Management Team

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Premier Consulting

Olu Aloba, Ph.D.

Vice President, CMC Services

Dr. Aloba has more than 25 years of leadership experience in pharmaceutical research and development, pharmaceutical technology, and regulatory strategy. He is a subject matter expert in drug product development, with special expertise in the application of quality-by-design (QbD) to formulation and process development, analytical development, and development strategy. He is a registered pharmacist and holds a US Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society.

Dr. Aloba joined Premier Consulting in 2014 and, in his current role, leads Premier Consulting’s Chemistry Manufacturing and Controls (CMC) service offerings focusing on pharmaceutical development strategising, planning, execution, and documentation in support of drug development programs for Premier Consulting’s clients. He also serves as senior technical advisor on Premier Consulting’s drug, device, and biologics initiatives and is responsible for continuing development of the pharmaceutical quality expertise, knowledgebase, and policy at Premier Consulting.

Consulting

Will Bainbridge

Sr. Director, Commercial Strategy Solutions

Will Bainbridge, Sr. Director, Commercial Strategy Solutions, leads commercial strategy at Premier Consulting. He has over 20 years of leadership experience in the Pharmaceutical, Biotech, MedTech, and Consulting industry across multiple therapeutic areas, business models and companies, including Novo Nordisk and GSK. He has held US and global strategic leadership positions with full P&L responsibility. Will has extensive experience in business development, strategic planning, portfolio strategy, and new product planning for small to mid-size Biotech companies and Big Pharma. It spans the entire clinical development journey. His combined operating and advisory experience enable him to provide firsthand client focus, define risk, create opportunity, and develop practical solutions to address complex business needs.

Medical Affairs, Rare Diseases and Pediatrics

Adam Bloomfield, M.D.

Vice President, Medical Affairs, Rare Diseases and Pediatrics

Dr. Adam Bloomfield oversees the Rare Diseases and Pediatrics Medical Affairs team at Premier Research. He brings to Premier extensive US and global experience in medical affairs leadership and clinical development strategy from his previous work at AstraZeneca, Sobi, and Moderna. In his current role, he provides medical monitoring oversight, therapeutic knowledge to study programs, and supports business development and consulting activities in the fields of Rare Disease and Pediatrics.  A pediatrician by training, Dr. Bloomfield has over fifteen years of clinical experience treating thousands of patients and brings a patient-centric perspective to research programs.

Dr. Bloomfield completed his pediatric residency training at New York University Medical Center. He holds a doctor of medicine degree from Rutgers New Jersey Medical School and a bachelor of science degree in mathematics from the University of Michigan – Ann Arbor. He is a fellow of the American Academy of Pediatrics and board certified by the American Board of Pediatrics.

MedTech

Heidi Boehm

Senior Director, Program Delivery, MedTech

Heidi joined Premier Research in 2021 and currently functions as operational support for therapeutically aligned programs to include client engagement and cross functional management. Prior to joining Premier Research, Heidi worked under two large CROs, where she gained extensive knowledge in global study delivery with an emphasis on medical device and diagnostics.

Heidi offers more than 25 years of CRO, academic, site management, and nursing experience with extensive experience in cardiology, medical device, and diagnostics. Heidi also offers proficiency in neuroscience, as well as in acute care, pulmonology, dermatology, women’s health, infectious disease, renal disorders, oncology, and surgical therapeutic areas. Heidi began her career as a registered nurse in 1998, working in acute care medical, oncology, and surgical units. Two years later, Heidi joined the cardiovascular acute and critical care unit. This experience led her to begin a new chapter in clinical research as a coordinator, working alongside physicians conducting research for over eleven years. In 2013,

Heidi joined the research team as a project manager at the University of Montana to study patient centered outcomes research in rural populations. Heidi then joined the CRO industry and has been actively working in a variety of roles with large to medium size CROs, gaining knowledge in diverse medical device and diagnostic fields of research.

