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Vice President - Translational Sciences - Kite Pharma Inc.
Adrian Bot, MD, PhD is the Vice President of Translational Sciences at Kite Pharma Inc, a biotechnology company developing genetically engineered T cell therapies, based in Los Angeles, CA. He has more than 20 years of experience in biomedical research and development.
Dr. Bot obtained his MD at the University of Medicine and Pharmacy in Timisoara, Romania and his PhD in Biomedical Sciences at Mount Sinai School of Medicine in New York. Subsequently, he was a Guest Scientist at the Scripps Research Institute in La Jolla and Scientist, Principal Scientist and Director of Immunology Research at Alliance Pharmaceutical Corp. in San Diego, CA. In Nov 2002, Dr. Bot joined Allecure Pharmaceuticals which became MannKind Corp, where he was a Director of Research and Development. He had several other appointments at MannKind: Sr. Director of Translational Medicine, Vice President of Scientific Management and Vice President of Research, prior to the appointment as Chief Scientific Officer and then Vice President of Translational Sciences at Kite Pharma Inc. Most currently at Kite Pharma, Dr. Bot has been responsible for overseeing the translational activities in support of the development of Axi-Cel, a novel CAR T cell therapy for B cell malignancies. He has been a long time SITC member and is currently serving on the SITC Industry leadership panel.
Dr. Bot’s background is in theoretical and experimental immunology, cancer research, cell therapies, biomolecules and small molecules spanning all stages of development. He authored or co-authored more than 100 research articles, abstracts, reviews, book chapters and monographs in basic and applied immunology. Dr. Bot is the current Editor in Chief of the International Reviews of Immunology and the Section Editor, Immunology and Immunotherapy of the Journal of Translational Medicine.
Deputy Director - Sanofi
Amlesh Ranjan is a lifescience professional, doing Leadership role in Biopharma. Having a rich past, experience of leading multiple strategic functions- Commercial Excellence; Market Access; Disease Management & KAM. His illustrious career is built on the robust foundations of Frontline Sales. A thought leader, Mr. Amlesh has been contributing at international and national industry forums as a speaker for almost a decade now. He is passionate about The Life, Learning & Leadership.
Professor, Department of Chemical Engineering - Indian Institute of Technology, Delhi
Dr. Anurag S. Rathore is a Professor at the Department of Chemical Engineering, Indian Institute of Technology, Delhi, India. He is also the Coordinator for the DBT COE for Biopharmaceutical Technology. His previous roles included management positions at Amgen Inc., Thousand Oaks, California and Pharmacia Corp., St. Louis, Missouri. His areas of interest include process development, scale-up, technology transfer, process validation, biosimilars, continuous processing, process analytical technology and quality by design. He has authored more than 500 publications and presentations in these areas. He is presently serving as the Editor-in-Chief of Preparative Biochemistry and Biotechnology and Associate Editor for Journal of Chemical Technology and Biotechnology and PDA Journal of Science and Technology. He also serves on the Editorial Advisory Boards for Biotechnology Progress, Electrophoresis, BioPharm International, Pharmaceutical Technology Europe and Separation and Purification Reviews. Dr. Rathore has edited books titled Novel Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts, Preparative Chromatography for Separation of Proteins and Peptides, Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Elements of Biopharmaceutical Production (2007), Process Validation (2005), Electrokinetic Phenomena (2004) and Scale-up and Optimization in Preparative Chromatography (2003). He has a Ph.D. in Chemical Engineering from Yale University. Dr. Anurag Rathore is presently serving as Dean, Corporate Relations, at IIT Delhi.
Senior Vice President, Clinical Research - Aurobindo Pharma Ltd.
Barbara and Edward Netter Professor - Cancer Gene Therapy, Founding Director of the - Clinical Cell and Vaccine Production Facility (CVPF) - University of Pennsylvania
Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 3,000 cellularproducts administered to >1,200 patients in clinical trials since 1996. He is co-inventor of the first FDA approved gene
therapy (Kymriah),chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr. Levine is co-inventor on 27 issued US patents and co-author of >180 manuscripts and book chapters with a Google Scholar citation h-index of 86. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. Dr. Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, serves as President of the International Society for Cell and Gene Therapy, and serves on the Board of Directors of the Alliance for Regenerative Medicine. Dr. Levine Bruce has written for Scientific American and Wired and has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Bloomberg, Forbes, BBC, and other international media outlets.
