MEDICAL & SAFETY MONITORING PERSONAL PROFILE

• 40 years as a physician.
• 30 years in clinical trials for drug development.
• 20 years as medical/clinical entrepreneur.

EXPERTISE Anesthesiology, Clinical Pharmacology, Surgery, Internal Medicine, Regulatory Affairs. Deep experience in regulatory affairs and project management including finding and contracting investigators and pharmacies as well as liaising with IEC and regulatory bodies. Graduated MD from University of Uppsala Medical School, Sweden. Specialty in Anesthesia and Intensive Care Medicine. Associate professor in Anesthesiology and Intensive Care Medicine at Uppsala University. With research focused on clinical pharmacology and pain management, has published 40 papers and ...
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TRANSLATIONAL MEDICINE / CLINICAL DEVELOPMENT PERSONAL PROFILE

• 18 years of in biotech/pharma ranging from drug target discovery through clinical drug development.
• 10 years in academic medicine and research.

EXPERTISE Translational Medicine and Strategy; Drug Research and Development; Clinical Development Planning; Trial Design; Medical Management of Phase 1-2 Clinical Trials; Development of Biomarker Strategies; PK/PD Assessments; Pharmacogenomics and Multi-omics Profiling. Specialties: Pediatrics, Clinical Genetics, Molecular Biology, Obesity, Diabetes, Autoimmunity, Cardiovascular, Infectious Diseases, Metabolism, Neurology, Oncology, and “Omics” Methods. Co-inventor on 18 filed patents, with over 40 publications and presentations. PROFESSIONAL EXPERIENCE Vice President, Translational Medicine, Rexahn Pharmaceuticals Develops translational ...
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ONCOLOGY, NEUROLOGY, CARDIOVASCULAR PERSONAL PROFILE

• 19 years in pharmacology, biotechnology, clinical/medical, pharmaceutical, and healthcare investment arenas.

EXPERTISE Pharmacology; Biotechnology; Pharma Research, Development, and Commercialization; Strategy; Medicine; Business Development/Fundraising/VC Partnerships; Due Diligence; Study Design, and Safety/Efficacy. Therapeutic Areas of Expertise: Oncology, Neuroscience (psychiatric and neurology), CNS, Autism, Neuropathic Pain, Intracellular Neurotrophic Signaling, Ophthalmology, Corneal Healing, Glaucoma, Fuch’s Dystrophy, Pulmonology, and Cystic Fibrosis. Developed novel therapies, including the invention, which have shown in vivo safety and efficacy in wound healing in neurotrophic Keratitis, and several Cystic Fibrosis stabilizer drugs to Lumacraftor, and drugs for the treatment of autism, and neurodegenerative ...
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MEDICAL DIRECTOR/MEDICAL AFFAIRS – CNS/ONCOLOGY/VIROLOGY PERSONAL PROFILE

• 40+ years as a medical practitioner, 33 years in medical research, and 23 years in the pharma industry.

EXPERTISE CMO/Senior Medical Executive; Clinical/Protocol Development, Life Cycle Management, and Global Strategy of Therapeutic Agents; Global Medical Affairs; Statistics; Regulatory Affairs; Biotechnology; Physician/Researcher (Specialties - Autoimmune Diseases, Urology, Dermatology, Pain, Anti-Infective, Clinical Immunology, Oncology, CNS, Transplantation, Hematology, and Neurodegenerative Disorders including MS and Alzheimer’s Disease); ABPI Code/Healthcare Compliance; Start-Ups; Integrated Summary of Efficacy (ISE) for FDA Applications. Physician executive expert in building and leading Medical Affairs and clinical development teams, taking drugs ...
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CLINICAL OPERATIONS PERSONAL PROFILE

• Seasoned, global clinical operations executive with 30+ years of pharma experience.

EXPERTISE Clinical Operations; Study/Project Management; Investigator Meetings, Site Selection and Qualification; Vendor/CRO RFP Development, Selection, and Oversight; Protocol/ICF/CRF/Study Report Development; Clinical Plans and Monitoring; Budgeting; Strategy; Leadership; Business Development; Global Acquisitions; Due Diligence; Vendor/Academic Relationships; Pharmacovigilance; Regulatory Document Collection and Submissions (global); Training; and Strategic Partnerships. Therapeutic Areas: Oncology (liquid and solid tumors, immunotherapy), Biotechnology (monoclonal antibodies, protein toxin), Cardiology, Devices, Gastroenterology, Gynecology, Hemophilia, Anti-Infectives (HIV/AIDS), Mega-trials, Neurology (epilepsy, MS), Respiratory, Smoking Cessation, Transplantation, and Wound Healing (burns, stasis ulcers). B.S., Nursing, University ...
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REGULATORY AFFAIRS PERSONAL PROFILE

• 30 years of experience in drug development across a diverse range of therapeutic areas and product types.

