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The true effect of an intervention is often not seen until real-world usage takes place, but with such a delay between R&D and healthcare delivery, how can the industry close the gap? And what is needed to deliver more effective interventions that patients really want?
The new trade regime unleashed by President Trump has not only heightened trade tensions, it has the potential to affect patient access to affordable medicines. His administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted foreign governments “freeriding” off of American investment in innovations.
Imagine your company just received FDA approval of a new pharmaceutical, the result of years of clinical research and difficult regulatory scrutiny. The product is being manufactured and is shipping to distributors and wholesalers. Providers and patient advocacy groups seem excited for the launch, and sales goals are considered aggressive. However, one key variable remains: coverage.
While the designation for what constitutes a combination product is clearly defined by the FDA, industry continues to push the boundaries for disease treatment with new and innovative breakthrough drug therapies. As regulatory professionals, the challenge we face is to align these new therapies with application-filing strategies including investigational new drug applications, new drug applications, biologics license applications, and medical devices.
Progress in development of gene and cell therapies around the world has potential to transform standards of care for a range of diseases and address significant areas of unmet need in healthcare over the coming years. In the U.S. alone, almost 20 gene and cell therapy products have been approved thus far,1 with many other development programs reaching later clinical stages. The technology platforms of many of these drugs also offer the potential for curative efficacy and expansion for use in multiple indications.
In recent years, a growing number of pharmaceutical companies have recognized the potential benefits of pre-launch access programs, either as components of later-stage clinical development or early access programs or to support importation of drugs into countries recognizing an FDA or European Medicines Agency (EMA) approval. These programs help patients access investigational therapies prior to regulatory approval or commercial launch and are generally reserved for therapies that have demonstrated an acceptable level of proof of concept and safety. In addition to expanding treatment options for patients, often in indications that have limited or no approved therapies available, pre-launch access programs are also widely seen to play a significant role in advancing many drug development programs.
Thanks to our relationship with LSTI and an outstanding team here at Accelovance, we have built a training program that is able to be leveraged moving forward to address an industry need.
My main reason for taking the course was to re-evaluate quality agreements and how to improve our current template. Coming out of this, I would like to compare a few of our supplier quality agreements against the structure and checklist given in the course to see how they align.
Cook Pharmica LLC
All parts of the training were useful, including the topics of Documentation, Change Control and Revisions. I will now review our current Quality Agreement to make sure the requirements are included, and if not, add them.
I took the course to get a better understanding of FDA requirements. As an ISO 9001 registered organization, we need to control and cooperate with suppliers and this gave me some ideas on more formal ways to do that. The webinar was easy to attend with clear audio.