The Mid-Atlantic Biotech Conference was a smashing success! I had the opportunity to listen to the following biotech leaders: Dr. Martine Rothblatt, founder and CEO of United Therapeutics; Thomas Watkins, CEO of Human Genome Sciences; John Crowley, CEO of Amicus; James Greenwood, CEO of BIO; Dr. Joshua Sharfstein, Principal Deputy Commissioner; and many more! Even more exciting was, with the exception of Dr. Sharfstein, subsequently meeting all those listed!
The speakers were indeed insightful. A few key highlights of the conference:
a) Many of us already know that the company founders are the ones that infuse the breath of life into their companies, but, in biotech, it literally means life and death! So, therefore, first and foremost of my key highlights — many successful biotech companies are successful due to the passion and relentless drive of their founders. The story of Amicus CEO John Crowley has been turned into a film, given the sacrifices he made to save his children from their deadly disease. His is truly an inspirational story. The film about Mr. Crowley, “Extraordinary Measures,” tells the story of a father’s commitment to save two of his three children from an Orphan (very rare) disease called Pompe disease. Mr. Crowley quit his job and raised money to establish his own biotech company called Amicus. He literally breathed new life into his children and his company. At the conference, Mr. Crowley stated: “It costs way too much and takes way too long to get much needed drugs to market”
b) Technology transfer / commercialization was a common theme throughout nearly every presentation / panel. The technology transfer topic focused on the new challenges that have arisen as a result of comparative effectiveness and scarce capital. It’s really not just about “technology” anymore – biotechs need to provide solutions at the lowest possible cycle time at the lowest possible cost and illustrate strong due diligence that what they are focused on WILL work
c) The next highlight may seem like an obvious one, but I found it interesting, having spent 17 years outside of the Life Sciences industry. According to several speakers, traditionally, the FDA has only looked at risk to evaluate drugs. Now, the FDA is establishing a risk-benefit framework for evaluating BLAs, NDAs and PMAs
d) We all know that the FDA was established to protect public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. I find this reoccurring message in a conference setting very interesting. Given a direct and indirect cost of ~$3B to get an NME to market, and the extreme revenue and margin compression that has been occurring in the Life Sciences industry, the unparalleled retraction of capital to the tune of 80-1000% (depending on the benchmark you’re looking at), not to mention the fact that there are many patients who need those riskier drugs to survive, I’m wondering how people perceived these repetitive remarks
e) Finally, the last insight I would share is from BIO’s James Greenwood’s speech, which I thought was truly brilliant! This gentleman understands that the Life Sciences industry is truly shattered and has just come through “the perfect storm.” Mr. Greenwood charismatically asked the audience questions about health care reform. One question was: “Do you think health care reform is going to make a positive impact on the biotech industry?” From the series of questions he posed to 300 people in the audience, there was a consensus that the reform is bad for biotech business. He then talked about an important initiative he’s working on called “the Next Big Thing”; this was a thrilling topic for me personally, as I would love to contribute to Mr. Greenwood’s efforts here.
Several implications come as a result of these insights. The key needs:
a) Breakthrough innovation in clinical development performance / operations – can you shorten the cycle time and lower the cost of getting a solution to market? Can this be done with the highest probability of success?
b) An industry framework for success – could there be an industry framework for operational, medical and market success to aid with “sure thing” technology transfer?
c) Breakthrough innovation in new solution development – do you have the right solution?
d) Breakthrough innovation – full stop – in Life Sciences industry dynamics – how can the Life Sciences landscape change to rebuild the value that has eroded?
Executive Vice President, Solutions