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The Burrill Report (December 31, 2012): Taking Stock: 2012, the JPMorgan Healthcare Conferece, and Beyond (.MP3,14.2 Mb)
As the life sciences industry readies for the annual JPMorgan Healthcare Conference in San Francisco, we take look back at last year and ahead to what we’ll be watching in 2013. We spoke to Adam Feuerstein, senior columnist for TheStreet.com about winners and losers of 2012, the year in new drug approvals, and what to look for at the JPMorgan Healthcare Conference and beyond.
The Burrill Report (December 24, 2012): Removing IP Barriers to Innovation (.MP3,13.16 Mb)
As drug developers look to changing models of collaboration to address flagging R&D productivity, intellectual property may pose a barrier to realizing the full benefits of the new approaches. Garret FitzGerald, director of The Institute of Translational Medicine and Therapeutics at the University of Pennsylvania’s Perelman School of Medicine, argues current management of intellectual property constrains interaction between industry and academia. We spoke to FitzGerald about how drug development is changing, lessons to be learned from other industries, and why the industry’s approach to intellectual property needs to change.
The Burrill Report (December 17, 2012): Measuring Returns from Innovation (.MP3,16.72 Mb)
The top pharmaceutical companies brought 30 percent more drugs to market in the past two years than the previous two, but at the same time saw a 30 percent drop in the total value of newly commercialized drugs, according to a new report from Deloitte and Thompson Reuters. But there’s reason for optimism because of a significant increase to both the value and volume of late-stage pipelines. We spoke to Julian Remnant, principal in life sciences R&D Strategy for Deloitte in Europe, and Neil Lesser Principal for Deloitte, about the new report, how pricing pressures and new development strategies may be affecting value of drugs in development, and what the future of R&D looks like for the industry.
The Burrill Report - Sponsored Podcast - The Virtual Scientific Workplace (.MP3,9.43 Mb)
Economic pressures and an increasing scarcity of expertise is leading companies to embrace new virtual networks models to draw on skilled scientific workers from around the globe to collaborate and share knowledge. In this final part of a three-part series of podcasts by The Burrill Report, produced in conjunction with Kelly Services, Harvey Yau, product manager for Kelly Services Americas Scientific Product Group, discusses the emergence of virtual networks in the life sciences, the benefits they provide, and what companies will need to do to be successful with these new workplace models.
The Burrill Report (December 10, 2012): FDA Touts Its Record on Approvals (.MP3,10.96 Mb)
The U.S. Food and Drug Administration approved 35 new drugs in fiscal 2012, according to a report from the agency that finds all but one of those were approved within their target dates for action. What’s more is about one-third of those drugs were approved under the agency’s Fast Track designation. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner about the new report, challenges the agency faces, and whether the improved performance reflects changes at the FDA, or better quality submissions from the industry.
The Burrill Report - Sponsored Podcast - 2020: The New World of Work (.MP3,11.69 Mb)
An evolution of the traditional employer–employee relationship, the emergence of highly technical groups of professional banding together in work groups, and the rise of virtual work environments where scientific professionals collaborate across the globe represents some of ways the workforce is transforming. In this second of a three part series of podcasts by The Burrill Report, produced in conjunction with Kelly Services, Allison Kerska, vice president of global accounts for Kelly, discusses the growing trends among skilled life sciences workers to act as free agents, how workplace models are evolving, and why life sciences companies will need to adapt to these changes to remain competitive globally.
The Burrill Report (December 3, 2012): Fiscal Cliff Threatens the Life Sciences Industry (.MP3,12.89 Mb)
As the U.S. government races toward the fiscal cliff, the lame duck Congress must reach an agreement on spending reductions and tax increases or face the trigger of $1.2 trillion in across the board budget cuts. The battle underway could have significant consequences for the life sciences industry. We spoke to David Gollaher, CEO of the California Healthcare Institute, about how sequestration will impact everything from the National Institutes of Health to the U.S. Food and Drug Administration, the likelihood of a resolution before year end, and what’s at stake for the life sciences industry.
The Burrill Report - Sponsored Podcast - No Longer a Working Experiment (.MP3,11.4 Mb)
From the largest pharmaceutical companies to the smallest labs performing research and development, pressures to do more with less, as well as advances in communications technology, and the desire among skilled workers for greater freedom and flexibility, is dramatically altering the scientific workplace. In this first of a three part series of podcasts by The Burrill Report, produced in conjunction with Kelly Services, Mark Lanfear, global life sciences leader for Kelly, discusses the rise of the free agent, emerging new workplace models, and why organizations need to embrace these workforce trends.
