|   From the Trenches

Keep Calm and Carry On: How to Survive an FDA Inspection

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.

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  |   From the Trenches

Leave A Ladder Down

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.  

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  |   From the Trenches

All A-Board

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.

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  |   LifeSciVC

Our Year In Review: Annual Talk On Macro, Biotech, and Atlas

By Bruce Booth, DPhil, Partner

At the end of every year, we host both our Atlas Venture Annual Meeting for our fund investors (Limited Partners) and our Atlas Retreat for senior industry executives.  As a kickoff for these two meetings, we typically open with a “Year In Review” to frame up some of the important themes facing biopharma. This year, for the first (and maybe only) time, we’ve decided to share a video recording of the Year In Review 2018 here at LifeSciVC, with voiceover accompanying the slides.  Here it is:

View the talk.


  |   LifeSciVC

Biotech Insider Stock Sales: Peer Benchmarks And Guidelines

By Bruce Booth, DPhil, Partner

Over the past six years, the biotech sector has experienced an incredible run of IPOs, reflecting the longest and largest “open window” for new offerings. Much has been written about post-IPO performance here and elsewhere, but there’s been little discussion about equity sales by executive teams following these IPOs.

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