LNP Summit 2025 – Session 1, Chaired by CordenPharma TSAB Board Member Dr. Chantal Pichon
Dr. Jayesh Kulkarni – Rational Design of Lipid Nanoparticles for Enabling Extrahepatic Nucleic Acid Delivery
- Jayesh shared valuable insights into his team’s work on developing LNP formulations for the safe and efficient delivery of genetic medicines to extrahepatic tissues. Their research includes: a pipeline of novel ionizable lipids, surface modifications to promote particle stability, tolerability and specificity, and fine tuning of the overall LNP lipid composition for enhanced cellular specificity and extrahepatic delivery.
Dan Shores – Navigating LNP IP Challenges and Freedom to Operate
- Dan presented thought-provoking points on navigating Intellectual Property (IP) challenges and freedom to operate. When developing LNP formulations and/or novel ionizable lipids, he focused on understanding how the IP landscape is essential, especially as you move from early development to the clinic and, ultimately, to commercial use.
Dr. Sean Bedingfield – Discussion on Timing & Sequence in Clinical Translation of Nanomedicines
- Sean led an engaging discussion on the critical path considerations of nanomedicine projects moving from concept to first human dose, including common missteps seen in startups and an outline of runway-saving approaches that grow ever more vital as the non-vaccine, extrahepatic space continues to heat up.
Dr. Jason Coleman – Regulatory Considerations for Novel Lipids
- As CordenPharma Lipids & LNPs Platform Director, Jason presented on the regulatory landscape for novel lipids used in LNP formulations, providing valuable insights if you’re considering taking your own ionizable lipid to the clinic. He explained what qualifies as a novel lipid from a regulatory perspective, and outlined key supplier requirements for developing clinical-scale novel lipids.
LNP Summit 2025 – Session 2, Chaired by CordenPharma Lipids & LNPs Platform Director Dr. Jason Coleman
Dr. Chantal Pichon – Challenges of Targeting Ligands for Specific LNP Delivery
- Chantal delivered an engaging presentation focused on the interface of chemistry and biology for the development of innovative delivery strategies for nucleic acids. She covered her research on lipid- and polymer-based delivery systems for enhanced targeted delivery, intracellular uptake and endosomal escape.
Dr. Yana Reshetnyak – pHLIP Technology for Targeting and Delivery of Gene Therapeutics and Other Therapeutic Payloads
- Yana shared the ground-breaking benefits of pHLIP® (pH-Low Insertion Peptides), pH-sensitive peptides that exploit pH differences between healthy and diseased cells as a biomarker for targeting and enhancing intracellular delivery of gene therapeutics and drugs.
Dr. Daniel Heller – Precision Nanomedicine for Targeted Drug Delivery
- Daniel shared insightful formulation approaches designed to enhance nanoparticle delivery to various organs and tumour micro-environments, stressing that one of the biggest challenges in the field of drug delivery is getting across the blood brain barrier. He also highlighted how his team is developing nanoparticles capable of penetrating this barrier to target brain tumors and other neurological diseases.
Dr. Umberto Romeo – Development and Optimization of TFF Purification for Lipid Nanoparticles: Advancing Yield & Purity
- As CordenPharma Global Head of Development for LNPs & Injectables, Umberto presented strategies to optimize LNP purification during early development stages. He also addressed key challenges in maintaining the desired Quality Target Product Profile (QTPP), including particle integrity, scaling up processes effectively, and ensuring high purity, alongside innovative approaches implemented to streamline purification workflows.
