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Linking nonclinical development to First-in-Human Linking nonclinical development to First-in-Human

Linking nonclinical development to First-in-Human

  • News
  • Read time: 7 minutes

Taking a drug candidate from preclinical development to First-in-Human (FIH) is a critical step in drug development. The science behind the molecule may be promising, but success often depends on how well all parts of the program are linked.

Every link in the development chain needs to be connected.

Pharmacology, Toxicology, Drug Metabolism & Pharmacokinetics (DMPK), Chemistry, Manufacturing and Controls (CMC), Regulatory Affairs, and Clinical Development all play an essential role. None of these disciplines can operate effectively in isolation. The strongest development programs are built on the connections between functions.

What we see in practice

Our experience is that real value is often created where scientific disciplines meet. When functions work closely together, key questions can be identified and addressed early:

  • Is the nonclinical package sufficient to support the proposed clinical starting dose?
  • Does the exposure data support the safety assessment?
  • Is the CMC package ready for regulatory submission?
  • Are regulatory risks identified and mitigated before they become issues or cause delays?
  • Would scientific advice from a regulatory agency provide critical input?
  • Are development timelines aligned across functions?
  • Is the First-in-Human study design aligned with the nonclinical package, regulatory strategy, and overall development goals?

One Team. One Strategy.

To achieve this, we bring together experienced LINK Medical specialists across key areas, including:

  • Nonclinical Development (Toxicology and DMPK)
  • CMC
  • Regulatory Affairs
  • Clinical Trial Unit (CTU)

By connecting every link in the development chain, we create a coordinated path from early development to clinical studies, with experts working toward the same goal: getting your program ready for the clinic efficiently and confidently.

From Strategy to Execution

For our clients, LINK Medical serves as a partner that understands the entire development chain, not just the individual parts.

Our experts support the design and interpretation of toxicology and DMPK programs, CMC strategy and documentation, regulatory strategy, planning and submissions, and the execution of clinical studies through our CTU. Working closely with the project team, Contract Development and Manufacturing Organizations (CDMOs) for drug substance and drug product manufacturing, and nonclinical Contract Research Organizations (CROs), we help align activities across functions, create realistic development plans, and establish an efficient path to First-in-Human studies.

Accelerating the Chain to the Clinic

Today’s development programs face increasing scientific, regulatory, and operational complexity. Navigating this complexity requires more than expertise within individual disciplines. It also requires alignment, collaboration, and a clear strategy across the entire development chain.

That’s where LINK Medical adds value.

We help clients link nonclinical development, CMC, regulatory strategy, and clinical execution into one coherent plan, turning complexity into progress and helping promising therapies reach the clinic faster.

From the first nonclinical study to the first dose in humans and beyond, LINK Medical provides the expertise, collaboration, and strategic perspective needed to move your drug development program forward with confidence.

Anita Annas – Principal Consultant Toxicology
Petri Vainio – Chief Scientific Officer CTU
Sanna Tikka – Site Manager CTU
Ulrika Andersson– Sr Director Drug Development
Bengt Hedin – Principal Consultant Pharmaceutical Development & CMC
Elsa Lilienberg – Principal Consultant Clinical Pharmacology & DMPK
David Dahlgren – Principal Consultant Clinical Pharmacology & DMPK
Ulrika Bergström – Senior Consultant Toxicology
Linda Nord – Principal Consultant Regulatory Affairs

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