Newsletter | October 8, 2020

10.08.20 -- New Podcast Episodes: Data Quality For FDA Submissions, CMC Considerations For FIH Studies, And More

 
     
 
 
 
 
Listen Now: Our Latest Podcast Episodes
 
 

Check out the latest from Business of Biotech, Biotech with the Bozenhardts, and Life Science Connect. As a member of the Life Science Connect community you have access to content beyond our weekly newsletters, including our podcast series. Don’t forget to subscribe so that you never miss an episode!

 
 
     
 
THE PODCAST FOR LEADERS OF EMERGING BIOPHARMA
 
 
 

 
 
First-In-Human Studies With Bolt Bio Drs. Edith Perez And Nathan Ihle
 
 

Bolt Biotherapeutics CMO, Dr. Edith Perez, and VP of CMC and quality, Dr. Nathan Ihle, bring a unique combination of patient and production process expertise to the table for an enlightening conversation on preparing chemistry, manufacturing, and controls (CMC) for an IND and ensuing first-in-human studies.

 
 
Data Quality Master Files With Dr. Robert Hariri
 
 

The development of Celularity's therapies is dependent on the large-scale collection of stem cells harvested from afterbirth in maternity wards across the globe. The approach begs for FDA oversight, which is why Celularity founder Dr. Robert Hariri makes for an excellent discussion on the importance of data quality and complete master files for FDA submissions. 

 
 
GMP And CMC Mastery With Dr. Shabbir Anik
 
 

Sutro Biopharma CTO, Shabbir Anik, has contributed to 15 INDs and 10 NDA’s over the course of his distinguished career. We sat down for a chat about the mechanics of GMP and chemistry, manufacturing, and controls (CMC) strategy in Sutro's efforts to move its antibody conjugate, bispecific antibody, and cytokine derivative candidates forward.

 
 
Dr. Gaurav Shah Rockets Chief Gene Therapist Virtuoso
 
 

Rocket Pharmaceuticals CEO, Dr. Gaurav Shah, shares the parallels between his leadership in the gene therapy space and his successes as a Grammy-nominated recording artist. Learn how Dr. Shah manages the scientific process, employees, finances, and stakeholder expectations by drawing from his mastery of music.

 
 
     
 
BIOTECH FACILITY DESIGN PODCAST
 
 

 
 
 

Herman and Erich Bozenhardt have a collective 55 years of bioprocess facilities design and equipment experience, and they’re here to share it all in our fresh Bioprocess with the Bozenhardts podcast series.

 
 
     
 
THE LATEST AND GREATEST FROM LIFE SCIENCE CONNECT
 
 

 
 
The Unusual Backstory Of The MiMedx Cover Feature
 

Ever wonder how a pharma executive gets to be on the cover of Life Science Leader? For Tim Wright, CEO of MiMedx, it was a chance encounter at a leadership conference a few years ago.

 
 
An Executive Order And PhRMA’s Response Spurs A Debate
 

Our guest, Outsourced Pharma chief editor, Louis Garguilo, talks about the response from readers — and PhRMA — to his editorial, “Is PhRMA’s White House Rebuttal Acceptable?”