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The Burrill Report: (January 3, 2011): Policy Victories of 2010 and the Battles Ahead in the New Year (.MP3,22.62 Mb)
The Burrill Report took a little break this week, but we didn’t want to forget loyal podcast listeners. So, this week we borrowed the audio stream from an interview The Burrill Report’s Daniel Levine did in the Fall 2010 with Jim Greenwood, CEO of the Biotechnology Industry Organization. The video is available on our sister site Burrill Mindshare if you prefer. The past year has been a big one on the policy front for BIO. We spoke to Greenwood about the challenges and successes of 2010 and what issues stand at the forefront of the industry’s agenda in 2011. The interview was recorded during the National League playoffs off between the Philadelphia Phillies and the San Francisco Giants. At the end of the interview, we ask the Philadelphia born Greenwood for his World Series prediction. As a San Francisco-based publication, we have decided to leave this in unedited because it still makes us chuckle. From all of us at The Burrill Report we wish you a happy, healthy, and prosperous New Year.
The Burrill Report (December 27, 2010): Prometheus Ruling Boosts Patents on Diagnostics (.MP3,10.76 Mb)
A U.S. Federal Court of Appeals has ruled that Prometheus Laboratories test for determining the proper dose of a drug for a specific patient with certain gastrointestinal ailments is patentable. Promethus had charged in a lawsuit that the Mayo Clinic infringed on two of its patents underlying its test, but a lower court ruled the patents were invalid because they failed to meet the standards of what is patentable. The decision comes at a time of heightened legal activity around the question of patentability for diagnostics. We spoke to Ken Chahine, visiting professor of law at the University of Utah, about the ruling, what it means for the diagnostics industry, and what it effect it will have on other cases winding their way through the courts.
The Burrill Report (December 20, 2010): What a Judge's Ruling Means to Healthcare Reform (.MP3,8.46 Mb)
On December 13, a Federal judge in Virginia struck down as unconstitutional a key provision of the healthcare reform legislation passed earlier this year. Judge Henry Hudson of the Federal District Court in Richmond said the law’s mandate that people get insurance exceeded the powers granted to Congress under the Commerce Clause. We spoke to Tevi Troy, former deputy secretary of the U.S. Department of Health and Human Services in the Bush Administration and a visiting senior fellow at the Hudson Institute, about the ruling, what it means for the future of healthcare reform, and what the decision will do to ongoing efforts to dismantle the legislation.
The Burrill Report (December 13, 2010): Kindler Out, Read In at Pfizer (.MP3,8.86 Mb)
Jeff Kindler’s sudden retirement as CEO of the drug giant Pfizer stunned the industry. Kindler leaves Pfizer at a critical time for the company as it braces for the loss of billions in revenue as patent protection expires on its best-selling drug Lipitor among others. Ian Read, group president of the worldwide biopharmaceutical business, has taken over the post of CEO. We spoke to Adam Feuerstein, senior columnist for TheStreet.com about Kindler’s departure, the selection of Read, and what it will take to make Pfizer the envy of the industry once again.
The Burrill Report (December 6, 2010): As Battle Readies, Industry, Public Question User Fees (.MP3,12.59 Mb)
Members of the life sciences industry don’t think the user fees it pays regulators to review its products accelerate the process. At the same time, consumers think fees from industry should not be used to speed drug reviews and have waning trust for the U.S. Food and Drug Administration in the face of high profile product recalls, a new survey finds. The survey from the tax and advisory firm PwC and the San Diego-based regional trade group Biocom points to a disconnect between the industry, consumers and the FDA as renewal of the Prescription Drug User Fee Act, set to expire in 2012, moves to the top of the policy agenda for the industry. We spoke to Mike Mentesana, pharmaceutical research and development advisory services leader for PwC, about industry frustrations with the pace of drug approvals, the public’s eroding confidence in the agency, and the fight ahead over reauthorization of user fees charged to companies.
