- 20+ years as a pharma executive, 27+ years in clinical development, and 30+ years as a physician.
CMO; Clinical Development (drugs, biologics, and medical devices); Global Clinical Trials (Phases 1 – 4); Product Registration and Post-Marketing Activities; Project Management of INDs, IDEs, NDAs, BLAs, CTDs, PIPs, PSPs, sNDAs, S/NDSs, PMAs, and 510(k)s; Regulatory Affairs (FDA, EMA, DCGI, MOHs for US, APAC, LA , non-EU countries, and Health Canada); Specialties: Anesthesiology, Internal Medicine, Epidemiology, and Biostatistics; Therapeutic Areas: Cardiovascular, Infectious/Rare Diseases, DIC, Rheumatology, Hematology/Oncology, OB/GYN, Endocrinology, Gastrointestinal, CNS, Metabolic Disorders, and Immunology.
With numerous papers, publications, and presentations, graduated MPH from Harvard School of Public Health (1988) and MD (Anesthesiology, 1983) and MBBS (Internal Medicine, 1978) from University of Kashmir, India.
Senior Product Development Consultant/Contractor, Kaul Consulting
Provide pharmaceutical, clinical development, regulatory, medical affairs, strategic, and due diligence consulting services to the biopharma community including medical monitoring services and safety and pharmacovigilance management.
Chief Medical Officer, Asahi Kasei Pharma America Corporation (formerly Artisan Pharma, Inc.)
Served as principal medical, regulatory, and corporate development leader. Spokesperson for company with the Board of directors, regulatory agencies worldwide, key opinion leaders (KOLs), clinical investigators, licensors, licensees, strategic alliances, business partners, advisors and consultants, investors, members of the media, and others. Provided strategic and tactical leadership in all facets of the ART-123 development including the Program Advisory Board (PAB), the Data Monitoring Committee (DMC), scientific awareness/conference strategy, broad-based publication planning, and product life cycle management.
Vice President, Clinical Development, Medical and Regulatory Affairs, Oscient Pharmaceuticals Corporation An Operating Committee member, served as the lead medical, clinical, regulatory, and product development representative of the company with the Board of Directors. Provided strategic and tactical leadership in all facets of drug development including regulatory approval, broad-based publication planning, product launch, post-launch support, and product life cycle management including implementation and maintenance of continuing medical programs (CMEs) and sales training. Duties included strategic and operational direction for development and execution, monitoring, and interpretation of Phase 1-4 clinical studies. Worked closely with team to ensure commercial success adhering to product labeling, and promotional and advertising regulations, and provided leadership in identifying product in-licensing and acquisition priorities. Served as the principal medical leader and spokesperson for the company with regulatory agencies worldwide, KOLs, clinical investigators, licensors, licensees, business partners, advisors and consultants, investors, members of the media, and others.
Division Vice President, Abt Associates Clinical Trials
Led the growth and operations of this full-service CRO as part of the Management Committee (Executive Management Team) and reported to CEO. Responsible for implementation and management of strategies to meet company goals. Oversaw all clinical contracts held by company including medical monitoring; signed off on all integrated clinical/statistical reports; and performed oversight, management, and coordination of clinical monitoring and project management operations. Provided expertise in the strategic planning, design, and management of non-clinical and clinical programs (Phases 1-4) including representation at regulatory agencies. Lead medical monitor for the development program of Bosentan for the treatment of pulmonary arterial hypertension (PAH), Laronidase for MPS 1, Imiglucerase for Type 1 Gaucher disease, and alpha-galactosidase for Fabry disease (Orphan Status for enzyme replacement therapy indications). These products were later commercialized as Tracleer®, Aldurazyme®, Cerezyme® and Fabrazyme®.