Julie Gerberding, MD, joined the FNIH as CEO on May 16, 2022. She served before that as chief Patient Officer and Executive Vice President, Population Health & Sustainability, at Merck & Co, Inc. She was responsible for patient engagement, corporate social responsibility, Environmental/Social/Governance issues, and other functions. Formerly, Dr Gerberding oversaw Global Public Policy and Strategic Communications for the company. She joined Merck in 2010 as President of Merck Vaccines and was instrumental in increasing access to the company’s vaccines to people around the world.

Kanika Suri is dedicated to developing and advancing creative, efficacious, and patient-compliant therapies to alleviate patients from debilitating conditions. With a strong focus on overcoming barriers to drug delivery for oral, topical, and parenteral routes of administration, she has established herself to lead the CMC development of pipeline drug products at Takeda. Leveraging her experience in research and development, Dr Suri brings a unique perspective to devising patient-centric pragmatic solutions. She is pursuing a PhD in Bioengineering and holds a Master's in Chemical Engineering from Carnegie Mellon University. Dr Suri's passion for ideation and her staunch advocacy for Women in STEM further underscore her commitment to driving excellence in the field.

Dr Shankar Swaminathan is an associate director at Astellas Institute of Regenerative Medicine leading drug product development and technical transfer activities for multiple preclinical cell therapy candidates. Dr Swaminathan obtained his doctoral degree in pharmaceutics focusing on creating new polymer-based drug delivery formulations for cancer nanomedicine. 

Soon after his PhD, he joined the pharmaceutical industry to work on drug eluting long-acting combination products. He later went on to complete his postdoctoral training in ophthalmic drug product development at the College of Medicine at University of Tennessee health science center, where he focused on creating new treatment approaches for debilitating eye diseases. As a young investigator, he obtained independent grant funding for supporting his ideas before successfully transitioning to the biopharmaceutical industry. Dr Swaminathan led CMC activities for multiple products/INDs submitted for approvals to various agencies.

He has about 15 years of combined industry and academic experience and has successfully overseen product development from early-stage discovery through late-stage submissions and validation. He is currently supporting multiple cell therapy projects, including immuno-oncology modality from development through GMP technical transfer and manufacturing. He is vastly experienced in aseptic drug product development, quality-by-design, advanced drug delivery, cryopreservation technology, CTM campaign execution and management, fill-finish, modified release solid orals and ocular drug delivery. He is an editorial board member in Scientific Reports and serves as a reviewer for over 20 peer-reviewed journals. He has published 15+ peer reviewed publications, commentaries and blogs.

As a Senior Staff Engineer for Research and Development at Enable Injections, Aaron Swick is focused on leading the connected healthcare program, collaborating with partners to determine the needs of the next generation of the enFuse technology. With 15 years of experience in medical device and healthcare innovation, Mr Swick uses research, strategy, and design to develop products that enhance the patient and provider experience. He earned his MSE and BSE in Biomedical Engineering from the University of Michigan.

Amir Tabaian is a Senior Combination Product Development Engineer at Pfizer. At Pfizer, he has worked on a variety of combination products including auto-injectors, prefilled syringes, and convenience kits. His current role is in the Biotherapeutics Pharmaceutical Research and Development organization and executes device development from conceptualization through initial production registration. Mr Tabaian’s current focus is on vaccine projects. Prior to Pfizer, Amir worked for a startup researching kinase inhibitors design and discovery. Mr Tabaian holds a bachelor’s degree in biomedical engineering from the University of Virginia.

Sakura Taneichi is a R&D scientist of NOF CORPORATION. She has been developing LNP formulations. She has made contributions to the development of mRNA-LNP platform using proprietary ionizable lipids.

Tim Tracy is a clinical pharmacologist and a Fellow with the American Association of Pharmaceutical Scientists, Dr. Tracy holds three patents related to drug delivery systems and has published over 100 scientific manuscripts, fifteen book chapters and edited two books. Prior to his work with Triastek, he served as CEO of Aprecia Pharmaceuticals, a 3D printing pharmaceutical company.

Mark Tunkel is Global Category Director, Services at Nemera leads the strategy for contract development and combination product services linked to commercial manufacturing capability. He was previously a partner at Insight Product Development, which was acquired by Nemera in 2019 and became Insight by Nemera. With more than 20 years of global business development experience and a deep understanding of the marketplace challenges and trends affecting the pharma industry, Mr Tunkel has advised many of the world’s leading companies on their product development and innovation strategies for drug delivery and medical devices.

Dr Siva Vaka is a Director of Formulation R&D, specialty product division at Amneal Pharmaceuticals. He obtained his PhD in Pharmaceutics & Drug Delivery from the University of Mississippi. After graduating, he worked at Kashiv Pharmaceuticals LLC, for about 8 years in R&D, focusing on 505(b)(2) programs. He developed GRANDE® (advanced gastric retention system) and KRONOTEC® (advanced osmotic oral drug delivery system) proprietary technology platforms for controlled drug delivery of challenging compounds that significantly improve efficacy, tolerability and compliance. He has authored 25+ research articles in peer-reviewed international journals, 2 book chapters and is an inventor on over 15 patents.

Thomas von Erlach, PhD co-founded Vivtex and joined as its Chief Scientific Officer when Vivtex was formed as a MIT spin-off in 2018. Prior to that he led the interdisciplinary efforts around gastrointestinal model systems for oral drug delivery applications at the Laboratory of Prof. Robert Langer and Prof. Giovanni Traverso at MIT. Dr von Erlach obtained his PhD from Imperial College London in Bioengineering and a BSc and MSc in Biochemistry and Biotechnology from ETH Zurich in Switzerland. His research interest include advanced in vitro models for drug development, oral drug delivery and gastrointestinal pharmacology. His work is published in several high impact journals such as Nature Materials, Nature Biomedical Engineering, and Nature Communications.

Daniel Waites serves as the Director of Research and Development at Enable Injections, leading the innovative programs and future development of the enFuse, from reconstitution to connected healthcare. Mr Waites has over 18 years of experience in medical device development, and currently supports all due diligence processes and feasibility programs with potential and current partners. Mr Waites holds a Bachelor of Science in Mechanical Engineering from the University of Cincinnati and is a licensed PE.