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.

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 ...
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Terrie Blalock

KOL & ENGAGEMENT AND MARKETING EXPOSURE PERSONAL PROFILE
  • 30 years in medical and pharmaceutical arenas
EXPERTISE Site and Patient Management, Key Opinion Leader (KOL) Development, Establishing Relationships, Competitive Intelligence, Patient Advocacy Groups and Professional Societies, Negotiations, Strategic Planning/Analysis. PROFESSIONAL EXPERIENCE Director, Medical and Professional Services – Merz Pharmaceuticals, LLC
Direct the strategic and tactical elements of Patient Advocacy groups, Key Opinion Leader development, and medical communications and education plans. Build strong customer service excellence through deliberate, positive, interpersonal interactions and cultivated professional relationships. Maintain a thorough understanding of the company’s products and services, industry regulations, and client ...
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Sheree Mann

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 & Agility; 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, Healthcare market sectors, and Academic institutions, overseeing project ...
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Scott Chase

COMPLIANCE, QA, & REGULATORY AFFAIRS PERSONAL PROFILE
  • 13 years in the compliance field.
EXPERTISE Developing Quality Systems; Part 11 Compliance (back and front end, software and hardware); Validation (process and equipment); Foreign CMO Oversight and Batch Record Review (France, Italy, Germany); GLP Studies (PK and Tox, rodents/primates); QC of Raw Materials, EM, Utilities, Cleanrooms, Facilities; GXP Training and Document Management; GCP Site Audits; EDC/RDC Data Verification. PROFESSIONAL EXPERIENCE QA Solutions
Duties for long-term projects include performing GXP vendor audits, serving as Supplier Quality Engineer, International Medical Device manufacturer of CT/MRI systems, FDA remediation team member, and SCAR ...
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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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Robert Mulrooney, MB, BCh, BAO

COMMERCIAL/MEDICAL STRATEGY PERSONAL PROFILE
  • 24 years in pharma medical management/leadership and commercialization strategies.
EXPERTISE Global Medical Leadership, Strategy and Operations, Commercial Assessment, In-Licensing, R&D, Medical Affairs, Marketing and Sales, Business Development, Change Management, Physician, Specialties: Small Molecules/Biopharmaceuticals, Hospital Internal Medicine, Cardiology, Immunology/Inflammation, Ophthalmology, Cardiovascular Diseases, Diabetes Mellitus, Osteoporosis, Stress Urinary Incontinence, and Rare Diseases (Pulmonary Arterial Hypertension and System Lupus Erythematosus/SLE). MB, BCh, BAO from University College Cork Medical School, National University of Ireland. Founder/Managing Director, Ardiem Lifesciences Ltd.
Biotech consultant providing strategic commercial support. Producing long- and short-range strategic plan for mid-size rare disease biotech leader ...
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Rachel Harrigan, MD

LEADERSHIP / CLINICAL DEVELOPMENT PERSONAL PROFILE
  • 29 years in drug development.
EXPERTISE CMO, Operational Oversight, Strategic Planning & Development, Clinical Development and Medical Oversight, Negotiating and Influencing, Team Leader, Line Manager, Team-Building, and Engagement. PROFESSIONAL EXPERIENCE Pharmaceutical Consultant, Harrigan Consulting, LLC
Strategic review partner for venture investors in drug development. Subject matter expert for clinical development, regulatory environment, and medical issues. Reviewer of numerous clinical development plans to advise on benefit/risk, challenges to implementation, and likelihood of regulatory success. Collaborate with innovator companies to discuss compounds and to review clinical and regulatory plans. Head, Worldwide Development Operations, Senior ...
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Philip Gregory Janicak, MD

PSYCHIATRIC CLINICAL TRIALS PERSONAL PROFILE
  • Nearly 40 years in the psychiatric medicine field
EXPERTISE Mood and Psychotic Disorders; Research Psychiatry; Therapeutic Neuromodulation ECT (electroconvulsive therapy) and TCM (transcranial magnetic stimulation); Psychiatric Drug Development (psychosis and depression); Clinical Trials; Management and Treatment of Schizophrenia, Depression and Bipolar; 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 including 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 ...
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Patti L. Arsenault, MBA

