A Proven Dual-Focus Specialty CRO for Women’s Health and Diagnostics
Health Decisions is a full-service CRO specializing in clinical studies of therapeutics for women’s health indications and studies of diagnostics for all therapeutic areas. Health Decisions has focused on women’s health since its inception more than 29 years ago, conducting more than 140 trials in women-only indications such as contraception and postmenopausal vasomotor symptoms. More than a decade ago, Health Decisions expanded into diagnostics studies with a large PMA study of a screening test for high-risk HPV types – the precursors of cervical cancer. Building on the success of the HPV study, Health Decisions has conducted successful diagnostics studies in a variety of other indications in women’s health and beyond, including diagnostics for risk of preterm birth, STIs, a variety of respiratory indications and oncology indications such as colorectal cancer and urothelial carcinoma. Health Decisions has provided services enabling many developers of both women’s health products and diagnostics to meet their development and business goals and looks forward to successful collaborations with many more. We take pride in offering the flexibility to tailor services to each sponsor in a manner that builds on the strengths of both development partners.
The CRO of Choice for Products that Address Any Aspect of Women’s Health
Health Decisions is committed to building the world’s leading CRO in women’s health. The commitment to leadership in clinical development of women’s health products includes products for traditional OB/GYN indications like menstrual disorders, contraception, sexual health and menopausal symptoms as well as gynecologic oncology indications and breast cancer. However, this commitment also encompasses all health conditions that affect women profoundly or disproportionately in fundamental health or quality of life. This extends to autoimmune disorders like multiple sclerosis and rheumatoid arthritis and other high-female-prevalence health conditions like migraine and depression. Health Decisions is determined to accelerate clinical development of therapeutics and diagnostics to improve healthcare outcomes for women in all these types of indications. We summarize this broad commitment in a single sentence: If it matters to women’s health, it matters to Health Decisions.
Outstanding Capabilities for Diagnostics Development in All Therapeutic Areas
Health Decisions provides efficient, high-quality clinical development services for diagnostics across the therapeutic spectrum. Diagnostics have long played a critical role in healthcare and clinical development. However, the explosion in the identification of biomarkers and development of molecular diagnostics has made the role of diagnostics more critical than ever. Health Decisions has provided successful development services for a variety of types of diagnostics in indications including but not limited to colorectal cancer, urothelial carcinoma, respiratory indications, sexually transmitted infections and tests for amniotic infection and risk of preterm birth. Health Decisions is committed to supporting diagnostics developers as they lead the transition to precision medicine, support biopharma development, enable better-informed treatment decisions and improve healthcare outcomes for people around the world. That is why we say: If diagnostics matter to you, you matter to Health Decisions.
Company History
Since 1989, Health Decisions has conducted more than 300 clinical trials, including more than 140 studies in women’s health indications and more than 20 studies of diagnostics. Health Decisions has a dual focus on clinical development in women’s health and diagnostics. The company’s initial focus on women’s health led to an extension into diagnostics more than a decade ago with a PMA study of a diagnostic for high-risk HPV. Regulatory approval and clinical adoption of the HPV diagnostic markedly improved screening for cervical cancer, enabling early detection that likely reduced the number of women whose HPV infections evolved into precancerous lesions and cervical cancers. Other Health Decisions successes include clinical development of a wide variety of contraceptives, including drugs, devices and drug/device combinations. Approval of these contraceptives has provided women with a greater selection of acceptable alternatives for managing their reproductive health. Successful development of women’s health diagnostics and novel contraceptives are but two examples of Health Decisions fulfilling its mission to improve health outcomes for women worldwide. Other Health Decisions studies have advanced clinical development of therapeutics and diagnostics in areas as diverse as vasomotor symptoms, pain management following childbirth, STIs, bacterial vaginosis, assessing risk of preterm birth and multiple sclerosis.
Testimonials
Instrumental in FDA Approval
It is so exciting to report that yesterday afternoon we received FDA APPROVAL for the combination program!!! You were instrumental in helping make the amendments to the protocol that the FDA requested within a day’s notice. Kudos!!!! Your team at Health Decisions has been wonderful and so responsive throughout this whole process. I cannot thank you enough!