Diagnostics

Charlie Chrisawn

Executive Director, Diagnostics

Charlie Chrisawn has spent his entire career focused on diagnostic development and has amassed over 15 years of experience designing and leading diagnostic trials including sample collection, validation, and utility studies. Mr. Chrisawn’s background consists of both small- and large-scale diagnostics studies, including management of all development stages of diagnostics across a range of study settings. Under Charlie’s leadership, Premier Research celebrated a milestone achievement enrolling 100,000 participants in their diagnostic studies worldwide.

Mr. Chrisawn’s programs have successfully garnered MA and 510(K) approvals, including the only FDA approved screening test for Colorectal Cancer and the first FDA cleared at-home test for COVID-19. Mr. Chrisawn has also enabled dual 510(k)/CLIA study execution and drug/device combination studies in the 505(b)(2) pathway. His expertise includes protocol and study design, domestic and international study startup, site management, sample accountability, staff training, and study closure.

Mr. Chrisawn earned a Bachelor of Science (BS) degree in Biology from Davidson College.

MedTech

Suzanne Courtney

Associate Project Director, MedTech

Suzanne has been with Premier Research since 2005 and is currently an associate project director in the MedTech group. Prior to her current role, she has held positions of increasing scope and responsibility including Quality Assurance Auditor, Biometrics Associate, and escalating positions within Project Management, including a focus on management of medical device projects. Prior to joining Premier Research, Suzanne was an independent consultant providing various regulatory, clinical, and quality services to medical device manufacturers in the US and in Europe, including development of regulatory strategies, quality systems and procedures, and facility inspection preparation. She held the position of Director, Regulatory and Quality Affairs for EDAP Technomed, Inc. and Manager, Regulatory and Quality Affairs for Dornier Medical Systems (Dornier MedTech USA) writing regulatory submissions, overseeing international manufacturing as well as preparing for and hosting successful FDA inspections at both international facilities. Suzanne brings experience in endocrine/metabolic indications and specifically in diabetes, as well as experience in analgesia, cardiology, dermatology, genitourinary, infectious disease, oncology, orthopedics, pediatrics, pulmonology, psychiatry, general and cosmetic surgery, and additional experience in radiation therapy delivery systems.

Women’s Health

Clint Dart, M.S.

Director, NIH Women’s Health Data Coordinating Center

Clint Dart is a statistician with over 25 years of clinical trial experience and provides statistical leadership for Premier Research. Mr. Dart has extensive experience designing and conducting women’s health and diagnostics studies, which includes statistical oversight of more than 30 pivotal trials. Mr. Dart has experience with negotiations with regulatory agencies and has provided lead statistical oversight for multiple pivotal studies that have led to product approval.

Mr. Dart serves as the Principal Investigator for the Statistical and Clinical Coordinating Center for the Contraceptive Clinical Trials Network of the National Institute of Child Health and Human Development, a unit of the National Institutes of Health.

Clint received a M.S. from the University of Georgia and a B.S. from the University of Cincinnati.

MedTech

Michael Edwards

Senior Director, Regulatory Affairs, MedTech, Premier Consulting

Michael has more than 25 years of experience in regulatory affairs and quality assurance acquired within the medical device and clinical research industry across a diverse range of medical device technologies and therapeutic disciplines, and organizations from start-ups to multinationals.

Michael’s expertise spans the complete product lifecycle including clinical research, design, development, technical support, project management, operations and business development in the medical devices sector. His knowledge of the device development process combined with the regulatory requirements, enables him to provide a balanced interpretation of the pre-market and post-market needs and expectations of regulatory authorities.

In his current role, Michael provides regulatory, quality and technical expertise to clients and sponsors to help bring their products to market safely, effectively and efficiently. His key strengths include developing, formulating and implementing regulatory strategies for device development and pathways to market to meet both existing and new regulations, standards and guidance documents.