DATA MANAGER PERSONAL PROFILE
  • 20 years in data management.
EXPERTISE Clinical Data Management, Database Developer, EDC/Site Vendor Selection and Management, Process Improvement, SOP Development, Internal Data and Sponsor Audits, Data/Vendor Management Plans, Case Report Form Authoring/Library, Protocol Violation Reporting, Adverse Event Management, Proposal Writing, GCP, ICH, and GMP Compliance, Project Management and Leadership, Trainer on Multiple Systems, Web Programming (asp, JavaScript, AJAX), Database Proficiencies (Oracle, SAS, CDISC), Data Management Certification. PROFESSIONAL EXPERIENCE Director, Clinical Data Management/Global Head, Clinical Data Management, Cytel, Inc.
Manage, plan, and coordinate activities of Data Management group: internal/consultant data managers, database developers, database ...
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Parker Ress

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 ...
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Oscar Segurado, MD, PhD

ONCOLOGY/INFLAMMATION/GENOMICS PERSONAL PROFILE
  • 30+ years in global clinical development, medical affairs and translational research.
EXPERTISE HIGHLIGHTS Global Clinical Development of Drugs/Devices/Diagnostics; Global Clinical Operations (registration, launch, post-launch, and study publications); Pharma Executive; Scientific and Industry Experience in Rheumatology/Autoimmune/Inflammatory Diseases, Oncology, and Hematology; Compliance, QA and Regulatory; Tenured Professor of Immunology. MD from University of Salamanca, Spain and PhD from University of Wurzburg, Germany. More than 100 publications and 150 abstracts. PROFESSIONAL EXPERIENCE HIGHLIGHTS: Chief Medical Officer, Crescendo Bioscience / Myriad Genetics
Defined and executed global clinical development program covering genetics, genomics, and proteomics, and including prospective clinical ...
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Oscar Laskin, MD

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 ...
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Melanie Raskin

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 ...
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Mary-Anne McKenna, M.Ed.

CLINICAL OPERATIONS PERSONAL PROFILE
  • 16 years, mostly in clinical operations.
EXPERTISE Clinical Trials; 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, hypercholesterolemia). PROFESSIONAL EXPERIENCE Associate Director Clinical Operations, Vertex Pharmaceuticals, Inc. Provide ...
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Marc S. Rudoltz, MD

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 I-IV), 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) ...
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Lynn B. Sutton

CLINICAL OPERATIONS PERSONAL PROFILE
  • 30 years in medical and pharmaceutical arenas.
EXPERTISE Cost Management, Process Improvement, Functional and Operational Efficiency, Strategic and Development Planning, Vendor Evaluation, Third Party and R&D Integration, Gap Analysis, Collaboration/Accountability/Decision-Making, CRO Partner Management. PROFESSIONAL EXPERIENCE Founder and Principal, Professional Clinical Consultants, LLC
Provides strategic, operational, and financial consulting for early through Phase 4 development for pharma, biotech, and full service CROs with focus on optimizing results in clinical product development domestically, globally, and virtually. Delivers strong clinical research and operations experience exclusively in life sciences, with extensive expertise in program oversight. Applies best ...
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Lou Vaickus, MD, FACP

FOUNDER & PRESIDENT PERSONAL PROFILE
  • 30 years in medicine and the pharmaceutical industry
  • 15 years of executive pharma leadership
EXPERTISE Physician Executive, Executive Leadership, Clinical Development & Medical Affairs, Preclinical Development, Regulatory Affairs/Quality Assurance, Business Development/Fundraising, Commercial Marketing, Medical Writing/Communications, 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, devices, diagnostics, assay development, and biosimilars. MD from Loyola University’s Stritch School of Medicine with training in Immunology, Internal Medicine, and Hematology/Hematologic Malignancies at the Mayo Clinic and in Hematology/ Oncology at ...
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Lindsey Lozano

MEDICAL WRITER PERSONAL PROFILE
  • 11 years in medical writing, specializing in medical/pharmaceutical/scientific drafting and editing.
EXPERTISE Writing – Protocols, Investigator Brochures, Annual Reports, Investigational New Drug (IND) Application Sections, Marketing Applications, Briefing Documents, Regulatory Meeting Slide Decks, Publications, Clinical Study Reports; Document Formatting and QC; Project Management. Proficient in International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and American Medical Association (AMA) style guidelines. PROFESSIONAL EXPERIENCE Independent Contract Medical Writer
Work with clients to complete clinical and regulatory projects across various indications (e.g., oncology, vaccines, medical device). Responsible for drafting ...
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Leonard Mattano Jr, MD