Operational Excellence & Quality
I liked the day-to-day interaction with the excellent project manager and all the team members, the quality of the CRAs and their visit reports and time from LPLV to DB Lock given the complexity of the study and the excellent quality of the final database.
Communication & Clarity
The level of interaction and communication and the clarity of discussion about who should do what and when were excellent. So were the business-oriented discussions that benefited both us and Health Decisions.
The Value of Timely Information
When something happened in the field, it was on my desktop in minutes or hours. We would literally react within 24 hours of receiving certain information and make changes either to things we did at specific sites or updates to the protocol. Partnering with Health Decisions enabled us to change and change quickly.
Effective Virtual Team
I appreciated the good team spirit and integration with our staff to make an effective virtual team.
Fast, Accurate Answers
The centralized point of contact had fast, accurate answers – I didn’t have to get transferred among many staff members to get answers or get action on something. She always returned calls and responded to emails quickly and with the information I was looking for.
Culture of Immediate Correction, Commitment to Quality
We love your culture of immediate correction where possible. This speaks to a commitment to quality of a type we rarely see. We are also impressed with Health Decisions’ responsiveness. You are doing what you say you’re doing. We have audited a lot of CROs and put Health Decisions in the top tier of all CROs we have audited.
Able to Get Products to Market and Recognize Less Promising Products Early
Health Decisions has multiple examples of being able to get useful products to market and recognize less promising products early on, reducing the financial risk of development.
Leadership
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.
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 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.
X
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, pain management during endometrial biopsy, and migraine.
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), a leading private gynecologic practice and 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.
X
With expertise in process optimization and innovative trial design, Dr. Gunn has led development programs through various steps in the R&D lifecycle, from preclinical development to post-approval marketing. She has served as a senior strategist for large and small pharmaceutical and biotechnology companies supporting large, global healthcare programs in women’s health, autoimmune disorders, and oncology. In addition, Dr. Gunn has significant experience in diagnostic development, with a focus on “point-of-care” strategies.
Her main concern in any program is maximizing efficiency to capture accurate data in a cost-effective and timely manner. To ensure program success, Dr. Gunn prioritizes high-functioning partnerships between sites, CRO, and Sponsor. Having been a participant in two clinical trials, Dr. Gunn has a firsthand understanding of the importance of patient-centricity.
Dr. Gunn has held several leadership roles in operational strategy and delivery, medical affairs, and business development. Before joining Health Decisions, she served as VP, General Management and Business Development, Head of Asia at ICON, where she oversaw Vision, Sales, Strategic Planning, Operations, Marketing, and Mergers & Acquisitions/Integration. Dr. Gunn previously held senior positions at Becton Dickinson, ClinTec International, Crucell (now Johnson & Johnson), and Pfizer.
Dr. Gunn has bachelor’s degrees in Economics and Psychology, an MBA from Brown University, a Law degree from the University of Edinburgh, and a Ph.D. in Psychology from Grand Canyon University.
X
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). 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.
X
Prior to joining Health Decisions in January of 2016, Garney 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. Garney 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.
X
Bickford’s therapeutic experience includes not only studies of novel drugs, but also studies of medical devices and Over-the-Counter (OTC) drug reformulations. 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, Bickford has continuously built upon a diverse project management and operations management skillset, 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. Bickford is skilled at analyzing operational and performance metrics to guide Sponsor and provider team members toward the best path for successful study conduct.
Bickford has a BS in Biological Sciences from the University of Vermont and certification from Northeastern University as an Emergency Medical Technician.
X
Dart frequently serves as lead study statistician and, in that capacity, has attended FDA meetings, provided input into Investigational New Drug filings, and lead the execution and review of analyses used in regulatory submissions. Dart has developed statistically sound methodologies that reduce monitoring costs while maintaining high data quality, including processes for both risk-based monitoring and reduced source data verification. Dart’s deep experience in Case Report Form (CRF) and database design includes an understanding of how these activities affect data quality and regulatory submission. In addition, Dart has managed Data Safety and Management Board committees, leading efforts to provide data necessary for the assessment of subject safety.
