aktaPD’s® experts personify our action-oriented work ethics. These seasoned, vetted professionals, listed by 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.

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Ross A. Reife, MD, MBA

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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Russell G. Clayton Sr., DO

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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Sandra Chica, MD

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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Scott Chase

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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Serge Guzy, PhD

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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Sheree Vaickus

OPERATIONS, MARKETING & SALES PERSONAL PROFILE
  • 18 years in pharmaceutical field.
  • 10 years of business ownership in marketing, production planning, branding and web design.
EXPERTISE Budget Oversight, Contract Negotiations, Strategic Planning, Project Management, Marketing, Operations, Entrepreneurial Attitude and Agility, and Relationship Broker. PROFESSIONAL EXPERIENCE Chief Operating Officer, Marketing, and Sales – akta Pharmaceutical Development (aktaPD®) As Head of Worldwide Contracts and Operations, manages all operational aspects of the company, developing corporate and operational strategies. Charged with facilitating these efforts across operations. Also serves as Account Executive for pharmaceutical, biotech, government and healthcare market sectors, and academic institutions, overseeing ...
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Stephen Villano, MD

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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Steven Bloom

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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Susan M. Smith

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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Susie Szembek, BS

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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Tim Freeman

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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Tom Parry, PhD, MBA

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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Tracy Wild Dachenhausen, MBA, CCDM

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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Vicki J. Abbas

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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Walter Carney, PhD

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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Zhihong Huang, MD, MS

PHARMACOLOGIST, NEUROSCIENTIST, STROKE EXPERT PERSONAL PROFILE
  • Harvard-trained pharmacologist with stroke, neurotrauma, cardiovascular and metabolic disease background with over 20 years of experience. Also a trained as a clinical scientist.
EXPERTISE In vivo pharmacologist with extensive preclinical model development experience and expertise in stroke and neurotrauma therapeutics. Recognized Expert—Received 1996 American Heart/Stroke Association Young Investigator Award in Stroke. More than 10 years of large biopharmaceutical company experience in drug discovery and early development. Extensive publication and citation record in leading journals. PROFESSIONAL EXPERIENCE Consultant, Skyline Biopharma, LLC Support client in vivo model development, study design, execution and data analysis ...
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