HEZEKIAH (HEZY) ADESANYA MD: MANAGING PRINCIPAL REMOTE PHARMA PHYSICIAN CONSULTANTS (RPPCONSULTS)

A Physician with experience on a variety of clinical practice, clinical development and drug safety, epidemiological and outcomes research, business development and product acquisitions during the last 33 years. Clinical practice experience as a physician includes: Pediatric and general medicine ICU/NICU, ward, emergency room, clinics, and research center management for years.

 Global pharmaceutical experience ranges across all therapeutic areas of drug development, including but not limited to: Cardiovascular, Anti-infectives, Metabolism and Endocrinology, Oncology, Respiratory and Allergy, Vaccines, Internal medicine, CNS, Pain, Medical Devices and Psychiatry. He has global management experience and have managed several groups with increasing responsibilities across multiple companies. Set up reimbursement accounts with large wholesalers and HMOs in the US.

Experience with Identifying and developing KOL network to advice and assist with clinical development programs.

Conducted Pharmaco-economic assessments on product portfolios for acquisition and in licensing across several therapeutic areas, disease burden and product positioning in the US and Europe. Assessed several products for acquisitions, in licensing and conducted several co-marketing agreements with smaller companies.

Served as Chief Medical Officer to small and Start up Pharma companies responsibility for managing clinical departments, clinical development, disease strategy, IN Licensing, M&A activities.

Clinical Reviewer for American Journal of Hospital Pharmacists (AJHP) Since 2004.

RPPCONSULTS (DansetH LLC)                                    

 January 2010-Present

Managing Partner

(Clinical development/safety/medical affairs consulting roles for global large/small pharma)

• Safety Risk Lead (SRL) for major pharmaceutical companies

• Chair the Risk Management Committees
• Provide continued monitoring of compounds in development and post-marketed
• Lead safety member of global product teams
• Present to executive teams outside of safety on newly determined risk findings
• Continuous benefit risk assessment of all assigned products
• Act on behalf of TA leaders
• Member, internal DMCs for assigned products
• Safety representative on external IDMCs
• Safety authorship and reviews of IBs, DSUR, PBRER, ISS and SCS

• Manage clinical teams responsible for study and CRF designs, medical monitoring and data cleaning
• Lead teams on investigator/site qualifications
• Manage several client safety risk management programs
• Provide oversight and management of drug safety department, mentoring of safety physicians and associates at client companies
• Leading company-client teams in responses to regulatory audits and questions
• Responsible for final authoring of PBRERs, ISS, SCS and other safety documents for clients
• Clinical Safety monitoring and overview of clinical trials (Phases 1-3)
• Review and monitor study for protocol discontinuation rules
• Serve as a resource to the clinical investigators for advice about management of AE/SAEs, interpretation of inclusion/exclusion criteria, and other clinical and safety related questions
• Initiate and implement signal detection and tracking tools across multiple therapeutic areas
• Interact and lead clinical and regulatory teams in safety reviews for clients in house
• Oversight and coordination of call center and feedback responses to inquiries from HCP and consumers

• Business/Medical Affairs Responsibilities:
  • Performed scientific evaluation of pre-clinical proof-of-concept human health licensing, collaboration and acquisition projects. 
  • Guiding the team that scientifically executes the therapeutic area licensing strategy by leading the Search & Evaluation component of the overall licensing process.
  • Leading the cross-functional scientific teams that are responsible for due diligence and scientific negotiations/approvals on major licensing projects.
  • Ensure medical quality, patient safety and scientific innovation as appropriate. Drive proposal review and ensure US/worldwide coordination of respective support programs
  • Drive US/worldwide Medical Affairs disease strategy and plan enhancing product profile, generating superior competitive value and aligned to client company disease strategy, franchise strategy and respective product strategies
  • Ensure suitable coverage of aspects of medical practice and patient management, drug combinations, health economics and outcomes research into plan
  • Develop publication trial strategy as well as strategy to support third-party sponsored research (e.g., investigator sponsored trials and cooperative study group sponsored trials) supportive of and aligned to respective development strategy

Prior to 2010 had served in increasing roles up to Senior Director, TA Head, Head of Safety and Chief Safety Officer for Large and Mid-size Pharma, including Sanofi, Merck, Eli Lilly and Teva ( formerly Cephalon) Pharma.