RNA Clinical Trials Articles

1. AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance 4/8/2024

   The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

2. FDA’s Updated Guidance On Human Genome Editing: New Implications & Remaining Questions 2/27/2024

   On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.

3. 1 In 300 People In The U.S. Is Living With HIV. That’s Not Okay With Jeff Galvin. 2/13/2024

   By modifying CD4 T cells using miRNA, Jeff Galvin’s company thinks it can deliver a functional cure for HIV. Here’s the ongoing story of Addimmune and its unique clinical strategy.

4. 2024’s Market Outlook For Cell & Gene Therapies 2/9/2024

   RSM is back for the third consecutive year to provide an outlook analysis of the cell and gene therapy market. This article discusses the 2024 state of the macroeconomy, its effects on cell and gene therapy companies, growing approval pipelines and approvals, funding factors, and the unique prospects for the market.

5. FDA Draft Guidance On “Rare Diseases: Considerations For The Development Of Drugs And Biological Products” 1/26/2024

   Accenture Applied Life Science Solutions' Raj Bandaru, Ph.D. breaks down, summarizes, and shares detailed insight on the recent FDA Draft Guidance that addresses “Rare Diseases: Considerations for the Development of Drugs and Biological Products.”

6. 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.

7. 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).”

8. “Alice In [mRNA] Wonderland:” 3 Realities Facing The mRNA Industry 8/7/2023

   The mRNA industry is an exciting place to be, and I have no doubt we will celebrate some significant triumphs in the future. But there are three critical realities (or perhaps difficult truths) I was reminded of during the mRNA Therapeutics Summit worth reiterating to keep us grounded through all our uninhibited dreaming.

9. 5 Promising Applications Of RNA Therapeutics 7/28/2023

   Ribonucleic acid (RNA), once considered a mere messenger molecule, has now emerged as a versatile tool in the development of novel therapies. In this article, we will delve into the world of RNA therapeutics, exploring their potential and five applications that could impact the future of medicine.

10. Excision BioTherapeutics & Guide RNA 7/27/2023

    Excision’s CEO Daniel Dornbusch to dig into its CRISPR-based therapy, EBT-101, as well as Guide RNA (gRNA) and why it is critical to EBT-101’s success.