Michael D. Young

MICHAEL D. YOUNG, MD, PhD, MBA
Biographical Sketch

Dr. Young is the Scientific lead of Mandala Partners International. He has more than 30 years of experience in drug development with direct responsibility for Clinical Research and Development; Preclinical Development; Product Formulation; and Regulatory Affairs within the healthcare industry including: both prescription (Rx) and over-the-counter (OTC) drugs; neutraceuticals and; cosmeceuticals. Furthermore he has a very broad degree of experience in the scientific support and management of marketed products, across the full range of healthcare products.

Dr. Young has personally managed the development and submission of market license applications (MLAs and/or NDAs) for over a dozen new chemical entities (NCEs) and, in addition, numerous supplemental applications (SNDAs) for major new indications/dosage forms or Rx to OTC switch. These applications have involved presentations (both public and closed) at FDA (CBER and CDER), as well as the EMEA, HPB, CSM, BGA and the French and Swedish MOH. Numerous therapeutic areas have been covered including: cardiovascular; respiratory; central nervous system; anti-infectives; vaccines; gastrointestinal; analgesia; gynaecological; oncology: dermatological; and OTCs; as well as neutraceuticals; cosmetics and/or cosmeceuticals.

In addition, he led one of the first true biotech submissions to FDA, namely the NDA for Engerix-B (SmithKline's recombinant DNA hepatitis-B vaccine). Since then Dr Young has been involved with numerous biological products, a full range of commercial vaccines and additional biotech developments based on recombinant technology and therapies based on nucleic acids (both DNA and RNA) even gene therapy.

He has extensive experience with presentations to the investment community and to the evaluation of mergers and acquisitions. He has unique experience of having been recruited to manage various risk management and pharmacovigilance efforts and the companies' responses to critical events in the marketplace (e.g. Selacryn and liver deaths, Dyazide and the Generic Drug Scandal, Rely and Toxic Shock, PhisoHex and brain damage in prematurity PhenFen and cardiovascular damage and finally reverse transcriptase in paediatric vaccines).

Dr. Young has served in all senior positions within the U.S. pharmaceutical industry's representative body, the Pharmaceutical Research & Manufacturers Association (PhRMA), including Medical, Regulatory and International Steering Committees and major industry /agency interactions (e.g.; the PhRMA / FDA User Fees Task Force; the Institute of Medicine Forum on Drug Development and; NIH's AIDS Committee). Many excellent contacts throughout the healthcare industry.