HEMATOLOGY/ONCOLOGY PERSONAL PROFILE
  • 30 years in medicine and the pharmaceutical industry.
EXPERTISE Pharma Executive; Hematology/Oncology Drug Development (Hematologic Malignancies, Sarcomas, Brain Tumors, Melanoma, Pediatric Cancer, and Hematologic Disorders); Academic Clinical Trial Strategy, Design, Management, Monitoring, Compliance, Reporting and Publication; Pediatric Hematology/Oncology; Global Regulatory; Administration; Management; Portfolio Global Strategy: Discovery – Post-marketing; Governance and Organizational Compliance; Programs Establishment and Expansion; Pediatric Investigation Plan Development, Writing and Negotiation; Communications; Collaboration/Outreach. Numerous publications, reviews, and invited presentations, has extensive industry, cooperative group, and pediatric hematology/oncology academic experience, including as co-chair of a 5300-patient Phase 3 frontline leukemia study. Global regulatory knowledge ...
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Larry Yarmaloff, CCRA, RQAP-GCP

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., ...
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Kimberly Potts

PROJECT MANAGER PERSONAL PROFILE More than 20 years of diversified experience in the administrative and customer service fields. EXPERTISE Project Management, Data Research and Compilation, Query Testing, Global Transparency Reports, Customer and Financial Reports (CTMS data validation), Sponsor Liaison, Sponsor Documentation (files, records, and reports), File Review and Audit, Information Coordination and Tracking, System/Project Updates and Maintenance (databases, time lines, tracking tools, project plans), Meeting Planning, Travel Arrangements, Budget/Project Tracking, Problem-Solving; Time Management, Communication. PROFESSIONAL EXPERIENCE Global Aggregate Spend Reporting Coordinator, Quintiles Researched and compiled data to ensure compliance with Open Payments (the Sunshine Act) and performed query testing ...
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John Patrick Hanrahan, MD, MPH, FCCP

RESPIRATORY / IMMUNOLOGY & REGULATORY AFFAIRS PERSONAL PROFILE
  • 15 years as a research/clinical development physician in the pharma industry.
  • 30 years in medicine.
EXPERTISE Physician Executive, Global Drug Development, Chief Medical Officer, Clinical Research, Clinical Trials Design and Implementation, Principle Investigator, Rare and Orphan Indications, International Regulatory Affairs/Filings, FDA Negotiations, Partnering/In-Licensing Evaluation, Staff and Contractor Management, Consulting. MD from Albert Einstein College of Medicine and MPH degree from the Harvard School of Public Health in epidemiology and statistics. Prior to industry, a practicing academic and pulmonary/emergency medicine hospital physician and full-time tenure-track faculty staff at Harvard Medical School ...
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John Bradford

PRODUCTIONS & MARKETING PERSONAL PROFILE
  • 25 years in production and project management of meetings and special events, specializing in pharmaceutical, corporate and technological industries
EXPERTISE Project Timeline Creation, Workflow Scheduling, Budget Development, Administration and Reconciliation, Meeting Theme Branding. PROFESSIONAL EXPERIENCE Director, Productions – The Right Plan (TRP) – Life Science Event Management Firm (now a division of aktaPD®)
Works closely with Director and Web Events and Audio Visual teams to produce one-of-a-kind and unforgettable events. Produce domestic and international programs for up to 2,500 attendees, administer budgets in excess of $5 million, develop key accounts and build ...
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Joel Hale

CLINICAL RESEARCH / CLINICAL OPERATIONS PERSONAL PROFILE
  • 23+ years of clinical research experience.
EXPERTISE Clinical Trial Design, Implementation, and Management; Clinical Operations; Clinical Research; Monitoring; Site Development; Clinical/Regulatory Guidance; Study Lead; Project Management; Writing- Protocols, SOPs, CRFs, Business Plans, Budgets, Operational Timelines, and Mission Statements; Investigator/Coordinator Training. PROFESSIONAL EXPERIENCE Product Research and Development Consultant, Ergogenic Research, Inc.
Provide CRO and individual services: establish research programs, identify and resolve operational issues, design and implement clinical trials, manage projects, and perform monitoring and site development. Provide clinical/regulatory guidance to establish research studies for an LED manufacturer developing a hand-held, ...
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Jeana Burt