Vice President (Technical) - Parexel Consulting
Cecil Nick has been working in regulatory affairs and clinical development for over 30 years; for over 25 years he has focused on biological medicines. He has expertise in monoclonals and biosimilars, having worked on over 20 such programs, engaged in over 50 interactions and meetings with regulatory agencies in the EU, US, Canada, Australia, Mexico, Brazil and supported 6 submissions in the EU and US. He has also participated extensively in Industry and International meetings on the subject. Additionally, Cecil Nick has extensive experience in orphan drugs and in numerous therapeutic areas including, but not limited to, oncology, inflammatory disease, diabetes, growth and hematology.
Since joining PAREXEL in February 2001 Cecil has applied his extensive scientific, drug development and regulatory experience in supporting pharma organizations with clinical development plans and regulatory strategies for EU, US and global approval. In the last five years alone, he has worked on scores of clinical development plans connecting the input from pharmacologists, statisticians, therapeutic experts, and feasibility analyses to craft plans which are effective, highly efficient and achievable. He has been working in Regulatory Affairs since 1979. From 1987 – 2000, prior to joining PAREXEL, Cecil served as Regulatory Manager at Novo Nordisk Ltd., working on the development and registration of biotechnological products and NCE’s.
Cecil is a 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. Cecil Nick was on the editorial panel of SCRIP Clinical Research and has authored many articles on regulatory and clinical development issues.
Director, AMBR Consulting - (former MHRA Senior Assessor and EMA CAT Committee Member)
Dr. Christiane has spent 12+ years in governmental medicines, tissue, cell and gene therapy regulation, last with the MHRA, where she worked until August 2019. She was the UK representative at the EMA committee for advanced therapies (CAT). Dr. Christiane was the Rapporteur/ Co-Rapporteur for several advanced therapy medicinal products (ATMPs) and many other biological product applications, including biosimilars. She acted as the Rapporteur and drafting group member for CAT guidelines.
Prior to joining the MHRA, Dr. Christiane worked for the UK competent authority responsible for the European Tissues and Cells Directive as an assessor and inspector. Dr. Christiane Nidederlaender has a Ph.D. and research background in cell-signalling, cancer and stem cells and obtained a law degree in 2005.
Director of Strategy – Gene Therapy - Pall Biotech
Dr. Clive Glover is the Director, Strategy at Pall Biotech where he leads Pall’s cell and gene therapy business. Previously he was responsible for driving product development efforts around cell therapy at GE Healthcare and has also held positions in marketing and product management at STEMCELL Technologies. Dr. Clive Glover holds a PhD in Genetics from the University of British Columbia.
Business Development Manager - Agilent Technologies
Dr. Debdip Ghosh, PhD is the Business Development Manager for the Agilent Chemistries and Supplies Division. He has been entrusted with the role of developing and growing the HPLC columns business among customers in the region. Prior to working in Agilent, he worked as a Staff Scientist at the National Institutes of Health, Bethesda, MD working on Bi-molecular Interaction Study of Peroxisomal Proteins that are targeted to theperoxisomal matrix by virtue of a peroxisomal targeting signal-1. Dr. Debdip Ghosh holds a Masters in Biophysical Chemistry and a PhD in Chemistry from the University of Michigan, Ann Arbor, having worked extensively on Protein Folding.
Senior Manager - United States Pharmacopeia
Dr. McCarthy is a Senior Manager in USP’s Global Biologics Department. She leads a team that focuses on development of new standards that can help address bottlenecks in the biotechnology industry. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where Dr. Diane McCarthy directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.
Professor of Microbiology, Division of Gastrointestinal Sciences, Christian Medical College, Vellore - Executive Director, Translational Health Science and Technology Institute
Dr. Gagandeep Kang received her training in medicine and microbiology at the Christian Medical College, Vellore in southern India and is Professor of Microbiology at the Christian Medical College (CMC) in Vellore, India. She is currently on sabbatical as the Executive Director, Translational Health Science Technology Institute, an Autonomous Institute of the Department of Biotechnology, Ministry of Science and Technology, Government of India, New Delhi. She works on enteric infections in children, particularly on transmission and immune responses, in order to design effective interventions.
Dr. Gagandeep Kang’s current studies include active hospital and community-based surveillance and clinical trials of new and existing vaccines, with use of molecular based assays to study the diversity of pathogens and the immune response of children with viral and parasitic enteric infections.
