10^th International Conference and Exhibition on Biologics and Biosimilars October 16-17, 2017 San Francisco, California, USA

With over 27 years of experience in the GMP Regulated Industries environment in the areas of Regulatory Compliance, Quality Systems, Regulatory Affairs, and Manufacturing. Mayra hold a Master of Science in, Thermodynamics and Materials Sciences Engineering from the University of Cincinnati, OH, and 2 Bachelor in Science, (1) in Analytical Chemistry, and (2nd) in Chemical Engineering from the University of P. Mayra had over 27 years of experience and depth knowledge of FDA, EMEA, ANVISA, COFEPRIS, ANMAT, CFDA KFDA, TGA, PMDA, INVIMA, SFDA ISO9001, ISO13485, Canadian Medical, Device Regulations, ICH Guidance, and others environment. She had experience managing including; facilities/utilities, equipment, De- Commissioning, Commissioning, Plant Startup, Validation Projects within pharmaceutical, Biotech, Medical Devices companies in the United States, Europe, Asia, Latin America, and Puerto Rico. Also Mayra’s experienced in the areas of Regulatory Compliance, Quality Systems, Regulatory Affairs, Design Controls, QSR, Quality Control, Quality Assurance, GAP analysis, extensive experience in FDA, – 483, Warning Letter and Consent Decree responses and remediation work plan strategy, Implementation of Quality Programs, SOP Development. Record of accomplishment for consistently meeting goals and delivering a high level sustained performance, proven the ability to build strong customer/client relationship including conducting vendor audits and contract manufacturing oversight. In addition, Mrs. Guzman-Kaslow prior experience includes auditing of Quality Systems, Design Controls, QSR, Quality Control, Quality Assurance, including Regulatory Compliance Audits, Deviation, OOS, CAPA, Complaints Investigation, Field Actions, and Validation, CSV, for Pharmaceuticals, APIs, Biotech, Biosimilars, CMOs, Medical devices including Device History, Design History, GAP analysis and remediation; Control Systems; Pharmaceutical Equipment; Electronic Records & Electronic Signatures (21 CFR Part 11); and computer/software, utilities, and manufacturing processes. Most recent, Mayra is the President & CEO of GK Regulatory Compliance in US and the General Manager of GK Pharmaceuticals CMO PR. She’s well known in the Biotechnology – Biosimilars industries in India and Europe. She was trained and certified by one of the gurus and innovators in Biosimilar.

Biosimilars, Regulatory Compliance, Quality Systems, Regulatory Affairs, Design Controls, QSR, Quality Control, Quality Assurance, GAP analysis, extensive experience in FDA, – 483

Dr. Anka G. Ehrhardt is a biophysicist with a doctorate degree in human physiology. She is currently working in the United States building and directing a team applying the latest technologies in support of the development of new live saving drugs

Biopharma, Biomarkers

Known as a pioneer of the stone-washed blue jean industry, a member of the Iowa Hawkeye NCAA Championship wrestling teams, Mark Emalfarb, CEO of Dyadic (OTCQX:DYAI) founded Dyadic in 1979. Since then, Mr. Emalfarb has successfully led and managed the evolution of Dyadic from its origins in the stone-washing business to the discovery, development, manufacturing and commercialization of specialty enzymes and other proteins, including human vaccines derived from DNA which are used in various applications to help feed, fuel and heal humankind. Mr. Emalfarb is an inventor of over 25 U.S. and foreign biotechnology patents, and is the architect behind the creation and development of Dyadic’s revolutionary patented C1 Protein Expression System,based on a recombinant Myceliopthora thermophile fungus. Mr. Emalfarb is also responsible for the formation of several strategic research, development, manufacturing and marketing relationships with U.S. and European global partners such as Sanofi Pasteur (human vaccines), BASF (food, feed and other enzymes),Abengoa (renewable non-food biofuels), and others.

discovery, development, manufacturing and commercialization of specialty enzymes and other proteins, including human vaccines derived from DNA

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

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.

