterparts and what pressures companies may feel to retain talent as the economy turns.The Burrill Report (December 4, 2009): Life Science Companies Face A Taxing Problem (.MP3,10.81 Mb)
The global financial crisis and healthcare reform efforts around the world will likely drive up the effective tax rate for the pharmaceutical and life sciences companies, according to a new report from PricewaterhouseCoopers. At the same time countries looking to attract research and development and manufacturing to bolster their economies are offering tax incentives to lure pharmaceutical companies. We spoke to Michael Swanick, partner and global pharmaceutical and life sciences tax leader for PricewaterhouseCoopers about the changing tax environment for pharmaceutical companies, potential areas of new tax obligations, and the growing complexity of managing these issues.
The global financial crisis and healthcare reform efforts around the world will likely drive up the effective tax rate for the pharmaceutical and life sciences companies, according to a new report from PricewaterhouseCoopers. At the same time countries looking to attract research and development and manufacturing to bolster their economies are offering tax incentives to lure pharmaceutical companies. We spoke to Michael Swanick, partner and global pharmaceutical and life sciences tax leader for PricewaterhouseCoopers about the changing tax environment for pharmaceutical companies, potential areas of new tax obligations, and the growing complexity of managing these issues.The Burrill Report (November 27, 2009): A Reserach Institute Seeks to Ignite Interest in Personalized Medicine (.MP3,10.38 Mb)
Earlier this month the Commonwealth of Virginia announced it would provide financial support to help establish a home for the newly created Ignite Institute, a unique non-profit focused on translating innovations in personalized medicine into patient care. At the same time, the Institute announced it had formed a major founding partnership with Virginia
Earlier this month the Commonwealth of Virginia announced it would provide financial support to help establish a home for the newly created Ignite Institute, a unique non-profit focused on translating innovations in personalized medicine into patient care. At the same time, the Institute announced it had formed a major founding partnership with
The Burrill Report (November 20, 2009): The FDA Grapples with Rules for Social Media (.MP3,9.59 Mb)
Earlier this month pharmaceutical companies joined with Internet companies for a hearing on social media held by the U.S Food and Drug Administration. At issue in the two day hearings was what if any regulations need to be put into place to control how drug and device makers promote their products online in forums ranging from blogs to Twitter. The lack of regulatory clarity has left many pharmaceutical companies cautious about wading into this brave new world. The hearings followed warning letters sent by the agency to 14 companies in April about their marketing of drugs online because they failed to include risk information. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest and a partner and director of global healthcare at Porter Novelli about why pharma companies want to engage with customers through social media, the regulatory issues surrounding its use, and why the questions raised by the industry’s use of social media will not be solved by simple answers.
Earlier this month pharmaceutical companies joined with Internet companies for a hearing on social media held by the U.S Food and Drug Administration. At issue in the two day hearings was what if any regulations need to be put into place to control how drug and device makers promote their products online in forums ranging from blogs to Twitter. The lack of regulatory clarity has left many pharmaceutical companies cautious about wading into this brave new world. The hearings followed warning letters sent by the agency to 14 companies in April about their marketing of drugs online because they failed to include risk information. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest and a partner and director of global healthcare at Porter Novelli about why pharma companies want to engage with customers through social media, the regulatory issues surrounding its use, and why the questions raised by the industry’s use of social media will not be solved by simple answers.The Burrill Report (November 13, 2009): Diagnostics Makers Sweat Out a Supreme Court Ruling (.MP3,11.61 Mb)
The diagnostics industry is carefully watching the Supreme Court as it recently concluded oral arguments in Bilski v. Kappos, which raises a fundamental question about what can and can’t be patented. Though the case centers on whether a method for hedging risk in commodities trading is patentable, a ruling in the case could up end the diagnostics industry by rendering the algorithms underlying molecular diagnostics unpatentable. We spoke to Ken Chahine, a professor of law at the University of Utah about the Bilski case, his readings on the oral arguments, and why its outcome is crucial to diagnostics makers.
The diagnostics industry is carefully watching the Supreme Court as it recently concluded oral arguments in Bilski v. Kappos, which raises a fundamental question about what can and can’t be patented. Though the case centers on whether a method for hedging risk in commodities trading is patentable, a ruling in the case could up end the diagnostics industry by rendering the algorithms underlying molecular diagnostics unpatentable. We spoke to Ken Chahine, a professor of law at the University of Utah about the Bilski case, his readings on the oral arguments, and why its outcome is crucial to diagnostics makers. The Burrill Report (November 6, 2009): A Sequencing Revolution Ushers in a New Era (.MP3,9.38 Mb)
Complete Genomics is helping to usher in a new era of biomedical research with breakthrough technology for low-cost genome sequencing that promises to help researchers unlock the genetic mysteries underlying diseases. The Mountain View, California-based company recently announced that the Institute for Systems Biology will work with it to sequence 100 genomes in a study of Huntington’s disease, an effort that will represent the largest human genome disease association study to date. We spoke to Cliff Reid, CEO of Complete Genomics about the project, how low-cost sequencing technology promises to revolutionize biomedical research, and his company’s ambitious vision.
Complete Genomics is helping to usher in a new era of biomedical research with breakthrough technology for low-cost genome sequencing that promises to help researchers unlock the genetic mysteries underlying diseases. The Mountain View, California-based company recently announced that the Institute for Systems Biology will work with it to sequence 100 genomes in a study of Huntington’s disease, an effort that will represent the largest human genome disease association study to date. We spoke to Cliff Reid, CEO of Complete Genomics about the project, how low-cost sequencing technology promises to revolutionize biomedical research, and his company’s ambitious vision. The Burrill Report (October 30, 2009): Biotechs Expand Their Financial Arsenal (.MP3,13.23 Mb)
Though money is flowing more freely into the biotech sector these days, one consequence of the financial turmoil of recent years has been that it’s forced companies to think more broadly about their funding sources. At the same time, a greater emphasis on translational research and increased funding to the National Institutes of Health is creating greater opportunities for companies. We spoke to Ram May-Ron, vice president of the Boston-based FreeMind Group, which specializes in helping companies raise money from government agencies through grants and contracts, about the opportunities for life sciences companies to get government funding today, how such grants fit into a broader funding strategy and why he’s been disappointed in the stimulus package so far.
Though money is flowing more freely into the biotech sector these days, one consequence of the financial turmoil of recent years has been that it’s forced companies to think more broadly about their funding sources. At the same time, a greater emphasis on translational research and increased funding to the National Institutes of Health is creating greater opportunities for companies. We spoke to Ram May-Ron, vice president of the Boston-based FreeMind Group, which specializes in helping companies raise money from government agencies through grants and contracts, about the opportunities for life sciences companies to get government funding today, how such grants fit into a broader funding strategy and why he’s been disappointed in the stimulus package so far.The Burrill Report (October 23, 2009): Biotech Investor Gather with Eye Toward Better Times (.MP3,9.2 Mb)
When the annual BIO Investor Forum was held a year ago, the financial world was reeling. It was a grim time for the biotech sector as share prices fell, the environment for raising money was bad as its ever been and companies cut employees and programs in an effort to forge strategies for survival. What a difference a year makes. As the industry returns to San Francisco for the forum this year, which runs October 28 and 29 at the Palace Hotel, stocks have lifted, money is flowing again into the sector and clinical successes are fueling optimism. We spoke to Jim Greenwood, president and CEO of the Biotechnology Industry Organization, about this year’s forum, how far we’ve come in the past year, and what case there is to be made for investing in the sector today.
When the annual BIO Investor Forum was held a year ago, the financial world was reeling. It was a grim time for the biotech sector as share prices fell, the environment for raising money was bad as its ever been and companies cut employees and programs in an effort to forge strategies for survival. What a difference a year makes. As the industry returns to San Francisco for the forum this year, which runs October 28 and 29 at the Palace Hotel, stocks have lifted, money is flowing again into the sector and clinical successes are fueling optimism. We spoke to Jim Greenwood, president and CEO of the Biotechnology Industry Organization, about this year’s forum, how far we’ve come in the past year, and what case there is to be made for investing in the sector today.The Burrill Report (October 16, 2009): Why Not Everyone Is Cheering For an Open IPO Window (.MP3,9.7 Mb)
A recent spate of public offerings is heating up optimism that the IPO window may be once again opening for biotechs. Indeed, money has been flowing into the sector and there have been a number of financings that have raised hope that it is possible for biotechs to once again go public. But not everyone thinks an IPO window for biotechs is such a good thing. And with cash rich pharmaceutical companies still in need of rebuilding their pipelines, they, rather than IPO investor, may be positioned to capture the best and the brightest of what could be the IPO class of 2010. We spoke to John McCamant, editor of the Medical Technology Stock Letter about the state of the IPO market for biotechs, what it will take for companies in the sector to go public, and lessons learned from past IPO windows.
A recent spate of public offerings is heating up optimism that the IPO window may be once again opening for biotechs. Indeed, money has been flowing into the sector and there have been a number of financings that have raised hope that it is possible for biotechs to once again go public. But not everyone thinks an IPO window for biotechs is such a good thing. And with cash rich pharmaceutical companies still in need of rebuilding their pipelines, they, rather than IPO investor, may be positioned to capture the best and the brightest of what could be the IPO class of 2010. We spoke to John McCamant, editor of the Medical Technology Stock Letter about the state of the IPO market for biotechs, what it will take for companies in the sector to go public, and lessons learned from past IPO windows. The Burrill Report: (October 9, 2009): Biotech's Reinvestment and Recovery Act (.MP3,8.89 Mb)
Lately there have been some encouraging signs of life on the biotech landscape. Stock prices are up, clinical trials results have been encouraging, and even Theravance won its long-awaited approval for its antibiotic after a three-year odyssey with regulators. Though the sector’s performance has lagged the major indices this year, public markets are showing greater receptivity and money is flowing into biotechs once again. We spoke to Peter Winter, editor of The Burrill Report, about where the industry is today, what’s been driving improvements in the sector and what to expect in the fourth quarter and beyond.
Lately there have been some encouraging signs of life on the biotech landscape. Stock prices are up, clinical trials results have been encouraging, and even Theravance won its long-awaited approval for its antibiotic after a three-year odyssey with regulators. Though the sector’s performance has lagged the major indices this year, public markets are showing greater receptivity and money is flowing into biotechs once again. We spoke to Peter Winter, editor of The Burrill Report, about where the industry is today, what’s been driving improvements in the sector and what to expect in the fourth quarter and beyond. The Burrill Report (October 2, 2009): The Search for New Financing Models for Biotech (.MP3,13.24 Mb)
In a recent commentary in Nature Biotechnology, Bruce Booth, partner with Atlas Ventures, argues that the days of the IPO market offering biotech companies cheap capital, and liquidity for its investors, are over. While many people are now focused on whether the IPO window is returning for biotechs, Booth argues that early-stage investors need to develop new models that don’t rely on IPOs as an exit. We spoke to Booth about lessons from the last IPO window, why it dampened rather than fostered innovation, and why he sees structured buyouts as the answer.
