Life Science Leader

Antibodies 2025: Venerable & Naked Or Complex & Multi-Specific? https://lnkd.in/eV6M-Nij - By Matthew Pillar, Editor, Bioprocess Online  Rather than give the venerable antibody short-shrift in the face of new modalities deemed higher priority for prognostication, we’re leaning into the antibody’s deeply-set roots and looking ahead to what’s in store for antibody-based drug development in 2025 and beyond. 

Bioprocess Online Live’s Matthew Pillar welcomes Pfizer’s Hooman Farsani, PhD MBA-Candidate PMP, Takeda’s Shruti Gopal Vij, Ph.D., and Sanofi’s Ramila Peiris, P.Eng. and Yuanyuan Cui, Ph.D. for a digital discussion exploring how digital twins and mechanistic modeling are transforming biopharmaceutical processes. Registration is free thanks to the support of Cytiva. https://lnkd.in/ei5nJYsG

👏 Congratulations to the TOP 10 MOST POPULAR GUEST COLUMNS on Cell & Gene this year! 👏 1. FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance By Tim Sandle, Ph.D., CBiol, FIScT (https://lnkd.in/ehT6JgBg) 2. FDA's CBER Issues Final Guidance For CAR T Cell Products By Anne Lamontagne and Wendy Liang, Dark Horse Consulting Group Inc. (https://lnkd.in/e9FqwAsP) 3. FDA Draft Guidance On 'Rare Diseases: Considerations For The Development Of Drugs And Biological Products' By Raj Bandaru, Accenture Applied Life Science Solutions (https://lnkd.in/ecDrbfc8) 4. 2024's Market Outlook For Cell & Gene Therapies By Justin Culbertson, CPA and Adam Lohr, CPA, RSM US LLP (https://lnkd.in/ecwW-gnb) 5. Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024 By Emily Marden and Kelly Cho, Sidley Austin LLP (https://lnkd.in/exmUHtr4) 6. Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products By Blake Bergam and Sara Mills, Dark Horse Consulting Group Inc. (https://lnkd.in/eWWd2UnN) 7. What Does FDA's Draft Platform Guidance Mean For CGT Companies? By Kimberly Benton, Dark Horse Consulting Group Inc. (https://lnkd.in/ejRP8Kwm) 8. Gene Editing Versus Gene Therapy: Is There A Difference? By Brent Warner and Blair Madison, Poseida Therapeutics, Inc. (https://lnkd.in/erE_frjv) 9. When Does GMP Matter In Non-GMP Settings? By Takehiro Okumura, PhD and Zeb Khan, Takeda (https://lnkd.in/esZFvqeX) 10. Imbalance In The CDMO Market And The Long-Term Implications By Alex Klarer, Engelex (https://lnkd.in/eJTEQVb2) #cellandgenetherapies #publishing #thoughtleadership

Join Us for "2025 CGT Regulatory Outlook" As the cell and gene therapy landscape evolves rapidly, join me and two of the field’s top regulatory experts—Dr. Kimberly Benton, with over two decades at the FDA, and Bambi Grilley, RPh, CIP, CCRC, CCRP, RAC, a pioneer in clinical research—to explore the regulatory challenges shaping our industry in 2025. When: Thursday, January 16, 2025, at 11:00 AM ET Duration: 1 hour This is a unique opportunity to gain forward-looking insights into FDA processes, regulatory strategies, and their impact on clinical trials and manufacturing. Registration is free—don’t miss it! https://lnkd.in/edTTvvMR

Tackling The Pharmacovigilance Crunch At The Local Level https://lnkd.in/ebfsxDCq - By Alex Brenchat, Ph.D. and José Miguel Rivas Romero Local affiliates face significant time demands, often with very limited resources.

Trends In Proposed Laws Aimed At Drug Patents https://lnkd.in/e4gJuGJA - By Sona De This article outlines the current system for resolving patent disputes, examines two proposed bills that could reshape it, compares data on branded drug patents, and explores future strategies.

Inside Interius' Global Regulatory Strategy https://lnkd.in/exM8gQn6 - By Matthew Pillar, Editor, Bioprocess Online As the trend toward seeking efficient and expeditious clinical progress goes, Interius has orchestrated a global regulatory strategy that’s centered in Australia. 

Translating Hidden Gems Into Medicines https://lnkd.in/eGC_GHMj "In the quest to clearly understand and define the medical problem, it is critical to conduct the experiment that you are afraid will prove the idea wrong. " - Louise Modis, Ph.D.

The Fork In The Road: Personal Decisions That Change Our Career Trajectory https://lnkd.in/eeufritp "When I look back, I can see that the decisions I’ve made in my journey have shaped the leadership values I hold dear." - Blandine Lacroix

Four Ways For Legal Departments To Create Financial Efficiency https://lnkd.in/eT3zjwRr - By Kristi Anne Gedid In today’s operating environment, legal departments often must do more with less.