5102 Overbrook Avenue Philadelphia, PA 19131 (215) 879-1983 – Direct (610) 520-2266 – Office (610) 581-7025 – Fax
Current Status: Pharmaceutical Regulatory Affairs Consultant
B.S. in Pharmacy, Temple University – 1962
Ph.D. in Pharmacology, Howard University – 1969
Pharmacy Licensure: Pennsylvania – 1962
Professional Highlights: My 30-year experience in the Worldwide Pharmaceutical industry includes Pharmaceutical Development, Clinical Development, Government Affairs, Non-Prescription Drug Regulatory Affairs, Prescription Drug Regulatory Affairs, Regulatory Affairs Operations, CMC Regulatory Affairs, and FDA Washington Liaison. Since 1996, I have practiced as an independent consultant to the Pharmaceutical Industry in Drug Regulatory Affairs, specializing in developing strategic regulatory approaches to new product approvals, and product protection for existing brands. During this period I have developed and implemented regulatory strategy and advised clients on regulatory approaches to new product approvals and product protection and market expansion strategies. I also have prepared numerous regulatory submissions including INDs, SNDAs, BLAs, Orphan Drug and Fast Track Petitions. Among my client during this period are: Bertek, MGI Pharma, Nestle, DSI, TEVA Pharmaceuticals USA, PhotoCure Pharmacia Upjohn, Biopure, Andaris Ltd. During my career in Regulatory Affairs at Smith Kline & French/SmithKline Beecham, I was the Regulatory Affairs point person responsible for twelve NDA approvals including six NDAs for OTC products four of which were Rx to OTC switch of NDAs. The most recent of these NDAs were for the anti-emetic ‘Kytril’ products and ‘Tagamet HB’. I conceived and executed the regulatory strategy for the Tagamet HB project that was later adopted by the industry for the Rx to OTC switch of the entire H2 antagonist class. I also conceived and implemented the regulatory strategy for SB generic versions of Dyazide and Tagamet. I was also responsible for chemistry and manufacturing control supplemental NDAs for the transfer of manufacture of 19 products and dose forms from Philadelphia to Puerto Rico. As Group Director, for FDA Liaison, I was responsible for the day-to-day interaction with the FDA offices from SB’s office in Rockville, Maryland. I set up and directed the SB FDA Liaison Office. Also, during this time, I interacted with all levels of FDA management including the Commissioner, Associate Commissioner, CDER Director, Office of Drug Evaluation Directors, and Directors of each Reviewing Division. I also have extensive liaison experience with DEA, US State Department, WHO, NDMA, and PhRMA. Several years ago, following some product tampering incidents, the consumer drug product ‘Contac’ was withdrawn from the marketplace. As Director of Regulatory Affairs for SKF Consumer Products, I had primary regulatory responsibility for the successful reintroduction of the product. Professional Chronology:
1996 to Present:
Pharmaceutical Industry Consultant specializing in Drug Regulatory Affairs. My practice involves keeping abreast of the rapidly changing FDA and worldwide drug regulatory environment, and advising clients on strategic issues. My services have included: Strategic Regulatory Planning, Project planning for IND, NDA, and SNDA submissions, Preparation of all categories of FDA submissions, preparation of Rx to OTC switch strategies, FDA Advisory Committee and other Meetings preparation.
Group Director, FDA Liaison US Regulatory Affairs, SmithKline Beecham. The major purpose of the FDA Liaison function was to represent SB in the Washington DC area and enhance the effectiveness of the regulatory department by establishing and maintaining an office in the area in order to promote effective working relationships with FDA personnel and representatives of other companies, industry associations, and professional associations. The function served to utilize that perspective to monitor the development of FDA regulatory policy initiatives, as well as other issues affecting the pharmaceutical industry in general, and SB in particular. Insights into the FDA regulatory process and personnel were used to advise the VP and other Group Directors of USRA in developing and implementing strategies and tactics aimed at facilitating and influencing negotiations and interactions with FDA personnel in order to assure favorable and expeditious review of SB submissions, proposals, and facilities.
Group Director, US Regulatory Affairs (Gastrointestinal Drugs). Primary responsibilities involved overall administration of all Regulatory Affairs activities for GI products including: Advising senior management on US Regulatory matters with potential to affect the business, directing and supervising staff on regulatory strategies for drug development, INDs/NDAs and associated FDA submissions, promotional copy review, and regulatory assessments of licensing and acquisition candidates. During this time, the GI group submitted six NDAs that were approved. I also directed act ivities resulting in approval of supplemental NDAs for the transfer of manufacture of 19 products and dose forms from Philadelphia to Puerto Rico.