EXPERTISE Global Regulatory Affairs, Oncology and Infection, Neuroscience, Drug Development, Seasoned  Executive, Strategic Thinking, Internal Change Management. PROFESSIONAL EXPERIENCE Vice President, Regulatory Affairs, Oncology and Infection, AstraZeneca Led the global regulatory function supporting oncology and infection therapeutic area, including development and marketed programs. Achieved approvals for IRESSA in EU and CAPRELSA in the US/EU as well as external partnerships including the acquisition of Novexel and licensing of ZINFORO from Forest and approval of ZINFORO in ...
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CLINICAL TRIALS/MEDICAL MONITORING / CARDIOLOGY PERSONAL PROFILE

• Board-certified cardiologist with 17 years of experience in clinical development, and more than 10 years on the faculty of a major medical school with clinical, clinical research, teaching, and administrative duties.

EXPERTISE Clinical Development, Clinical Trials Design / Plan (Phases 1-4), Medical Monitoring, Investigator Meetings and Site Interactions, CRO Management, Documents, Review / Synthesis of Trial Results, FDA Interactions (all phases of development), Due Diligence, In-licensing / Out-licensing, Partnering Initiatives, Presentations, and Leadership. Therapeutic Areas: Cardiovascular, Rare Disease, Gastroenterology, and Hematology. Authored/co-authored more than 40 peer-reviewed manuscripts, book chapters, and reviews; ...
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PHARMACOVIGILANCE & MANAGEMENT PERSONAL PROFILE

• 20 years of global clinical trial management in oncology, neuroscience, anti-infective, and ophthalmology.

EXPERTISE Protocol Writing/Feasibility, Clinical Supply Chain, CTA Application, Statistical Analysis Plan, Strategic Vision and Planning, Data Management (OC-RDC), Patient Recruitment Plan, Clinical Monitoring, Consensus-building, Clinical Study Reports, Global Team Management, Contract and Vendor Negotiation, Large-Scale Budgets/Finance Plans, Compound Migrations/Transitions, Risk Analysis and Assessment, Project Management, Process Streamlining, and Team Leadership. PROFESSIONAL EXPERIENCE Director of Clinical Operations, Euthymics Bioscience, Neurovance, Inc. Design operational protocols, clinical development plans, budgets, and operations documents. Conduct vendor and consultant selection and contract negotiations, oversight, risk ...
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CLINICAL OPERATIONS & STUDY MANAGEMENT PERSONAL PROFILE

• 10 years of global study management experience.

EXPERTISE Global Study Management; Vendor Selection and Oversight; Project, Budget, and Time Line Management; Issue Management; Team Leadership and Training; Site Identification and Selection; Enrollment Models; Clinical Supply Planning; Investigator/Vendor Meetings; Monitoring Plans; Study Forms (Consent Forms, Trial Master File, EDC/Case Report Forms, and Clinical Study Reports); IxRS Systems; Data Review, Cleaning, and Database Lock; Study Therapeutic Areas of Expertise: Analgesia/Anesthesiology, Gastroenterology, Hepatic Disorders, Immunology, Infectious Diseases, Inflammatory Diseases, Oncology, Skeletal Diseases, Respiratory, Pediatrics, and Neurology. PROFESSIONAL EXPERIENCE Clinical Trial Manager, Takeda Pharmaceutical Company ...
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ONCOLOGY, NEUROLOGY, CARDIOVASCULAR PERSONAL PROFILE

• 14 years experience in pharmaceutical industry; 20+ years as a surgeon and intensive/emergency care physician.

EXPERTISE 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. PROFESSIONAL EXPERIENCE Chief Medical Officer and Managing Partner, Reininger and Associates LLC Conceptualize and optimize clinical ...
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TOXICOLOGY PERSONAL PROFILE

• Board-certified toxicologist with 30+ years of research experience in toxicology.
• 20+ years experience in pharmaceutical drug development.

EXPERTISE Regulatory/Biochemical Toxicology; Preclinical Toxicology Program Development; Lab Management/ Leadership; Global Submissions for Small Molecules and Biotherapeutics (INDs, NDAs, BLAs, CTDs ); Early/Late State Drug Development Oversight (new molecular entities, medical devices, reformulations of marketed products) Preclinical Safety Assessment Programs (toxicology, pathology, drug metabolism, pharmacokinetics/ toxicokinetics, bioanalytics); Risk Assessment Design/Analysis; Preclinical Regulatory Strategies; Global Drug Registration/Support; FDA/USDA Inspections; FDA, ICH, MHW, and OECD Regulations. Authored/co-authored 35 publications and 40 abstracts. PROFESSIONAL EXPERIENCE Vice President/Global Head, Drug Safety Evaluation, ...
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CRO GOVERNANCE, OPERATIONS, BIOSTATISTICS/DATA PERSONAL PROFILE

• Expert clinical data sciences professional leveraging 20+ years of experience in research computing and 10 years proven leadership in operational aspects of drug development at CROs.

EXPERTISE Drug Development Operations; Vendor Selection and Quality Oversight; Development and Evaluation of Project Scope and Specifications; Analytical Review and Coordination of Project Management Plan and Timeline, Clinical Monitoring Plan, Risk Mitigation Plan, Data Management Plan, eCRF / CRF Completion Guidelines, User Acceptance Testing, and Statistical Analysis Plan; Data/Statistics Strategic Resourcing; SOPs; Medical Writing; Business Development; and Leadership. Therapeutic Areas of Expertise: neuroscience (Tourette syndrome, Parkinson’s ...
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MEDICAL EXECUTIVE / ONCOLOGY PERSONAL PROFILE

• Clinical oncology expert with 20 years of extensive pharmaceutical experience, strong analytical capabilities in multidisciplinary areas of oncology research and development, and deep expertise in pharma and biotech: academic medicine and research (from clinic to bedside), pharmaceutical drug development (from preclinical to post-marketing), and medical/regulatory oversight review (from IND to NDA).