The Burrill Report (November 26, 2012): Questioning Values (.MP3,17.31 Mb)
The move of healthcare systems around the world to value-based care from fee-for-service models is adding to the financial pressures the pharmaceutical industry faces. Drugmakers will need to rethink their approach to R&D, clinical strategies, and sales and marketing as physicians, patients, and payers demand proof that their new products deliver value for the money. We spoke to Steve Arlington, global pharmaceutical and life sciences advisory leader at PriceWaterhouseCoopers, about the firm’s new Pharma 2020 report, what drugmakers will need to do to drive product success, and why, despite all of the challenges the industry faces, he remains optimistic.
The Burrill Report (November 19, 2012): QB3's Grandest Experiment Pays Off (.MP3,15.95 Mb)
The University of California’s QB3 is the home of cutting edge life sciences research, but perhaps its greatest experiments are focused on finding new ways for academia to work with industry and creating new resources for entrepreneurial faculty and students to launch their own companies. A recent case study in Science Translational Medicine reviews the success QB3 has had in launching startups. We spoke to Doug Crawford, director of industry alliances and Associate Executive Director of QB3, about its notion of the responsibility scientists have to improve the nation’s economic well-being when they accept federal funding, steps the institute has taken to foster new company formation at the university, and what to make of the recent proliferation of industry-academic alliances in the life sciences.
The Burrill Report (November 12, 2012): A Step Closer to Diagnostic Makers Getting Paid for Value (.MP3,12.15 Mb)
New regulations scheduled to take effect in 2013 will provide reimbursement for molecular diagnostics based on the function they perform rather than the process thanks to the implementation of a new coding system by the Centers for Medicare & Medicaid Services. Though the changes are welcomed by diagnostic makers, it represents just part of an ongoing fight for the industry to get paid for the value its tests provide. We spoke to Bruce Quinn, senior health policy analyst at the law firm Foley Hoag about the new codes, why they matter so much to payers and the industry, and what diagnostics firms will need to do to get paid for value going forward.
The Burrill Report: (November 5, 2012): Outlook for U.S. Research Funding Grows Grim (.MP3,15.44 Mb)
Biomedical and health research and development spending in the United States fell by more than $4 billion in fiscal 2011 according to the nonprofit education and advocacy group Research America!. It was the first drop in spending since the group began tracking it in 2002. The situation is likely to grow grimmer as deep budget cuts under sequestration could hit in the new year. We spoke to Mary Woolley, president and CEO of Research America! about the United States investment in biomedical research, the likelihood for a lame duck Congress to take action to avoid across the board cuts, and what effects the election could have on research spending.
The Burrill Report (October 29, 2012): How A Troubled Drugmaker Reinvented Itself (.MP3,15.41 Mb)
A U.S. Food and Drug advisory panel earlier this month unanimously recommended the agency approve NPS Pharmaceuticals’, Gattex, an experimental drug to treat the rare condition known as short bowel syndrome. Short bowel syndrome is a disorder in which the body is unable to absorb enough nutrients and fluids through the gastrointestinal track to sustain life. The move toward approval represents a dramatic reversal for NPS, which in the past several years has completely remade itself after an FDA setback in 2006. We spoke to Francois Nadar about the company’s shift in focus to rare diseases, why he embraced an outsourcing model, and what other companies can learn from NPS’ experience.
The Burrill Report (October 22, 2012): Harnessing Data to Improve Care (.MP3,18.27 Mb)
The health insurance giant Aetna recently launched Aetna Innovation Labs, an effort to harness all of the data at its disposal and translate it into actionable information to cut costs and improve care. Through its Innovation Labs, Aetna is testing specific initiatives to do such things as improve prediction and intervention, as well as determine the best treatment for individual patients. We spoke to Michael Palmer, head of Aetna Innovation Labs, about the effort, the challenges it faces, and what it will take to move personalized medicine into clinical practice.