Senior Vice President - Head, FDA Policy and Regulatory Strategy Practice - Avalere Health, LLC
Dr. Gillian Woollett, M.A., D.Phil., SVP at Avalere, leads the FDA Policy and Regulatory Strategy Practice at Avalere and provides the “prequel” of scientific and technical expertise that supports drugs, biologics and devices gaining approval at the FDA in a manner that allows them to be commercially successful in the public and private reimbursement world. She launched the FDA Practice in 2012. Dr. Woollett and her Team translate into practical action all aspects of regulatory engagement strategy and policy development relevant to commercial success for multiple multi-national clients. Concurrently, she created the Avalere FDA Fellows Program to enable scientists to transition effectively into the policy environment with ~40 now having used this steppingstone to transition their careers.
Previously, Dr. Woollett was Chief Scientist, and Administrator, at the law firm of Engel &Novitt, LLP – a boutique food and drug law firm that fully integrates sound science into all its services, and notably won an unreasonable delay suit against FDA during her tenure. Prior to that, she was VP, Science and Regulatory Affairs at BIO, where she established a new Department to support BIO companies’ interactions with regulatory agencies in all aspects of the discovery, development, and manufacture of biologic medicines from a scientific, technical and policy perspectives. She joined BIO after serving as AVP at PhRMA, where her group led on the negotiation and creation with FDA of the comparability protocol in support of manufacturing changes to already licensed biologics (that became the conceptual basis of biosimilarity). At both trade associations, Dr. Woollett managed the interface between bio/pharma
companies and the US Government in a manner that enabled their collective ability to expedite product development without invoking any concerns of anticompetitive activity. In her PhRMA capacity, she testified before Congress on human cloning, and with four Ambassadors on bioweapon issues.
Dr. Woollett has represented the biopharma industry in the media as the industries’ voice on international, as well as domestic, regulatory and scientific issues. She has been appointed to Federal Advisory Committees; for example, she represented industry on CDC’s Board of Scientific Counsellors to the National Center for Infectious Disease. She currently represents biotechnology on the Material Technical Advisory Committee (MTAC) at the Department of Commerce and chairs the Biotech Work Group that addresses export controls and the Biological Weapons Convention, among other issues. She also provides a point of scientific interface with academic and professional organizations. She is an appointee to the Nomenclature and Labeling Expert Committee of the United States Pharmacopeia (USP), was on the Board for the Foundation for The Accreditation of Cellular Therapy (FACT) and is on the
Science Board of the Pharmaceutical Education Research Institute (PERI).
Dr. Woollett earned her B.A., M.A. in Biochemistry from the University of Cambridge, and her D.Phil. in
Immunology from the University of Oxford in the UK. She was a post-doc in the Department of Molecular Biology at the University of Edinburgh, and at the Biomedical Research Institute, Rockville, MD funded by USAID. Dr. Gillian Woollett is well published in the peer reviewed literature.
Senior Vice President – R&D - Biocon Biologics
Head Vector and CAR-T Cell Processing - Immuneel Therapeutics Pvt.Ltd.
Dr. Hemant Dhamne obtained his Ph. D from the ACTREC, Mumbai (2014) in Applied Virology. His Ph.D. thesis was on the Lentiviral Vector Mediate Long Term Expression of Therapeutic Proteins. He completed his doctoral work in the labs of Dr. Robin Mukhopadhyaya and Dr. Rajiv Kalraiya. His doctoral studies mainly focused on developing the novel LV platform using the inhouse HIV-1 derived vector system and its application for cell engineering and tumor targeting in pre-clinical models. From 2014 to 2015, he was a post doctoral fellow in the laboratory of Dr. Amit Dutt in the same institute working on functional genomics aspects spanning novel miRNA discovery and novel mutations in cancer causing genes and associated pathways. Thereafter, he joined Gene Therapy Division at Intas Pharmaceuticals, Ahmedabad. Dr. Dhamne worked on early stage product development of AAV mediated gene therapy for diseases such hemophilia, neuronal and eye disorders. He successfully developed the pilot scale manufacturing platforms using suspension cell lines in upstream and chromatography in downstream process. He also contributed for assay development. He also developed early stage designs and assays for CAR-T research.
In 2018 to 2019, Dr. Hemant completed Diploma in International Business Management from Ahmedabad Management Association in affiliation with California State University.
In 2019, he joined Immuneel Therapeutics as Head of Vector & CAR-T Manufacturing. His work encompasses the process development and GMP grade manufacturing of autologous CAR-T cells for clinical trials. The disease areas mainly include the leukemias and lymphomas.
Dr. Hemant Dhamne has 7 peer reviewed publications in the field of gene therapy and functional genomics.
Whole-time Director & CSO - Enzene Biosciences
Managing Director - Maven E&L Ltd.
