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.

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.

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.

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.

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).

Marshika Keith-Vickers is an experienced clinical operations leader and brings more than 15 years of experience spanning Phase 1-4, registry, and late phase clinical trials for multiple therapeutic indications, specializing in Women’s Health, Oncology and CNS. Keith-Vickers’ extensive experience includes providing leadership and management of global teams for large and mid-size CROs.

In her current role, Keith-Vickers is committed to providing strategic and operational leadership to ensure high quality performance and delivery.

Keith-Vickers holds a Bachelor of Science in Chemistry from Shaw University and a Master of Science in Biochemistry, with a concentration in Pharmacology and Physiology from North Carolina Central University.

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).

Brant Nicks is a seasoned executive with more than 26 years of clinical research experience. Mr. Nicks applies his strong leadership and communication skills to provide end to end drug development strategies and solutions for clients. He has extensive experience cultivating preferred provider relations in the hematology/oncology space and is adept at matching customer needs with the right solutions. His experience spans the clinical development spectrum from first in man, early development, dose finding, cohort management studies, through to pivotal, Late Phase needs and FSP.

Prior to joining Premier, Brant worked for extended stints at PPD and PRA Health Sciences in a variety of positions supporting project management and delivery. He also has experience working on the sponsor/Biotech side given prior tenure with Millennium Pharmaceuticals.

In his role, Mr. Nicks is responsible for growth and delivery of the hematology/oncology business through creating customer-specific solutions that employ Premier’s technology and nimble organizational structure and mindset. Mr. Nicks has a strong track record of setting global strategy and spearheading high-value solutions across the product development lifecycle all the while with a pragmatic demeanor focused on trial efficiency.

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 conducting specialty studies (including pediatric and rare disease studies) for more than 20 years. She has provided oversight and full management support for rare disease studies at Premier Research for over 16 years, including global programs in ultra-rare indications.

Ms. Robinson has supported FDA Pre-IND meetings, IND submissions and NDA project directorship. At Premier Research, Ms. Robinson was involved with the launch of the first Best Pharmaceuticals for Children Act – Coordinating Center, collaborating with leadership staff at NICHD in this capacity. Ms. Robinson’s experience includes multiple study designs including PK/PD, adaptive design and she has worked with products granted expedited designations by the agencies including FDA fast track, Breakthrough therapy and PRIME designations — including advanced medicines. Specifically in orphan drugs Ms. Robinson has supported six orphan drug products resulting in FDA and EMA approval including two enzyme replacement therapies approved in 2015.

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.

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.

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.