The rising cost of specialty drugs continues to be a battleground between drugmakers, healthcare providers, and payers over the cost of innovative therapies. Express Scripts recently did a study that suggested more than $9 billion will be wasted by U.S. Health Plan sponsors in 2015 and separately added 66 exclusions to its formulary that included several newly approved and high profile drugs. We spoke to Steve Miller, chief medical officer of Express Scripts, about striking a balance between innovation and costs, how waste in the system can be addressed, and whether and when biosimilars will begin to curb rising costs.

The biotechnology company Affiris recently announced encouraging early-stage results for a therapeutic vaccine for Parkinson’s disease. The trial, backed by the Michael J. Fox Foundation, is the first clinical trial of a therapeutic to target alpha-synuclein, a protein abundant in the brain that may play a role in the development of the disease. We spoke to Kuldip Dave, director of research programs for the Michael J. Fox Foundation, about the Affiris trial, what the results tell us, and why alpha-synuclein may be a compelling target in the fight against Parkinson’s disease.

The decision-making process for cancer treatments is growing more sophisticated with the broadening of data used to determine the best course of treatment for an individual patient. Perthera, a precision cancer therapy company, is leveraging recent scientific breakthroughs to perform a complete molecular analysis of a patient’s cancer to determine the best therapies and drug trials to treat each patient’s unique cancer. We spoke to Dendy Young, chairman of Perthera, about the company, the benefits of looking beyond the genetics of tumors to determine the course of treatment to use for a patient, and whether these personalized medicine approaches in cancer will take hold in other disease areas.

The rapid decline in the cost of genome sequencing is creating an information technology bottleneck as servers designed for general purposes have proven a bit clunky at assembling and analyzing the output from sequencers. Edico Genome thinks it has an answer with its DRAGEN Bio-IT Processor, designed specifically for processing genomic data. We spoke to Pieter van Rooyen, CEO of Edico about tackling the computing bottleneck, how the company plans to use the $10 million in funding it just raised, and what the implications of a dramatic reduction in time and cost will have on how sequencing is used.

Following the mapping of the human genome, the sectors of sequencing, personalized medicine, and synthetic biology have taken hold. A new report from the law firm Marks & Clerk examines patent filings in these areas over the past decade and shows the different stages at which these emerging sectors are in their development. We spoke to Gareth Williams, partner with Marks & Clerk, about the report, where the sources of innovation are today, and the changing landscape for intellectual property.

The U.S. Food and Drug Administration recently issued two long-awaited draft guidances for drug and device makers' use of social media. The first concerns risk and benefit information, and the second addresses correcting misinformation published by others on the web. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest, about the issues of concern to the agency, why the industry has been slow to embrace social media, and how these new ways to communicate with patients are accelerating broader changes in the healthcare landscape.

Evaluate Pharma released an upbeat World Preview 2014 report at this year’s BIO International Convention, revising previous estimates upward and forecasting average industry growth of 5.1 percent a year through 2020. We spoke to Anthony Raeside, head of research for Evaluate Pharma, about the report, the tension between innovation and pricing, and why he sees signs that R&D productivity is improving for the industry.

The global biotechnology industry is continuing its robust performance from 2013, but much of the commercial success remains concentrated in a handful of companies, according to the new Beyond Borders report from EY. We spoke to Glen Giovannetti, EY’s Global Life Sciences Leader, about the new report, why R&D productivity remains a critical issue for the industry despite the market successes, and what strategies companies can use to unlock value from their pipelines.

Nexvet is a global biotechnology company developing monoclonal antibodies, but what makes it unusual is that it’s developing these therapeutics for pets. Nexvet’s platform technology can take a human monoclonal antibody and customize it to target a new species, such as cats and dogs. We spoke to Mark Heffernan, CEO of Nexvet, about the $25 billion global animal health drug market, the company’s technology, and why he expects his products to be cost competitive.

As BIO 2014 kicks off in San Diego, the international convention comes to one of the world’s richest clusters of top research institutions, new technologies, and emerging biotech companies. We spoke to Joe Panetta, president and CEO of the Southern California trade group Biocom, about how the San Diego biotechnology sector has evolved since the last time BIO came to town, how biotechnology is converging with digital health, and what conference attendees might want to do when they stray beyond the halls of the convention center. 

 

As the 2014 BIO International Convention kicks off in San Diego June 23, executives gathering for the largest annual industry meeting should be upbeat as they enjoy robust financial markets, clinical successes, and strong product performance. We spoke to Jim Greenwood, CEO of the Biotechnology Industry Organization, about the upcoming meeting. Greenwood discussed ongoing pricing concerns, a follow-up to the JOBS Act, and why there hasn’t been much of a follow through in Washington to the Obama administration’s National Bioeconomy Blueprint.