The Burrill Report (October 15, 2012): Open Science and Reinventing Discovery (.MP3,13.23 Mb)
Not long ago, the barriers to conducting drug discovery research stood high. Today, thanks in part to the Internet and the advent of research exchanges, anyone with a laptop and access to funding can embark on the search for a cure for what ails them. We spoke to Kevin Lustig, CEO of the online pharmaceutical research marketplace Assay Depot, about how both public and private exchanges like his are empowering citizen scientist, revamping Big Pharma R&D, and not only addressing rising cost of drug discovery, but perhaps the problem of flagging innovation as well.
The Burrill Report (October 8, 2012): Medtech Ready to Outshine Pharma (.MP3,11.98 Mb)
The medtech industry, long overshadowed by the pharmaceutical industry, is expected to grow at a much faster rate than pharma, according to a new report from EvaluatePharma. EvaluateMedTech World Preview 2018 forecast growth of 4.4 percent a year to $440 billion by 2018. We spoke to Anthony Raeside, head of research for EvaluatePharma, about the new report, what’s driving growth for the medtech industry, and why Big Pharma may become a big acquirers of some of these companies.
The Burrill Report (October 1, 2012): MD Anderson Launches $3 Billion Moon Shots Program Against Cancer (.MP3,17.71 Mb)
The University of Texas MD Anderson Cancer Center is launcing what its dubbed its Moon Shots Program, an ambitious $3 billion effort over ten years to cut cancer deaths. The program is focused translating discoveries into new diagnostics, drugs, devices, and policies that can lead to new ways to prevent, detect and even cure cancer. We spoke to Ron DePinho, president of MD Anderson, about the program, its goal-oriented focus, and why he thinks we may be at a unique point in the history of the fight against cancer to radically alter our relationship to the disease in the next several years.
The Burrill Report (September 24, 2012): Will Biotech Double Life Expectancy? (.MP3,15.4 Mb)
With a new understanding of the biology of aging, we may be on the cusp of pushing life expectancy to ages once considered unimaginable. Journalist and author David Ewing Duncan in his book When I’m 164, examines the potential technologies that could lead us to radical life extension and some of the consequences should science bring about a dramatic demographic shift. We spoke to Duncan about his book, how close we are to scientific advancements in the area, and why not everyone wants to live forever.
The Burrill Report (September 17, 2012): Opexa Returns to the Clinic with Personalized Immunotherapy for MS (.MP3,17.68 Mb)
Opexa Therapeutics has returned to the clinic with its Tcelna, a personalized immunotherapy derived from a patient’s own T-cells to treat multiple sclerosis. After more than three years since its last clinical trial, the company has been refining its clinical strategy, building clinical and manufacturing capabilities, and strengthening its ranks. We spoke to Neil Warma, CEO of Opexa, about Tcelna, why the company has decided to target secondary progressive multiple sclerosis as its lead indication, and the benefits and challenges of a personalized therapy for MS.
The Burrill Report (September 10, 2012): Creating Personalized Medicine Bit by Bit (.MP3,17.93 Mb)
Personalized medicine is taking hold and leading to better therapies for patients. But the real promise of personalized medicine lies in its ability to not only personalize treatment, but predict and prevent disease, and allow for early interventions. We spoke to Alexis Borisy, partner with Third Rock Ventures, about the state of personalized medicine, the exploding world of data that needs to be harnessed to transform healthcare, and the challenges ahead.
The Burrill Report (September 4, 2012): Alnylam Plants Its RNAi Technology with Monsanto (.MP3,19.31 Mb)
Alnylam has been working to develop a new class of therapeutics that harnesses RNA interference, a naturally occurring biological process to regulate genes. But a new strategic alliance with the agbio giant Monsanto is pushing the technology into new uses. The agreement gives Monsanto worldwide exclusive rights to use Alnylam’s technology and intellectual property over a 10-year period. In exchange, Alnylam gets $29.2 million in upfront payments, as well as potential milestones and royalties. We spoke to Laurence Reid, chief business officer of Alnylam, about the agreement, how Monsanto is expected to use the technology, and what it means for advancing Alnylam’s own efforts in therapeutics development.
The Burrill Report (August 27, 2012): Feeling Love for Orphans (.MP3,10.22 Mb)
Orphan drugs, which are developed to treat rare diseases, are being recognized for their big market potential. A new study from Thomson Reuters finds that not only is orphan drug growth outpacing the growth of non-orphan drugs, but that the lifetime revenue potential for these drugs rivals the lifetime revenue potential for drugs targeting more common health conditions. We spoke to Kiran Meekings, life sciences consultant at Thomson Reuters, about the new report, what’s driving the industry’s interest in orphan drugs, and why they represent promising opportunities for growth.