Prior to joining Premier Consulting, Michael has held various senior management positions in regulatory affairs, quality assurance and technical with high-profile, international medical device and clinical research organizations.

Statistical Consulting

Abie Ekangaki, Ph.D.

Vice President, Statistical Consulting

Dr. Abie Ekangaki is responsible for bringing expertise in biostatistics to shape clinical trial design strategies and methodologies for regulatory submissions and otherwise, and provides broad biostatistical consulting for both internal and external clients. He advises on efficient trial designs for clinical trial programs and applies his statistical expertise, drug development, and operational experience across different therapeutic areas.

With 28 years of experience as a biostatistician, Dr. Ekangaki has worked as a research scientist with the World Health Organization in Switzerland, as a statistics lecturer at Macquarie University in Australia, and has 23 years of experience in the pharmaceutical industry in both large pharma and CROs, where he has held several lead technical and senior leadership positions.

Dermatology

Ayman Farahat, MD

Executive Director, Medical Affairs

Dr. Ayman Farahat is a certified dermatologist with over 10 years of clinical practice dermatology experience plus more than 20 years of research and development experience. His expertise supports clients with strategic planning and study execution starting early in development through to regulatory submission for marketing authorization. In his role at Premier Research, he helps clients to optimize study design during protocol development and program planning in addition to supporting medical monitoring/oversight, ongoing cumulative data review and production of the clinical study report.

Dr. Farahat’s therapeutic knowledge spans all areas of dermatology including atopic dermatitis, psoriasis, alopecia, vitiligo, acne, rosacea, impetigo. In addition to drug development, he has significant experience supporting MedTech sponsors completing clinical studies.

Prior to joining Premier Research, Dr. Farahat was led dermatology strategy at Paraxel. He spent seven years practicing as a physician in dermatology, andrology, and general surgery in Egypt and Saudi Arabia. He received his medical degree, his M.Sc. in Dermatology, and his postgraduate degree in surgery from Menoufiya University in Egypt. He also completed postgraduate diploma studies in pharmaceutical medicine in Wales University.

Oncology

Elaina Haeuber, M.S.

Senior Vice President, Oncology

Elaina Haeuber, M.S., Senior Vice President, Head of Oncology, has more than 20 years of leadership and project management experience in the biotechnology, pharmaceutical, and CRO industries. She is passionate about driving innovation and bringing new treatments to patients.

In this role Ms. Haeuber oversees a team of oncology/hematology experts in the delivery of tailored and strategic clinical development programs. Along with her team, Ms. Haeuber is dedicated to understanding the acute needs of both patients and sponsors to create impactful project plans, mindful of risk, budget, and time to market.

Ms. Haeuber gained her clinical research operations and project management experience in the biopharmaceutical industry at companies including Actinium Pharmaceuticals, Syneos Health, WCG, and PPD. Programs she supported have led to marketing approval in both the US and EMA. Ms. Haeuber earned a B.A. from Boston University and an M.S. from the University of Illinois at Chicago.

Oncology

Ashley Herrick, Ph.D.

Vice President, Oncology Strategy

Dr. Ashley Herrick provides strategic planning, coordination, knowledge, and expertise for oncology projects. She has more than 13 years of experience in oncology clinical trial oversight and drug development. She has experience with all phases of clinical trials but has a keen interest and deep knowledge of early phase and first-in-man studies. She has led numerous global clinical trials and has experience with strategic management, study oversight, study start-up, efficient enrollment, and study close-out/CSR development.

Prior to joining Premier Research, Dr. Herrick was Director of Operational Strategy Management for a mid-sized CRO overseeing the strategic planning for studies. She also supported their Oncology Site Network and was responsible for oversight of a biomarker driven patient matching group. She has also served as Project Director, Project Manager, and CRA throughout her years working in the CRO industry and has devoted her entire career to Oncology research. Prior to joining the CRO industry, she worked as a Program Manager for largest Phase I clinical trial unit in the country at MD Anderson Cancer Center, where she was responsible for oversight of more than 50 industry sponsored and investigator led Phase I clinical trials.

