Therapeutic proteins and emerging gene and cell-based therapies are important approaches in the development of drugs to treat many severe and chronic diseases. However, their development and optimal clinical application can be complicated by the induction of unwanted immune responses. This immune response, characterized by the development of specific anti-drug antibodies (ADA), can alter drug pharmacokinetics and pharmacodynamics leading to impaired efficacy and can occasionally lead to safety adverse events, and it is in this context that regulatory agencies require the immunogenicity risk to be thoroughly explored and characterized.
There has been a growing interest over the past decade in developing methods to assess the risk of unwanted immunogenicity during preclinical drug development, with the aim of mitigating the risk during the drug design phase. To this end, a range of in silico and in vitro tools have been developed to identify the risks inherent to the product itself, and, where possible, guide the removal of liabilities, such as T cell epitopes or deamidation sites, etc. These evaluations can be used to narrow down from a larger panel of drug candidates to select a lead candidate to progress to manufacturing and clinical development.
Register for this webinar to hear experts from Abzena discuss some of the approaches to therapeutic protein immunogenicity risk assessment, with particular attention paid to the use of in silico tools and different in vitro assays to mitigate risk and design drugs with a better chance of success in the clinic. Through case studies we illustrate complementary approaches that can be applied to different classes of proteins.
Speakers
Campbell Bunce, PhD, Chief Scientific Officer, Abzena
Campbell is the Chief Scientific Officer at Abzena, a global Partner Research organisation supporting development of drugs and vaccines from discovery to GMP manufacture. His focus is in delivering high quality and tailored services to ensure a quick and de-risked route from drug concept and design to clinical testing. Campbell has been with Abzena for 5 years and beforehand spent 20 years working in the biotech sector for companies such as Cantab Pharmaceuticals, Piramed Pharma and Immune Targeting Systems. He has led the development of many novel vaccine and therapeutic technologies targeting infectious disease, cancer, inflammatory and autoimmune disease, taking them through discovery and design stages to clinical evaluation. Campbell has a PhD in Immunology from the University of Manchester and has published numerous papers on immune mechanisms and novel drug development.
Message Presenter
Alyson Rust, Director Bioassays, Abzena
Alyson Rust has over 14 years’ extensive experience within the field of biologic immunogenicity at Abzena and is currently Director of Bioassay, Cambridge, UK. Since joining Abzena, Alyson has developed and optimised an array of ex vivo assays to aid in the pre-clinical immunogenicity risk assessment and safety of biologics.
These have included T-cell epitope mapping strategies to support the de-immunisation of biologics in the early-stage development process. Alyson leads the Bioassay team delivering high quality projects and reports on the immunogenicity risk of biological candidates to reflect regulatory guidelines. Prior to Abzena, Alyson held positions at Lorantis (Cambridge-based Biotech) and Aventis.
Message Presenter
Rob Holgate, PhD, Senior Director Discovery and Protein Engineering, Abzena
Rob has over 20 years’ experience in Drug Discovery and early stage Development. After obtaining his PhD in Molecular Medicine at UCL, he moved to The University of York as a post-doctoral researcher. He subsequently worked at Cambridge Antibody Technology (now part of AZ) where he was a Senior Scientist within Antibody Engineering then Team Leader of the High Throughput Expression team. Rob joined Antitope (now Abzena) in 2008 as a Research Manager and now leads Abzena’s Discovery and Protein Engineering group overseeing Abzena’s antibody discovery, antibody humanization, protein deimmunisation and bespoke engineering projects.
Message PresenterWho Should Attend?
- Pharmaceutical Companies
- Small Biotech (SMEs)
- Biopharmaceutical Consultants
- Conjugation Chemists
- Scientists & Project Leaders
- CMC Management & Operations
- Directors, Preclinical Development
- Directors, Biotherapeutics
- C-levels: CSO/COO/CEO
- Scientific Leaders
- Synthetic Chemists
What You Will Learn
In this webinar, participants will:
- Learn about recommendations for how to de-risking a project upfront
- Understand the application of early design and developability technology
- Discover ways of increasing the chances of candidate success
- Understand why immunogenicity is an issue for drug development
- Consider the implications of not evaluating immunogenicity risk
Xtalks Partner
Abzena
Abzena is a leading contract provider of integrated discovery, development and manufacturing services for biologics and antibody drug conjugates (ADCs). Abzena provides the most complete set of solutions in integrated early discovery to mid-phase biotherapeutic and bioconjugation drug development and manufacturing in the biopharmaceutical industry. The company maintains resources around the world, with facilities in the US and UK. Abzena is owned by Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors. For more information, please see www.abzena.com.
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