- 14 years experience in pharmaceutical industry; 20+ years as a surgeon and intensive/emergency
CMO; Design, Implementation, and Execution of Global Clinical Trials and Key Documents (Phases 1 to 3); Clinical/Regulatory Strategic Planning; Global Regulatory and IND/NDA Submissions (US, EU, China, Japan, and Canada); Pharmacovigilance; Quality Assurance and Compliance; CRO Management; Product Launch and Life Cycle Management; Medical and Scientific Specialties: Neurology (neurodegenerative dementia/movement disorders), Oncology, and Cardiovascular Disease. Fluent in English and German.
Chief Medical Officer and Managing Partner, Reininger and Associates LLC
Conceptualize and optimize clinical development and commercialization and/or globalization of personalized medicinal products including combination products and medical devices. Special expertise in development of targeted agents in neurodegenerative diseases, cardiovascular disease, and oncology including targeted radio-pharmaceuticals.
Senior Vice President and Chief Medical Officer, Navidea Biopharmaceuticals
Represented company’s medical and scientific interests with regulatory authorities, investigators/physicians, the investor community, and at major medical/scientific meetings including advisory boards. Led the expansion of Medical Affairs to include Pharmacovigilance/Call Center support and to assist in the launch and commercialization of Lymphoseek for lymph node mapping in breast cancer and melanoma. Successfully conceptualized, implemented, and executed the Clinical Development program for the amyloid-targeted PET radiotracer (NAV4694) into Phase 3, including interactions with regulatory bodies in the US, EU, Canada, and Japan. Developed the clinical protocol and achieved Special Protocol Assessment FDA approval for the US Phase 3 development program for the DAT-targeted SPECT radiotracer (NAV5001). Provided clinical and medical expertise to support the initial FDA approval of Lymphoseek and subsequent filing and approval of two supplemental NDAs (for lymph node mapping in head and neck cancer and solid tumors). Positive interactions with the EU’s MAA led to central approval of indications in Europe.
Senior Director of Clinical Research, Bayer HealthCare Pharmaceuticals
As Global Clinical Leader (GCL) for Molecular Imaging, played a major role in advancing molecular imaging franchise. Successfully conceptualized and led the global clinical development program for the β-amyloid-targeted PET radiotracer (florbetaben). Oversaw conduct of Clinical Pharmacology and Development teams in the US, EU, and Japan through Phases 1-3 including completion of the submission dossier. Phase 2 data was published in Lancet Neurology. Represented company at the FDA Advisory Board meeting to discuss the role of β-amyloid imaging in the diagnosis of Alzheimer’s disease in 2008 and provided scientific/medical input to the then novel EU/EMA “Biomarker Qualification” process. Represented company at numerous international congress symposiums, bi-annual SNMMI Emerging Science sessions, and the Alzheimer’s Association’s Scientific Roundtable sessions. Consulting member of the cross-business therapeutics teams supporting design, conduct, and quality assurance of therapeutic trials utilizing diagnostic imaging/biomarkers as endpoints.
Director of Clinical Research, Medical Diagnostics, General Electric Healthcare (by acquisition, formerly Amersham Health)
Cross-business consultant on design, implementation, and execution of prospective clinical trials for medical imaging, surgical devices, and software. Led global Phase 4 life cycle program and developed and implemented Phase 3 Coronary Computerized Tomography Angiography (CCTA) clinical development program for the X-ray contrast agent Visipaque. Provided medical/scientific input for and oversaw the Phase 3 conduct of the Clinical Development team, including completion of the EU submission dossiers for DaTscan for the Parkinson’s disease and DLB indications. Data was published in Lancet Neurology and was used for the DaTscan submission in the US. As a member of the Brand Team, provided scientific/medical input for DaTscan launch, commercialization, and life cycle activities.