Overview
The legislation widely known as the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act), signed into law as part of the year-end appropriations legislation, is a long-anticipated provision that aims to make samples of brand drugs or biologics needed for pre-approval testing more readily available to generic companies. The CREATES Act authorizes manufacturers seeking to develop generic 505(b)(2) or biosimilar products to file civil action against brand drug or biologic manufacturers to obtain samples. This webinar will summarize the provisions of the CREATES Act and discuss its potential impact on the generics, biosimilar, and brand name drug industries.
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Speakers
Sharon Coleman, Senior Regulatory Counsel, FDA – CDER
Karin Hessler, Assistant General Counsel, Association for Accessible Medicines
Andrew Wasson, Partner, Haug Partners LLP
Moderated by Rachel Turow, Executive Counsel, Regulatory Law, TEVA Pharmaceuticals USA, Inc. and Member, FDLI Board of Directors
KARIN HESSLER is Assistant General Counsel for the Association for Accessible Medicines (AAM). She provides legal advice to AAM staff and member company representatives on issues relating to generic and biosimilar medicines in the US She works on advocacy strategy and engagement, provides advice on Hatch-Waxman and pharmaceutical patent issues and helps manage amicus briefs on behalf of AAM. Before joining AAM in March 2019, Karin was a partner at Wiley Rein LLP, where she represented clients on intellectual property matters, with a special focus on patent litigation in the biotechnology and medical device industries. She has played a lead role in all phases of numerous Hatch-Waxman litigations, including expert discovery, fact discovery, claim construction, trials, regulatory analysis and settlement negotiations. Karin has significant experience in FDA regulatory issues as well as IPR process. Karin received her JD from NYU School of Law, an MA in biochemistry from Duke and her BS in biochemistry from Lafayette College.
RACHEL TUROW is Executive Counsel, Regulatory Law at Teva Pharmaceuticals Ltd. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination products and digital health projects. Previously, Rachel was Director, Regulatory Policy, at Novo Nordisk Inc. Prior to joining Novo Nordisk, Rachel spent five years at FDA. She was a Regulatory Counsel in CDER’s Office of Regulatory Policy and she served as Special Assistant to Jeff Shuren, Director of CDRH. Rachel holds a JD and MPH from the University of Michigan and a BA in Biology from Stanford University. 
ANDREW WASSON is a partner and Chair of Haug Partners’ FDA practice in the New York office. Andrew has a broad range of experience in both the brand and generic side of pharmaceuticals, especially with respect to issues involving intellectual property law and regulatory law. Having grown up with a father who is a patent lawyer, Mr. Wasson has been involved in patents in one way or another for the better part of his life and has the advantage of being able to deal with complex patent law concepts in a very natural way. Mr. Wasson is registered to practice before the US Patent and Trademark Office and has published extensively in both scientific and legal literature. Mr. Wasson also serves on the Editorial Advisory Board for FDLI’s Food and Drug Law Journal.
