Management Team

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.

Sandi Bihary-Waltz is a senior level executive and subject matter expert with extensive knowledge of the rare disease and hematology/oncology landscape. She has more than 30 years of experience coaching pharma, biotech, and CROs in effective global regulatory strategy development and implementation. She has also worked with BARDA as a subject matter expert for regulatory affairs and quality affairs.

She is a candidate for her Doctorate in Business Administration from Wilmington University (2023) and has a Master of Science in Nursing from Widener University. She earned her Bachelor of Science in Nursing from Carlow University. In 2018, she was the recipient of the Carlow Laureate award, in recognition of outstanding professional achievement and academics as well as acts of community service. In 2019, Sandi was recognized as one of the Outstanding Women in Business in Delaware, for her contribution to the pharmaceutical industry and community involvement.

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.

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.

Charlie Chrisawn has spent his entire career focused on diagnostic development and has amassed extensive 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 several studies enrolling approximately 25,000 subjects worldwide.

Under his strategic direction, programs have successfully garnered PMA and LDT approvals. Mr. Chrisawn has also enabled 510(k) 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.

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.

With more than 23 years in the industry, Dr. Doshi is an experienced professional with demonstrated leadership skills in clinical operations, global project/program management, customer management and strategy development. Her experience spans the clinical development spectrum from pre-IND to NDA and she has also led global teams in the execution of full service complex clinical trials across all phases.

Dr. Doshi brings drug discovery and clinical development experience with biologics, small molecules as well as cell and gene therapy products over a range of indications. Her doctoral research focus was on breast cancer, her post-doctoral research was in site directed mutagenesis and she holds patents in the area of angiogenesis. Dr. Doshi has also supported three products resulting in agency approval.

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.

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.

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.

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).

Brandi Howard, Ph.D., Executive Director, Program Strategy, Women’s Health, has deep expertise leading clinical development and medical affairs strategy in women’s health. With more than 20 years of industry experience, she recognizes the challenges of this underserved area of research and assesses new technologies and regulatory pathways as well as commercial viability in order to design and implement smarter, safer, meaningful clinical trials that enable innovation to reach women and families efficiently and effectively.

Dr. Howard is responsible for leading the successful completion of numerous women’s health development programs as well as market launch of women’s health assets, particularly in reproductive medicine and sexual health. Her past roles include the development and leadership of large, global teams within pharma and biotech organizations. Dr. Howard has also been actively involved in investor relations and business development.

Dr. Howard received her Ph.D. from the University of Pennsylvania where her research focused on adolescent sexual behaviors and contraceptive use. She earned a Master of Science, Women’s Health and Perinatology, from Georgia State University and her Bachelor of Science, Nursing, from the Medical College of Georgia.

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).

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.

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.

Robb Lawrence spent 10 years as a health care entrepreneur before becoming part of Premier Consulting, building companies designed to bring new and innovative pharmaceutical products to the US market. He founded and served as CEO of two virtual specialty pharmaceutical companies, TLC Therapeutics and Tropical Disease Therapeutics (TDT), both of which were created to execute on co-development partnerships with larger global pharma companies.

Prior to founding TLC and TDT, Mr. Lawrence launched and managed the day-to-day operations of Salient Consulting, a boutique strategy consulting practice focused on strategic product development and go-to-market strategies for novel medicines. Prior to his entrepreneurial endeavors, Mr. Lawrence held numerous positions at Merck and Company and played a key role on the marketing team responsible for launching Merck’s Diabetes Franchise (Januvia® and Janumet®).

Mr. Lawrence holds a Master of Business Administration with a focus in Health Sector Management from Duke University’s Fuqua School of Business and a Bachelor of Arts in Literature and History from Wake Forest University.

Dr. Lukes is a board certified OBGYN and the Vice President of Women’s Health and Diagnostics. She has served as a principal investigator in more than 130 clinical trials, and is an expert on protocol development for clinical trials in women’s health.

Dr. Lukes received her masters in biostatistics, as well as her MD and MHSc from Duke University, and completed residency at UNC Chapel Hill. After her training she returned to Duke University Medical Center for 10 years where she served as Director of Gynecology for the Women’s Hemostasis and Thrombosis Clinic. After leaving Duke University, she developed a private practice and research center located in Durham, North Carolina.

Dr. Lukes is a recognized expert on abnormal uterine bleeding, uterine fibroids, endometriosis, contraception and more. She has extensive publications including within the New England Journal of Medicine and Obstetrics and Gynecology.

