Laszlo Endrenyi is Professor Emeritus of pharmacology and biostatistics in the University of Toronto. He has served the university in various positions including on its Governing Council and as Associate Dean of Graduate Studies. He sat on the Board of Directors of the American Statistical Association and the Canadian Society for Pharmaceutical Scientists; he was a president of the latter and received its Lifetime Achievement Award. Externally, he has served on grant review committees and editorial boards of research journals. He has received several recognitions, including an honorary doctorate from the Semmelweis University of Medicine. He is a Fellow of the Canadian Society for Pharmaceutical Sciences and of the American Association of Pharmaceutical Scientists. Dr. Endrenyi published a book on Kinetic Data Analysis and over 180 research papers. He has advised and widely consulted with industry and regulatory agencies.

Interested in the Comparability of biologics and Evaluation of highly variable drugs and drug products.

Dr. Luis H. Camacho, M.D., M.P.H. is the Director of Center for Oncology and Blood Disorders at Houston, TX, USA. He had also been the Associate Section Chief of Oncology in the Oncology Section, Internal Medicine Service at CHI St. Luke’s Health, Baylor St. Luke’s Medical Center - Cancer Center of Houston. He had been awarded Fellowship in Medical Oncology and Hematology. Joan and Sanford I. Weill Medical College of Cornell University / Memorial Sloan-Kettering Cancer Center, New York, NY. He completed his Master in Public Health from School of Public Health and Health Sciences. The George Washington University, Washington, DC in 1998. He graduated as Medical Doctor from Universidad Militar “Nueva Granada”, Bogotá, DC Colombia, South América in 1988.He is also associated with number of international societies and associations.

Oncology

Shay Tamari has extensive experience in biosimilars. He has led global business development, strategy and commercial development from both sell and buy sides of the industry. Currently, Shay leads biosimilars business development and portfolio strategy for Baxalta. Shay holds an MBA from Columbia University.

novel compounds, biosimilars, complex generics, Immunology, Oncology and CNS therapeutic areas

Kristin Connarn has completed her BS at Worcester Polytechnic Institute (WPI) and JD from Suffolk University Law School. She is a partner at McDermott Will & Emery. Kristin is known for her work in strategic portfolio development and management, patent prosecution, opinions, licensing, due diligence and related counseling for life science companies. She has a particular focus and expertise in the developing law of biosimilars, and regularly speaks and writes on the topic, as well as counseling biologics innovators on appropriate intellectual property strategies to protect their innovative products. Kristin also serves as the co-chair of the AIPLA biosimilars committee.

Biosimilars, Intellectual Property Rights

Mario DiPaola is CSO and co-founder of Blue Stream Laboratories, Inc. He holds a PhD in chemistry and also an MBA and has been in the biopharmaceutical industry for 20 + years in various roles from scientist to company executive.

Biopharmaceutics, Biologics, Biosimilars

Dr. Zvi G. Loewy is the Professor and Chair of Pharmaceutical and Biomedical Sciences and the Immediate Past Dean of Touro College of Pharmacy. He has extensive research works in the field of pharmaceutical sciences.

Biomedical Sciences

Dr. Jianguo Yang, is the Vice President of Abpro, USA and the CEO of Abpro, China. He was the principal scientist , leads late stage biologics commercial projects at Genzyme/ Sanofi. Prior to Genzyme, he worked on early, late stage and commercial biologic drug development in MedImmune /Astrazeneca and Abbott labs , respectively . With over 16-year bio-pharm industry experience, and achieved world record high mammalian cell line productivity, he is an international recognized expert in biologics development, and frequently invited keynote speaker / chairperson / scientific advisor for international conferences, a member of Editor and Advisor Board for Bioprocess International Journal, reviewer for scientific and professional Journals, and authored numerous publications and patent applications. He holds both M.S. and Ph.D. degrees in molecular cell biology and biotechnology from Illinois Institute of Technology.

Biosimilars, Biologics, Biotechnology, Molecular Biology

Dr Fratazzi devised the concept of a Strategic Clinical Innovation Organization (SCIO) and founded the first SCIO –Boston Biotech Clinical Research (BBCR), LLC in 2009, with the objective of actively contributing to innovation in streamlining clinical research and developing strategic clinical regulatory pathways to product approval. Dr. Fratazzi has worked on several Biosimilars’ development with special attention to the major variables that impact costs. As the President of BBCR, LLC, Dr. Fratazzi acts as a consultant to biotech, pharmaceutical medical device companies, and investors on optimum clinical plan development and how to design clinical trials that reduce product development risk. She is a renowned Immunologist with over 15 years of experience in Orphan Petitions in US and EU and phase 1-4 clinical programs, contributed to the registration and approval of 4 successful products.Dr. Candida Fratazzi expertise includes Drug, Device as well as Combination Products. . Recipient of 2013, 2014 and 2015 Best Pharmaceutical Consultant, Cambridge Award, 2015 Cambridge Business Hall of Fame Award,and 2014 Top Ranked US Executives, National Council of American Executives. Act as Member of Advisory Board and Board of Directors in Life-science

Biologics and Biosimilars

Mariana Babayeva MD, PhD is an Associate Professor at Touro College of Pharmacy, New York, NY. In addition to her role at Touro, Dr. Babayeva is also an Adjunct Professor at RockefellerUniversity and Visiting Scientist at Arnold and Marie Schwartz School of Pharmacy of LIU.Dr. Babayeva has over 10 years of experience in clinical practice. She is recognized for her expertise in the pharmacokinetics and the use of animal and organ models. Dr. Babayeva has conducted several international research projects. Dr. Babayevahas been publishedin peer-reviewed journals and serving as an editorial board member of repute.

pharmacokinetics and the use of animal and organ models.

Dipti Gulati completed herPh.D at the age of 25 years from Allahabad University and postdoctoral studies from Indian Institute of Sciences, India and Albert Einstein College of Medicine on Protein-Carbohydrate Interactions, USA.Currently, she is the President of PJI Biotech, a Consulting Services Organization. Previously, she heldvarious Management Positions at Amgen, BioMerieux, Emergent Bio Solutions, Diosynth and SmithKline Beecham Pharmaceuticals. She has published more than 25 papers in reputed journals and is serving as a Committee Member for several interest groups of PDA.

Biologics and Biosimilars