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Biosimilars Webinars

Past Events/Recorded Webinars

Biosimilars, generally, are larger molecular drugs, derived from, or made by an organism, in which, the patent for the original drug has expired, and subsquently, a similar molecule can be designed and marketed. There are a wide range of topics covered in our webinars under the term, biosimilars - from testing immunogenicity of biosimilar drugs and testing biosimilars in clinical trials, to conducting safety assessments of biosimilars and meeting FDA guidelines. The biosimilar webinars listed here are recordings of past events. Simply register, for free, for any webinar by clicking the download archive button on each webinar page. If biosimilars is to broad a term, don’t forget, you can search for a more specific webinar using our search bar or browse through our catalogue of other topics

  Synopsis Webinar Title Date

LifeSciences - The presenters will discuss the opportunities and challenges and provide tips on how to achieve success in running biosimilar clinical trials
Speakers: Dan Ramos, North America Customer Liason, Fisher Clinical Services
Khaled ElGendy, Associate Director – Head Comparator, Fisher Clinical Services
Biosimilars in Clinical Trials: Smart Reference Drug Sourcing and Advanced Blinding Techniques May 17, 2016

 

LifeSciences - The presenters will discuss new solutions and strategies for streamlined glycosylation analysis
Speakers: Alicia Bielik, PhD, Product Manager, Glycobiology, New England Biolabs
Paula Magnelli, PhD, Scientist, Glycobiology, New England Biolabs
Improved Methods for Structural Characterization of Therapeutic Proteins Jun 19, 2015
LifeSciences - In contrast to traditional antibody-based methodologies, such as ELISA and Western blot, mass spectrometry can provide more detailed characterization and quantitation of individual host cell proteins (HCP) and other protein impurities, without affinity-based bias
Speaker: Daniel Chelsky, Chief Scientific Officer, Caprion Proteomics
Comprehensive Identification and Quantification of Host Cell Proteins by Mass Spectrometry Jun 8, 2015
This webinar will discuss new Biologics, Biosimilars, and Biobetters programs using case studies to illustrate strategy choices and the similarities and differences between each program
Speakers: Judith Newmark, PhD, Program Manager, Pharmacology/Toxicology/Ocular, Toxikon Corporation
Franck Grall, PharmD, PhD, Director, Cellular and Molecular Toxicology, Toxikon Corporation
Biologics, Biosimilars and Biobetters: Strategies for Nonclinical Safety Testing Mar 12, 2015
This webinar focuses on Covance's experience with in vitro assays to demonstrate pharmacological similarity between biologics and biosimilars
Speaker: Sinnathamby Gomathinayagam, PhD, Senior Scientist, Biomarker Center of Excellence, Covance
Biomarker Challenges in Biosimilar Drug Development Nov 6/13
The webinar will review the current regulatory landscape and guidance for nonclinical and clinical development of biosimilars with a focus on safety-related aspects and discuss the current challenges and future perspectives in this area
Speaker: Joerg Bluemel, Director Toxicology within Biologics Safety Assessment / Translational Sciences, MedImmune, Gaithersburg MD

Nonclinical and Clinical Safety Assessment of Biosimilars: Status and Perspective

Jul 25/13

LifeSciences An in-depth look at the challenges and solutions in conducting biosimilar trials
Speaker: Rodeina Challand B.Sc., Executive Director, Biosimilars Development, Scientific Affairs, PRA
Challenges and Solutions in Conducting Biosimilar Trials May 15/13
In this presentation, a detailed description of the requirements for registration and post-marketing, as well as a Pharmacovigilance plan will be discussed
Speaker: Vijay Tammara, VP Global Regulatory Affairs, Nuron Biotech, AAPS Member

Biosimilar Regulatory Guidelines in Emerging Markets – India

Jan 24/13

The goal of this presentation is to provide an understanding of the current regulations and continued challenges, future directions by the regulatory authorities and provide insight into the regulatory pathway for biosimilar and biobetter registration
Speaker: Dr. Steven Engel, MS, PharmD, Senior Principal Scientist, Worldwide Regulatory Affairs, Merck & Co., Inc.

FDA New Guidelines for Biosimilars and Biobetters: An Outlook for 2013

Jan 16/13

LifeSciences This webinar will explore the current regulatory and scientific challenges facing industry engaged in developing biosimilars with emphasis on EU and US regulatory framework.
Speakers: Carolyn Finkle, Vice President, Global Regulatory Consulting, Catalent Pharma Solutions
Vincy Abraham, Senior Manager, Bioanalytics Catalent Pharma Solutions
Biosimilars: Creating Workable Solutions to Global Regulatory and Analytical Challenges Nov 30/12
LifeSciences This webinar is part of a series about innovative approaches and specialized techniques to bioanalytical studies
Speaker: Chris Beaver, Director, Immunochemistry and Cell Biology Operations, PharmaNet/i3
Immunogenicity Testing Considerations for Biosimilar Drug Development Sep 17/12
LifeSciences This webinar will provide an overview of simulation modeling and how it can be used to improve clinical development efforts, including enhancing choice of target population, powering, and operational feasibility, as well as understanding performance in real-world settings
Speaker: Badri Rengarajan, MD, Medical Director, Archimedes Inc.
Simulation Modeling for Optimizing Design of Clinical Trials and Registries Mar 20/12
LifeSciences A discussion of how an integrated drug development perspective will allow biopharmaceutical developers to bring biosimilars to market quickly
Speakers: Tom Fritz, Managing Partner, Swiftwater Group LLC
Tom Stover, Ph.D., Associate Principal, Swiftwater Group LLC
Developing Biosimilars in the US – The Dawn of a New Era? Nov 16/11

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