The Burrill Report (August 20, 2012): Putting Academic Research to the Test (.MP3,16 Mb)
A crisis in academic research is brewing as some estimates suggest the majority of research from academic labs can’t be reproduced. That has serious consequences for biopharmaceutical companies that spend significant time and money pursuing promising new drug targets only to find they can’t validate them. Now the scientific services marketplace Science Exchange, along with the open access journal PLoS, and the open data repository Figshare have launched the Reproducibility Initiative to address the problem. We spoke to Elizabeth Iorns, CEO and co-founder of Science Exchange, about the problem, how the initiative seeks to address it, and what it will take to get academic researchers to submit their work to this new type of scrutiny.
The Burrill Report (August 13, 2012): Pharma Heads Back to School (.MP3,12.35 Mb)
Plagued with poor R&D productivity and the loss of revenue from blockbusters going off patent, top pharmaceutical companies have increasingly turned to alliances with universities to cure what ails them. The announced agreement between Novartis and the University of Pennsylvania over a cancer immunotherapy is among the most recent of growing list of partnerships. We spoke to Stewart Lyman, owner and manager of Lyman BioPharma Consulting in Seattle, about the trend, whether it will solve Big Pharma’s needs, and what the implications are for biotech.
The Burrill Report (August 6, 2012): Regulate Me (.MP3,14.96 Mb)
The personal genetics company 23andMe said it has delivered its first round of 510(k) documentation to the Food and Drug Administration in an effort to win FDA clearance for aspects of its personal genome service. The company says it is the first in the industry to announce it is working towards FDA clearance. We spoke to Dan Vorhaus, editor of The Genomics Law Report and an attorney with Robinson Bradshaw and Hinson, about 23andMe’s decision to seek FDA clearance, why the company is taking the unusual step, and what the regulatory process might look like for 23andMe and others that follow.
The Burrill Report (July 30, 2012): Building a Better Cancer Drug (.MP3,19.83 Mb)
New cancer therapies are expanding an ever-more powerful arsenal of targeted drugs against variations of the disease, but problems of toxicity often limit their use. Genzyme founder Sheridan Snyder and Chris Liang, who played a key role in the development of the cancer drug Sutent, launched Xcovery in 2006 with the hope of building better molecules. The company’s lead therapeutic, now in early-stage clinical testing, is essentially a safer version of Sutent. We spoke to Samuel Broder, senior Scientific and Clinical Strategist for Xcovery, about the challenges toxicity poses in cancer therapies, how this limits not only dosing but combination therapies, and how Xcovery’s approach to altering existing drugs can make them safer or enhance other properties.
The Burrill Report (July 23, 2012): Confidence Shaken (.MP3,13.96 Mb)
By nature and necessity, venture capitalists are an optimistic breed. So the newly released National Venture Capital Association’s annual confidence survey, conducted with Deloitte, is noteworthy for the sober outlook expressed by respondents. We spoke to Mark Heeson, president of the National Venture Capital Association, about the survey results, why biotech is one of the sectors generating the lowest confidence levels among venture investors, and the geographic difference between where venture investors feel most confident about investing their money and where they feel best able to raise it.
The Burrill Report (July 16, 2012): The Already-Approved Drug Researchers Think Can Combat Aging (.MP3,12.24 Mb)
Rapamycin, an immunosuppressant used to treat transplant and cancer patients, has gotten the attention of researchers who believe the already approved drug may have new uses to combat disease of aging. We spoke to Brian Kennedy, president and CEO of the Buck Institute for Age Research, about our changing understanding of aging, ways we are learning to slow the aging process, and why Rapamycin or related compounds may provide a new means of extending life.
The Burrill Report (July 9, 2012): Rare Disease Community Scores a Big Victory (.MP3,11.8 Mb)
Congress has passed the Food and Drug Administration Safety and Innovation Act, which renews the Prescription Drug User Fee Act for another five years. That allows the FDA to continue to collect user fees from industry to fund the review of new drugs. But perhaps the biggest winner in this new incarnation of PDUFA is the rare disease community, which won significant concessions in the legislation. We spoke to Emil Kakkis, president of the Everylife Foundation for Rare Diseases about the legislation, why rare disease advocates were so successful in shaping the law, and how it will change the landscape for rare disease drug development.
