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European Biopharmaceutical Review

Sudden Impact

The development of biological therapeutics such as humanised antibodies has led to remarkable clinical benefits in many indications. Despite this success, the induction of anti-drug antibodies (ADAs) due to the potential immunogenicity of these therapeutics remains a significant challenge to the successful development of biotherapeutics.

The decades that followed the approval of the first biotherapeutic (Insulin, 1982) have seen a dramatic increase in both the number and rate of approvals. Biologics now account for over 30% of licensed pharmaceutical products and over 25% of the new drugs approved by The Center for Drug Evaluation and Research in 2015. For monoclonal antibodies (mAbs) alone, since the commercialisation of the first mAb in 1986, this class of product has increased significantly. By 2014, 47 mAb products had been approved in the US and Europe. At the current approval rate, it can be anticipated that approximately 70 mAb products will be on the market by 2020, with combined worldwide sales of nearly US$125 billion (1).

Despite this success, biologics can elicit immunological responses when administered to patients, which can affect their safety and efficacy. These side effects fall into two categories: pharmacological (largely predictable adverse reactions resulting from the interaction between the biologic and its target) and non-pharmacological. Non-pharmacological adverse events contain immunotoxicity, which includes both immuneresponseand non-immune response-mediated reactions.

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Dr Gary Bembridge is Senior Director of scientific affairs (immunology) at Abzena. Since joining the company in 2013, he has managed business development activities associated with immunological responses to biotherapeutics, ensuring that immunogenicity assessment and bespoke immunological studies are tailored to partners’ needs. Prior to this, Gary worked at Huntingdon Life Sciences (Envigo) as a Biopharmaceutical Product Development Manager and shared responsibility for designing safety studies and nonclinical development programmes for all biologics, providing scientific support and advice to the immunology department. He completed his PhD at the University of Bristol, UK, and the Department of Veterinary Medicine.

Dr Karen Hills is in marketing and business development at Abzena in Cambridge, UK. She is a consultant in pharma/biopharma business development and marketing. Since joining Abzena, Karen has focused on marketing across the areas of cell-line development, chemistry manufacturing, and immunology. Karen has a PhD in molecularb from Cambridge University, UK, and an MBA from the London Business School, UK. Her background includes sales, marketing, and business development for companies ranging from start-up biotech to Big Pharma.
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Dr Gary Bembridge
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Dr Karen Hills
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