Comparability for Change Implementation and for Biosimilars
Biosimilars and Biobetters
Bioassays for Biologics
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CONFERENCE SERIES: Biological Therapeutic Products
Recorded at: BioAnalytical Summit
About this Product:A digital course led by experts in the field examining the current opportunities, profit potential and penetration strategies for biosimilar products. It offers advice on collecting a robust data package for the authorities, clarifies current regulatory pathways around the globe, and provides strategies for dealing with the remaining uncertainties. It also examines the complex legal issues and advises on how to work out freedom to operate and how to clear the path for development. This digital course will arm investigators with the information required for entering this exciting and potentially highly rewarding field.
About this Product:6 PresentationsOver 279 Slides
Site License: $1699
Agenda At A Glance:
Strategy for Entering the Biosimilars Market Louis-Christian Clauss, Ph.D., Principal Consultant, RA & QA Healthcare, Atheln BiomedA review of the global biosimilars market including the regulated (the EU), the to be regulated (Japan, UA, NZ, Australia, Canada etc.) and the unregulated. It will examine:
In addition, the following will be discussed:
Biosimilars in Europe: 5 years of Successes and Failures Chris Holloway, Ph.D., Group Director, Regulatory Affairs, ERA Consulting GroupThe presentation will begin by explaining this legal basis and its ramifications for products claimed to be "biosimilar". The concept of "similar biological medicinal products", or "biosimilars" as they have become known, was first introduced in the EU in 2003 but the legal basis was not established until 2004. The directives were followed by a series of guidelines issued by the European Medicines Agency in 2005, which address quality, non-clinical and clinical requirements, and provide some product-specific guidelines. More recently, a draft guideline has been issued for non-clinical and clinical development of biosimilar monoclonal antibodies and a concept paper for biosimilar interferon-beta has also been published by the European Medicines Agency. These guidelines will be discussed in the light of experiences to date, both successes and failures.
The fact that several biosimilars have been approved, demonstrates the "achievability" of a marketing authorisation through the biosimilar route. The "failures" are interesting and important to illustrate the limitations of the biosimilar paradigm and the issues that need to be considered by sponsors during development, particularly with regard to comparability in the context of "equivalent safety". The presentation will conclude with an overview of the ongoing challenges facing the "biosimilar industry".
Biography: For the past 23 years, Chris has held the position of Group Director of Regulatory Affairs of the ERA Consulting Group, during which time he has been involved in projects on the development of more than 400 biological medicinal products, ranging from natural products to advanced therapy medicinal products (gene, cell and tissue engineered products). Previously, he was Professor of Clinical Biochemistry and Physiological Chemistry at Hannover Medical School in Germany, where, in the early 1980s, he became involved in the evolving evaluation process for products of recombinant DNA products, which at that time were in their infancy. He remains a member of the teaching faculty of Hannover Medical School.
Apart from his expertise in regulatory strategies for novel biopharmaceutical products in Europe and the US, and work on issues relating to comparability of biologicals, Chris has a particular interest in the challenge and needs of evaluating complex medicines in emerging countries and the developing world, to which end he has provided training sessions for regulators of those jurisdictions.
Managing the Life-Cycle of Biologics in a World with Biosimilars Gillian R. Woollett, M.A., D.Phil., Chief Scientist, Engel & Novitt, LLPAs biosimilars have enter the global market place in other highly regulated markets, we all know that the US will not be far behind. Whether sponsors choose to use the new biosimilar pathways in BPCIA or not, the biologics market is changing and how originator biopharmaceuticals are researched and developed must take this into account. We will discuss what aspects of the development of any biologic will give opportunities to manage and predict the likely competitive environment that it will face, and how to consider these from the very beginning of development to avoid surprises later.
Biography: Gillian Woollett is Chief Scientist at Engel & Novitt, LLP, a boutique law firm with a global client base, which develops and implements science-based solutions to resolve legal/regulatory and public policy issues affecting the biopharmaceuticals industry. Dr. Woollett leads a unique multi-disciplinary team to devise strategic approaches to assist the law firm’s pharma and biotech clients in achieving their strategic business objectives.
