Critical Issues in Drug Development: How to Not Get Derailed in Developmental Efforts

By Matthew Weinberg & Kristen Booth

Make Sure You Are Following All FDA Regulations and Requirements when Manufacturing Pharmaceutical Products Your Manufactu

Pharmaceutical companies spend massive amounts of money on drug development.  Regardless of a firm’s size, the investment is substantial; the smallest error can have catastrophic consequences, especially for small firms.  As an example, a recent article from the Wall Street Journal discussed contamination in cell lines.  “Scientists who think they are studying liver cancer, for example, are in fact doing nothing of the sort.”  The article goes on to explain that this type of contamination is causing what is being called the ‘reproducibility crisis,’ which refers to “studies whose results can’t be duplicated and are untrustworthy if not invalid.”

One of the problems this highlights is the need for ever vigilant monitoring of both non-clinical and clinical studies.  As this issue is being faced by more and more firms across the world every day, there must be some way to overcome these hurdles and conduct a successful and reliable study on the first try.  The only way to do this is by constantly monitoring the development program. Many firms don’t see the need for this, or are concerned about the short-term budget impact.

Yet, the cost of failure is far greater than the cost associated with finding an issue and fixing it before it becomes critical.  Having independent verification of your results only strengthens the development effort.  As the WSJ article points out, many studies can’t be replicated and this can cost a lot of time and money.  These issues can be avoided.

The Weinberg Group designed a service to help you avoid this issue.  Because we are independent and because we have over 30 years of experience, we know what to look for and what pitfalls to avoid.  We can help ensure that your research and clinical studies are conducted in a respectable and compliant manner, which will help you obtain FDA approval for your product in less time and for less money.

How do we do this?  By integrating successful Good Development Practices into both the regulatory submissions and GxP parts of our business, we provide our clients a comprehensive quality approach to drug and device development, aimed at reducing unforced errors.  The focus of our work is developing drugs in a rational manner designed to create usable and approvable data.  This includes:

  • Submitting applications to the FDA that meet all regulatory requirements, when submitted;
  • Conducting regular GCP and GMP audits assures that your studies and manufacturing processes are compliant with FDA’s standards;
  • Creating an appropriate quality system; and
  • Conducting successful meetings with the FDA.

These are challenging tasks and you must do them all correctly.  The Weinberg Group has a long history of helping our clients achieve successful interactions with FDA.  Our proprietary approach, which combines a deep scientific understanding with an extensive regulatory background, can help ensure that your product meets all of FDA’s regulations and requirements.

Interested in learning more about how our services can help you get your product through FDA? Contact us today to learn more.
Written by Matthew Weinberg, CEO, and Kristen Booth, Marketing Associate at The Weinberg Group, the world’s leading food and drug consulting firm.  If you have any questions or thoughts on this blog post or others, please contact us today.