QbD in Pharma Development World Congress Keynote Speakers

Brian Carlin Director, FMC BioPolymer Brian Carlin is the 2012 recipient IPEC Foundation award for Industry Research Achievement in Excipient Technology. He is currently the Director Open Innovation (Pharma), FMC Health & Nutrition. Previously he was the Global Mgr Pharmaceutical R&D. He has been with FMC for eighteen years. He also Chairs IPEC QbD and Excipient Composition Committees, and serves on USP Excipient Committee. He worked at SmithKline Beecham & Richardson Vicks in new product development for sixteen years. He is Doctorate in Interfacial Rheology, University of London, and BSc(Hons) Pharmacy, University of Aston.He also teaches distance learning MSc in QbD at Demontfort University, as honorary visiting Professor. He is also an Excipient science and QbD leader.
Barry Gujral Director, Patheon Dr. Barry Gujral is working as Director, Corporate Quality Analytics at Patheon Inc. He has an experience of working in pharmaceutical industry for more than twenty years. Barry has completed several Analytics projects saving multi-million dollars including a project with the FDA on Statistical Modeling and Quality by Design. Dr. Barry holds a Master of Chemistry degree from Illinois Institute of Technology, Chicago and PhD in Analytical Chemistry. Dr. Barry earned his MBA from Fuqua School of Business, Duke University. He has published several scientific publications, co-author of five books and a US Patent. Dr. Barry is a Certified Lean Six Sigma Master Black Belt.
Ajaz Hussain Consultant, Insight Advice & Solutions LLC Dr. Ajaz S. Hussain’s mission is to improve predictability of medicinal product development and regulatory approvals. He has led some of the U.S. Food and Drug Administration's major initiatives to develop regulatory policies that already have, and will continue to have, a significant impact on product development and approval in many geographies. His current practice continues this mission, with a focus on helping his clients identify and mitigate risk in their development projects and in non-compliance with regulations. Among his recent career accomplishments: (1) Ajaz has led the development and/or regulatory submissions of first-in-class Biosimilar, Follow-on Protein and Complex Generic products at Sandoz during a critical phase for the company when it had to successfully navigate through uncharted organizational, legal and regulatory terrains; (2) At Philip Morris International, he took on the challenge of higher levels of uncertainty (regulatory and business) and product complexity to build strategies and systems to successfully move forward development programs on plant-based vaccines, products for tobacco harm reduction, and ensure credibility of scientific evidence to seek regulatory discussions and submissions, and (3) Ajaz’s experience at Wockhardt has helped him to understand the opportunities and talent companies in India have, the challenges they face, and how they can bring forward effective solutions to maintain and enhance competitiveness and credibility. His broad experience in industry combined with his experience at the FDA form the foundation of his current practice. The solutions he can offer to your enterprise are based on a deep understanding of the challenges faced by business decision-makers as well as the factors that contribute to risk of development failure and regulatory non-compliance; an understanding that spans multiple products, sectors, and organizational cultures.
Krishna Venkatesh Vice President, Dr Reddy's Laboratories Ltd Krishna has over 17 years of experience in pharmaceutical product and process development. Krishna holds a Bachelor’s degree from BITS Pilani and a Masters degree from University of Mississippi. He has worked in the areas of Preformulation using advanced solid state characterization instrumentation, product development, technology transfer, scale up/ optimization and commercialization. Krishna has participated in several Industry-FDA collaborative programs in association with GPhA (USA) and has been an invited trainer in FDA inspectorate training programs for the OGD review division. He has been an invited speaker in several conferences in the USA and in India on the topics of Product Development, Quality by Design, PAT deployment and commercialization. Krishna’s interests are in the areas of structured product development using QbD concepts, process design and process control using fit-for-use PAT capabilities for DRL in exploring continuous and continuous to batch manufacturing and other control systems. Krishna worked for Barr Labs, followed by Teva Pharmaceuticals in the USA before joining Dr. Reddy’s labs in 2010. Krishna is currently Vice-President and leads the Global Oral Solid Dosage development for Dr. Reddy’s with end to end responsibility from portfolio selection to commercialization.