Jessica Merryfield has been involved in global clinical research for more than 20 years, specializing in rare diseases for the last 10 years. As executive director, 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.

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.

Scott Millard has spent his 25-plus year career focused in analgesia study delivery overseeing the strategy through to execution for analgesia programs. Mr. Millard’s leadership of the analgesia business and study execution expertise is the perfect pairing to provide sponsors with clean data that can be used confidently to support the marketing applications for their drugs in development.

Since joining Premier Research, Mr. Millard has served in a variety of roles with increasing scope and responsibility, including Senior Clinical Research Associate, Team Lead, Senior Manager, Project Manager, Senior Project Manager, Project Director, Senior Director, Executive Director, and Vice President. Mr. Millard served at a director level managing project managers and sponsor programs, specializing in analgesia and rheumatology.

Mr. Millard has a bachelor’s degree from the University of Texas and was certified as a Certified Clinical Research Associate in 1995 by the ACRP.

Michael Mueller brings more than 17 years of industry experience in various areas of clinical research within both CROs and sponsor companies. His experience spans a variety of Phase 1 to 4 clinical trials and indications with extensive involvement in oncology, specifically immunotherapy studies. His therapeutic areas of expertise include: breast cancer, first line DLBCL, multiple myeloma, melanoma, muscle invasive bladder cancer, non-small cell lung cancer, acute myeloid leukemia.

With his experience in global project management from study planning and start-up through close-out and regulatory license applications, Mr. Mueller has developed an acute ability to analyze study processes and devise integration and collaboration strategies.

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).

Relying on more than 20 years of success, Mr. Nowland helps sponsors to optimize regulatory strategy as they seek to bring new diagnostics to market. He has helped companies from venture capital backed start-ups to large global entities, to develop and advance innovative technologies, including molecular diagnostics, medical devices, surgical robotics, and blood products.

Mr. Nowland has firsthand experience working within biotech, device, and diagnostics companies to develop and oversee pre- and post-approval activities in areas including, but not limited to, oncology, neurology, cardiology, inflammation, and infectious disease. Under Mr. Nowland’s leadership, Premier supports diagnostics developers with strategic planning, regulatory strategy, process improvement, risk mitigation and quality assurance, clinical monitoring, and regulatory submissions.

Dr. Pandit is a board-certified Hemato-Oncologist with 20 years of oncology experience in world  leading companies, including AbbVie, Johnson & Johnson, and MD Anderson Hospital. She also led and supported global hematology/oncology clinical trial strategy and managed high-profile clinical programs within the oncology space. She earned her M.D. from King Edward Medical University, Pakistan, and her residency and fellowship from King’s College London, U.K. Dr. Pandit also holds an M.S. in Molecular Oncology and an MBA in Healthcare Management from the National University of Singapore.

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 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.

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 eight 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.

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.

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.

As Executive Director, Clinical 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 sand 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.

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.

Ms. VanWye is an executive with more than 19 years of dermatology experience providing strategic support for all dermatology programs through key stakeholder engagement and cross functional management. She works closely with teams ensuring operational excellence within the dermatology franchise. Ms. VanWye has worked in several positions during her 30-year tenure within the clinical trial environment such as dermatology strategist, senior director of dermatology project management/operations, quality assurance director, independent consultant, project manager, clinical research associate and safety officer.

Ms. VanWye has oversight and strategic experience with more than 20 dermatology indications including some rare dermatology conditions and aesthetic trials conducted in over 30 countries across the globe. Her educational background along with her extensive history in dermatology provides her the experience to support her operational oversight position in an efficient and competent manner. She has been an author on several dermatology articles and has contributed to various presentations.

Ms. VanWye holds a Master of Science in Nursing from Wilmington University.

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.

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.

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.

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.

Daniel Zamfir, Executive Director, Program Strategy, Cell and Gene Therapy, draws on his nearly 25 years of preclinical and clinical research experience to develop operational strategies for clients in the Cell and Gene space and rare diseases. He has directly managed more than two dozen phase I-IV global trials across a variety of therapeutic areas including oncology, neuroscience, and dermatology, and acquired a passion for advanced therapeutics and precision medicine.

Prior to joining Premier Research, Daniel was Executive Lead of Operational Strategy Management for a large CRO overseeing the strategic planning of trials in oncology/hematology with a specific focus on Cell and Gene Therapies.

Daniel holds an MBA in International Business Management and a BSc in Health Sciences.