Dr. Nina Brahme is a Scientific Reviewer at FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB) since 2019, where she contributes to providing clear scientific advice for biosimilar and interchangeable product development. She previously worked as a product quality reviewer in FDA’s Office of Biotechnology Products (OBP) for two years. Dr. Brahme holds a Bachelor's in Molecular and Cell Biology from UC Berkeley, a PhD in Cell Biology from Yale, and a Masters of Public Health from Harvard T.H. Chan School of Public Health. As a National Cancer Institute Postdoctoral Fellow, she also participated in OBP research and review work.

Dr. Christopher Downey is the Director of the Division of Pharmaceutical Manufacturing Assessment VI in CDER/OPQ’s Office of Pharmaceutical Manufacturing Assessment (OPMA), a role he has held since May 2022. His division ensures product quality and sterility for CDER-regulated biologics by assessing microbiology controls and manufacturing data in BLAs, and leading pre-license inspections (PLIs) of manufacturing facilities. Previously, Dr. Downey was a Review Chief (2017–2022), Team Lead (2014–2017), and Reviewer (2012–2014) in the Office of Biotechnology Products. He holds a PhD in Biochemistry from the University of Colorado at Boulder and was a postdoctoral fellow at the University of Colorado and Georgetown University Medical Center.

Ms. Sarah Ikenberry is a Senior Communication Advisor at the FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB) in CDER, where she manages education and stakeholder engagement for biosimilars. She provides strategic communication support to senior leaders on biosimilar initiatives and priorities. With over 20 years of experience in public health and regulatory roles, Sarah has expertise in strategic communication planning, stakeholder outreach, campaign management, message development, and content creation for both web and traditional media. She holds a Master of Arts in Communication from Johns Hopkins University.

Dr. Kristen Nickens is a Product Quality Team Lead in the Office of Product Quality Assessment III (OPQAIII) within the Office of Pharmaceutical Quality (OPQ) at CDER, FDA. She leads teams to ensure compliance with regulatory standards for biosimilars and biologics. Dr. Nickens began her regulatory career in 2013 as an NIH-FDA Interagency Oncology Task Force Fellow at CBER, focusing on cell and gene therapies. In 2014, she joined CDER as a Product Quality assessor, specializing in CMC assessment of complex biologics. She has expertise in the regulatory lifecycle of biotech products, from early development to post-licensure. Dr. Nickens holds a Ph.D. in Molecular Medicine, specializing in Oncology, from The George Washington University.

Dr. Stacey Ricci is the Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars at CDER. She has contributed to FDA guidance and standards for biotechnology-derived therapeutic proteins, particularly biosimilars. Dr. Ricci leads a multidisciplinary team overseeing the review of biosimilar and interchangeable products, advancing biosimilar policy, scientific research, and stakeholder engagement. Before joining the FDA in 2005, she completed post-doctoral research at the University of Pennsylvania and earned her Doctor of Science from Tulane University, along with a Master of Engineering and Bachelor of Science from Cornell University

Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical assessor at the UK MHRA (1998-2004) and later joined the European Medicines Agency, serving as Head of Biologicals Section (2010-2013) and Head of Quality Office (2013-2021). Since 2021, he supports the Biologics and Biosimilar Working Party as scientific secretary at EMA.

Mr. Gregory Smith is the Director of the India Office in the FDA’s Office of Global Policy and Strategy (OGPS). With over 12 years at the FDA, he previously led CDER’s Special Projects Staff and worked as a regulatory project manager in CVM’s Office of New Animal Drug Evaluation. He specializes in complex scientific, regulatory, legislative, and operational issues, including user-fee negotiation, supply chain assessment, and portfolio management. Mr. Smith also has experience in clinical trial management, risk evaluation, and post-marketing surveillance. He is a certified project and portfolio management professional and graduated from the University of Maryland, College Park.