The Burrill Report (September 25, 2009): Getting Extra Mileage Out of the Biodefense Budget (.MP3,6.48 Mb)
Since 2001, the United States government has spent substantial resources on preparing the nation against a bioterrorist attack. The Obama administration’s proposed biodefense budget for fiscal 2010, the first since the attacks of Septmeber 11, 2001 from an administration other than the Bush administration, continues to grow the budget after a period of flattening. The bulk of the funding, though, is directed into areas that have multiple goals that extend beyond biodefense to include such things as vaccine development and public health planning. Crystal Franco, senior analyst at the Center for Biosecurity at the Univeristy of Pittsburgh Medical Center in Baltimore analyzes the budget in an article “Billions for Biodefense,” which appears in the latest issue of Biosecurity and Bioterrorism. We spoke to Franco about the allocation of the funding, the focus on multiple goals, and whether or not we’re getting any bang for our buck.
The Burrill Report (September 18, 2009): Lack of Health Insurance Claims 45,000 Lives Annually (.MP3,7.24 Mb)
A study published in the online edition of the American Journal of Public Health estimates that nearly 45,000 deaths annually are associated with a lack of health insurance. That figure is about two and a half times higher than an estimate from the Institute of Medicine in 2002 based on data from 1993. The researchers found that uninsured, working-age Americans have a 40 percent higher risk of death than their privately insured counterparts, up from a 25 percent excess death rate found in 1993. We spoke to Steffie Woolhandler, study co-author and professor of medicine at Harvard University about the findings, why the problem has grown more acute in recent years and what the reserach adds to the ongoing debate over healthcare reform.
The Burrill Report (September 11, 2009): Biotech Industry Readies for Healthcare Reform, Advances Legislative Agenda (.MP3,11.54 Mb)
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Congress is back from its summer recess and President Obama, with his address to a joint session of the House and Senate, is trying to push healthcare reform legislation across the finish line. We spoke to Jim Greenwood, president and CEO of the Biotechnology Industry Organization about healthcare reform, other items on the industry’s legislative agenda, and whether new NIH director Francis Collin’s idea to boost his agency’s funding by collecting royalties from the industry, has any chance of flying.
Congress is back from its summer recess and President Obama, with his address to a joint session of the House and Senate, is trying to push healthcare reform legislation across the finish line. We spoke to Jim Greenwood, president and CEO of the Biotechnology Industry Organization about healthcare reform, other items on the industry’s legislative agenda, and whether new NIH director Francis Collin’s idea to boost his agency’s funding by collecting royalties from the industry, has any chance of flying.The Burrill Report (September 4, 2009): New York Fights Back Against Fat (.MP3,7.91 Mb)
The New York City Department of Health is pulling no punches on its fight against obesity with a new ad campaign aimed at getting New Yorkers to cut calories by cutting back on sugar-laden beverages. The campaign, which will run in subways, features a beverage being poured, but the liquid transform into a visually-disturbing stream of human fat that fills and spill over a waiting glass. The ad asks, “Are you pouring on the pounds?” We spoke to Cathy Nonas, director of the New York City Health Department’s Physical Activity and Nutrition Programs, about the ad campaign, what’s driving it, and what cities need to be doing to combat obesity as the nation seeks to bring healthcare costs under control.
The New York City Department of Health is pulling no punches on its fight against obesity with a new ad campaign aimed at getting New Yorkers to cut calories by cutting back on sugar-laden beverages. The campaign, which will run in subways, features a beverage being poured, but the liquid transform into a visually-disturbing stream of human fat that fills and spill over a waiting glass. The ad asks, “Are you pouring on the pounds?” We spoke to Cathy Nonas, director of the New York City Health Department’s Physical Activity and Nutrition Programs, about the ad campaign, what’s driving it, and what cities need to be doing to combat obesity as the nation seeks to bring healthcare costs under control.The Burrill Report (August 28, 2009): Challenge Grows For Helathcare Reform After Kennedy's Death (.MP3,10.21 Mb)
The death of Senator Edward Kennedy comes at a critical time for healthcare reform, an issue he helped put center stage in the Obama administration’s agenda. Kennedy, who called healthcare reform “the cause of my life,” was viewed as someone skilled at reaching across the aisle. He also represented a critical vote on the legislation that will likely need 60 votes to pass in the Senate. We spoke to David Wasserman, house editor for The Cook Political Report, about what Kennedy’s death means to healthcare reform efforts, whether Democrats will be able to rally around his memory, and what it will take to pass the legislation.
The Burrill Report (August 21, 2009): Investors Say They're Bullish on Biotech (.MP3,10.63 Mb)
Investors in biotechnology are overwhelmingly bullish on the sector, according to a newly released investor sentiment survey from the Biotechnology Industry Organization and Thomson Reuters. The study, which can be accessed through the link below, is based on the response of participants representing firms with $2.3 trillion in assets under management, including $266 billion in healthcare and $76 billion in biotech. We spoke to John Craighead, managing director of investor relations and business development at BIO about the study, what investors are looking for as catalysts for biotech stocks, and what keeps them up at night. The report can be accessed by clicking here.
Investors in biotechnology are overwhelmingly bullish on the sector, according to a newly released investor sentiment survey from the Biotechnology Industry Organization and Thomson Reuters. The study, which can be accessed through the link below, is based on the response of participants representing firms with $2.3 trillion in assets under management, including $266 billion in healthcare and $76 billion in biotech. We spoke to John Craighead, managing director of investor relations and business development at BIO about the study, what investors are looking for as catalysts for biotech stocks, and what keeps them up at night. The report can be accessed by clicking here. The Burrill Report (August 14, 2009): Diagnostic Dealmaking Heats Up (.MP3,7.29 Mb)
The emergence of a new generation of molecular diagnostics that is helping to usher in an era of personalized medicine is fueling dealmaking within the sector. Pharmaceutical companies are searching for biomarkers that can improve the efficiency of their drug development, they are seeking out companion diagnostics that can stratify patients for their new therapeutics, and regulators are increasingly requiring biomarker testing to guide prescribing of a growing list of drugs. A new report from PricewaterhouseCoopers entitled Diagnostics 2009: Moving Towards Personalized Medicine, examines the forces that are driving these trends. We spoke to Gerry McDougall, a principal in PricewaterhouseCoopers’ Healthcare Advisory Services, about the growing deal activity in the diagnostic sector, why pharmaceutical companies have an increasing appetite for these companies and what’s ahead in 2010.
The emergence of a new generation of molecular diagnostics that is helping to usher in an era of personalized medicine is fueling dealmaking within the sector. Pharmaceutical companies are searching for biomarkers that can improve the efficiency of their drug development, they are seeking out companion diagnostics that can stratify patients for their new therapeutics, and regulators are increasingly requiring biomarker testing to guide prescribing of a growing list of drugs. A new report from PricewaterhouseCoopers entitled Diagnostics 2009: Moving Towards Personalized Medicine, examines the forces that are driving these trends. We spoke to Gerry McDougall, a principal in PricewaterhouseCoopers’ Healthcare Advisory Services, about the growing deal activity in the diagnostic sector, why pharmaceutical companies have an increasing appetite for these companies and what’s ahead in 2010.The Burrill Report (August 7, 2009): Examining the True Cost of Medical Innovation (.MP3,11.41 Mb)
A new generation of cancer drugs is providing greater results for patients, but they carry a heavy price tag. The average cost of providing a colorectal cancer patient with a 24-week chemotherapy regimen increased to $36,300 in 2005, up from just $127 in 1993. But researchers at Cornell University argue that the true cost of cancer drugs – once longevity and quality of life are considered – is actually as much as 30 percent less than a decade ago. We spoke to study author Sean Nicholson, associate professor in the Department of Policy Analysis and Management at Cornell University and a Faculty Research Fellow at the National Bureau of Economic Research, about the study, how he and his colleague arrived at those numbers and how policymakers, payors and patients should measure the value of innovative medical technologies that may be more expensive than their predecessors, but provide important new benefits.
The Burrill Report (August 3, 2009): Why Some Big Tobacco Welcome FDA Regulation (.MP3,14.51 Mb)
New legislation granting the U.S. Food and Drug Administration jurisdiction over tobacco products represents a serious compromise on the part of tobacco control advocates, according to an essay in the open access journal Public Library of Science— Medicine. Stanton Glantz, professor of medicine at the University of California, San Francisco and director of the Center for Tobacco Control Research and Education and his colleagues say that the new policy is another example of legislative compromise with the tobacco industry that can lead to short-term public health gains at the expense of long-term progress. We spoke to Glantz about his concerns over the legislation, why it may be an obstacle to meaningful regulation of the industry, and why some in big tobacco welcome FDA regulation.
The Burrill Report: (July 24, 2009): New Approaches to Treatment Needed in Pediatric Cancer (.MP3,9.78 Mb)
In this third in a series of podcasts focused on rare disease patient advocates jointly produced by The Burrill Report, the California Healthcare Institute, and the Children’s Rare Disease Network, we speak to Susan Cornelius, business advisor to The Nicholas Conor Institute for Pediatric Cancer Research. When her granddaughter struggled against cancer, she was frustrated that new technology was unavailable to her and that all doctors could offer were surgery, radiation or chemotherapy – what she characterized as cut, burn, or poison the child for a disease, in her granddaughters case, that was genetically-based. Cornelius lost her granddaughter to cancer in 2008, but now works to bring about changes to the way research is conducted.
In this third in a series of podcasts focused on rare disease patient advocates jointly produced by The Burrill Report, the California Healthcare Institute, and the Children’s Rare Disease Network, we speak to Susan Cornelius, business advisor to The Nicholas Conor Institute for Pediatric Cancer Research. When her granddaughter struggled against cancer, she was frustrated that new technology was unavailable to her and that all doctors could offer were surgery, radiation or chemotherapy – what she characterized as cut, burn, or poison the child for a disease, in her granddaughters case, that was genetically-based. Cornelius lost her granddaughter to cancer in 2008, but now works to bring about changes to the way research is conducted.The Burrill Report (July 17, 2009): A New Model for Funding Reserach (.MP3,9.25 Mb)
In this second in a series of podcasts focused on rare disease patient advocates jointly produced by The Burrill Report, the California Healthcare Institute, and the Children’s Rare Disease Network, we speak to Beth Anne Baber, CEO of The Nicholas Conor Institute for Pediatric Cancer Research. When Baber’s son Nicholas was diagnosed with stage 3 neuroblastoma she and her husband, both cancer researchers, fully understood the seriousness of the diagnosis. Because of the location of the tumor, radiation and surgery were not options. But as they explored treatments they discovered a startling fact. Most cancer therapies used to treat children were about 25 years old and drug companies weren’t generally pursuing new therapies for children with various cancers because the markets simply weren’t large enough. Her institute offers a new model. It seeks out industry partners to help develop specific technologies it wants to bring into the clinic while helping to fund that work.
