Opexa Therapeutics, which is in mid-stage clinical testing for its personalized immunotherapy for the treatment of secondary progressive multiple sclerosis, has been busy over the past year. The company has completed a number of financings to fund its ongoing clinical trial and entered into a licensing agreement with Merck Serono for its lead therapeutic Tcelna. We spoke to Neil Warma, president and CEO of Opexa, about Tcelna, possible other indications for the experimental therapy beyond MS, and what the environment today is like for smaller biotechs raising money.

Flush with cash, in need of stronger pipelines, and seeking potential cost savings, many life sciences companies are on the hunt for acquisitions. But a new report from L.E.K. Consulting suggests acquisitions are more likely to destroy value than create it. We spoke to Michael Connerty, managing director and partner with L.E.K., about the report, why it’s hard to realize revenue and cost synergies, and what successful companies do to beat the odds.

Stocks hit record highs this year and the IPO market is the best for the biopharmacetucial sector in 13 years, but a new report from Evaluate Pharma’s EP Vantage raises questions about a biotech bubble and notes that the richer valuations are dampening licensing activity. We spoke to Lisa Urquhart, editor of EP Vantage, about the report, the activity during the first half of 2013, and if we are in a bubble, what’s going to pop it.

The approvals of Seattle Genetics' Adcetris in 2011 and Genentech's Kadcyla this year have raised interest in antibody-drug conjugates, a new class of therapeutics that marry the targeting of antibodies with powerful toxic payloads directed at cancer cells. In October, leaders in the field will be gathering in San Francisco to discuss advances in the area. We spoke to Trevor Hallam, chief scientific officer for Sutro Biopharma, about the promise of these drugs, the challenges of making them, and his company’s technology to build a better ADCs.

Some of the world’s deadliest infectious diseases have proven difficult targets for vaccines, but the nonprofit Seattle BioMed is applying systems biology to develop new ways to halt their devastating effects. Such an approach has led to the development of an experimental malaria vaccines that’s showing promise in human clinical testing. We spoke to Stefan Kappe, professor at Seattle BioMed, about the research institute, the benefits of a systems biology approach, and what it will take to commercialize a malaria vaccine.

Matching the right drug to a particular patient’s tumor type, though increasingly common in treating certain types of cancer, is not yet the norm for ovarian cancer patients. The Clearity Foundation is trying to change that by providing ovarian cancer patients molecular profiling of their tumors so their physicians can make more informed treatment decisions. We spoke to Laura Shawver, founder of the organization, about her work, her own experience with the disease, and how the foundation is using personalized medicine to change the way physicians treat patients with ovarian cancer.

Sangamo BioSciences announced in August an agreement to acquire the privately-held gene therapy company Ceregene. The transaction, for about $1 million worth of Sangamo stock upfront, gives Sangamo access to Ceregene’s extensive experience with the delivery of gene therapies, as well as its pipeline, and patent portfolio. We spoke to Edward Lanphier, CEO of Sangamo, about the transaction, its strategic value to the company, and the outlook for gene therapy.

Some folks look at insects and see danger. Others look at flowers and see beauty. Jim Olson looks at such things as spiders and petunias sees a potential new arsenal of weapons against cancer and other diseases. This month, the researcher at the Fred Hutchinson Cancer Research Center launched Project Violet, an effort to develop a new class of therapies derived from nature. To drive and fund the effort, Olson has turned to citizen scientists and crowdfunding. We spoke to Olson about Project Violet, the promise of the new class of drugs he dubs “optides,” and why he’s turned to an unconventional source of funding to shake up drug development.

M&A activity for privately-held life sciences companies is providing a growing number of exits for venture investors, a trend expected to continue, according to a new report from Silicon Valley Bank. The report paints a generally encouraging picture, but also raises concerns, particularly for the funding of early-stage companies. We spoke to report author Jonathan Norris, managing director with SVB Capital, about the future of venture investing in the sector, the effects of the resurgent IPO market on M&A activity, and why big medical device companies should worry about innovation in the sector.

How well the pharmaceutical industry is doing at producing innovative drugs may depend in part on what and how you measure its output. A new study in the August issue of Health Affairs by staffers at the U.S. Food and Drug Administration suggests the industry might be doing better than some believe. We spoke to Michael Lanthier, operations research analyst on the FDA’s economics staff and lead author of the study, about what he found, the importance of looking beyond a simple count of new drug approvals, and why he finds encouraging signs in the data.

