Medical and Pharmaceutical Consultant

Expertise

• Clinical development and drug safety, epidemiological and outcomes research, business development and product acquisitions of 30 years with a variety of clinical practices.
• Physician practice includes: Pediatric and general medicine ICU/NICU, ward, emergency room, clinics, and research center management.
• Global pharmacovigilance 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 and psychiatry.
• Global management of several groups with increasing responsibilities across multiple companies.
• Setting up reimbursement accounts with large wholesalers and HMOs in the US. I have conducted several Rx to OTC switches in the Past.
• Pharmaco-economic assessments on product portfolios for acquisition and in licensing across several therapeutic areas, disease burden and product positioning in the U.S. and Europe.
• Product assessed for acquisitions, licensing or co-marketing agreements.
• Served as consultant to foreign governments in assessments of healthcare systems and capacities, population epidemiology and disease burdens, pharmaco-economics and drug formulary portfolios. (Caribbean, West Africa Health Organization and other African countries).

Experience

Undisclosed Company, Independent Medical Consultant, 2009 - Present

Managing Partner

• Serving various roles: Clinical Development, Safety and Medical Affairs consulting for key global pharmaceutical companies.
• 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.
• Member, clinical teams responsible for study and CRF designs, medical monitoring and data cleaning.
• Lead teams on investigator and 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 and 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 Representative

• 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 and evaluation component of the overall licensing process.
• Leading the cross-functional scientific teams that are responsible for due diligence and scientific negotiations and 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 U. S. and 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.

Merck Research Laboratories, North Wales, PA, Senior Director, 2007 - 2009

• Oversaw the Therapeutic Area, Clinical Development, Risk Management and Safety Surveillance.
• Clinical development and post marketing for drugs in CNS, Diabetes, Vaccines and Oncology TA areas with the following:
• Provided clinical and strategic input to clinical development plan and relevant documents (e.g., protocols, study reports, investigator brochure, integrated safety summaries and other documents needed for product approval).
• Core Product team Member, responsible for overall strategic planning and execution of clinical programs for assigned products.
• Streamlined PSUR operational efficiencies for improved delivery and high-quality reports
• Interacted with clinical teams, regulatory affairs, external bodies (DSMBs, and regulatory agencies), marketing regarding all safety issues.

Review Board-Medical Member

• Ensured that promotional marketing materials were medically accurate and in line with DDMAC guidelines and product claims were supported by available clinical data.
• Claims and studies used for marketing materials met FDA requirements for the data validity and fair balance.
• Review of branded and generic online information for patient lifestyle and medication support.
• Review of speaker text, video and audio transcripts to ensure alignment with guidelines.
• Provided mentoring and support for physician staff for medical evaluation and review of serious adverse events, spontaneously reported globally and for those SAEs reported for clinical trials and post marketing surveillance, both local and global to ensure compliance with global and local regulatory requirements.
• Collection, analyzation, and understanding clinical safety and epidemiologic data throughout drug life cycle.
• Developed and conceptualized risk management plans for drugs and vaccines supporting drug application to health authorities. This was done in collaboration with clinical safety, marketing, legal, pre-clinical, and drug regulatory affairs.
• Participated internal research/safety meetings/boards including: DSMB, labeling, medico-legal, and others.
• Performed evidence-based benefit-risk assessment.
• Participated in several and multiple physician education/information sessions.
• Responded to safety inquiries from large HMOs and pricing bodies in the US and Ex-US for assigned products.:
• Supervised Physicians, Line Manager and a team of Scientists for operational deliverables and support for products.

Cephalon Inc., Senior Director, 2006 - 2007

• As Corporate Chief Safety Officer, Managed all therapeutic areas (CNS, oncology, medical devices and pain).