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 ...
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JD Bernardy

REGULATORY AFFAIRS PERSONAL PROFILE
  • 30 years of experience in domestic and international pharmaceutical and medical
    device industry.
EXPERTISE Regulatory Affairs, Clinical and Quality Assurance/Compliance and Operations Systems, GCP Compliance, Project Management, Investigational (IND, IDE, CTA, CA, and EC submissions) and Marketing Applications (NDA, BLA, and PMA; MAA and CE Mark Conformity Assessment), Clinical Studies, GMP Manufacturing Facilities, GLP Compliance, Products/Specifications/Procedures (GMP compliance, CAPA, change control, and supplier quality), CMC Submissions, Pharm/Tox Studies, Commercialization, SOPs. PROFESSIONAL EXPERIENCE Vice President, Regulatory Affairs and Clinical Research, Aeris Therapeutics, Inc.
Guided strategy on development projects, focusing on regulatory and clinical ...
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Jamie Blackburn

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 DevelopmentTM (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 ...
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James Bolognese, M.Sc.

BIOSTATISTICIAN PERSONAL PROFILE
  • 40 years in life sciences as a biostatistician
EXPERTISE Biostatistician; Statistical Analysis; Clinical Development Program and Trial Design; Adaptive Designs and Implementation; Statistical Support of Biomarker Development; Technical Oversight/Guidance of Statistical Analysis Vendors; Software Design, Development, Testing, and Refinement. Authored nearly 100 peer-reviewed publications and articles and made numerous presentations. PROFESSIONAL EXPERIENCE Senior Director, Strategic Consulting / Clinical Trial Services, Cytel, Inc. Assist pharmaceutical and biotech clients with design of clinical development programs and clinical trials, including adaptive designs and implementation. Provide statistical/technical guidance and oversight of out-sourced services for statistical analysis and reporting of ...
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Dr. Jacqueline Parkin, MBBS, FRCP, PhD

IMMUNOLOGY PERSONAL PROFILE
  • 34 years in medicine and clinical development
EXPERTISE Senior Level Clinical Development (first-in-man and translational studies through Phase 3 and regulatory filing); Adult/Pediatric Specialties: Immunological, Allergic, Metabolic, and Infectious Diseases; Expertise in: Biologics (including ‘high-risk; molecules), NCEs, Oligonucleotide, Stem Cell, and Gene Therapies, Immuno-Inflammatory Disorders (RA, SLE, organ-specific autoimmune diseases), Therapeutic Vaccines, Rare Diseases, and Nutritional Interventions; US/EU Regulatory; Global Leadership and Management; Business Development; Alliance Partnerships. Academically-trained pharmaceutical physician with extensive technical, clinical, and pharmaceutical development capabilities. Global leadership and medical governance roles at senior level; adept in management of virtual teams and strategic ...
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Inder Kaul, MD, MBBS, MPH

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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Helena Champion, MS, MBA

COMPLIANCE/QUALITY SYSTEMS SPECIALIST PERSONAL PROFILE
  • 25 years of US and international experience in pharmaceutical and biotechnology manufacturing and testing, medical devices, and product development.
EXPERTISE Quality and Regulatory Compliance Support for Pharmaceuticals, Medical Devices, and Chemical Reagents; Audits; Supplier Qualification; Optimization of Contract Manufacturers, Testing Laboratories, and Suppliers; FDA/European Global Requirements; Product and Process Development; Manufacture of Clinical Trials Materials; Chemistry, Manufacturing, and Controls Support; Development of Procedures and Quality Systems; Training; Scientific Background in Analytical Chemistry, Organic Synthetic Chemistry, Protein Chemistry, Biology, Microbiology, and Biochemistry. PROFESSIONAL EXPERIENCE Principal Consultant Drug Quality Assurance, LLC Quality Assurance: Perform audits ...
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George Naumov, PhD

ONCOLOGY: RESEARCH & LEADERSHIP PERSONAL PROFILE
  • 15+ years of professional experience as a scientist and executive working in oncology.
EXPERTISE Scientist/Researcher, Oncology Specialty, Start-ups, Angel Investment/VC, Business Development and Strategy, Management Consultant. PROFESSIONAL EXPERIENCE Management Consultant, DavCard Group and MedPharma Partners Provide advisory services to VC portfolio companies regarding product development, commercialization strategy, R&D management, re-structuring, corporate strategy, and other business opportunities. Provide analysis and guidance on merger and acquisitions associated with oncology asset VC portfolio. Worked on corporate takeover of a biomedical company that develops and offers diagnostic tests for the practical delivery of personalized medicine ...
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Gema Gomez

