Akari Therapeutics announced the appointment of Beth-Anne Lang, as Senior Vice President, Regulatory Affairs. Ms. Lang has more than 20 years of experience in regulatory strategy, regulatory affairs, and drug development. She will start at Akari in this role on September 1, 2023.
“Beth has a long track record of successful drug approvals in the U.S. and rest of world. Her extensive experience will be instrumental as we approach key development milestones and advance our two registrational Phase 3 clinical trials in pediatric and adult HSCT-TMA and bring our PAS-nomacopan program into the clinic,” said Rachelle Jacques, President and CEO of Akari. “Speed matters for patients with significant unmet needs and Beth’s experience and capabilities are invaluable as we urgently pursue the regulatory filings that may give patients access to this potential treatment option.”
Before joining Akari, Ms. Lang was Senior Vice President, Regulatory Affairs and Pharmacovigilance for Enzyvant Therapeutics, where she led regulatory strategy, drug safety and operations to support therapeutics for rare diseases including congenital athymia and pulmonary arterial hypertension. Previously, she was Vice President, Regulatory Affairs for Horizon Therapeutics, leading a global regulatory organization and directing regulatory strategy ahead of the acquisition of Viela Bio and subsequent integration. Ms. Lang served as Vice President, Global Head of Regulatory Affairs at LEO Pharma A/S, where she led all aspects of global regulatory and the local support for various global locations. She held roles of increasing scope and responsibility at Takeda Pharmaceuticals including Vice President, Global Regulatory Affairs, Marketed Products. Earlier in her career, she held various regulatory, quality, and CMC development positions at TAP Pharmaceutical Products and Abbott Laboratories.
“There has been great progress to date on Akari’s priority pipeline programs, including granting of Rare Pediatric Disease, Orphan Drug, and other important designations. I am delighted to join the company at this exciting time as we finalize study design for the pivotal portions of nomacopan Phase 3 clinical trials in HSCT-TMA, prepare to enter the clinic with PAS-nomacopan as a potential treatment for geographic atrophy, and plan for key interactions with the FDA and other regulatory authorities,” said Ms. Lang.
Ms. Lang received a B.S. with honors from University of Illinois at Urbana-Champaign and an M.B.A. in leadership studies from Marquette University. She received the professional certification of US RAC from the Regulatory Affairs Professional Society.
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