18^th European Biosimilars Congress

Dr. Pawan Saharan, with a vision to provide Health for all, Invented World’s 1st Immunity Enhancement Drug to treat HIV and host of other Immunity problems via Broad Spectrum Antiviral and New Generation Immuno-modulator- RECEPTOL®. Prestigious Who’s Who American Historical Society (Boston) nominated Dr. Saharan as a World.Leader in healthcare industry responsible for changing the destiny of nations & human race via the creative contribution in the healthcare sector via Receptol that builds body’s own immune system, providing hope to most disenchanted terminally ill patients globally. He has global experience in running healthcare industry, including the Pharmaceuticals MNCs and hospitals at the top management level in India & USA.He created the first truly Nano-Bio-IT Helix via inventing Radha 108 Nano-Peptides for AIDS therapy : RECEPTOL® along with reusable micro-chip diagnostics for AIDS, Cancer, TB and other infections, costing a fraction of current tests creating a paradigm shift in healthcare & bringing smile on Billion Faces who could not afford modern treatment.Late Dr. Abdul Kalam, former President of India, nominated Dr. Saharan for India’s new drug discovery with a funding of Rs 120MM (US$ 3MM), by Dept of Science & technology, Govt. of India.He has a Ph.D. Major in Medicine West Virginia Medical Center, USA & topped First Rate Jawaharlal Nehru University in New Delhi while pursuing Master in Life Sciences and has several International Publications / Presentations including in Top Scientific Journal_ Nature. He has organized several global conferences and lead the Global Impact of Nanobiotechnology in Healthcare. Canadian and UK Govt. invited Dr. Saharan as the state guest in recognition for his contribution to healthcare and technological alliances between North America and India via Canada India. Business Council. UK Prime Minister invited Dr. Saharan in March, 2011 as a key note speaker at the UK India. Business Council for the key note address on affordable health care. American Association for the Advancement of Science (AAAS), Washington DC nominated him for the best US Graduate Student Scientist Award.

Dr. Saharan created the first truly Nano-Bio-IT Helix via inventing Radha 108 Nano-Peptides for AIDS therapy : RECEPTOL® along with reusable micro-chip diagnostics for AIDS, Cancer, TB and other infections, costing a fraction of current tests creating a paradigm shift in healthcare & bringing smile on Billion Faces who could not afford modern treatment.

Mircea Ciuca, MD is currently Global Head of Medical & Clinical Drug Safety at Vifor Pharma in Switzerland. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings. Mr. Ciuca has about 13 years of experience in drug safety. Prior to join Vifor Pharma he held various positions (Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large pharmaceutical companies in The Netherlands, after successfully establishing and leading the medical- scientific department of a medium-size CRO in Rotterdam.

Clinical Drug Safety, clinical practice,Pharmacovigilance

Mircea Ciuca, MD is currently Global Head of Medical & Clinical Drug Safety at Vifor Pharma in Switzerland. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings. Mr. Ciuca has about 13 years of experience in drug safety. Prior to join Vifor Pharma he held various positions (Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large pharmaceutical companies in The Netherlands, after successfully establishing and leading the medical- scientific department of a medium-size CRO in Rotterdam.

Clinical Drug Safety, clinical practice,Pharmacovigilance

Tirasak completed his Ph.D. from Faculty of Microbiology, Mahidol University, Bangkok, Thailand. He has his postdoctoral training at NeuroVirology and Cancer biology Center, Temple University, Philadelphia. At present, he is a full professor in Microbiology and Immunology, Graduate Program of Medical Technology, Rangsit University, Thailand. He is interested in various academic subjects of science and liberal arts, in addition of music and sports. His scientific fields mainly focus in viral and cellular interaction, bacteriophage and viral diseases in invertebrate animals. However, his research’s interests expand to viral vaccines, autoimmune disease and cancer biology including the relationship of MHC molecules to some specific diseases and viral vaccines. He enjoys being a reviewer for several journals and an advisor to develop young medical scientists with the wish that they would co-operate and/or succeed to solve all the problematic diseases, now and then, in a proper way with genuine scientific thinking.

Viral and cellular interaction, bacteriophage, viral diseases, viral vaccines, autoimmune disease and cancer biology including the relationship of MHC molecules to some specific diseases and viral vaccines

David KREHER is an Associate Professor of Chemistry in UPMC who received a Ph.D. in organic and materials chemistry, Universities of Angers (France) and Zaragoza (Spain) in 2001: project of 4 years in Angers, funded by CNRS (National Centre of Scientific Research) and including 1 year’ studies and formation (HPLC, MS, RPE) in Zaragoza and Barcelona (Spain), a Post-graduate diploma before the Ph.D., specialization in materials chemistry (DEA Chimie Fine) at the Science Faculty, University of Angers, an Engineer's diploma at Ecole Nationale Supérieure de Chimie de Montpellier (ENSCM), a leading National College of chemical engineering, a Postgraduate engineering degree, equivalent to M. Sc. plus one year specialisation in organic and materials chemistry, biochemistry and environment and aMaster of Science specializing in physical chemistry, University of Grenoble, including 9 months’ studies in Montreal and Ottawa (CANADA) through an exchange between France and Quebec, David Kreher became a part of the ENSTA ParisTech by integrating the department of chemical engineering.

2D-3D self-assembled systems, organic chemistry, electrochemistry, optoelectronic materials, organic emissive materials. Current search includes design, synthesis and studies of (macro) molecular materials for organic electronics, bipyridazine biphasic fluo / phosphorescent transmitters.

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. 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.

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

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.