11^th European Biosimilars Congress April 26-27, 2018 Rome, Italy

Robert Salcedo comes with over 25 years of experience in biotechnology. Has worked for both Amgen and Genentech in leadership roles. He has also lead a start-up biosimilar company which developed and filed multiple applications in both US and EU. He is the co-founder of BiosciencesCorp and Biosimilar solutions which are dedicated to helping both Biotech companies and Biosimilar companies develop their strategy and bring products to commercialization. Robert often writes brief and powerful articles which are published as part of his linked in profile.

Biotechnology and Solid Dose Manufacturing

Dr. Francois-Xavier Frapaise, M.D has over 30 years of international drug development, strategic planning and marketing experience at major pharmaceutical companies including Sanofi, Bayer, Boehringer, Merck and Abbott; he has hold multiple C-level positions (CSO,CMO,CEO) in different Pharmacos in the US and Europe. He is currently heading Clinical Development, Medical Affairs and Pharmacovigilance at Merck KGaA Biosimilars Division; he has extensive experience of biosimilars development (Boehringer-Ingelheim, Pfenex); He has been the CSO and SVP of Optimer, has served as the CEO of Asphelia Pharmaceuticals, Inc.VP R&D and Corporate Officer of TAP , CMO of Ocera Therapeutics, VP of Scientific Affairs at Abbott International , Head of Medical Affairs at Bayer Europe, Medical Director at Bayer France, VP of R&D at Delagrange, Head of Anti-thrombotics Strategic Marketing at Sanofi, Medical Director at Choay. Dr. Frapaise holds an M.D. degree from Faculté de Médecine Paris and is a INSEAD alumni. Dr. Frapaise holds an academic position at the Thrombosis Research Center at the Loyola Medical Center in Maywood (IL).

Drug development & strategic planning

Dr. Kamali Chance is a Vice President and Head, Global Biosimilars Regulatory Strategy, Biosimilars Center of Excellence. She has over 25 years of work experience in the healthcare industry, including the last 17 years in regulatory affairs/regulatory strategy. Dr. Chance has extensive experience working with the FDA and EMA. She advises pharmaceutical and biotechnology companies in the development of region specific and/or global regulatory strategy for the development of biosimilar products. Dr. Chance has authored/co-authored number of articles on the development of biosimilars. She has a PhD in Nutrition/Nutritional Biochemistry, Masters of Public Health and Regulatory Affairs Certification.

Regulatory strategy for number of biosimilar products currently in development including biosimilars of Enbrel, Remicade, Herceptin, Rituxin/Mabthera, Humira, Avastin, Erbitux, Epogen, Insulins, Forteo and Neupogen/Neulasta.

Dr Fiona Greer was a founding Director of M-Scan, contract analytical laboratories specializing in biopharmaceutical characterization. Following acquisition in 2010, she is now Global Director, Biopharma Services Development, SGS Life Sciences. Following a Ph.D. in Protein Biochemistry from Aberdeen University (1984) she joined M-Scan to establish and direct biologics characterization services. Here, she pioneered new developments in Mass Spectrometry for structural analysis and sequencing of proteins and carbohydrates resulting in numerous publications and patents. She was instrumental in expansion of the group, establishing a US facility where she was appointed VP. With over 35 years experience in glycoprotein analysis using mass spectrometry and other instrumental techniques, she has been involved with a diverse range of biotechnology products, both novel and biosimilar and consults to companies throughout the world. She is regularly invited to give presentations and workshops at international meetings and has designed and presented various technical training courses.

Structural analysis of proteins and glycoproteins

Cecil Nick is a Biochemistry graduate and regulatory professional with over 30 years experience specializing in the clinical delopment of biological and biotech products. Supported 7 biosimilar marketing approvals and over 80 biosimilar Agency interactions in EU, US, Canada and RoW.Offers extensive expertise to clients particularly with respect to biosimilars, comparabilty, clinical development, orphan drugs and training. Fellow of TOPRA and has been a guest lecture at Cardiff University MSc in Clinical Research and Greenwich University MSc in Pharmaceutical Sciences courses and Biotech Module leader for the TOPRA MSc course. He was on the editorial panel of SCRIP Clinical Research.

Clinical delopment of biological and biotech products

Captain Brouker recently completed an illustrious 30 year naval career. He began his naval career leading a number of hospital pharmacy departments in the United States, overseas and onboard ships. He served as Executive Officer at an overseas naval hospital and Commanding Officer at one of the largest naval hospitals worldwide. Captain Brouker also served as Chief of Staff for Navy Medicine West, responsible for 10 hospitals spanning the West Coast to the Indian Ocean and healthcare for 700,000 patients. In this position he provided executive coaching and day to day mentoring for 10 Commanding Officers. Captain Brouker is the first, and only, Pharmacy Officer in the United States Navy to serve as Commanding Officer of one of the 5 premier Navy Medicine Family Medicine Teaching hospitals. He is also the first, and only, Pharmacy Officer in the United States Navy to serve as regional Chief of Staff of one of the 3 Navy Medicine regions world-wide. In 2013, Captain Brouker founded Brouker Leadership Solutions, a company dedicated and passionate about helping leaders succeed on their leadership journey. Captain Brouker earned a Bachelor of Science degree in Pharmacy from Northeastern University, an MBA from National University and a Doctor of Pharmacy degree from the University of Rhode Island, which included studies at the University of Rennes in Rennes, France, and completion of a post-doctoral fellowship in Pharmacoeconomics. He is also a graduate of the Naval War College. Captain Brouker is a board certified Pharmacotherapy Specialist (BCPS), as well as board certified in healthcare management as an American College of Healthcare Executive Fellow (FACHE). Captain Brouker is the recipient of numerous leadership awards and has presented over 100 leadership seminars to thousands of military and civilian professionals both in the United States and abroad.

