Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44Big Data Emergin Alte Special Populations 30 TUESDAY, SEPTEMBER 19, 2017 l Symposium 13 l 8:00 am – 12:00 pm 21st Century HIV/AIDS: An Evolving Drug Development & Technology Paradigm DISCOVERY TRACK Offers both CME and CPE Credit UAN #0238-0000-17-016-L02-P ACPE – 3.5 CONTACT HOURS/APPLICATION-BASED CO-CHAIRS: Jomy George, PharmD, Pharmacokineticist, National Inst of Health Parag Kumar, PharmD, Director, Clinical Pharmacokinetics Research Unit, National Inst of Health TARGET AUDIENCE: The target audience would be healthcare professionals including pharmacists, physicians and nurses, plus research scientists in academia, industry and regulatory agencies with an interest in clinical pharmacology applications specific to HIV/AIDS treatment and prevention, HIV cure and HIV-associated co-infections. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Describe novel bioanalytical approaches and target reservoirs in the search for an HIV cure; 2. Explain the recent advances in drug formulations for both HIV treatment and prevention; 3. Identify challenges in the current regulatory process of the development and approval of biologics for HIV; 4. Appraise the evolving body of evidence on HIV therapeutics and the potential role of novel biologic agents; 5. Describe advancements and challenges in the treatment of HIV- associated opportunistic infections. 8:00 – 8:25 am Advances in Formulations for HIV PrEP & Treatment: Injectable Nano Formulations Parul Patel, PharmD, Clinical Pharmacology Program Leader for Cabotegravir, ViiV Healthcare 8:25 – 8:50 am Advances in Formulations for HIV PrEP & Treatment: Solid Implantable Formulations Jay Grobler, PhD, Director of Infectious Disease Biology, Merck & Co 8:50 – 9:20 am Advances in Formulations for HIV PrEP: Topicals & Implantables Craig Hendrix, MD, Wellcome Professor & Director, Div of Clinical Pharmacology, Johns Hopkins Univ School of Medicine 9:20 – 9:30 am Q&A 9:30 – 10:00 am / Break 10:00 – 10:30 am Broadly Neutralizing Monoclonal Antibodies: Next Generation of HIV/AIDS Therapeutics Edmund Capparelli, PharmD, Professor of Clinical Pediatrics & Pharmacy, Univ of California, San Diego School of Medicine & Skaggs School of Pharmacy & Pharmaceutical Sciences 10:30 – 10:55 am Regulatory Perspectives on the Development of New HIV Treatment & Prevention Modalities Kimberly Struble, PharmD, Antiviral Medical Team Leader, US Food & Drug Administration 10:55 – 11:20 am Clinical Pharmacology of Novel Regimens & Formulations for HIV/AIDS-associated Co- infections Parag Kumar, PharmD, Director, Clinical Pharmacokinetics Research Unit, National Inst of Health 11:20 – 11:50 am Novel Bioanalytical & Pharmacometric Approaches to Targeting Viral Reservoirs in the Search for an HIV Cure Angela Kashuba, PharmD, John & Deborah McNeill, Jr Distinguished Professor, Director, CFAR Clinical Pharmacology & Analytical Chemistry Core Adjunct Professor, Infectious Diseases, UNC Eshelman School of Pharmacy 11:50 am – 12:00 pm Q&A Symposia