Keynote Panel Discussion Information
Wednesday, October 3
Chair: Robert Chess
- Identifying cross-sector opportunities for advancing healthcare by developing next-generation products.
- Evaluating technologies to discover commercially viable approaches.
- Creating the right business and policy environment to stimulate cross-sector exploration.
- Building life sciences companies with the capabilities needed to support and advance cross-sector product development.
“While there have been huge strides made in developing new treatments by biopharma and device companies, for the most parts the efforts have been siloed—drug companies develop drugs, device companies develop devices, and never the twain shall meet,” Chess says. “With the success of products such as drug-eluting stents, the insulin pump, and asthma and insulin inhalers, it is being recognized that one of the largest untapped opportunities is finding innovative ways of combining drug and device technologies to improve patient outcomes.”
“Today's biotech environment is rich with opportunities and rewards for the companies that can conceptualize how genomics, nanotechnology, electronics, and microfluidics can be integrated to solve a myriad of problems,” says panelist Thomas L. Gutshall, cofounder and chairman of Cepheid (Sunnyvale, CA). “The scientific advances of the last decade now allow for the delivery of more-precise and timely diagnostic information than ever envisioned.”
Panelist William Hunter, MD, president and CEO of Angiotech Pharmaceuticals (Vancouver), says that pharma companies see combination products as an opportunity to develop new markets and augment the life cycles of their compounds. On the other hand, he says, device companies see such products as a mechanism through which they can technologically differentiate their product offerings, enhance pricing, and be seen by their customers as being on the cutting edge of interventional medicine. “In classic business parlance: pharma is being driven primarily by greed, and device companies are being largely driven by fear,” Hunter says.
Hunter says the most difficult challenge in pairing technologies is the inherent knowledge imbalance between the two companies. “Each partner has a different understanding, not just of the product attributes, but perhaps more importantly, the potential clinical, regulatory, toxicological, and commercial shortcomings of the molecule or device,” he says. “When a medtech company is evaluating a molecule, it never feels like it has a complete handle on the overall cost, timeline, or development risk profile. When a pharma company is evaluating a combination product, it often doesn't have a grasp on the regulatory pathway, the market opportunity, or the wants and needs of the end user.”
Without a deep understanding of the medical, technical, commercial, and regulatory aspects of an out-of-sector technology, it is difficult to become comfortable with the risks involved with a new opportunity, says Howard B. Rosen, vice president for commercial strategy at Gilead Sciences Inc. (Foster City, CA). He adds, “Margins and levels of R&D investment can vary significantly across sectors, so there can be a business mismatch. Similarly, the regulatory environment can be quite different between biopharmaceuticals and medical devices, and it can be challenging to get the two sectors to understand and appreciate one another.”
In addition to challenges related to differing perspectives on technologies and risks, cross-sector partnerships must cope with uncertainties associated with a still-emerging policy environment for such collaborations. Panelist Peyton Anderson, CEO of Affinergy Inc. (Research Triangle Park, NC), says that regulatory pathways for cross-sector explorations are still largely unknown. “The practical challenges are daunting to get two or more companies that have different core competencies to collaborate on new product concepts within a regulatory context that is still being defined,” he says.
Hunter says that, clearly, regulatory bodies—primarily FDA—need to lead the way in setting standards. “The object isn't merely to subject the product to double the regulatory evaluation, but rather to tailor the review to the specific clinical issues relevant to the product under examination,” he says.
In addition to an uncertain regulatory pathway, products developed through cross-sector partnerships can face challenges when it comes to reimbursement. “The reimbursement codes, criteria, and availability are often very different and difficult to predict prior to a product's launch,” Chess says. “As a result, companies may be reluctant to initiate product development into such an uncertain payment environment.”
During the keynote discussion, panelists will discuss these and other topics related to developing business opportunities in the rapidly growing market for innovative healthcare products.