Altasciences

EPISODE #9: Choosing the Right CRO for your Clinical Trial Monitoring by The Altascientist

EPISODE #8 - Cannabis and Clinical Trials Overview with Dr. Beatrice Setnik and Ingrid Holmes by The Altascientist

EPISODE #7: High-Potency Manufacturing Solutions by The Altascientist

Altasciences offers liquid-filled two-piece capsules services as a tool to effectively formulate poorly soluble drugs and supplements, while reducing development time and costs. Liquid filling also offers the ability to control R&D compounds, which are expensive and in limited supply.

• Learn about the clinical trials required to support market applications for tobacco products in the US

• Discover the clinical trial methods to evaluate the abuse potential, pharmacokinetics and smoking cessation

• Examine how drug administration, dosing, and selection of study subjects is handled

• Discuss the relevance of examining biomarkers in clinical trials

Altasciences' experienced team provides contract manufacturing and analytical services to the pharmaceutical industry, including formulation development, Phase I through commercial manufacturing, and ICH stability testing.

Want to watch the video? https://www.youtube.com/watch?v=47hlQnne5LQ&t=3s

Scientists around the world are working around the clock to find and test potential COVID-19 treatments, and get them to the market as quickly as possible. A promising option is to repurpose existing treatments for use in a different therapeutic area (such as COVID-19), via the 505(b)(2) process.

In this recorded discussion, Altasciences’ experts offer insight into how to navigate through the different challenges of the (re)approval process, including:

• The steps taken by the Regulatory Agencies when analyzing such submissions

• The clinical studies required and reasoning for further clinical testing of previously approved drugs

• The estimated timeline for approval of a 505(b)(2) submission

• The process for inclusion of non-U.S. trial data to support a 505(b)(2) submission

Want to watch the video? https://www.youtube.com/watch?v=Rxal6Khm7dM

Getting a Vaccine to Market: The Timeline, the Process, and What to Expect with Dr. Beatrice Setnik of Altasciences by SOSNA+CO