*INVITE* KOL call on Recent FDA Changes

Research evidence excerpt

*INVITE* KOL call on Recent FDA Changes

USA | Biotechnology EquityMayResearch20, 2026

Join Akash Tewari and KOL Lynne Ensor this Friday, May 22th at 2:30PM ET

to discuss Makary's resignation, Diamantus's appointment as Interim Director,

pot'l future candidates for Director, and current FDA office dynamics/sentiment.

Lynne worked at the FDA for 21 years as a Senior Leader at CDER's Office

of Pharma Quality and Generic Drugs, Deputy Office Director for Process and

Facilities, and CDER Master Peer Reviewed Reviewer.

**Please click HERE to register**

KOL Biography: Dr. Lynne Ensor, PhD, is the Owner and Regulatory Consultant at Ensor Pharma

Biotech Consulting (03/2025-present). In this role, she provides pharma biotechnology regulatory

consulting, including regulatory strategy, regulatory affairs, compliance, and GMP consulting

across a product's lifecycle. Prev, Dr. Ensor was the Senior Global Managing Director for Pharma

Biotech and Life Sciences Training at Parexel (03/2024-03/2025). Before that, she was the Senior

Vice President and Head of Global Compliance Consulting at Parexel International Corporation

(08/2019-12/2023). Earlier, she was the Deputy Office Director for CDER/OPQ/OPF at the FDA

(08/1998-08/2019). Her expertise includes sterile biopharmaceutical manufacturing, quality, safety,

and testing methods for new, generic, biologic and biosimilar products. She completed her PhD in

microbiology at the University of Maryland (1992-1997).

Thanks,

Akash & Team

Akash Tewari

Global Head of Biopharmaceutical Research

E: atewari@jefferies.com

W: 212-284-3416 | C: 929-595-5735

Akash Tewari * | Equity Analyst

1 (212) 284-3416 | atewari@jefferies.com

Amy Li, PharmD * | Equity Analyst

+1 (332) 236-6802 | ali8@jefferies.com

Manoj Eradath, MBBS, Ph.D. * | Equity

Associate