In this second in a series of podcasts focused on rare disease patient advocates jointly produced by The Burrill Report, the California Healthcare Institute, and the Children’s Rare Disease Network, we speak to Beth Anne Baber, CEO of The Nicholas Conor Institute for Pediatric Cancer Research. When Baber’s son Nicholas was diagnosed with stage 3 neuroblastoma she and her husband, both cancer researchers, fully understood the seriousness of the diagnosis. Because of the location of the tumor, radiation and surgery were not options. But as they explored treatments they discovered a startling fact. Most cancer therapies used to treat children were about 25 years old and drug companies weren’t generally pursuing new therapies for children with various cancers because the markets simply weren’t large enough. Her institute offers a new model. It seeks out industry partners to help develop specific technologies it wants to bring into the clinic while helping to fund that work.The Burrill Report (July 10, 2009): Searching for a Cure (.MP3,8.29 Mb)
In this first in a series of podcasts focused on rare disease patient advocates jointly produced by The Burrill Report, the California Healthcare Institute, and the Children’s Rare Disease Network, we speak to Debra Miller, president and founder of Cure Duchenne. When Miller’s five-year-old son was diagnosed with Duchenne Muscular Dystrophy, she faced grim news. The progressive muscle loss caused by the disease typically leaves these children wheelchair-bound by age 10 and robs them of their lives by 20. As she and her husband explored treatment options and ways they could become to raise money for research, they found that existing organizations were often focused on palliative care and focused on academic research rather than working with industry. Miller and her husband launched Cure Duchenne to help fund promising research at biotech companies in the hopes of seeing these therapies developed and commercialized. We spoke to Miller about her son’s story, new approaches to treating Duchenne, and the problems of funding cutting-edge research
In this first in a series of podcasts focused on rare disease patient advocates jointly produced by The Burrill Report, the California Healthcare Institute, and the Children’s Rare Disease Network, we speak to Debra Miller, president and founder of Cure Duchenne. When Miller’s five-year-old son was diagnosed with Duchenne Muscular Dystrophy, she faced grim news. The progressive muscle loss caused by the disease typically leaves these children wheelchair-bound by age 10 and robs them of their lives by 20. As she and her husband explored treatment options and ways they could become to raise money for research, they found that existing organizations were often focused on palliative care and focused on academic research rather than working with industry. Miller and her husband launched Cure Duchenne to help fund promising research at biotech companies in the hopes of seeing these therapies developed and commercialized. We spoke to Miller about her son’s story, new approaches to treating Duchenne, and the problems of funding cutting-edge research The Burrill Report (July 3, 2009): Strong Markets Buoy Biotech in the Second Quarter (.MP3,7.45 Mb)
The second quarter saw the markets come roaring back as the Dow Jones Industrial Average rose 12 percent and the Nasdaq Composite Index soared 20 percent. The biotech sector didn’t fare as well, but managed to end the quarter in positive territory as the Burrill Biotech Select Index gained 3 percent. Nevertheless, some biotech stocks, such as Dendreon, showed they could be explosive, while others just seemed to blow up. We spoke to Peter Winter, editor-in-chief of The Burrill Report about the sector’s performance in the second quarter, the financing and dealmaking activity, and what to expect in the second half of 2009.
The Burrill Report (June 26, 2009): Why We Must Address The Primary Care Crisis for Healthcare Reform to Succeed (.MP3,11.65 Mb)
Thomas Bodenheimer thinks it will not be possible to have successful healthcare reform without addressing the crisis in primary care. Bodenheimer, a professor at the Center for Excellence in Primary Care in the Department of Family and Community Medicine at the University of California, San Francisco recently co-authored a perspective for the New England Journal of Medicine in which he agrues that a comprehensive federal initiative is needed to revitalize primary care in the United States. He calls for a three-point plan to reform primary care payment, invest in infrastructure and organization, and improve the work life of these physicians. We spoke to Bodenheimer about why young physicians are not pursuing careers in primary care medicine, why fixing this problem is critical to fixing healthcare, and whether or not the problem is recognized by lawmakers hammering out healthcare reform legislation.
Thomas Bodenheimer thinks it will not be possible to have successful healthcare reform without addressing the crisis in primary care. Bodenheimer, a professor at the Center for Excellence in Primary Care in the Department of Family and Community Medicine at the University of California, San Francisco recently co-authored a perspective for the New England Journal of Medicine in which he agrues that a comprehensive federal initiative is needed to revitalize primary care in the United States. He calls for a three-point plan to reform primary care payment, invest in infrastructure and organization, and improve the work life of these physicians. We spoke to Bodenheimer about why young physicians are not pursuing careers in primary care medicine, why fixing this problem is critical to fixing healthcare, and whether or not the problem is recognized by lawmakers hammering out healthcare reform legislation.
The Burrill Report (June 19, 2009): How to Fuel the BioEconomy (.MP3,9.65 Mb)
For four decades, an informal network of public-private partnerships has collaborated to support the advancement of the life sciences. The result has been jobs, wealth creation, improved healthcare, and prospects for new sources of energy. But those partnerships are cracking under pressure from a range of forces including constrained public budgets, the turmoil in capital markets, and the prospects of healthcare reform. Corey Goodman, former president of Pfizer's Biotherapeutics and Bioinnovation Center and an adjunct professor at the University of California, San Francisco, will be featured as a panelist at The first BioEconomy Summit, which will be held June 25 in Silicon Valley. We spoke to Goodman about the pressures on the bioeconomy, what needs to be done to make sure it continues to grow, and why policymakers should care about its future health.
For four decades, an informal network of public-private partnerships has collaborated to support the advancement of the life sciences. The result has been jobs, wealth creation, improved healthcare, and prospects for new sources of energy. But those partnerships are cracking under pressure from a range of forces including constrained public budgets, the turmoil in capital markets, and the prospects of healthcare reform. Corey Goodman, former president of Pfizer's Biotherapeutics and Bioinnovation Center and an adjunct professor at the University of California, San Francisco, will be featured as a panelist at The first BioEconomy Summit, which will be held June 25 in Silicon Valley. We spoke to Goodman about the pressures on the bioeconomy, what needs to be done to make sure it continues to grow, and why policymakers should care about its future health. More information on The BioEconomy Summit can be found on the event’s website.
The Burrill Report (June 12, 2009): Making a Case for Personalized Medicine (.MP3,8.21 Mb)
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Since the mapping of the human genome in 2003, the pace of new discoveries about the genetic underpinning of diseases and the ability to use this information to better segment patients for targeted therapies has advanced at a dizzying pace. The emergence of personalized medicine as a powerful force reshaping healthcare is starting to change everything from the way drug companies develop therapies to the way doctors treat patients. But barriers remain from realizing the benefits of this new approach. We spoke to Ed Abrahams, executive director of the Personalized Medicine Coalition about “The Case for Personalized Medicine,” a new report from the organization. Burrill & Company, publisher of The Burrill Report, is a member of the Personalized Medicine Coalition. We talked to Abrahams about the promise of personalized medicine, hurdles that need to be overcome, and the critical role it could play in healthcare reform.
Since the mapping of the human genome in 2003, the pace of new discoveries about the genetic underpinning of diseases and the ability to use this information to better segment patients for targeted therapies has advanced at a dizzying pace. The emergence of personalized medicine as a powerful force reshaping healthcare is starting to change everything from the way drug companies develop therapies to the way doctors treat patients. But barriers remain from realizing the benefits of this new approach. We spoke to Ed Abrahams, executive director of the Personalized Medicine Coalition about “The Case for Personalized Medicine,” a new report from the organization. Burrill & Company, publisher of The Burrill Report, is a member of the Personalized Medicine Coalition. We talked to Abrahams about the promise of personalized medicine, hurdles that need to be overcome, and the critical role it could play in healthcare reform.The Burrill Report (June 5, 2009): What You Know About Funding Start-Ups Is Wrong (.MP3,7.42 Mb)
A new study that examines undercapitalized technology companies is turning the conventional wisdom about start-ups on its head, showing that ventures with moderate levels of undercapitalization can still be successful and that a great management team is not more important than having a top-notch technology when it comes to securing sufficient amounts of capital. We spoke to study co-author David Townsend, an assistant professor of management, innovation and entrepreneurship at North Carolina State University, about his findings, the importance of great management versus great technology, and what undercapitalized companies can do to not only survive, but succeed today.
The Burrill Report (May 29, 2009): Why Biotech's Business Models May No Longer Be Sustainable (.MP3,11.47 Mb)
In its annual report on the biotechnology industry, Ernst & Young warns that the global financial crisis threatens to render the business models that have driven the sector to date unsustainable. The funding drought is placing these business models that fueled biotechnologies growth since its inception under unprecedented strain, the reports says. But emerging trends will likely open the way for new and more sustainable ways of funding drug development, according to E&Y. We spoke to Glen Giovannetti, Ernst & Young’s Global Biotechnology Leader, about the pressures on the industry today, why existing business models may not work going forward and what new business models the changing landscape point to for the future.
In its annual report on the biotechnology industry, Ernst & Young warns that the global financial crisis threatens to render the business models that have driven the sector to date unsustainable. The funding drought is placing these business models that fueled biotechnologies growth since its inception under unprecedented strain, the reports says. But emerging trends will likely open the way for new and more sustainable ways of funding drug development, according to E&Y. We spoke to Glen Giovannetti, Ernst & Young’s Global Biotechnology Leader, about the pressures on the industry today, why existing business models may not work going forward and what new business models the changing landscape point to for the future. The Burrill Report (May 22, 2009): Comparing the Effectiveness of the Comparers (.MP3,16.13 Mb)
For some, comparative effectiveness is the cure for a healthcare system ailing from runaway costs. For others, it is a bureaucrat’s dream that provides a tool to reign in spending by limiting access to expensive new drugs. This week at the 2009 BIO International Convention, the Deloitte Center for Health Solutions released a new report that did something that appeared quite natural. It compared comparative effectiveness systems in countries where such systems are well established. We spoke to Paul Keckley, executive director of the Deloitte Center for Health Solutions about what lessons there are to learn from the comparative effectiveness systems around the world, what works and what doesn’t, and why a cut-and-paste approach won’t work here.