The Burrill Report (July 1, 2012): Overhauling R&D with Nothing but Net (.MP3,13.06 Mb)
Biopharmaceutical research and development needs a new approach that is adaptive, cost-efficient, fast, and open, according to the latest annual Beyond Borders report from Ernst & Young. In it, the firm lays out a new R&D model it calls the “holistic open learning networks.” We spoke to Glen Giovannetti, Global Life Sciences Leader for Ernst & Young about how these networks can address the problems we face in drug development today, how they would work, and what benefits they would provide.
The Burrill Report (June 25, 2012) Seeing a Silver Lining to Big Pharma's Patent Cliff (.MP3,11.58 Mb)
This year we are in the midst of the steepest portion of the patent cliff, with Big Pharma expected to lose protection on $33 billion worth of blockbusters. At this year’s BIO International Convention we caught up with Anthony Raeside, head of research for Evaluate Pharma to discuss his firm’s World Preview 2018 report. We talked about Big Pharma’s failure to get an adequate return on investment in R&D, why he thinks acquisition strategies have been too aggressive, and the patent cliff may not be all bad for the industry.
The Burrill Report (June 18, 2012): Genentech's Big Bet on New Cancer Drugs (.MP3,20.72 Mb)
News of impressive late-stage clinical results for Genentech’s breast cancer antibody-drug conjugate T-DM1 was one of the major stories to emerge from this year’s American Society of Clinical Oncology meeting. It is the most advanced antibody-drug conjugate in Genentech’s growing pipeline of this class of drugs. We spoke to Stuart Lutzker, head of the clinical oncology early development group for Genentech, about the technical challenges antibody drug conjugates pose, their potential, and how the company is leveraging its expertise in monoclonal antibodies to make a big bet on the role these drugs will play in the future of cancer care.
The Burrill Report (June 17, 2012): A Pitch to Employees (.MP3,11.99 Mb)
When representatives from economic development agencies around the world descend on Boston for this year’s annual BIO International Convention, the folks from Research Triangle Park will be taking an unusual tack. Instead of targeting employers, a new campaign from the region seeks to attract employees. We spoke to Jennifer Bosser, assistant executive director from Wake County Economic Development about the new Work in the Triangle Campaign, the thinking behind the strategy, and the global competition for talent today.
The Burrill Report (June 11, 2012): Why Dendreon May Have Felt Less Pain at ASCO than Expected (.MP3,16.21 Mb)
Prostate cancer drugs took center stage at this year’s meeting of the American Society of Clinical Oncology, with Johnson & Johnson Zytiga and Medivation’s Enzalutamide generating excitement. David Miller, president and CEO of Biotech Stock Research, says the news is not all bad for Dendreon, which faces new competititon for its prostate cancer Provenge. We spoke to Miller about the recently concluded ASCO meeting, who the big winners were this year, and why Big Pharma has come to dominate the headlines at the conference.
The Burrill Report (June 4, 2012): Will Reimbursement Be the Next Major Policy Fight for BIO? (.MP3,15.68 Mb)
Last year at the BIO International Convention, BIO CEO Jim Greenwood unveiled an ambitious five-year policy agenda for the organization that ranged from tax breaks that would make investment in high-risk biotechs more attractive to FDA reform. The document seemed that much more audacious given the mood in Washington to clamp down on spending. One year later as BIO gets ready for its annual convention in Boston, the group can boast of substantial victories. We spoke to Greenwood about the policy agenda, what progress has been made, and what the priorities for the industry will be in the year ahead.
The Burrill Report (May 29, 2012): Wall Street Turns Its Eyes to ASCO (.MP3,12.1 Mb)
Wall Street will be watching when cancer specialists from around the world gather in Chicago June 1 to 5 for the annual meeting of The American Society of Clinical Oncology. Investors take keen interest in the ASCO proceedings in hopes of gaining insight into which cancer therapies moving through clinical trials will be successful. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about the ASCO, what the already-released abstracts are telling us, and what companies to watch as the meeting gets underway.