The California Institute for Regenerative Medicine plans to spend $70 million over five years to create a network of stem cell clinics to conduct trials in the hopes of accelerating the translation of experimental therapies into available treatments. As part of the plan, a coordinating center will aid the clinics in enrolling patients, managing regulatory hurdles, and become a repository of knowledge about how to best tackle clinical development issues surrounding cell therapies. We spoke to Alan Trounson, president of the voter-created institute, about the role the clinics will play, the gap they seek to fill, and how they fit into the institute’s greater mission.

An outbreak of measles in Wales is calling attention to the lasting impact of a now discredited paper that suggested a link between the MMR vaccine and autism. We spoke to Paul Offit, chief of infectious diseases at The Children’s Hospital of Philadelphia, about the outbreak, the power of fear over reason, and what happens when science and beliefs clash.

Symplmed, a spin out of the biotech Xoma, is trying to radically alter the business model for pharmaceutical companies. What makes the company compelling is not its products, but the way it’s selling them. Symplmed is using technology to change the way drugs are marketed and the way drugmakers interact with patients, providers, and payers. We spoke to Erik Emerson, president and CEO of Symplmed about the company’s approach, what’s wrong with the way drugs are sold today, and the opportunities for drugmakers to provide greater value than their medications alone.

Though the advent of personalized medicine and the changing way doctors treat and manage disease has been most apparent in the area of cancer, new molecular diagnostics are transforming care in many other disease areas. Crescendo Bioscience’s Vectra DA test for rheumatoid arthritis is one such example. We spoke to Crescendo CEO Bill Hagstrom about the test, how it’s changing the way physicians manage and treat RA patients, and how the company has addressed the challenges of adoption and reimbursement.

New York’s Harlem is not generally thought of as a hotbed of biomedical innovation, but a new incubator looking to hatch life sciences startups may soon change that. This fall, Harlem Biospace will launch with $626,000 in backing from the New York Economic Development Corporation. We spoke to Sam Sia, founder of Harlem Biospace and an associate professor of biomedical engineering at Columbia University, about the incubator, the challenges entrepreneurial academics face in New York City, and the environment for biomedical startups in the Big Apple.

Worldwide prescription drug sales in dollar terms fell for the first time in 2012, a result of competition from generic drugs, price controls, and austerity measures in the eurozone. But Evaluate Pharma sees a return to modest growth in 2013 and some encouraging signs for the outlook for the industry longer term. We spoke to Jonathan de Pass, CEO of Evaluate Group, about the company’s newly released World Preview report, the growing importance of biologics as a driver of growth for the pharmaceutical industry, and why both the quantity and quality of newly approved drugs should provide encouragement to investors.

There are some indications that the biopharmaceutical industry has increased its output of innovative products because of the recent uptick in new drug approvals. Bernard Munos, founder of the InnoThink Center for Research in Biomedical Innovation, took a closer look at the drugs that have come to market over the last 12 years to determine how innovative the industry has really been. We spoke to Munos about his recent study in Nature’s Clinical Pharmacology & Therapeutics, what the numbers tells us about innovation in drug development, and whether the industry is addressing the issues that have undermined its ability to innovate in the past.

The health insurance company Cigna announced it has entered into a 10-year agreement with Catamaran, the nation’s fourth largest pharmacy benefits manager. With Cigna’s 8 million customers, the deal secures Catamaran’s place among the nation’s largest PBMs. We spoke to Adam Fein, founder and president of Pembroke Consulting, about the agreement, the importance PBMs like Catamaran play in the world of healthcare today, and what the growing power of these organizations mean to drugmakers.

Johnson & Johnson this month unveiled its new Johnson & Johnson California Innovation Center, one of four regional hubs being established in leading life science clusters. The center will house a diverse team of expert who are focused on forging early-stage collaborations with emerging companies, entrepreneurs, and academic centers. We spoke to Diego Miralles, who heads the center, about how it will operate, some of the deals it’s already made, and whether large pharmaceuticals companies need to change to better recognize and drive innovative products to market.

The University of California’s QB3 has been at the forefront of finding innovative ways to work with industry to address the gap in funding translational research and take steps to ensure promising discoveries don’t languish in university labs. A recent series of agreements at QB3 highlight its continued efforts to do just that. We spoke to Doug Crawford, director of industry alliances and associate executive director of QB3, about the institute’s new agreements with Roche and Bayer, the development of additional incubator space to hatch new startups, and why QB3 has succeeded where others have stumbled.

The American Society of Clinical Oncology’s ASCO 2013 Annual Meeting kicks off in Chicago May 31. Though the meeting attracts cancer researchers and physicians from around the world, it is closely watched by Wall Street for news of clinical trial results that could send stocks soaring or sinking. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about a new class of cancer therapies likely to get big attention at this year’s meeting, what other news will be coming out of the conference, and whether concerns about payers willingness to continue meeting the high price commanded by new cancer therapies becomes a topic of discussion in Chicago.