EXPERTISE CMO; Development / Management / Oversight / Execution of Phases 1-4 Clinical Trials; Medical Regulatory Oversight and Review; Regulatory Submissions (NDAs, MAAs); Due Diligence; Business Development; Program Budget Oversight; Vendor Selection and Management; Biotech Startups; Clinical and Business Strategy / ...
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MEDICAL EXECUTIVE PERSONAL PROFILE

• 24 years as a Hematologist/Medical Oncologist
• 20 years in clinical practical experience
• 4 years experience physician executive.

EXPERTISE Medical Affairs Strategy and Oversight; Management Oversight and Development of Clinical Phases 1-4 Clinical Trials; Post-FDA Approval Investigator Initiated Research (IIR); Investigator-Initiated Sponsored Research (IISR); Strategy and Content Creation for Global Key Opinion Leaders (KOLs); Product Marketing Strategies and Commercialization; Medical, Educational, and Promotional Review and Presentations; Medicare and Insurer Reimbursement Support; Research Grants; Global and Small Post Start-up Management of Oncology Therapeutic and Cancer Molecular Diagnostic Companies; and Budget Development. Therapeutic Areas of Expertise: Lung ...
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PHARMACOLOGY/CLINICAL DEVELOPMENT PERSONAL PROFILE

• Over 30 years in clinical research field and pharmaceutical industry.

EXPERTISE Scientist/Researcher, Senior Pharma Executive, Drug Development, Clinical Trials (IND - Phase 4), Early Clinical Research, PK/PD Analysis, Globalization of Clinical Pharmacology, FDA Interactions (INDs, NDAs, sNDAs), Contracts/Budget Management PhD in Pharmaceutical Sciences from State University of New York at Buffalo. An innovative leader in globalization of clinical pharmacology function and early clinical research, with nearly 50 author/co-author publication credits; patent-holder of sustained-release dosage form for water-soluble compounds. PROFESSIONAL EXPERIENCE Company President and Founder, MaierMetrics and Associates, LLC Provide clients with a wide ...
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MEDICAL EXECUTIVE/CMO PERSONAL PROFILE

• 40+ years as successful C-suite pharma executive, Chief Medical Officer, and board member of large and small companies, with global experience ranging from preclinical development of biologics, devices, diagnostics, and drugs, to post-marketing studies.
• 2017-Present: BOD to Plakous Therapeutics
• 2016-Present: CMO to ArunA Biomedical
• 2015-Present: Principal, MedSurgPI, LLC
• 2011-2015: President and CEO, Entera Health, Inc.
• 2010-2011: Chief Medical Officer, Oxygen Biotherapeutics
• 2010-2011: Consulting Chief Medical Officer, Talecris Biotherapeutics/Grifols
• 2005-2010: Chief Medical Officer/ VP, Global Medical and Clinical Affairs, Talecris Biotherapeutics
• 2003-2005: Vice President of Medical Affairs, Clinical Research, and Safety, Dey/Merck KGaA
• 2003-2005: North Bay ...
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ONCOLOGY MEDICAL MONITORING AND CLINICAL TRIAL LEAD PERSONAL PROFILE

• 21 years of clinical trial leadership and medical monitoring specializing in oncology and internal medicine.

EXPERTISE Clinical Trial Leadership and Management, Medical Monitoring, Medicine (attending physician), and Academia. Specialty: Medical Oncology and Internal Medicine. Has 23 publications, two grants, and nine invited presentations, internationally. MD, University of TX Medical Branch. PROFESSIONAL EXPERIENCE Medical Monitor and Clinical Trial Lead Providing medical monitoring and clinical trial leadership for a variety of oncology exploratory to Phases 1-3 studies for pharma clients including Bristol-Myers Squibb; Apexigen, Inc.; Hengrui Therapeutics, Inc.; NewLink Genetics Corporation; ...
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EXECUTIVE BUSINESS CONSULTANT PERSONAL PROFILE

• 41 years in healthcare and medical biologics products industries, delivering expert business consulting strategies to organizations ranging from Fortune 500 companies to start-up medical device and healthcare firms.

EXPERTISE Business Development, Strategic Business Planning, Revenue Growth Strategies, Process Improvement, Program Development, Contract Negotiation, COS Reduction, Organic/Acquisition Growth, Budget Administration, Product Distribution Strategies, National Sales Leadership, Performance Management, Change Management, M&A Sales Integration, Operations Management, Competitive Intelligence, Training and Mentoring, Industry Partnering, and Sales Reporting. Therapeutic Areas: orthopedic and reconnective surgery in spine and trauma, and sports medicine specialties. PROFESSIONAL EXPERIENCE President/Owner, C.C. I ...
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MEDICAL EXECUTIVE, CLINICAL DEVELOPMENT PERSONAL PROFILE

• 20+ years as a pharma executive, 27+ years in clinical development, and 30+ years as a physician.

