Our Experts

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 ...

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 – ...

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 ...

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 ...

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 ...

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 / ...

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; ...

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., ...

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 ...

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 ...

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 COVID-19) ...
  
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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) ...

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, ...

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 ...

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 ...

TOXICOLOGIST / DRUG DEVELOPER PERSONAL PROFILE

• 30+ years in global pharmaceutical and biotechnology drug discovery and development

EXPERTISE Pharmacology / Safety; Drug Metabolism / Pharmacokinetics (DMPK); Toxicology; Good LaboratoryPractices (GLPs); INDs; Clinical Trial Applications (CTAs); NDAs; MAAs; Internal Reports and InternationalRegulatory Filings and Interactions (IBs, CTAs, PIP); Safety Evaluation Program Operations; QA Audits /Technical Assessments; Predictive Computer Models; Presentations; Leading Cross-functional Teams;Excellent Oral and Written Communications. Therapeutic areas include pulmonary and neuromuscular diseases, oncology, and anti-infectives. Earned a BS in Biology at Purdue University and Master of Science and PhD (toxicology/pharmacology) at NC State University. Has more than ...

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 ...

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 ...

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,​ ...

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 ...