Alix Alderman Kentfield is a longstanding presence in the biopharmaceutical sphere who has held leadership responsibilities with InterMune, Amylin, Abbott/AbbVie, Ultragenyx, BridgeBio, PellePharm, Neumora, and the Board of Directors at TOPRA. She has built the Regulatory Affairs functions at multiple firms and helped ensure the successful worldwide regulatory approval and patient access of therapies in immunology, pulmonology, endocrine, dermatology, oncology, neuropsychiatric, neurodegenerative, cardiovascular and rare disease conditions. Alix Alderman Kentfield has successfully negotiated FDA and EMA Orphan Drug designations, global labels, and multiple US Breakthrough Therapy designations for novel therapies.

A graduate of the University of California, Davis, Ms. Alderman earned her pre-med BS in kinesiology and was recognized with a Regents’ Scholarship, National Student-Athlete Award, and Outstanding Senior Award. Co-captaining the women’s Division I gymnastics team, she earned WIC Conference All-Around Champion recognition as an undergraduate and served as a research assistant with the Human Performance Lab.

While employed with UC Berkeley Cal Athletics, Ms. Alderman worked with NBC Sports as a production assistant for the US Gymnastics Championships in 1999. She joined InterMune in 2000 (acquired by Genentech), where she was responsible for regulatory leadership and strategy for four orphan drugs in areas such as pulmonology, virology, and ovarian cancer, and was then recruited to lead global regulatory strategy and diligence for Amylin’s novel neuroendocrine peptide franchises across diabetes (SYMLIN Pen approval), obesity (pramlintide+metreleptin; secured partnership with Takeda and licensing agreement with Shionogi), lipodystrophy (MYALEPT approval) and their neuro franchise at the Psylin subsidiary (Amylin acquired by BMS 2012). Ms. Alderman continued to guide and build global regulatory affairs while taking on strategic roles at Abbott/AbbVie as Global Product Strategy executive, Ultragenyx as rare bone disease franchise head (CRYSVITA approval), BridgeBio as regulatory and diligence advisor, PellePharm’s executive team (secured partnership with LEO Pharma and acquisition by Sol-Gel Technologies), and Neumora’s regulatory chief (IPO 2023). Ms. Alderman founded Starling Access, a nimble strategic solutions shop, in 2017 supporting start-up companies with interim regulatory, patient advocacy and access leadership, IND and NDA/BLA/MAA advice, key regulatory filings (eg, Fast Track, BTD, and ODD applications, Agency advice requests), diligence, strategic corporate and program/portfolio advisement.

Alix Alderman Kentfield