Prior to joining Engel & Novitt, LLP, Dr. Woollett was Associate VP at PhRMA with responsibilities for all activities concerning biologics and biotechnology, including the originator industry efforts, jointly with FDA, that resulted in the Comparability Guidance in 1996, and that became the conceptual basis of ICH Q5E to enable manufacturing changes to existing biologic products and, ultimately, the EU Biosimilars pathway. Subsequently, she was appointed Vice President, Science and Regulatory Affairs, at the Biotechnology Industry Organization (BIO) and led BIO’s initial efforts to ensure that biosimilars are made to the same standards as originator products, and that all regulations will be based on sound science.
Dr. Woollett earned her B.A., M.A. in the Natural Sciences Tripos (Biochemistry) from the University of Cambridge, and her D.Phil in Immunology from the University of Oxford in the United Kingdom.
Exploring the Interplay Between the Biosimilar Pathway and Patent Law for Biologics Kathleen Williams, Partner, Intellectual Property, Edwards Angell Palmer & Dodge LLPThis presentation focuses on the issues that face companies developing therapeutics which are biologics. Whether new, generic or follow-on biologic therapeutics, the commercial markets are significant, and the regulatory pathways still uncertain. How do intellectual property issues such as patent protection as well as third party patent infringement arise and get resolved for biologics? How do concerns as to equivalency--bioactivity, glycosylation, half-life, immunogenicity play a role in IP? What have we learned from history? EPO (Amgen/TKT; Amgen/Roche), Avonex, Pergonal? How does one create a clear pathway as to one's patent strategy and make statements to the FDA in seeking product approval that is clear and consistent?
Biography: Dr. Williams is an intellectual property attorney who specializes in complex legal issues surrounding the protection of discoveries in the life sciences. One area of special interest to Kathy is biologics and biosimilars, for peptides as well as large proteins such as antibodies. She has extensive experience advising biotech and pharmaceutical companies, as well as investors, on strategic legal issues relating to intellectual property, including assisting companies in avoiding roadblocks and laying the groundwork for new commercial efforts. Kathy provides advice to clients on patent portfolio creation and management of product life cycle; performs assessments as to patentability, and procures effective patent protection of commercially valuable products. She advises companies as to freedom to operate, how to avoid litigation, and provides legal opinions as to third party patents. Kathy works closely with companies to ensure that intellectual property is effectively protected and/or avoided in their business deals, and is active in negotiating agreements involving partnering and licensing. She also assists investors by performing due diligence as part of the decision-making process underlying their investments, and has attended several high profile biotech patent trials in order to advise as to potential outcome during active patent litigation. Her clients include start-up biotech companies, as well as mature biotech and pharmaceutical companies, research institutions, venture capital firms, fund managers, and analysts.
EU Regulatory Approach towards Comparability for a Biosimilar
Keith Chidwick, Ph.D., Senior Pharmaceutical Assessor, Biologicals Unit, MHRA
This talk will focus on the scientific principles of the comparability exercise for biosimilars, particularly with regard to clinical data requirements and extrapolation of efficacy and safety data to other indications of the reference product, not studied during the clinical development of the biosimilar. This talk will also include experiences with biosimilar applications in the EU, address concerns raised about biosimilars and, in this context, highlight the importance of proper communication of the biosimilar concept, consistent use of terminology, and a global agreement on data requirement for biosimilars.
Biography: Dr Chidwick is currently a Senior Pharmaceutical Assessor at the Medicinal Healthcare Related products Agency (MHRA) in the UK. He works within the Biologicals group that assesses biotechnology products, blood products and vaccines. He has conducted assessments on 10 centralized biotechnology products, including a Quality by Design application. He is a member of advisory committees at the EMEA for guideline drafting and for EDQM.
Keith was previously a Consultant with Technomark Consulting Services. The projects with which he was involved included:
He was previously a Project Scientist with Bio-Products Laboratories developing large-scale bio-manufacturing processes, during which time he obtained his MBA.
Keith was a Senior Lecturer in biotechnology at the University of Westminster and has conducted post-doctoral research at the London Hospital Medical School in the field of inflammation. He obtained his PhD from the University of London.
US Regulatory Approach Towards Comparability for a Biosimilar
Gillian R. Woollett, M.A., D.Phil., Chief Scientist, Engel & Novitt, LLP
In the US we must now address how standards for innovator products will compare to those for biosimilars and alternative and second generation biologics using the new 351(k) pathways described in BPCIA. This presentation will discuss the need for consistency in regulatory standards and what can be learnt from markets that already have biosimilars and how those approaches may or may not comply with the new US statute.
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