For some, comparative effectiveness is the cure for a healthcare system ailing from runaway costs. For others, it is a bureaucrat’s dream that provides a tool to reign in spending by limiting access to expensive new drugs. This week at the 2009 BIO International Convention, the Deloitte Center for Health Solutions released a new report that did something that appeared quite natural. It compared comparative effectiveness systems in countries where such systems are well established. We spoke to Paul Keckley, executive director of the Deloitte Center for Health Solutions about what lessons there are to learn from the comparative effectiveness systems around the world, what works and what doesn’t, and why a cut-and-paste approach won’t work here.The Burrill Report (May 15, 2009): Burrill Addresses State of the Industry (.MP3,9.11 Mb)
For 40 years, G. Steven Burrill has been involved in the growth and development of the biotechnology industry. Burrill, the CEO of the merchant bank Burrill & Company and the publisher of The Burrill Report, sees this as a time of both change and opportunity as the rules under which the biotech industry operates are being rewritten. We spoke to Burrill about the the evolving environment for the biotech industry, what companies will need to do be successful going forward, and his upcoming super session at the 2009 BIO International Convention.
For 40 years, G. Steven Burrill has been involved in the growth and development of the biotechnology industry. Burrill, the CEO of the merchant bank Burrill & Company and the publisher of The Burrill Report, sees this as a time of both change and opportunity as the rules under which the biotech industry operates are being rewritten. We spoke to Burrill about the the evolving environment for the biotech industry, what companies will need to do be successful going forward, and his upcoming super session at the 2009 BIO International Convention.The Burrill Report (May 8, 2009): The Biotech Industry Set to Meet in Atlanta in Less Than Peachy Times (.MP3,7.24 Mb)
In just a matter of days, the biotechnology industry’s attention will shift to Atlanta. No, we’re not expecting a major pronouncement from the Centers for Disease Control and Prevention. Instead, the 2009 BIO International Convention will kick off in The Big Peach May 18. It is the largest annual gathering for the industry drawing people from 60 countries. The event this year comes at a time of great change for the industry, so we thought we’d check in with Peter Winter, editor in chief of The Burrill Report, about the mood going into the convention, the hot topics this year, and what to look for at the conference.
In just a matter of days, the biotechnology industry’s attention will shift to Atlanta. No, we’re not expecting a major pronouncement from the Centers for Disease Control and Prevention. Instead, the 2009 BIO International Convention will kick off in The Big Peach May 18. It is the largest annual gathering for the industry drawing people from 60 countries. The event this year comes at a time of great change for the industry, so we thought we’d check in with Peter Winter, editor in chief of The Burrill Report, about the mood going into the convention, the hot topics this year, and what to look for at the conference. The Burrill Report (May 1, 2009) A Medical Historian Discusses Lessons from A Pandemic Past (.MP3,18.17 Mb)
As the swine flu spreads across more and more countries, the number of people infected with the disease for now remains low. But public health officials are worried that a deadly pandemic may be unfolding before our eyes. The World Health Organization has pushed its influenza pandemic alert to the second highest level and instructed all countries to immediately activate their pandemic preparedness plan. Alexandra Stern, associate director of the Center for the History of Medicine at the University of Michigan, has conducted extensive research into the response of U.S. cities to the 1918-1919 influenza pandemic. We talked to Stern about the challenges of containing a pandemic in our interconnected world today, about why efforts to contain the 1918 pandemic failed in some major cities, and what lessons public health officials can learn from the past.
As the swine flu spreads across more and more countries, the number of people infected with the disease for now remains low. But public health officials are worried that a deadly pandemic may be unfolding before our eyes. The World Health Organization has pushed its influenza pandemic alert to the second highest level and instructed all countries to immediately activate their pandemic preparedness plan. Alexandra Stern, associate director of the Center for the History of Medicine at the University of Michigan, has conducted extensive research into the response of U.S. cities to the 1918-1919 influenza pandemic. We talked to Stern about the challenges of containing a pandemic in our interconnected world today, about why efforts to contain the 1918 pandemic failed in some major cities, and what lessons public health officials can learn from the past.The Burrill Report (April 24, 2009): Rethinking University-Industry Relationships To Get Better Returns On Public Investment (.MP3,10.35 Mb)
Reg Kelly, the director of the California Institute for Quantitative Biosciences or QB3, thinks even though the Obama Administration’s stimulus package promises to direct billions of dollars into research, it is critical to change the way universities engage with the private sector to achieve the full benefit of such public investment in basic research. At a recent conference held by BayBio, the Northern California biotechnology industry association, Kelly spoke about some of the efforts underway at QB3 to interact differently with industry in the hopes of speeding the translation of discoveries to products that can benefit both the patients and the economy. Following his keynote address, we spoke to Kelly about the changing role of the university, why technology transfer alone is inadequate for delivering university discoveries to the public, and the need to create incentives to drive academics to focus on work that benefits the public good.
Reg Kelly, the director of the California Institute for Quantitative Biosciences or QB3, thinks even though the Obama Administration’s stimulus package promises to direct billions of dollars into research, it is critical to change the way universities engage with the private sector to achieve the full benefit of such public investment in basic research. At a recent conference held by BayBio, the Northern California biotechnology industry association, Kelly spoke about some of the efforts underway at QB3 to interact differently with industry in the hopes of speeding the translation of discoveries to products that can benefit both the patients and the economy. Following his keynote address, we spoke to Kelly about the changing role of the university, why technology transfer alone is inadequate for delivering university discoveries to the public, and the need to create incentives to drive academics to focus on work that benefits the public good. The Burrill Report (April 17, 2009): New Stem Cell Technology Gets A Boost From Collaboration (.MP3,11.12 Mb)
iZumi Bio, a young South San Francisco, California-based company working in the emerging area of induced pluripotent stem cells, has just announced a collaboration around the technology with Kyoto University where the pioneering work in coaxing adult cells into pluripotent cells was performed. iZumi, founded in 2007 and backed with funding from Kleiner Perkins Caufield and Byers and Highland Capital Partners, is pursuing applications of the cells for both drug development and therapeutics. We spoke to iZumi CEO John Walker about the excitement around iPS cells, the new agreement with Kyoto University
iZumi Bio, a young South San Francisco, California-based company working in the emerging area of induced pluripotent stem cells, has just announced a collaboration around the technology with Kyoto University where the pioneering work in coaxing adult cells into pluripotent cells was performed. iZumi, founded in 2007 and backed with funding from Kleiner Perkins Caufield and Byers and Highland Capital Partners, is pursuing applications of the cells for both drug development and therapeutics. We spoke to iZumi CEO John Walker about the excitement around iPS cells, the new agreement with
The Burrill Report (April 10, 2009): Looking Behind the First Quarter Numbers (.MP3,8.37 Mb)
The Dow Jones Industrial Average posted its worst January performance ever and worst February since the Great Depression, and then in March it did an about face and generated one of its biggest one-month gains in years. The IPO market still remained closed to biotechs, but on the financing side the numbers actually looked pretty good in the first quarter as the industry posted a 47 percent increase over the same period a year ago. With Roche’s purchase of Genentech, the collective market cap for the biotech sector sunk below the $300 billion mark, but the deal also fuels the discussion about whether it even has meaning anymore to talk about a pharmaceutical industry and a biotechnology industry that are separate and distinct from each other. We spoke to Peter Winter, editor of The Burrill Report about the first quarter numbers, where the money went, and what it all means.
The Dow Jones Industrial Average posted its worst January performance ever and worst February since the Great Depression, and then in March it did an about face and generated one of its biggest one-month gains in years. The IPO market still remained closed to biotechs, but on the financing side the numbers actually looked pretty good in the first quarter as the industry posted a 47 percent increase over the same period a year ago. With Roche’s purchase of Genentech, the collective market cap for the biotech sector sunk below the $300 billion mark, but the deal also fuels the discussion about whether it even has meaning anymore to talk about a pharmaceutical industry and a biotechnology industry that are separate and distinct from each other. We spoke to Peter Winter, editor of The Burrill Report about the first quarter numbers, where the money went, and what it all means. The Burrill Report (April 3, 2009): Downsizing and Job Searching in the Life Sciences (.MP3,6.46 Mb)
There are signs that the economy may be stabilizing. After six consecutive months of decline, factory orders rose for the first time in February. The stock market, after a dismal start to the year, soared in March and has now moved into positive territory for the year. And there are some signs of the housing market leveling off. Nevertheless jobless numbers continue to reach records and the pharmaceutical and biotech industries have not been immune to the job cuts. A tally by The Burrill Report found in the first quarter alone, 90 companies announced nearly 30,000 job cuts as the number of new U.S. claims for state unemployment benefits jumped to a 26 year high last week. John Challenger, CEO of the outplacement firm Challenger, Gray, & Christmas, offers some perspective on the job losses in the life sciences, how companies should go about their downsizing, and what newly displaced workers should do to get new jobs.
There are signs that the economy may be stabilizing. After six consecutive months of decline, factory orders rose for the first time in February. The stock market, after a dismal start to the year, soared in March and has now moved into positive territory for the year. And there are some signs of the housing market leveling off. Nevertheless jobless numbers continue to reach records and the pharmaceutical and biotech industries have not been immune to the job cuts. A tally by The Burrill Report found in the first quarter alone, 90 companies announced nearly 30,000 job cuts as the number of new U.S. claims for state unemployment benefits jumped to a 26 year high last week. John Challenger, CEO of the outplacement firm Challenger, Gray, & Christmas, offers some perspective on the job losses in the life sciences, how companies should go about their downsizing, and what newly displaced workers should do to get new jobs. The Burrill Report (March 27, 2009): Comparative Effectiveness Readies for Prime Time (.MP3,13.04 Mb)
Comparative effectiveness research, long an area of debate among academics and policy wonks, is suddenly racing toward primetime. The U.S. Department of Health and Human Services has just named a 15-member to a panel that will advise the government on how to spend the $1.1 billion in federal stimulus funding the Obama administration has set aside for comparing the effectiveness of medical treatments. We spoke to Tony Coelho, chairman of the Partnership to Improve Patient Care, a coalition of physicians, patient, and industry groups focused on the issue, about the role of comparative effectiveness research, concerns about its use as a blunt tool to cut spending at the expense of patient access to new drugs, and the political fight ahead.
