Newsletter | June 21, 2021

06.21.21 -- FDA's Safety And Performance-based Pathway

 
Sponsor
Articles
How CRO-Sponsor Partnerships Spurred Innovation In 2020
 

The clinical research industry in 2020 speedily adapted its practices to accomplish remarkable feats of rapid and high-quality vaccine and therapeutic development. This was atypical for the industry. To study this transition, the Avoca Industry Survey in 2020 focused on practices related to clinical research innovation, and in this article we draw from the data to explore the role played by CRO-sponsor relationships.

The 3-Step Approach To Unlock The Power Of Historical Trial Data
 

Many biopharmas still find it difficult to make sharing and using external trial data routine. How do we build on new momentum to continue and accelerate the use of historical trial data to transform R&D in the future?

SPACs, Opioids, And COVID-19: Ensysce Biosciences Making “Virtual” History
 
If Ensysce Biosciences were a ball of yarn, we’d be unwinding it for hundreds of miles from its location in La Jolla, CA. We’d unravel solid oral dose programs — new opioids and a COVID-19 treatment, an all-outsourced model, and now one of the first biotechs to go public via a SPAC (special purpose acquisition company).
FDA’s Safety And Performance-Based Pathway: An Alternative To Substantial Equivalence For 510(k) Submissions
 

The FDA's 510(k) clearance of medical devices is based on proven substantial equivalence with claimed predicate device(s). In concert with the goal of adopting the least burdensome approaches, the FDA provides an alternate pathway based on proven safety and performance characteristics, instead of devices’ equivalence to other predicates. 

Video
Taking A Biopharma Public Via M&A During The Pandemic
 

In this executive virtual roundtable (EVR) segment, Tom Frohlich, CBO of Chinook Therapeutics, discusses what led to the company opting to go public via a merger with Aduro Biotech in June 2020, along with the pros and cons of such an approach. Joining the conversation are David Perry, cofounder and chairman of Better Therapeutics, and Macrio Souza, CEO, Praxis Precision Medicines. 

Podcasts
Special Edition #8: Preparing For A Virtual J.P. Morgan Healthcare Conference (JPM)
 

We thought it would be interesting to have a discussion with three biopharmaceutical executives about how they are preparing for this unique 2021 JPM and how those preparations are different than what they’ve done in the past.

2021 CRO Leadership Awards Digital Edition
 

Inside you will find more on:

  • Otsuka
  • Research
  • Partnerships
  • Awards Philosophy

View the digital edition.

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