LNP Summit Retrospective Video
Our speakers
Dr. Jayesh Kulkarni
Co-Founder & Chief Scientific Officer, NanoVation Therapeutics
Dr. Kulkarni obtained his PhD from the University of British Columbia and has over 12 years of academic and industry experience in the nanoparticle drug delivery field. He has published over 40 peer-reviewed articles in prestigious journals and co-inventor on numerous patents. Dr. Kulkarni’s research has focused on the role of the various lipid components in LNP and the biophysics that governs particle formation. His work has contributed to clinical translation, including scale-up and manufacturing of LNP systems in accordance with GLP and GMP regulations. Dr. Kulkarni is a leader in the design and development of lipid nanoparticle (LNP) formulations of small molecule and nucleic acid therapeutics. He currently serves as the Chief Scientific Officer of NanoVation Therapeutics, an LNP-RNA formulation developer.
Dan Shores
Partner, Rothwell Figg
Dan Shores
Partner, Rothwell Figg
Dan Shores is a partner at Rothwell Figg and founder of its Boston office. He serves companies operating in dynamic biotech markets building patent portfolios, litigating complex patent disputes, negotiating strategic collaborations, and conducting due diligence and landscape investigations. Dan has served companies utilizing the following technologies (without limitation): mRNA; lipid nanoparticles; in vivo CAR-T; oligonucleotides; genetically engineered swine organs for xenotransplantation; artificial intelligence for drug discovery; small molecules; biologics, materials science, and numerous other technologies throughout his 20-year career. Dan has a J.D. from the Georgetown University Law Center and a B.S. in engineering and materials science from the University of New Hampshire. He is a member of the bars of the Supreme Court of the United States, United States Court of Appeals for the Federal Circuit, and United States District Court for the District of Massachusetts.
Dr. Sean Bedingfield
Senior Advisor, Lilly Genetic Medicine, Eli Lilly & Company
Dr. Sean Bedingfield
Senior Advisor, Lilly Genetic Medicine, Eli Lilly & Company
Sean Bedingfield is a drug delivery specialist bridging gene editing & gene therapy early discovery and clinical translation with work spanning multiple platforms and modalities. Currently in Lilly’s Genetic Medicine division, he leads a small team in a blend of specific portfolio projects, internal platform development, external collaborations and vetting external technologies. Lilly’s interests are broad and ambitious in genetic medicine, as highlighted by their public partnerships including Dicerna Therapeutics, Scribe Therapeutics and Sangamo Therapeutics and acquisitions such as Prevail, Akouos and Verve Therapeutics. Receiving his PhD in Biomedical Engineering from Vanderbilt University, his publications include high impact papers relating to intracellular assay development, RNA delivery leveraging targeted nanoparticles, protein engineering applications (now licensed by Anchor Biologics), and nanomedicine-related material science investigations. Prior to this role, he worked as a technical lead in business development for Pendant Biosciences.
Dr. Jason Coleman
Associate Director, Lipids & LNPs Platform, CordenPharma
Dr. Jason Coleman
Associate Director, Lipids & LNPs Platform, CordenPharma
Jason Coleman is the Associate Director of the Lipids & LNPs Platform at CordenPharma. Jason’s focus is on building this platform to help clients as they create the latest lipids and non-viral delivery carriers for RNA based therapeutics. Previously, Jason was Associate Director of R&D at iCeutica where he focused on developing and taking a novel bioavailability enhancement technology from lab scale to FDA approval and commercialization. Jason also led the Global Field Application Scientists team at Precision Nanosystems / Cytiva with a focus on using a platform mixing technology to help clients develop and scale-up nanoparticle-based delivery systems. Jason received his PhD in Chemical and Biological Engineering from Drexel University with a focus on nanoparticles for drug delivery.
Prof. Dr. Chantal Pichon
INSERM ART ARNm US55 Innovative Therapies and Nanomedicine
Prof. Dr. Chantal Pichon
INSERM ART ARNm US55 Innovative Therapies and Nanomedicine
Chantal Pichon is a Full Professor at the University of Orléans (France) and holds the prestigious Chair of Innovation at the Institut Universitaire de France. She is also an invited Professor at the Berlin Institute of Health at Charité (Germany). Professor Pichon leads a cutting-edge R&D laboratory within Inserm, France’s premier institute for medical research, dedicated to advancing RNA-based technologies for therapeutic applications. Her work bridges chemistry, biology, and physics, fostering interdisciplinary research at the interface of fundamental science and translational medicine. Her research focuses on messenger RNA (mRNA) for use in vaccination, cell therapy, and protein replacement. She has developed innovative delivery systems and patented a breakthrough mRNA bioproduction platform using engineered yeast—an approach that significantly reduces production costs compared to existing methods. Chantal has an established track record of over 200 scientific publications and has secured 39 competitive research grants from both public and private sources.