Before joining Health Decisions, Dart analyzed clinical trials at one of the nation’s largest healthcare companies. He holds a Master’s Degree in statistics from the University of Georgia.
X
In addition to her role at Health Decisions, Taylor-Scott is an Adjunct Professor of Advanced Data Management at Campbell University in the Master of Clinical Research program and serves as a Data Management course development consultant for clinical research programs at various other local universities.
Taylor-Scott is a two-time graduate of the University of North Carolina at Chapel Hill, with a BA in English and a Master of Business Administration. She holds a MS in Organizational Development from Pfeiffer University.
X
Board of Directors
Mr. Holzworth currently fulfills the role of Executive Chairman for Bivarus, Inc. a patient centered analytics company co-founded by a UNC and Duke physician. He is Executive in Residence at the University of North Carolina (UNC) Gillings School of Global Public Health, as well as Chairman of the School’s Advisory Council, and an Adjunct Professor of Health Policy and Management. In 2011, he co-founded and now serves on the board of Veritas Collaborative, a specialty behavioral hospital system serving adolescents and adults with severe eating disorders. In addition, Mr. Holzworth serves as an entrepreneur in residence for the Blackstone Entrepreneurs Network, as an advisory board member for the Frank Hawkins Kenan Institute for Private Enterprise, and as an advisor to Southern Capitol Ventures and Bull City Venture Partners.
Since 2006, Mr. Holzworth has served as a member of the Board of the Accordia Global Health Foundation, which is creating a network of Centers of Excellence to drive health innovation in Sub-Saharan Africa. He is also the founder of Giving Positively, a non-profit organization providing vocational scholarships to HIV-positive young adults in Kampala, Uganda.
In 2003 and again in 2007, Mr. Holzworth was recognized by the North Carolina Council for Entrepreneurial Development with its Entrepreneurial Excellence Award. In 2005, Ernst & Young named him as a Carolinas Entrepreneur of the Year®. He subsequently served as both a regional and national judge for this prestigious program. Mr. Holzworth’s public health experience led to a 2008 appointment to the Presidential Advisory Council on HIV/AIDS.
Mr. Holzworth holds a BS and MS in Computer Science and Environmental Science from Miami University in Oxford, Ohio. He also completed advanced graduate studies in statistics at North Carolina State University in Raleigh, North Carolina.
X
Paula Brown Stafford is a biopharmaceutical services executive and leadership consultant with more than 30 years of industry experience. She is currently the President and Chief Operating Officer for Novan, Inc., as well as a Managing Director for Habergeon LLC.
Ms. Stafford retired in 2015 from her position as President of Clinical Development at Quintiles (now part of iQvia). Ms. Stafford’s global responsibilities encompassed Phase I-IV clinical research services and she served as a member of Quintiles Executive Committee. She was an Independent Director for BioImaging, later BioClinica (NASDAQ: BIOC), from 2002 to 2008. In addition, Ms. Stafford served as a member of the CDISC (Clinical Data Interchange Standards Consortium) Board of Directors for 9 years, serving as Chair for 2 years and as a member of the Executive Committee for 6 years.
Ms. Stafford is an Adjunct Professor in Public Health Leadership for the UNC-CH Gillings School of Global Public Health and emeritus member of the UNC-CH Public Health Foundation Board. In 2011, Ms. Stafford received the Triangle Business Journal’s Women in Business Award. FierceBiotech named Ms. Stafford one of the 10 top women in biotech in 2012.
Ms. Stafford holds a Bachelor of Science and a Master of Public Health in Biostatistics from the University of North Carolina at Chapel Hill. In 2016, the university honored Ms. Stafford with its Distinguished Alumna Award.
X
For more than 30 years, Dr. DeCherney has led quality improvement initiatives based on statistical process control in both healthcare delivery and research processes. He often provides strategic advice to Health Decisions’ clients and private equity firms, drawing on extensive experience in medical research at multiple levels.
