Our Experts

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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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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PHYSICIAN EXECUTIVE PERSONAL PROFILE

• 15 years of proven executive performance in research and development, medical affairs, regulatory affairs, and quality operations in small company settings to support initiation of clinical development programs and product commercialization, and 25 years as a physician.

EXPERTISE Executive Leadership / Governance in Preclinical and Clinical Pharmaceutical / Medical Device Research and Development (protocols, clinical development plans and studies, target product profiles, investigator brochures, safety review/data monitoring committee charters, and regulatory meetings and submissions/institutional review board documents); Medical Affairs; Regulatory Strategy / Affairs; Quality and Clinical Operations; Strategic Growth / Business Development / Corporate ...
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ONCOLOGY, CLINICAL DEVELOPMENT, IMAGING PERSONAL PROFILE

• 15 years of pharmaceutical industry and clinical research experience.

EXPERTISE Clinical Development, Imaging, and Research (oncology, small molecules, biologics, medical devices, and diagnostics); Clinical Development Plans; Scientific, Medical, and Operational Leadership of Clinical Trials (all phases); Clinical and Regulatory Strategy; Protocol Development; Site/CRO/Vendor Selection and Oversight; Data Analysis and Interpretation; FDA Submissions; Clinical Investigator/KOL Relationships; Leading Global Cross-Functional Teams; Medical Writing (regulatory documents and publications). MD from CES University in Columbia, South America; board-certified physician, surgeon, and radiologist. PROFESSIONAL EXPERIENCE Consultant, Scientific Advisor, and Independent Reviewer Advise pharmaceutical, biotechnology, and medical ...
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COMPLIANCE, QA, & REGULATORY AFFAIRS PERSONAL PROFILE

• 13 years in the compliance field.

EXPERTISE GXP Auditor, Training, and Document Management; Developing Quality Systems; Part 11 Compliance (back and front end, software and hardware); Validation (process and equipment); Global CMO Oversight and Batch Record Review (France, Italy, Germany); GLP Studies (PK and Tox, rodents/primates); QC of Raw Materials, EM, Utilities, Cleanrooms, Facilities; GCP Site Audits; EDC/RDC Data Verification. PROFESSIONAL EXPERIENCE QA Solutions Performed GXP vendor audits and served as Supplier Quality Engineer, International Medical Device manufacturer of CT/MRI systems, FDA remediation team member, and site SCAR manager. QA ...
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STATISTICAL EPIDEMIOLOGY, PHARMACOMETRICS, PHARMACOKINETICS, & PHARMACODYNAMICS PERSONAL PROFILE

• 27 years in pharmacometrics, global modeling, and simulation for private companies and in academic settings.

EXPERTISE Pharmacometrics; Statistical Epidemiology; Mathematical and Statistical Modeling; Clinical Trial Simulation; Pharmacokinetics; Pharmacodynamics; Compartment Analysis; Experiment Design; Algorithm Optimization; Non-continuous Likelihood-based Response Analysis (continuous/discrete Markov processes, generalized time/event analysis [single/multiple, and right-/left-/interval-centered events], count data analysis [Poisson and negative binomial], categorical multi-level analysis); PK/PD/Clinical Endpoint Simulation; Delay Differential Equations; Transit Compartment Expansion; Quantitative Risk Analysis; Portfolio Analysis Optimization; Management Strategy Development; Real Option Analysis; Stochastic NPV Analysis; Business Software Development; Conjoint Analysis; Product Design Optimization; ...
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CLINICAL TRIAL DESIGN & OVERSIGHT, MEDICAL MONITORING PERSONAL PROFILE

• 19 years of experience in pharmaceutical industry; 10 years in medicine and laboratories.

