Biosimilars and Biologics

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

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

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.

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.

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.