Immunotoxicology
The immunological effects of drugs range from intended immunomodulatory/pharmacological effects to off target and unanticipated liabilities. Navigating the complexities of the drug discovery and development pathway of any modality is demanding on time and resources. Often dealing with non standard small and large molecules and new technologies, we have the expertise, knowledge and understanding to support you to develop bespoke, cost effective IND enabling programmes. We will guide you every step of the way, ensuring you are informed and reassured, giving you the confidence you need as your project progresses.
Our experienced immunotoxicologists will
- Design bespoke, cost effective, fit for purpose study packages based on our considerable experience of CRO settings, allowing decisions to be made based on relevant evidence.
- Provide advice should a study highlight a potential toxicity concern to help you understand why, gather and examine evidence to support relevance to humans or mitigate risks if initial findings are likely to be translated to clinical trials.
- Be science led, navigate the relevant regulatory landscape and interpret the data gathered to formulate a narrative that will provide a successful route through the drug development process.
- Guide strategic decision making for a portfolio of assets.
Drug discovery risk assessment
Manipulating the immune system to achieve a desired therapeutic effect almost always comes with risks. One of the most important aspects of drug safety is how these risks can be understood and managed. A variety of assessments can guide and inform , including scientific reviews, broad target safety and weight of evidence assessments.
Derisking approaches in strategic pipeline design
Some complex safety related issues span a portfolio of drugs and can affect multiple projects in a company’s development pipeline. Developing a strategy to be systematically applied across a pipeline can help provide a contextualised decision making approach for moving the best candidates forward.
Testimonial – ““I have found the team to be very responsive to requests and I feel that they are part of the team delivering to our project.”
VP of Biology, UK Biotech Company
Testimonial – “Your immunological knowledge is really key in helping us understand both the likely mechanisms in play and the limits of what can be quantified / predicted.”
Head of Toxicology, Large Global Pharmaceutical Company”
Design and interpretation of in vitro and in vivo pharmacodynamic and safety studies.
Being able to monitor measurable parameters of efficacy and/or potential toxicity and translate this information from nonclinical to clinical studies is critical. Selecting the right biomarkers is important for the translational value of nonclinical studies and can have a major role in a drugs risk benefit profile within the clinic.
Nonclinical and clinical biomarker selection.
Being able to monitor measurable parameters of efficacy and/or potential toxicity and translate this information from nonclinical to clinical studies is critical. Selecting the right biomarkers is important for the translational value of nonclinical studies and can have a major role in a drugs risk benefit profile within the clinic.
Toxicity signal/concern interpretation and investigation.
The immune system is complex, and immune mediated toxicities occur in toxicology programs and in the clinic. Through careful investigation and expert insight, it is possible to understand the mechanisms involved, the translational relevance, and to take the appropriate course of action to drive projects forward.
CRO selection and auditing.
Delivering relevant studies that are undertaken competently and efficiently is vital. Using our vast experience of the CRO landscape, we will impartially help you find the right partners to conduct pivotal pharmacology and toxicological studies. The correct oversight can ensure a project generates robust data, at the right time, and within budget, making the development process as efficient and effective as possible.
Our Immunotoxicologists
Dr Sean Hammond
PhD
Sean is the Immunotoxicology Lead at ApconiX, specialising in identification and mitigation of immune safety issues for the pharmaceutical industry at all stages of drug development. Sean has discovery and project experience across multiple drug modalities including small molecules, biologicals and advanced therapies. He specialises in delivering project and drug pipeline strategies to reduce risk associated with target and modality. Specific focuses of his research include nonclinical immunogenicity evaluation, autoimmune immune related adverse events associated with immunomodulatory drugs and hypersensitivity/idiosyncratic reactions.
As an Honorary Senior Lecturer at the University of Liverpool, he contributes to the conceptualisation and supervision of research in both mechanistic immunotoxicology and the development of assays for nonclinical safety assessment of new drugs.
Marie Cumberbatch
MSc
Marie has is an established immunologist with over 35 years of experience gained in large pharma and academia. As former team leader of the Molecular Pathology Group in Oncology Translational Science at AstraZeneca, Marie brings immune expertise to the development and validation of oncology, immunoncology and immunotoxicology biomarkers for small and large molecules in the context of mechanism, resistance, patient selection and safety from early target identification through to clinical trials. Marie has presented and published widely in her specialist area of immunotoxicology and immunoncology.
Marie supports the ApconiX team and clients with her extensive experience in nonclinical model selection and biomarker analyses for immunoncology projects, in addition to in vitro immunoncology mechanistic studies, together with expertise in interrogating clinical tissue based and circulating biomarker outputs. From her breadth of experience within the biotech industry, Marie provides current insights into translational biomarker strategies for all stages of immunoncology drug discovery and development.
Dr Amy Shepherd
PhD
Amy is an experienced immunologist with 10 years’ experience in nonclinical and clinical safety programme design for both biologic and small molecule compounds, and has previously led cross functional drug development teams globally within a large CRO.
Amy supports the Immunotoxicology Team at ApconiX as a Senior Project Manager, supporting clients and the ApconiX team with all aspects of project and program management, from discovery and lead compound selection through to first in human clinical studies. Amy has a wealth of experience with different modalities and provides a key insight into the CRO landscape for immunomodulatory compounds. She has a strong reputation for building client relationships and managing projects, combining a passion for pharmaceutical development with fostering collaborative relationships.
Heather Brown
Heather is a Senior Scientist within the Safety Science Group, having previously graduated with a degree in Biology from the University of York. Her projects have focused on immune related adverse events associated with checkpoint inhibitors and capability development within early discovery phases.
Heather delivers high quality target safety assessments to clients in order to derisk and understand primary target biology at early stages of drug discovery for immunology focused projects, and is known for her attention to detail and aptitude for scientific research projects.