Understanding ATMPs IMPS & Clinical Trials

Understanding ARMPs IMPS and Clinical Trials

by Steve Mannering (Thermo Fisher Scientific)

Our 2025 UK GDP Association Conference brought together some of the most respected leaders shaping the future of pharmaceutical quality and compliance. In this blog we will be spotlighting speaker Steve Mannering of Thermo Fisher Scientific whose speaker session demystified the complex world of ATMPs, IMPs and clinical trial development.

Introducing Steve Mannering

Steve Mannering, Vice President of Quality at Thermo Fisher Scientific, has over two decades of experience in global quality leadership, spanning pharmaceuticals, biologics, sterile manufacturing, and increasingly, the world of advanced therapeutics.

Steve’s expertise positioned him perfectly to guide delegates at the conference through both foundational concepts and emerging regulatory expectations. His session, “Understanding ATMPs. IMPs and Clinical Trials” was a return to basics enriched with real-world insight, practical interpretation, and foresight for where the pharmaceutical industry is heading next.

About Thermo Fisher Scientific

As the worlds leading science focused organisation, Thermo Fisher Scientific supports researchers, pharmaceutical developers and healthcare systems with technologies and services that accelerate life changing science. The company provides end-to-end solutions across medicines life cycles, including drug discovery, advanced therapy development, clinical trial support, manufacturing, and global distribution. Their work in cell and gene therapies, clinical services, and analytical technologies please them at the forefront of innovation, helping bring complex therapies from concept to patients faster and more reliably.

Back to Basics: IMPs, ATMPs and Clinical Trials

Steve opened the session with an important reminder that in order to understand IMPs, ATMPs and clinical trials, we must begin with clear definitions.

Investigational Medicinal Products (IMPs)

IMPs are the active medicines or placebos used within clinical trials to assess efficacy and safety. These include new drugs, combination products, and vaccines. To manufacture IMPs, organisations must hold both a Manufacturer’s/Importer’s Authorisation (MIA) and an IMP licence. Without these dual approvals, IMP production cannot legally proceed.

Producing IMPs is governed by a series of stringent frameworks, including:

• • • GMP and GDP guidelines
    • GCP clinical trial standards
    • Clinical Trial Regulation (CTR) 2022
    • FDA CFR Part 312
    • And importantly, new UK guidelines due in April this year (2026) designed to align UK processes more closely with EU requirements.

Regulatory approval requires robust data to justify a clinical trial, to not only demonstrate safety, initial efficacy, optimal dosage but to compare to existing treatments or previous formulations.

Clinical Trials – Multi-Stage Evidence Building

Steve walked the audience through the four phases of a clinical trial:

1. Phase 1 – 20-100 participants: Dose safety
2. Phase 2 – 100-300 participants: Side effects and optimal dose
3. Phase 3 – 300 – 3000 participants: Large-scale comparison, data for Marketing Authorisation (MA) submission
4. Phase 4 – Post-marketing surveillance

The average clinical trial now takes around 7 years, although this varies by therapy area, demographic, and urgency. The Covid-19 pandemic introduced the concept of fact-tracked trials, which may influence future emergency-response frameworks.

Steve also emphasised the key roles involved in clinical trials:

• Sponsor – funds, designs and ensures compliance
• Clinical Research Organisation (CRO) – Executes the operational trial work
• Investigator – Typically a physician overseeing patient involvement
• Participant – Healthy volunteers or patients living with the disease/condition the medicines being trialled whose adherence is critical

Clinical Trial Study Design and Blinding

Robust trial design requires:

• • • Clear, measurable objectives
    • Comparative assessments
    • Exploration of new indications

Blinding strategies remain essential:

• Single Blind – Patient unaware if medicine given is active or placebo
• Double Blind – Patient and doctor unaware if medicine given is active or placebo
• Open Label – Both informed

Where blinded trials operate, the separation between placebo and active product knowledge must be absolute, any breach risks compromising the entire dataset.

Data management rounds out the framework, with processes to ensure accurate, monitored and securely handled clinical information.

ATMPs – The New Frontier of Personalised Medicine

One of the most compelling parts of Steve’s session explored Advanced Therapeutic Medicinal Products (ATMPs), innovative gene, and stem therapies, tailored to individual patients. These personalised medicines have the potential to transform treatment outcomes; however, they bring unique supply chain challenges.

Why ATMPs are Different

ATMPs exist within a rapidly evolving regulatory landscape. Frameworks must continuously adapt to scientific advances, creating what Steve described as a “regulatory revolution.”

Key challenges include:

• • • Ultra-low temperature storage requirements (far beyond the capabilities of many hospitals)
    • 72-hour transport restrictions due to product fragility
    • Extremely high production costs sometimes exceeding £1 million per dose!
    • Risk of catastrophic loss from temperature excursions or batch failures
    • Specialised packaging, labelling, and handling requirements
    • Limited facilities able to manage ultra-low storage conditions
    • These therapies represent the cutting edge of personalised medicines, but their success relies on a robust, skilled, and responsive Good Distribution Practice (GDP) ecosystem.

A Thought-Provoking and Practical Session

Steve Mannering’s contribution to the 2025 conference was both educational and energising.
Delegates left with a stronger understanding of the scientific and regulatory foundations underpinning clinical development, knowledge essential not only for GDP professionals but for anyone touching the modern medicines supply chain.

By breaking down complex concepts into the clear, structured explanations, Steve provided a roadmap for the future of clinical trial medicines and advanced therapies. His emphasis on quality, compliance and operational excellence aligns strongly with the UK GDP Association’s mission to foster best practice across the sector.

As the industry accelerates toward more personalised, temperature-sensitive, and scientifically advanced treatments, sessions like Steve’s ensure that the UK’s GDP professionals remain informed, prepared, and ready to meet the needs of tomorrow’s patients.

Registering for the 2026 conference

The UK GDP Association C.I.C (Community Interest Company) is delighted to announce that our third Annual Conference will be held on Tuesday 16th June 2026 and Wednesday 17th June 2026, in Northampton.

There are discounted tickets available for UK GDP Association members, members can save £100 when attending both conference days. However, our commitment to low-cost, high-value educational content means that conference tickets will still be the best value whether you chose to join as members or not.

Membership is only £29 +VAT per individual, per year and offers reduced costs on consulting, training and conference tickets. If you buy tickets for both conference days, there is an even greater discount. Costs for non-members is just £224.50 per day, a fraction of the cost of other industry events!

In addition, on the evening of Tuesday 16th June, we will be hosting an evening event of dinner, networking, and even some of Dave’s infamous karaoke, for just £49 +VAT per person. This is a fundraising dinner in aid of the MVA Society.

Please see here for more information on the conference and to book your conference and evening dinner tickets.

We are very much looking forward to seeing you all at the conference!