Q: Should there be legislation to gain alignment between payors, providers, and drug development companies in an effort to facilitate more cost-effective drug development?
We are always open to looking at ways to bring down R&D costs for small, emerging biotech companies, but we are not convinced that legislation such as this would be appropriate for meeting this goal. Our goal must always be ensuring access to quality patient care and outcomes, which is the cornerstone of any payment system reform. We believe change needs to take place within the FDA regulatory approval process and within the reimbursement landscape. Further, we believe that we need to shift our innovation paradigm — the focus should be on the long-term goal of reducing the overall burden of disease through innovative new drugs to reduce the incidence of chronic disease. Despite the best efforts of industry, academia, and the FDA, new drug approvals are not keeping up with investment in R&D.
Alan Eisenberg serves as executive VP for emerging companies and business development at the Biotechnology Industry Organization (BIO).
Q: How have you been able to incorporate social media into your business model, given the lack of FDA guidance?
Working in R&D, there are a number of places where we have been able to incorporate social media today without waiting for formal FDA guidance. One example is our use of social media to engage stakeholders on diverse topics related to R&D without discussing specific products, such as our community of R&D bloggers at Pfizer Think Science Now (www.thinksciencenow.com). While comments are moderated to monitor for appropriate conversation as well as the potential safety reports, we are able to engage with diverse stakeholders on topics ranging from policy to technology to other relevant trends. Another area has been around applications for patient recruitment — from basic one-way advertising on social media sites to more sophisticated use of video or even engagement with patient bloggers. There are some ambiguities without proper guidance, but it is unrealistic to continue to sit on the sidelines.
Craig Lipset is head of clinical innovation within worldwide R&D at Pfizer. In this role, he works across units and stakeholders to define Pfizer’s vision for the future of clinical trials and enables the initiatives and investments to create that future.
Q: What company do you view as a model for learning from past experiences and improving development of new and innovative medicines?
I don’t think there is just one model that can successfully translate cutting edge science into medicines. Companies of all sizes are already doing it (e.g. Novartis, Vertex, Biogen, virtual pharmas). These companies share two characteristics — embrace risk-taking and breakthrough science. These are the values that made the industry great. Fifteen years ago, many companies moved away from that model, hoping to lower risk and make innovation more predictable. It did not work and seriously damaged their innovation culture. Some companies, such as GSK, Sanofi, and Roche, have returned to real translational science and are again letting their scientists work on important problems, not just replacements to blockbusters. This will not only strengthen innovation, but also help burnish the industry’s image.
Bernard Munos founded the InnoThink Center for Research in Biomedical Innovation, a consultancy that focuses on pharmaceutical innovation. He previously served as an advisor for corporate strategy at Eli Lilly and Company.
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