Self Administration of Subcutaneous Therapeutics: Development Realities

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Sherri joined AstraZeneca in 2018 and is Head of Device Development. She is responsible for parenteral drug delivery development including early-stage technology strategy, clinical device development and late stage scale-up for commercial manufacturing. Currently, her group is developing products such as prefilled syringes, autoinjectors, on-body delivery systems, and pen injectors as well as a range of new technologies to meet the AstraZeneca pipeline needs. A particular focus of her group is understanding user needs and business needs to design the right product for patients and health care providers. Prior to working at Astra Zeneca, Sherri was Director of Device Development at Genentech and Director of Product Development at Alexza Pharmaceuticals developing both injection and inhalation products. Sherri earned a PhD in Chemical Engineer from the University of Pennsylvania and a BS in Chemical Engineering from Rensselaer Polytechnic Institute. While in industry she has been active in various academic and industry-based organizations. She has taught several university engineering courses and publishes and presents frequently. 

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Scott Ariagno is Vice President of Engineering and Development Services at EdgeOne Medical and has over 25 years in medical device and combination product design, development and manufacturing. His expertise includes development and global launch of various single-use, disposable medical devices, infusion systems and combination products, strategic/technical development of device platforms and IP development. Throughout his career, he has held management roles in engineering including heading device development and external manufacturing at Shire (now Takeda). Mr Ariagno is a named inventor on over 20 patents and applications. Mr Ariagno has Bachelor of Science in Mechanical Engineering from Bradley University and a Master in Engineering Management from Northwestern University.

Advait leads the organization within Pfizer’s Biotherapeutics Pharmaceutical Sciences organization focused on identifying and developing formulations and processes to support Pfizer’s entire biotech & vaccine portfolio with accountability for novel delivery technologies, adjuvant vaccines, RNA-based modalities. and microbial and mammalian produced proteins. The focus is on all things related to Drug Product from the early Research stages up to Licensure including Commercial and Life Cycle Management support. In his role as- Head of Nanoparticle Development, Advait’s accountability includes scientific, technical, strategic, and regulatory leadership of Pfizer’s mRNA/LNP and nanoparticle-based portfolio. Advait is accountable for establishing internal capabilities and expertise for formulation, process development, scale-up, and tech transfer to enable clinical and commercial supplies. In addition to this, there is a focus on external strategic alliances and collaborations. Advait received his Ph.D. in Pharmaceutical Sciences from the College of Pharmacy and Health Sciences, Mercer University (Atlanta, GA) and a MS in Pharmaceutics from Auburn University, Auburn, AL. He also has a BS in Pharmacy from Pune University (India). He is a member of PDA, AAPS and Controlled Release Society, and has authored 8 patents, published over 30 articles in professional scientific journals, and presented more than 50 short papers, posters and talks.