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.

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.

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.

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.

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.

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.

 

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.

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.

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.   

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.

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 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.

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.

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 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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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 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.