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 Technology companies. Invited speakers and chairman at international conferences. Authored over 50 scientific papers in peer review journals and several book chapters. Dr Fratazzi helps international companies to enter the US and EU markets.Dr Fratazzi received her early training in biomedical research at the Johns Hopkins University and Harvard University in the USA, and at Imperial College in London, UK.

Biologics and Biosimilars

He has done PhD in Biology,MsC in Biotechnology, MsC in Microbiology and Genètics, MsC in Environmental sciences, BS in Biology and BS in Biotechnology with 16 years of experience in the biotechnology and bio-pharmaceutical industry. I developed as a professional in the area of small molecules, peptides, biotherapeutics and in the last years specially in New Biological entities and Biosimilars. Professionally, I am interested in functions related to science and business (research and development, business development, technology transfer, project management) in the biotech and biopharma sectors.

Biotech and biopharma sectors

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

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 works of Tracks 2-3 (Comparability of biologics) and 5-4 (Evaluation of highly variable drugs and drug products).

Ruediger Jankowsky is the Managing Director at Cinfa Biotech, the biosimilar company of the Spanish Cinfa/Infarco group. He was appointed Managing Director of Cinfa Biotech in 2014 with the goal to establish the company in the market for high-quality biosimilars. From 2014 until today, Ruediger has built the operational structure of Cinfa Biotech at a fully integrated level. Furthermore, he has successfully brought the first biosimilar product candidate to clinical development stage. His responsibilities include the development of Cinfa Biotech’s product portfolio, the setup of development, manufacturing and commercialisation structures as well as the corporate strategy. Ruediger is a PhD biochemist by training. He has over 15 years of experience in the pharmaceutical industry where was in charge of the development of numerous medicinal products in the areas of oncology and inflammation. He has successfully led development programs for small molecule and protein-based medicinal products through different stages of early- and late-stage clinical development. Ruediger held various senior executive positions in global and mid-size pharmaceutical companies. Before he joined Cinfa Biotech, Ruediger was responsible for the global project management of multiple biosimilar development projects at Sandoz Biopharmaceuticals.

Biologics, Biosimilars, Biotechnology, Clinical Development, Oncology, Biopharmaceutics, Drug Development, Immunology, Autoimmune Diseases

Dr. Saharan has MS in Life Sciences (JNU); Ph.D in medicine (WVU) & Post Doc. (Stanford University).He has several International Publications / Presentations including in Top Scientific Journal Nature from the age of 21. Nominated for several Global Awards including by New Drug Discovery Programme of Department of Science & Technology (GoI) funded US$ 3 million grant and the best US Scientist Award at age 22 years by AAAS, Washington DC. Dr. Pawan Saharan has been CSO & CEO for large MNC & founder of Biomix Network Inc. USA & India.

Infectious Diseases, HIV, AIDS

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.

\"Medical Doctor, trained in B\'ham (UK), MBA and Master in SME, a number of years in pharmaceutical industry positions, including International Marketing Director at Ferrer Grupo, founded Trifermed in 2002, a Business Modelling and Business Development on-demand services company specialised in Life Sciences. Board experience on project management and deal making (more than 120 deals signed over the last more than one decade) both in Human and Animal Health, for biotech, pharma and medical devices. Actively participating as speaker in international congresses, mentor for different programs in public and private Business and Science Universities and Professor at Esade Entrepreneurship Institute for Healthcare Entrepreneurship. Speciality: Business in Life Sciences\"

Biotechnolgy, Life Sciences, Technology Transfer

Dr. James Yang is the Chief Executive Officer at Abpro, China and also Vice President of the Abpro, USA. Previously he had been associated with Genzyme , Qilu Pharmaceuticals, Sanofi, MedImmune , Astrazeneca, Abbott Laboratories.

Biologics, Protein Purification, GMP

Racho Jordanov Co-Founder, President and CEO. Racho Jordanov is a biotech pioneer with more than 30 years of experience building and leading manufacturing operations in development-stage and multi-national biopharmaceutical companies. Mr. Jordanov started his career with Genentech, Inc. in 1981 in San Francisco, where he led the facility start-up and managed on-going commercial manufacturing of the first biotech products to be approved by FDA: insulin and rhGH. Over his 20-year career at Genentech Mr. Jordanov was at the forefront of innovations in biopharmaceutical manufacturing, from introducing the first processes for monoclonal antibody (mAb) production, to establishing Genentech\'s outsourcing capabilities for drug substance, drug product and medical devices, to most recently starting-up new biomanufacturing facilities in the US and Singapore. In addition to Genentech, Mr. Jordanov led North America manufacturing operations for Serono S.A. (now Merck Serono; Switzerland) and served as the Vice President of Manufacturing and Operations for two California-based biotech start-ups: Cholestech and Telios Pharmaceuticals. Mr. Jordanov earned his B.S. in Chemical Engineering from the University of California, San Diego, and an M.B.A. from National University in San Diego.

Biotechnology, Monoclonal antibody (mAb) production, Biomanufacturing,

Dušanka Martinović Kaliterna completed her undergraduate studies from University of Belgrade, Master Studies () and PhD from University of Zagreb. She has been working at University Hospital of Split since 1983, and finished her residence in Internal Medicine in 1987. She is a full Professor of Internal Medicine and Rheumatology at the University of Split, School of Medicine and Head of Division of Rheumatology and Clinical immunology. Her main interest and field of scientific work is rheumatology and immunology For many years she has been active in organization of international scientific meeting and educational curses of this field in Croatia and partly in Europe. She initiated and supported patient’s organizations for autoimmune diseases. She is awarded by Croatian Medical Association for her contribution in medical science in Croatia. She is author and coauthor in 10 books and 90 internationally indexed papers.

Immunology, Rheumatology