BioInvestor Forum discusses Policy & Valuation
October 2015 – One of the topics at the 2015 BioInvestor Forum in San Francisco was the impact of governmental regulation and policy on the valuation of life science products being developed. The life sciences area already has a very long development cycle compared to other technologies; however, there is a proportionately long market cycle that is available to the products. Recently these development cycles and market opportunity cycles have been disrupted and adjusted due to government regulation and policies. This is true on both an international and domestic basis for these products.
Some of the activities are benefiting the investment community by extending the exclusive manufacturing period for some product. This is in the area of the pediatric re-indication or reuse of existing drugs for rare diseases for a 15 year exclusive extension. However, this is also complicated by category definitions for antibiotics. The wording and the timing from the FDA needs clarification as it is subject to interpretation for applicability. The clarification is a challenge due to FDA staffing and budget limitations which restricts access to response on all open issues.
One of the issues discussed was the area of personalized medicine. The methods, interpretation and determination of the approval process for these drugs. The FDA has yet to provide clarity on this topic, and this is impacting the late stage validation and preparation to release these products. Without the ability to have valid predictions on product release dates, the viability of investment in these products is in jeopardy.
The panel also touched on PDUFA VI. This is coming up for a vote soon, and time tables along with their associated transparency on the financial processes being used to perform the assessment and determination are not in place. This is causing uncertainty in the financial reporting and planning for many drugs, as the right matrix of revenue and product roll out cannot be created.
