Our Experts

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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