Designing and Developing Drug Delivery for LMICs

Dr. Monica Swinney has more than 20 years of experience in the design and development of medical devices, pharmaceuticals, and combination products. She is currently the Sr. Director of New Product Planning and Drug Delivery Innovation for Gilead Sciences. Prior to Gilead, she held both strategic and technical leadership roles with Eli Lilly, Becton Dickinson, Johnson & Johnson, and Dexcom. Dr. Swinney holds a Ph.D. in polymer science from MIT a B.S. in chemistry from the University of Massachusetts, is the recipient of many industry awards in innovation and product development, and is an inventor on over 75 patents.

Bo Kowalczyk has an extensive career spanning more than 25 years in the biopharmaceutical industry encompassing the entire spectrum of pharmaceutical drug development, and currently serves as the Chief Commercial Officer. Mr Kowalczyk brings a wealth of expertise to ApiJect and is spearheading the company’s efforts to develop and commercialize its injectable drug delivery technology platform. Prior to joining ApiJect, Mr Kowalczyk was the Vice President of Sales, North America, at Syngene International's Chemical Development and Manufacturing division. He skillfully aligned operational excellence with targeted prospecting, identifying optimal business opportunities and enhancing client satisfaction. As Global VP at Eurofins Biologics Bioanalytical Services, Mr Kowalczyk's leadership seamlessly integrated services crucial for clinical trial logistics and sample testing support by merging Bioanalytical Services with Eurofins Central Lab Services. He served as Vice President, Business Development and Marketing at AIT Bioscience, where he achieved remarkable sales and profitability growth over five years. Notably, he established a network of third-party preclinical toxicology service providers, strategically positioning AIT Bioscience for early access to promising therapeutic candidates transitioning into clinical trials and future commercial launch. Mr Kowalczyk's client-centric, solution-oriented approach to business development with a robust network in the drug development industry to connect sponsors with service providers have solidified his industry reputation.

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.

Dr. Niya Bowers joined the Bill & Melinda Gates Foundation in 2015, as a Senior Program Officer in Chemistry, Manufacturing and Controls (Integrated Development). She works closely with foundation’s strategy teams and partners and provides technical expertise and strategic guidance for therapeutic drug development in Global Health. Dr. Bowers has over 30 years of experience in pharmaceutical product development, including the end-to-end development of drug substances, drug products, and analytical. She also has in-depth experience in Process Analytical Technology (PAT), regulatory, and project management. Prior to joining the Foundation, she was a managing partner of Garden State Pharmatech, LLC, a CMC consulting firm. From 2010 to 2014, she was an executive director in Merck’s Global Science Technology and Commercialization organization. She was responsible for late phase analytical development for both drug substance and drug product and the head of Merck’s Global Process Analytical Technology. Before Merck, she was a director of Oral and Specialty Product Development in Schering-Plough Research Institute. She led the development, filing and approval of over 15 commercial products at Schering-Plough and Merck.