Mr. Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independent consultant providing advice in the area of extractables and leachables, after working for GSK in the area of extractables and leachables since the mid 1990’s. Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority relating to the support that GSK has given to extractables and leachables (E&L).
Before setting up Maven E&L Ltd, he was the director of a team of analytical chemists who are responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities. This included; biopharmaceutical and small molecules including Inhalation, Parenteral and Cell & Gene Therapy use. He has had the pleasure of commenting on PQRI guidelines on E&L for GSK, the E&L section in EMEA guidelines on inhalation and nasal products and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.
Mr. Creasey has been a member of several external groups concerned with the development of best practice guides for extractable and leachables issues these include; the IPAC-RS material working group, BPOG and continues as a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE. Currently Mr. Creasey is working and commenting on risk- based approaches to E&L requirements, which he hopes will form part of an ICH guidance in the not too distant future.
Technical Vice President - Parexel
Dr. Jorge Camarero is a technical Vice President – Clinical, Regulatory and Access at Parexel.
With more than 15 years of experience, he has worked as a clinical assessor at the Spanish Medicines Agency (AEMPS) and as alternate member of the Committee for Medicinal Products for Human Use (CHMP) and member of the Oncology Working Party (OncWP) in the European Medicines Agency (EMA) . He has considerable experience in oncology products.
Dr. Jorge was a member of the Regulatory Consulting Services team within Regulatory and Access. He has immense experience and expertise in Oncology products and rare diseases, including small molecules, monoclonal antibodies, biosimilars and other protein products. He provides scientific advice and assessment of medicinal products in EU (EMA) and is an expert for the Spanish Ministry of Health in the assessment of advanced therapies (CAR-T cells)
Dr. Jorge has completed his Pre-doctoral and Post-doctoral researcher in Pharmacology Department of the Medicine School (Complutense University, Madrid; Spain). He is a Master of Science - Research and Development of new medicines, Navarra University, Spain. Dr. Jorge Camarero has completed his MSc Assessment and Market Access in the Pharmaceutical Sector, Carlos III University, Spain
Sr. Product Manager - Thermo Fisher Scientific
Kevin Mullen is currently a Sr. Product Manger a Thermo Fisher Scientific and is based in Logan Utah. Kevin has been with Thermo Fisher for 3.5 years and is the primary product manager for Single-Use Bioreactors and Single-Use Fermentors. Kevin has helped the Thermo Fisher development team enhance and better characterize the performance attributes of single-use hardware systems. Kevin is primarily responsible for new hardware development and strives to make sure that single-use systems are developed and maintained to meet performance requirements of today and the future. Prior to joining Thermo Fisher, he spent 13 years as an engineer and product manager in the medical device industry. Kevin Mullen holds an M.S. degree and an MBA from Utah State University majoring in Biological Engineering and business respectively.
Dy Director - Serum Institute of India
Vice President - Innovation Science and Technology, Intas Pharmaceuticals
Dr. Lakshmikanth Gandikota is the Head of the Center for Gene and Cell therapy and additional charge for the Manufacturing Sciences and Technology (MSAT) for Biopharma at Intas Pharmaceuticals.
He is responsible for Cell and Gene therapy program is focused on development of cell-based therapies such as CAR-T and stem cell transplant therapy. He is also accountable for Development of Autologous and Allogenic Cell lines for treatment of several blood disorders and cancers. Development of Lentivirus for CAR-T therapy and Adeno-associated virus based viral particles for monogenic disorders.
Dr. Gandikota is involved in Novel Vaccine development: plasmid DNA based Vaccines, DNA based live attenuated viral vaccines, AAV based vaccines for COVID. Prior to Intas, he was Vice President at Biological E. Limited where he was responsible for Analytical and Process Development of Complex Generics. At Dr. Reddy’s Laboratories as Director of Fermentation Technology Development Center, he headed the downstream process and analytical development, Biosimilars Product Development along with Monoclonal Antibodies and other therapeutic proteins. As a head and GM of Analytica R&D at Sanofi India Limited, he led a team for Biopharmaceutical Characterization of Proteins, Polysaccharides, Protein-Polysaccharide Conjugates and Live Virus Vaccine Candidates.
Dr. Lakshmikanth has completed his PhD. In Biophysics from Tata Institute of Fundamental Research (TIFR) and is a Damon Runyon Cancer Foundation Fellow of Cellular and Molecular Biology at Stanford University School of Medicine. Dr. Lakshmikanth Gandikota is a Gold Medalist in Master of Chemistry at University of Hyderabad.