EXPERTISE CMO; Clinical Development (drugs, biologics, and medical devices); Global Clinical Trials (Phases 1 – 4); Product Registration and Post-Marketing Activities; Project Management of INDs, IDEs, NDAs, BLAs, CTDs, PIPs, PSPs, sNDAs, S/NDSs, PMAs, and 510(k)s; Regulatory Affairs (FDA, EMA, DCGI, MOHs for US, APAC, LA , non-EU countries, and Health Canada); Specialties: Anesthesiology, Internal Medicine, Epidemiology, and Biostatistics; Therapeutic Areas: Cardiovascular, Infectious/Rare Diseases, DIC, Rheumatology, Hematology/Oncology, OB/GYN, Endocrinology, Gastrointestinal, CNS, Metabolic Disorders, and Immunology ...
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REGULATORY AFFAIRS & DRUG DEVELOPMENT PERSONAL PROFILE

• 26 years of experience in new drug development in pharma and biotechnology; 19 years as senior Regulatory Affairs management.

EXPERTISE Design / Conduct / Oversight / Monitoring of Clinical Trials Phases 1-3 and GLP Nonclinical Safety Studies; Defining Clinical Indication, Sample Population / Size, Primary and Secondary Endpoints; Regulatory Affairs and Strategic Planning / Analysis; Global GCP Compliance; FDA / EMA Negotiations (special protocol assessment, end of Phase 2 discussions, pre-Phase 3, defense of proposed trial design); Pre-NDA, INDs/CTAs, and IMPD ; Pre-submissions; Safety Reporting; Electronic Submissions Preparation; Scientific Advising; Health ...
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eLEARNING / KNOWLEDGE TRANSFER PERSONAL PROFILE

• 25 years in F100 and Life Sciences Information Technology

EXPERTISE Project Management, Six Sigma, Systems Integration, Technical Architecture and Custom Software Development. Senior leader with proven ability to drive projects successfully and to collaborate with a wide variety of people in a fast-paced environment. PROFESSIONAL EXPERIENCE Director, Virtual Platforms & IT Solutions – akta Pharmaceutical Development® (aktaPD) Responsible for product and service delivery of training by focusing on knowledge transfer within life sciences companies. Provide integration of new technologies and delivery methods for adult learning and knowledge transfer. VP, Learning Operations – ...
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CLINICAL OPERATIONS SUPPORT / TRIAL ASSISTANT PERSONAL PROFILE

• 11 years in clinical operations support.

EXPERTISE Operations Management, Information Systems Management, Regulatory Affairs Management, Fiscal Management, Clinical Trial Assistant (cardiology, dermatology, device, gynecology, gastroenterology, oncology/hematology, urology), Process Analyst, Data Flow Analysis and Documentation of US Clinical Trial Process, In-house CRA, and Project Management. PROFESSIONAL EXPERIENCE CEO, Carolina Research & Consulting Services, Inc. Specializes in operations management, information systems management, regulatory affairs management, fiscal management, document management, report editing (continuity, spelling, grammar, completeness), clinical trial report and trial master file auditing, master file maintenance, investigator meeting planning, investigator grants ...
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RARE DISEASE AND INNOVATIVE SPECIALTY MEDICINES, STRATEGIC GLOBAL DRUG DEVELOPMENT PERSONAL PROFILE

• Strategic, results-oriented physician with 25 years of global drug development and medical affairs experience in biotech, pharma, and CRO settings across development phases and molecule types.

EXPERTISE Global Drug Development, CMO/Clinical Leadership, Translational Medicine, Clinical Research Strategies and Execution, Development Plans, Clinical Studies, Risk Assessment/Mitigation, Pipeline Advancement (proof-of-concept to registration to lifecycle management), Regulatory (FDA advisory committees, BLA/NDA teams, EU and MAA filings), IND/CTA Filings, Drug Safety/REMS/RMPs, and Leadership. Specialties: Rare Diseases, Immunology, Diverse Therapeutic Areas, Biologics, Small Molecules, Drug/Device Combinations, Microbiome, and Gene Therapy. MD ...
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WRITER / COPY EDITOR / PROPOSALS PERSONAL PROFILE

• 15 years in the writing and copy editing field; and 20+ years in personal and team training and proposalwriting

EXPERTISE Creative Copywriting; Editing; Communications Consulting; Website and Promotional Copy; CVs and Cover Letters; Storytelling; Education and Curriculum Creation; Brand Alignment; Program/Model Design and Implementation; Proposals; Employee Recruitment, Orientation, and Training; Team Development; Employment Policies; Educational and Corporate Presentations and PowerPoints; and Literacy and Inclusion Classes. Earned an MFA from Vermont College of Fine Arts and a Masters / Teaching Certification from Georgia State University. Has a literary work of creative ...
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PROGRAM MANAGER, MEDIA/MARKETING, SOCIAL MEDIA PERSONAL PROFILE

• 30 years in the communications, media, and marketing field.

