Our Team

Tom Oakley

Founder and Principal Regulatory Affairs Consultant

Tom has a doctorate in cancer research and more than 20 years of experience in the pharmaceutical and biotechnology industries. During his career, he has led EU, US, and UK regulatory projects in industry and consulting, including numerous agency meetings, scientific advice procedures, orphan drug applications, paediatric plans, and marketing applications.

Tom started Somerville Development Partners to support innovative biopharma companies in bringing new medicines to patients.

Colin Wheeler

Principal Clinical and Regulatory Affairs Consultant

Colin has more than 20 years of drug development experience and regulatory roles in the EU and US. Colin is qualified as a UK Registered Physician (MBChB) with a Diploma of Pharmaceutical Medicine (DipPharmMed) and is a Fellow of the Faculty of Pharmaceutical Medicine (FFPM).

Previously, Colin founded Southwood Research in 2016 – the company quickly became a major drug development and regulatory consulting group. Southwood Research supported numerous global (new drug application/marketing authorisation application) filings – frequently for new oncology or rare disease therapeutics.

Sofia Volante

Director, Regulatory Affairs

Sofia holds a Master’s degree in Pharmaceutical Sciences, an MBA, and certifications in Project Management and Management Consulting. With over 16 years of experience in Regulatory Affairs, she has held several roles within both pharmaceutical and consultancy companies.

She has worked on projects for the EU, US, Latin America, and APAC markets. Her expertise spans the entire regulatory lifecycle, including regulatory strategy, clinical trial applications, pre- and post-marketing activities and labelling, across several therapeutic areas.

Additionally, Sofia has led large-scale, cross-functional projects within pharmaceutical companies, fostering collaboration across teams, managing stakeholders, and mentoring junior team members. She has also contributed to global pharmaceutical initiatives focused on process optimisation, change management, and the implementation of new Regulatory Information Management (RIM) systems.

At Somerville Development Partners, Sofia is dedicated to helping clients succeed in the ever-evolving and complex regulatory landscape.

Carolien Van den Bout

Senior Medical Writer

Karen Ilsley

Finance Manager

Karen has over 20 years’ experience as an operations manager, specializing in business and office management. She has a wealth of experience managing regulatory contracts, confidentiality agreements (CDAs) and Standard Operating Procedures (SOPs).

Karen manages all the day-to-day financial aspects and financial tracking for our regulatory affairs consultancy businesses – including payroll, budget tracking, payments and reconciliations.

Eva Sagri

Associate Director, Regulatory Affairs 

Eva is a licensed pharmacist with a Master’s in Clinical Pharmacology and a decade of experience in the pharmaceutical industry, specialising in Regulatory Sciences. She has led regulatory projects across the EU, UK, and US, including regulatory strategy, clinical trial applications, scientific advice procedures, orphan drug designations, paediatric investigation plans, and marketing authorisation applications.

Eva also serves as an Ethics Committee member, dedicated to supporting the conduct of ethical and scientifically sound clinical research.

At Somerville Development Partners, Eva is committed to helping organisations navigate the ever-changing global regulatory landscape and bring safe and effective treatments to patients.

Caroline Jenkins

Senior Manager Regulatory Affairs 

, Caroline has a doctorate in cell biology with a focus on modelling multi-drug resistance mechanisms seen in cancer. After a postdoc in developmental biology, she left the lab bench and spent over 14 years facilitating academic translational medical research and innovation, (including phase I/II clinical trials) through research contract negotiation, reviewing grant proposals and network building. A second career pivot saw her enter the world of regulatory sciences. Caroline now has over 5 years of experience crafting pre- and post-authorisation submissions to EU, UK and US regulatory agencies (including scientific advice procedures, orphan drug applications, paediatric investigation plans, PRIME-related activities and dossiers to support marketing authorisation applications/variations), and regulatory strategy reports.

At Somerville Development Partners, Caroline is committed to ensuring high-quality science is translated into safe and effective medicines for patients with unmet medical needs. She is closely supporting a product that has recently been granted PRIME eligibility by the EMA, and is particularly interested in facilitating the development of medicines for rare diseases and paediatric patients.