As the American Psychiatric Association prepares to release the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders, or DSM-5, a long brewing controversy over the work has erupted into the mainstream. We spoke to Allen Frances, professor emeritus at Duke University and chairman of the DSM IV task force, about his criticism of the new manual, the damage he fears it will cause, and what he calls “the medicalization of normal.”

The Obama administration is seeking to bring transparency to the murky area of hospital pricing. The U.S. Department of Health and Human Services recently released data that shows staggering variation across the country and within communities in what hospitals charge for common inpatient services. We spoke to Ron Pollack, executive director of the consumer health organization Families USA, about the data, what it tells us, and why transparency is critical to addressing the high cost of healthcare.

Gene therapy is getting new attention, following the approval in Europe of UniQure’s Glybera, the first gene therapy approved in the western world. We spoke to Elemer Piros, managing director and senior equity research analyst for Burrill Securities, which recently held an institutional investor conference about gene therapy. Piros discussed the state of gene therapy, what progress has been made in the area, and why the field is of growing interest for Big Pharma. Burrill Securities, a division of Burrill & Company, publisher of the Burrill Report, has not received any compensation from companies mentioned in this podcast during the past 12 months, nor are any of the companies Burrill Securities clients.

As healthcare systems move from fee-for-service to value-based models, biotech companies can’t rely on just addressing questions of safety and efficacy, but must consider how payers view the value of their products as well. We spoke to Glen Giovannetti, Ernst & Young’s Global Life Sciences Leader about why companies can’t afford to wait until launching their products to address questions of value, why data is becoming a key driver of value for products, and why most biotech companies remain in denial about operating in the evidence-based world that is emerging.

As the BIO International Convention gets underway in Chicago April 22, the industry’s biggest companies are trading at record highs, the U.S. Food and Drug Administration has picked up the pace of new drug approvals, and potential new products in development offer reasons for enthusiasm. But financing remains challenging, global intellectual property and regulatory issues are growing, and the challenge of securing rewards for innovation remains a concern. We spoke to Jim Greenwood, president and CEO of the Biotechnology Industry Organization, about the state of the industry on the eve of the convention, the policy matters before it, and what’s ahead in the coming year.

Last month, the Centers for Disease Control and Prevention sounded the alarm on “nightmare bacteria” that pose an increasing threat because of their resistance to the strongest weapons in today’s antibiotics arsenal. David Martin, CEO of AvidBiotics, says we’ve created the problem through the ubiquitous use of broad spectrum antibiotics. He thinks the answer to attacking resistant strains of bacteria lies in the use of extremely narrow spectrum drugs. We talked to Martin about Avidocin, his company’s protein antibacterial technology, and how we are moving toward highly targeted precision medicine to combat these infections.

It’s been a year since the JOBS Act became law, easing regulatory demands on emerging growth companies seeking to raise capital through initial public offerings. We spoke to Alan Mendelson, partner at Latham & Watkins and co-chair of the firm’s Emerging Companies Practice and Life Sciences Industry Groups, about the law, how it’s changed the process of going public for life sciences companies, and what’s been learned since its enactment.

The U.S. Supreme Court recently heard oral arguments in a case that could put an end to so-called pay-for-delay settlements between branded pharmaceutical makers and their generic competitors.  Critics of these agreements argue that they are anticompetitive, costing consumers billions of dollars by delaying competition from entering the market. Others, though, say that these agreements benefit consumers because they actually bring generic drug competition to the market faster. We spoke to Gregory Conko, senior fellow at the Competitive Enterprise Institute, about the case, why he thinks the Federal Trade Commission has taken the wrong position on it, and why listening to Justice Stephen Breyer may provide the best insight into the court’s thinking.

 

Recent Congressional hearings examined the emerging world of healthcare information technology and whether regulation will quell innovation in the sector. We spoke to Joe Smith, chief medical and science officer of the West Health Institute, about his testimony at the hearings, what it will take to get medical devices in hospitals to communicate with each other, and the barriers digital health technologies will need to overcome to transform healthcare.

A recent study published in Nature Biotechnology looks at the sources and capital flows in innovative life sciences investment in key emerging markets over the past decade. It found that contrary to popular perception, venture investment in these countries is relatively modest and that the problem is not one of supply, but demand. We spoke to Justin Chakma, analyst with Thomas, McNerney & Partners and one of the authors of the study, about some of its surprising findings, the role governments are playing to fund the sector, and what strategies venture investors can take to enter these markets.

