Regulatory Considerations to Bring Antibody Therapies to Market

GTCbio | May 9th, 2017

As novel Antibody and Protein-based therapies are showing clinical promise in human trials, the field will require new measures of coordination with regulatory agencies to ensure these new therapeutic approaches are brought safely and in a timely fashion to market. Although, there is high interest in expediting Antibody and Protein-based therapies, the regulatory approval is a complicated and daunting gauntlet. The improved understanding of specific criteria for specific disease targets through early communication with key regulatory personnel can significantly facilitate the approval process.   

We invite you to a panel discussion, “Regulatory Considerations for bringing Antibody Therapies to Market”, which is part of the Antibody & Protein Therapeutics Summit scheduled for July 11-12th, 2017 at the Royal Sonesta Harbor Court in Baltimore, MD. The following panelists will contribute to the meeting by bringing decades of experience in regulatory affairs to give insights on how to best overcome regulatory hurdles in clinical trials for novel biotherapeutics:


Owen Fields

Owen Fields – Vice President Regulatory Strategy, Pfizer

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Dan Zhang – CEO, Fountain Medical Development Ltd.

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Ezio Bonvini – CSO & Senior Vice President of Research, MacroGenics

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Amy Grenham – Director of Regulatory Affairs, AztraZeneca

GTCbio’s Antibody & Protein Therapeutics Summit has developed into a meeting to learn about the latest Antibody & Protein based therapies from leading researchers and commercialization insights from business leaders in the industry.   This meeting will create opportunities for face to face interactions with key thought leaders from big pharma, biotech companies, government agencies, healthcare organizations and distinguished academics.   The summit agenda will include interactive programming to facilitate dialogue between attendees and speakers and engage participants to promote research sharing, partnering and deal-making opportunities.

The Antibody & Protein Therapeutics Summit consists of three co-located conferences, along with plenary & keynote sessions:

1. Antibodies in Oncology & Beyond: Highlights include Antibody based therapies in Oncology, Infectious Diseases, Autoimmune disorders, antibody engineering, and more.

2. 3rd Antibody Drug Conjugates:  Highlights include Pre-clinical discoveries and clinical trials, novel linkers & payloads, personalized healthcare, and site specific attachments.   

3. Novel Protein Therapeutics: Highlights include alternative protein scaffolds, multispecific antibodies, antibody mimetics, and novel protein discovery technologies.