Comparative effectiveness research, long an area of debate among academics and policy wonks, is suddenly racing toward primetime. The U.S. Department of Health and Human Services has just named a 15-member to a panel that will advise the government on how to spend the $1.1 billion in federal stimulus funding the Obama administration has set aside for comparing the effectiveness of medical treatments. We spoke to Tony Coelho, chairman of the Partnership to Improve Patient Care, a coalition of physicians, patient, and industry groups focused on the issue, about the role of comparative effectiveness research, concerns about its use as a blunt tool to cut spending at the expense of patient access to new drugs, and the political fight ahead.The Burrill Report (March 20, 2009): Biotech Braces for a New FDA Chief (.MP3,9.88 Mb)
President Barack Obama named Margaret Hamburg, former New York City Health Commissioner, to head the FDA. At the same time, he also named Baltimore City Health Commissioner Joshua Sharfstein as Hamburg’s principal deputy. Sharfstein previously worked for Democratic Congressman Henry Waxman, a harsh critic of the pharmaceutical industry. When Obama announced his choices, much of his comments focused on food safety issues, an area of public embarrassment for the agency during the past year. Little, however, was said about the agency’s mission to regulate drugs and medical devices. We spoke to Peter Pitts, former FDA associate commissioner and president of the Center for Medicine in the Public Interest about Obama’s selections, what the President’s picks will mean for industry, and the challenges ahead for Hamburg and Sharfstein in their new jobs.
President Barack Obama named Margaret Hamburg, former New York City Health Commissioner, to head the FDA. At the same time, he also named Baltimore City Health Commissioner Joshua Sharfstein as Hamburg’s principal deputy. Sharfstein previously worked for Democratic Congressman Henry Waxman, a harsh critic of the pharmaceutical industry. When Obama announced his choices, much of his comments focused on food safety issues, an area of public embarrassment for the agency during the past year. Little, however, was said about the agency’s mission to regulate drugs and medical devices. We spoke to Peter Pitts, former FDA associate commissioner and president of the Center for Medicine in the Public Interest about Obama’s selections, what the President’s picks will mean for industry, and the challenges ahead for Hamburg and Sharfstein in their new jobs. The Burrill Report March 13, 2009: Obama Overturns Bush Restrictions On Stem Cells (.MP3,13.01 Mb)
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President Barack Obama’s executive order removing barriers to scientific research involving human embryonic stem cells overturned Bush era restriction that significantly limited federal funding of this work. At the same time, Obama issued a memorandum on scientific integrity – part of an effort, he said, to “restore scientific integrity in government decision making.” We spoke to Stacie Propst, vice president of scientific policy and outreach for the advocacy group Research!America about the Obama executive order, the changes he is bringing to the nation’s science policy, and whether there’s any hope for science to become delinked from politics in the future.
President Barack Obama’s executive order removing barriers to scientific research involving human embryonic stem cells overturned Bush era restriction that significantly limited federal funding of this work. At the same time, Obama issued a memorandum on scientific integrity – part of an effort, he said, to “restore scientific integrity in government decision making.” We spoke to Stacie Propst, vice president of scientific policy and outreach for the advocacy group Research!America about the Obama executive order, the changes he is bringing to the nation’s science policy, and whether there’s any hope for science to become delinked from politics in the future. The Burrill Report: Patent Reform Pending (.MP3,9.81 Mb)
This week, leaders in the House and Senate joined to introduce legislation to reform the United State patent system. This follows failed efforts at patent reform in the previous two sessions of Congress. The high-technology industry has long pushed for patent reform, but their efforts have been at odds with the biotechnology and pharmaceutical industries, which are concerned that the legislation would weaken patent protections and consequently cripple their ability to raise capital. We spoke to the Biotechnology Industry Organization’s CEO Jim Greenwood about the new legislation, how it differs from previous versions, and the concerns that remain for the biotech companies.
The Burrill Report: Genzyme Ready To Spend On Personalized Medicine (.MP3,8.75 Mb)
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Recently Genzyme CEO Henri Termeer was quoted as saying he was ready to go on as much as a $600 million shopping spree for new personalized medicine treatments. Big Pharma companies are no different. They’ve embraced personalized medicine as a central part of their future as key patents expire, generic competition grows, and demands to demonstrate the value of their medicines increase. We spoke to The Burrill Report’s editor Peter Winter about Termeer’s comments and the growing personalized medicine trend within Big Pharma.
Recently Genzyme CEO Henri Termeer was quoted as saying he was ready to go on as much as a $600 million shopping spree for new personalized medicine treatments. Big Pharma companies are no different. They’ve embraced personalized medicine as a central part of their future as key patents expire, generic competition grows, and demands to demonstrate the value of their medicines increase. We spoke to The Burrill Report’s editor Peter Winter about Termeer’s comments and the growing personalized medicine trend within Big Pharma.The Burrill Report: Biotechnology Industry Turns Profitable (.MP3,8.75 Mb)
Stock prices have tanked, financial markets have seized and companies are laying off staff and putting promising projects on ice. In the midst of all of this grim news it’s easy to overlook an important milestone for the biotechnology industry. Peter Winter, editor of The Burrill Report, though, has been crunching the numbers and he says some 40 years after the industry began, it actually hit a major milestone in 2008 by turning profitable for the first time in its history. It’s not all good news by any means, but we talk to Winter about this major milestone for the industry, what we should make of it, and the emerging world of the biotechnology haves and the biotechnology have-nots.
Stock prices have tanked, financial markets have seized and companies are laying off staff and putting promising projects on ice. In the midst of all of this grim news it’s easy to overlook an important milestone for the biotechnology industry. Peter Winter, editor of The Burrill Report, though, has been crunching the numbers and he says some 40 years after the industry began, it actually hit a major milestone in 2008 by turning profitable for the first time in its history. It’s not all good news by any means, but we talk to Winter about this major milestone for the industry, what we should make of it, and the emerging world of the biotechnology haves and the biotechnology have-nots. The Burrill Report: Roche Turns Up The Heat On Genentech (.MP3,9.18 Mb)
Back in July, the Swiss pharmaceutical company Roche offered $43.7 billion, or $89 a share, for the 44 percent of Genentech it doesn’t already own. Since then, talks have not progressed well. Roche last week said it would launch a hostile bid for the company at $86.50 – less than it originally offered. Genentech, which has told Roche it’s worth $112 a share, asked its shareholder not to act on the bid. But with the latest maneuvering by Roche came filings with the U.S. Securities and Exchange Commission that shed new light on the behind the scenes wrangling between the two companies. We spoke to TheStreet.com’s senior columnist Adam Feuerstein, who is also responsible The Street’s investment newsletter Biotech Select, about the emerging drama between the two companies and where it will all end.
The Burrill Report: Advancing Healthcare Reform After Daschle (.MP3,13.77 Mb)
The Obama Administration’s drive to reform healthcare suffered a serious setback when the president’s pick to lead the effort, Capitol Hill veteran Tom Daschle, suddenly bowed after embarrassing tax revelations. Daschle withdrew his nomination to head the U.S. Department of Health and Human Services. In addition, he said he will not serve as director of the newly created White House Office of Health Reform. The end of Daschle’s cabinet bid was a blow since many believed the Democrat from South Dakota, who spent 26 years in Congress, was uniquely qualified to lead the reform effort. Daschle was respected on both sides of the aisle and was viewed as someone who could shepherd complex and controversial healthcare reform through the rough-and-tumble world of Washington politics. What’s more, he had penned the book Critical: What We Can Do About the Health-Care Crisis, which provides a blueprint for overhauling the U.S. healthcare system. We spoke to Henry Aaron, a senior fellow at the Brookings Institution, about what Daschle’s withdrawal means to healthcare reform and where the Obama administration goes from here.
The Obama Administration’s drive to reform healthcare suffered a serious setback when the president’s pick to lead the effort, Capitol Hill veteran Tom Daschle, suddenly bowed after embarrassing tax revelations. Daschle withdrew his nomination to head the U.S. Department of Health and Human Services. In addition, he said he will not serve as director of the newly created White House Office of Health Reform. The end of Daschle’s cabinet bid was a blow since many believed the Democrat from South Dakota, who spent 26 years in Congress, was uniquely qualified to lead the reform effort. Daschle was respected on both sides of the aisle and was viewed as someone who could shepherd complex and controversial healthcare reform through the rough-and-tumble world of Washington politics. What’s more, he had penned the book Critical: What We Can Do About the Health-Care Crisis, which provides a blueprint for overhauling the U.S. healthcare system. We spoke to Henry Aaron, a senior fellow at the Brookings Institution, about what Daschle’s withdrawal means to healthcare reform and where the Obama administration goes from here.The Burrill Report: Pfizer's $68 Billion Buy (.MP3,8.88 Mb)
The week began with a bang when the world’s largest pharmaceutical company Pfizer announced plans to purchase Wyeth for $68 billion. The deal comes as Pfizer faces the loss of billions of dollars in revenue in the coming years as several of its blockbuster drugs go off-patent and face competition from generics. Back in November, Barbara Ryan, managing director for Deutsche Bank Securities, issued a report where she said Big Pharma companies such as Pfizer would need to make precisely these types of acquisitions to address patent expirations and the massive overcapacity within the industry. We spoke to Ryan about the Pfizer deal and what other deals may be coming in its wake.
The week began with a bang when the world’s largest pharmaceutical company Pfizer announced plans to purchase Wyeth for $68 billion. The deal comes as Pfizer faces the loss of billions of dollars in revenue in the coming years as several of its blockbuster drugs go off-patent and face competition from generics. Back in November, Barbara Ryan, managing director for Deutsche Bank Securities, issued a report where she said Big Pharma companies such as Pfizer would need to make precisely these types of acquisitions to address patent expirations and the massive overcapacity within the industry. We spoke to Ryan about the Pfizer deal and what other deals may be coming in its wake.The Burrill Report: FDA Gives Stem Cells A Boost (.MP3,8.84 Mb)
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After a long and often frustrating back-and-forth with regulators, Geron said it had won clearance from the U.S. Food and Drug Administration to begin human clinical trials of its experimental therapy derived from human embryonic stem cells to treat patients with acute spinal cord injury. It is the first human embryonic stem cell-derived therapy to enter the clinic. We spoke to Bernard Siegel a leading expert on stem cell policy and the founder and executive director of the Genetics Policy Institute, about the significance of Geron finally getting a green light from the FDA to begin clinical trials and what might be ahead for the field under the new Obama administration.
After a long and often frustrating back-and-forth with regulators, Geron said it had won clearance from the U.S. Food and Drug Administration to begin human clinical trials of its experimental therapy derived from human embryonic stem cells to treat patients with acute spinal cord injury. It is the first human embryonic stem cell-derived therapy to enter the clinic. We spoke to Bernard Siegel a leading expert on stem cell policy and the founder and executive director of the Genetics Policy Institute, about the significance of Geron finally getting a green light from the FDA to begin clinical trials and what might be ahead for the field under the new Obama administration. The Burrill Report: The Biotech Industry Braces For Obama (.MP3,18.16 Mb)
As the Obama administration takes over in Washington, the biotechnology industry is readying for a busy year on the legislative front. Ongoing fights over issues such as patent reform and biosimilars will continue, but new ones surrounding healthcare reform, the regulatory environment, and comparative effectiveness could dramatically alter the landscape for the industry. And, with the seizing of capital markets, the biotechnology industry is turning to Washington to help with a more immediate crisis as 300 publicly traded biotechnology companies— 75 percent of all public biotech companies – have less than one year of cash remaining, and 120 of those have less than six months cash on hand. We spoke to BIO CEO Jim Greenwood and BIO chairman Joshua Boger about what’s in store for the industry under the new administration.
