DMHC analysts discuss presentations from the Advanced Therapies conference

Supporting links
Cell and Gene Therapy Podcast
https://www.biomedtracker.com/reportdetail.cfm?reportid=1683

Editing The Future Report
https://www.biomedtracker.com/reportdetail.cfm?reportid=1608

Peripheral T-Cell Lymphoma (PTCL) Market Spotlight
https://www.biomedtracker.com/reportdetail.cfm?reportid=1050

Gene, Cell, & RNA Therapy Landscape Q4 2022 Report
https://www.biomedtracker.com/reportdetail.cfm?reportid=1721

Other platforms
Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836​

Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz​

TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/​

Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67​

DMHC podcast - Advanced Therapies

Commercialization is a tough road to navigate even for the most established bio/pharmaceutical therapies. But as cell and gene therapies (CGTs) continue to form roots and make a splash worldwide—but specifically in the US—commercialization forms its own version of standardization and best practices.  

In this exclusive interview with Pharmaceutical Executive, Lung-I Cheng, vice president of CGT, Cencora (formerly AmerisourceBergen), discusses: 
1) defining CGT commercialization strategies and foundational knowledge—and the best music metaphor
2) what he wishes companies knew about commercialization strategies
3) common knowledge gaps of CGTs
4) how CGT developers can overcome key challenges, including those related to patient access, regulatory requirements, and market access
5) how planning for allogeneic cell therapies differs from autologous cell therapies and gene therapies
6) how companies can demonstrate CGT value as more products enter the development pipeline (and competition intensifies)
7) when to start planning a CGT commercialization strategy
8) predictions for the CGT market in five years

Avoiding Commercialization Pitfalls for CGTs

In this issue, we review the key considerations and regulatory guidance for nonclinical cell and gene therapy development, including expert approaches to mitigating complex challenges, improving study efficiency, and maximizing translational opportunities to first-in-human trials.

CHAPTERS: 
- 00:07 — About This Audiobook
- 01:57 — Introduction
- 05:34 — Species Selection 
- 09:00 — Germline Mitigation Studies
- 13:22 — Planning Your Nonclinical Studies
- 14:44 — Case Study 1
- 17:18 — Case Study 2
- 19:08 — Conclusion

Click here to read Issue 36: https://www.altasciences.com/sites/default/files/2023-09/The-Altascientist-Issue36-Cell-and-Gene-Therapy.pdf

Traditional approaches modulate the course of disease but do not provide a cure, particularly in the case of monogenic diseases, which are caused by mutations in single genes that a person is born with. It is estimated that there are greater than 6,000 monogenic diseases, affecting over 350 million people worldwide. For these diseases, cell and gene therapy may provide hope for a cure.

There are significant challenges associated with the successful development of these complex, leading-edge therapies. Challenges involved in the in vivo preclinical study of cell and gene therapies include understanding on- and off-target activity, immune responses, and other serious adverse events. All of these must be carefully monitored, rigorously assessed, and managed to the highest extent possible.

About Altasciences:
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

Issue 36 — Nonclinical Studies in Cell and Gene Therapy

In the latest episode of the In Vivo podcast, Edwin Stone, CEO of UK-based Cellular Origins, talks about how robotics can increase access to safe cellular therapies. The type of biology-agnostic robotics his company develops can help companies scale up cell manufacturing while lowering the cost of production.

Automating Cell Therapy Manufacturing: Cellular Origins' CEO Talks Robotics

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

The Pharm Exec Podcast goes beyond the pages of the Pharmaceutical Executive print magazine and PharmExec.com to bring the latest commercial insights to the C-suite through in-depth interviews. Podcast episodes examine current trends, key conferences, and critical topics in the industry.

As an end-to-end CRO/CDMO, we have expert knowledge in all early stages of drug development, and we’re sharing that knowledge with you in The Altascientist: The Audiobook. 

Each issue is a deep dive into a specific area of early-phase drug development, providing insider tips, considerations, and case studies. 


Altasciences is a drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

New tracks tagged #cellandgenetherapy