Medical Doctor with Expertise in all Phases of the Drug Development Process for Pharmaceuticals, Devices, and Dietary Supplements

Expertise

• All phases of the drug development process, including medical, legal and policy issues related to pharmaceuticals, devices, and dietary supplements.
• Therapeutic areas included asthma, epilepsy, cancer, cardiovascular disease, infectious disease, sleep, depression, and prostate cancer.
• Drug development initiatives, protocol development, data analysis, review and revision submission materials and manuscripts, safety data review, medical monitoring, and medical review of marketing materials.
• New compound review and analyze, medical device, rapid assessment of compounds for in-licensing.
• New drug application, FDA preparation submission, regulatory review, documents, and warning letter response, mitigation.
• Projects encompassing devices, dietary supplements and vitamins.

Experience

Undisclosed Company, Group/Senior Director, 2005 - Present

• Directing migraine and pain group ranging from 10 to 20 members throughout the drug development lifecycle.
• Managed programs for Imitrex, Amerge, and Treximet products.
• Interacted with key opinion leaders, external experts, the FDA, and internal multidisciplinary teams to propel compound development, regulatory approval, and product launch initiatives. Chaired and presented to Advisory Boards.
• Assessed a variety of new compounds for pain and migraine, including iNOS, CB2 agonists, p38i, and potential in-licensing compounds, leading to final go / no-go decision.
• Designed Phase II-IV clinical trials from proof of concept, dose selection, efficacy, and safety to clinical support for regulatory approval.
• Oversaw the execution of over 15 clinical trials, data assessment and reporting, and submission of data to the Clinical Trial Registry for the FDA.
• Collaborated with JV partner Pozen, a pharmaceutical company, to develop Treximet, a combination product to treat migraines that was approved by the FDA.
• Delivered medical support for marketed compounds, including clinical trial design, implementation, and reporting; FDA and publication submission; risk management effectiveness plans; and marketing support.
• Created the post-marketing strategy and delivered clinical support for Amerge and Imitrex, currently a top-selling treatment for migraine.
• Initiated Phase II programs and development plan for a pain compound and treatment for neuropathic pain and migraine prophylaxis.
• Mentored clinical development scientists, served as a medical monitor on a Phase IIB study, and delivered medical input for additional studies.

Baker & Daniels, Indianapolis, IN Counsel, 1999 - 2001

• Legal consulting for an established law firm in Indiana, with more than 250 employees and offices in Indiana, Washington, DC, and China.
• Provided legal counsel to the pharmaceutical and medical device industry in the areas of medico-legal issues, including FDA regulatory requirements, medicare coverage, reimbursement, product liability, health care regulations, and clinical trial design as related to Medicare reimbursement as well as white papers related to policy issues.
• Clients ranged from Fortune 500 to small companies.
• Presentations to CMS and FDA included rationale for product coverage and reimbursement issues.

Lorex Pharmaceutical Company, IL, Director, Clinical Research, 1989 - 1993

• Directed medical research department with approximately 25 employees supporting clinical drug development, regulatory approval, Phase II-IV US clinical trials, and medical review of marketing materials for a broad range of therapeutic areas, including sleep, epilepsy, anxiety, GI, and assessment of new compounds in neurology and strokes.
• Delivered clinical input and supported the regulatory approval for Ambien (currently a top-selling hypnotic worldwide) by presenting data and analyses to the FDA and Canada's Health Protection Bureau, including presenting rational for Schedule V to the FDA Advisory Board based on potential for abuse.
• Collaborated with legal and marketing teams throughout the successful approval process, label preparation, and development of post-marketing strategy for Ambien, Kerlodone, and Kerlidex.

Northwestern University, Chicago, IL, Associate Professor, Director, 1986 - 1989

• Neurological Testing Center and Comprehensive Epilepsy Program Manager for a department of up to 15 employees responsible for performing testing, including EEG, EMG, evoked potentials, sleep studies, and video EEG monitoring.
• Developed an epilepsy program and set up long-term video EEG monitoring.

Montreal Neurological Institute, Montreal, Quebec, Canada, 1982 - 1986

Assistant Professor, 1983 - 1986

Research and Clinical Instructor, 1982 - 1983

• Performed clinical research in Positron Emission Tomography and epilepsy.
• Published research and presented findings at national and international meetings.

Honors & Publications

Credentials

• Assistant Professor of Clinical Neurology, Indiana University Medical School.
• Adjunct; Associate Professor, Clinical Neurology, Northwestern University.
• Adjunct in Medicine, Evanston Hospital.
• Flexible Internship, Methodist Hospital, Indianapolis, IN
• Juris Doctor studies, John Marshall Law School, Chicago, IL
• Neurology Residency, Indiana University School of Medicine, Indianapolis, IN
• Electroencephalography & Neurophysiology Fellowship, Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada

Licenses

• Medical: Indiana
• Medical Inactive: Illinois
• Legal: Indiana

Academic and Professional Affiliations

• American Academy of Neurology
• American Medical Association
• American Bar Association
• Academy of Legal Medicine

Publications and Patents

• Author and Co-Author in medical journals, educational text, international symposiums, and. conferences.

Education

• M.D. Medicine, Indiana University School of Medicine, IN
• J.D. With honors, Northwestern University School of Law, Chicago, IL
• B.S. Biochemistry, (with distinction), Purdue University, Lafayette, IN