Dr. Herrick holds a doctorate degree in molecular and cellular biology with a focus on hematologic malignancies from Baylor College of Medicine. She is CCRP certified and is a member of the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO). She is an active volunteer with the Leukemia and Lymphoma Society (LLS).

Premier Consulting

Dr. Madelyn Huang

Toxicologist, Nonclinical Safety and Toxicology

Dr. Madelyn “Mimi” Huang is a Toxicologist at Premier Consulting, a business unit of Premier Research. She provides expert advice to sponsors and innovators addressing various critical nonclinical aspects of therapeutic product development. Her areas of expertise include designing nonclinical programs to support clinical studies, writing and reviewing regulatory submissions for global regulatory authorities, and crafting regulatory strategies. She has experience in the development of small molecules and cell and gene therapies, as well as in developing drug products via the FDA’s 505(b)(2) pathway.

Dr. Huang obtained her Ph.D. in Toxicology at the University of North Carolina at Chapel Hill and is a Diplomate of the American Board of Toxicology (2022-present). She has published 18 articles in peer-reviewed journals on topics spanning a wide range of toxicology, from basic environmental chemical research to pharmaceutical regulatory strategy.

MedTech

Frank Keulen, M.Sc.

Director, Program Delivery, MedTech

A Director Program Delivery currently working at Premier Research being responsible for overseeing key device programs ensuring successful management and coordination of efforts assigned to all members of the global project team to support milestone achievement and overall project delivery. Frank line manages the EU project management team (PM level).

Frank is a flexible, thorough and ambitious team player with good organizing skills who likes to lead projects to achieve milestones as efficient as possible. Frank has over thirteen years’ experience in medical device clinical research, including project management and line management, overseeing the different phases of clinical investigations throughout the device life cycle and worked as Project Manager for two other CROs (Medpace/MediTech Strategic Consultants) prior joining the Premier Research team.

Frank has experience working in the field of cardiovascular and wound healing/skin augmentation research managing studies throughout the device life cycle (FIM, pre- and post-market, registry studies), including global coverage. He has been involved in a variety of therapeutic indication including, but not limited to; Left atrial appendage closure devices, aortic valve replacement (surgical), transcatheter aortic/pulmonary valve replacement (TAVR/TPVR), transcatheter repair of mitral regurgitation, catheter based ventricular assist devices, cardiac (catheter) ablation of atrial fibrillation, EVAR for Abdominal Aortic Aneurysm Peritoneal dialysis (sodium removal, chronic heart failure), dermal fillers and scaffold for full thickness wounds arising from skin lesion (BCC/SCC) excision.

Frank obtained a Master Degree (MSc) in Physical Activity and Health, Specialization: Biology of Human Performance and Health at Maastricht University (Maastricht, Netherlands) and also holds a Bachelor Degree in Medical Technologies at the Higher Technical School Zuyd (Heerlen, Netherlands).

Strategic Development

Michael King Jolly, PharmD

Senior Vice President, Strategic Development

Michael King Jolly joined Premier Research in 2016 to oversee strategic drug development partnerships and to implement innovative technologies and alliances. He has more than 35 years of clinical research and drug development experience, having held senior positions in strategic partnering, medical and regulatory affairs, clinical operations, and R&D at some of the industry’s leading companies.

Dr. Jolly holds a Doctor of Pharmacy degree from the University of Texas-Austin and a bachelor’s degree in zoology from the University of North Carolina-Chapel Hill, and is a graduate of the Burroughs Wellcome Management Institute. He teaches at the School of Pharmacy at the University of North Carolina-Chapel Hill.

