Mark is a product development consultant with over a decade of experience in the Medical Device and Pharmaceutical sectors. As the Director of Engineering at PSN Labs, Mark leads the engineering department, offering invaluable support to clients in new product development, test method development, functional prototyping, contract manufacturing, and on-market remediation. His team specializes in designing devices that incorporate various design principles, including manufacturing, assembly, sustainability, biocompatibility, reprocessing, and reliability. Mark’s background encompasses the development of innovative healthcare solutions in areas such as drug delivery, surgical robotics, pharmaceutical packaging, and catheters. His expertise ensures patient safety and regulatory compliance throughout the design process. Mark holds a Bachelor of Science in Mechanical Engineering from Purdue University and a Master of Science in Mechanical Engineering from the University of Cincinnati.

Molly is currently the Chief Operating Officer at ApiJect where she leads the development of their platform of BFS based products. Molly’s 15 years of experience in medical technology engineering and leadership includes serving as Vice President for Containment Systems & Portfolio Management at West Pharmaceutical Services. Prior to West, she was VP of Quality & Regulatory and Chief Compliance Officer at Unilife Medical Corp. At Becton Dickinson’s Medical Surgical Systems, she spent three years as Principal Engineer, analyzing new business opportunities and leading a new concept development team. Molly has a B.S. in mechanical engineering from Brown University and a PhD in mechanical engineering materials science from Duke University, where she was a founding member of the Nanooptics Laboratory.

Mr Kram is an Engineer and pharmaceutical business development professional and is presently the Managing Director for Rommelag Engineering’s US office. For more than 20 years he worked with companies to develop aseptic product fill/finish solutions using Blow/Fill/Seal technology. This work includes container development, clinical trials, regulatory filings, combination device development, primary drug packaging, machine sizing, validation/qualification, and commercial/contract manufacturing. For ten years he has worked to introduce temperature sensitive biotech and vaccine products to BFS technology and has received two foundation grants for the testing of injectable vaccines with BFS technology and CPAD device development. Mr Kram regularly consults and gives presentations to BFS operators, industry groups and regulatory organizations: PDA, ISPE, DCVMN, FDA, Gates Foundation and PATH. He received a B.S. in Electrical Engineering from the Missouri University of Science and Technology.

Stephen Spagnol is a Director of Business Development & Licensing, Enabling Technologies at Merck. He leads Search & Evaluation efforts related to Drug Delivery & Formulation, Discovery Vaccines, Vaccines & Biologics Bioprocess as well as Genetic Medicines spanning Cell & Gene Therapy, mRNA/RNA Therapeutics and Gene Editing. Prior to Business Development & Licensing, Dr Spagnol led Research & Development efforts spanning novel and new modality therapeutics including mRNA Vaccines, RNA Therapeutics and Viral Vector Platforms for Cell & Gene Therapy. He has led development of novel platforms for mRNA/RNA drug delivery technologies and viral vector platforms. He has also led formulation and process development including for late stage/Phase 3 clinical programs. He received a Ph.D. in Chemical Engineering from Carnegie Mellon University and a B.S. in Chemical Engineering from the Pennsylvania State University.

Nelson boasts over 27 years of experience in groundbreaking technology development, covering diverse areas such as medical devices, drug delivery, semiconductors, and robotics. As a seasoned mechanical engineer, Nelson is passionate about smaller, high-performance/impact companies, contributing leadership in scientific research, engineering, product development, project management, and innovation. With a background spanning design, manufacturing engineering, quality engineering, and R&D, he has built world-class engineering teams. Nelson’s expertise includes successfully commercializing over 12 products, enhancing marketability for previously unfeasible technologies. Holding over 70 patents, his contributions range from diabetes sensing to smart capsule drug delivery.

Mike is an entrepreneur/investor in the drug delivery field for 17 years, starting-up DSM BioMedical, InGell Labs, Hy2Care and MyLife Technologies, and now his new venture OncoLize. He has initiated and raised over €120 Mln public and private funding to do so.

Before, Mike worked for 20 years with DSM-Pharma, DSM-China, SHELL-BioTech and UniLever, and he holds degrees in Molecular Biology/Tumor Virology (Leiden) and Business Administration (RSM, IMD). Mike has a special interest in making cancer therapies more bearable for both patients and their loved ones. Based on his extensive experiences in China, India and Indonesia, his drive extends to ensuring Triple A products: Affordable and Accessible for All, wherever.

Eric Sugalski has over two decades of experience developing novel devices for pharmaceutical and medical device applications. His cross-functional experience spans engineering, human factors, regulatory affairs, and commercial strategy. Eric has led teams in the development of novel autoinjectors, pre-filled syringes, infusion pumps, inhalers, and novel drug delivery technologies. He holds a B.S. in mechanical engineering from the University of Colorado and an M.B.A. from MIT.

