Patrick Phillips, BSc (Hons), D.Phil. –
Chief Executive Officer
Dr. Patrick Phillips, Chief Executive Officer of Health Decisions, is an experienced and respected clinical development executive and industry leader. He is responsible for executive oversight and strategic leadership of Health Decisions. In his role as CEO, Dr. Phillips has redoubled Health Decisions’ focus on women’s health, expanded the organization’s therapeutic focus to encompass a greater range of indications that affect women’s health and a greater range of potential products that address women’s healthcare needs, including drugs, diagnostics and medical devices, throughout the life-cycle. In Dr. Phillips’ vision for Health Decisions, if a healthcare issue matters to women, it matters to Health Decisions. Dr. Phillips agrees with the assertion of the International Council on Women’s Health Issues (ICOWHI): The Health of Women and Girls Determines the Health and Well-Being of Our Modern World. To further his vision for Health Decisions, Dr. Phillips is establishing a Health Decisions Center of Excellence in Women’s Health.
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Before his appointment as CEO, Dr. Phillips served for over two years as Health Decisions’ Vice President of Clinical Affairs. He frequently advises current and potential Health Decisions’ sponsors on program strategy, study design and operational challenges of clinical development projects for drugs, diagnostics and other medical devices.
In a career spanning more than 23 years, Dr. Phillips has defined and managed value-driven, innovative strategic partnership agreements on behalf of sponsors and CROs alike. He has provided executive oversight and led operational delivery on more than 200 regional and global clinical development projects in all major therapeutic areas, across all phases of drug development as well as a variety of medical device and diagnostics studies. His oversight has included development programs and clinical trials resulting in successful NDAs for four drugs and numerous successful PMA approvals and 510(k) clearances for IVDs.
Dr. Phillips frequently speaks at industry events and serves on advisory boards for key industry conferences on clinical development. Dr. Phillips holds a BSc (Hons) in Biochemistry from Liverpool University and a D Phil in Clinical Biochemistry from the University of Oxford in England. Dr. Phillips’ pro bono work has included serving as a board director for the British American Business Council.
Andrea S. Lukes, MD, MHSc, FACOG –
Chief Medical Officer
Andrea S. Lukes is a board-certified OB/GYN, a Fellow of The American Congress of Obstetricians and Gynecologists and an expert on clinical development of women’s health products across a wide range of indications and across the female lifecycle. Her areas of expertise include but are not limited to heavy menstrual bleeding, uterine fibroids, hysteroscopy, minimally invasive gynecology, endometrial ablation, endometriosis, adenomyosis, contraception, menopause and vasomotor symptoms, migraines, bleeding disorders, and hereditary cancer screening. Dr. Lukes advises Health Decisions and our clients on development and implementation of research protocols as well as communications and presentations to the FDA.
An experienced principal investigator in industry-sponsored, NIH and CDC clinical trials, Dr. Lukes has conducted or overseen more than 80 clinical trials of investigational women’s health products, including both drugs and devices, in the last ten years. Recent experience includes studies of sedation during hysteroscopic tissue removal, treatment of anemia associated with uterine leiomyomas, treatment of vulvovaginal atrophy, transcervical ablation of uterine fibroids, combination drug therapy for management of menstrual bleeding associated with uterine fibroids in premenopausal women, a vapor treatment for excessive uterine bleeding, analgesia for endometriosis-associated pain, management of pain during endometrial biopsy, as well as preventive treatments for migraine headaches.
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Dr. Lukes’ articles have appeared in journals including Obstetrics and Gynecology, the American Journal of Obstetrics and Gynecology, Fertility and Sterility, the Journal of Minimally Invasive Gynecology, Women’s Health, Women’s Healthcare, Contemporary OB/GYN, the International Journal of Women’s Health, Cancer, the British Journal of Hematology, the Journal of Medicine, Current Medical Research & Opinion and Drug Safety. She has served on advisory committees for FDA meetings on topics including a clinician’s perspective on thromboembolism, heavy menstrual bleeding and alkaline hematin assessment, and clinical trial design for treatment of vaginal laxity and female sexual dysfunction.
Dr. Lukes founded the Carolina Women’s Research and Wellness Center (CWRWC) and the Women’s Wellness Clinic, a leading private gynecologic practice within the clinical research center. She also co-founded and served as the Director of Gynecology for the Women’s Hemostasis and Thrombosis Clinic at the Duke University Medical Center and founded and chaired the OB/GYN Alliance, an online network of 8,000 OB/GYN physicians in the United States.
Dr. Lukes received a bachelor’s degree and a combined medical degree and master’s degree in statistics from Duke University. She completed her residency at the University of North Carolina School of Medicine.
