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Covid Vaccines & Beyond - mRNA vaccine future uses and the role of excipient lipid nanoparticles

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As we approach the first anniversary of the launch of the FDA’s Novel Excipient Review Pilot Program, join us for an exciting two-part event focused on excipient innovation.  Part one is described below.  For information on part two (and registration bundling options) visit our event page: Modernizing Excipient Technology - Need for excipients designed for purpose

Save when you register your team! Contact Courtney Nazareno to take advantage of our "Buy 4 get 1 Free" offer.

Delivery of nucleic acids using lipid nanoparticles: Role of lipids
Presented by: Jay Natarajan

Lipid nanoparticles (LNP) have shown great promise for delivery of nucleic acids – including DNA, siRNA, and mRNA, thanks to the recent approvals of COVID-19 vaccines. Beyond vaccines, LNP are considered as a gold standard for gene and cell-based therapies. The success of an LNP delivery system is highly dependent on the formulation design for enhanced efficacy and safety. In this presentation, we will review the role of individual functional excipients that are typically included in the LNP formulation. A case study shall be presented and discussed for one of the excipients, namely cholesterol. In addition, we will discuss the recent developments of LNPs in vaccines and beyond with closing remarks on current challenges and a future outlook.

The Evolution of Vaccines Technology
Presented by: Jennifer Sloan

This presentation reviews the progression of mRNA-based vaccines, their potential future applications, and the historical evolution of various vaccine technology. The pros and cons of different types of vaccines available today are reviewed. Clinical trial structure for vaccines and other considerations such as multiple doses and storage conditions are also discussed.

Novel Lipid Nanoparticle Platform Enables RNA Delivery for Vaccines and Other Applications in Genetic Medicine
Presented by: Samuel Clarke

RNA can be designed to silence, express, and edit specific genes providing a flexible and powerful approach to treating disease. However, RNA are large molecules that require nanoparticles for delivery to target tissues and cells. Precision NanoSystems has developed a lipid nanoparticle (LNP) platform and a microfluidic-based manufacturing platform. The LNP platform leverages a library of proprietary lipids for making unique LNP formulations that encapsulate RNA. The microfluidic platform is designed for rapid development and scalable manufacture of RNA-LNPs, enabling progression from lab scale (mL) to GMP manufacturing (litres) within weeks or months. In this talk, we will showcase data in the areas of RNA vaccines and ex vivo cell therapies to demonstrate the versatility of these platform technologies to accelerate development of genetic medicines.


  • Jay Natarajan

    Director, Strategic and Technical Marketing
    APAC|Health Care|Nutrition and Care
    Evonik (SEA) Pte Ltd

    Jayaganesh (Jay) Natarajan is currently director of strategic and technical marketing APAC at Evonik (SEA) Pte. Ltd, in Singapore. Before beginning this role, Jay held previous positions within Evonik as director of technical business development and marketing in Singapore and R&D head in Vancouver, Canada. Jay started his professional career with Sun Pharma and was instrumental in the commercial scale up of LipoDox. Thereafter, he held various positions within various institutes of Nanyang Technological University (NTU), Singapore, albeit his focus always revolved around the R&D of nanomedicines, particularly lipid nanoparticles. Jay Natarajan holds a Ph.D. from NTU in Singapore and is the author of ten papers and an inventor on two patents.

  • Jennifer Sloan

    PSQA BTx Portfolio Lead
    Pfizer Global Supply
    Pharmaceutical Sciences Quality Assurance

    In 2001, Jennifer joined the Pfizer Quality Assurance team supporting BioTherapeutics in the Pfizer pipeline. Jennifer began her career in pharmaceutical sciences working on non-clinical and clinical research in the field of ophthalmology, including allergy and immunology, glaucoma, and dry eye syndrome. Jennifer also worked in the field of pediatric pharmaceuticals in Medical Affairs, authoring clinical study protocols and reports, auditing clinical trial sites, analyzing clinical data, and authoring APRs and NDA submissions. Jennifer’s areas of focus in pediatric pharmaceuticals included asthma, pain management, infectious disease, and nutrition. She has published several papers in the fields of ophthalmology and pediatric clinical research.

    Jennifer participated in the Quality by Design FDA pilot program, and has met with both the US FDA and European Medicines Agency on these topics. Jennifer has also led various Board of Health inspections and meetings over the years.

    Jennifer conducted her undergraduate and graduate studies at Tufts University, and holds dual B.S. degrees in Biology and Chemistry and a M.S. in Engineering Management.

  • Dr. Samuel Clarke

    Director of Product Development
    Precision NanoSystems

    Dr. Samuel Clarke is an expert in the development of nanoparticles for research, diagnostic and therapeutic applications with more than 15 years’ experience in the field. Samuel is currently the Director of Reagents at Precision NanoSystems where he is responsible for the development of lipid nanoparticle reagents for genetic medicine applications. He has a PhD and post-doc from McGill University and École Normale Supérieure.

October 5, 2022
Wed 11:00 AM EDT

Duration 2H 0M

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