The Burrill Report (May 21, 2012): A Venture Investor Cries Mea Culpa (.MP3,15.78 Mb)
Much has been made in recent years about the venture capital model being broken. Returns over the past decade, despite some high profile successes, have left investors generally disappointed. The Ewing Marion Kauffman Foundation, which has invested in venture capital funds for more than 20 years, conducted an analysis of its own investments and concluded that it is the limited partner model that’s broken. We spoke to Diane Mulcahy, director of private equity for the Kauffman Foundation, about its report, why the foundation finds venture capital funds and their LPs interests are often misaligned, and what needs to be done to fix the problem.
The Burrill Report (May 14, 2012): Keeping Score at the FDA (.MP3,13.92 Mb)
The U.S. Food and Drug Administration’s performance in its review of new drug applications varies widely depending on the therapeutic area involved, according to a new report from the California Healthcare Institute and the Boston Consulting Group. The report suggests that the agency could learn from areas in which it is high performing to improve its approach in others. We spoke to David Gollaher, CEO of the California Healthcare Institute, about the report, why the numbers used to track FDA performance may provide an incomplete picture, and the need for new measures of success.
The Burrill Report (May 7, 2011): Protalix Approval a Win for Its Manufacturing Technology (.MP3,12.04 Mb)
Protalix BioTherapeutics and Pfizer on May 1 recived U.S. Food and Drug Administration approval to begin marketing Eleylyso for the treatment of Gaucher disease, a rare inherited lysomal storage disorder affecting about 10,000 people worldwide. The approval puts the two companies in direct competition with Sanofi’s Genzyme and its drug Cerezyme. The approval, the first for Protalix, is a big victory because it serves as a proof-of-concept for the company’s manufacturing, which uses plant cells, rather than mammalian, cells. We spoke to David Aviezar, CEO of Protalix, about the approval, the advantages the company’s manufacturing process offers, and the company’s strategy to pursue biosimilars.
The Burrill Report (April 30, 2012): Saying "No" to an IPO (.MP3,18.23 Mb)
Argos Therapeutics recently completed a $25 million financing round to advance its personalized immunotherapy as a treatment for kidney cancer. The company had hoped to raise $86.3 million in an IPO, but pulled that deal last month after it decided it wasn’t willing to sell stock at prices that public market investors were willing to pay. We spoke to Jeff Abbey, CEO of Argos, about the reception biotech companies receive on Wall Street today, the difficult calculus they face in deciding whether to take what they can get or seek alternative sources of funding, and with less money than they will need to commercialize their lead product, what the path forward for Argos looks like from here.
The Burrill Report (April 23, 2012): Funding Early-Stage Companies with Radical Technologies (.MP3,12.69 Mb)
The Thiel Foundation recently announced the first grants awarded through its Breakout Labs, a revolving fund created to help finance early-stage companies pursuing radical goals in science and technology. A total of six companies received grants of up to $350,000 each. We spoke to Hemai Parthasarathy, science director of Breakout Labs, about the goals behind organization, the problem it’s trying to address, and how it goes about deciding a company is worthy of receiving one of its grants.
The Burrill Report (April 16, 2012) What's Ahead for Biotech Stocks (.MP3,11.65 Mb)
Biotech stocks got off to a blazing start in the first quarter as the sector seemed ready to put the ugliness of the second half of 2011 behind it as M&A deals and positive clinical trial results helped lift the sector. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about the winners and losers, what drove the activity, and what to be watching in the second.
The Burrill Report (April 9, 2012): Forging a Launch Pad for Emerging Growth IPOs (.MP3,16.26 Mb)
On April 5, President Barack Obama signed into law The JOBS Act, legislation intended to provide easier access to public markets for emerging growth companies. The law lowers the cost and regulatory burdens these companies face in raising capital and being public by providing exemptions to existing securities regulations. We spoke to James Lebovitz, corporate and securities partner with the law firm Dechert, about the new law, what it actually does, and what it will mean to capital hungry life sciences companies looking to go public.
The Burrill Report - Sponsored Podcast - How Free Agents are Reshaping the Life Sciences (.MP3,14.38 Mb)
What will the employees of a scientific company look like in 10 or 20 years? That question is explored in a new white paper from Kelly Scientific Resources, which sees life sciences companies using highly skilled contingent workers in new ways. We spoke to Alan Edwards, vice president and product leader for Kelly Services and author of the white paper, about how the life sciences laborforce is changing, why companies will need to think differently about how they recruit and manage highly skilled science workers, and the strategic benefits these new ways of working provide to both skilled labor and employers.