Pharmacy and Healthcare

Dr. George Perry received his PhD in Marine Biology from Scripps Institution of Oceanography, University of California at San Diego. He completed his Postdoctoral Fellowship in the Department of Cell Biology, Baylor College of Medicine, Houston, Texas.Dr. Perry joined the UTSA faculty in 2006 from Case Western Reserve University where he was Professor of Pathology and Neurosciences and Chair of the Department of Pathology. He is also distinguished as one of the top 20 Alzheimers disease researchers with over 800 publications, one of the top 100 most-cited scientists in Neuroscience & Behavior and one of the top 25 scientists in Free Radical research . He currently serves as and President for the American Association of Neuropathologists. He is on the editorial board of over 60 journals including American Journal of Pathology and Journal of Biological Chemistry, and is Editor-in-Chief of Journal of Alzheimer’s Disease.

His studies are focused on the mechanism of formation and physiological consequences of the cytopathology of Alzheimer disease. We have shown that oxidative damage is the initial cytopathology in Alzheimer disease. They are working to determine the sequence of events leading to neuronal oxidative damage and the source of the increased oxygen radicals. Their current studies focus on (i) the mechanism for RNA-based redox metal binding; (ii) the consequences of RNA oxidation on protein synthesis rate and fidelity; (iii) the role of redox active metals in mediating prooxidant and antioxidant properties; (iv) the signal transduction pathways altered in Alzheimer disease that allow neurons to evade apoptosis; and (v) mechanism of phosphorylation control of oxidative damage to neurofilament proteins.

For the past 12 years, Dr. Adel served as director of the Oncology Residency Program and manager of Clinical Pharmacy Services at Memorial Sloan-Kettering Cancer Center. Dr. Adel earned her PharmD from the School of Pharmacy at Lebanese American University in Byblos, Lebanon. She received her first undergraduate degree, a bachelor of science in geology, at the American University of Beirut. After receiving her PharmD, Dr. Adel moved to the United States and received post graduate training at St. Jude Children’s Research Hospital through the International Outreach Program. She then worked as a research assistant at The Johns Hopkins Hospital, where she continued on to complete a pharmacy practice residency (PGY-1) as well as an oncology specialty residency (PGY-2).Since she began her tenure at Sloan-Kettering in 2004, oncology treatment has undergone a “major evolution” with thousands of new medications approved, including targeted drugs and immunotherapy. “These developments call on pharmacists to become more specialized, generating growth in hiring of pharmacists, more collaboration between pharmacists and oncologists, and a greater appreciation for the role of pharmacists,” said Dr. Adel. She also served as an associate clinical professor at St. John’s University College of Pharmacy and Health Sciences. Prior to joining Sloan-Kettering, Dr. Adel worked as a clinical specialist in hematology/oncology at Children’s National Medical Center in Washington, D.C. While in Washington she also was an instructor in pharmacology at the University Of Maryland School Of Pharmacy in Baltimore. Dr. Adel has spoken and published widely, and worked on numerous special projects in oncology. Among her more significant achievements, she has made meaningful strides in the improvement of patient care.

Hematology/Oncology

Dipti Gulati completed her Ph.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 held various 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 groups of PDA.

Biologics and Biosimilars

He holds the MTA-PE Lendulet professorship in Translational Glycomics and directs the Horváth Csaba Laboratory of Bioseparation Sciences in University of Pannonia (Hungary). His work is focused on capillary electrophoresis and CESI-MS based glycomics and glycoproteomics analysis of biomedical, cell biology and biopharmaceutical, interests. Professor Guttman has more than 290 scientific publications, wrote 35 book chapters, edited 4 textbooks and holds 23 patents. He is on the board of several international organizations, on the editorial boards of a dozen scientific journals, has been recognized by numerous awards and member of the Hungarian Academy of Sciences.

His research interests include the glycomics and glycoproteomics analysis of biomedical, cell biology and biopharmaceutical.

Christoph Volpers earned a PhD in Molecular Biology from the University of Mainz, Germany, and an MBA from Bradford University, UK, both with Distinction. Chris has almost fifteen years of experience in Intellectual Property and Licensing. Before he joined the patent law firm Michalski Hüttermann & Partners, Dusseldorf/Munich, as Senior Patent Consultant in early 2015, he was Director IP Biologics of the Teva Pharmaceutical Industries/ratiopharm group for six years with global responsibility for innovative biologics and biosimilar products. He is founder of a biopharmaceutical consultancy firm, author of more than 20 publications and a member of the Licensing Executive Society.

Intellectual Property and Licensing