Conference Day One

Monday, April 17 2023

7:30am Registration & Morning Coffee

8:20 am Chair’s Opening Remarks

LNP as it Stands: Navigating the Innovation Landscape & New Paradigms

8:30 am Navigating the IP Landscape – Patenting & Licencing of Your LNPs

Synopsis

  • Understanding how to avoid patent conflicts with existing ones
  • Designing new lipids that are novel for patent protection and keeping utility
  • Navigating the challenges of expensive patent licencing fees

9:00 am Panel Discussion – LNP Beyond Vaccination – What’s Next?
Moderated by: Russel Johnson

Synopsis

The COVID-19 LNP-mRNA vaccine shone the spotlight on LNP potential as a clinically effective delivery mechanism and drove huge re-investment across

biopharma and manufacturing facilities. However, their clinical utility doesn’t stop at vaccination, and now doors have opened for new applications.

Hear experts outline the LNP landscape as it stands, and what’s next from gene therapy, gene editing, and more. Where have we been, what are the

future opportunities, and what is the route of action to get there?

9:30 am New Approaches for Rapid, High-Dose Manufacturing of mRNA Vaccines for Pandemic Preparedness

  • Ian Johnston Senior Research Associate - Product Development, Precision NanoSystems

Synopsis

  • Insights into the production of pandemic response-scale batches using a series of representative LNPs
  • Experiences that leverage modular microfluidic platform technologies to enable rapid development, testing, and scale-up of mRNA vaccines and therapeutics 
  • How to increase LNP manufacturing capacity and deploy a rapid vaccine development strategy to future proof against emerging SARS-CoV-2 variants and infectious diseases for pandemic preparedness

10:00 am
Morning Break & Speed Networking

Synopsis

Enjoy a morning coffee while networking with fellow experts

Track A:

LNP Discovery, Biology & Characterization

Track Chair: John Androsavich, Global Head – RNA Medicine Lead, Pfizer

10:45 am Identifying Novel LNPs by Combining High Throughput Screening & Single Cell Multiomic Readouts

Synopsis

  • Identifying novel delivery vehicles with varied tropisms with LNP screening
  • Adding single cell RNA sequencing to both identify novel LNPs, and confirm delivery to rare to characterize cell types
  • Single cell RNA sequencing could potentially be used to identify toxic / immunogenic LNPs

11:15 am Multiplexed Screening of LNPs In Vivo Enabled by Nucleic Acid Barcoding

  • Cory Sago Former Senior Director, Head of LNP Discovery, Beam Therapeutics

Synopsis

  • Using barcoding technology to test many LNPs in vivo in the same experiment
  • Applying of these screening technologies for identification of LNPs for extrahepatic cell-types
  • Discussing challenges of the delivery of next-generation RNA payloads

11:45 am Particle Engineering & Synthesis

Synopsis

Session Reserved for Particle Works

11:45 am Session Reserved for Certest

Track B:

Formulation Considerations & Assay Development
Track Chair: Mohit Gupta, Senior Scientist, Tessera Therapeutics

10:45 am Session Reserved for Etherna Manufacturing

11:00 am Pre-formulation Considerations For Different Nucleic Acid Delivery Methods

  • Liping Zhou Senior Director - Advanced Drug Delivery, AstraZeneca

Synopsis

  • Taking advantage of the lipid chemistry and preparing the formulation for a particular therapeutic target
  • Current gaps in intracellular delivery methods
  • Strategies for formulation optimization

11:30 am Assays, Analytical Development of LNPs

Synopsis

Session Reserved for Advanced Instruments

11:45 am Platforming Assays: Challenges with Evolving mRNA-LNP Vaccines

Synopsis

  • Navigating speed to clinic and regulatory expectations for product characterization
  • Monovalent toward multivalent; discussion of expectations, challenges, and approaches
  • Potency exploration toward platforming to support next generation vaccines

12:15 pm End of Track

Track C:

LNP Manufacturing & CMC





10:45 am Session Reserved for Millipore Sigma

11:15 am Managing Early Lifecycle Technology Transfers

Synopsis

  • Intellectual property and knowledge management considerations
  • Internal vs external transfers
  • Scale out vs scale up

11:45 am Session Reserved for Micropore Technologies

12:00 pm Moving to PAT & Continuous Manufacturing of Complex Parenterals

  • Diane Burgess Distinguoished Professor, University of Connecticut

Synopsis

  • Achieving LNPs with tight control of all CQAs
  • Outlining advantages of reduced human intervention from the start till the finish
  • Utilizing this technology for particle size and stability control

