The life sciences community is descending on San Francisco this week for the annual BIO International Convention, an unparalleled opportunity to network with peers, make deals and weigh in on some of the industry’s most pressing problems. Here’s a small taste of some of the issues that will be occupying the collective minds of BIO-goers.
Regulation
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
In the ongoing dance between life science companies and government regulators, questions pile on top of questions: data needs, approval timelines, fast-tracking, orphan status. How is the regulatory environment evolving? On Tuesday morning, FDA Commissioner Dr. Robert Califf will be holding a fireside chat to address these and other issues.
There will be other regulatory discussions, including dives into regulatory reform in China and India. There’s been a great deal of controversy over Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) drug eteplirsen, in part due to strong advocacy from DMD families. A panel on Wednesday will address how patient input should factor into the regulatory process.
Drug Pricing
The cost of medicines was an issue long before Martin Shkreli came on the scene. Gilead’s hepatitis C efforts and several oncology drugs were already under the spotlight. On Wednesday, an industry panel will discuss how pharma and insurance companies can find common ground in the pricing war.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In addition, there should be much chatter about SB 1010, a bill in the California legislature that would require companies to report out if a drug price increases by 10 percent or exceeds $10,000 per year. The California Life Sciences Association is spearheading a digital campaign against the bill.
Industry Growth
Ernst & Young just released a new report that shows the industry’s growth rate is declining. Unrelated to the report, there will be a state of the industry panel Monday afternoon. That’s the macro view, but how do thousands of corporate decisions, large and small, play into that? BIO will offer a number of panels that address some aspect of business development, such as how small biotechs should address viability crises and the constant quest for early-stage financing.
These are just a few issues that will be consuming BIO attendees this week. There also will be tracks addressing clinical trials, digital health, intellectual property, personalized medicine and much more. Don’t worry about it, you’ll sleep next week.