The American Society of Clinical Oncology’s ASCO 2014 Annual Meeting kicks off in Chicago May 30. Though this is a scientific meeting, it is closely watched by biotech investors looking for clinical results that can drive stock prices. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about how ASCO has become a Big Pharma story, how a new class of cancer immunotherapies continues to dominate the meeting, and what news to be watching that may be off the radar of investors.

The cancer death rate in the United States is declining thanks to progress made in the detection and treatment of cancers such as breast and colorectal cancer, but the death rate for pancreatic cancer is rising and expected to become the second leading cause of cancer death around 2020, according to a new study in Cancer Research. We spoke to Lynn Matrisian, vice president of scientific and medical affairs at the Pancreatic Cancer Action Network and senior author of the paper, about the study, why we haven’t seen the progress in pancreatic cancer we’ve seen elsewhere, and what’s being done to change that.

Scientists at The Scripps Research Institute have engineered a bacterium that expands the chemical units that make up its DNA to include new building blocks not found in nature. The breakthrough suggests it will be possible to eventually synthesize novel proteins to create new drugs and materials. We spoke to Floyd Romesberg, associate professor of chemistry at The Scripps Research Institute, about the acheivement, its implications for synthetic biology, and what will be needed to advance the work.

Much can be gained by payers and drugmakers working together to address common challenges in the changing world of healthcare, but a new report from EY finds one problem is that payers don’t trust pharmaceutical companies. The new Progressions report also suggests payers will continue to focus on cost containment and prefer predictable expenses rather than turning to outcome-based approaches to drug pricing. We spoke to Patrick Flochel, EY’s global pharmaceutical leader, about the report, what payers are doing to contain drug costs, and what pharmaceutical companies need to do to better adapt to the changing landscape.

There's significant variance in the performance of the different devisions within the U.S. Food and Drug Administration and determining the cause of that variance could accelerate the introduction of new drugs and have dramatic impact on the cost of drug development, extend lives, and improve the economy, according to a new report from the Manhattan Institute. We spoke to Joe DiMasi, director of economic analysis at the Tufts Center for the Study of Drug Development and one of the authors of the report, about its findings and recommendations.

The success of U.S. biomedical research threatens to become its undoing, according to a group of leading scientists writing in the Proceedings of the National Academy of Sciences. They argue reform is needed to address what’s become an unsustainable hypercompetitive system that makes it difficult for seasoned investigators to do their best work and discourages the most promising young scientists from pursuing careers in research. We spoke to Bruce Alberts, a professor at the University of California, San Francisco and one of the authors of the piece, about the imbalance in the supply and demand for researchers, the perverse incentives created in the current system, and what steps should be taken to remedy the situation.

Reduced patent expirations, the introduction of the largest number of new drugs in a decade, and growing use of healthcare services helped increase total U.S. spending on drugs in 2013 by 3.2 percent, according to a new report from IMS Institute for Health Informatics. We spoke to the Institute’s Executive Director Murray Aitken about the report, what it tells us about the biopharmaceutical industry’s ability to bring innovative therapies to market, and the evolving debate of the cost and benefits of these new drugs.

Treating cancer has long been a trial and error process for doctors, but Champions Oncology is hoping to take the guess work out of choosing the right therapy through the use of its mouse avatars. The company engrafts a patient’s tumor in mice to determine what drugs are most effective. We spoke to Joel Ackerman, CEO of Champions Oncology, about the personalization of cancer therapy, the benefits the mouse avatars provide, and how the same technology is being used to improve drug development.

Gilead Sciences breakthrough hepatitis C drug Sovaldi has changed the treatment and prognosis of the disease, but it’s also fueling a broader debate about the price of innovative therapies. We spoke to Seamus Levine-Wilkinson, group analyst with Decision Resources, about the emerging therapies for hepatitis C, how doctors and payers are viewing them, and what drug companies are learning about pricing breakthrough therapies.

A biotech sell-off in March has some investors jittery as the dramatic rise of stocks in the sector over the past two years has fueled talk of a biotech bubble. We spoke to Adam Feuerstein, senior columnist with TheStreet.com, about the trading activity in March, if there’s cause for concern about a bubble, and whether growing scrutiny of drug prices will bring the biotech party on Wall Street to a crashing halt.

The JOBS Act may have helped fuel the resurgence in life sciences IPOs, but Greg Simon believes it will help transform the landscape for early-stage financing. Simon, CEO of Poliwogg, is providing a new way for accredited investors, most who have never invested in private companies, to back promising startups in the sector. We spoke to Simon about Poliwogg, how it seeks to address a critical gap in life sciences financings, and why it could expand the pool of private capital directed into the sector.