12:15 pm End of Track

12:45pm Networking Lunch

Track A:

LNP Discovery, Characterization, LNP-Payload Interactions


1:30 pm Looking into the Molecular Interactions Between Lipids & Cargo

Synopsis

  • A brief history of liposome and lipid nanoparticle
  • What we’ve learned in the past decades
  • Current challenges and future developments

2:00 pm Developing Novel LNPs for RNA-based Vaccines & Therapies: From Lipid Design to In Vivo Screening

Synopsis

  • Identifying challenges associated with the delivery of large nucleic acid molecules such as self-amplifying RNA
  • Considerations to make when designing novel lipids for LNP formulation
  • Looking into preliminary results of in vivo screening of Ziphius’ novel LNP library

2:30 pm Session Reserved for NOF

3:00 pm Thermal Activity Tracing (TAT): Investigation & Characterization Tool in Pharmaceutical R&D

  • Nawel Khalef Assosciate Professor, University of Grenoble Alpes

Synopsis

  • Chemical stability of lipids assessment by TAT
  • How can TAT be used for physical st ability assessment of particles and process/storage conditions optimisation
  • Application of TAT for interactions assessment

Track B – LNP Analytics & Analysis

Track Chair:
Venkat Krishnamurthy, Senior Vice President, Korro Bio

1:30 pm Investigating Structural Basis of LNP Assembly in Liquid, Frozen & Lyophilized Formulations

Synopsis

  • Understanding the impact of molecular assembly of multiple lipid components
  • Elucidating high-resolution structural details to understand the interplay of formulation processing and composition parameters
  • Offering the molecular understanding of this highly dynamic process for drug product design, and probing formulation robustness and quality

2:00 pm Panel Discussion: Discussing the Importance of Storage Capabilities & Storage Conditions
Moderated by: Zohreh Amoozgar

Synopsis

  • How to ensure your formulation is viable to provide the population with the best therapeutic available
  • How much does lack of storage capabilities, or requiring conditions that are not feasible limit progression?
  • Identify formulation design, and processing improvements to allow storage at more

2:30 pm LNPs from Discovery to Commercialization

Synopsis

  • Formulation and process considerations for a successful transition across development stages
  • Looking into the role of the analytical toolbox in monitoring mRNA LNP formulation processes

3:00 pm Session Reserved for WuXi STA

Track C:

LNP Manufacturing & CMC




1:30 pm Session Reserved for Catalent

2:00 pm LNP Products for Low- & Middle-Income Countries

  • Dennis Lee Senior Program Officer, Bill & Melinda Gates Foundation

Synopsis

  • Navigating therapeutic and vaccine needs in LMICs
  • Product characteristics to enhance deliverability in low and middle-income countries
  • BMGF investment portfolio interests

2:30 pm Upstream Process Development

Synopsis

Session Reserved for Unchained Labs

2:45 pm Session Reserved for Ardena

3:00 pm Q&A with Presenters

3:30pm Afternoon Break & Poster Session

Synopsis

Get interactive, ask your questions, and learn new content in this poster session where emerging LNP enthusiasts will be able to share their scientific findings. This is your chance to vote for you ‘rising star’ in the LNP field,

Next Generation LNPs & New Therapeutic Approaches

4:15 pm Cancer Immunotherapy Application: LNP Delivering Programmable mRNA

  • Weiyu Zhao Senior Scientist, Strand Therapeutics Inc.

Synopsis

  • Unravelling the mRNA cancer immunotherapy landscape
  • Outlining LNP delivering programmable mRNA for cancer immunotherapy
  • Looking to the future of cancer immunotherapy

4:45 pm Formulation for Next Gen LNPs

  • Sakya Mohapatra Director - Formulation Development, ReCode Therapeutics, Inc

Synopsis

  • Exploring diverse lipid chemistry, treatment regimens and immunotherapy
  • Ensuring preferential delivery for efficacious benefits

5:15 pm Therapeutic Applications of LNPs for Immunotherapy

Synopsis

  • Exploring diverse lipid chemistry, treatment regimens and immunotherapy
  • Ensuring preferential delivery for efficacious benefits

5:45 pm Chair’s Closing Remarks

5:50 pm End of Conference Day One