Jonathan Nolasco is a Senior Scientist at Novo Nordisk. Mr Nolasco holds a B.S from UC Berkeley (2016) and a Master’s from Harvard University (2020). Although formally trained as a cell biologist, he has worked extensively on developing non-viral delivery vehicles for prophylactic and gene therapy applications. He has worked on delivery vehicles for mRNA, self-amplifying mRNA, circular mRNA, siRNA, and Cas9/sgRNA. Mr Nolasco has worked on several projects ranging from early discovery to clinical. Prior to joining Novo Nordisk, he led a small team in the development of inhalable LNPs for the treatment of Cystic Fibrosis at Omega Therapeutics.

Penny Carlson has 27+ years of experience in the pharmaceutical industry and is currently Head of Global Clinical Development Operations, which includes Clinical Program Leadership, Study Management, Business Operations and Partnership Health and Supplier Management. Prior to this, Penny held various roles of increasing responsibility across several disciplines and multiple therapeutic areas. She started her career working for a small Contract Research Organization supporting NIH sponsored Vaccine and Infectious Disease studies, followed by several years working for large pharma in various data management roles, eventually transitioning to clinical operations in the Oncology therapeutic area, where she stayed for a number of years.

In 2011 Penny joined Takeda (previously Millennium) initially as a Clinical Program Manager and was later responsible for multiple assets in the early development space and was the Clinical Operations Lead for the Gastroenterology Therapeutic Area. For 5+ years, Penny has been an executive leader in the Global Development Organization, leading transformative initiatives for Takeda and focusing on clinical trial delivery, external partnerships and innovative ways of delivering medicines to patients.

Sheraz Khan is Director of Data Science at Pfizer. Sheraz lead operational-AI/ML group in AI/ML Quantitative and Digital Sciences. He obtained his PhD in Computational and Applied Mathematics from the Ecole Polytechnique, France, and has major interests in machine learning, Bayesian statistics and information geometry. He has over two decades of experience in developing signal processing and machine learning algorithms for multivariate time series data. Before joining Pfizer in 2022, he was an Assistant Professor at the Harvard University.

Venky Iyer is Director of Data Strategy & Automations within Information Management Group at Pfizer.  He has over three decades of experience in the pharmaceutical sector delivering key enablers for multiple clients to drive business value. Currently, he is actively involved in several AI/ML strategic initiatives partnering with key stakeholders and driving key concepts for enablement.  He holds a master’s degree in Mathematics and has been with Pfizer since 2019.

TBA

Matthieu is the head of Curadigm platform at Nanobiotix. He holds a doctorate in biotechnology. He has joined Nanobiotix in 2004. With over 15 years in nanomedicine, he is the author of more than 15 publications and scientific communications and is the inventor of 15 patents. He has held multiple positions in Nanobiotix and managed both domestic and international projects before taking the lead at Curadigm in 2018.

Mary Lou Glotzbach is a Business Development Executive for Grand River Aseptic Manufacturing (GRAM). Mary Lou’s career experience ranges from diagnostic and drug delivery devices through the manufacturing of injectable drugs. She is currently focused on combination products and the role of aseptic fill and finish manufacturing in the development and supply of drug delivery devices.

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.