Chief Scientific Officer - Polpharma Biologics
Dr. Louis Boon received his Ph.D. in Biochemistry at the University of Amsterdam. He was one of the founders of PanGenetics. Thereafter Dr. Boon was for 2 years Director of Preclinical R&D of MacroZyme BV, where he was responsible for a small molecule project in the metabolic field and various potential protein-based therapeutic molecules. In 2003 he was one of the founders of Bioceros BV where he held a position of CSO. In addition, he held a position as CSO for 4AZA Bioscience NV and VP Preclinical (ad interim) for PanGenetics BV until the end of 2006. He has extensive experience in molecular and cellular immunology and in therapeutic antibody development. Dr. Boon is author of over 300 papers in international scientific journals in the field of medical biotechnology.
In his position as CSO of Bioceros he was responsible for the pre-clinical development of monoclonal antibodies and the generation of production cell lines/processes for the industry and used the proprietary CHOBC® platform to generate a portfolio of cell lines producing biosimilar monoclonal antibodies and to generate cell line/processes for developing NBEs. Since the acquisition of Bioceros by EPIRUS Biopharmaceuticals he builds on this expertise and has developed a complete process modulation toolbox to fit biosimilar CQAs in their relevant Tier ranges. After the acquisition of Epirus NL by the Polpharma Biologics group Dr. Louis Boon has continued to work on biosimilar development and innovative new molecular antibody entities. During that period the novel SPOT™ and SLIM™ technologies were developed.
Advisor Biotechnology Research - Wockhardt Ltd.
Dr. Maharaj Kishen Sahib is an Advisor Biotechnology Research at WOCKHARDT Ltd. He was an Ex-Director – Genomics & Biotechnology. He completed his education from PhD/Biochemistry, C.D.R.I., Luknow, Year 1967; M.Sc/Biochemistry, Aligarh Muslim University, Aligarh, 1964. Before joining Wockhardt Dr. Sahib was Sr. Asst. Director CDRI Lucknow, 1986 to 1991; Scientist, Asst. Director 1971 to 1986. He was a Visiting Scientist at: NIH, Bethesda, Maryland, USA, 1975-1977; National Institute of Medical Research Mill Hill, London, UK, 1989-1990; Institute Pasteur, Paris France and INSERM, France. 1988-89
Dr. Sahib was an Assistant Professor / Lecturer in University of Colorado, School of Medicine, Denver, Colorado, USA, 1970-1971; Banaras Hindu University, Varanasi, 1967-1968.He was a Research Associate at Harvard Medical School, Boston 1968-1970. Dr Sahib is a recipient of several Awards and Honors like: Governor of Maharashtra State’s (India) nominee to membership of Management Council & Senate, Dr. Babasaheb Ambedkar Marathwada University, Aurnagabad, Maharashtra.Dr. C.R. Krishnamurty memorial oration award 2000, several awards from Wockhardt.
Dr. Maharaj Sahib has More than 100 in peer reviewed International Journals and several international patents to his credit. His Achievements include Started and established Biotechnology Research Center at WOCKHARDT. Leading R&D Team for successful development of biosimilars/vaccines/fermentation products.
Principal Consultant Clinical Pharmacology - Parexel
Dr. Matthias is a Principal Consultant Clinical Pharmacology at Parexel Regulatory & Access. He heads the Pharmacokinectics and Pharmacometrics at Parexel. With more than 20 years of medical and scientific expertise in early drug development, he is a clinician internal medicine. Dr. Kruse is a member of the German Association for Applied Human Pharmacology and the Drug Information Association. He is certified Clinical Pharmacologist, with diversified experience in the areas of basic and advanced pharmacokinetics, pharmacodynamics, toxicology and bio–pharmaceutical methodologies. He has broad expertise in study design, data analysis and interpretation of results including preparation of clinical study reports and market application documents. Dr. Matthias has completed his specialization in Clinical Pharmacology from University of Berlin, Germany, Ph.D. Pharmacology & Toxicology from University of Tübingen, Germany and Medical School from University of Tübingen, Germany
Head – R&D-MTech-CMC - Sanofi Healthcare India Pvt. Ltd.
Dr. MRK Raju Matena, Head of R&D-MTech-CMC at Sanofi Healthcare India Pvt. Ltd. He has 19 years of experience in Vaccine & Biomolecule research & development, technology transfer & Quality control. Dr. Matena has a strong exposure to Indian and WHO regulations related to Vaccines & working experience with these regulators on harmonization.
He has got his doctorate from the University of Melbourne, Department of Microbiology & Immunology, Melbourne, Australia. And did his M.Sc. Biotechnology, Barkatullah University, Bhopal, India. Dr. Matena has authored many publications as well.
