John Patton, PhD
Head of Inhaled Therapeutics
John has extensive experience in Biotech industry startup. He co-founded Inhale/Nektar Therapeutics in 1990 after leading the drug delivery team at Genentech, founded Dance Biopharm (now Aerami Therapeutics) in 2009, co-founded InCarda in 2009, and iPHarma Limited in 2016.
Erica pascal, Phd, jd
Consulting Head of IP Strategy
Erica is the founder of Ingensity™ IP, P.C., a provider of IP strategy for life sciences start-ups. Prior to the that, she was partner at DLA Piper. Erica began her career in gene expression, got her BS in biology from MIT, a Ph.D. in biochemistry and molecular biology from UC Berkeley, and a postdoc at the University of Illinois.
Truc le
Consulting Head of Quality and Compliance
>35 yrs in Operations, Quality, Regulatory Affairs, CMC. 16 yrs COO and CTO for Biopharm companies that developed drug/ device. Prior to this, 18 years for Johnson & Johnson as VP of Global Quality and Regulatory Affairs. Specialized in Due-Diligence, FDA consent decree mitigation, and Pre-Approval Inspection (PAI) readiness.
Mei-chang Kuo, PhD
Consulting Head of Pharmaceutics
Mei-chang has >35 years experience in start-up and mid-sized Biotech companies with an excellent track record of bringing new and lifecycle-
management products through different phases of research and development. He developed the formulation of Exubera (inhaled insulin) at Inhale/Nektar and cofounded iPharma Limited in 2016.
Christopher Rhodes, phd
Consulting Drug Products
Chris has extensive formulation and drug delivery experience and is the CEO of Drug Delivery Experts, which he founded in 2014. He played a key role in the development of Byetta and Bydureon (injectable and exenatide microsphere), Myalept (leptin protein), Afrezza (inhaled insulin), and Lusedra (propofol prodrug).
Ronald Wolff, PhD
Consulting Board Toxicologist
Ron has >30 years in nonclinical drug development with Lilly, Nektar, Novartis, and as a consultant for 8 years. He played key roles in development of Zyprexa (olanzapine), Movantik (pegylated naloxone), Tobi Podhaler (inhaled tobramycin), and Inbrija (inhaled levopdopa) and has overseen support for >30 INDs.
Michael Eldon, PhD
Consulting Clinical Pharm
Mike is the former Vice President of Clinical Pharmacology at Nektar Therapeutics, and a clinical pharmacology, pharmacokinetics/pharmacodynamics and pharmacometrics expert with >35 years of experience in the pharmaceutical industry. He is an Expert Consultant in the firm NDA Partners.
Robert Langer, phd
Science Advisor
Bob, one of 11 Institute Professors at MIT, is a superstar in the development of drug delivery systems and pioneered the development of the first FDA approved PL/GA extended-release products. Bob has >1,500 articles, >325,000 citations; his h-index of 280 is the highest of any engineer in history and has >1,400 issued and pending patents
Lee Simon, md
Regulatory Consultant
Lee has served as the FDA’s Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products, and on multiple FDA advisory committees and has extensive experience in drug development as a senior investigator for celecoxib in the US. Lee was a senior consultant to Pharmacia/Searle on COX-2 development.
Allan Green, PhD, JD
Regulatory Consultant
Allan is a physician, lawyer and scientist, with experience as an operating officer in the pharmaceutical industry. His legal practice focuses on the needs of FDA regulated industry. Dr. Green has successfully represented many American and Foreign clients in their relationships with the U.S. Food and Drug Administration (FDA).