Whole genome sequencing has been working its way into clinical applications, but a new study published in the Journal of the American Medical Association suggests despite the dramatic drop in cost, several challenges remain to widespread clinical adoption. We spoke to Euan Ashley, associate professor of medicine and genetics at Stanford University and one of the authors of the study, about its findings, the various impediments to clinical use, and how long it will take before doctors embrace the technology as an essential tool.

Patients with the neurodegenerative disease ALS face a grim prognosis with few treatment choices. The nonprofit ALS Emergency Treatment Fund is trying to provide new alternatives to these patients through the use of so-called expanded access programs. We spoke to Jess Rabourn, managing director of the ALS Emergency Treatment Fund, about the regulations surrounding expanded access programs, how his organization gets experimental drugs into the hands of patients, and why drugmakers’ view of these programs is evolving.

Clostridium difficile, or C. diff, is a bacteria that can wreak havoc on a body, often following the use of antibiotics in hospitals. These infections can be tough to treat and life threatening, but the use of fecal transplants have been found to be an effective way to combat recurrent C. diff. Openbiome, a new nonprofit fecal bank, is offering doctors transplant material. We spoke to James Burgess, co-founder and director of OpenBiome, about the organization, the regulatory issues surrounding fecal transplants, and what it will take to move to synthetic treatments in the future.

Megamergers, according to conventional wisdom, are more likely to destroy, rather than create, value. But a new study from McKinsey & Company finds in the pharmaceutical industry, the numbers suggest otherwise. The analysis argues that these deals have been critical for the longer-term sustainability of acquirers. We spoke to Myoung Cha, principal in the Silicon Valley of McKinsey and co-author of the report, about the study, how deals aimed at consolidation fared relative to deals focused on driving growth, and why the benefits often justify the disruption these deals create.

Though the past two years represented a surge in high value drug approvals, a new report from EP Vantage suggests this year will likely produce the launch of only three drugs to become blockbusters by 2018. The report, Biggest Launches of 2014, says that could change should a new class of cancer immunotherapies speed to market this year. We spoke to Jonathan Gardner, report author and EP Vantage deputy news editor, about the study, the drugs that are generating the most excitement, and why the biggest launches are coming in therapeutic categories other than cancer.

he National Institutes of Health, along with a group of top drug companies and non profits, announced the launch of the Accelerating Medicines Partnership, an effort to join forces to identify and validate promising biological targets for drugs. The program, backed with $230 million from NIH and its partners, hopes to accelerate the development and reduce the cost of bringing needed drugs to market. The initial focus of the partnership will be on Alzheimer’s disease, type 2 diabetes, and autoimmune disorders. We spoke to NIH Director Francis Collins about the program, what it took to get competitors to collaborate, and why he hopes the benefits of this approach will extend far beyond the diseases being targeted.

The reproducability of scientific experiments has become a growing concern among drug companies, scientific journals, and academic research centers. In a recent piece in Nature, Francis Collins and Lawrence Tabak of the National Institutes of Health take up the issue. We spoke to Tabak, principal deputy director of NIH, about the agency’s concerns, the causes of the problem, and what the agency is doing to address it.

With the recent news that Illumina’s latest sequencers have broken the $1,000 genome barrier, there’s great anticipation about the acceleration of personalized medicine. We spoke to Ed Abrahams, president of the Personalized Medicine Coalition, about the significance of the milestone, the move of whole genome sequencing to the clinic, and the barriers that still need to overcome.

Regenerative medicine companies raised more than $1.3 billion dollars during 2013 and an expanding range of products continues to advance in the clinic. We spoke to Geoff MacKay, chairman of the Alliance for Regenerative Medicine, about the state of the industry, the growing success of the sector, and how investors and Big Pharma have changed their view of these technologies.

The world’s biggest pharmaceutical companies laid low on the M&A front in 2013 with biotech and specialty pharmaceuticals making headlines with acquisitions. The rising stock market suggests a tougher time ahead for Big Pharma as likely targets have grown more expensive and competitors for assets have grown stronger. We spoke to Jeff Greene, EY's global life sciences transaction advisory leader, about his firm’s recent report on Big Pharma M&A, how despite new drug approvals they are losing market share, and why, even with their rising market caps, they are in a worse position to do deals today.

Biotech stocks soared in 2013 and, as the industry readies for the annual J.P. Morgan Healthcare Conference in San Francisco January 13-16, there’s little to temper investor enthusiasm for the sector. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about the year that was in biotech, what to be watching at JPMorgan conference, and what the new year will bring for the sector.