Area of presentation – Excipients - Excipient Management for Encapsulated products: going beyond the risk assessment exercise
Speaker: Kaat Bracquine - Senior. Manager, Quality and Regulatory Affairs
1. What are the current global trends driving the pharmaceutical sector you are working in? How does your company respond to those trends?
The pharmaceutical industry is experiencing a period of heightened regulatory scrutiny both in the US and globally. This scrutiny is occurring in a number of areas, including: sales and marketing practices, government drug price reporting, privacy of patient and/or customer health information, clinical operations, post-marketing drug safety reporting, and in quality control activities around manufacturing operations.. This trend is driving a powerful reaction among companies to put in place robust enterprise-wide compliance management programs designed to reduce risk, enhance management controls, and ensure compliance. The industry’s regulators have also provided guidance that enables innovation and potential cost savings in manufacturing operations. A thorough understanding of the new guidance and a commitment to embed it in the way companies work can bring truly competitive advantage.
2. What are the top challenges faced by the pharmaceutical sector you represent at this moment? How does your company deal with these challenges?
In recent years, several highly publicized contamination incidents have underscored the challenges associated with the increasing complexity of global supply chains and outsourcing. Good Distribution Practices (GDPs) provide guidance on best practice related to transportation, distribution and warehousing to ensure product integrity and quality. The ultimate aim is to provide door-to-door reliability throughout the value chain around the world. The globalization of the industry also introduces the challenge of meeting the requirements of all target markets in an environment which is highly regulated but not harmonized. It is critical that excipient producers engage with customers to clarify where the finished product will be marketed or intended to be marketed in the future. This will not only mitigate the risk for regulatory barriers, but also opens the opportunity to design products that maximize the specific future market potential.
3. What topic are you presenting at the Pharma Insight Briefings and why is this subject so important to the market at this time?
In 2015, the European Union published new guidelines (2015/C 95/02) that require the pharmaceutical industry to demonstrate appropriate excipient Good Manufacturing Practices (GMPs) through a formalized risk assessment. By now, pharma companies should have conducted these formalized risk assessments and have them available to EU regulatory inspectors. The presentation will look beyond the sole excipient risk assessment exercise really questioning the potential influence of excipients (here the capsules) in the drug product manufacturing and performance.
4. What can attendees to your session expect to gain and which challenges does this content address? Why should they include your presentation in their agenda?
The current regulatory framework on medicinal products requires excipient suppliers to be carefully selected – from start-up throughout the product’s lifecycle.Therefore, pharmaceutical formulators should embark on a dialogue with raw material suppliers to build a genuine understanding of the excipient characteristics and variables based on its starting materials, their origin and manufacturing processes. The presentation will look closely at this excipient supplier – user relationship to be built to ensure a science and risk-based selection for a robust formulation by taking into account the use and function of the excipient in the finished drug product.
5. How do you see your sector of the market evolving in the next 5 years?
As demonstrated in several scientific studies over the past decade, excipients are not inert substances. In fact, they may play a role, for example, in mitigating multidrug resistance and mediating metabolism. While there has been an initial reluctance to acknowledge and describe such an active role, the scientific community will continue to articulate and expand such evidence and bring it to the regulatory authorities’ attention. This will lead to a more open and robust dialogue and the development of comprehensive guidelines on the use of such materials. Formulators work with compounds that are increasingly complex. Access to powerful tools will only benefit pharmaceutical development as a whole. Suppliers will continue to investigate, develop and innovate through more advanced products that, for example, target specific applications such as targeted delivery of drug product to the small intestine. This is evidenced by the recent launch of Vcaps® Enteric and enTRinsic®, two unique capsule based platforms that bring a high level of complexity through inherently enteric and gastro-protective functions.