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An INVITATION to AAPS Indiana/Ohio Discussion Group (I/ODG) Mini-Symposium Event: Diagnostics: Challenges/Perspective Symposium When: 4:00 pm, Wednesday, October 30, 2013 Where: Atherton Union, Reilly Room, Butler University, 4600 Sunset Avenue, Indianapolis, 46208 Program Poster/Displays Viewing and Social Dinner Seminar Introduction Seminar (Speaker 1) Seminar (Speaker 2) Poster Winners Introduction Poster Award winners presentation 4:00 - 6:00 PM 6:00 - 6:45 PM 6:55 - 7:00 PM 7:05 - 7:45 PM 7:45 - 8:25 PM 8:25 - 8:30 PM 8:30 - 9:00 PM (10 minutes each for 3 awardees) Speaker 1: Dr. Chitra Edwin, PH, RAC, Director of Regulatory and Quality Affairs, Cleveland HeartLab, Cleveland, OH. Topic: “Regulatory aspects of IVDs (in vitro diagnostics; included under medical devices) and companion diagnostics” Speaker 2: Jim S. Strickland, President and Founder, FAST BioMedical Inc., Indianapolis, IN. Topic: “Developing combination products: One company's perspectives” 1 Registration Information Pre-Registration (‘til October 24th) - $35.00 (mail checks by October 21st) Students Pre-Registration - $15.00 Late Registration (After October 24th) - $40.00 at door For more information contact: Felicia F. Kpakima – Eli Lilly and Co., Phone: 317-651-5658 [email protected] th 46 Street Hampton Drive Sunset Avenue Available Parking Butler University Gold Sponsor Bronze Sponsors 2 MEETING REGISTRATION FORM NAME _________________________________ INSTITUTION _________________________________ ADDRESS _________________________________ _________________________________ TELEPHONE _________________________________ EMAIL ADDRESS _________________________________ Please return registration form by fax or e-mail before Thursday, October, 24th. Payment Options: By cash or check: please mail the check (payable to AAPS I/ODG) and registration form Online using PayPal (before October 24th), indicate meal preference via email: https://sites.google.com/site/aapsiodg/ Felicia F. Kpakima (Attn I/ODG) Lilly Corporate Center, DC-0724 Indianapolis, Indiana 46285 Phone:317-651-5658 Fax:317-651-6330 Meal Preference (Default meal is vegetarian, if meal preference is unchecked) ____Vegetarian ____Chicken ____Fish RED CURRY THAI VEGETABLES WITH TOFU Red Curry Thai Vegetables with Tofu. MEDITERRANEAN STUFFED CHICKEN Mediterranean Stuffed Chicken, Fingerling Potato, Grilled Squash. PESTO SALMON Pesto Salmon, Red Pepper Basmati Pilaf, Garlic Snow Peas 3 Abstract Submission to I/ODG Mini-Symposium Event: Diagnostics: Challenges/Perspective Symposium Deadline: October 18th, 2013 Submission Guideline: • • • • • • Any topic that fall into the general range of topics (PK/PD and drug metabolism, design of clinical trials, pharmaceutical science &technology, drug delivery, toxicology, pharmacology, state of the industry, regulatory affairs, analytical science, Bio/medical engineering etc.) is in-scope. Abstract that has been previously presented in other meetings is acceptable. The meeting where the poster was previously presented should be noted. Your abstract should be created in Microsoft Word. Please use Times New Roman 10 point font with top and left margins of 1 inch (2.54 cm) and bottom and right margins of 0.75 inches (1.91 cm). Abstract should include a title, author, and affiliations followed by abstract itself. The abstract should be no more than 1 page long. Figures, tables, and symbols are allowed provided that the abstract stays within the page-length requirements. Save your abstract as yourfirstname_yourlastname_IODG_poster2013.doc. All posters will be displayed from 4:00 – 9:00pm (poster set-up begins at 3:30 pm). Presenting authors must be available for one hour from 5:00 – 6:00pm during presentation times to answer questions and participate in discussions. Poster board will be 8ft x 4ft and approximately, 24 Power Points slides (81/2x11in) will fit comfortably. Push pins will be provided. Abstract Example: Metabolism and Disposition of LY2196044, an Opioid Receptor Antagonist, in Humans. Anthony G. Borel, Ping Yi, Chad Hadden, Robert J. Barbuch, Jennifer Witcher Department of Drug Disposition. Lilly Research Laboratories, Eli Lilly and Company. Indianapolis, IN 46285. Correspondence to: Anthony G. Borel Email: [email protected] Disposition and metabolism of the opioid receptor antagonist LY2196044 in healthy male subjects was characterized following oral administration of a single 100 mg (100 mCi) solution dose. LY2196044 was well absorbed, only 2% of unchanged drug appearing in feces; and cleared primarily by metabolism (~60%), and urinary excretion (~28%). LY2196044 and its major metabolite, M1 (LSN2340637), were the major circulating species in plasma, accounting for approximately 42% and 19% of systemic exposure (based on AUC0-), respectively. There were two major metabolic pathways that generally characterized the 20 identified metabolites – carboxamide hydrolysis to M1 and ethyltetrahydropyran oxidation accounted for 24% and 18% of the dose, respectively. Of the oxidative metabolites, M29, the most prominent, is proposed to result from an unusual rearrangement related to oxidation of the ethyltetrahydropyran to a hemiacetal followed by ring opening and reclosure to form an acetyl substituted lactam. I/ODG-AAPS best poster award will be selected for the top three posters based on scientific content, background, innovation and style. The winners will have the opportunity to showcase the work as a podium presentation and be granted an award. 4