Sponsored by Richmond Pharmacology

The landscape of drug development is evolving rapidly. While small molecules continue to play an important role, advances in gene editing, RNA therapeutics (depending on classification) cell therapies and other advanced therapy medicinal products (ATMPs) are expanding treatment possibilities across a broad range of diseases and therapeutic areas.

This scientific progress is translating into growing clinical activity. According to the Cell and Gene Therapy Catapult's 2025 UK ATMP Clinical Trials Database, there were 193 ongoing ATMP clinical trials in the UK during 2025¹, building on an approximately 70% increase in Phase I advanced therapy studies conducted in the UK in 2024². The UK now participates in 57% of Europe's advanced therapy clinical trials¹, reinforcing its position as one of the leading environments for early clinical research.

At the same time, the technologies themselves continue to mature. RNA therapeutics have evolved well beyond first-generation approaches, advances in CRISPR-based gene editing, base editing and RNA interference (RNAi) are expanding the range of diseases that can potentially be treated. As these modalities move into clinical development, sponsors face increasingly diverse scientific, operational and regulatory considerations³.

Unlike conventional medicines, advanced therapies frequently involve novel mechanisms of action, biomarker-driven participant selection, adaptive study designs and enhanced safety monitoring. Manufacturing timelines, specialised clinical procedures and long-term follow-up requirements can all influence study delivery. Early phase clinical research has therefore become much more than demonstrating safety—it increasingly provides the critical evidence that informs dose selection, proof of mechanism and future development decisions. For sponsors, considering these requirements early can help identify operational dependencies and potential barriers before they affect study delivery.

This evolution has changed what sponsors look for in a clinical research partner. Therapeutic area expertise remains important, but equally valuable is experience across multiple advanced modalities, supported by specialist clinical infrastructure, regulatory expertise and the ability to recruit both healthy volunteers and patients (often with rare disease). For first-in-human research, MHRA Phase I accreditation can provide additional assurance that studies are supported by established clinical governance, safety oversight and operational systems appropriate for complex early phase research.

London has become a natural hub for this activity. The capital combines internationally recognised academic institutions, specialist NHS centres, an established biotechnology sector and close collaboration with regulators, creating an environment well suited to first-in-human and proof-of-concept research. Between 2020 and 2025, the number of advanced therapy trials initiated in London increased by 83%, with more than half conducted in Phase I or II and over 86% sponsored by industry, demonstrating the city's growing role in translating scientific innovation into clinical development4.

The decisions made during early clinical development can influence the trajectory of an entire programme. For sponsors, generating robust evidence around dose selection, biomarkers and participant characteristics at this stage can help inform regulatory strategy and subsequent clinical development.

Within this evolving landscape, Richmond Pharmacology has developed to meet the changing needs of sponsors. Since 2001, the organisation has completed more than 500 early phase clinical studies, contributed to the development of over 30 approved medicines and built a participant database of more than 300,000 volunteers and patients. Based at its dedicated private healthcare clinic and 40-bed clinical research unit in London Bridge, Richmond conducts studies across healthy volunteer and patient populations with specific expertise across cardiometabolic disease, respiratory medicine, haematology and rare diseases. Its MHRA Phase I accredited clinical research unit provides the governance, safety oversight and operational infrastructure required to support complex first-in-human and early phase studies including long-term safety follow-up.

Richmond's location within London's life sciences ecosystem, based next to Kings College London Guys Campus, also enables close collaboration with leading NHS trusts, academic institutions and biotechnology companies. Combined with experience supporting first-in-human and proof-of-concept studies, this provides sponsors with access to an established environment for delivering complex early phase research.

The organisation's recent experience reflects the growing diversity of advanced therapies entering clinical development. Richmond has supported programmes involving CRISPR-Cas9 gene editing, base editing, and other RNA therapeutic approaches. This has been done through working with biotechnology and pharmaceutical companies developing investigational medicines across a range of indications, including transthyretin amyloidosis, familial hypercholesterolaemia and alpha-1 antitrypsin deficiency. Richmond’s experience across multiple advanced modalities and indications reflects the increasing diversity of advanced therapy pipelines entering early clinical development.

As advanced therapies continue to mature, early phase clinical research will become increasingly specialised. Success will depend not only on scientific innovation, but on the ability to generate robust clinical evidence through carefully designed studies, experienced investigators and operational excellence. Organisations with expertise across emerging modalities, access to specialist clinical infrastructure and a proven track record in early phase delivery will be well placed to help sponsors translate promising science into the next generation of medicines.

1. Cell and Gene Therapy Catapult. UK Advanced Therapy Medicinal Product (ATMP) Clinical Trials Database 2025; BioIndustry Association (BIA), 2026.
2. Cell and Gene Therapy Catapult. UK Advanced Therapy Medicinal Product (ATMP) Clinical Trials Database 2024; BioIndustry Association (BIA), 2025.
3. Dowdy SF, et al. RNA therapeutics: expanding the druggable genome. Nature Reviews Drug Discovery. 2025.
4. MedCity. Advanced Therapies: London's Landscape. 2025 (incorporating analyses from GlobalData, ClinicalTrials.gov and Dealroom).