As the Obama administration takes over in Washington, the biotechnology industry is readying for a busy year on the legislative front. Ongoing fights over issues such as patent reform and biosimilars will continue, but new ones surrounding healthcare reform, the regulatory environment, and comparative effectiveness could dramatically alter the landscape for the industry. And, with the seizing of capital markets, the biotechnology industry is turning to Washington to help with a more immediate crisis as 300 publicly traded biotechnology companies— 75 percent of all public biotech companies – have less than one year of cash remaining, and 120 of those have less than six months cash on hand. We spoke to BIO CEO Jim Greenwood and BIO chairman Joshua Boger about what’s in store for the industry under the new administration.The Burrill Report: What To Look For At The JPMorgan Conference (.MP3,9.4 Mb)
It’s that time of year when thousands of executives, bankers and investors involved in the life sciences industry emerge for the JPMorgan Annual Healthcare Conference and check if they see their own shadows. The conference, which brings together more than 7,000 people for four days of presentations and meetings at the Westin St. Francis hotel in San Francisco, runs January 12 through 15. Traditionally, the industry has looked to the meeting to gauge sentiments on the outlook for the new year, appetite for deals, and how eager investors will be to buy shares in IPOs. Though not many IPOs are expected to be filed in the first half of the new year, raising money will likely be among the top concerns of many of the companies gathered for the event. Even companies not invited to attend will fill the lobby of the St. Francis and meet in surrounding hotels and restaurants. We spoke to G. Steven Burrill, CEO of Burrill & Company and the Publisher of The Burrill Report about this year’s conference and what he’ll be looking for as he makes his way through meeting rooms.
It’s that time of year when thousands of executives, bankers and investors involved in the life sciences industry emerge for the JPMorgan Annual Healthcare Conference and check if they see their own shadows. The conference, which brings together more than 7,000 people for four days of presentations and meetings at the Westin St. Francis hotel in San Francisco, runs January 12 through 15. Traditionally, the industry has looked to the meeting to gauge sentiments on the outlook for the new year, appetite for deals, and how eager investors will be to buy shares in IPOs. Though not many IPOs are expected to be filed in the first half of the new year, raising money will likely be among the top concerns of many of the companies gathered for the event. Even companies not invited to attend will fill the lobby of the St. Francis and meet in surrounding hotels and restaurants. We spoke to G. Steven Burrill, CEO of Burrill & Company and the Publisher of The Burrill Report about this year’s conference and what he’ll be looking for as he makes his way through meeting rooms. The Burrill Report: Outlook For The Capital Markets (.MP3,5.85 Mb)
Many of us will be happy to see 2008 over. It was a year where the economy tanked, stocks sank, and capital became a lot harder and more expensive to obtain. We spoke to Burrill & Company CEO G. Steven Burrill, publisher of The Burrill Report, about the year past and the outlook for 2009 as he completes his latest book on the outlook for the life sciences industry. This is the first in a regular series of conversations we’ll be conducting with Mr. Burrill. Here we begin with a look at the capital markets.
Many of us will be happy to see 2008 over. It was a year where the economy tanked, stocks sank, and capital became a lot harder and more expensive to obtain. We spoke to Burrill & Company CEO G. Steven Burrill, publisher of The Burrill Report, about the year past and the outlook for 2009 as he completes his latest book on the outlook for the life sciences industry. This is the first in a regular series of conversations we’ll be conducting with Mr. Burrill. Here we begin with a look at the capital markets.Creating Solutions: A Discussion On How To Protect Innovation In Molecular Diagnostics (.MP3,16.31 Mb)
Many technological breakthroughs in molecular diagnostics have helped change the face of healthcare in the past decade. However, innovators in the space face a number of complex regulatory and reimbursement issues that have begun to slow the pace of innovation and the promise of personalized medicine. The California Healthcare Institute hosts a roundtable of industry experts to explore the issues.
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Another Inconvenient Truth (.MP3,12.83 Mb)
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On this edition, we speak with Jim Wells, director of the Small Molecule Discovery Center at the Univeristy of California, San Francisco. Wells recently coauthored an editorial for the journal Science about the need for scientists to work with advocacy groups to accelerate public awareness in support of basic research. He points to the success former vice president Al Gore has had in raising awareness around climate change and global warming and sees in that a populist model that could help bring in new support for biomedical research at a critical time of spreading disease and when our genomic understanding remains in its infancy.
On this edition, we speak with Jim Wells, director of the Small Molecule Discovery Center at the Univeristy of California, San Francisco. Wells recently coauthored an editorial for the journal Science about the need for scientists to work with advocacy groups to accelerate public awareness in support of basic research. He points to the success former vice president Al Gore has had in raising awareness around climate change and global warming and sees in that a populist model that could help bring in new support for biomedical research at a critical time of spreading disease and when our genomic understanding remains in its infancy. Guinea Pig Zero Speaks (.MP3,47.38 Mb)
For much of his adult life, Robert Helms worked as a professional medical test subject. He chronicled his experiences, and that of others, in his zine Guinea Pig Zero. Excerpts of the publication are available in the book Guinea Pig Zero: An Anthology of the Journal for Human Research Subjects. “When I rent my healthy body to medical science, I am the temporary employee of a research team, paid as a contractor for each job. I do my bleeding, pissing work in a blurry area between patient and subject. This blurry area has made for intense public debate, and the questions relating to the guinea pig as a worker are not even considered by lawmakers in this country (yet they are in Canada or France)." We spoke to Helms about his career choice, the day to day lives of professional guinea pigs, and the role of human test subjects in modern medical science.
For much of his adult life, Robert Helms worked as a professional medical test subject. He chronicled his experiences, and that of others, in his zine Guinea Pig Zero. Excerpts of the publication are available in the book Guinea Pig Zero: An Anthology of the Journal for Human Research Subjects. “When I rent my healthy body to medical science, I am the temporary employee of a research team, paid as a contractor for each job. I do my bleeding, pissing work in a blurry area between patient and subject. This blurry area has made for intense public debate, and the questions relating to the guinea pig as a worker are not even considered by lawmakers in this country (yet they are in Canada or France)." We spoke to Helms about his career choice, the day to day lives of professional guinea pigs, and the role of human test subjects in modern medical science. Full Podcast: A Magic Formula (.MP3,25.75 Mb)
On this edition we speak with Ernst & Young’s Global Biotechnology Leader Glen Giovannetti about Big Pharma’s efforts to reinvent itself through changing models of collaboration and acquisitions. We also speak with the Milken Institute’s Ross DeVol about the economic toll of chronic disease and why healthcare reform efforts must address this growing problem if they are to be successful.
A Chronic Problem (.MP3,12.68 Mb)
It’s not just diabetes, but heart disease, hypertension, cancer and other chronic conditions that are at the heart of America’s healthcare crisis. An estimated 133 million people, almost half of all Americans today, live with at least one chronic condition, and the number continues to grow. Consider that 75 percent of the $2.1 trillion spent on healthcare in the United States goes to treat people who suffer from chronic conditions, according to the Centers for Disease Control and Prevention. We spoke to the Milken Institutes’ Ross DeVol about the economic toll of chronic disease and why healthcare reform efforts must address this growing problem if they are to be successful.
Reinventing Pharma (.MP3,14.4 Mb)
When Roche acquired a majority stake in Genentech in 1990, it led to what would become one of the most productive and successful relationships between a pharmaceutical company and a biotech. Now, nearly two decades later, Big Pharma seems to finally be taking notice, and taking steps to leave some autonomy and independence with the biotechs they acquire in the hopes of preserving the culture of innovation that attracted them in the first place. We spoke to Ernst & Young’s Global Biotechnology Leader Glen Gionvannetti about this emerging trend and why now that it’s happening, Roche is trying to buy the rest of Genentech.
FULL PODCAST: July 2008 (.MP3,39.5 Mb)
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On this edition, we travel to San Diego for the BIO 2008 International Convention, the largest annual gathering for the biotechnology industry. We’ll begin with BIO president and CEO Jim Greenwood, who talks about why the industry is lobbying to get more money for the folks who regulate it. We’ll also speak with Ed Holmes, executive deputy chairman for Clinical-Translational Sciences at the Biomedical Research Council of the Agency for Science, Technology and Research or A*STAR about Singapore’s efforts to become a biotechnology powerhouse. Amgen’s Senior Vice Present of Research and Development Joe Miletich discusses both the art and science of early stage research. And we finish with Deloitte’s National Managing Principal for Biotechnology Matthew Hudes on measuring innovation.
On this edition, we travel to San Diego for the BIO 2008 International Convention, the largest annual gathering for the biotechnology industry. We’ll begin with BIO president and CEO Jim Greenwood, who talks about why the industry is lobbying to get more money for the folks who regulate it. We’ll also speak with Ed Holmes, executive deputy chairman for Clinical-Translational Sciences at the Biomedical Research Council of the Agency for Science, Technology and Research or A*STAR about Singapore’s efforts to become a biotechnology powerhouse. Amgen’s Senior Vice Present of Research and Development Joe Miletich discusses both the art and science of early stage research. And we finish with Deloitte’s National Managing Principal for Biotechnology Matthew Hudes on measuring innovation. Lobbying For Regulators (.MP3,11.22 Mb)
Most industry groups lobby to get regulators off their backs, but the biotechnology industry may be unique in complaining that the folks who regulate it need more money to do so. With new scrutiny on food safety and drug safety, the industry is worried that the agency doesn’t have the resources it needs to review new drug applications in a timely manner, and that its already sizeable contribution to the agency through user fees is also undermining the public’s trust in both the FDA and the industry. We talk to BIO president and CEO Jim Greenwood about industry efforts to get Congress to find more money for the FDA.
Tall Order (.MP3,8.55 Mb)
About a year and a half ago Ed Holmes along with his wife Judy Swain, both distinguished researchers in the United States, found themselves lured to Singapore where the government was backing its great ambitions to become a leading biotech center with billions in investment. Holmes, the executive deputy chairman of A*STAR's Biomedical Research Council, is helping lead the second phase of Singapore's biomedical sciences initiative with a focus on translational efforts. He is working to build capabilities and attract the talent needed to translate basic research into potential new drugs, devices and diagnostic tools. We spoke to Holmes, a member of the TJOLS advisory board, about both the successes Singapore has enjoyed and the challenges it continues to face.
