![]() ![]() Akari’s lead asset, investigational nomacopan, is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity. She received the professional certification of US RAC from the Regulatory Affairs Professional Society.Īkari Therapeutics, plc (Nasdaq: AKTX) is a biotechnology company developing advanced therapies for autoimmune and inflammatory diseases. in leadership studies from Marquette University. ![]() with honors from University of Illinois at Urbana-Champaign and an M.B.A. 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. “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. Earlier in her career, she held various regulatory, quality, and CMC development positions at TAP Pharmaceutical Products and Abbott Laboratories. ![]() She held roles of increasing scope and responsibility at Takeda Pharmaceuticals including Vice President, Global Regulatory Affairs, Marketed Products. 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. 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. 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. “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.”īefore joining Akari, Ms. 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. “Beth has a long track record of successful drug approvals in the U.S. She will start at Akari in this role on September 1, 2023. Lang has more than 20 years of experience in regulatory strategy, regulatory affairs, and drug development. 02, 2023 (GLOBE NEWSWIRE) - Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the appointment of Beth-Anne Lang, as Senior Vice President, Regulatory Affairs. ![]()
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