The Burrill Report (November 29, 2011): Hey Now You're a Rock Star (.MP3,14.46 Mb)
Blondies’ Debbie Harry and Poison’s Brett Michaels are featured in a new GQ Magazine spread along with some of the world’s leading scientists who are trying to unlock the mysteries of the costliest diseases faced by mankind. The campaign from Geoffrey Beene Gives Back dubbed The Rock Stars of Science kicks off its second year with the spread. We spoke to Meryl Comer, organizer of the campaign, about the origins of the Rock Stars of Science, the public conversation it is seeking to spark, and the potential societal costs that comes from people knowing Britney Spears, but not Francis Collins.
The Burrill Report: (November 22, 2010): StemCells Seeks Human Clinical Trial in Spinal Cord Injury (.MP3,17.29 Mb)
StemCells has filed an application with Swiss regulators to conduct a clinical study of its neural stem cell therapy to treat patients with chronic spinal cord injury in Switzerland. The move puts StemCells in a race with Geron and Neuralstem to bring stem cell-based therapies as treatments for these patients to market. We spoke to Martin McGlynn, president and CEO of StemCells, about the study, what the company has learned from a previous human clinical trial of its therapy in Battan disease, and how its approach differs from its competitors.
The Burrill Report: (November 15, 2010) Republicans Get Ready to Play Healthcare Reform Jenga (.MP3,10.78 Mb)
Congressional Republicans, emboldened by big victories in the mid-term elections and a new majority in the House of Representatives, are vowing to repeal healthcare reform. While such efforts are unlikely to succeed with a Democratic majority in the Senate and President Obama and his veto pen still in the White House, Republicans are exploring different tactics to dismantle or undo the legislation. We spoke to Tevi Troy, former deputy secretary of Health and Human Services in the Bush Administration and a visiting senior fellow at the Hudson Institute, about the newly elected Congress, what it means for healthcare reform, and why Republicans may face challenges moving from symbolic to substanative battles over the legislation.
The Burrill Report (November 8, 2010): A U.S. Policy Reversal on Gene Patents (.MP3,12.87 Mb)
The evolving legal battle over the patentability of genes heated up recently when the U.S. Department of Justice stepped into the Myriad Genetics case with an amicus brief that argues as products of nature, genes should not be patentable. The brief breaks with long-standing federal policy on gene patents and adds to the concerns of the biotechnology industry that sees such protections as critical to the ability of the industry to attract investors. We spoke to Ken Chahine, visiting professor of law at the University of Utah, about the DOJ’s brief, the argument the government is making, and what affects this could have on the outcome of the case and the future of the industry.
The Burrill Report (November 1, 2010): Yanking Pharma's Supply Chain (.MP3,15.48 Mb)
The globalization of the life sciences business is raising new concerns for the industry. As companies increasingly look to contract manufacturing organizations overseas or to the growth opportunities in emerging markets, they are finding a need to implement new types of controls and having to protect against counterfeiting, product diversions, and the theft of intellectual property. A new report from Axendia Research and co-sponsored by PriceWaterhouseCoopers highlights these issues. We spoke to Wynn Bailey, pharmaceutical and life sciences advisory services partner for PwC, about the drive towards globalization, the challenges it’s creating for the life sciences industry, and why companies need to change their approach to outsourcing.
The Burrill Report (October 25, 2010): Why Medtech Needs to Reinvent Itself (.MP3,12.58 Mb)
The medical technology industry struggled to sustain historic rates of revenue growth in 2009, but managed to improve overall net income by nearly 11 percent. In fact, the medtech industry has fared better than any other in the current economic downturn. Nevertheless, new challenges will put increasing strain on the industry’s long-standing business model, according to Ernst & Young's just issued annual report on the industry. We spoke to John Babbit, Ernst & Young's Medtech Leader for the Americas, about the challenges the industry faces, why medtech companies need think about opportunities in emerging markets, and why they will need to embrace new business models to succeed in the changing environment.
