Intertek supports orphan drug development for rare diseases
22 Oct 2015
Intertek brings expertise to upcoming Regulatory Convergence Conference
Mississauga, ON – Intertek, a leading provider of quality solutions worldwide, supports companies struggling to understand the regulatory requirements for orphan drug development.Orphan drugs are pharmaceuticals and biologics that have been developed specifically to treat rare medical conditions or diseases. In the past, it was difficult to develop these products due to the challenges associated with conducting clinical trials in small populations, and the limited sales potential for manufacturers to recover developmental costs. The Orphan Drug Act addresses some of these issues; the U.S. Food and Drug Administration (FDA) provides incentives such as tax credits, grants, and market exclusivity to sponsors for orphan drug development. In recent years, the FDA has also implemented programs to accelerate the development of these products such as the Rare Pediatric Disease Priority Review Voucher Program and the Breakthrough Therapy Designation. Companies developing orphan drugs have become more educated and have an improved understanding of the strategies that can be used to make development more simple and efficient. As a result, there has been significant growth of treatment options for treating rare conditions and diseases that previously did not exist.
To help clients navigate the regulatory changes, Intertek experts will be available to discuss drug development strategies during the upcoming RAPS’ (Regulatory Affairs Professional Society) Regulatory Convergence on Oct 24-28, in Baltimore, MD. This annual event is a multi-day gathering of regulatory professionals and provides a unique opportunity for attendees to learn, grow, lead and share. If you would like to arrange for a meeting with Intertek experts in advance, please visit https://www.intertek.com/events/2015/10-24-exhibits-raps-2015/.
Intertek’s Vice President, Regulatory Affairs for Intertek Scientific & Regulatory Consultancy,
Dr. Anna Metcalfe states, “Intertek is uniquely able to provide one of the most complete service offerings on the market today with our ability to provide bundled solutions combining our regulatory and compliance expertise and our global structure for analytical testing. Our experts provide access to decades of experience, and are able to develop comprehensive product development strategies to meet international standards, focused on global regulatory and toxicology requirements.”
To learn more about the regulatory and drug development services offered by our experts and within the larger Intertek organization, please visit https://www.intertek.com/pharmaceutical/.
Contacts:
For Media Inquiries:
Global Marketing Manager
Health, Environmental and Regulatory Services (HERS)
Intertek Life Sciences
Tel.: +1 905 542-2900
Email: tracy.veale@intertek.com
For Market Inquiries:
Dr. Anna Metcalfe
Vice President, Regulatory Services
Intertek Scientific & Regulatory Consultancy
Direct: +1 905 542-2900
Email: anna.metcalfe@intertek.com
About Intertek
Intertek is a leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value for its customers by helping improve the quality and safety of their products, assets and processes. With a network of more than 1,000 laboratories and offices and over 38,000 people in more than 100 countries, Intertek supports companies’ success in the global marketplace, by helping customers to meet end users’ expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide. Visit www.intertek.com