BioPharm America 2010 opened yesterday at the Copley Marriott in Boston, MA. We went to a fantastic session chaired by Reeve Brock of Harvard Stem Cell Institute on "Regenerative Medicine: Bridging the Gap between Science and Commercial Success". On the panel were some of the rising stars and stars of the regenerative medicine fields such as Tengion, Pervasis Therapeutics, iPierian and J&J. Some of the issues and challenges highlighted included
- willingness of patients to be the first treated with a new technology
- modifying the current standard of care as this will involve a fundamental paradigm shift
- absence of reimbursement codes
- governing bodies acceptance of new tools/methods in this field
- the need for new bioprocessing methodolgies
Fantastic discussions and a great way to kick off the event. The Access to Innovation session focussed on Biomarkers and combination therapies. I have to say over and over again we have been hearing about the increasing importance of Biomarkers.
Chris Hillier, CEO of Sistemic highlighted the session Proof of Relevance: The New Standard for Partnering". It seems no longer sufficient to simply have proof of concept for a molecule, proof of relevance is also needed which is a measure to reduce commercial and regulatory risk as opposed to the traditional need to reduce scientific risk. Chris mentioned that "SistemRNA is a platform which can be utilized to measure proof of relevance to select the initial and downstream indications to inform on early strategy". Ed Saltzman, the chair of the session mentioned that drug developers need to build biomarkers into their strategy from day one as Pharma have zero tolerance towards regulatory and commercial risk.
Day Two brings presentations from Big Pharma and biotechnology companies alike. Sistemic's CEO Chris Hillier, will be speaking about their SistemRNA platform and the breath of fresh air it brings to the Biomarker and Quality Control markets amongst others, in the Enabling Technologies session at 12 noon in the Clarendon room.