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 specif ..read more

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 huma ..read more

In this issue, we will review the applications of PCR analysis for your gene therapy programs, and present two case studies. Click to read this audiobook: https://www.altasciences.com/sites/default/files/2023-10/the-altascientist-issue-37-pcr_4.pdf Gene therapy continues to accelerate through preclinical and clinical research arenas. These programs are developed with targeted and personalized medicines in mind. The goal of gene therapy is to safely deliver and incorporate a genetic alteration to restore or repair the protein of a missing or faulty gene. Preclinical assessments of gene therapie ..read more

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 ..read more

The demand for HPAPIs has been increasing over the past decade, mainly driven by oncology research. The overall HPAPI market is predicted to reach $31.5 billion USD by 2029, with more than 25% of drugs currently on the market formulated with HPAPIs. In this issue, we examine the intricacies involved in manufacturing highly potent active pharmaceutical ingredients, herein referred to as HPAPIs. This examination of HPAPIs includes a review of the relevant guidance, classification systems, and safety processes. We also delve into how CDMO facilities, equipment, and processes for HPAPIs should be ..read more

Understanding a novel drug's PK and PD properties begins with nonclinical studies and evolves through early phase clinical trials. In this issue, we take a closer look at the collection and use of PK/PD data in early phase drug development. CHAPTERS: - 0:08 — Introduction to Issue 34 - 1:32 — Nonclinical Studies - 2:39 — IND Requirements and Translation to Clinical PK/PD - 5:37 — Translating Nonclinical Knowledge of PK/PD Analyses to Clinical Study - 8:51 — Case Study - 12:32 — Conclusion Click here to read Issue 34: https://www.altasciences.com/sites/default/files/2023-08/the-altascientist-is ..read more

A consideration with a measurable impact on early phase clinical studies is the location where trials are performed; this is especially true for first-in-human trials. Conducting early phase clinical research on novel compounds in Canada can provide significant advantages versus other locations. CHAPTERS: - 0:43 — Introduction - 3:12 — Canadian Clinical Trials: Time and Cost Savings - 3:46 — CTA (Health Canada) vs. IND (FDA) - 5:17 — CTA: Health Canada vs. EMA - 7:52 — Regulatory Review Process Predictability - 10:19 — Business Efficiency Cost Savings - 11:28 — Clinical Trial Participants - 13 ..read more

The different parts of the nervous system (or CNS for short), including the brain and spinal cord, and the peripheral nervous system, are important drug targets for many serious diseases affecting human health. As the body’s processing center, the CNS is responsible for all functions of our bodies, including thoughts, emotions, memories, and behaviors. Unsurprisingly, drugs working on the CNS are subject to stringent regulatory requirements, and specialized safety assessments are often mandated. To confirm CNS activity without safety concerns, dedicated nonclinical and early phase clinical stu ..read more

In this issue, we describe the numerous benefits of incorporating a stable isotope labelled internal standard for quantitative liquid chromatography-mass spectrometry, and detail recent advances in MS technology. Several case studies are presented, which exemplify novel bioanalytical workflows that are required to meet the challenges faced in both non-clinical and clinical development, across a variety of drug classes. - 0:42 Introduction - 5:33 The Case for Stable Isotope Labelled Internal Standards for LCMS Quantitation - 8:34 Recent Innovations in Mass Spectrometry - 15:38 Case Study: Dried ..read more

Liquid-filled hard-shell capsules are a popular formulation for oral solid delivery of chemical drugs and nutraceuticals. Often selected for drugs with poor solubility and/or poor bioavailability, liquid-filled hard-shell capsules also have applications in a number of other situations, including specific benefits during early phase clinical development. In this issue of The Altascientist, you will hear about: • 0:57 — Applications of liquid-filled hard-shell capsules • 5:32 — The production process • 8:13 —The role of excipients • 9:54 — Other advantages of liquid-filled hard-shell capsules ..read more