MEDICAL DIRECTOR/MEDICAL AFFAIRS – CNS/ONCOLOGY/VIROLOGY
- 40+ years as a medical practitioner, 33 years in medical research, and 23 years in the pharma industry.
CMO/Senior Medical Executive; Clinical/Protocol Development, Life Cycle Management, and Global Strategy of Therapeutic Agents; Global Medical Affairs; Statistics; Regulatory Affairs; Biotechnology; Physician/Researcher (Specialties – Autoimmune Diseases, Urology, Dermatology, Pain, Anti-Infective, Clinical Immunology, Oncology, CNS, Transplantation, Hematology, and Neurodegenerative Disorders including MS and Alzheimer’s Disease); ABPI Code/Healthcare Compliance; Start-Ups; Integrated Summary of Efficacy (ISE) for FDA Applications.
Physician executive expert in building and leading Medical Affairs and clinical development teams, taking drugs to market, and obtaining reimbursement from payers (NICE). With PhD, MSc, MRCPath, and FRCPath, seasoned researcher experienced in cellular biology and immunochemistry (immunotherapy of lymphomas, graft-versus-host disease, immunological reconstitution following bone marrow transplantation and the immune system of the elderly). Speaker at numerous events, with 31 peer-reviewed industry-focused publications.
CNS: At Biogen Idec, responsible for designing and implementing Educational Plan for Tysabri® as well the Patient Management Algorithms; both adopted by the EMEA and used globally. At Serono, in charge of global clinical development of 3 biotechnology drugs, recombinant human interferon beta-1a (Rebif®) and recombinant human interleukin 6 (Sigosix®) as well as recombinant TNF binding protein, in about 20 clinical indications. Built and led team that achieved global marketing authorization of interferon beta-1a in MS.
ONCOLOGY: Managed early development of Rebif® and Sigosix® for indications such as colorectal cancer, non-small lung cancer, breast cancer, glioma, myelodysplastic syndromes (MDS), peripheral blood progenitor cell transplantation (PBPC), for patients with solid tumors and hematological malignancies.
ANTI-INFECTIVES: Mycafungin for invasive candidiasis, Fidaxomicin for clostridium difficile infections, and Isavuconazole for Aspergillosis and Rare Moulds.
VIROLOGY: Managed development of Rebif® in chronic Hepatitis C/B, CIN, and condyloma acuminatum.
Principal, A3 Pharma Counseling Ltd.
Provide clinical development and medical affairs expertise to the biopharmaceutical industry.
Senior Vice President, Medical Affairs & Health Economics, Astellas Pharma EMEA
Led large global Medical Affairs, Health Economics, and Outcome Research group in Europe, the Middle East, and Africa: 100 physicians, pharmacists, and scientists. Oversight of Phase 3B/4 studies, managing 20 to 25 multicenter, multinational, global studies in 6 therapeutic areas. Focused on medical leadership, medical excellence, brand team and affiliates support, management of clinical trials, affiliate and HQ staff medical training, recruitment and staffing, compliance, and publication strategy.
Chief Medical Officer, AC Immune SA
Responsible for the global development of therapeutic vaccines and small molecules for the treatment of Alzheimer’s disease.
Chief Medical Officer, Trigen GmbH
Responsible for day-to-day management in organization specializing in the development of innovative agents for thromboembolic diseases (myocardial infarction and stroke); lead compound was PR-15, a first in-class biologic. Managed strategy, development, manufacturing, and financial plans as well as business development and fundraising.
Vice President/Head International Medical Affairs, Biogen Idec International
As part of Biogen Idec, founded Eidetica Biopharma GmbH. Led International Medical Affairs team as Chief Scientific Officer. Designed biosimilars development programs in fields of rheumatology, gastroenterology, oncology and MS.
Vice President, Medical Director, Head Clinical Development for CNS, Berlex Laboratories, USA
Led Clinical Development and Medical Affairs for CNS in the US. Steered company to plan and conduct large development program in MS.