EXPERTISE CMO; Protocol Design and Writing; Medical Monitoring; Clinical Trials Phases 1-4; Clinical R&D/Operations Oversight; Data Analysis; Safety/Pharmacovigilance Assessments; Medical Affairs; Medical Writing - Clinical Study Reports, Regulatory Documents (NDA), IND Updates, Safety Reports, Investigator Brochures, Abstracts, Posters, and Publications; Budgeting and Resource Allocation; KOL Recruitment and Liaison; Pipeline Strategy; Business Development; Presentation Support. Medical Areas of Expertise: Infectious Diseases and Internal Medicine. MD from John Hopkins University School of Medicine; has authored 29 publications and ...
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CHIEF STRATEGY OFFICER / BUSINESS AND CORPORATE DEVELOPMENT LEADER PERSONAL PROFILE

• Senior Executive with 35 years of experience in the life sciences industry leading teams in corporate development, commercial planning, corporate affairs, and strategic consulting.

EXPERTISE Corporate Development; Commercial Strategy and Planning; Corporate Affairs; Corporate / Department / Project Strategic Consulting, Planning, and Support; Business Development / Fundraising; Public Offerings; Long-term Financing; KOL Development; Brand Strategy; Reimbursement Planning; In-licensing; IR / PR Planning; Corporate Footprints (Commercial / Medical / Distribution); Corporate Branding / Rebranding and Positioning; Company Liaison / Advocate; Social Media Program Planning for Patient Enrollment; Medical ...
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QUALITY ASSURANCE, BUSINESS PLANNING & ANALYSIS, AND PROJECT MANAGEMENT PERSONAL PROFILE

• 18 years in pharmaceutical quality systems, technical writing, metrics, and project management.

EXPERTISE ICH/GCP and GMP, Quality Systems (Document Management/Training), Project Coordination and Management, Costs and Operational Efficiencies, Organizational Data Analysis, Strategic Mapping, Training, eTMF Inspection Preparedness, Budgeting and Headcount Analysis, Metrics and Goals Reporting, Continuous Improvement, SOP Development, Process Mapping, Internal Auditing for Training, and Technical Writing. Special expertise: SharePoint, Veeva, and Trackwise. PROFESSIONAL EXPERIENCE Consultant 2017 – Present  Tesaro, Waltham, MA 2017 – 2017   Aegerion, Cambridge, MA 2016 – 2017  Seres, Cambridge, MA 2016 ...
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PHARMACOVIGILANCE, SAE REPORTING, MEDICAL CODING, MONITORING PERSONAL PROFILE *20 years of global pharmacovigilance, safety protocols, medical coding, and database management. EXPERTISE Pharmacovigilance; Safety Protocols in Phase 1, 2, and 3 Clinical Trials; Database Management; AE/SAE Reporting and Narration Development; Coding Reviews; Reconciliation; Program Management; Physician Interaction; Marketing. Study Therapeutic Areas of Expertise: Oncology, Allergy, Pain, Diabetes, Cardiology, Cardiac Devices, Pruritus in Renal Disease, and Insomnia. PROFESSIONAL EXPERIENCE Medical Coder, eClinical Solutions Appropriately coding adverse events, medical history, concomitant procedures, and concomitant medications using WHODrug and MedDRA dictionaries. Drug Safety Consultant, Drug Safety Solutions, Inc. Executes AE/SAE management activities including receiving ...
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CLINICAL PROJECT MANAGEMENT, TRIAL LOGISTICS, OPERATIONS PERSONAL PROFILE

• 30+ years in clinical drug development, with strong history in trial logistical and operational knowledge
• 15+ years as a functional manager
• 19+ years in project management
• 20+ years in sound operational strategies, functional areas, and project resources

EXPERTISE Clinical Project Management, Operational Strategies, Project Resourcing, Trial Logistics/Measures/Metrics, Prototype Data Reports, Remote Monitoring Processes, Payment Solutions, Clinical Operations SOPs, Project Management Tools (performance and trial oversight), Team F2F and Interactive Training/Guidance/Reviews, Department Infrastructure Development, Project Review, Budget Management, and Timeline Templates. Therapeutic Areas: Oncology (chemotherapy-induced anemia, liquid/solid tumors - Phases ...
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PHARMACOLOGY, NONCLINICAL SAFETY, NONCLINICAL DRUG, BUSINESS DEVELOPMENT PERSONAL PROFILE

• Pharmacologist / safety scientist / director with 24+ years in pharma drug development.