Medical Device

Janet Kube

Executive Director, Program Delivery

Janet Kube is responsible for ensuring operational excellence in collaboration with leadership and in support of the overall Medical Device & Diagnostics group, including collaborating with global resourcing on assignments as well as activity and metrics reporting, overseeing assigned project managers and directors, and empowering them to lead and direct global cross-functional teams and manage client expectations to achieve client satisfaction. In her role, Mrs. Kube also operates at a strategic support level for complex, critical, therapeutically aligned programs through key stakeholder engagement and cross-functional management.

With more than 20 years of experience in clinical drug development as well as medical device licensing exclusively in the CRO environment, she has taken on the responsibility of operational delivery on various trials and clients, with a focus on the cardiovascular as well as the orthopedic and pediatric fields. Before joining the drug development industry, Mrs. Kube worked as a Registered Pediatric Nurse in several departments of the pediatric hospital, including the neuro-pediatric and oncology ward.

Women’s Health

Kathleen LeMaitre, MD, FACOG

Executive Director, Medical Affairs

Dr. Kathleen LeMaitre is a board certified OBGYN with over three decades of clinical experience in women’s health. As Executive Director, Women’s Health, she works with Premier Research’s team of women’s health experts to drive research advancements in diseases that directly impact women. Dr. LeMaitre leverages her extensive clinical experience to help sponsors enhance their study plans in order to optimize patient outcomes and impact.

Dr. LeMaitre received her BA in biology from Amherst College, her MD from Georgetown University, and completed her OB/GYN residency at University of Massachusetts. She brings extensive clinical experience, including work at a tertiary care teaching hospital, where she delivered comprehensive obstetric and gynecologic care leveraging both evidence-based care and technological innovations to improve patient care.

Sanjay Machado, MBBS

Executive Director, Program Delivery

Sanjay brings over 25 years of global experience in the pharmaceutical, CRO, and site management organization (SMO) industries. Sanjay offers extensive and detailed knowledge of all phases of the drug development process, including the design, implementation, conduct, issue escalation, mitigation, and governance of clinical trials. His therapeutic experiences include dermatology as well as rare diseases, oncology, neurology, infectious diseases, and gastroenterology.

Sanjay has worked on studies involving sites in the North America, Latin America, Asia-Pacific, along with European and MENA regions.

Cell & Gene Therapy

Jessica Merryfield

Vice President, Project Delivery, Cell & Gene Therapy

Jessica Merryfield has been involved in global clinical research for more than 20 years, specializing in rare diseases for the last 10 years. As vice president, project delivery, gene and cell therapy; Ms. Merryfield advises, consults, plans, and directs the design and strategy for prospective and ongoing gene and cell therapy studies. In her role, she provides operational excellence by driving best practices, identifying global needs for innovation and improvements, and leading Premier’s Continuous Learning Program for Advanced Therapeutics.

Through stakeholder engagement and cross-functional management, Ms. Merryfield operates at a strategic support level for complex, critical therapeutically aligned programs. She coordinates strategic direction and delivery for gene and cell therapy with Premier’s innovative partners, including regulatory and statistical consulting, therapeutic experts, patient engagement, and strategic development.

Ms. Merryfield has extensive experience in phase 1-4 studies, including autosomal, neurological, metabolic, and hematology disease utilizing innovative precision medicine technologies. Her key experience areas include pediatrics, rare/ultra-rare disease, cardiology, immunology/autoimmune disorders, dermatology, and CNS.

Premier Consulting

Greg Meyer

Vice President, Regulatory Affairs

Greg has been in the pharma, biopharma and medical device industry for over 30 years and has gained regulatory approvals in more than 20 countries. He has represented companies during numerous interactions with the FDA, European national and EU regulators, and the Australian TGA and has worked on the development, submission, and commercialization of NMEs and 505(b)(2) products in oncology, neurology, and dermatology. His specialty areas include biologics and drug-device combination products.