Emily Friedman, CPA, CGMA -
Emily Friedman, Head of Corporate Finance at Health Decisions, is a seasoned financial professional with over 30 years of experience in both public accounting and private industry. Ms. Friedman provides the Health Decisions’ Board of Directors and Executive team with the information they need to provide executive oversight and strategic leadership to the company and provides operational teams with the information they need to leverage their therapeutic expertise and deliver efficient, high-quality clinical development services. Ms. Friedman has experience in all areas of finance, including accounting, reporting, analysis and management, and has managed finance across a broad range of corporations and industries.
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Ms. Friedman’s experience includes serving as Director of Finance and Administration for a medical device company and as Controller for a technology company from startup through full commercialization and acquisition. Her background also includes serving as a Senior Audit Accountant for PwC (Price Waterhouse). Ms. Friedman received a B.S. in Accounting summa cum laude from California Polytechnic State University. She is a Certified Public Accountant and a Chartered Global Management Accountant.
Kevin Bickford -
Kevin Bickford, Head of Clinical Operations at Health Decisions, is a clinical operations executive with 20 years of clinical development experience spanning many therapeutic indications and virtually every phase of clinical research. Mr. Bickford is committed to supporting a focused, specialized, and dedicated Health Decisions Operations team in the arena of Women’s Health as well as IVD development and precision medicine research. Mr. Bickford’s extensive experience includes providing team leadership and executive oversight for both Sponsor and CRO companies and managing operational teams ranging from large global teams on multi-protocol development programs to small teams executing studies of investigational products for rare disease and orphan indications.
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Mr. Bickford’s therapeutic experience includes not only studies of novel drugs, but also studies of medical devices and Over-the-Counter (OTC) drug reformulations. Mr. Bickford’s extensive experience in global research includes hands-on management of clinical trials in Europe, Africa, and the Middle East. During his 20-year career, Mr. Bickford has continuously built upon a diverse project management and operations management skill set, with the goal of optimizing effectiveness and efficiency for study teams under his direction. His focus on service delivery and effective partnership among study team stakeholders has guided his efforts in Risk, Quality, and Resource Management, including on multiple Governance Committees. Mr. Bickford is skilled at analyzing operational and performance metrics to guide Sponsor and provider team members toward the best path for successful study conduct.
Mr. Bickford has a BS in Biological Sciences from the University of Vermont and certification from Northeastern University as an Emergency Medical Technician.
Erin Garney -
Erin Garney, Head of Human Resources at Health Decisions, is responsible for leading Health Decisions through acquisition, development, retention and enrichment of the organization’s culture and talent brand. As a strategic partner to the business, she is responsible for HR strategy and planning, staffing and retention, talent management, as well as compensation and benefits, leadership development and training. Erin has over twenty years of experience specializing in small to mid-size start-up organizations within the software technology, energy services, risk specialty and CRO sectors.
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Prior to joining Health Decisions in January of 2016, Erin provided HR consulting services to technology and non-profit organizations, served as Vice President of Human Resources and Community Engagement with the Redwoods Group and HR Director for SciQuest, Inc. Erin is a graduate of the University of North Carolina- Asheville with a degree in Business & Marketing Management. She is active in various community organizations and most recently served on the Board of Directors for the Lucy Daniels Center.
Clint Dart, MS -
As Head of Data Services at Health Decisions, Clint Dart is responsible for oversight of Biometrics, Data Management and Medical Writing. Over his 20-year career in clinical research, Clint has had a broad range of experience extending from the planning phase to the reporting phase of clinical trials. He serves as 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 has designed protocols that incorporate interim analyses and sample size re-assessments, as well as designing Case Report Forms that are focused on collecting the critical data for analysis and regulatory approval. His first concern in every clinical trial is ensuring that all trial activities “defend the statistical analysis.”
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Clint has been the lead statistician attending FDA meetings, provided input into Investigational New Drug filings, and has often played a leading role in executing and reviewing analyses used in submissions for regulatory approval. In addition, Clint has provided leadership for the Health Decisions team developing statistically sound methodologies for reducing monitoring costs while maintaining high data quality, including processes for both risk-based monitoring and reduced source data verification. Clint has a wealth of experience in CRF and database design and an understanding of how these activities affect data quality and ultimately regulatory submissions. Clint has also led efforts on multiple rescue studies, which involve taking data from a previous CRO and transferring the data to Health Decisions part way through the study. Clint has managed Data Safety and Management Board committees for a variety of sponsors and led efforts providing data for committees to review in order to make assessments of subject safety. During his years in clinical research, Clint has collaborated closely with other departments at Health Decisions, enabling him to create and support efficient processes across the organization.
Before joining Health Decisions, Clint analyzed clinical trials at one of the nation’s largest healthcare companies. Clint’s experience spans phases 1-3 and a wide variety of therapeutic areas, including Women’s Health, Oncology, Central Nervous System, Anti-Infectives, Anti-Virals, Gastrointestinal, Analgesics, Neurology, Urology, Devices and Diagnostics. Clint holds a Master’s Degree in statistics from the University of Georgia.