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Explore the key considerations for successful formulation development and manufacture for safety assessment, and learn about the strategies Altasciences employs to support sponsors.

- 0:35 — Introduction
- 3:34 — Considerations for Preclinical Drug Formulation
- 7:36 — Preclinical Drug Product Manufacturing 
- 9:46 — Steps in Preclinical Drug Product Manufacturing
- 13:49 — Quality Assurance and Control 
- 14:33 — Regulatory Aspects
- 15:42 — Risk Management 
- 17:17 — Case Study 
- 21:27 — Conclusion 

Formulating and manufacturing drugs for preclinical testing is an early, crucial step toward human trials. At the preclinical stage, the goal is to maximize exposure for safety testing, formulating to the limits of solubility and maximum volumes. To optimize the formulation for preclinical testing, one must consider the route of administration, selection of excipients, stability testing, plans and options for scale-up, and contingency plans.

Issue 38 — Optimal Preclinical Formulation and Drug Product Manufacture

Biomarkers can provide insights into experimental therapies, identify patients who are likely to benefit from them, and improve chances for clinical success. Charles River Laboratories offers a range of early biomarker discovery services, leveraging the expertise of its scientists to identify biomarkers in the early stages of drug development programs. We spoke to Stefan Kostense, director of biology at Charles River Laboratories, about the benefits of conducting biomarker discovery early in the drug development process, how it can drive development decisions in the preclinical phase and beyond, and how it benefits patients.

Using Early Biomarker Discovery to Secure Clinical Success

Dermal drug delivery approaches are on the rise in a variety of therapeutic areas, including reformulation of existing medications. In many instances, the improvements in delivery systems can lead to a successful 505(b)(2) application, extending the patent life of a drug for its sponsor, or creating a marketing opportunity for a company developing dermal delivery of an already marketed drug. New medications are being specifically designed for dermal delivery, and advancements in the field continue as innovative approaches are being tested for the market. 

In this audiobook, we review the specific nonclinical requirements to move a dermal program forward to Phase I clinical trials, as well as the approaches and considerations that minimize inherent challenges. 

Chapters: 
- 1:32 — Current Trends in Dermal Delivery Systems 
- 3:38 — Managing Challenges in Dermal Drug Development
- 5:43 — Species Selection for Dermal Studies 
- 7:49 — Commonly Required Nonclinical Studies 
- 9:02 — Dermal-Specific Studies
- 11:02 — Case Study
- 14:27 — Conclusion 

Read Issue 39 instead: https://www.altasciences.com/sites/default/files/2024-04/the-altascientist-issue-39-nonlcinical-dermal-studies.pdf

Issue 39 — Considerations for Nonclinical Dermal Studies: Advancing to Phase I

Emma and Summer meet with oncology analyst Flora to discuss the therapeutic potential of exploring the tumor microenvironment.

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​

September 2024 Datamonitor Healthcare Podcast: Diving into the TME

Summer Colling speaks with Emma Wille about the Psychedelic Symposium at the University of Wisconsin-Madison and what the future of psychedelic therapeutics could look like.

Datamonitor Healthcare Podcast: Psychedelic Symposium at the University of Wisconsin-Madison

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 Big4Bio Podcast shares podcasts that give insight and information about/from biotech and life science leaders and organizations within the Big4Bio regions. Check out our Playlists to hear podcasts by region.

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.

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