Pre and Post Market Support

• Responsible for providing technical, scientific and managerial oversight of the managers of each of the functions within GPS and provide strategic oversight in integrating and coordinating the individual function activities.
• Responsible for ensuring compliance, preparing and managing the budget and overseeing performance management.
• Led and Provided oversight for training of company personnel and external vendor staff on drug safety processes, establishing company processes in line with local and global SOPs.
• Led review of multiple vendors in assessment and choice of safety databases. Implemented testing and deployment of safety database.
• Provided clinical and strategic input to clinical development plan and relevant documents (e.g., protocols, study reports, investigator brochure, integrated safety summaries and other documents needed for product approval).
• Led investigator and monitor training. Led clinical teams in site qualifications and safety monitoring plans
• Member, clinical teams responsible for study and CRF designs, medical monitoring and data cleaning.
• Led teams on investigator and site qualifications.
• Led clinical and regulatory teams for GCP and pharmacovigilance audits by regulatory agencies
• Interacted with clinical teams, regulatory affairs, external bodies (DSMBs and regulatory agencies), marketing regarding all safety issues.
• Provided medical evaluation and review for serious adverse events, spontaneously reported globally.
• For SAEs reported for clinical trials and post marketing surveillance, both local and global to ensure compliance with global and local regulatory requirements.
• Responsible for surveillance and medical review activities for all Cephalon products, providing medical and strategic guidance for all surveillance activities.
• Initiate and implement signal detection and tracking tools across multiple therapeutic areas.
• Coordination of safety surveillance activities for clinical projects, study teams and initiatives, including signal detection and analysis.
• Provided medical support to case processing, ensuring high quality outputs for both clinical safety and post marketing cases.
• Member for Investigator Initiated Studies review team, approval of protocols.
• Member, Corporate Risk Management Policy and Strategic team.
• Ensured that promotional marketing materials were medically accurate and were in line with DDMAC guidelines, product claims were supported by available clinical data.
• Claims, and studies used for marketing materials met the FDA requirements for the data validity and fair balance.
• Review of branded and generic online information for patient lifestyle and medication support.
• Review of speaker text, video and audio transcripts to ensure alignment with guidelines.
• Responsible for executive level safety presentations and review.
• Responsible for final review of regulatory documents for submissions.
• Safety representative for regulatory interface meetings.
• Member, Corporate Labelling Review Board. Participated in several and multiple physician education and information sessions.
• Responded to safety inquiries from large HMOs and pricing bodies in the US and Ex-US for assigned products.
• Responsible for Corporate Safety communication to external stake holders.
• Supervised a team of 20 local employees, international employees, Safety physicians for surveillance activities and medical review of cases, risk management operations group, case operations group for ICSR processing, and contracts group for managing alliance partners
• Safety writing group for aggregate reports.
• Oversaw E.U., QP and local pharmacovigilance affiliates worldwide in meeting safety needs.

Sanofi-Aventis Pharmaceuticals, Senior Direct 2002 - 2006

Global Safety Officer - Global Pharmacovigilance and Epidemiology

• Therapeutic areas: Cardiovascular, CNS, anti-infectives, respiratory/pulmonary, and oncology.
• Phase 1-4 (early phase development, NDA support and post-marketing).

Risk Management (Global and U.S.)

• Oversaw local and international reporting and pharmacovigilance activities, supporting affiliates in analytic reviews and third-party questions on safety for assigned products.
• Coordination of safety surveillance activities for assigned local and global clinical projects, study teams and initiatives, including signal detection and analysis.
• Served as expert for all safety issues for assigned investigational products.
• Documented and evaluated the risk profile with the local and global project and study team, ensured ongoing risk and benefit assessment in cooperation with the global clinical director, communicated ongoing benefit and risk analysis to project and clinical study teams.
• Provided pharmacovigilance input to clinical development plan and relevant documents (e.g., protocols, study reports, investigator brochure, integrated safety summaries and other documents needed for product approval).
• Contributed to investigator and monitor training. Interacted with clinical teams, regulatory affairs, external bodies (DSMBs, steering committees and regulatory agencies), marketing, regarding all safety issues.
• Coordinated and directed activities of study safety physicians and managers at regional and local levels, ensured compliance with corporate standards in receipt and handling of safety information.
• Aggregate safety data review: For assigned products, ongoing global clinical overview of all adverse event reports, including review of relevant literature for safety information pertinent to product safety, detection and evaluation of potential safety signals, periodic review and documentation of all safety data.
• Communication and documentation of product safety assessment: including writing and coordination of all PSURs, SERs, labeling update proposals for the global labeling committee and U.S. Package Insert Committee, development of safety action plans as appropriate, preparation and review of all company internal and external safety documentation.
• Communication of benefit and risk analysis with relevant units (including regulatory, marketing, legal, QA, labeling and medical affairs), provide expert advice for internal and external customers regarding product safety profile.
• Led global and local teams in responding to safety queries from regulatory authorities or third parties worldwide for all assigned products.
• Participated in training of company personnel and external vendor staff on drug safety processes, establishing company processes in line with local and global SOPs.
• Involved in interviewing, hiring, mentoring and training of employees, locally and internationally.
• European MRP and central submission process, E.U. label variation and other international regulatory agency submission support.
• Implemented pharmacoepidemiology principles and initiated epidemiology searches and studies as appropriate.

