Over my experience building several therapeutics companies, I’ve sometimes observed a Field of Dreams approach to therapeutics: if we build it, they (patients, health system, payors) will come. Last month’s hearing in Congress on pharmaceutical access, and the overall debate on how to pay for new therapies drives home that adoption of a therapy doesn’t always naturally follow an approval. Articulating the value of each therapy we deliver to the health care system is a critical complement to all of the clinical data we generate to maximize the likelihood that our innovations get to patients who need them.
This blog was written by Ankit Mahadevia, CEO and founder of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC.
JB Harvey broke his personal record earlier this winter by skiing over 22 trails in a single day at Loon Mountain. It was an awesome day. And 22 runs would be a huge day for anyone, but it was particularly so for JB, as he’s an 11-year-old with Duchenne Muscular Dystrophy (DMD).
It was apparently random, although I secretly suspect it was karmic punishment for my lack of imagination in writing the 2019 quality goal. It has been ‘Maintain the quality management system and documentation in inspection-ready form’ for the past 3 years. While we take quality and regulation seriously, our assumption, like that of many early-phase companies, had been that an actual FDA inspection was several years off. I had previously been involved in pre-approval inspections and the questions regarding early studies were always the most difficult to piece together; the team who ran the study had moved on or the asset was in-licenced. For this reason, we had invested in making sure we had a good filing structure from the start and were maintaining the appropriate documentation. It now appeared that these efforts would be put to the test.
This blog was written by Aoife Brennan, CEO of Synlogic, as part of the From The Trenches feature of LifeSciVC.
In May 2007, I trekked to Everest Base Camp in Nepal. Situated at an altitude of over 17,000 feet, Base Camp is the starting point for an ascent of the world’s highest mountain. The first feature on the climbing route is also the deadliest: the Khumbu Icefall. The Icefall is a frozen waterfall that cascades for more than two miles in length – and 2000 feet in height – from a spectacular hanging valley known as the Western Cwm to a point just a few minutes’ walk from the tents at Base Camp. At half a mile wide, you can’t go around the Icefall: you have to go through it.
This post was written by Ros Deegan, President and CBO of Bicycle Therapeutics, as part of the From The Trenches feature of LifeSciVC.
In a 2014 analysis of biotech boards and a reprise analysis in 2016, Bruce Booth worked with life science recruiter Catalyst Advisors on this board talent blog. They estimated the demand for talent at>600 biotech Board Director spots needing to be filled in the few years following October 2016.
This blog is written by Samantha Truex, Atlas EIR and CEO of a stealth-stage biotech, as part of the From The Trenches feature of LifeSciVC.