Dr. DeCherney has managed clinical research staff in 53 countries; provided executive oversight on numerous clinical studies in a wide range of indications; served as Principal Investigator for over 100 clinical trials during 11 years in the Christiana Care Health System in Wilmington, Delaware; and served for five years as a Guest Researcher at the National Institute of Diabetes, and Digestive and Kidney Diseases, National Institutes of Health (NIH). He was formerly a senior executive at Quintiles Global Transnational and PRA International.
Dr. DeCherney’s current activities in clinical research include: reviewing protocols, study designs and operational plans for clinical trials conducted by Health Decisions; reviewing clinical research protocols and study design as a member of the University of North Carolina, Chapel Hill, Institutional Review Board; serving as Trustee, William Harvey Research Institute, of Queen Mary Medical College, London, St Barts and The London Hospitals, London, England; serving as Chair, University of Delaware Research Foundation; serving as Trustee, Christiana Care Health System, Delaware.
Board-certified in internal medicine and endocrinology/diabetes, Dr. DeCherney is Clinical Professor of Medicine, University of North Carolina at Chapel Hill. He is also Professor (Adjunct) in the Kenan-Flagler School of Business at the University of North Carolina, where he teaches a course in pharmaceutical economics. Earlier in his career, Dr. DeCherney served as an associate professor at both the University of Delaware and Thomas Jefferson University.
Dr. DeCherney received his medical degree from Temple University in Philadelphia and an MPH, Healthcare Management, from Columbia University School of Public Health. He completed his residency at the Graduate Hospital of the University of Pennsylvania and performed his endocrinology training at Vanderbilt University. Dr. DeCherney is a graduate of Columbia College, Columbia University in New York City, from which he received a BA in Molecular Biology. Dr. DeCherney has served as director of a variety of organizations and corporations in the United States and the United Kingdom, including the Museum of Life and Science in Durham, North Carolina.
X
Mr. Eisenach served as CEO of pharmaceutical services company Acurian Inc. from October 2001 until May 2005. His experience also includes holding a variety of senior executive positions at Covance Inc., where he led worldwide business strategy, mergers and acquisitions, business partnerships and global marketing efforts and served on Covance’s Global Leadership Council. In 1999, Mr. Eisenach founded Nexigent Inc., an e-business subsidiary of Covance Inc. for the development of technology-enabled clinical trial services, and served as its Chief Operating Officer.
Earlier in his career, Mr. Eisenach spent eight years at The Boston Consulting Group, serving as Executive Officer and advising many pharmaceutical companies. His experience also includes serving as a tax economist at Price Waterhouse. Mr. Eisenach currently serves as Director of Molecular Imaging, Inc. In addition to serving in executive and consulting positions, Mr. Eisenach holds Series 82 and Series 63 security licenses with Walter Greenblatt & Associates, Ridgeview Partners’ investment banking partner.
Mr. Eisenach received his AB from Harvard College.
X
X
Success Stories
For an oncology biologic program, we worked with the client to combine PoC and dosing studies into a single study based on ability to continuously track outcomes. One of the other key features was continuously projecting where the study would end up, based on data to date. The design provided for stopping the study when an adequate signal was defined. This contrasts with the rigid fixed-sample traditional approach that may leave the sponsor with too much or too little data. Less than halfway through the planned timelines, the predictive probability of success exceeded 94% with reasonably tight credible intervals.
Health Decisions functions as a full-service virtual development organization for an innovative women’s health company, formulating program strategy and designing and executing studies of products in a variety of indications. The program is progressing rapidly toward NDAs.
Health Decisions terminated a clinical study of a pain therapeutic in osteoarthritis early for futility, enabling the sponsor to identify a responsive subpopulation and refocus resources, demonstrating an approach to increasing efficiency in a CNS clinical trial.
Health Decisions completed a metastatic breast cancer study a full year ahead of schedule and saved the sponsor approximately $2 million in direct costs through agile enrollment and a tiered global enrollment strategy, demonstrating the ability to achieve rapid enrollment and reduced cost in oncology clinical trials.