The Burrill Report (October 18, 2010): A Call to Arms for Personalized Healthcare (.MP3,15.11 Mb)
Though much has been made about a new era of personalized healthcare that shifts the practice of medicine from a focus on treating disease to one of prevention and wellness, many impediments remain in turning that vision into a reality. David Ewing Duncan, director of the Center of Life Science Policy at the University of California, Berkeley and author of Experimental Man, is addressing that with a “call to arms.” With financial backing from the Kauffman Foundation, Duncan unveiled a Personalized Health Manifesto at the Translational Medicine Alliance Forum with the hope of catalyzing scientists, healthcare providers, and policymakers to bring about needed action to bridge gaps that prevent the incorporation of personalized health into the healthcare system. We spoke to Duncan about the challenges ahead, how to craft economic incentives to change the way doctors practice, and why altering personal behaviors may be the toughest piece of the puzzle to solve.
The Burrill Report (October 11, 2010): Emerging Biotechs Grapple with Financing Challenges (.MP3,10.12 Mb)
Despite the improved economic environment compared to a year ago, the mood seemed a tad glum at this year’s BIO Investor Forum as relief about the worst of the financial downturn being over has given way to the reality of a prolonged period of financing challenges for emerging biotechs. We spoke to Rachel King, CEO of GlycoMimetics and former chair of the Biotechnology Industry Organization’s Emerging Companies Governing Body. We discussed the financial challenges biotech’s face, the changing demands from venture investors, and what a company needs to do today to ensure it has adequate financing to be successful.
The Burrill Report (October 4, 2010): Seeing an Opportunity in Biosimilars (.MP3,13.66 Mb)
As the FDA readies for hearings in November on the pathway for biosimilars, companies are already eyeing new market opportunities. One company positioning itself to capitalize on the introduction of biosimilars in the United States is Antares Pharma. Antares believes its technology for patient self injection will be a critical market differentiator for companies looking to introduce biosimilars. We spoke to Paul Wotten, president and CEO of Antares, about how the market for biosimilars will likely differ from that of small molecule generics, what the company’s experience has been in Europe with its partner Teva, and why companies will not be able to rely on price alone as a way to differentiate themselves.
The Burrill Report (September 27, 2010): How Will the FDA Decide A Biosimilar is Enough Like the Real Thing (.MP3,16.61 Mb)
The U.S. Food and Drug Administration plans to hold two days of public hearings in November to discuss how it will review so-called biosimilars, alternative versions of biologics that have gone off-patent. Unlike generic drugs, which are copies small molecules that are chemically-synthesized, the molecular complexity of biologics and the fact that they are produced by living cells raises challenges for the regulator on how to determine that a biosimilar is as safe and efficacious as the original product. We spoke to Kay Holcombe, senior policy advisor for Genzyme, about the upcoming hearings, what the most contentious issues will likely be, and why there’s more at stake for the industry than just a possible financial hit from lower priced competition.
The Burrill Report (September 20, 2010): Crafting an Innovation Agenda (.MP3,11.11 Mb)
A group of venture investors and life sciences entrepreneurs have launched a new policy group they say will be focused on advancing medical innovation in the United States. The group, the Medical Innovation and Competitiveness Coalition, is meant to address an agenda that sometimes is neglected or ignored by the large life sciences trade groups. We spoke to Kelly Slone, a member of the steering committee of the coalition about the new group, policy areas of concern, and why they think it is needed today.
The Burrill Report (September 13, 2010): What's in Store for the 2010 Home Stretch (.MP3,11 Mb)
It’s been a bumpy road for biotech in 2010, but as we head into the home stretch investors are looking at a long list of upcoming events that could spark movement in biotech stocks. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about his recent Fall Preview for the publication. Feuerstein discusses the ongoing dance between Sanofi and Genzyme, the race for a new obesity drug, and what events are expected to occur before year end that may deliver some punch to the sector.
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.
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.
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 Burrill Report (May 24, 2010): Transforming the Life Sciences Labor Force (.MP3,12.04 Mb)
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.
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 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.
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 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.
The Burrill Report (April 12, 2010): BIO Readies To Address Big Issues in the City of Big Shoulders (.MP3,9.53 Mb)
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.
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.
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.
The Burrill Report (March 15, 2010): Convergence of Technologies Transforms Healthcare (.MP3,7.49 Mb)
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.
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.
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.
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.
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.
The Burrill Report (February 1, 2010): With Healthcare Reform Uncertain, BIO's Policy Fights Remain (.MP3,9.31 Mb)
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.
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.
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.