- 30 years in medicine and the pharmaceutical industry
- 15 years of executive pharma leadership
Physician Executive, Executive Leadership, Clinical Development & Medical Affairs, Preclinical Development, Regulatory Affairs/Quality Assurance, Business Development/Fundraising, Commercial Marketing, Medical Writing/Communications, C-suite Activities.
Extensive experience at start-up small-, medium-, and large-sized companies in all aspects of drug development and clinical medicine including new chemical/molecular entities, biologics, devices, diagnostics, assay development, and biosimilars.
MD from Loyola University’s Stritch School of Medicine with training in Immunology, Internal Medicine, and Hematology/Hematologic Malignancies at the Mayo Clinic and in Hematology/ Oncology at Stanford University. Faculty at the University of Iowa College of Medicine and then Roswell Park Cancer Institute before joining industry in 1993. Triple board-certified in Internal Medicine, Hematology/Hematologic Malignancies, and Medical Oncology. Popular speaker at numerous events, with more than 60 peer-reviewed academic and industry-focused publications.
President & Founder, akta Pharmaceutical DevelopmentTM (aktaPD®) – global company engaged in the design, development, and commercialization of treatments of diseases
Preclinical Discovery and Clinical Development. RNAi interference technology. Publicly-traded startup biotech company. Target disease identification and in-depth assessment of a variety of diseases including orphan and rare diseases: oncology, hematology, pulmonary and other fibrotic disorders, infectious diseases, inborn errors of metabolism, autoimmunity, lipid metabolism, and iron homeostasis.
Preclinical, Clinical, and IND Development. Proprietary in situ chemovaccination platform to stimulate anti-tumor immunity. Privately-funded startup. Overall development plan and first-in-human protocol development. Solid tumors and lymphoma.
Phase 2/3 Study Design and Preclinical Development. Biosimilar monoclonal antibody. Small publicly-traded biotech company. Colon, breast, lung, glioblastoma, renal cell carcinoma, and ovarian cancer.
Independent Safety Evaluation Committee Member and Phase 1/2 clinical study. tRNA analog endogenous immunity and inflammation modulator. Privately-funded biotech with recent successful IPO. Rare muscle diseases and inflammatory myopathies.
Interim Chief Medical Officer. NCE FAK/Pyk inhibitors, PI3K/mTOR inhibitor, and combination therapies with immune-oncologic agents. Medical oncology and hematologic malignancy indications. Small, publicly-traded company. Inhaled antifungal agents for CF, asthma, and pulmonary infections in immunocompromised hosts. Small, publicly-traded company. Peptide vaccine/diagnostic/device for immunological tolerance in autoimmune disorders. Privately-funded biotech startup.
Medical Monitor and Clinical Development for Phase 1/2 studies. Heparan sulfate mimetic. Small, publicly-traded biotech company. Metastatic pancreatic cancer and other solid tumors.
Product Development. NCEs to modulate protein homeostasis and chaperones. Private startup companies. Multiple indications including cystic fibrosis.
Product Development. Diagnostic platform technology in immune-regulated diseases to diagnose and monitor disease status and therapeutic response. Publicly-traded commercial stage company. Chronic and latent infectious diseases, oncology, autoimmunity, and inflammatory states.
Post-marketing Surveillance, Clinical Trials Transparency, Regulatory Affairs. NCEs in neuroscience, rare diseases, gastrointestinal, and internal medicine. Publicly-traded global specialty biopharmaceutical company. Multiple indications.
Development Consultant: Startup company with immune agonist monoclonal antibody for oncology indications.
Chief Development Officer: GRAS nutritional and probiotics for immunological changes to gut micro biota in oncology and autoimmune indications. Privately-funded, venture capital asset-centric development companies with two distinct products.
Vice President and Head, Clinical Development, Global Medicines Development and Affairs –
Vertex Pharmaceuticals, Inc.
Chief Medical Officer, Vice President and Head, Clinical Development/Medical Affairs –
Tolerx, Inc – Biopharmaceutical Company
Senior Vice President, Medical Affairs and R&D, and Senior Vice President, Medical Operations – Sunovion Pharmaceuticals, Inc. (formerly Sepracor Inc.)
Medical Director, Rebif Multiple Sclerosis Strategic Business Unit (SBU), Medical Director of Virology/Oncology, Medical Director of Immunology/Oncology – EMD Serono (formerly Ares-Serono Inc.) – Biopharmaceutical Division of Merck KGaA, Darmstadt, Germany, a Global Pharmaceutical and Chemical Group.
Clinical Development and Medical Affairs: Supervision of clinical operations and development including vendor relationships and management on national and international levels, with scope ranging from discovery to indication evaluation and pre-IND planning; design and execution of Phase 1- 4 clinical trials; and submission of NDA, sNDA, BLA, and response to clinical holds.
Preclinical Development: Medical supervision of lead optimization and selection, preclinical IND-enabling and active IND support studies including assay methodology, tech transfer, in vivo non-human animal studies (murine to primate), qualification assays to support clinical trials, and generation of products to qualify in vitro assays.
Regulatory Affairs/Quality Assurance: Supervision of medical/clinical FDA/EMA interactions including teleconferences, face-to-face meetings, identification and oversight of consultants, GXP activities, orphan designations, and pharmacovigilance. Experience spans pre-IND to product label negotiations.
Executive Leadership: Facilitation of overall company direction and strategy; BOD and SAB updates, presentations, and interactions; business development including co-development deals, in-licensing, due diligence, IPO, fundraising, and M&A activities; recruiting, hiring, team-building of departments and functions; and medical representation on discovery teams. Participation on scientific advisory and grant review committees.
Medical Writing and Communications: Supervision of in-house and outsourced medical and technical writing of protocols, amendments, regulatory authority submissions, study reports, abstracts, manuscripts, site communications, website content, publication planning, and press releases.
Commercial/Marketing: Provision of insight and leadership from product conception to marketing activities including support of sales and MSL teams; CMS and other payer presentations and strategy; and medical affairs oversight of the most successful launch of a branded product into a generic marketplace.