Following Where Science Leads (.MP3,10.79 Mb)
As Senior Vice President, Research and Development at Amgen, Joe Miletich leads the translational science efforts for the biotechnology giant. As such, Miletich serves as both a gateway and guardian over the company’s future. This critical part of Amgen’s R&D effort unlocks the promise of early discoveries by demonstrating their potential to alter disease in a beneficial way. We caught up to Miletich at the BIO 2008 Confernece and talked to him about the changing process of translational research and the sometime challenge of following where science leads.
Measuring Innovation (.MP3,10.99 Mb)
“Given the volatility and the pace of scientific discovery in recent years, there is a need for a fact-based analysis to better understand which innovations are emerging as the most promising and, conversely, which technologies are losing ground,” said Matthew Hudes, U.S. managing principal, Biotechnology, for Deloitte Consulting's Life Sciences & Health Care practice. Using data collected over the past six years, Deloitte researchers created a three-stage measurement model covering discovery, development and realization to measure the inputs and outputs of innovation during the process of bringing new products to market. We caught up with Hudes, a member of the TJOLS business advisory board, at the BIO 2008 Conference and talked about the emerging technologies reshaping the biotech sector and how exactly you go about measuring innovation.
Full Podcast: A Conversation On Healthcare Reform and Income Security (.MP3,61.42 Mb)
On this edition of the Journal of Life Sciences podcast, we travel to the campus of Stanford University for a conversation on healthcare reform and income security featureing George Shultz and John Shoven. Shultz, professor of economics at Stanford Graduate School of Business and Distinguished Fellow at the Hoover Institution, and Shoven, professor of economics and director of the Stanford Institute for Economic Policy Research, discuss the issues of their new book Putting Our House in Order: a Guide to Social Security and Health Care Reform. The healthcare economist Victor Fuchs moderates the discussion. The California Healthcare Institute hosted the April 29 event, which was sponsored by Fenwick & West.
FULL PODCAST: A 20/20 Vision to 2020 (.MP3,20.13 Mb)
On this special edition of The Journal of Life Sciences Podcast, we travel to Half Moon Bay, California for the annual limited partners meeting of the San Francisco-based life sciences merchant bank Burrill & Company. TJOLS was permitted to record portions of this closed-door conference held this year at the end of April. Steve Burrill, CEO of Burrill & Company and co-publisher of TJOLS, spoke about his vision for the changing world of healthcare in the year 2020. It is the focus of Burrill & Company's annual report on the biotech industry Biotech 2008-Life Sciences: A 20/20 Vision to 2020. Steve discusses how we are moving from a world of treatment to one of prediction and prevention, how technology will be harnessed to invisibly monitor patients as they go about their everyday activities, and how 12 years from now when people need medical treatment, they will go to Wal-Mart.
FULL PODCAST: The Journal of Life Sciences April 2008 (.MP3,27.96 Mb)
On this edition, the Journal’s editor-in-chief William Patrick is joined by Harvard-MIT Division of Health Sciences and Technology Director Martha Gray, California Institute for Quantitative Biosciences Director Reg Kelly, and journalists Ellen Durckel. They discuss the convergence of biology with the quantitative sciences, efforts to get industry and academia to collaborate more effectively and how harnessing nanotechnology to create an artificial retina may restore limited vision to the blind.
Same As It Ever Was (.MP3,3.12 Mb)
The Journal's Editor-In-Chief William Patrick offers a few thoughts on convergence.
Hands On Medicine (.MP3,6.4 Mb)
For nearly 40 years, the Harvard-MIT division of Health Sciences and Technology has worked to bring innovations in non-medical fields such as information technology, engineering and materials science to the patient bedside and to clinical research. The catchword for the program is convergence with faculty focusing on fostering collaboration among researchers from disparate fields. Now, HST through a unique program aimed at training a new class of highly versatile health professional, is taking its model to India. The move could lead to new treatments and technologies.
The Smiling Heretic (.MP3,8.77 Mb)
For Reg Kelly, the director of the California Institute for Quantitative Biosciences, or QB3, research breakthroughs are not enough. Kelly notes that Q2’s mandate is not only to improve public health, but California’s economic well being as well. To that end, QB3 has aggressively pursued relationships with industry, sought to find sources of funding for faculty created start-ups, and even created incubator space for new companies within its headquarters on the Mission Bay campus of the University of California, San Francisco to see that researchers’ discoveries get translated into products that can ultimately benefit public health.
A Bionic Eye (.MP3,7.86 Mb)
No one would ever confuse William Boyd with Steve Austin, the iconic and bionic hero of the 1970’s TV series the six million dollar man. Boyd, who spent his career at a Nabisco bakery in Houston mixing dough to make Ritz Crackers, though, may become something of a bionic man himself. In 1979, Boyd developed retinitis pigmentosa, a genetic condition that causes a degeneration of the natural photoreceptors that line the retina in the back of the eye. Thirty years after his diagnosis, Boyd may be one of the first patients implanted with an artificial retina in the hopes of restoring limited sight to him.
The Last Word (.MP3,2 Mb)
The Journal's Web Editor Daniel S. Levine offers the best podcast segment you've ever heard.
Full Podcast: The Journal of Life Sciences (.MP3,18 Mb)
On this edition, Tjols' editor-in-chief William Patrick is joined by Jaxon White, chairman of Medmarc Insurance Group, and Dr. David Dale, president of the American College of Physicians. They discuss the recent U.S. Supreme Court decision on liability for medical device makers and the need for greater research into the medicinal uses of marijuana.
On this edition, Tjols' editor-in-chief William Patrick is joined by Jaxon White, chairman of Medmarc Insurance Group, and Dr. David Dale, president of the American College of Physicians. They discuss the recent U.S. Supreme Court decision on liability for medical device makers and the need for greater research into the medicinal uses of marijuana.Immunizing Device Makers (.MP3,7.17 Mb)
In a major victory for the medical device industry, the U.S. Supreme Court ruled that medical device makers could not be sued over harm done by devices that had gone through the U.S. Food and Drug Administration’s premarket approval process. The 8-1 decision in the case of Riegel v. Medtronic decision reaffirms two previous lower court rulings. The medical device industry said the decision makes clear that the FDA, and not a patchwork of state regulation and jury verdicts, is the determiner of the safety and efficacy of medical devices. Jaxon White, chairman of MedMark Insurance Group, discusses the significance of the decision with Tjols' editor-in-chief William Patrick.
Turn on, Tune in, and Research (.MP3,8.08 Mb)
Marijuana has for centuries been smoked for its medicinal benefits. There are both clinical and anecdotal evidence of many potential uses, but research expansion has been impeded by a complicated federal approval processes, limited availability of research grade marijuana and the debate over legalization. The American College of Physicians, the nation’s second largest physician group, is calling for programs and funding for rigorous scientific research into the medical uses of marijuana. Tjols' editor-in-chief William Patrick talked to Dr. David Dale, president of the ACP and a professor of medicine at the University of Washington, about the organization’s recent policy statement.
The Last Word (.MP3,3.64 Mb)
The Journal’s Daniel S. Levine offers some thoughts on the Journal of Visualized Experiments or JoVE.com, a website dedicated to making biological experiments easily reproduced by allowing researchers to see how they are performed.
FULL PODCAST: The Journal of Life Sciences (.MP3,17.27 Mb)
On this edition, the Journal’s editor-in-chief William Patrick is joined by New Republic Assistant Editor Bradford Plumer, law professor Lori Andrews, and TJOLS Publishers and California Healthcare Institute CEO David Gollaher. They discuss Congress’ legislative agenda, patent issues surrounding nanotechnology, and the challenges that lie in getting doctors to practice evidenced-based medicine.
Nurturing our Nerds (.MP3,1.73 Mb)
The Journal's Editor-in-Chief William Patrick talks about the importance of nurturing our nerds.
Untethering Innovation (.MP3,5.02 Mb)
The expectation is that Congress will be relatively quiet in this election year, but not completely. Patent reform legislation, and bills creating a pathway for follow-on biologics will likely come up for votes in the months ahead. Congressional drug-safety hearing could affect the way the FDA does business, while scores of smaller bills—from genetic non-discrimination rules to small-business grants—could have significant effects on medical innovation. While trade groups and lobbyists may be looking ahead to 2009 and the possibility of a democrat in the white house, Bradford Plumer reports in the February issue of the Journal of life sciences that there’s still plenty to focus on in this session.
Thinking Small (.MP3,5.02 Mb)
As the emerging science of nanotechnology converges with biopharmaceutical sciences, the blurring boundary lines threaten to create a nightmare for regulators. As Lori Andrews reports in the February issue of the Journal of Life Sciences, both the U.S. Food and Drug Administration and the U.S. Patent and Trademark Office are bring criticized for their approaches as they attempt both to encourage and to impose order on the field.
A Healthcare GPS for Doctors (.MP3,3.95 Mb)
Evidence-based medicine could help physicians navigate the complexities of patient care by collecting, interpreting and disseminating data on outcomes. At first, it would seem to be nothing more than common sense. After all, who wants medicine based on mere opinion? If outcomes data confirm a treatments benefits, doctors should use it: if it’s harmful they shouldn’t, but as David Gollaher writes in the February 2008 issue of The Journal of Life Sciences, while evidenced-based medicine can improve quality and cut costs in the U.S. Healthcare system there are obstacles, not the least of which are doctors.
The Last Word (.MP3,2.82 Mb)
The Journal's Web Editor Daniel S. Levine shares a letter to his wife, the doctor.
FULL PODCAST: The Outlook for 2008 (.MP3,14.65 Mb)
On this special New Year’s edition editor-in-chief William Patrick is joined by Steve Burrill, CEO of the San Francisco-based life science merchant bank Burrill & Co., and David Gollaher, CEO of the California Healthcare Institute. The two co-publishers of the Journal of Life Sciences discuss the year ahead in business and policy for the life sciences industry.
The Year Ahead on the Business Front (.MP3,6.58 Mb)
The biotechnology industry enjoyed a solid year in 2007. As the final trading sessions of the year approach it appeared the Burrill Biotech Index would better than double the returns of the Dow Jones Industrial Averages for the year. The industry raised nearly $46 billion and saw nearly 30 IPOs. But 2007 was also a year when the pharmaceutical industry saw concerns about safety step to the forefront and that added to the pipeline pressures already being felt as caution at the FDA helped made this year one marked by the fewest new drugs approved in nearly a decade. Steve Burrill joins Bill to take a look back and a look forward for the industry in 2008.
The Year Ahead on the Policy Front (.MP3,8.21 Mb)
Though in 2007 concerns over patent reform and efforts to create a pathway for so-called follow-on or generic biologics dominated the policy front for the industry, no resolution on these issues were reached. As we head into an election year, healthcare reform will likely take center stage, but these unresolved issues will continue to remain high on the agenda for the industry. David Gollaher joins Bill to discuss the big policy concerns of 2007 that continue to be front and center for the industry as we move forward.