Kinetic Data Analysis,pharmacology and biostatistics

Gregory J. Glover, MD, a registered patent attorney and non-practicing physician with Pharmaceutical Law Group PC, is one of the nation’s experts on the complex interaction of food and drug laws and intellectual property, including the patent and non-patent provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”). Greg represents life sciences companies, investors, and trade associations on strategic product development issues, including market protection analyses based on intellectual property laws, FDA regulations, and patent portfolio evaluations. Greg has also testified on behalf of the research-based pharmaceutical industry before committees of both houses of Congress on legislative matters affecting market protection for pharmaceutical, biotechnology, and medical device products, and he has made presentations on behalf of research-based companies on market protection issues before the Food and Drug Administration, the Federal Trade Commission, and the Department of Justice. Greg received his A.B. in biochemical sciences from Harvard College and his JD from Harvard Law School. Following law school, he completed medical school at Duke University and served as an intern at New England Deaconess Hospital in Boston, MA.

Market protection for pharmaceutical, Biotechnology, and Medical device products

Dr. Milind Antani leads Pharma & Healthcare practice at multi-skilled, research-based international law firm, Nishith Desai Associates with offices in Mumbai- Nariman Point, Silicon Valley, Bangalore, Singapore, New Delhi, Mumbai – BKC, Munich and New York. He also leads Social Sector Practice. He represents clients in JVs, MnAs, VC and Private Equity investments, Collaborations, Regulatory advice, IP, licensing and commercialization matters. He has authored and co-authored many articles, publications related to the pharma and healthcare industry including a book on CRAMS. He is a regular speaker and panelist at various national and international forums on the subjects of pharma, biotech, IP, clinical trials, healthcare, CSR and e Health. He is also a visiting faculty at many institutions in Mumbai and Gujarat. He is also recipient of certificate on “Managing and Transforming Professional Service Firms-India” an executive program organized by HARVARD BUSINESS SCHOOL. He has been included as one of the world's leading practitioners in ‘Who's Who Legal’ for Life Sciences 2014, 2015, 2016 and 2017 in the ‘Regulatory’ section as the only lawyer from India. He is also involved in policy making and drafting. A soft skill trainer by passion, runs “Surgically Ruthless Soft skill endeavors” that conducts workshops. He is also a GK Quiz master by interest. He has had his career as an ENT surgeon in Anand, Gujarat for 14 years before he changed career to law and moved to Mumbai 13 years ago.

international law ,, IP and regulatory matters including corporate mergers and acquisitions, investments, regulatory and transactional matters, intellectual property prosecution and litigation,

Oleg Gradov is a Faculty of Institute for Energy Problems of Chemical Physics, RAS, Moscow, bld. His international experience includes various programs, contributions and participation in different countries for diverse fields of study. His research interests reflect in his wide range of publications in various national and international journals. He is published one of article is In Situ Tunable Laser Diode Spectroscopy OF The Processes And Products OF The Microwave-Induced Self-Organization In The Soft Mater Active Media. His Research interests are Photoinduced Self-Organization, Self-Oscillations, Self-Focusing, CAD, CAE, d'Arcy-Thompson, Artificial Cells, Morphogenesis, Abiogenesis.

spectroscopy

Gregory J Glover is a registered patent attorney and non-practicing physician with the Pharmaceutical Law Group. He has experience in food and drug law, intellectual property law, and technology licensing. He has particular expertise in the patent and non-patent market exclusivity provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (“the Hatch-Waxman Act”). He received an AB, magna cum laude, in Biochemical Sciences from Harvard College in 1981 and a JD, cum laude, from Harvard Law School in 1986. Following law school, he completed medical school at Duke University in 1987, and served as an intern in Internal Medicine at New England Deaconess Hospital in Boston.

Drug Price Competition and Patent Term Restoration Act