Dr Kerry Benenato joined Sail in February 2024 as Chief Platform Officer, bringing to the company a distinguished career in the development of mRNA products and product candidates. Prior to Sail, she served as Chief Scientific Officer of 76Bio, a startup focused on the development of a novel targeted protein degradation modality using mRNA/lipid nanoparticle (LNP) technologies. Prior to this, she spent eight years in positions of increasing responsibility at Moderna, most recently serving as Vice President, Platform Chemistry and Formulation Discovery, where she led the Platform team, with oversight for the discovery and development of mRNA delivery tools for multiple modalities (infectious disease, rare disease, immuno-oncology, auto-immune diseases) and the development of tools for LNP biophysical characterization.

In 2022, Dr Benenato was awarded the American Chemical Society Heroes of Chemistry award for her work contributing to Moderna’s mRNA-based COVID-19 vaccine (Spikevax™). She began her industry career in scientific research at AstraZeneca, after completing a research fellowship at Harvard University as a National Institutes of Health Postdoctoral Fellow. She holds a Ph.D. in Organic Chemistry from Boston College and a B.S. in Chemistry from Providence College.

Dr Patrick Anquetil is Portal Instrument’s CEO. He is a distinguished leader in the bioengineering field, renowned for developing world-class teams and successfully transitioning bioengineering enterprises from the conceptual stage to commercial success. Before establishing Portal, he co-founded two medical diagnostics companies: SynapDx and Aretais. His professional journey began as an equity research analyst at the boutique investment firm Susquehanna International Group, authoring and promoting equity research reports to portfolio managers and hedge funds. Dr Anquetil is an accomplished academic, holding a PhD in bio-instrumentation from the Massachusetts Institute of Technology (MIT), an MBA from Harvard Business School, and master's degrees from ETH Zurich and the University of Tokyo. He holds several patents and his scientific work has appeared in peer-reviewed publications as well as mainstream media, including MIT Technology Review, Wired Magazine, PBS, and CNBC.

Carl DeSelm, MD PhD, joined the Washington University faculty in June 2018 as an assistant professor of Radiation Oncology with a laboratory in the Bursky Center for Human Immunotherapy and Immunology Programs (CHiiPs). After earning his undergraduate degree from Dartmouth College, Dr. DeSelm earned his MD and PhD from Washington University School of Medicine in 2012, during which time he studied under Dr. Steven Teitelbaum. As a PhD student, Dr. DeSelm described a secretory pathway in the bone resorbing osteoclast that utilizes authophagy pathway proteins, and characterized the role of IL-17 in the pathogenesis of osteoporosis. His work led to the Needleman Pharmacology Award from Washington University and a patent for a new therapy for osteoporosis. Dr. DeSelm subsequently redirected his energy toward oncology, and after completing an internal medicine year at Washington University’s Barnes Jewish Hospital, underwent radiation oncology residency training at Memorial Sloan Kettering Cancer Center (MSKCC) in New York. During his time at MSKCC, he became highly interested in immunotherapy, in particular CAR T cell therapy, as some of the first leukemia patients treated with the novel therapy began to exhibit remarkable responses. This prompted him to join the laboratory of Dr. Michel Sadelain, a founding member of the field of CAR T cell therapy, as a Holman Research Fellow. Upon finishing residency, Dr. DeSelm completed a Translational Research Fellowship at MSKCC, continuing to study the combination of radiation with cellular immunotherapy under Michel Sadelain. Currently, Dr. DeSelm clinically focuses on treating lymphoma, and is actively developing novel CAR T cell approaches to treating solid tumors, including lymphoma, pancreatic cancer and glioblastoma.

Yevgeny (Yev) Brudno received dual B.A. degrees in Chemistry and Biophysics from the University of Pennsylvania and his PhD in Organic Chemistry from Harvard University, working with David Liu to develop directed evolution technologies. From there, Dr Brudno worked as a postdoctoral fellow at the Wyss Institute at Harvard with Prof. David Mooney, developing controlled release drug delivery technologies for cancer and regenerative medicine. Dr Brudno’s research interests span organic synthetic chemistry, materials science, and cellular immunotherapy. Mostly recently, his lab develops materials to improve cell therapies, including CAR T cells. His lab’s research is rooted in the belief that advances in chemistry and the basic molecular sciences can generate meaningful change in how therapies are designed, produced, and administered.

Ali Shamoun is a highly motivated, experienced, delivery and client-focused executive in a multi-billion dollar pharmaceutical company. Currently, he is a leader in the Global Development IT organization at Regeneron. He leads Architecture, Compliance, Regional/Global Services, and Vendor Governance in support of Global Development.