EXPERTISE Film, TV, Video, and Multimedia Productions; Promotions and Presentations; Content/Creative Development; Media Planning and Placement; Live Media Coordination and Distribution; Social Media Strategy and Implementation; Project Leadership and Management; Strategic Planning and Implementation; Media Tracking; Event Planning, Organization, and Management; Public Relations; Market Research; Writing; Campaign Management; Forecasting; Budget Management; Brand and Market Imaging; Data Analysis; Team-Building; Commercial and Sports Marketing; Location/Talent Scouting and Resourcing. PROFESSIONAL EXPERIENCE The Media Pro Award-winning full-service media, marketing, and communications agency specializing in writing, video ...
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CLINICAL OPERATIONS PERSONAL PROFILE

• Clinical Operations Manager with a strong background in psychology, specializing in neuroscience-focused operations in clinical trials.

EXPERTISE Clinical Trials Oversight / Operations; Protocols; Clinical Development Plans; Budgets; Operations Documents; Site Monitoring / Auditing; Consultant / Vendor Selection, Contracts, and Oversight; Risk Assessment; Project Management; Medical / Scientific Article Writing; Programming Statistics; Regulatory / FDA Reporting and Quality Control; eTMFs; Documentation QC (GCP); Tracking; Clinical / Patient Data Analysis; Clinical Supply Manufacturing and Labeling; Investigator’s Meetings; Board Presentations and Posters; and Team-building. MA in Psychology - Pepperdine University; BS in Psychology (specializing in behavioral / ...
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PHARMACOVIGILANCE/SAFETY COMPLIANCE PERSONAL PROFILE

• 30 years of experience in pharmacovigilance, specializing in establishment and optimization of inspection-ready global pre- and post-marketing PV function. Expertise in large and small pharma companies, including PV operations, cross-functional integration, compliance, safety data exchange agreements, outsourcing (vendor selection and management), signal detection and management, benefit-risk assessment/management, and safety governance.

EXPERTISE Pharmacovigilance; SOPs; Vendor and Safety Database Selection and Management; Safety Signal/Risk Detection and Management; Safety Governance; PV Regulatory Compliance, Report Preparation, and Management; Global PV Operational Assessment, Strategy, and Implementation; Cross-functional Integration of PV; Risk Management Plans (REMS/Core/EU RMPs); Safety Data Exchange Agreements; Safety Management Plans; ...
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MEDICAL EXECUTIVE PERSONAL PROFILE

• Drug Development consultant: 20+ years as successful C-level biopharma executive, including Chief Medical Officer and board member, specializing in drug development (Phases 1-4), translational medicine, and commercial strategy. Strong track record in clinical trials, regulatory strategy, medical governance, and risk management. Proven expertise in FDA strategy/meetings submission, entrepreneurship, business development/venture capital, and strategic partnerships.
• President, CMO, and Board Member of Furiex Pharmaceuticals (acquired by Actavis/Allergan).
• Chief Operating Officer, CMO, and Strategic Advisor of Innovate BioPharmaceuticals.
• Public, private biotech and venture philanthropy board experience (see below).
• Vice President, Clinical Safety/Risk Management at GSK. Member: senior medical ...
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PROJECT MANAGER PERSONAL PROFILE More than 20 years of diversified experience in the administrative and customer service fields. EXPERTISE Project Management, Data Research and Compilation, Query Testing, Global Transparency Reports, Customer and Financial Reports (CTMS data validation), Sponsor Liaison, Sponsor Documentation (files, records, and reports), File Review and Audit, Information Coordination and Tracking, System/Project Updates and Maintenance (databases, time lines, tracking tools, project plans), Meeting Planning, Travel Arrangements, Budget/Project Tracking, Problem-Solving, Time Management and Communication. PROFESSIONAL EXPERIENCE Global Aggregate Spend Reporting Coordinator, Quintiles Researched and compiled data to ensure compliance with Open Payments (the Sunshine Act) and performed query testing ...
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PROJECT MANAGEMENT / CLINICAL OPERATIONS & DEVELOPMENT PERSONAL PROFILE

• 24 years in clinical development of investigational therapeutic and diagnostic products.

EXPERTISE  Clinical Operations; Monitoring; Clinical Research Line Management; Domestic and International Phase 1-4 Pharmaceutical Studies and Pilot, Pivotal, and Post-market Medical Device Studies; Investigational Site Feasibility and Management; Training of Investigators, Study Coordinators, and Study Monitors; GCP/ICH Auditing; Vendor Qualification and Management; Institutional Review Board (IRB) Investigator/Site Assessments; Project Management; Clinical Trial Documentation (i.e., protocols, case report forms [CRFs], informed consent documents, investigator brochures, instructions for use); Reports for Regulatory Submissions; Client Infrastructure and Quality Systems (i.e., ...
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REGULATORY AFFAIRS PERSONAL PROFILE

• Seasoned, versatile physician executive and academic, board-certified in internal medicine and medical oncology, with 35+ years of medical, clinical, and pharma research and development experience.

EXPERTISE Pharma Research / Development, Clinical Strategy / Plans, Trials Design / Writing / Management / Conduct (Phases 1-3), Protocols, Regulatory Interactions (NDAs, INDs, special protocol assessments), Medical Affairs, Licensing, and Sales Support. Therapeutic Areas: Oncology and internal medicine. Has 50 publications, 53 abstracts, five book chapters, and six letters to the editor. BA -Haverford College; PhD - Brandeis University; MD - University of Miami School of Medicine ...
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MEDICAL WRITER PERSONAL PROFILE

• 11 years in medical writing, specializing in medical/pharmaceutical/scientific drafting and editing.

