Our Experts
aktaPD’s® experts personify our action-oriented work ethics. These seasoned, vetted professionals, listed by name and category, are ready to leap into action for your next short-term or long-haul project. Their goal? To bring their vast knowledge, experience, and innovation to your team and leverage your resources and extend your capabilities so you can meet your goal.
Use the drop-down menu to sort experts by category.
James Wachholz, BS, MBA
REGULATORY AFFAIRS & DRUG DEVELOPMENT PERSONAL PROFILE
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- 26 years of experience in new drug development in pharma and biotechnology; 19 years as senior Regulatory Affairs management.
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Jamie Blackburn
eLEARNING / KNOWLEDGE TRANSFER PERSONAL PROFILE
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- 25 years in F100 and Life Sciences Information Technology
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Jeana Burt
CLINICAL OPERATIONS SUPPORT / TRIAL ASSISTANT PERSONAL PROFILE
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- 11 years in clinical operations support.
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Jeffrey Gelb, MD
RARE DISEASE AND INNOVATIVE SPECIALTY MEDICINES, STRATEGIC GLOBAL DRUG DEVELOPMENT PERSONAL PROFILE
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- 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.
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Jessica Lee
WRITER / COPY EDITOR / PROPOSALS PERSONAL PROFILE
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- 15 years in the writing and copy editing field; and 20+ years in personal and team training and proposalwriting
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John McKinney, BS MA
CLINICAL OPERATIONS PERSONAL PROFILE
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- Clinical Operations Manager with a strong background in psychology, specializing in neuroscience-focused operations in clinical trials.
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Judi Sills, PharmD
PHARMACOVIGILANCE/SAFETY COMPLIANCE PERSONAL PROFILE
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- 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.
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Larry Yarmaloff, CCRA, RQAP-GCP
PROJECT MANAGEMENT / CLINICAL OPERATIONS & DEVELOPMENT PERSONAL PROFILE
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- 24 years in clinical development of investigational therapeutic and diagnostic products.
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Lee Schacter, PhD, MD
REGULATORY AFFAIRS PERSONAL PROFILE
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- 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.
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Lou Vaickus, MD, FACP
CHIEF EXECUTIVE OFFICER & FOUNDER PERSONAL PROFILE
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- 35+ years in medicine and the pharmaceutical industry
- 20+ years of executive pharma leadership
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Lynn B. Sutton
CLINICAL OPERATIONS PERSONAL PROFILE
- 40+ years in medical and pharmaceutical arena.
- 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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Marc S. Rudoltz, MD
ONCOLOGY CLINICAL DEVELOPMENT PERSONAL PROFILE
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- More than 26 years in radiation oncology.
- 13 years in pharma industry oncology clinical development.
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Mary-Anne McKenna, M.Ed.
CLINICAL OPERATIONS PERSONAL PROFILE
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- 16 years, mostly in clinical operations.
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Melanie Raskin
STAFF WRITER PERSONAL PROFILE
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- 33 years in the communications field, specializing in medical/pharmaceutical, health/wellness, and state government/public interest.
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Michael Fafunso, MD
ONCOLOGY CLINICAL TRIALS, SITE MANAGEMENT, MONITORING PERSONAL PROFILE
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- 9 years of pharma clinical trials management experience; 14 years as a physician.
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Michael P. Carver, PhD
TOXICOLOGIST / DRUG DEVELOPER PERSONAL PROFILE
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- 30+ years in global pharmaceutical and biotechnology drug discovery and development
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Oscar Laskin, MD
RESPIRATORY & ONCOLOGY PERSONAL PROFILE
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- 27 years of drug development experience in large and small pharma companies.
- 36 years in medical/research field.
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Parker Ress
GRAPHIC DESIGNER PERSONAL PROFILE
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- 15 years as a data-driven graphic design expert in a broad range of industries including pharma, manufacturing, military, and higher education.
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Patrick Sarmiere, PhD
TRANSLATIONAL RESEARCH, CLINICAL DEVELOPMENT, & BIOMARKERS PERSONAL PROFILE
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- 40 years as a physician.20+ years of translational research and bioanalytics experience in biotech and pharma.
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Peter Johnson, MD, FACS
MEDICAL EXECUTIVE/CMO PERSONAL PROFILE
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- 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.
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