Immunotoxicology
We have the expertise, knowledge and understanding to support you to develop bespoke, cost effective IND/CTA enabling programmes. We will guide you every step of the way, ensuring you are informed and supported as your project progresses.
Our experienced immunotoxicologists will:
- Guide the strategic design and placement of nonclinical experimentation
- Investigate the mechanistic basis and translational consequence of immunological signals
- Advise you to make informed, scientifically driven project/pipeline decisions and navigate the development of regulatory strategies
- Interpret immunological data
Drug Discovery Risk Assessment
Manipulating the immune system to achieve a desired therapeutic effect potentially comes with significant risks. One of the most important aspects of drug safety how these risks can be understood and managed. A variety of assessments can guide and inform, including scientific reviews, 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.
Delivering a scientifically driven, fit for purpose and regulatory compliant nonclinical package for pharmacology and toxicology is key for project progression. Careful selection and design of studies is critical to ensure the validity of project data from proof of concept through to clinical trial design to avoid costly mistakes and ensure timely completion.
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 at all stages of drug development. Sean has discovery and project experience across multiple drug modalities including small molecules, biologicals and advanced therapies, and is an expert in delivering project and drug pipeline strategies to reduce risk associated with target and modality. He also conceptualises and supervises immunotoxicology research as an Honorary Senior Lecturer at the University of Liverpool, UK.
Marie Cumberbatch
MSc
Marie has over 35 years of experience gained in large pharma and academia. She specialises in the development and validation of oncology, immuno-oncology 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 supports clients with her extensive experience in nonclinical model selection and biomarker analyses for immuno-oncology projects, in addition to in vitro immuno-oncology mechanistic studies, together with expertise in interrogating clinical tissue based and circulating biomarker outputs.
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 as a Senior Project Manager, supporting projects 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. She has a strong reputation for building collaborative client relationships and managing projects.
Heather Brown
Heather is a Senior Scientist within the Safety Science Team, 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.