Cell & Gene Therapy

Kenneth Ndugga-Kabuye, MD, FACMG

Vice President, Cell & Gene Therapy

Dr. Ken Ndugga-Kabuye is Vice President, Gene & Cell Therapy at Premier Research. A clinical geneticist by training, Dr. Ndugga-Kabuye is an expert in the management and clinical development of rare genetic diseases. He has extensive experience executing clinical studies that leverage cutting edge approaches in the treatment of hereditary disease inclusive of Synthetic Biotics, RNAi, AAV-Mediated Gene Therapy and Enzyme Replacement Therapy. ​​

In previous roles, Dr. Ndugga-Kabuye has supported CRO and biotechnology clients in the hereditary and rare disease space. Dr. Ndugga-Kabuye received a Bachelor of Science in Microbiology, Immunology & Molecular Genetics (MIMG) from the University of California, Los Angeles (UCLA) and a medical degree from Ross University School of Medicine. Dr. Ndugga-Kabuye performed his residency and fellowship training in Medical Genetics & Genomics at the University of Washington in Seattle, WA. He is board certified in Clinical Genetics and Genomics, by the American Board of Medical Genetics and Genomics (ABMGG).

Regulatory Affairs

Caroline Perez, Ph.D.

Associate Director, Regulatory Affairs

Caroline Perez has more than 20 years of international clinical research experience in medical devices and pharmaceutical products. As Associate Director of Regulatory Affairs, she oversees critical elements of regulatory strategy and business acquisition, advising customers and members of the company’s clinical team on regulatory and technical subjects.

Prior to joining Premier Research in 2009 as a Senior Project Manager, Dr. Perez was a Project Manager and Clinical Research Associate at MedPass International, a Paris-based contract research organization specializing in medical devices. She also worked as a Clinical Research Associate at Ciba VISION, a producer of contact lenses, and at Bristol Myers Squibb. Her broad therapeutic experience spans medical devices, ophthalmology, oncology, and neurology.

Dr. Perez holds a doctorate in organic chemistry from the Institute for the Chemistry of Natural Substances in Gif-sur-Yvette, France, and did a post-doctorate study in organic chemistry at the Martin Luther University of Halle-Wittenberg in Germany.

Betsy Reid

Senior Vice President, Pediatrics

Betsy Reid is responsible for providing the strategic direction for portfolio growth and operational excellence through direct leadership of the project management teams focused on executing pediatric studies and programs.

Betsy is a results driven executive with a proven track record of developing and leading groups and organizations to increased profitability, productivity, and growth. She has a proven track record of success in driving execution of organizational strategy in support of operational excellence as well as in developing, negotiating, and implementing strategic alliances and partnerships to support strategy. Betsy achieves these goals by developing and implementing a clear business strategy, building committed, motivated
and successful teams, and leading through change to optimal results for the organization.

Specialty Areas

Angi Robinson

Senior Vice President, Specialty Areas

Angi Robinson has been designing and conducting specialty studies, including pediatric and rare disease studies, for more than 22 years. She has provided strategy, oversight, and full management support for rare disease studies at Premier Research for over 18 years, including global programs in ultra-rare indications.

Ms. Robinson has a thorough understanding of drug development with extensive supervisory experience and management in conducting registrational-enabling clinical trials for orphan drugs. Ms. Robinson’s experience encompasses complex study designs such as PK/PD and adaptive design, and she has worked with products granted expedited designations by the agencies like FDA Fast Track, Breakthrough Therapy and PRIME designations — including advanced medicines. Specifically in orphan drugs, Ms. Robinson has supported ten products resulting in FDA and EMA approval.

Ms. Robinson earned a bachelor’s degree in cell and molecular biology from Tulane University in New Orleans, LA.

Premier Consulting

William Salminen, Ph.D., DABT, PMP

Vice President, Nonclinical Safety and Toxicology

Dr. Salminen has over 20 years of drug development experience for an array of drug products and indications. He is board-certified in toxicology (DABT) and project management (PMP) and a subject matter expert in nonclinical safety and toxicology support for drug product development. His experience includes regulatory strategy and advice, nonclinical safety and toxicology strategy and advice, US FDA pre-Investigational New Drug (pre-IND) meetings, IND applications and maintenance, and New Drug Application (NDA) and Biologics License Application (BLA) submissions.

