regulatory-affairs
(6)
Caroline Shleifer
Caroline Shleifer is the founder and CEO of RegASK, a Singapore-based regtech company that pairs an AI engine built for regulatory content with a global network of 1,800+ subject matter experts. A pharmacist and scientist by training with a PharmD-PhD in medical physics from the University of Paris V, she spent years leading regulatory and scientific affairs across Asia Pacific at SPRIM before founding RegASK in 2018 to bring regulatory work into the AI era.
Priya Paul
Priya Paul (Bhutani) is the founder and CEO of RegDesk, an AI-powered regulatory intelligence and management platform for medical device and pharmaceutical companies. A biomedical engineer turned regulatory strategist, she spent years watching life-changing devices stall in regulatory limbo - up to 80% of applications get rejected for reasons unrelated to safety - and built RegDesk in 2014 to compress submissions that once took months into days. She leads the company's product vision and global growth, and RegDesk is a certified Minority Business Enterprise.
Alvin Luk
Alvin Luk is a biotech executive, neuroscientist and entrepreneur with more than three decades in global drug development. He is President & Chief Medical Officer (Group) and U.S. CEO of HanchorBio, a clinical-stage immunology and immuno-oncology company building Fc-based designer biologics, and co-founder and CEO of CRISPR gene-editing company HuidaGene Therapeutics. Across his career he has contributed to roughly two dozen approved products and more than 250 global regulatory submissions, including LUXTURNA, the first FDA-approved gene therapy. A 2025 TIME100 Health honoree, he wants to turn HanchorBio into the 'Genentech of Asia.'
Benjamin Arnold
Benjamin Arnold is the co-founder and CEO of COR Medical Ventures, a Solana Beach medical-device venture studio that partners with surgeon-inventors and corporations to push the next generation of orthopedic and spine devices to market. A Cornell-trained engineer who has shepherded more than 25 devices to launch, he sits at the 'center of rotation' the company is named for, running a portfolio of roughly a dozen companies spanning surgical robotics, spinal fixation, fracture hardware, and wearable rehab tech.
John Balian
John D. Balian, MD is a physician-turned-executive who co-founded ClinChoice, one of the world's larger full-service contract research organizations, and serves as its CEO, International. He spent years inside the FDA, then ran drug safety and regulatory operations at Pfizer, Bristol-Myers Squibb and Johnson & Johnson before building a global CRO spanning the US, Europe and Southeast Asia. He is also a published novelist whose debut, Gray Wolves and White Doves, draws on his Armenian heritage and the Armenian Genocide.
Moriah Nachbaur
Moriah Katherine Nachbaur is the Chief Business Officer at Pheast Therapeutics, a clinical-stage immuno-oncology company in Redwood City, California, pioneering macrophage checkpoint inhibitors to teach the immune system to destroy cancer cells. Drawing on two decades of cross-functional biopharma experience - from lab benches at Genentech to executive boardrooms at Coherus BioSciences and her own consulting firm MKN Biotech - she brings a rare blend of scientific literacy, operational depth, and strategic vision to one of oncology's most promising new frontiers: the innate immune system's untapped power against solid tumors.