FULL PODCAST: The Journal of Life Sciences (.MP3,16.88 Mb)
On this edition, the Journal’s editor-in-chief William Patrick is joined by journalist Theresa Moore, author Ann Parson and eHarmony senior research scientist Gian Gonzaga. They discuss Kaiser Permanente’s efforts to change patients health through the introduction of farmers markets at their facilities, Geron’s push into the clinic with its embryonic stem cell-derived therapy and how not just marriage, but good health may be the payoff from finding the love of your life.
Fix-Me-Itis (.MP3,1.95 Mb)
The Journal's Editor-in-Chief William Patrick offers some thoughts on love and wellness and what the emerging area of social neuroscience is telling us about the two.
Love is a Drug (.MP3,5.35 Mb)
eHarmony specializes in getting singles to connect. Now the matchmaking site hopes landmark research will show that good health, not just marriage, is a possible outcome of its pairings. If a dating service seems an unlikely venue for serious research that could influence both health psychology and personalized medicine, it helps to remember that eHarmony’s business proposition is not to find you a few dates, but a partner for life. Gian Gonzaga, senior research scientists with eHarmony talks to Bill about the research being conducted by the company.
Nurse, Get This Patient Some Arugula (.MP3,4.62 Mb)
HMO Kaiser Permanente is helping set up farmers markets at its medical centers across the nation on the principle that good food leads to good health. Since the first weekly markets opened at the Kaiser facility in Oakland in May 2003, farmers markets have sprouted at 32 Kaiser centers in California, Oregon, Washington, Colorado, Georgia and Hawaii. As journalist Theresa Moore reports in the December issue of The Journal of Life Sciences, it’s one thing to tell patients to eat more fruits and vegetables and its another thing to make high quality produce available at its medical centers.
Eye on the Prize (.MP3,4.26 Mb)
In 2008, Menlo Park, California-based Geron expects to begin a much-anticipated clinical trial in which doctors will transplant a type of neural stem cell into humans. The trial is significant because, if successful, it would represents the first time that a product derived from embryonic stem cells could be shown to be safe and effective. But as author Ann Parson reports in the December issue of The Journal of Life Sciences, even though the company’s expectations are modest, success in treating patients with spinal cord injuries would validate a lengthy and costly effort.
The Last Word (.MP3,2.02 Mb)
A report from Physicians for Social Responsibility puts a price tag as high as $660 billion on what the country will eventually spend caring for the mental and physical damage done to U.S. military personnel from the war in Iraq. Northwest Regional Director Physicians for Social Responsibility Evan Kanter recently spoke to The Journal of Life Sciences about the war’s physical and mental toll on veterans, the long-term cost of caring for those who served, and why the situation is worse than in previous conflicts.
FULL PODCAST: The Journal of Life Sciences (.MP3,34.54 Mb)
On this edition, The Journal’s editor-in-chief William Patrick is joined by journalist Sally Lehrman, author Catherine Brady and The Journal’s Web Editor Daniel S. Levine. They discuss the emergence of consumer genetic tests, the career of groundbreaking scientist Elizabeth Blackburn and the challenges of making personalized medicine a reality.
Junk Science, Junk Food (.MP3,5.14 Mb)
The Journal's Editor-In-Chief William Patrick offers some thoughts on Gary Taubes Good Calories, Bad Calories and the trouble that ensues when scientists yield to pressures from political, financial and other considerations.
Getting Personal (.MP3,9.09 Mb)
The notion of personalized medicine is seductive. Proponents say it will increase the efficiency of drug development, cut wasteful spending on therapies that don’t work for certain patients, and deliver more effective treatments. But as Daniel S. Levine reports in the November issue of The Journal of Life Sciences, the adoption of personalized medicine on a large scale faces significant barriers. The science of identifying appropriate biomarkers for diagnostics can be evasive. The business models to align pharmaceutical and diagnostic companies’ interests remain undefined. And the regulatory and reimbursement models are not yet in place to allow companies to recoup their sizable R&D investment in products designed to reach smaller and smaller populations within a subset of a disease.
Genes 'R Us (.MP3,8.28 Mb)
Empowerment through genetics is now at everyone’s finger tips – or so we’re told. A quick trip online will direct you to tests that claim to identify your genetic propensity for diabetes, breast cancer, cystic fibrosis, or iron overload disease. You can secretly check your baby’s paternity and learn its gender in as few as six weeks from conception. You can go to Target.com and buy a genetic home collection kit for the whole family, with results that tell you how your DNA makes you unique. But as Sally Lehrman reports in the November issue of The Journal of Life Sciences, some question whether the trend toward making genetics testing as easy as fixing a TV dinner is putting the market ahead of the science.
The Unlikely Mentor (.MP3,9.49 Mb)
Reserved, introspective, uncomfortable with head-to-head competition, Elizabeth Blackburn might seem an unlikely role model and mentor for young scientists. But her predilection for exploring unconventional explanations and her aversion to jostling for position in a crowded race led her to a seemingly obscure byway that became a thriving research field with significant implications for human health. The functions of telomeres and telomerase in the aging of cells influences human aging, and telomerase also plays a role in the growth and metastasis of cancer. Catherine Brady, author of the newly released Elizabeth Blackburn and the Story of Telomeres: Deciphering the Ends of DNA joins Bill to discuss the career of this pioneering scientist.
The Last Word (.MP3,5.16 Mb)
The Journal's Managing Editor Eric Wahlgren offers some thoughts on the zymergy experts of biotechnology who apply their professional skills in the science of fermentation to the art of brewing beer.
FULL PODCAST: The Journal of Life Sciences (.MP3,16.57 Mb)
On this edition, The Journal’s editor-in-chief William Patrick is joined by journalist Ellen Durckel, Author Bruce Goldman and Christopher Meyer, chief executive of Monitor Networks. They discuss Houston's efforts to emerge as a center for biotechnology, a promising new cancer vaccine, and the biotechnology company Maxygen, which shows how biological systems are providing new organizational models for businesses.
The Biomolecular Economy (.MP3,2.12 Mb)
The Journal's Editor-in-Chief offers some thoughts on the biomolecular economy and how biological principles are informing organizational structures.
Houston, We Have a Problem (.MP3,16.57 Mb)
For all the size and scope of its medical infrastructure, Houston lags behind in translating biomedical research into biotech commerce. A 2005 Ernst & Young study showed that California was leading the nation with more than 400 biotechnology companies, but Texas was toward the end of the list with fewer than 50. In the current issue of the Journal of Life Sciences, Ellen Durckel takes a look how the biggest city in Texas is hoping institutional partnerships will change that.
An Injection of Hope (.MP3,2.9 Mb)
A Glioblastoma is a relatively rare illness, but a nasty one. About 10,000 patients get diagnosed with it in the United States annually and only half of them will live a full year after their diagnosis. Even when the tumors have been surgically removed from the brain, half the time they will return within six months. But a vaccine in tests for this aggressive cancer has patients living more than twice as long as those treated with radiation and chemotherapy and, as author Bruce Goldman reports in the October issue of the Journal of Life Sciences, has some wondering if it could serve as a model for other types of cancer.
A Turning Point (.MP3,6.62 Mb)
Maxygen CEO Russell Howard has said that “Life is characterized not only by death, but by reproduction, passing on the DNA, the thread that produce progeny and is the real essence of life. Most businesses are the genesis of another business. They may spin off another company, and the parent may die, but the spin-offs survive and succeed. I use the analogy not only of inevitable death, but of life’s continuous process of recreation.” In 2002, Monitor’s Chris Meyer took a close look at Maxygen, itself has been an extraordinarily adaptive enterprise, following an evolutionary biological model when it comes to its organization, leadership, and product development. In this month’s Journal, Meyer revisits the company five year’s later.
The Last Word (.MP3,0 Kb)
The Journal's Web Editor Daniel S. Levine tells how two oncologists from the University of Chicago are trying to tackle the high cost of cancer drugs with a little grapefruit juice.
FULL PODCAST: The Journal of Life Sciences (.MP3,19.7 Mb)
On this edition, The Journal's editor in chief William Patrick is joined by David Gollaher, president and CEO of the California Healthcare Institute, Lori Andrews, professor of law at Chicago Kent College of Law and author Ann Parson.
The Story Contained in a Stamp (.MP3,3.77 Mb)
A few thoughts from The Journal's editor-in-chief William Patrick on the many enemies of progress.
Tissue Culture (.MP3,6.35 Mb)
The now-iconic 1997 photograph of a mouse with a human-shaped ear growing on its back stimulated the development of tissue engineering, both among basic researchers and entrepreneurs. But it also had a profound effect on two Australian artists, Oron Catts and Ionat Zurr. They looked at the ear, created by seeding bovine cartilage cells on biodegradable scaffolding, and said to each other, "that's sculpture."
From Rehab to Regeneration (.MP3,5.66 Mb)
Radical improvements in emergency triage, medical evaluation and body armor mean more soldiers are surviving battlefield trauma than ever before. The unfortunate corollary is that more survivors are living with harsh injuries. Two new military-sponsored research projects in regeneration could revolutionize an amputee's prospects. In the future, when a roadside bomb blows a soldier's arm off, he might be rushed to a regenerative medicine complex where his own cells are put to work to grow a new limb.
The California Experiment (.MP3,4.9 Mb)
It was in 2004 that stem cells entered the mainstream of American politics. On election night, November 2, in Los Angeles' venerable Checkers Hotel, supporters of a ballot measure called Proposition 71 gathered to watch the polling results. By midnight, the initiative that would authorize $3 billion in state bonds to fund 10 years of embryonic stem cell research, was winning by a 59-41 percent landslide. At that moment, California seemed about to write a bold new chapter in the history of life sciences. Its sheer magnitude made prop 71 the greatest application of direct democracy to science policy in history, but in so doing it has also created something big to fight over.
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- Sanofi Chief Extends Hand to Bypass Genzyme `Brick Wall'
Bloomberg - U.S. Court Rules Against Obama’s Stem Cell Policy
The New York Times - Takeda Says Lifestyle-Disease Drugs Will Drive Growth
Bloomberg - Study Says Brain Trauma Can Mimic Lou Gehrig’s Disease
The New York Times - Two New Paths to the Dream: Regeneration
The New York Times - Medical Device Makers Face Revamped U.S. Rules for Approvals
Bloomberg - Pfizer May Gain as U.S. Devises Speedy Alternative to Animal Safety Tests
Bloomberg - Judge lets Virginia healthcare challenge proceed
Reuters - F.D.A. Clears Way for Embryonic Stem Cell Trial Using Patients
The New York Times - Technologies Help Adult Children Monitor Aging Parents
The New York Times