Bringing a new medicine from discovery to the clinic requires a series of complex scientific, technical and regulatory decisions.
With increasing pressure to accelerate timelines, manage risk and maximise resources, many sponsors look for experienced guidance to help navigate critical development milestones.
In this article, Stuart McDougall, Head of Scientific Consulting and Principal Research Fellow at Arcinova, alongside fellow consulting leaders Dr. Thomas Nunns and Dr. Alan Jeuken, explores how strategic drug development consulting helps sponsors make informed decisions, overcome development challenges, and build efficient pathways from molecule to clinic.
Navigating Complexity in Modern Drug Development
Today's drug developers face increasingly complex challenges. Programmes must progress rapidly while meeting regulatory expectations, securing investment, and generating robust scientific data.
Decisions made early in development can have significant downstream consequences. A synthetic route selected for preclinical studies may later prove difficult to scale. An analytical strategy that supports early-stage development may not provide the data required for regulatory submissions. Delayed planning for radiolabelled studies can create bottlenecks that impact critical ADME programmes.
Addressing these challenges requires an integrated understanding of the development pathway rather than focusing on individual activities in isolation.
Strategic consulting helps sponsors identify risks early and establish development plans that support both immediate objectives and future milestones.
Turning Scientific Challenges into Development Strategies
Effective consulting is not about managing individual tasks. It is about helping sponsors make informed decisions that support efficient development.
At Arcinova, consulting teams work closely with scientific and operational specialists to design programmes tailored to the specific needs of each molecule. This may include:
- Developing scalable synthetic routes for IND-enabling studies
- Designing analytical strategies to support product characterisation and regulatory submissions
- Planning radiolabelling programmes for metabolism and pharmacokinetic studies
- Establishing manufacturing strategies for clinical supply
- Aligning development activities with regulatory expectations from the outset
Experience That Shapes Better Decisions
One of the greatest advantages of strategic consulting is access to specialists who have encountered similar development challenges many times before.
Leading Arcinova's consulting team is Stuart McDougall, Head of Scientific Consulting and Principal Research Fellow, who brings more than 35 years of experience in drug metabolism, pharmacokinetics, and bioanalysis.
Throughout his career at organisations including Sanofi, Covance, Arcinova, and Quotient Sciences, Stuart has supported a wide range of development programmes across multiple therapeutic areas. His expertise spans both the scientific and regulatory factors that influence programme success.
His longstanding involvement with industry groups such as the European Bioanalysis Forum and Global Bioanalytical Consortium also provides valuable insight into evolving industry standards and best practices.
As Stuart notes:
"Successful development programmes are built on informed decision-making. Understanding how activities connect across the broader development pathway helps sponsors avoid unnecessary delays and focus resources where they will have the greatest impact."
Specialist Expertise Across Critical Development Areas
Many development challenges require highly specialised knowledge.
For sponsors advancing drug substances towards clinical development, Dr. Thomas Nunns, Director of Drug Development Consulting, provides expertise in process chemistry and chemical process development.
Tom works closely with clients to establish scalable, phase-appropriate manufacturing routes capable of supporting both preclinical studies and future clinical supply requirements. This includes evaluating process efficiency, impurity control strategies, manufacturability, and regulatory considerations that can influence programme timelines.
According to Tom:
"The decisions made during early process development can significantly impact future scale-up, regulatory submissions and manufacturing costs. Identifying the right strategy early often saves considerable time later in development."
Radiolabelling programmes present another area where specialist expertise can add substantial value.
Dr. Alan Jeuken, Director of Drug Development Consulting, supports sponsors with the design and delivery of radiolabelled compound programmes that underpin ADME studies and regulatory submissions.
Radiochemistry projects often require careful coordination with analytical, bioanalytical and regulatory activities. Alan's experience helps sponsors determine the most appropriate labelling strategy while ensuring these studies integrate effectively with overall programme objectives.
As Alan explains:
"Radiolabelled studies provide critical information about a molecule's metabolic fate, but expert planning is essential. Holistic project design across chemistry, formulation, analytical and regulatory requirements prevents unnecessary delays and paves the way to a successful ADME study."
Supporting Progress from Discovery to Clinic
As programmes move from discovery through IND-enabling studies and into clinical manufacture, new technical and operational challenges emerge.
By combining expertise across chemistry, analytical sciences, bioanalysis, radiochemistry, formulation, manufacturing and regulatory support, Arcinova helps sponsors maintain continuity and build efficient development pathways from molecule to clinic.
This integrated perspective helps ensure development activities remain aligned with both immediate objectives and long-term programme goals.
Advancing Programmes with Confidence
Every development programme is unique, but the objective remains the same: delivering promising therapies to patients as efficiently as possible.
Achieving that goal requires scientific expertise, practical development experience, and a clear understanding of how decisions made today will affect future milestones.
By combining strategic consulting with integrated scientific expertise across chemistry, manufacturing, bioanalysis and radiolabelling, Arcinova helps sponsors make informed development decisions and accelerate progress from molecule to clinic.
To discuss your programme and development strategy, contact our scientific consulting team here.