RNA Formulation Articles

  1. RNA Vaccines: Just Scratching The Surface 12/28/2023

    RNA vaccines have shown promise in preventing infectious diseases and treating cancer, but clinical development varies markedly between the two. HDT Bio’s Dr. Berglund discusses this and how they can be improved.

  2. How To Break RNA's “4-Minute Mile” 12/20/2023

    Four CEOs provide their take on some of the hot topics of discussion in the RNA therapeutics space. Whether they be homing in on platform development, much-needed scientific advancements, or commercialization considerations, each of these experts’ quotes speaks to the important “training efforts” we should be building into our “workout” regimens to condition our companies and our products to achieve (and surpass!) RNA’s own “four-minute mile(s).”

  3. FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities 10/25/2023

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

  4. Defining The RNA Therapeutics Industry In 2023 1/16/2023

    Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

  5. mRNA & RNA Therapeutics In 2023: Where Do We Go From Here? 12/7/2022

    To figure out what the future holds for companies in the RNA sector of the ATMP space, I sat down with four executives to discuss their wildest hopes, dreams, and expectations. As you’ll note, there is no shortage of work facing the RNA therapeutics industry in the year(s) ahead. But there’s also a lot for which we can hope.

  6. The Expanding Patent Landscape For RNA-Based Therapeutics 11/16/2022

    The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.

  7. The Promising Future Of Oligonucleotides 10/31/2022

    Episode 35 of Cell & Gene: The Podcast features Dr. Michelle Mellion, PepGen’s SVP Head of Clinical Development at Cambridge, MA-based biotech PepGen. In it, Dr. Mellion talks all about the company’s oligonucleotide therapeutics that were developed to treat severe neuromuscular and neurologic diseases, such as Duchenne Muscular Dystrophy (DMD).

  8. A (More) Mature mRNA Therapeutics Industry: 4 Best Practices To Get There 9/27/2022

    Throughout the two-day mRNA Therapeutics Summit, there were four key takeaways that clearly demonstrated how the mRNA industry could incrementally achieve one speaker's industry prediction that, within the next 10 years, every person in the world will have had the opportunity to benefit from mRNA.

  9. Breakdown Of Cell & Gene Live: Advancements In Targeted mRNA Delivery 9/21/2022

    During our Cell & Gene Live, Advancements in Targeted mRNA Delivery, Dr. Murat Kalayoglu, CEO of Cartesian Therapeutics, Walter Strapps, Ph.D., Co-Founder and CEO of Carver Biosciences, and I spent the hour talking about the delivery of mRNA-based therapeutics. Our expert panelists discussed the specific challenges and opportunities in delivering conventional RNA therapeutics clinically, as well as the specific challenges and opportunities in delivering the RNA cell therapies clinically. You can view the full-length presentation here. For your convenience, we’ve broken down the hour into bite-size chunks based on the important topics we discussed throughout the hour.

  10. Capstan Therapeutics' Next Steps For In Vivo CAR Therapies 9/19/2022

    Capstan Therapeutics is a brand-new biotech company dedicated to developing and delivering precise in vivo cell engineering to patients. With $165 million in financing, Capstan Therapeutics aims to build on the foundational insights of leaders in mRNA and cell therapy from the University of Pennsylvania. Laura Shawver, Ph.D., leads the company as President and CEO, and on the heels of the biotech’s recent news, I caught up with her to learn more about the company’s plans for developing in vivo CAR therapies.