Dr. Sarah McMullen is the Country Director for the FDA India Office. Her professional experience has included analytical method development and testing for multiple FDA-regulated commodities, establishment inspections, import operations and policy, and foreign office service. Her FDA career has spanned over 20 years working as a chemist, tissue residue specialist, consumer safety officer, and leader. The last nine years of her experience has focused on international arenas including import operations and foreign office service. Dr. McMullen has a Doctor of Philosophy in inorganic chemistry and a Bachelor of Science in chemistry from Emory University.

Dr. Natalie Mickelsen has accepted the position of Deputy Country Director of the India Office, after a brief detail acting in the position. The last five years of her experience have been working for the FDA India Office – most recently as the FDA India Office Supervisory Consumer Safety Officer. In 2013, she joined the FDA as a consumer safety officer conducting human and animal food and bioresearch monitoring inspections. Prior to working with the FDA, she was a large and small animal veterinarian in private practice. She also worked at the USGS National Wildlife Health Center conducting research on Chronic Wasting Disease in deer and at the University of Kentucky Medical Center conducting research on Lyme Disease.

Ms. Kristan Callahan is an international relations specialist in the India Office of the USFDA, Office of Global Policy and Strategy, focusing her work on medical products and bioresearch monitoring. Prior to this role, she worked as a public health advisor in the Office of Trade, Mutual Recognition, and International Arrangements. She started in OGPS in 2018. Prior to joining OGPS, Kristan served as a lead regulatory counsel in the Center for Drug Evaluation and Research. While there, she advised CDER’s Office of Management, Division of User Fee Management and Budget Formulation staff on matters related to the user fee amendments involving biosimilar biological products, brand name and generic drug products, and compounding pharmacies.

Greg is the new Deputy Director for the India Office. He joined FDA’s India Office in 2022 as an International Relations Specialist focusing on the Drugs portfolio. Previously, Greg directed CDER’s Special Projects Staff - a multi-disciplinary staff working on mission-critical scientific, regulatory, legislative, and operational projects. Greg joined FDA in 2011 as a CVM Project Manager serving as the primary liaison on the drug approval process for sponsors and review teams. Prior to the FDA, Greg managed various aspects of Phase I-IV clinical trials for global CROs.

Mr. Dhruv Shah is a Public Health Specialist working as a Senior Technical Advisor with the FDA India office. Prior to joining FDA, Dhruv worked with major Pharmaceutical R&Ds. He brings around 10 years of experience in formulation development of diverse dosage forms for US, EU, and other regulated markets. His domain expertise includes product development using Quality by Design (QbD) concepts, process development, optimization, scale up, validation and technology transfer. Mr. Shah holds a Master of Pharmacy degree with specialization in Pharmaceutical Technology & Pharmaceutics.

Dr. O’Connor joined the FDA in 2013, serving as a CMC reviewer in the Office of Generic Drugs and then as a team leader in the OPQ Science Staff before joining Div. of Product Quality Research (DPQR) in the Office of Testing and Research (OTR). He subsequently became the Division Director of DPQR, and in this role Tom has planned, managed and directed the regulatory research program across several interdisciplinary areas including characterization of complex drugs, manufacturing science, post market product quality surveillance and emergent public health issues (e.g., nitrosamines and hand sanitizer studies).

Sharmista Chatterjee is currently the Division Director in Division of Pharmaceutical Manufacturing II, within FDA’s Office of Pharmaceutical Manufacturing Assessment (OPMA), in CDER, FDA. She has been with the FDA since 2006. During her tenure she has been actively involved in many agency initiatives that include Quality by Design efforts, FDA-EMA QbD pilot program, KASA, NIR guidance, Continuous Manufacturing, and in the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) . She has served in many roles of increasing responsibility including serving as the CMC Lead for QbD (Quality by Design) in the Office of New Drug Quality Assessment (ONDQA) and as the technical lead for the FDA-EMA QbD pilot.

Manuel Osorio is the lead for the Advanced Technologies Program in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Prior to this role, Dr. Osorio was a researcher/reviewer for 16 years in the Office of Vaccines Research and Review in CBER. He received a BS degree from UCLA in Biochemistry and PhD degree in Cellular Immunology from the University of California at Santa Cruz. He was a postdoctoral fellow at the National Institutes of Health before joining the FDA.

