Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Chris Spivey

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If the Alliance for mRNA Medicines (AMM) tested the waters in June 2023 at the BIO Conference in Boston, then they engaged in a full-fledged triathlon in September, in the heat and humidity of Washington, DC. It is refreshing to relate that government has continued its early support of this technology (a relationship between the US Army Medical Research Institute of Infectious Diseases, Novartis, and the Biomedical Advanced Research and Development Authority). A documentary feature explaining this background debuts this month.

The potential for mRNA medicines extends beyond vaccines into myriad other indications, but also represents efficiencies in pharmaceutical manufacturing, workforce education strengthening, and for high paying jobs. With the possibility of viewing its somewhat straightforward manufacturing as a single “platform” for regulatory approvals, this then could have the salutary effect of freeing up FDA staff, through this a potential new form of consolidated consanguinity management and approval. Time will tell.

AMM’s diverse membership was represented in Washington, DC by organizations such as Acuitas Therapeutics, Adjuvant Partners, Akron Bio, Arcturus Therapeutics, BioNTech, CSL Behring, Danaher Corp, The Johns Hopkins University, Leavitt Partners, Maravai Life Sciences, MJH Life Sciences, Precision Medicine Group, Replicate Bioscience, Precision Medicine Group, and Texas A&M Engineering. Their representatives enjoyed a free-flowing back and forth dialogue on optimizing the opportunity RNA presents the world, with Peter Marks, director of FDA’s Center for Biologics Evaluation and Research; leadership from Cancer Moonshot and White House Office of Science and Technology Policy; The Center for Medicare and Medicaid Innovation; the Office of Senator Gary Peters (MI) Chair, Senate Homeland Security and Governmental Affairs; the office of Bill Cassidy Ranking Member of the Senate HELP Committee; the office of Brett Guthrie, Chair of the House Energy and Commerce Committee, Health Subcommittee; the office of Senator Casey, Chairman of the Senate HELP Subcommittee on Children and Families; among other governmental groups.

It’s surprising that AMM, a group scheduled to officially launch in Berlin in October, was granted access to such a range of influential decision makers. Further, AMM was requested to not only assist in convening expert panelists but also offer advice for ongoing health systems and organizations re-shaping. A testament to the talent and knowledge of the AMM members, who transferred a strong sense of competence, knowledge, and trust.

Chris Spivey is the editorial director of 

When referring to this article, please cite it as Spivey, C. Washington, DC Houses mRNA Leadership. 

Articles

If the Alliance for mRNA Medicines (AMM) tested the waters in June 2023 at the BIO Conference in Boston, then they engaged in a full-fledged triathlon in September, in the heat and humidity of Washington, DC.

Washington, DC Houses mRNA Leadership

In this excerpt from a recent episode of the 

, Chris Spivey, editorial director, hosts a panel on advances in mRNA. In this clip, Chris, Kate Broderick, and Tom Madden discuss how extensive research is being conducted around various gene editing techniques and what that means for the future of mRNA. Other topics include epigenetic approaches to modulate gene expression, the expression of monoclonal antibodies, and protein replacement treatments.

For the complete discussion, check out the full podcast episode 

, chief innovation officer at Maravai LifeSciences has extensive experience and expertise in leading and liaising with multi-disciplinary groups from discovery and R&D to engineering and clinical teams. She brings strong and broad scientific expertise to TriLink Biotechnologies, which covers multiple areas, including gene delivery, medical devices, gene therapies for the treatment of various infectious diseases, cancer immunotherapies and vaccine development. Additionally, she has extensive experience with non-viral delivery systems for a wide range of vaccine targets and cancer immunotherapies.

, president & CEO of Acuitas Therapeutics, is a world-renowned expert in the area of nanotechnology. Dr. Madden co-founded Acuitas Therapeutics in February 2009 and has guided the company into its position as a global leader through the development and application of lipid nanoparticle (LNP) technology. Acuitas Therapeutics partners with leading pharmaceutical and biotechnology companies and prestigious academic institutions around the world, providing its proprietary LNP delivery technology to enable new drugs based on nucleic acid therapeutics.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Videos

Extensive research on various gene editing techniques could inform the future of mRNA therapies.

Nascent Science is Likely the Future for mRNA

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden

President & CEO at Acuitas Therapeutics. 

Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expression moving toward the clinic. We conclude with the huge potential for RNA expression of monoclonal antibodies and protein replacement applications.