Director, US Regulatory Affairs, SmithKline & French Labs. The principal function of the Director’s position is to manage the Regulatory Affairs function in a therapeutic area under the general supervision of a Group Director. During this time, I had responsibility for CNS, Cardiopulmonary, Anti-Rheumatic, and Metabolic/Endocrine products.
Director, Regulatory Affairs, and SmithKline Consumer Products. The position reported to the VP of R&D and it’s major purpose was the overall administration of the Consumer Products’ Regulatory Affairs Department; including personnel management (personnel hiring, performance appraisals, promotions), budget administration, and generating and executing regulatory strategy (including approaches to FDA approval of NDAs, comments on OTC monographs, content and format of FDA submissions).
During this time, I was responsible for the submission and approval of NDAs for four OTC products, the successful and timely reintroduction of the flagship product ‘Contac’, and defeat of a WHO proposal to regulate the nasal decongestant propylhexedrine as an addicting drug (this involved testifying before US State Department and WHO committees). I also developed the H2 antagonist OTC switch strategy during this period.
Associate Director, Regulatory Affairs, SmithKline Consumer Products.
Manager, Regulatory Affairs, SmithKline Consumer Products.
Assistant Director, Biomedical Operations, SmithKline & French Labs.
Senior Investigator, Development, Scientific Support, SmithKline & French Labs.
Senior Scientist, Development Support, Science Information, SmithKline & French Labs.
Pharmacist, People’s Drug Store, Washington DC.
Junior Investigator, Wyeth Laboratories.
American Association for the Advancement of Science American Pharmaceutical Association APHA Academy of Pharmaceutical Sciences Delaware Valley Regulatory Affairs Forum (past President)
Food and Drug Law Institute Conference on The FDA Export Reform and Enhancement Act of 1996,
June 27, 1996, Panelist on Export Certificates. Drug Information Association 31st Annual Meeting, June
28, 1995, Rx to OTC Switches, Industry Experiences.
Ragland, R: Phenylpropanolamine & Psychiatric Disturbances. American Pharmacy, Vol. NS23, No. 2,
Beg, M.A., Ragland, R.: Safety of Tienilic Acid. Postgraduate Medical J, 1979, 55 (Suppl. 3), 127-131.
Beg, M.A., Ragland, R., Zuccarello, W.A., Ziv, D.S., & Donikian, M.A.: A review of renal function
during ticrynafen therapy. Proceedings of the Symposium on a New Class of Renally-Active Compounds with Anti-Hypertensive, Diuretic, and Uricosuric Properties, Montreal, Canada, June 17-18, 1978.
Ragland, R., Booker, W.M., & Tillman, R.L. Electron microscopic auto radiographic studies of the effect
of metaraminol on the uptake of triturated norepinephrine. Fed Proc 28:673, #2313, 1969.
Bhagat, B. & Ragland, R. Effect of infusion of metaraminol on the response of reserpine pretreated spinal
cats to Tyramine and to nor adrenaline. Brit J Pharmacol 27:507-13, 1966.
Ragland, R., Bhagat, B., & West, F.R. Restoration of the binding sites of norepinephrine to normal
function in reserpine pretreated heart. Fed Proc 25:260, #405, 1966.
Ragland, R., Bhagat, B., & West, F.R. Super sensitivity to various false neurotransmitters induced by
continuous nerve stimulation. Pharmacologist 8(2): 198, #145, 1966.
Ragland, R., Gilliam, J. Jr., & Bhagat, B. The development of and escape from tachphylaxis to Tyramine
and the influence of bretylium and BW.392C60. Pharmacologist 7(2): 186, 1965.
Bhagat, B., Bovell, G., & Ragland, R. Restoration of the response to Tyramine by metaraminol in
reserpinized cats. Brit J Pharmacol 26:358-62, 1962.
Wednesday, July 31 – Saturday, August 3, 2013: YMCA of the Rockies This convention participant has/or is subject to: (Please check appropriate box(es)and briefly describe the condition, severity, and treatment of each. Attach separate sheet if necessary.) ___ Youth Convention Staff Member ___ Pastor Please Print ________________________________________________ Name__________________
6. See the discussion in S. Brownlee, “Doctors without Borders,”13. D. Healy, letter to Peter J. Pitts, Associate Commissioner for Ex- Washington Monthly, April 2004. ternal Relations at the Food and Drug Administration, February 19,7. See J.M. Drazen and G.D. Curfman, “Financial Associations ofAuthors,” NEJM 346 (2002): 1901-1902. 14. “Depressing Research,” Lancet 363 (2004