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 Special Populations 32 TUESDAY, SEPTEMBER 19, 2017 l Symposium 15 l 1:30 – 5:30 pm Biosimilars: An Evolving Science DISCOVERY TRACK Offers both CME and CPE Credit UAN #0238-0000-17-018-L01-P ACPE – 3.5 CONTACT HOURS/APPLICATION-BASED CO-CHAIRS: Darrell R. Abernethy, MD, PhD, Associate Director for Drug Safety, Office of Clinical Pharmacology, US Food & Drug Administration Bernd Meibohm, PhD, Professor & Associate Dean, Univ of Tennessee Health Science Ctr, Coll of Pharmacy TARGET AUDIENCE: This Symposium will be useful for clinical pharmacologists in drug development and regulatory sciences, physicians and pharmacists exposed to biologics biosimilars in clinical practice and students, trainees and fellows in clinical pharmacology and related disciplines. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Provide detailed insights into the definition and assessment of critical quality attributes for biosimilars, determination of clinically-meaningful pharmacokinetic and pharmacodynamic differences between biosimilars and reference products, or the lack thereof, and the challenges and limitations to assess immunogenic potential during the clinical section of the comparability exercise; 2. Outline the requirements, interpretation and clinical application of results from comparability exercises for biosimilars relative to reference products; 3. Identify how a biosimilar becomes interchangeable. 1:30 – 1:35 pm Introduction Darrell R. Abernethy, MD, PhD, Associate Director for Drug Safety, Office of Clinical Pharmacology, US Food & Drug Administration and Bernd Meibohm, PhD, Professor & Associate Dean, Univ of Tennessee Health Science Ctr, Coll of Pharmacy 1:35 – 2:15 pm The Determination of Critical Quality Attributes in the Assessment of Biosimilarity (Invited) Marjorie Shapiro, PhD, Chief, Laboratory of Molecular & Developmental Immunology, Office of Biological Products, Office of Pharmaceutical Quality, Ctr for Drug Evaluation & Research, US Food & Drug Administration 2:15 – 2:55 pm Determination of “No Clinically-meaningful Difference”: The Role of Pharmacokinetic/ Pharmacodynamic Evaluations TBD 2:55 – 3:30 pm Immunogenicity Assessment of Biosimilar Products Gopi Shankar, PhD, Senior Director & Head, Bioanalytical Sciences & Immunogenicity, Janssen Research & Development 3:30 – 4:00 pm / Break 4:00 – 4:40 pm When Does a Biosimilar Become an Interchangeable? Darrell R. Abernethy, MD, PhD, Associate Director for Drug Safety, Office of Clinical Pharmacology, US Food & Drug Administration 4:40 – 5:30 pm Panel Discussion Alte Emergin Symposia