PROJECT MANAGEMENT PERSONAL PROFILE
  • 27 years in clinical project management and innovation.
EXPERTISE Clinical Project Management, Innovation, and Technology; SOP Development; Process Improvement; Vendor Selection and Management; Early-Stage and Post-Marketing Global Clinical Development; Large-Scale Global Phase II-IV Pharmaceutical Studies; Relationship-Building and Management; Training Development and Facilitation; Public Speaking. PROFESSIONAL EXPERIENCE Associate Director, Global Clinical Project Management (GCPM) & Clinical Innovation Group Leader, UCB Responsible for researching, identifying, and reviewing all vendor capabilities for eSource, eConsent, eCOA (Clinical Outcome Assessments), and eISF (investigator Site Files), as well as educating GCPM and related departments on innovative clinical trials technologies.

Gary Maier, PhD

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 IV), 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 and a patent-holder of sustained-release dosage form for water-soluble compounds. PROFESSIONAL EXPERIENCE Company President and Founder, MaierMetrics and Associates, LLC Provide clients with ...
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Erika Pelzer

Clinical Research, Program Operations PERSONAL PROFILE
  • 14+ years in project management, clinical operations, and clinical trials; 12+ years of team management.
EXPERTISE Drug Development; Clinical Trials Policy and Procedure Development; Database Creation and Management; Budget and Contract Development; Research and Medical Writing; CNS Neurology – Traumatic Brain Injury, Computer Tomography Imaging, Depression, Mild Cognitive Impairment (amnestic), Multiple Sclerosis, Peripheral Neuropathy, and Spinal Cord Injury; CNS Psychiatry – Alcohol Addiction, Bipolar, Depression, Drug Addiction, General Anxiety Disorder, Major Depression, and Schizophrenia; Oncology – Multiple Myeloma, Cancer, and Neuropathy. PROFESSIONAL EXPERIENCE Senior Project Manager, CNS Business Unit, Worldwide Clinical ...
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Edward C. Dow, MD

HEMATOLOGY & ONCOLOGY PERSONAL PROFILE
  • 27 years as a Hematologist/Medical Oncologist, 20 years of clinical practice experience, and
    3 years as a physician executive.
EXPERTISE Physician Executive, Medical Affairs, FDA Label Approvals, Oncology Genomic Profiling, Global Management in Oncology Therapeutics and Cancer Molecular Diagnostics, Clinical Studies Oversight, KOL Relations, Specialties: Hematology, Oncology, Lung Cancer, Genitourinary Cancer, Hematological Malignancies (myeloma and bone marrow transplantation), Thrombosis and Hemostasis Diseases, Cardiovascular), Collaboration and Team-building, Advisory Boards. MD from Tufts University Medical School. Authored/co-authored 5 publications and 7 abstracts and/or invited presentations. PROFESSIONAL EXPERIENCE Director, Medical Affairs, Foundation Medicine, Inc. (FMI) ...
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Cornelia Reininger, MD, PhD

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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Bradley Tait, PhD

PROJECT MANAGEMENT PERSONAL PROFILE
  • Nearly 30 years in the science and pharma fields
EXPERTISE Scientist, Pharmaceutical Leadership, Project Management, Therapeutic and Technology Group Management, Pharmaceutical and Discovery Management (delivered 17 compounds in areas of Infectious Disease, Allergy Respiratory, Inflammation, Atherosclerosis, Cardiovascular, Cystic Fibrosis), Licensing, Portfolio Analysis, Restructuring, Infrastructure Development, Presentations, Aggressive Time Lines, Patents (28), Publications (29), Abstracts (31). Post-doc, Yale University PhD, Organic Chemistry, Wayne State University in Detroit, MI PROFESSIONAL EXPERIENCE Independent Consultant – Brad Tait Enterprise LLC Provide pharmaceutical consulting in the areas of medicinal chemistry strategy, chemistry intellectual property, licensing, due diligence, project ...
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Bob Clay