Dr. Matsuda is a pharmacist and a senior scientist for Quality, Pharmaceuticals and Medical Devices Agency (PMDA). He received Ph.D. degree in Medicine from Tokyo Medical and Dental University in 2003. He joined the Pharmaceuticals and Medical devices Evaluation Center, the predecessor of PMDA, in 2003 and he is currently responsible for quality assessment of medicines. He was a member of ICH Q9 Expert Working Group, ICH Quality Implementation Working Group (Q-IWG) and ICH Informal Quality Discussion Group (IQDG). He leads Innovative Manufacturing Technology Working Group (IMT-WG) at PMDA and he is a regulatory chair of ICH Q13.

Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER’s Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory scientist, team lead, Associate Director for Science, Deputy Office Director, Office Director, and Deputy Super Office Director of Science. He has provided exemplary leadership in developing OPQ science, research and testing programs to support quality assessment, inspection, surveillance, and policy.

As Vice President for Manufacturing Services at USP, Dennis Hall is focused on developing and delivering solutions to reduce barriers to adoption of Advanced Manufacturing Technologies. Mr. Hall has been a key leader at USP since 2001 in a variety of areas including strategy, and marketing roles including leading USP’s Global Growth initiative focused on Asia, Europe, and Latin America. Mr. Hall holds an MBA in Strategic Management and Marketing from University of Maryland Smith School of Business, a Master of Arts in Education from the College of William and Mary, and a Bachelor of Science in Physics from Clarion University of Pennsylvania.

Dr Karen Loft is a chemist by training, obtaining a PhD in Organic Chemistry at the University of Melbourne. Prior to joining the TGA, she spent a number of years in medicinal chemistry research. Karen has over 10 years’ experience at the TGA in the areas of pharmaceutical chemistry evaluation (new registrations and variations), including products manufactured using advanced processes, as well as Risk Management Plan assessment. Karen now works in the Regulatory Strengthening Program, providing technical assistance to countries across Southeast Asia and the Pacific.

Dr. Robin Meier is Scientific Director at L.B. Bohle Maschinen und Verfahren GmbH. Together with his experienced team of process and automation engineers he is responsible for the continuous manufacturing technology QbCon®, the numerous scientific collaborations with universities / scientific consortia and the continuous improvement and development of the existing batch machines and the continuous manufacturing equipment.Robin is a pharmacist by education, specialized in pharmaceutical technology and biopharmacy and works with continuous manufacturing technologies for ten years.

Rajeev is currently working as Executive VP & Head – API R&D at Dr. Reddy’s Laboratories Limited. He holds a Masters and a Ph.D. degree in Organic Chemistry from Maharaja Sayajirao (M.S.) University of Baroda. He has over 30 years of experience in the areas of academic research at M.S.University, followed by Process Chemistry of generic APIs at Sun Pharma’s R&D centre at Baroda, leading to numerous DMF/ANDA filings for a gamut of molecules of varying complexities, including Peptides. He is very passionate about R&D collaboration cutting across cross-functional domains,both within and outside the company, including external subject matter experts.

Dr. Manjinder is responsible for process intensification and development of continuous process for API from development to validation in a GMP environment and continuous down-streaming process, reducing the manufacturing footprint by adopting greener process increasing the atom economy, increasing efficiency. Development of API in various therapeutic area, over 40 patent and publications.

Ms S. Aparna is currently Secretary to the Government of India, in the Department of Pharmaceuticals since 1st October 2020. She is a member of the Indian Administrative Service, for the past three decades. She has a wide range of experience in the national, state and local governments. After her initial years in the District administration, her principal areas of experience have been Public Finance, Development Policy and Planning, and Urban governance. She has served on the Board of Directors of over 15 public sector companies, operating in energy, industrial infrastructure, and financial services.

Dr. Venugopal G Somani is the Drugs Controller General of India (DCGI) since July 2019. Dr. V.G. Somani did his MPharm and PhD in Pharmaceutical Sciences from Nagpur University, India. Earlier he worked as a Joint Drugs Controller (India) in CDSCO heading the Divisions of Regulation of Medical Devices & In vitro Diagnostics, Stem cells & Blood Products, New Drugs (which are Subsequent & Fixed Dose Combination), He has also worked as Joint Drugs Controller (India) heading the divisions of Biologicals, Clinical Trial, New Drugs and Cosmetics, Enforcements for several years. He was primarily involved in dossier assessment, monitoring, and framing of proposals for amendments in Rules, policies, and guidelines.