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3633 Central Avenue, Ste. I Hot Springs, AR 71913 Phone: 501 542-4052 Fax: 501 321-2886 E-mail: infoburkepharmac

. . 3633 Central Avenue, Ste. I

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3633 Central Avenue, Ste. I Hot Springs, AR 71913 Phone: 501 542-4052 Fax: 501 321-2886 E-mail: infoburkepharmac

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    2. 3633 Central Avenue, Ste. I • Hot Springs, AR 71913 Phone: (501) 542-4052 • Fax: (501) 321-2886 E-mail: info@burkepharmaceutical.com • Website: www.burkepharmaceutical.com

    4. To develop innovative dermatology products for unmet medical needs: Develop new indications for approved drugs Develop New Delivery Systems Develop improved formulations Rx or OTC (NDA, ANDA, monograph products) Employ 505(b)(2) NDA regulatory strategy

    8. Dowling B. Stough M.D., F.A.A.D., C.C.T.I. Dr. Stough is the founder and practicing dermatologist of The Dermatology Clinic, P.A. and medical director of Burke Pharmaceutical Research.  Founded in 2000, Burke Pharmaceutical has grown from a small clinical trials unit within a dermatology practice to a national leader in clinical trials of skin disease. Currently, it employs an experienced site manager, three clinical coordinators, a full time advanced nurse practitioner and three physician investigators.  Over the last 10 years, Burke Pharmaceutical Research has been involved in over ninety clinical studies.  Dr. Stough has served as the medical director for various pharmaceutical companies conducting clinical trials, and has conducted multiple investigator-initiated studies. Dr. Stough holds patents on a medical device known as the “Wart Eraser.”  He has also been instrumental in developing other medical devices. Dr. Stough is the founder and past president of the International Society of Hair Restoration Surgery. He was the author of two leading textbooks dedicated to hair restoration surgery.  He has written over 50 scientific publications and has contributed numerous textbook chapters. He has presented over 180 medical lectures at scientific meetings and was the recipient of the “Golden Follicle Award” by the International Society of Hair Restoration Surgery. He is a fellow of the American Academy of Dermatology and holds a certified physician investigator designation from the Association of Clinical Research Professionals. His interest in dermatologic drug development is preceded by over 15 years of hands on exposure to clinical trials and protocol development.

    9. Dowling B. Stough M.D., F.A.A.D., C.C.T.I. Dr. Stough has always had an interest in research, after his medicine internship at Baptist Hospital in Memphis, Tennessee; he was involved in research during his dermatology residency at the University of Arkansas Medical School. Following this, Dr. Stough was accepted into a one year fellowship sponsored by the American Academy of Cosmetic Surgery.  After maintaining an active dermatology practice for 20 years, he recently divested his practice to devote full time attention to clinical research and drug development.  He continues as Clinical Assistant Professor of Dermatology at the University of Arkansas for Medical Sciences. He maintains active licenses in Arkansas, Florida, Texas, Tennessee, and New York and continues to see research related patients. BURKE Pharmaceutical is dedicated to the commercial development of pharmaceutical products and will draw upon the experience and knowledge gained thru years of research and medical practice. The targeted products will be physician driven and will fill voids that have not been currently addressed by other pharmaceutical companies.

    10. Tim Dugan, BS, CCRC Mr. Dugan has over 11 years of experience in clinical research. He has developed a large database of contacts with key personnel in the industry. Seven years ago, he became the director of clinical operations for Burke Pharmaceutical Research. As director, Mr. Dugan handles all the clinical and regulatory aspects involved in the trial studies; oversees all assisting personnel, negotiates contracts and budgets, and supervises subject conduct during the trial. He is also instrumental in feasibility studies in the early development of proprietary drugs initiated by BLU Pharmaceutical. After graduation from the University of Arkansas, he began his career in clinical trial research at Physicians Group Research Clinic. While employed, he successfully attained his certificate as a Certified Clinical Research Coordinator. He then became the regional director of Clinical Operations for Research Solutions, a national site management organization based in Little Rock, Arkansas. He served as the director overseeing 10 clinical research sites and managed a dozen research coordinators.   Mr. Dugan received a B.S. in Biology from the University of Arkansas. He also holds certifications from the Association of Clinical Research Professionals, Certified Clinical Research Coordinator (CCRC), Model Agreement Group Initiative, and Clinical Research Contract Professional (CRCP).

    11. William R. Pfister, Ph.D. Ph.D. in Pharmacology and Toxicology. Senior level executive with 30 years of pharmaceutical company experience in: quality control, technical service, product development, preclinical and clinical affairs, regulatory affairs & quality assurance, project management, scientific affairs and business development. Held senior management positions and supported pharmaceutical product research and development at Hoffmann La-Roche, American Critical Care, Dow Corning Corporation, PharMetrix Corporation, Lavipharm Laboratories, NexMed USA, NAL Pharmaceuticals and BLU Pharmaceuticals, Inc. Expertise in topical, transdermal, parenteral products and controlled release systems. Developed regulatory strategy and authored and filed numerous INDs and amendments (CMC, preclinical and clinical), NDAs and eCTDs. Certified Regulatory Affairs Professional (RAC), Diplomate of the American Board of Toxicology (DABT), and is author of several patents, publications and books including: “Transdermal and Topical Drug Delivery Systems, (1997) and “Intraoral Drug Delivery: Molecules to Market” (2005).

    13. 2. Improved OTC Dermatology Products: 1. Novel Rx Dermatology Products:

    21. An analysis which factors efficiency into the cited percent response rates determined the cost of the varying wart treatments as follows: Interferon Alpha $ 1,681 Liquid Nitrogen $ 1,248 Squaric Acid $ 982 Pulsed-dye Laser $ 690 Bleomycin $ 669 Candida Antigen $ 381 Carbon Dioxide Laser $ 356 Source: Comparing Therapy Costs for Physician Treatment of Warts, Journal of Drugs in Dermatology, Dec 2003, Robert J Clemons, Annette Clemons-Miller, Sandra Marchese Johnson, Susan K Williamson, Thomas D Horn.

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    32. Thank You for Your Attention!

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