July 15, 2021

The Analytical Detective: Benefit-Risk Balance and the Analytical Testing Process

In any pharmaceutical development program, there are risk-benefit analyses being done to assist with decision-making processes. Expedited development presents a different balance to a company’s risk-benefit in order to bring a particular molecule forward as quickly as possible because of the potential benefits.
June 17, 2021

The Analytical Detective: Understanding Impurities in the Molecule Assessment Process

Colman Byrne, a senior analytical services expert at DSI, describes the molecule assessment process as detective work, in which physical chemists assess different pieces of information to solve a puzzle. Questions that must be answered in the process include: What is the product supposed to be and do?
June 3, 2021

Meetings Between the FDA and Sponsors Aren’t Quite What You Think They Are

FDA Meetings aren’t what many people think they are especially when it comes to the CMC-focused discussions. We look at seven common opinions about formal meetings between the FDA and Sponsors or Applicants of PDUFA Products when it comes to CMC compliance and compare them to reality.
April 15, 2021

Material Characterization and Formulation Development

Learn how to guide sponsors in the critical exercise of materials characterization and the establishment of reference standards for NCEs as well as in the formulation of drug products from the IND-enabling stages of development through postapproval evergreening changes.
April 1, 2021

Establishing Regulatory Starting Materials & Understanding the ICH

There are many ways for companies to get approvals for expedited development. This is primarily based on trials and data from clinical studies. The biggest issue has always been how acceleration impacts CMC. In many cases, the data and the programs need time and cannot be expedited. So how do you ensure CMC doesn't become the bottleneck?
March 18, 2021

Expedited Drug Development and CMC Management

DS InPharmatics' Senior Drug Substance Consultant, James Mencel, provides us with insight on his background with CMC management and the impact that expedited drug development programs have had on the pharma industry. Learn how to break down regulations, breakthrough designations, and the best practices suitable when it comes to these programs.