Team

Company Founder 

Randy Wheelock

Randy graduated with honors from East Tennessee State University, Johnson City, Tennessee in 1983 receiving Bachelor of Business Administration Degree with an accounting, business, and computer science concentration. He began working in public accounting in 1983 attaining partner status in 1986, then served as a trust and investment officer from 1990-1992, and as VP and CFO for a manufacturing firm from 1993-1999 before launching his first business venture in 2000.

In 2007 he began working with researchers and foundations, full time since 2009, to advance research and treatment availability for choroideremia. In 2011 he founded GeneraBio, Inc., a biotechnology company focused on translational medicine opportunities for choroideremia and other genetic disorders. As part of this work he has collaborated with other researchers and rare disease organizations that support research for diseases having characteristics and challenges in common with choroideremia in order to leverage resources and scientific knowledge. He has participated in over one hundred conferences, meetings and webinars with the US Food and Drug Administration, the Drug Industry Association, EURORDIS / Rare Disease Europe, NORD / National Organization for Rare Disorders, Genetic Alliance and other rare disease groups. Leveraging research, data, treatment strategies, technology, project management, accelerated regulatory pathways and commercialization strategies are areas of particular focus. He also created and maintains a choroideremia research and information resource at CHMINFO.WIKISPACES.COM.

From 2000-2009 he formed partnership operating entities and served as Chief Manager. From 2000-2005 the entities operated mobile extracorporeal shockwave devices providing equipment, personnel, supplies, training, and support services to hospitals and surgery centers for orthopaedic and urologic indications. He also participated in supporting FDA trial cases and establishment of third party reimbursement and coverage policies for a new device. Equity interests were acquired by a private investor in May 2005. In January 2005 he co-founded US Surgical Services, LLC, a mobile services provider of equipment, personnel, supplies, training, and support services to hospitals and surgery centers for cryosurgery for prostate, renal, liver, and other cancers. This entity was acquired by HealthTronics, Inc. in September 2009 and he continued to manage the entity as agreed until December 2010. HealthTronics was acquired by Endo Pharmaceuticals, Inc. in May 2010.

As an entrepreneur he internally developed and operated a patient advocacy and appeal support service to assist patients in obtaining third party reimbursement. He facilitated over 5,000 specialized patient procedures with urological surgeons, interventional radiologists and orthopedic surgeons. This involved formation of operating partnerships with providers, recruiting and facilitating training of over 500 surgeons, contracting with over 200 hospitals and surgery centers, and establishment of reimbursement for new procedures with insurers, government programs and self funded employer groups. In addition to payer contracting, establishment of reimbursement included representing and supporting patients and providers in over 500 appeal processes and hearings with payer appeal panels.

Randy is a member of the Association for Research in Vision and Ophthalmology and the American Institute of Certified Public Accountants. He serves on a volunteer basis as Chief Advisor for Research and Therapy Development for the Choroideremia Research Foundation and is a volunteer member of the National Institutes of Health / National Center for Advancing Translational Sciences Global Rare Disease Registry IRB Panel.

Regulatory Advisors

Joy A. Cavagnaro, PhD, DABT, RAC

Dr. Cavagnaro is the President of Access BIO, Boyce, VA, a consultancy specializing in science-based regulatory strategies and preclinical product development services to facilitate biomedical research and emerging technologies. Specific product areas of expertise include vaccines, cellular and gene therapies, animal-based and plant-based biotherapeutics, biotechnology-derived and tissue engineered products. Dr. Cavagnaro received her Ph.D. in Biochemistry at the UNC Chapel Hill followed by postgraduate work at Duke and Boston University Medical Centers. She has over 25 years experience in biotech spanning academia, the CRO and biotech industries and government.

Prior to establishing Access BIO, Dr. Cavagnaro was Vice President of Regulatory Affairs at Human Genome Sciences, Inc. Dr. Cavagnaro enjoyed a career in government at the FDA Center for Biologics Evaluation and Research before rejoining industry. During her tenure she was appointed to the Senior Biomedical Research Service, served as FDA’s topic lead for safety for the ICH initiative for seven years and rapporteur for the ICH S6 Guidance on Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals. She also chaired the working groups responsible for FDA’s 1996 Comparability Guidance Document and 1995 Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals. Her last official FDA duty was to Chair the Annual FDA Science Forum on Regulatory Sciences, December 1997. Prior to joining FDA Dr. Cavagnaro was principal study director for biotechnology products at Covance (formerly Hazleton Labs).

Dr. Cavagnaro is Past Chair of the Regulatory Affairs Professional Society, National Capital Area Chapter of the Society of Toxicology and Immediate Past Chair and Founder of BioSafe, a focused expert science committee within BIO which identifies key scientific and regulatory issues and developments related to the preclinical safety evaluation of biopharmaceutical products. Dr. Cavagnaro is current North American Chair of DIA’s Biotech SIAC and is co-chair of Chesapeake Research Review’s Independent IRB. She also serves on the Steering Committee for the NIH National Gene Vector Laboratory and is a member of the Clinical and Regulatory Affairs Committee of the American Society of Gene Therapy. Dr. Cavagnaro was the US BIO representative to the ABPI/BIA Early Stage Clinical Trials Taskforce. -¬†Joy Cavagnaro CV

Deborah Lavoie Grayeski, J.D., RAC

From 2007-2010 Deborah was with GE Healthcare. Deborah held the positions of Director, Regulatory Affairs Programs, followed by Global Manager of Regulatory Affairs.

Deborah has over 12 years of experience in regulatory and clinical affairs for the biologics and medical device industry. Her areas of therapeutic expertise include peripheral vascular, cardiovascular, ENT, embolization devices, dental and orthopedic devices, with particular technological expertise in cell, tissue and gene therapy products, implantable devices, minimally invasive surgical systems, and imaging devices. Deborah works effectively with both large corporations and small start-up companies.

As Senior Project Manager, Deborah is involved in all aspects of regulatory & clinical strategies and works directly with FDA in coordination of correspondence, negotiations and meeting preparations. Deborah’s primary activities include regulatory strategy development for Class I, II (IIa & IIb) & III devices and biologics, and preparation of 510(k), PMA, IDE, IND, BLA, and international regulatory submissions, including regulatory submissions for device/biologic and device/drug combination products.

Formerly with G.E. Healthcare, Deborah held the position of Director, Regulatory Affairs Programs, followed by Global Manager, RA. Prior to her work with G.E., she served seven years with FDA, elevating to Supervisory Consumer Safety Officer, (Branch Chief, Regulatory Project Management), at FDA’s Center for Biologics Evaluation and Research, Office of Cellular Tissues and Gene Therapies.

Deborah holds a Juris Doctor and is RAC certified.