Eli Lilly and Company, Pharmacovigilance Director, 1999 - 2002

• Global safety monitoring Physician in cardiovascular, CNS and endocrinology (Phase I-3 and Post marketing surveillance).
• Provided medical evaluation and review for serious adverse events, spontaneously reported globally and for those SAEs reported for clinical trials and post marketing surveillance, both local and global to ensure compliance with global and local regulatory requirements.
• Aggregate safety data review: For assigned products, ongoing global clinical overview of all adverse event reports, including review of relevant literature for safety information pertinent to product safety, detection and evaluation of potential safety signals, periodic review and documentation of all safety data.
• Communication and documentation of product safety assessment including writing and coordination of all PSURs, SERs, labeling update proposals for the global labeling committee.
• U.S. Package Insert Committee, development of safety action plans as appropriate, preparation and review of all company internal and external safety documentation.
• Communication of benefit-risk analysis with relevant units, provided expert advice for internal and external customers regarding product safety profile.
• Coordination of safety surveillance activities for assigned local and global clinical projects, study teams and initiatives, including signal detection and analysis.
• Served as expert for all safety issues for assigned investigational products.
• Documented and evaluated the risk profile with the local and global project and study team.
• Ensured ongoing risk and benefit assessment in cooperation with the director medical research and project team leaders, communicated ongoing safety analysis and benefit/risk analysis to project and clinical study teams.
• Coordinated and directed activities of study safety managers at regional and local levels, ensured compliance with corporate standards in receipt and handling of safety information.
• Provided pharmacovigilance input to clinical development plan and relevant documents (e.g., protocols, study reports, investigator brochure, integrated safety summaries and other documents needed for product approval).
• Contributed to investigator and monitor training.
• Interacted with clinical teams, regulatory affairs, external bodies (DSMBs), marketing regarding all safety issues.
• Supervised development, training and day-to-day activities of safety associates and scientists.
• Led physician global safety team; reviewing AEs, MedDRA coding, reviewing for trends and important signals, responding to safety requests from global IRBs and regulatory authorities.
• Provided medical expertise to program and product teams and vendors on safety data and SAE reconciliation process.
• Determination of safety parameters required for clinical trials, monitoring of safety trends in clinical trials, and ensuring proper documentation of AEs.
• Provided leadership for review and assessments of adverse events relationship to study drugs and follow up action on events.
• Provided pharmacoepidemiology principles.
• Supervised; Safety Associates, Regional safety MD and /local affiliate MDs in TA areas.

FMAS, Drug Safety and Clinical Research, Associate Director, 1998 - 1999

• Safety Physician managed in the; CNS, CV and metabolic areas.
• Managed large phase 2-4 therapeutic and safety studies, coordinating SAE review with clinical research teams. Assessment of AEs and ADRs for signal detection and analysis.
• Provided drug safety input to clinical trial protocols, clinical development sessions, and study development phases for clinical trials phase 4 trials.
• Medical monitor clinical trials, responding to client and investigational site requests for safety information.
• Monitored and prepared sites for GCP compliance audits.
• Provided medical expertise to program and product teams and vendors on safety data and SAE reconciliation process.
• Determination of safety parameters required for clinical trials, monitoring of safety trends in clinical trials, and ensuring proper documentation of AEs.
• Provided leadership for review and assessments of adverse events relationship to study drugs and follow up action on events.
• Responsible for clinical contents of study development, protocols and other study documentation.
• Involved in interviewing, hiring, and training of staff.

The Medical Clinic and Research Center, San Fernando, Trinidad, Medical Director, 1995 - 1997

• Manage this collaborative regional center for international pharmaceutical companies.
• Supervised and conducted multiple site clinical trials and epidemiology studies.
• Execution of clinical trials phases 3-4.
• Patient selection and enrollment in studies.
• Monitored patient response in clinical trials for safety and efficacy.
• Assessment and reporting of AEs, SAEs to sponsors, monitoring of trends and signals for products.
• Analysis of clinical data collected from studies.
• Assessment of adverse events in relationship to study drug.
• Initiated and closed out of sites.

Independent Consultant and Community Lecturer, 1994 - 1997

• Diagnosis, prevention, treatment of common conditions in children.

San Fernando General Hospital, Trinidad, West Indies, 1987 - 1994

• Senior Medical Officer, Emergency Medicine and Surgery, 1994
• Clinical Residency, Pediatrics and Family Medicine, 1989 - 1994
• Internal Medicine, Surgery, OB&GYN, and Pediatrics, 1987 - 1989

Honors & Publications

Credentials

• Full Registration, Nigerian Medical Council Residency
• Pediatrics & Family Practice (previous)Trinidad and Tobago
• Full Registration, Nigerian Medical Council
• Clinical reviewer, AJHP

Academic and Professional Affiliations

• Drug Information Association (DIA)
• American Academy of Pharmaceutical Physicians (AAPP)
• American Medical Association (AMA)

Education

• M.D. College of Medicine University of Lagos, Nigeria