HelixTalk #144 - mRNA Technologies and their Implications in Therapeutics: Q&A with Dr. Martin
Date posted: March 1, 2022, 6:00 am
In this episode, we interview Dr. Danyelle Martin, a Medical Science Liaison (MSL) at Moderna, in order to learn more about the what, how, and future of mRNA-based therapeutics, and what impact it can have on healthcare and healthcare professionals in general.
Moderna has a “Research Engine” proprietary service that takes an mRNA idea from a web-based digital designer, to a digital ordering system, and finally to a production facility where mRNA constructs are synthesized and quality tested.
Pharmaceutics play a big role in the formulation of mRNA particles. Lipid nanoparticles (LNPs) play an important role for stability and delivery of mRNA cargo. After LNPs and mRNA are co-formulated, the product is purified, filtered, frozen, and subjected to a series of good manufacturing practice (GMP) tests to ensure product quality.
COVID-19 vaccines are a small glimpse into the potential future of mRNA-based therapeutics. Moderna’s pipeline includes mRNA vaccines for other viruses (including RSV, influenza, Zika and CMV) as well as therapeutics for non-viral diseases (including a personalized cancer vaccine and a VEGF-A mRNA molecule for myocardial ischemia).
Moderna's Forward-Looking Statement:
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not limited to, statements concerning the timing, design, objectives and other parameters of the Phase 1, Phase 2 and Phase 3 clinical studies of mRNA-1273. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this presentation are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: preclinical and clinical development is lengthy and uncertain, especially for a new class of medicines such as mRNA, and therefore our preclinical programs or development candidates may be delayed, terminated, or may never advance to or in the clinic; no commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) or other regulatory agencies, the FDA, EMA or such other regulatory agencies may not agree with Moderna’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in clinical trials, preclinical work, overall operations, regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.