Former Vice President – R&D - Biocon
Narendra Chirmule is the co-founder and CEO of SymphonyTech Biologics, a data analytics company focused on engineering solutions to biology. As former Head of R&D at Biocon (Bangalore), and leadership positions in Amgen (Thousand Oaks, CA) and Merck Vaccines (West Point, PA), has contributed to clinical development of vaccines and biopharmaceuticals. Dr. Chirmule completed his PhD on development of a leprosy vaccine, from Cancer Research Institute, Mumbai; post-doctoral studies on pathogenesis of AIDS from Cornell University Medical College-North Shore Hospital, New York. He has been teaching and conducting research as assistant professor in gene therapy at University of Pennsylvania, Philadelphia. Dr. Chirmule is on the NIH advisory committee for HIV vaccines.
Director - Moderna Therapeutics
Dr. Paloma Giangrande is an Associate Professor of Internal Medicine(U of Iowa) and a Director of Research (Moderna Therapeutics, Cambridge, MA). She obtained her BS in Biochemistry at Wheaton College in 1994 and her PhD in Pharmacology andCancer Biology at Duke University in 1999. She is an internationally recognized expert in oligonucleotide therapeutics and delivery and was the first to demonstrate that RNA ligands (aptamers) can be used to deliver siRNAs to specific cell-types in vivo. Her career has been dedicated to the development of RNA-based therapeutic approaches (including aptamers, siRNAs, and mRNA) for cancer, cardiovascular disease, rare diseases, and critical illness. Her contributions to the field have been recognized with awards from several scientific societies. Dr. Palima Giangrande’s 60+ publications/9+ patents are a testament to her commitment to the development of novel RNA-based therapies for many diseases.
Chief Operating Officer - Drop Bio
Program Director – Office of Rare Diseases Research - National Center for Advancing Translational Sciences (NCATS), National Institute of Health (NIH)
Dr. P.J. Brooks is a Program Director in the NIH National Center for Advancing Translational Sciences (NCATS) Office of Rare Diseases Research (ORDR). He received his Ph.D. in neurobiology from the University of North Carolina at Chapel Hill. After completing a postdoctoral fellowship at the Rockefeller University, he became an investigator in the NIH intramural program. He developed an internationally recognized research program focused on rare neurologic diseases resulting from defective DNA repair. Since joining NCATS and ORDR, Dr. Brooks is interested in accelerating clinical trials in rare diseases by moving beyond “one disease at a time” approaches. Examples include the development of therapeutics that target shared molecular mechanisms underlying multiple rare diseases, platform technologies for the delivery of nucleic acid therapeutics, and the implementation of recommendations regarding the acceleration of gene therapy clinical trials. He is also the coordinator of the NIH Common Fund’s Somatic Cell Genome Editing (SCGE) program. Dr. Brooks was recently elected as the Interdisciplinary Scientific Committee Chair for the International Rare Diseases Research Consortium.
GM, Scientific Documentation & Compliance - Serum Institute India Pvt. Ltd.
Ms. Rajeshwari Adhiseshan holds a Masters degree (first class with distinction) in Pharmaceutical Sciences, from BITS, Pilani. She has over 20 years of industry experience that includes Sun Pharma, Dr. Reddys laboratories , and Biological E limited, in positions pertaining to Regulatory affairs, Clinical QA and Compliance. Presently, Ms. Rajeshwari Adhiseshan is heading the Scientific documentation and Compliance team at Serum Institute of India , Ltd, Pune.
Chief Executive - Biologicals, Panacea Biotec Ltd.
Mr. Rajinder Kumar Suri, Chief Executive-Biologicals, Panacea Biotec Ltd. has over 42 years of experience in Pharmaceuticals & Biological products in India & International markets out of which around 25years at the top management level including four years on the Board of Directors of the Indian subsidiary of Sanofi Pasteur. He brings with him over 3 years of consulting experience as CEO & Senior Advisor, Arete Business Advisors.
Mr. Rajinder is founder member of Indian Vaccine Manufacturer’s Association (IVMA) and also on the Board of EBPMN (Emerging Biopharmaceutical Manufacturers Network). He is founder member of APCRI (Association of Prevention & Control of Rabies in India).
Mr.Suri is former Member-Policy & Planning Committee (PPC), an advisory body to GAVI Board, representing DCVMN from October 2013 till June 2017, as also a Member of GAVI Steering Committee for Supply & Procurement Strategy. Mr. Rajinder has been Member Executive Committee & Vice-President, DCVMN for a period of two years from Oct.2014-Oct.2016.
