Dr Michael Song leads the Device and Packaging plus Shipping Validation function at Moderna overseeing development, submission, and on-market support activities. Prior, he has held positions as Director of Sterile Packaging at GSK and Associate Director at Takeda. Through Dr Song’s career, also formed and led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca as well as Device, Package, and Process Engineering group at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Dr Song holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Dr. Speaker has worked in various science and engineering roles related to medical devices and drug delivery for the past three decades, accumulating a wide variety of experience and numerous patents and publications. At the startup TransDerm he developed a dissolvable microneedle platform that led to a long-term passion for innovation specific to Global Health and especially the needs of LMIC populations. As the recipient of a Gates Foundation Grand Challenges Exploration grant, he led a team that produced the first demonstration of a microneedle-administered antimalarial CSP vaccine. In his present role at AbbVie, he continues to drive a culture of patient-centered innovation within the Combination Products Development group. Dr. Speaker is also a member of the Microneedle Array Patch (MAP) Regulatory Working Group, part of the PATH Center of Excellence for MAP technology, a consortium of experts that seeks to expedite clinical translation of microneedle patch technology into meaningful patient benefit. He plays various additional roles, primarily advising small companies involved in rapid diagnostic tests and prevention of insect-borne disease, especially as relevant to LMIC.

Colin Spencer is a project manager and the head of the technology transfer group at Oakwood Laboratories. At Oakwood, he has worked on a variety of technology transfer projects, leading the transfer of both commercial and developmental products into Oakwood's FDA approved, GMP, aseptic manufacturing facility. Colin also has experience at Oakwood working on long-acting injectable products, working both on the initial feasibility of new products and the scale-up and large-scale manufacturing of clinical materials. His other roles include leading the process improvements initiative at Oakwood, investigating new technologies that can further enhance Oakwood's development and manufacturing capabilities.

Dr Srini Sridharan is currently the Head of Drug Delivery & Product Strategy at Bristol Myers Squibb. Dr Sridharan has 25 years of experience in the area of CMC, drug delivery and combination products in a variety of roles from R&D, Manufacturing, Business Development and Product Development. He has developed and launched numerous products worldwide ranging from coronary catheters, drug eluting stents, glucose sensors, insulin delivery devices, prefilled syringes, sub-cutaneous injection devices and pharmaceuticals. Dr Sridharan is passionate about addressing unmet needs through a Patient Centric mindset to develop the best possible therapies. He is a Chemical Engineer and received his Bachelors from the Indian Institute of Technology, Madras and a MS and PhD from Georgia Tech, Atlanta. Dr Sridharan enjoys all outdoor sports & activities, traveling and is also a home brewer.

Rob Steendam, PhD, is co-founder and Chief Technology Officer at InnoCore Pharmaceuticals, a biopharmaceutical drug delivery company specialized in the development of long-acting injectable medicines for the treatment of chronic and site-specific diseases. At InnoCore he heads the development of InnoCore’s bioresorbable polymer-based LAI drug delivery technologies and oversees the execution of InnoCore’s partnered drug delivery product development programs. He is an inventor of several patents related to novel biodegradable multiblock copolymers and their application in parenteral drug delivery and drug eluting implants. Prior to founding InnoCore in 2004, he worked for Polyganics, a venture capital funded biosurgical start-up company, where he played a key role in developing the company and managed the pre-clinical and clinical development of novel bioresorbable medical devices and tissue regeneration products in the fields of peripheral nerve repair and general surgery. He holds a PhD in Pharmaceutical Technology and Biopharmacy and a MSc degree in Polymer Sciences, both from the University of Groningen in The Netherlands.

Alina Su is the founder and CEO of NovaXS Biotech. Prior to NovaXS, Dr Su served as researcher at UC Berkeley QB3 Laboratory under rejuvenation pioneer, Professor Irina Conboy. Her extensive experience in drug-device combination and drug delivery efficacy set up the foundation of the science at NovaXS. Dr Su is currently a PhD student at Harvard Medical School.

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 a Team Lead at Astellas Institute for Regenerative Medicine leading drug product development activities for multiple preclinical and clinical cell therapy candidates. Dr Swaminathan obtained his doctoral degree in pharmaceutics focusing on creating new polymer based drug delivery formulations for cancer nanomedicine and delivery of labile small and large molecules. 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 ophthalmology investigator, he obtained independent grant funding for supporting his ideas before successfully transitioning to the biopharmaceutical industry. Dr Swaminathan has supported 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 submission. He has been associated with ophthalmic drug delivery and development for over 10 years. 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.