Project Management
A well designed and executed toxicology package can make the difference between success and failure. It is essential that these studies are designed appropriately, conducted to the highest standards, and reported with clarity, in the required timelines. An independent project manager, working alongside an internal or external study monitor project toxicologist, helps to select the right Contract Research Organisation (CRO), oversees the running of the nonclinical studies, and ensures delivery of an on time quality end product that meets the needs of the project. The ApconiX Project Management Team has in excess of 95 years of experience working in nonclinical toxicology, and extensive knowledge of managing nonclinical toxicology programmes, having previously worked either in CROs or within large pharma.
ApconiX Project Managers are oriented, effective communicators and organisers, with strong interpersonal skills, They are extremely flexible to each individual client’s needs, acting as an extension of the client’s internal development team, and who will be a valuable and consistent interface between the client and CRO by:
- overseeing and coordinating clinical programmes and other strategic initiatives, working with multi faceted development teams, both technical and scientific
- tendering multiple CROs for quotations, and comparing quotes to assist the client with CRO selection, ably supported by our extensive knowledge of the CRO network and specialisms
- ensuring compound is in the right place at the right time
- assisting with protocol development and review
- tracking the status of each studies milestones and timelines within the programme based on specific regulatory deadlines, building programme specific Gantt charts to streamline and visualise the programme for the whole development team
- being integrated into the project team, setting agendas, chairing meetings, writing minutes and tracking actions, to ensure efficient working practices
- identifying and mitigating any risks to the programme
- assisting with data and report reviews
Our Project Managers
Pauline Garner
Pauline is an experienced Genetic Toxicologist and Programme Manager, with over 27 years in nonclinical safety. As a Genetic Toxicology Study Director and latterly the Section Manager of a small team of scientists and technicians at a medium sized CRO in the UK, Pauline is extremely knowledgeable in Good Laboratory Practice and all aspects of in vitro and in vivo genetic toxicology study design, conduct and reporting across a diverse range of indications. During her time specialising in Programme Management over the last 12 years, Pauline combines a passion for science and pharmaceutical development, with the knowledge of client’s project and commercial needs. Pauline has a strong reputation in communication and an eye for detail. She particularly enjoys building enduring customer relationships to support the optimum delivery of nonclinical safety programmes.
Dr Kerry Illston
PhD
Kerry is an experienced Project Manager with over 27 years of experience in molecular toxicology, new target identification/validation and nonclinical safety within large pharmaceutical and biotech companies and contract research organisations. She has a strong background in driving complex, valuable, high profile drug development programmes. Kerry draws on her knowledge and passion for science in drug development to identity and solve problems with innovative thinking.
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.
Joanne Wilson
Joanne has more than 21 years of experience as a DMPK scientist and project manager gained at a large pharmaceutical. In this role, she led cross functional teams to drive the optimal and efficient development of novel drugs. Joanne has worked across all therapy areas with a special expertise in oncology. Joanne brings a blend of scientific expertise and project management skills to optimise drug discovery and development processes.
Stacey Owen
Stacey is an experienced customer facing professional programme manager with extensive experience in nurturing and establishing long term relationships to ensure optimal delivery. She is an excellent communicator with the experience needed to manage complex projects with rapidly changing and competing priorities. A true customer advocate, Stacey brings calmness and clarity to provide the best service possible, eliciting and listening to feedback to improve outcomes.