The Burrill Report (April 2, 2012): Understanding the Shifting Patent Landscape (.MP3,11.84 Mb)
The intellectual property landscape for life sciences companies is in flux. A recent U.S. Supreme Court ruling that invalidated a Prometheus Laboratories patent has diagnostic makers struggling to understand its ramifications. The Indian government’s compulsory license for Bayer’s patented cancer drug Nexavar has drugmakers thinking about how to protect their intellectual property in emerging markets. And patent reform, passed six months ago, still brings uncertainty and change to the industry. We spoke to Courtenay Brinckerhoff, partner with Foley & Lardner, about these developments, how significant these changes are, and whether life sciences companies need to rethink their IP strategies.
The Burrill Report (March 26, 2012): Healthcare Reform Gets Its Day in Court (.MP3,14.75 Mb)
On March 26, the U.S. Supreme Court will begin hearing oral argument on the Patient Protection and Affordable Care Act, the Obama administration’s landmark healthcare reform law passed in 2010. The court will consider several constitutional challenges to the law and could let it stand, strike down all or part of it, or simply put off taking action. We spoke to Tevi Troy, senior fellow at the Hudson Institute and former deputy secretary of the U.S. Department of Health and Human Services in the Bush Administration about the case, what the issues are before the court, and why any ruling from the Supreme Court won’t end the fight over healthcare reform.
The Burrill Report (March 19, 2012): California Cigarette Tax Could Ignite Cancer Research (.MP3,11.58 Mb)
California voters in June will decide on Proposition 29, a measure that would generate more than $700 million a year for cancer research and anti-smoking efforts through a new $1 a pack tax on cigarettes. The measure is opposed by tobacco companies, as a “$735 million tax hike” that is “flawed and poorly drafted,” but proponents including patient advocacy groups and universities argue it will bring significant health and economic benefits to the Golden State. We spoke to Jim Knox, vice president of legislative advocacy for the American Cancer Society and a member of the Yes on 29 board, about the proposition, what passage could mean to cancer research, and what it would do for California’s status as a center for biomedical innovation.
The Burrill Report (March 12, 2012): The Single Biggest Opportunity to Improve Health Outcomes (.MP3,14.95 Mb)
An epidemic of chronic diseases, aging populations, and changing lifestyles that come with growing prosperity in emerging economies are threatening to overwhelm healthcare budgets and economic growth. Ernst & Young in its newly issued Progressions report calls changing behaviors the single biggest opportunity to improve health outcomes. We spoke to Glen Giovannetti, Global Life Sciences Leader for Ernst & Young, about the report, the promise of digital health technology to get people to change unhealthy behaviors, and how biopharmaceutical companies themselves will need to change to succeed in this new world of healthcare.
The Burrill Report (March 5, 2012): The Long Journey from the Amazon to the FDA (.MP3,14.14 Mb)
At the end of February, the U.S. Food and Drug Administration notified Napo Pharmaceuticals that it would grant it a priority review for the company’s application to market its experimental drug Crefelomar to treat chronic diarrhea in people living with HIV or AIDS on antiretroviral therapy. Though legal battles continue for the company over its agreement with partners on the drug, the FDA’s acceptance of its application marks a milestone for a drug and a company that have traveled a long and winding trail to get to this point. We spoke to Lisa Conte, CEO of Napo, about the drug that is derived from a tree that’s plentiful in the Amazon, the company’s unusual development model, and the potential for the drug beyond its initial indication.
The Burrill Report (February 27, 2012): A Push for Accelerated Approvals (.MP3,13.62 Mb)
Two separate bills seeking to provide accelerated approval for certain drugs have began their trek through the legislative process in Congress. The first, known as TREAT, comes from Democratic Senator Kay Hagen of North Carolina. It would accelerate approval of drugs for unmet medical needs, that significantly advance the standard of care, or are highly targeted for distinct sub-populations. The other, known as ULTRA, was introduced by Republican Representative Cliff Stearns of Florida and Democrtic Representative Ed Towns of New York, and seeks to accelerate approval for therapies for ultra rare diseases. We spoke to Emil Kakkis, founder of the EveryLife Foundation for Rare Disease and CEO of Ultragenyx Pharmaceuticals, about both bills, how they fit into the renewal of the prescription drug user fee act, and what it will take to get them passed.