EXPERTISE Writing – Protocols, Investigator Brochures, Annual Reports, Investigational New Drug (IND) Application Sections, Marketing Applications, Briefing Documents, Regulatory Meeting Slide Decks, Publications, Clinical Study Reports; Document Formatting and QC; Project Management. Proficient in International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and American Medical Association (AMA) style guidelines. PROFESSIONAL EXPERIENCE Independent Contract Medical Writer Work with clients to complete clinical and regulatory projects across various indications (e.g., oncology, vaccines, medical device). Responsible for drafting ...
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CHIEF EXECUTIVE OFFICER & FOUNDER PERSONAL PROFILE

• 35+ years in medicine and the pharmaceutical industry
• 20+ years of executive pharma leadership

EXPERTISE Physician Executive, Executive Leadership, Clinical Development and Medical Affairs, Preclinical Development, Regulatory Affairs/Quality Assurance, Business Development/Fundraising, Commercial Marketing, Medical Writing/Communications, and 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/biosimilars, cell therapies, devices, diagnostics, and assay development. MD - Loyola University’s Stritch School of Medicine, with postdoctoral training in Immunology, Internal Medicine, and Hematology/Hematologic Malignancies at the Mayo Clinic and ...
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CLINICAL OPERATIONS PERSONAL PROFILE

• 40+ years in medical and pharmaceutical arena.

EXPERTISE Strategic and Development Vision and Planning, Product Development, Clinical Operations Leadership, Cost/Program Management, Process Improvement (Functional/Operational Efficiency), Third Party and R&D Integration, CRO/Vendor Management/Evaluation, KOL Relationships, Gap Analysis, Clinical QA, Internal Study Audits, Sponsor/ Medical/Clinical Scientific Liaison, Inspection Readiness and Rapid Submissions, Collaboration/Accountability/ Decision-Making, Employee Retention, Resource Leveraging, Quick and Cost-Effective Results, Nurse Practitioner, and Motivational and Presentations Skills. 10 Publications and Presentations. PROFESSIONAL EXPERIENCE

• Founder and Principal, Professional Clinical Consultants, LLC Consults pharma and biotech industry (focus on immune-oncology, oncology, rare diseases, and ...
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ONCOLOGY CLINICAL DEVELOPMENT PERSONAL PROFILE

• More than 26 years in radiation oncology.
• 13 years in pharma industry oncology clinical development.

EXPERTISE Practicing Radiation Oncologist, Oncology Clinical Trials (Phases 1-4), Chief Medical Officer, Global Clinical Development, Research (academic and pharma), Regulatory Filings, Commercialization, Strategic Decision-Making and Operational Processes, Scientific Writing, Communications, Education/Teaching, Lecturing/Public Speaking. BS from MIT in Cambridge, MA and MD from SUNY Upstate Medical University in Syracuse, NY.   Adjunct assistant professor at Robert Wood Johnson Medical School Department of Radiation Oncology, has authored/co-authored nearly 50 publications, and has participated in numerous invited lectures. Shared patent-holder (pending) ...
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CLINICAL OPERATIONS PERSONAL PROFILE

• 16 years, mostly in clinical operations.

EXPERTISE Clinical Trials Management; Compliance; Protocol Synopsis/Development; Project Budgets and Timelines; Management of Field CRAs and Internal Project Coordinators; Vendor Selection, Oversight, and Audit (CROs, labs, imaging, drug distribution); Patient Recruitment and Retention; SAEs and Regulatory Reporting; Site Feasibility, Selection, and Management; Monitor Training and Mentoring; Close-Out Activities; Project Management; Medical Writing/Editing; Start-Up Experience; Cross-Functional Project Team Leadership; Collaboration; Therapeutic Areas (Diabetes, Ovarian Cancer, Non-small Cell Lung Cancer, Hepatitis C with HIV, HCV in special populations, Bipolar/Depression and Hypercholesterolemia). PROFESSIONAL EXPERIENCE Senior Clinical Study Manager (Oncology), Takeda, ...
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STAFF WRITER PERSONAL PROFILE

• 33 years in the communications field, specializing in medical/pharmaceutical, health/wellness, and state government/public interest.

EXPERTISE Writing - Video, Audio, Print, Web/e-, and PR/Marketing; Communications Project Management; Video and Audio Producing/Directing; Client Relations/Sales and Expectations Management; KOL/Patient/Clinician Interviewing; Copy Editing; Creative Brainstorming; Storytelling and Audience Engagement; Public Speaking/Workshops; Voiceover Narration; Customer Service. PROFESSIONAL EXPERIENCE Writer/Producer-Director/Voiceover Artist – MMR Pitches and delivers creative communications for a variety of clients, specializing in medical/pharmaceutical, health/wellness, and state government/public interest. Writes, produces, directs, and manages crisp, clear, creative, and compelling copy that works for the target audience–from in-depth needs ...
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ONCOLOGY CLINICAL TRIALS, SITE MANAGEMENT, MONITORING PERSONAL PROFILE

• 9 years of pharma clinical trials management experience; 14 years as a physician.