Dr. Salminen has significant experience with 505(b)(2) NDAs and the unique regulatory, nonclinical, and clinical strategies involved with developing drugs under this pathway. He also has FDA-applied research experience with developing new biomarkers of drug-induced liver injury.

MedTech

Nicole Sativtsky

Associate Project Director, MedTech

Based in MA (USA), Nicole has 22 years of clinical research experience within the Medical Device and CRO environments. Nicole is a proven leader with her organizational skills and oversight of all activities related to the execution and success of clinical trials. Nicole was a CRA for over 15 years, moved into project management over 10 years ago and is currently an Associate Project Director. Nicole oversees and ensures operational delivery by means of study oversight within the study teams. Nicole has managed large global trials in Cardiovascular, Alzheimer’s Disease, Gastroenterology, Pulmonary along with other therapeutic areas.

Nicole has an excellent background between her clinical research experience and education of a BS in Chemistry and Clinical Investigation Certification from MGH Institute.

Medical Affairs Neuroscience & Analgesia

Andreas Schreiner, M.D.

Senior Vice President, Medical Affairs Neuroscience & Analgesia

Dr. Schreiner has considerable experience as a  clinician and investigator as well as more than 20 years of global experience within the pharmaceutical industry and clinical research environment. In his role, he is responsible for providing strategic planning, coordination, knowledge, and expertise in neuroscience and analgesia for projects and/or standalone consultative services for development programs covering entire product lifecycles.

Dr. Schreiner is a certified psychiatrist and neurologist. He studied medicine at the Universities of Heidelberg and Mannheim, Germany, and completed residencies in the University Department of Neurology and in Psychiatry at the Central Institute of Mental Health, both in Mannheim, Germany.

Neuroscience

Adam Simmons

Vice President, Program Strategy

As Vice President, Program Strategy, Adam is responsible for providing strategic planning, coordination, knowledge, and expertise in neuropharmacology for clinical research projects and/or standalone consultative services. Adam has over 20 years of experience in drug and device research working for pharmaceutical companies and academic medical centers with over 30 publications across neuroscience indications and research methodologies. He also supported scientific communication and media appearances in support for the launch of LYBALVI®, a program for which he served as Alkermes’ Clinical Lead and presented data at major scientific congresses. Additionally, Adam has overseen clinical trials conducted in over 25 countries across North and South America, Europe, and Asia Pacific.

Adam holds a Master’s in Public Health in Epidemiology from Emory University and a bachelor’s degree in Health and Society from the University of Rochester. Currently, Adam sits on the steering committee for the STARR Coalition, a non-profit patient advocacy organization which connects people living with mental illness to clinical research. He has also been involved as a speaker or in support of patient advocacy activities with organizations including the National Alliance of Mental Illness, the Depression and Bipolar Support Alliance, the National Council for Mental Wellbeing, and others.

MedTech

John Thomas, M.Sc.

Director, Program Delivery, MedTech

Based in the UK, John brings more than 20 years of industry knowledge within the CRO, pharmaceutical, biotech and medical device environments. John joined Premier Research as a senior CRA in 2008 and has since leveraged his leadership skills to gain roles of increasing responsibility in clinical management and project management. John is a proven leader, organizer, and director of all activities related to the execution of complex international clinical projects and small programs.

John is experienced in managing a wide range of medical device and pharmaceutical phases 1 – 3b clinical trials. He successfully delivered projects and managed sites on ASD closure devices, drug eluting cardiac stents, LAA closure devices, pacemakers, gastrointestinal medical devices, knee implants, septal closure devices for Patent Foramen Ovale, sham controlled devices for the treatment of diabetic foot ulcers, fecal incontinence studies and necrotizing enterocolitis in premature and low birth weight infants. John has a thorough background in researching a range of therapeutic areas in both medical devices and pharmacological compounds.