The Burrill Report (February 20, 2012): Will Obama's Budget Hinder Innovation? (.MP3,15.66 Mb)
President Obama proposed budget for fiscal 2013 created concerns among researchers, the pharmaceutical industry, and patient advocates. Under it, NIH funding would remain flat, industry would shoulder a greater share of FDA’s expenses, and pharmaceutical companies would kick in an additional $156 billion in Medicare Part D rebates over the next 10 years. We spoke to Margaret Anderson, executive director of FasterCures, about the President proposed budget, what it means for research and development, and what can be done to ensure pressure to cut spending doesn’t hinder innovation.
The Burrill Report (February 13, 2012): Can the FDA Get California's Biotech Sector Growing Again? (.MP3,14.85 Mb)
After two decades of steady job growth, employment in California's biomedical industry stalled while the state has struggled to recover from the deep global recession, according to the 2012 California Biomedical Industry Report from the California Healthcare Institute, BayBio, and PwC. California is the source of more than a quarter of the nation's biomedical pipeline and remains a world leader of new innovation in the life sciences, but California's biomedical companies are expanding their out-of-state and foreign operations. We spoke to David Gollaher, CEO of the California Healthcare Institute, about the state of California’s biomedical industry, how companies are coping with the growing risk aversion of investors, and how the regulatory environment in the United States has both companies and investors turning away.
The Burrill Report (February 6, 2012): Fixing Drug Development with the Wisdom of Crowds (.MP3,14.48 Mb)
Transparency Life Sciences is betting on the wisdom of crowds when it comes to designing clinical trials. The company believes that it can address problems of falling R&D productivity that have plagued the pharmaceutical industry by using crowdsourcing and digital health technologies to design and conduct clinical trials more efficiently. We spoke to Tomasz Sablinski, CEO of Transparency, about what’s broken in drug development today, what his company is doing to change traditional approaches, and what needs to be done to prove Transparency's model works.
The Burrill Report (January 30, 2012): What's Driving Roche's $5.7 Billion Bid for Illumina (.MP3,15.03 Mb)
Roche’s $5.7 billion hostile bid for the sequencing company Illumina could create a personalized medicine powerhouse capable of not only driving a transformation in the treatment of disease, but its diagnosis as well. Roche has big visions, but the deal has raised some eyebrows. We spoke to Chris Bowe, U.S. Healthcare analyst for Scrip about Roche’s efforts, what it means for personalized medicine, and what some other M&A activity tells us about the industry's changing landscape.
The Burrill Report (January 23, 2012): Can Pharma Cure Its Social Anxiety Disorder (.MP3,15.86 Mb)
The world of social media is transforming the way people seek out healthcare information. Today, 70 percent of people search for health related information online and 43 percent turn to social media to find answers to their health related questions. LiquidGrids is working to help phamamaceutical companies tap into the massive amounts of real-time information being generated on social networks and using these outlets to engage directly with consumers. We spoke to Malcolm Bohm, CEO of LiquidGrids, about how pharmaceutical companies can use social media, the regulatory concerns surrounding it, and what it will take for the industry to throw out its old marketing playbook and use the new tools available to it.
The Burrill Report (January 17, 2012): Why Regenerative Medicine Might Fix Healthcare (.MP3,17.59 Mb)
The rising cost of healthcare is being driven in part by aging populations around the world and the growing incidence of chronic diseases. Some argue that the only way we will reign in cost is through innovation rather than cost cutting care. We spoke to Gil Van Bokkelen, chairman of the Alliance for Regenerative Medicine and Chairman and CEO of Athersys, about the role regenerative medicine can play in addressing these problems, the landscape today, and the challenges these companies face in funding innovative therapies in the current environment.
The Burrill Report: (January 9, 2012): Biotech Investors Get Their War Face on for JPMorgan (.MP3,16.15 Mb)
The annual JPMorgan Healthcare Conference kicks off in San Francisco Monday, January 9, a gathering of the tribes for the biotech industry. Investors and executives will meet in and around the conference to provide updates, talk deals, and take the temperature on the industry. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about how the sector fared in 2011, what to look for at this year’s conference, and what’s ahead for the biotech industry in 2012.