EXPERTISE Oncology Clinical Trials Phases 1-3 (breast, hepatic, renal, prostate, GI, melanoma); Study Protocols; Site Selection, Management, and Monitoring; Sponsor / KOL Relationships; Study Forms and Documents; Vendor Management; Budgets and Contracts; Study Best Practices (including compliance / adherence and regulatory requirements); and On-site Data Management. MD from University of Ibadan in Nigeria. PROFESSIONAL EXPERIENCE: Senior Site Manager, InSeption Group Responsible for clinical study conduct: site selection, qualification activities, and management; field monitoring; compliance/regulatory requirements; good clinical ...
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RESPIRATORY & ONCOLOGY PERSONAL PROFILE

• 27 years of drug development experience in large and small pharma companies.
• 36 years in medical/research field.

EXPERTISE Physician Scientist, Medical Executive, Translational Medicine, Academic Clinical Investigator, Clinical Pharmacology, Drug Development, Clinical Trials, Oncologics, Biologics, Chief Medical Officer, Global Management, Regulatory, Advisory Boards, Emerging Markets. World authority on translational medicine and clinical pharmacology. Pioneer in field of antiviral chemotherapy and proof-of-concept trials. Deep experience and knowledge of drug development, from discovery to global registration including oncologics and biologics. Extensive expertise in executive management of global sites with broad teams and large budgets ...
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GRAPHIC DESIGNER PERSONAL PROFILE

• 15 years as a data-driven graphic design expert in a broad range of industries including pharma, manufacturing, military, and higher education.

EXPERTISE Presentation Design, Poster Design, Branding, Marketing Materials, Visualizing and Simplifying Complex Concepts. PROFESSIONAL EXPERIENCE Virtual Apiary, Inc. – Owner/Graphic Designer Specializes in fast turnaround, budget conscious, and user-friendly design with an emphasis on PowerPoint and other data-driven presentation design. Also offers PowerPoint expertise and project backup for other graphic design agencies. TBM Consulting Group, Inc. – Graphic Designer Manages and designs all company training material for Lean/Six Sigma consulting company. Develops executive ...
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TRANSLATIONAL RESEARCH, CLINICAL DEVELOPMENT, & BIOMARKERS PERSONAL PROFILE

• 40 years as a physician.20+ years of translational research and bioanalytics experience in biotech and pharma.

EXPERTISE Preclinical Development; Translational, Molecular, and Cellular Research; Nonclinical Development Study Design; Pharmacology; Biotherapeutic Manufacturing; SBIR / STTR Grant-writing; Pre-IND / IND​ Writing; Biomarker​ ​Identification; Bioanalytics,​ Informatics,​ ​and​ Data​ Analysis, In Vivo Studies; and Imaging. Seven invited seminars, and more than 40 publications, reviews, chapters, and abstracts. PROFESSIONAL EXPERIENCE Principle Consultant, Skyline Biopharma, LLC Supports clients’ nonclinical development study design, biotherapeutic manufacturing processes, SBIR / STTR grand-writing and submission, pre-IND and IND​ ​section​ ​writing,​ ...
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MEDICAL EXECUTIVE/CMO PERSONAL PROFILE

• 30+ years as successful C-suite executive, Chief Medical Officer, and board member, expert in drug and biotech Medical/Scientific/Clinical strategy and management, development/commercialization, funding, and entrepreneurism.

EXPERTISE CMO/CEO/Executive Management; Vision and Strategic Planning; Drug Development/Commercialization; Program Creation; Clinical Trials Research, Development, and Management; Medical/Scientific Affairs; SAEs/AEs; New Product R&D and Strategic Planning; Intellectual Property Development; Program/Market Analysis; KOL Engagement; Program Database Development and Data Analysis; Sales and Marketing; Sales Force Development/Management; Venture Capital/Business Development; Recruitment; Communications; Board Membership; Academia (teaching surgery, bioengineering, business administration); Medical/University Administration; and Clinician. MD – SUNY Health Sciences Center at ...
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PSYCHIATRIC CLINICAL TRIALS PERSONAL PROFILE

• 40 years in the psychiatric medicine field

EXPERTISE Mood and Psychotic Disorders; Research Psychiatry; Therapeutic Neuromodulation ECT (electroconvulsive therapy), and TMS (transcranial magnetic stimulation); Psychiatric Drug Development (psychosis and depression); Clinical Trials; Management and Treatment of Schizophrenia, Depression, and Bipolar Disorder; Psychopharmacology; Scientific Writing; Education/Teaching; Lecturing/Public Speaking. BS and MD from Loyola University in Chicago, Stritch School of Medicine, with more than 500 publication credits. Editorial board member of Directions in Psychiatry, Essential Psychopharmacology, and Psychiatric Annals. Principal lecturer in over 500 courses, seminars, symposia, and related professional events, with memberships in ...
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CMO, INTERNAL MEDICINE, ONCOLOGY PERSONAL PROFILE

• 30 years in academic oncology.
• 9 years in pharma industry as a medical executive.
• US Board-Certified in Internal Medicine and Oncology.