Mr. Rajinder Suri has played a lead role in negotiations & interactions with Ministry of Health, Government of India, UN agencies and other Global organizations like WHO, UNICEF, Bill & Melinda Gates Foundation, Clinton Health Access Initiative & several others.
Vice President - Scientific Outreach, Biologics United States Pharmacopeia.
Dr. Ranjan Chakrabarti has over 23 years of experience in Pharmaceutical and Biopharma industries. Before joining to Industry, he worked in Academics at USA and successfully coordinated research projects in Cancer Cell Biology and Diabetes. He has guided several Ph. D. students. Before joining USP, Dr. Ranjan was leading the Biology Group at Dr. Reddy’s Drug discovery and also served at key management position in GVK Biosciences. He has worked with several National and International companies for discovery and development of both chemical and biological molecules.
Dr. Ranjan is the Co-Inventor of 32 US Patents; published 60 papers in peer reviewed International Journals and presented 90 lectures in International and National Conferences.
Assistant Professor in Engineering Sciences - Institute of Chemical Technology
Dr. Ratnesh Jain is Assistant Professor in Engineering Sciences and Ramalingaswami Fellow at Department of Chemical Engineering, Institute of Chemical Technology (ICT). Dr. Jain is heading “National Facility for Analytical Characterization of Biopharmaceuticals” being setup by Department of Pharmaceuticals, Govt. of India, in addition to the existing Biologics Characterization Lab at ICT. From 2012, Dr. Jain has taken various initiative towards biosimilar characterization and educational initiative e.g. Biosimilar Workshop to support biopharmaceutical sector related to skill development, infrastructure development and entrepreneurship. Dr. Ratnesh Jain has more than 55 publications and 150 presentations.
Head – Vaccine Development Department - International Vaccine Institute (IVI)
SI, FRSB, FPAMS, FACB, Founder - Karyo Biologics, Adello Biologics and PharmaSci, Adjunct Professor University of Illinois and University of Houston
Dr. Sarfaraz K. Niazi, teaches how to stay a step ahead of the change in adopting therapies to alleviate human suffering. He advises regulatory agencies including FDA and creates technology to make medicines more accessible. He has authored more than 50 books and has more than 100 patents in the pharmaceutical and biopharmaceutical field. He has taken several products to market and continues to analyze the biosimilar guidance to make it more sustainable and scientifically robust. Dr. Niazi has developed patented testing methods including thermodynamic testing for biosimilarity establishment.
Dr. Niazi has created safety testing protocols for genetic vaccines; developed scale-up of mRNA vaccines and provided advisory to the FDA on evaluating the phase 3 data on COVID-19 vaccines.
Dr. Sarfaraz Niazi is an inductee into the Entrepreneur Hall of Fame for his leadership and raising hundreds of millions of dollars. He is recognized by the Forbes magazine, as "the most interesting man changing healthcare."
Business Manager – Cell Cuture Technologies Asia - Sartorius Stedim India Pvt. Ltd.
Director and V.P. Marketing - GVS Cibatech Pvt. Ltd.
Senior Vice President - Oblique Therapeutics AB, Sweden
Dr. Sreesha Srinivasa has more than 20 years of experience in global biotechnology and pharmaceutical organizations. He has broad experience in drug discovery and development with special focus on novel therapeutics, translational sciences and oncology. He has led and contributed to several discovery and development programs which have gone onto clinical development including FDA approved drugs Crizotinib and Palbociclib. During a 20+ years career in biopharma, Dr. Sreesha has held leadership positions at CGI Pharma (now Gilead), Pfizer, Jubilant, Piramal and Biocon. Currently, he is Sr. Vice President at Oblique Therapeutics, Gothenburg, Sweden. Dr. Sreesha Srinivasa holds a Ph.D. in Molecular Biology & Biochemistry from Washington University School of Medicine, St. Louis, USA.
Vice President & Head Biosimilars Product Development (Biopharma Division) - Intas Pharmaceuticals Ltd.
A leader with 14 plus years of experience in the biosimilar industry with a focus on developing molecules for US and EU markets. Dr. Sridevi is presently Vice President and Head of Biosimilar Product Development at Intas and has several patents and publications to her credit. She is also a part of the Protein Therapeutics Expert Committee of USP. Dr. Sridevi Khambhampaty has served as a Lymphoma Leukemia Society fellow at Stanford University School of Medicine, California and has a Doctorate degree from the NCBS-TIFR, Bangalore.
