Download the 2017 Full Agenda
Get your copy of the newly released Full Agenda. With a stellar lineup of already confirmed speakers and an esteemed advisory board that helped design the program, this is a not to be missed industry event! Featured companies include: Pfizer, Sandoz, ...
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Past Attendee List
Here is a list of the organizations and job titles that joined us at the last summit! and who we anticipate to be in the room come February.
Convince Your Boss Letter
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2016 Presentation Packet
These are some of the presentations from our expert speakers from the event this past March. Such as Danny K. Chou, PharmaD, PhD President, Compassion BioSolution, LLC. Thomas Sullivan, President, Rockpointe and Bonita (Bonnie) Rup of Bonnie Rup Consulting.
Take a look at the attendee snapshot for insight into who you can expect to meet & network with at the event.If you would prefer to receive a copy via email contact Stephen.Aponte@IQPC.com
Additional Content Download
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Forming Bioanalytical and Immunogenicity Strategies that Support Biosimilar Product Development
Bonita (Bonnie) Rup of Bonnie Rup Consulting, discusses PK and Immunogenicity in BiotherapeuticDevelopment and Use, What regulatory guidancessay about bioanalysis/immunogenicity analysis, What to consider in selecting the right population for your study, How to incorporate assay data into the overall study design, How to effectively interpret and present bioanalytical and...
Establising Structural Comparability with Effective Preclinical Characterization Methods
Danny K. Chou, PharmaD, PhD President, Compassion BioSolution, LLC, presents on key issues in biosimilar drug product development, general strategy for developing biosimilars that are comparable with or superior to innovator drugs, how to improve market competitiveness by incorporating a high concentration formulation into pre-filled syringe or alternative delivery systems,...
Biosimilars Regulations in the US Market: Where Do We Go From Here?
Thomas Sullivan, President, Rockpointe, takes a look at 2015-2016 at FDA and around the world, differences between EMA and FDA biosimilars regulations, FDA developments, CMS JCODES, state substitution laws, and the future of biosimilars.
Market Snapshot - Top 10 Biosimilars Manufacturers 2015
With the approval of the first biosimilar product in the United States this year, cost containment pressures and a pending patent cliff, Pharma IQ takes a closer look at the current biosimilars market. If you prefer to receive a copy via email contact us at enquiryIQPC@iqpc.com with the subject line...
The Future of Biosimilars - A Case of Untapped Potential?
The patents on a majority of the top-selling biologic drugs currently on the market will have expired by 2020, an amount which may be equivalent to $67 billion. Can we expect then a rush of biosimilar products to the market, drastically lowering spend on biological drugs? If current trends are...
ASD - BIOSIMILARS - Regulatory Framework and Pipeline Analysis
ASD Report about the regulatory framework and pipeline analysis in the Biosimilar industry.
Exclusive Interview: EMA & Health Canada
Featuring EMA and Health Canada: Meet our regulators, Andrea Laslop from the EMA and Agnes Klein from Health Canada, who will be giving keynote presentations and Q&A sessions at the upcoming Biosimilars Clinical Studies & Analytical Similarity Summit in Boston. Check out the interview below to hear their responses to...
Exclusive Interview: Global Head Biologics Safety Assessment at MedImmune Inc.
Ahead of the Biosimilars Clinical Studies & Analytical Similarity Summit this March in Boston, we sat down with Dr. Rakesh Dixit, Vice President R&D, Global Head Biologics Safety Assessment at MedImmune Inc. to provide you with a sneak peek at what he will be discussing during his session at this...
The Race to Develop Adalimumab Biosimilars
The impending loss of basic patent protection for adalimumab (commonly known as Humira), allied to the large revenues it generates, provides a clear incentive for other companies to develop adalimumab biosimilars in attempts to capture a share of over $10 billion revenues... Download the article to continue reading. If you...
Biosimilars Landscape and FDA Regulatory Expectations
The Congressional Budget Office (CBO) has estimated that the United States could save $25 billion from the use of biosimilars over 10 years, and according to analysis the worldwide market for biosimilars will grow to $3.7 billion by 2015
7 questions you might have about biosimilarity, answered
David Rosen, FDA practice group leader and co-chair of the Life Sciences Industry Team at Washington, D.C.-based Foley and Lardner, LLP, has more than 35 years of experience in various aspects of biopharmaceutical regulation, with a strong focus on generic drugs. BioPharma Dive spoke to Rosen about the evolving role...
Delivering on the Potential of Biosimilar Medicines
This report from the QuintilesIMS Institute describes the potential role for biosimilars and their contribution to healthcare systems; the risks for stakeholders to realize that full potential value; and the requirements for competitive functioning markets in order to capture the full value. To learn more about the QuintilesIMS Institute, explore their...
Pharmacovigilance on biologicals and biosimilars: a Danish perspective
The development of biological medicinal products is in rapid growth and as patents for reference products expire, new biosimilar products become available. This has a marked impact on several stakeholders; from patients and physicians to decision-makers, and on activities; from treatment of patients to the conduct of pharmacovigilance. This article...
How the biosimilars market is changing
Access to high quality medicine at affordable prices without jeopardizing patients’ health is one of the key challenges in developed countries where rising life expectancy and growing average age puts pressure on national healthcare systems. Courtesy of www.gabionline.net
Biosimilars: achieving long-term savings and competitive markets
As biosimilars begin to increase their share in the market, it is critical for payers to adopt strategic approaches to: (1) ensure a competitive and sustainable biosimilars market; (2) achieve value for money from their use. Here we propose a strategic approach we think could achieve bothgoals.