Dr. Joel Welch is the Deputy Office Director for the Office of Product Quality Assessment III in the Office of Pharmaceutical Quality at CDER, FDA. His office assesses product quality for small molecule APIs and biological products (excluding microbiology). He serves as the Rapporteur for the ICH revision to Q5A(R1) and Chair for the Emerging Technology Program. Previously, Dr. Welch was Associate Director for Science & Biosimilar Strategy, focusing on policy and emerging issues in the biosimilar program. He has held roles as Review Chief, Team Leader, Primary Assessor, and Regulatory Project Manager. Prior to FDA, he worked in industry for six years on late-stage analytical development of small molecules

Dr. Annam Visala serves as Joint Drugs Controller (India) and assists DCGI in matters pertaining to Division of IND, New Drugs, recombinant products,Cell & Gene Therapy Products.Prior to her current role she served as Deputy Drugs Controller India at CDSCO commencing 2012 to 2024.She significantly contributed to the review and approval of Global clinical trial protocols, serious adverse events & compensation division, ethics committee registration divisions and enforcement division of CDSCO, HQ. During 2017 to 2022 she headed the Zonal Office of CDSCO, Hyderabad. She formerly worked at DCA, Telangana & Andhra Pradesh as Drugs Inspector and Assistant Director.

Mr. Ramdhan Guguloth, Joint Director, Licensing Authority & Controlling Authority, Drugs Control Administration, Telangana, has 27+ years of experience in pharmaceutical regulation. Starting as a Drugs Inspector, he ensured compliance for 12 years, then served as Assistant Director for another 12 years, focusing on enforcement and oversight. As Deputy Director for three years, he led regulatory monitoring of manufacturing and distribution. In his current role, held for five months, he oversees licensing and compliance, ensuring safe, effective, and high-quality medicines in Telangana, strengthening drug control frameworks.

Ms. Constance (Connie) Richard-Math is a Supervisory Consumer Safety Officer (SCSO). Connie joined FDA in 1998 and prior to joining the New Delhi office, she worked as a supervisor with multiple FDA offices and as the Director, Investigations Branch in Baltimore, MD. She has experience managing multiple program areas (Drugs, Device, Foods (human and animal), Imports, BIMO and Biologics and has previously worked as a consultant in the Drug and Device areas. Connie is a graduate of Iowa State University with a Bachelor of Science in Animal Science.

Dr. Jacquin (Jackie) Jones is an International Relations Specialist with a diverse background in public health, regulatory compliance, policy development, and clinical research. She has held roles as program lead and consumer safety officer in the Office of Compounding Quality and Compliance, policy lead in the Office of Policy for Pharmaceutical Quality, and project manager in CDER for drug applications. Dr. Jones also worked as a nurse at NIH managing research protocols and clinical care. She holds a Doctor of Health Sciences with a Global Health concentration, a Master of Science in Nursing Informatics, and a Bachelor of Science in Nursing.

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. Phillip Nguyen is a physician and policy staffer at the US FDA’s India Office, having previously worked on FDA’s biomedical research monitoring program. Before FDA, Dr. Nguyen’s experience spanned working in the nonprofit sector on regulatory systems strengthening, supply chains, and pharmaceutical quality standards with multilateral organizations. A former Assistant Professor of the Georgetown University School of Medicine, Dr. Nguyen holds a medical doctorate from Tufts University, and a bachelor’s in Molecular & Cell Biology, cum laude, from Harvard University.

Dr. McCarthy is Senior Director, Science and Standards in the Global Biologics Department at the US Pharmacopeia. She leads development and maintenance of standards and tools to support quality of medicines and oversees the USP biologics laboratories in the US and India. Her team supports a diverse range of biological therapies, including monoclonal antibodies and other protein therapeutics, vaccines, peptides, and cell and gene therapy. Prior to joining USP, Diane worked for several small CROs that focused on the use of mass spectrometry for characterization of biologics, host cell proteins, and biomarkers. Dr. McCarthy earned her Ph.D. in Biochemistry from the University of Texas at Austin.

Mr. Peter Twomey, Head of Inspections at EMA, oversees compliance with GMDP, GCP, GLP, GVP, and BE practices for medicines, market surveillance, quality defects, recalls, and policy development. He chairs the Expert Working Group revising ICH GCP E6 (R3). Previously, he was a senior GCP/Pharmacovigilance inspector and manager at the Irish Health Products Regulatory Authority and a Pharmacovigilance inspector at UK-MHRA. He also held roles in PV (QPPV and manager), medical affairs, and wholesaling. Mr. Twomey holds a BSc, a Master’s in pharmacy, and two Bachelor of Laws degrees.