Improving Inclusion of Diverse Sub-groups in Clinical Trials: A CRO Perspective

Tuesday, December 9, 2014
3:00 p.m.-4:00 p.m.
FDA-White Oak Bldg. 2 Room 2047
Ann Anonsen
301 405 0285


Rose Blackburne, MD, MBA

Global Head, Medical Delivery Solutions, Quintiles, Rockville MD


Dr. Blackburne currently serves as Global Head of Medical Delivery Solutions, and, concurrently is the Interim North America Head, Oncology at Quintiles. She has held numerous TDU (Medical & Scientific Services) leadership roles of increasing scope, most recently as the Global Medical Head for Immunology/Internal Medicine for US, Canada, Latin America and India, and has served as Medical Advisor on numerous global clinical trials (Ph 1-4) in a range of therapeutic indications including: Reproductive health, menopause management, high-risk obstetrics, urology, androgen insufficiency, GI diseases, dermatology, immune disorders, osteoporosis, high risk obstetrics, ovarian cancer, pelvic surgery, benign hematology and HPV/cervical dysplasia and female genital tract malignancies.
Dr. Blackburne is committed to impacting health inequities and has been instrumental in educating the medical and lay community regarding Diversity in Clinical Research, health care reform and the Affordable Care Act.
Dr. Blackburne is Board Certified in Obstetrics and Gynecology; and was a practicing Obstetrician/Gynecologist for 10 years prior to joining Quintiles, and was an Investigator for clinical trials in Women’s Health. She is passionate about improving health and health care delivery having extensive expertise in Women’s Health and Minority Health Policy. She has proven negotiation and leadership ability and has forged solid relationships within the medical and research community, health advocacy organizations, FDA, CMS, Congress and PhRMA. Dr. Blackburne is an engaging presenter and an effective trainer with excellent written and oral communication skills able to connect with Key Opinion and Thought Leaders in various specialty areas.
Dr. Blackburne received her medical degree at the Morehouse School of Medicine, Atlanta, Georgia and completed an Obstetrics and Gynecology residency at Columbia University in New York. She holds a Master of Business Administration from the Darden Graduate School of Business with a concentration in Strategy and Global Business, studied Health Policy and Health Care Delivery at Harvard University John F. Kennedy School of Government, and completed her undergraduate studies at University of Virginia, in Charlottesville, Virginia on the Dean’s List. Dr. Blackburne also has Congressional Legislative experience as a Legislative Assistant in the US House of Representatives, where she co-developed policy on healthcare, science and technology and women’s issues.
Dr. Rose Blackburne is the Chair of the Physician Executive Section of the National Medical Association, and has served as the Vice Chair of the Physician Executive Section from 2010-2013. Dr. Blackburne has been a member of the NAACP National Health Committee for over 10 years and is a Life Member of the NAACP. During this time she has worked to shape the Association’s health policy agenda in the areas of health care reform, childhood obesity and HIV/AIDs prevention.
Lecture Abstract:
CROs have played an increasingly broader role in drug development in the past 5-10 years.  By partnering with pharmaceutical companies, biotechnology and medical device companies, Quintiles has, for example, successfully contributed to the development of 50 of the most recently approved products in the past 5 years. CROs, Industry, academia, regulatory authorities and clinicians must work together to build awareness of the scientific importance of having diverse sub-groups appropriately reflected in clinical trial populations. CROs offer a unique perspective in the clinical research landscape by working across all therapeutic areas, disease states and also have access to a breadth of sites and investigators across all geographic regions. Additionally, CROs have the internal operational and therapeutic expertise to support pharmaceutical, medical device and biotechnology companies in taking on the challenge to identify and engage potential investigators that routinely treat underrepresented sub-groups.


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