EXPERTISE CMO; Medical Monitoring; Phase 1-3 Clinical Trials; Medical Expertise for Study Feasibility, Design, Site, Conduct, Analysis, Reporting, Databases, and Efficacy/Safety; Regulatory Submissions; RFPs and RFIs; Business Development; Pharma Scientific Presentations; Internal Training/Teaching; Medical Specialties: Oncology, Hematology, Internal Medicine. MD from University Rene Descartes in Paris, France. Former member of EORTC (The European Organisation for Research and Treatment of Cancer) and founder of Measurable Tumors Group, former member and chair ...
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CLINICAL OPERATIONS/PROGRAM MANAGEMENT PERSONAL PROFILE

• Performance and results-driven executive in Europe with 30 years of extensive experience impacting corporate performance in the life science sector: from start-ups to big pharma companies to CROs.

EXPERTISE Clinical Operations, Program Management, CRO Contracting / Governance, Clinical Trials Management (mainly in Europe), Executive Leadership, Business Development, Entrepreneurship, Collaborations / Strategic Partnerships, and Licensing. Native speaker in Swedish and Finnish; fluent in English. PROFESSIONAL EXPERIENCE Consultant/CEO, Arandi Innovation AB, Stockholm, Sweden Consultancy company supporting life science start-ups in delivering results through research, development, and commercialization strategy, including program and project management. Head, Uppsala ...
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PHARMACOLOGY, DRUG DISCOVERY, DRUG INFUSION DEVICES & NONCLINICAL DRUG DEVELOPMENT PERSONAL PROFILE

• Pharmacologist / implantable device scientist / consultant with 25+ years in pharma drug discovery / development and medical devices.

EXPERTISE Pharmacology, Nonclinical Drug Discovery / Development, Management / Leadership, Regulatory Filings (IND / NDA), Grant Applications, and Collaborations. Therapeutic and Technical Specialties: Neuroimmunology, Glial Biology, Neuropathic Pain, Analgesic Drug Discovery / Development, Translational Model Development, Implantable Intrathecal / Epidural Drug-delivery Devices. Has over 45 peer-reviewed publications (cited > 2700 times) and holds five issued patents. PROFESSIONAL EXPERIENCE Principal, Skyline Biopharma, LLC Support clients in nonclinical development ...
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TOXICOLOGY, SAFETY PHARMACOLOGY, & DRUG DEVELOPMENT PERSONAL PROFILE

• Board-certified toxicologist with more than 20 years of experience in pharma drug development, including small and large molecule programs at all stages of development in a wide variety of therapeutic areas.

EXPERTISE Nonclinical Safety – Toxicology, Pharmacology, PK / ADME, Small / Large Molecule Programs, Nonclinical Program Design / Implementation, CRO Selection, Protocol Design / Development, Study Monitoring, Data Interpretation / Reporting, Compliance, Regulatory Document Preparation, Regulatory Interactions, Due Diligence, In- / Out-licensing, Gap Analysis, Budgets / Timelines, and Program Challenge Management. PROFESSIONAL EXPERIENCE Consultant, Aclairo Pharmaceutical Development Group, Inc ...
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MOBILE LEARNING / PATIENT RECRUITMENT / E-TRAINING EXPERT EXPERTISE Robert Dickerson is aktaPD’s software developer, our technology design guru who integrates training solutions on mobile devices and tablets. What's that all about? It’s the future of patient recruitment and the best way to educate clinicians/staff/patients and your sales force. We call it e-Learning and it’s the realm, an organic path for accessible learning that’s applicable for everyone. Robert and aktaPD’s technology team will work closely with our healthcare and pharmaceutical industry clients who understand the value of education and its importance in propelling them forward. e-Learning on mobile devices and tablets ...
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TRANSLATIONAL MEDICINE, CLINICAL TRIALS, CARDIOLOGY PERSONAL PROFILE

• Experienced cardiologist/internist and clinical trialist with more than 15 years of clinical research experience, as well as industry experience as a medical director in pharmaceutical R&D.

EXPERTISE Clinical Trials, Trial Design, Protocol Development, Medical Monitoring, Safety Review and Reporting, Trial Execution/PI (Phases 1-3), Cardiology Leadership, R&D Medical Director, Translational Medicine, Nonclinical/Clinical Pharmacology, PK/Safety, Cardiology Devices, Transplant Medicine, FDA Meetings, and Scientific and Medical Advisory Boards. Practicing physician and academic with board certifications in Internal Medicine, Cardiology, and Advanced Heart Failure and Transplantation. Strong publication and presentation record. PROFESSIONAL EXPERIENCE Professor, Department ...
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MEDICAL EXECUTIVE PERSONAL PROFILE

• > 25 years in pharma industry, building top-tier global teams that consistently achieved strategic and financial objectives. Strong leader with the ability to create a global vision, effectively allocate resources, and customize/operationalize regional medical strategies that support business growth.
• > 10 years (prior to industry) in clinical/academic neurology practice.

EXPERTISE Medical Executive/Chief Medical Officer with experience spanning Global R&D and Commercial Strategy and Operations (Europe, Asia-Pacific, Latin America), In/Out Licensing, M&A Strategy/Due Diligence, Clinical Study Design, Pharmaceutical Development (all phases), Alliance-based Product Development, Regulatory Compliance, Global New Product Launches, Corporate Team-building, Leadership and Management ...
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