Principal Scientist, SLS – Global Regulatory and Validation Consulting group - Pall Biotech
Sudhakar Nagaraj has been in Pharmaceutical industry for over 18 years and has held positions of increasing responsibility in Pharmaceutical QC/QA, R&D, Validations and Regulatory affairs. He joined Pall during 2006 in Scientific Laboratory Services (SLS) organization and has been involved in updating Pall’s technical support portfolios with rapidly evolving end-user and regulatory requirements, to streamline customer selection, adoption and successful regulatory approval of Pall technologies.
Currently, he is part of SLS Global Regulatory and Validation consulting team which is focused to provide streamlined technical guidance and scalable, customer-focused solutions to facilitate customer specification, qualification, validation and regulatory approval with Pall technologies. Examples of customer-focused solutions include application risk assessments for adoption of Pall technologies, development of improved Extractables and Leachables validation service, toxicology service, high risk filter validation (SOAR) service, customer-aligned change management model, online access to controlled filter integrity test values, standardized material compatibility information, Biotech material resins repository, BPOG & USP extractables datasets and QbD/QRM support packages.
He is an active PDA India chapter member and represents Pall in Asia. He has completed post-graduation in Microbiology and based out at Bangalore, India.
Director – R&D and Manufacturing - Human Vaccine Development - Serum Institute of India Pvt. Ltd.
Dr. S.K. Jana is a Ph. D. in Engineering, an M. Tech. in Biochemical Engineering, B. Tech. in Chemical Technology, Jadavpur University, Calcutta, B. Sc. in Chemistry, Calcutta University PGDOM (Post Graduate Diploma in Operations Management), New Delhi. His Ph. D. Thesis was on ‘An Industrial scale process development for the production of Vaccine-grade recombinant Hepatitis B Surface Antigen (r-HBsAg) expressed intracellularly in methylotrophic yeast, Pichia pastoris. Dr. Jana is a University Gold Medalist, National Scholarship holder & GATE qualified, Govt. of India, SRF & JRF (DBT & DST). He has been awarded the ‘BEST Scientist & Employee award’ from Shantha Biotechnics Ltd. (A Sanofi group), India.
The last 29+ years of his work experience have been gathered working in Biopharmaceuticals industry with increasing responsibilities. During this tenure he has worked on several interesting and challenging projects with some highly reputed Biotech organizations in India in various capacities. His core expertise is in the areas of early stage, late stage, pilot scale development & commercial scale production of Upstream & Downstream Process Development, Bioanalytic methods development, Polysaccharide-protein conjugate vaccine, Technology Transfer, Project planning & execution. Dr. Jana has eextensive experience is in process & Technology development, optimisation, validation & Technology transfer. He is proficient in analysing and interpreting research results and technical data and is sharp at identifying potential in the design of early phase of the project, troubleshoot and solve problems associated with the process. He has proven track record of participating in various research projects with real-time experience in planning, execution, application of methodologies, documentation and presentation of findings. Currently as a Director, he is involved in Pneumococcal Polysaccharide Conjugate Vaccine related activities & other vaccines at Serum Institute of India Pvt Ltd.
Baskets of the products which he has developed and worked either on the Biopharmaceutical Process Development or Tech Transfer is:
Lovastatin, rh-G-CSF, Hepatitis-B vaccine (r-HBsAg), rh-IFN-a 2b, r-Streptokinase, rh-Insulin, r-Erythropoietin (CHO cell line), rh-t-PA, DTP, ACP (Acellular pertussis-recombinant & non-recombinant), Hib conjugate vaccine, HPV(Antigen of 5 as a single polypeptide), DTP-HepB-Hib Penta valent vaccine of Diptheria, Tetanus, Pertussis, Hepatitis-B & Hib, live Cholera vaccine.
Dr. SK Jana has 15 national and internationals patents along with 8 paper publications.
Principal Investigator and CMC Reviewer - US Food and Drug Administration
Dr. Zuben E. Sauna is a Principal Investigator and also a CMC Reviewer at the US Food and Drug Administration. His research interests lie in understanding the pharmacogenetic basis of the immune response to proteins used in therapeutic interventions as these affect efficacy and safety. His laboratory exploits a combination of computational, in vitro and ex vivo approaches to understand why some individuals and/or sub-populations develop immune responses while others do not. Work from his laboratory has been published in high impact journals such as Nature Biotechnology, Nature Medicine, Science, Science Translational Medicine and Nature Reviews Genetics. Dr. Zuben Sauna has received his Ph.D. from Poona University, India with subsequent training at the National Cancer Institute, Bethesda, USA.