It was about two years ago when we first sat down with Jim Posada to discuss his company Resolve Therapeutics and his pursuit of a business model that could combat the long road to an exit for investors and entrepreneurs. Now, Resolve has entered into an agreement with Takeda Pharmaceuticals for development of RSLV-132, the company’s experimental lupus drug. The deal provides Resolve $8 million upfront and a potential of up to $247 million in milestones, as well as royalty payments. We spoke to Posada about the deal, how it provides a proof-of-concept for his business model, and what he has learned along the way.

An Indiana farmer has raised the ire of the agbio giant Monsanto and found himself a plaintiff in a patent infringement suit now before the U.S. Supreme Court. The case is being closely watched by the biotechnology industry because the eventual ruling could have broad ramifications for not just the agbio sector, but also for diagnostics, therapeutics, and beyond. We spoke to Michael Ward, partner and chair of the patent practice group for the law firm Morrison & Foerster, about the case, what’s at stake for the industry, and the emerging view of this court on life sciences patents.

Like it or not, aging is a byproduct of the daily activity of life. But Aubrey de Grey believes that the molecular and cellular damage that defines aging and creates disability and disease can be targeted for medical interventions that restore health and radically extend life. We spoke to de Grey, chief scientific officer and founder of the SENS Research Foundation, about the need to think differently about aging, how a new era of regenerative medicine might slow or reverse its effects, and why it is necessary to focus on medical interventions rather than prevention to have a significant impact.

The need to find new ways to reduce the cost and improve the quality of healthcare is leading to new models of access and delivery. WhiteGlove Health is one such company that is providing disruptive innovation to healthcare. We spoke to Bill Kerley, CFO of WhiteGlove, about the company, how it is altering traditional healthcare delivery, and what the Affordable Care Act means for the company's plans. Burrill & Company, publisher of The Burrill Report, is an investor in WhiteGlove.

As pharmaceutical companies have reinvented their R&D operations through partnerships with academia, contract research organizations, and biopharmaceutical companies, a talent gap is growing in the scientific workforce, according to a new report from PwC's Health Research Institute. PwC argues that the new R&D models need equally innovative HR strategies to find the right mix of scientific talent, skills, and incentives. We spoke to Mike Mentesana, U.S. pharmaceuticals and life sciences R&D advisory services leader for PwC, about the report, how companies are trying to address the talent gap, and why pharma needs to think differently about the role of its HR departments.

New drugs to treat migraines are moving through the clinic giving hopes to sufferers who have been unable to treat the problem with existing therapies. In some cases, drug developers are targeting a peptide known as CGRP, a well-validated target that’s been shown to trigger migraines. We spoke to John Latham, chief scientific officer for Alder Biopharmaceuticals, about his company’s efforts to develop a monoclonal antibody to treat these recurrent and disabling headaches. Latham disccuses what we know about migraines, why an antibody may represent a more effective therapy than small molecule drugs, and why the company’s platform technology may push antibodies into other disease areas where they haven’t been used before.

Patient advocacy groups have entered the drug development fray, mostly by providing funding for research and development for drugs they consider promising. The Myelin Repair Foundation, which is focused on developing new treatments for multiple sclerosis and related diseases, has taken a different tack in the hopes of addressing problems that make drug development today slow and expensive. We spoke to Scott Johnson, founder and CEO of the organization, about what’s wrong with drug development today, how the Myelin Repair Foundation has sought to fix it, and why their model might have implications for other disease groups.

Efforts to improve quality and reduce costs in healthcare sometimes come in unexpected places. AlixaRx, a new company unveiled last October, thinks it can do this by using technology to bring automated pharmaceutical dispensing machines to long-term care facilities and elsewhere. We spoke to Neil Kurtz, president and CEO of AlixaRx’s sister company Golden Living, where the machines are already being used. Kurtz discusses why these dispensaries promise to improve care, eliminate waste, and cut costs.

California’s biomedical industry has shown resilience through the deep recession of recent years, according to a new report from BayBio, the California Healthcare Institute, and PwC. The state’s biomedical industry has grown at an average annual rate of 0.5 percent over the past five years and the state leads the nation in producing new treatments, capturing venture investment, and NIH research dollars. We spoke to Gail Maderis, president and CEO of BayBio, about the report, the challenges that life sciences companies face today, and what the changing landscape for both investment and reimbursement means to companies in California and elsewhere.

The field of regenerative medicine is here today with a growing list of products already on the market treating patients. As the Alliance for Regenerative Medicine readies to offer its annual State of the Industry Briefing in San Francisco January 8, the organization’s new chairman Geoff MacKay spoke to us. Mackay, who is also president and CEO of Organogenesis, discussed developments in the field, the challenges the industry faces, and why 2013 could be a big year for clinical developments in regenerative medicine.