EXPERTISE Pharmacology/Safety (toxicology), Nonclinical Drug Discovery / Development, Management / Leadership, Regulatory Filings (IND / NDA), Nonclinical Support of Clinical Trials (Phases 1-2), Post-marketing, In-licensing, Business Development, Grant Applications, Collaborations, and Budgets. Therapeutic and Technical Specialties: Cardiovascular, CNS, Oncology, Renal, Diabetes / Endocrine, Immunology. Has over 40 peer-reviewed publications and over 50 abstracts, 19 invited presentations and seminars; worked on 4 approved product programs, 9 in-licensing / business development products, and holds nine patents. PROFESSIONAL EXPERIENCE ...
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DATABASE MANAGER PERSONAL PROFILE

• 21 years in database management.

EXPERTISE Certified Clinical Data Management Professional; Oncology; Project Management; CRO and Vendor Management; Process Improvements; SOP Development; Data/Vendor Management Plans; Standards Creation and Management; Contracts and Financial Analytics; Process Improvement; GCP, ICH, and GMP Compliance; Cross-Departmental Trainer of Multiple Systems and Compliance Topics; Branding and Negotiation; Public Speaking and Communications. PROFESSIONAL EXPERIENCE Principal Consultant, Adaptive Clinical Consulting, LLC Provides individual, flexible, high quality guidance and hands-on support for biotech and pharma drug industry. Specializes in strategy, contract negotiation, and tactical execution of Clinical Data Management, Training and eLearning Development, ...
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CLINICAL AND RESEARCH OPERATIONS PERSONAL PROFILE

• 30 years in medical and pharmaceutical arenas.

EXPERTISE Clinical Operations and Research, Operational Planning and Management, Protocol Development, Pharmaceutical Drug Development (Phases 1 - 3), Regulatory Compliance, Quality Assurance, Program Management, Strategic Planning/Development/Implementation, CRO Oversight, Cost/Resources/Budget Maximization, Vendor/Clinical Supplies Management, e-CTD Submissions and Documentation, Biotech Startups, Presentation and Report Writing, Collaboration/Accountability/Decision-Making, Recruitment/Mentoring/Team Management, Critical Care Nursing. Clinical Expertise: Sepsis, Acute Respiratory Distress Syndrome, Multiple and Head Trauma, Acute Pancreatitis, Inflammatory Bowel Disease, Non-Insulin-Dependent Diabetes, AIDS, Kaposi’s Sarcoma, Pancreatic CA, Irritable Bowel Syndrome, Parkinson’s, Epogen Comparator/Drug Accountability, COPD, Oral Mucositis, Head and Neck ...
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ONCOLOGY & SCIENTIFIC/EXECUTIVE LEADERSHIP & RESEARCH PERSONAL PROFILE

• 35+ years in diagnostics and pharma scientific clinical research and executive leadership in Oncology, Immunology, and Infectious Diseases; integration of Dx biomarkers into pharma clinical trials; and translational cancer research.

EXPERTISE Chief Scientific Officer, C-Suite Executive/Diagnostic and Pharma Management, Biomarkers/Companion Dx, Liquid Biopsy Tests, Clinical Trials, Regulatory/FDA Submissions, Assay Development, Molecular Biology, Virology, Business Development, and Commercialization Strategies. Therapeutic Areas of Expertise: Biomarkers, Biotechnology, Oncology, and Tumor Immunology, including analysis of tissue and circulating immune cells, such as T cells, B cells, macrophages, etc.; analysis of the tumor micro-environment with ...
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