By professional background, he has specialized in respiratory therapeutics but throughout his career, he has also accumulated practical experience and theoretical knowledge of phase 1 CNS compounds, oral diabetic agents, and cardiovascular medicinal compounds. He has an excellent portfolio of testing techniques for a range of diseases and has academic accreditation to match his experiences.

Data Protection

Victoria Watts, LLB

Vice President, Privacy and Global Data Protection Officer

Victoria Watts, CIPT, is the Global Data Protection Officer at Premier Research.  She has compliance and legal risk management experience in a variety of industries, most recently within clinical research. Ms. Watts has extensive experience formulating, operationalizing, and implementing data protection compliance programs and is an expert in interpreting the General Data Protection Regulation (GDPR) as it relates to clinical research. Prior to joining Premier Research, she held positions of increasing responsibility in the fields of data protection and legal compliance.

Ms. Watts has a Master of Studies from the University of Oxford and both a Bachelor of Laws degree from the University of Law in the United Kingdom and a Bachelor of Arts degree from Royal Holloway, University of London. In the field of data protection, she is a Certified Information Privacy Technologist (CIPT) and holds other relevant certifications.  Ms. Watts is currently a member of the Training Advisory Board of the International Association of Privacy Professionals (IAPP) as well as a key contributor to the European CRO Federation (EUCROF) initiative to draft a GDPR Code of Conduct for the CRO industry.

Clinical Informatics

Stacy Weil, DHI

Senior Vice President, Business Operations and Patient Centricity

Stacy Weil translates Premier Research’s strategy into actionable data initiatives that enable internal and external customers to achieve the highest level of performance and success. Prior to joining Premier Research, Ms. Weil was Vice President of Clinical Data Operations at PatientiP and held prior roles in leadership in the process improvement, data analytics, learning services, and project management groups at a large, global CRO.

Ms. Weil’s operations experience spans multiple therapeutic areas and her trial oversight includes global and domestic trials and teams in the U.S., Canada, Latin America, Asia-Pacific, and the European Union. She holds a master’s degree in biomedical informatics from the University of Texas-Health and is currently working toward a doctoral degree in health informatics through the University of Texas-Health. Ms. Weil is a member of the Health Information and Management Society and her credentials include CPHIMS, Prosci Change Management and Lean Six Sigma certifications.

Rare Disease & Pediatrics

Leslie Wetherell

Executive Director, Program Strategy

Leslie Wetherell, Executive Director, Program Strategy, Rare Disease and Pediatrics, is a clinical research professional with over 25 years of global drug development experience, with a focus in rare disease. In her role, Wetherell’s therapeutic and operational expertise supports biotech and pharmaceutical companies to achieve key results in rare disease and pediatric studies. Her focus is producing strategic efficiencies that support patient-centric and timely program delivery.

Wetherell has a depth of experience overseeing operational strategy, delivery, and efficiency in phase 1-3 trials in rare disease, oncology, hematology, and general medicine. Her past roles include data management, project management, procurement, and global strategy development positions. She holds a bachelor’s degree from San Diego State University.

Premier Consulting

Willette Jones Whitmore, CCRP

Senior Director, Quality Assurance and Compliance

Willette Jones Whitmore is a Certified Clinical Research Professional with over 20 years of diverse biotech industry experience in various phases of global clinical trials management and quality assurance (QA) for regulated medical devices, pharmaceuticals, and biologics. She has spent more than 12 years with CROs, focusing on compliance with global health authority regulations and ICH GCP guidelines. She is a transformational and innovative Leader with proven successes in developing global quality and clinical/operational teams, strategies, and other specialized services within QA. She has also authored various controlled documents, user manuals, course platforms, and training curricula.