Podcasts

An mRNA conversation about the recent past, current hot topics, and probable future.

Drug Solutions Podcast: mRNA Past, Present, and Future

In this excerpt from the most recent episode of the 

, Chris Spivey, editorial director, hosts a panel on advances in mRNA. There is promise of personalized cancer vaccines through the inherent nimbleness of mRNA platform. From a manufacturers point of view, how can we best to automate, miniaturize and speed up performance?

Experts discuss the promise of personalized cancer vaccines through the inherent nimbleness of mRNA platform.

Miniaturing Personalized Cancer Vaccines Through mRNA

Highlights from a wide ranging discussion on COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences, and Dr. Tom Madden, President & CEO, Acuitas Therapeutics.

Topics include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expression moving toward the clinic. We conclude with the huge potential for RNA expression of monoclonal antibodies and protein replacement applications.

Catch the full podcast episode featuring Broderick and Madden when it goes live at the 

Dr. Kate Broderick is Chief Innovation Officer at at TriLink Biotechnologies, a Maravai LifeSciences company. Prior to joining TriLink, Kate spent 15 years with Inovio Pharmaceuticals where she assumed positions of increasing responsibility, starting as Scientist, to her most recent position as Senior Vice President, R&D. She received her B.Sc. in Genetics and her Ph.D. in Molecular Genetics from the University of Glasgow.

Dr. Tom Madden is President & CEO at Acuitas Therapeutics. A world-renowned expert in the area of nanotechnology. Dr. Madden co-founded Acuitas Therapeutics in February 2009 and has guided the company into its position as a global leader through the development and application of lipid nanoparticle (LNP) technology. Dr. Madden obtained his BSc. and Ph.D. in Biochemistry from the University of London, U.K.

Highlights from a wide ranging discussion on COVID-19 pandemic response from Kate Broderick, Chief Innovation Officer at Maravai LifeSciences, and Tom Madden, President & CEO at Acuitas Therapeutics.

Unpacking COVID-19 Pandemic Response

The term microbiome may have first been used in an agriculture paper (1), but widespread traction was sparse until Francis Collins (then head of the National Human Genome Research Institute) talking through upcoming funding limits for simply sequencing yet another organism, with Broad Institute head, Eric Lander, had a true eureka moment, to seize upon sequencing the human microbiome—skin, gut, hair, and so forth, for multiple funding projects going forward. Suddenly all things microbiome became in vogue. However, as recently as February 2020, scientific papers were still proposing vague notions that, “The mechanisms by which microbiomes impact on cancers can yield new diagnostics and treatments, but much remains unknown” (2). What had seemed administrative legerdemain at that time of Collins eureka moment is, in 2023, absolutely a therapeutic window to drill down on. The tumor microenvironment as therapeutic approach has come of age, and the tool of the hour is messenger RNA (mRNA).

Acknowledging that bacteria and fungi form complex colonies with solid tumors, an approach to unravel this microbiome community was developed with mRNA molecules encoded to produce a toxin lethal to cohabitating bacteria. In this experiment, pseudomonas exotoxin A domain III was packaged into lipid nanoparticles and injected into the tumor bed. “We hypothesized that encoding the active domain only, without the binding and translocation domains of the original toxin, will allow potent intracellular effect upon mRNA translation, while reducing the risk of side-off effects in case of toxin release from target cells,” related professor Dan Peer, co-lead author of the study (3). Unlike chemotherapy where resistance gathers pace during extended exposure, this approach is easily amenable to simply switching to a different natural toxin. The study goes on to describe that most of the lipid nanoparticles reached cancer cells, destroying 44–60% of them.

While the history of drug discovery science is replete with false dawns, it is encouraging to see mRNA make an alliance with deeper understanding of the mechanics of the tumor microbiome. mRNA may be a modality whose chief advances are yet to come.

2. Xavier, J.; Young, V.; Skufca, J., et al. The Cancer Microbiome: Distinguishing Direct and Indirect Effects Requires a Systemic View. 

March 6(3), doi: 10.1016/j.trecan.2020.01.004.

3. Granot-Matok, Y.; Ezra, A.; Peer, D.; et al. Lipid Nanoparticles-loaded with Toxin mRNA Represents a New Strategy for the Treatment of Solid Tumors. 

When referring to this article, please cite it as Spivey, C. New Magic from mRNA. 

mRNA may be a modality whose chief advances are yet to come.