Conference to Discuss Scientific and Regulatory Challenges of Complex Drug Development

NEW YORK, October 25, 2016 — On Wednesday, November 9, 2016, a range of experts, industry executives, and government officials will gather at the New York Academy of Sciences for an all-day conference on the topic, "Equivalence of Complex Drug Products: Scientific and Regulatory Challenges." The program is presented by the Academy, the Non-Biological Complex Drugs Working Group and the Nanotechnology Characterization Laboratory (NCL) of the National Cancer Institute's Frederick National Lab for Cancer Research.

The rise of bio- and nanotechnologies has accelerated the development of complex drug products. This class of products includes biological complex drugs (e.g., vaccines, allergenics, somatic cells, gene therapies, tissues, and recombinant proteins) as well as non-biological complex drugs (NBCDs) (e.g., glatiramoids, iron-carbohydrate complexes, polymeric micelles, complex ocular emulsions, and liposomes). NBCDs are composed of complex structures (often nanoparticulate), which cannot be fully measured and characterized by physical and chemical analytical methods. The nature of NBCDs and other complex drug products means that minute variations in the manufacturing process can substantially change the composition of final products. This poses a challenge for the development of regulatory guidelines, particularly for the development of generic or follow on versions. This is further complicated by the difficulty of aligning strategies of international regulatory bodies with different legal frameworks. To advance research and build consensus, it is necessary to stimulate a dialogue between key stakeholders from academia, regulatory bodies, industry, and drug manufacturing.

"Addressing scientific and regulatory challenges related to complex drugs is becoming increasingly important," says Scott E. McNeil, PhD, Director of the Nanotechnology Characterization Laboratory. "As pharmaceuticals become more sophisticated—involving targeted therapies, nanotechnology, drug combinations, etc., a greater number are being classified as complex drug products." He noted that the FDA has recently proposed a new pre-ANDA program for complex products. "This meeting will bring together stakeholders with an interest in developing a rational, science-driven approach to the process of making generic versions of complex drugs available and affordable, without compromising on safety or efficacy in comparison to innovator products."

The convening aims to identify the best approaches for complex drug development and regulation, outline outstanding challenges in the assessment of complex drug equivalence and consequences of the interchangeability of products, address whether biosimilars (drugs designed to have biological properties that are similar to existing drugs) should be used as models for other complex drugs, and clarify the differences and commonalities in the behavior of biological and non-biological complex drug (NBCD) classes.

"Developing guidelines for and accelerating the launch of complex drug products has the potential to improve the well-being of patients in many therapeutic areas," says Jon de Vlieger, PhD, Business Developer for Lygature, which facilitates the activities of the NBCD Working Group. "At the same time, it is important to ensure the safety and benefit of patients through a science-based approach. Our hope is that this meeting will help generate a consensus on the best way forward on these issues."

For press inquiries, including press passes to the conference and interview or photo requests, please contact Margaret Ceres (mceres@nyas.org; 212-298-8612).

About the New York Academy of Sciences

The New York Academy of Sciences is an independent, not-for-profit organization that since 1817 has been committed to advancing science, technology, and society worldwide. With more than 20,000 members in 100 countries around the world, the Academy is creating a global community of science for the benefit of humanity. The Academy's core mission is to drive innovative solutions to society's challenges by advancing scientific research, education, and policy. Please visit us online at www.nyas.org.

About the Nanotechnology Characterization Laboratory (NCL) of the Frederick National Lab for Cancer Research

The NCL serves as a national resource and knowledge base for all cancer researchers to facilitate the regulatory review of nanotechnologies intended for cancer therapies and diagnostics. By providing critical infrastructure and characterization services to nanomaterial providers, the NCL accelerates the transition of basic nanoscale particles and devices into clinical applications, thereby reducing suffering and death from cancer. Working in concert with the National Institute of Standards and Technology (NIST) and the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI) established the NCL to perform preclinical efficacy and toxicity testing of nanoparticles. For more information, go to: http://ncl.cancer.gov.

About the Non-Biological Complex Drugs Working Group

The NBCD Working Group, established in 2009, aims to ensure patient benefit through a science-based approach for the approval of NBCD products and follow-on versions. Hosted by Lygature, a not-for-profit organization based in the Netherlands, the NBCD Working Group consists of experts from industry, academia, and knowledge institutes. The partnership encourages dissemination of data, engages in education, and provides a platform for open discussions. For more information, visit: www.lygature.org/nbcd.