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 EU ...
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Ayad Abdulahad, MB, ChB, PhD, MSc, MRCPath, FRCPath

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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Audrey Rossow

PROJECT MANAGEMENT PERSONAL PROFILE
  • 20+ years in clinical research, Phases I through IV primarily in US, and some in Canada, Iceland,
    and Eastern and Western Europe
EXPERTISE Project Management, Clinical Operations, Site Selection, Study Start-Up, Patient Recruitment, CRA, Trial Master Files, Investigators Meetings, Vendor Management, Training and Mentoring. PROFESSIONAL EXPERIENCE Independent Consultant – Rossow Consulting LLC. Manage clinical research projects in therapeutic areas including COPD, hyperlipidemia, hyperphosphatemia, skin/soft tissue infections, bacteremia, oncology (hematologic, colorectal, and pain management), restless legs syndrome, diabetes, urinary incontinence, HIV/AIDS, osteoporosis, psoriasis and psoriatic arthritis, glaucoma, partial epilepsy, gout, and ischemic stroke. Provide ...
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Anthony Kohut, RN

PHARMACOVIGILANCE & MANAGEMENT PERSONAL PROFILE
  • 15+ years in pharmacovigilance.
EXPERTISE International Pharmacovigiliance (Phases I-IV); Medical Specialties: Cardiovascular, Dermatology, Endocrinology, Gynecology, Hematology, Neurology, and Oncology; EDC Specialties: ARISg Safety System, DataFax, DATATRAK (Data System Blinded), Medidata Rave, and OmniComm; BSN/Registered Nurse. Associate Director of Pharmacovigilance, Pharm–Olam Overall responsibility for and management of clinical and post-marketing functions, ensuring all are delivered to a high quality and with medical/clinical integrity. Work with an international team of medical monitors and safety officers to ensure the medical/clinical integrity and quality of studies are in compliance with all applicable competent authority regulations and ...
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Annette Dubois

MEDICAL WRITER PERSONAL PROFILE
  • 17+ years in medical/regulatory/scientific writing and editing.
EXPERTISE Writing and Editing – Protocols, Protocol Amendments, Briefing Documents, International Regulatory Documents, Investigator Brochures, Safety Updates, Patient Narratives, Clinical Trial Reports, Statistical Analysis Plans, Funding Proposals, Articles, Manuscripts, and Conference Materials (brochures, posters, AV presentations, press releases). Specialties include oncology, neurology, rheumatology, immunology, inflammation, growth and metabolism, HIV/AIDS, and infertility. English native speaker; fluent in French and Spanish (spoken and written) with basic knowledge of German and Japanese. PROFESSIONAL EXPERIENCE Freelance Scientific Writer and Editor, Luminaria Science Writing Senior Medical Writer, Merck Serono. Medical Writer, ...
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Angela Esteva

EVENT MANAGEMENT & PRODUCTIONS PERSONAL PROFILE
  • 15 years planning events and meetings
EXPERTISE Event Planning, Project Management, Sales & Marketing, Account Management. Classically trained in the European school of world class hospitality and in developing, motivating, managing, training, and leading diverse teams in short- and long-term corporate environments. Fluent in 5 languages. PROFESSIONAL EXPERIENCE Director, Business Development & Account Executive – The Right Plan – Life Sciences Meeting Planning Firm (now a division of aktaPD®)
Responsibilities include new business development and project management of key accounts in tourism, sports, film, government, and international sectors. Serves dual roles ...
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Anders Tamsen, MD, PhD

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 ...
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Aleksander Chudnovsky, MD

CLINICAL RESEARCH & DEVELOPMENT PERSONAL PROFILE
  • 14 years in medicine and 9 years in academics and clinical research.
EXPERTISE Clinical Research; Genitourinary (GU) Oncology Clinical Trials, Medical Device Development Trials; Academic and Clinical Medicine; Medical and Legal Interpreting (Russian and Ukrainian); Specialties: Urology and Oncology (Prostate Cancer, Bladder Cancer, Kidney Cancer, and Testicular Cancer), BPH, Kidney Stone Disease, Bladder Dysfunctions, and Men’s Health. MD from Boston University School of Medicine and Urology Residency from SUNY in Buffalo, NY. Andrology Fellowship (Male Infertility and Reproductive Medicine and Surgery, Male Sexual Dysfunction) from University of Illinois in Chicago. Currently ...
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