Dr. Yana Reshetnyak
CEO & President, pHLIP
Dr. Yana Reshetnyak
CEO & President, pHLIP
Dr. Reshetnyak is the CEO and President of pHLIP, Inc., a Professor of Physics at the University of Rhode Island, and a Commissioner at the RI Atomic Commission. She is also a co-inventor of pHLIP technology and a co-founder of pHLIP, Inc. Her laboratory has focused on the molecular mechanisms of membrane-associated folding and unfolding. Dr. Reshetnyak, along with her colleagues, Prof Engelman from Yale and Prof Andreev from URI, developed a novel pHLIP delivery approach. Dr. Reshetnyak’s achievements include being a Wood/Whelan Fellow, an NSF Advanced Faculty Fellow, a Laureate of the G. Weber International Competition, and a recipient of the Research Excellence Award and the Maitland P. Simmons Memorial Research Award. She has also received multiple Outstanding Inventor Awards. With over 100 publications and 44 patents and patent applications, Dr. Reshetnyak is a prolific contributor to her field. As CEO of pHLIP, Inc., she currently leads the pre-clinical development of pHLIP technology for targeted delivery of gene-regulating therapeutics and immuno-modulators.
Dr. Daniel Heller
Head, Cancer Nanomedicine Laboratory, Sloan Kettering Institute
Dr. Daniel Heller
Head, Cancer Nanomedicine Laboratory, Sloan Kettering Institute
Dr. Daniel A. Heller, PhD, is Head of the Cancer Nanomedicine Laboratory and Member of the Molecular Pharmacology Program in the Sloan Kettering Institute, and Co-Director of The Pat and Ian Cook Doctoral Program in Cancer Engineering at Memorial Sloan-Kettering Cancer Center. He is also Professor in the Department of Pharmacology at Weill Cornell Medicine. Dr. Heller obtained his PhD in chemistry from the University of Illinois at Urbana-Champaign in 2010 and completed a Damon Runyon Cancer Research Foundation Postdoctoral Fellowship in the laboratory of Robert Langer at MIT in 2012. Dr. Heller’s research group develops nanotechnologies for the research, diagnosis, and treatment of cancers and allied diseases. He has published over 100 peer-reviewed publications, is an inventor on over 20 pending or issued patents, and he established several active startup companies to advance these technologies to industry practice or clinical trials. He is a 2012 recipient of the National Institutes of Health Director’s New Innovator Award, among other honors.
Dr. Umberto Romeo
Global Head of Development: Injectables & LNPs, CordenPharma Caponago
Dr. Umberto Romeo
Global Head of Development: Injectables & LNPs, CordenPharma Caponago
Umberto Romeo brings over 15 years of experience in drug product process design and development for both chemical and biological entities across all clinical phases through to commercialization. He currently serves as Global Head of Development for Injectables and Nanomedicines at Corden Pharma, where he oversees formulation—including nanoparticle-based systems and ATMPs—analytical development, validation, industrialization, and clinical manufacturing operations. Previously, he was Development Director at the Corden Pharma Caponago site and held leadership roles at Evotec, managing integrated drug development programs (Discovery to Phase 3), and at UCB, where he established the Drug Product Process Design and Development function supporting the biological pipeline. Umberto holds a degree in Pharmaceutical Biotechnologies from the University of Milan and has a strong track record of driving CMC innovation and operational excellence in drug product development.