Newsletter | November 21, 2022

11.21.22 -- Tips For Your Virtual Meetings With FDA
 
Sponsor
From The Editor
The "Outsourcing Master Class:" 10 Modules For Success
 
By Outsourced Pharma

Darren Dasburg, a long-tenured executive at GSK, Medimmune/AZ, well-regarded consultant, and currently chief business officer at CRISPR Biotech, didn’t write the book on outsourcing. He did, though, design and teach the defining class on the subject. The “Outsourcing Master Class” is a capstone-case-review, team-based course sanctioned by the International Association of Outsourcing Professionals (IAOP). 
Featured Editorial
Tips For Your Virtual Meetings With The FDA
 
By Kate Cook, Catherine M. Cook Group, LLC

It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.
Autonomous Supply Chain Planning Is Within Reach
By Elizabeth McGuire and Linda Plumley, Clarkston Consulting

In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.
Industry Insights
Establishing A Remote Audit Process As A CDMO
Article | By Adara Kurtz, Jerrad Tosti, and Patti Fiscus, Singota Solutions

Compliance audits are not immune to the effects of the pandemic. We have been required to adapt quickly to the changing environment to maintain high service levels while protecting employee and client safety.
Insights On Cell And Gene Therapy Manufacturing
Article | Andelyn Biosciences

Since the early 1990s, gene therapy has revolutionized medicine. In the coming years, it will continue to become more relevant in the treatment and cure of some of the most severe diseases and disorders.
Three Reasons Integrated CDMO Models Are Best
Article | Pfizer CentreOne

Some of pharma’s top brands developed their own responses to the demand for strategic outsourcing, creating a distinct class of contract development and manufacturing services suppliers.
Spotlight On Clinical Operations
Q&A | Quotient Sciences

The role of clinical operations plays an important part in the overall drug development process. Ian Nisbet, global vice president of clinical operations at Quotient Sciences, shares more about clinical operations.
Solutions
Patient Over Process: The inSeption Group Difference
inSeption Group
Reusable Shipper Program Fact Sheet
Thermo Fisher Scientific
Get Your Biologic To Clinic And Market Faster
Catalent
Outsourced Pharma Live
 

Available On Demand! Throughout the year, chief editor Louis Garguilo brings together industry experts to discuss some of the biggest challenges being faced by both sponsors and CDMOs. Our archived videos can be accessed at any time by registered site users.