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Consultancy Services

Seda has a team of experienced Project Leaders that can provide a full consultancy service for our customers.

Our services span CMC, Clinical Pharmacology and DMPK. This ranges from input at the pre-clinical / discovery phase, through first-in-human (FiH) and early clinical trials (CTs) and onwards to product approval.

Chemistry Manufacturing and Controls (CMC)

Our CMC capability covers both drug substance and drug product development. Specific activities include:

  • Drug substance project strategy development and integration with drug product, safety and clinical planning
  • Expertise in chemical development at the Discovery interface, Preclinical and Clinical Development, including synthetic route design, process design, solid form selection and analytical method development
  • Definition of drug product (formulation strategy) through FiH/early CTs, Phase 2, Phase 3 and Launch, using rapid prototyping, in-silico formulation tools and product design thinking
  • Management and delivery of pharmaceutical development elements of drug development programs (including estimation of costs, timings and resource requirements)
  • Design of CMC programs based on the latest Quality by Design thinking
  • Definition of Quality Target Product Profile (QTPP) and Quality Risk Assessment (QRA)
  • Sourcing and management of Drug Substance and Drug Product activities from third party contract service providers
  • Authoring and review of the CMC technical elements of regulatory dossiers to ensure authorization for clinical trials and marketing
  • Representation of client companies in interactions with Health Agencies
  • Conduct of Due Diligence review on prospective asset purchases

Clinical Pharmacology and DMPK

Our DMPK and Clinical Pharmacology Project Leaders can provide expertise to support the following activities:

  • DMPK profiling, problem solving and compound selection / progression at all stages of drug discovery
  • Design of molecules to avoid DMPK liabilities
  • Prediction of human pharmacokinetic (PK) profiles and therapeutic doses
  • Selection and justification of FiH dose
  • Authoring and review of the DMPK and Clinical Pharmacology technical elements of regulatory dossiers (including label) to ensure authorization for clinical trials and marketing
  • Design of the pharmacokinetics elements of FiH Clinical Studies (with a focus on FiH studies in Cancer Patients) and Clinical Study Protocol writing e.g.
    – PK sampling time points
    – Inclusion and exclusion criteria
    – Concomitant medications
  • Interpretation of clinical PK and PD (pharmacodynamic) data and justification of clinical dose
  • Design of drug-drug interaction studies

All of the above can be provided as an individual offering or as a fully integrated service.

Ask our team a question

Expertise:

  • Oral Drug Delivery
  • Complex Parenterals
  • Paediatric Product Development
  • Regulatory CMC

Paul W Stott

BPharm (Hons) PhD

Director & CEO

Paul W Stott

BPharm (Hons) PhD

Director & CEO

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Paul is an established pharma executive with extensive global experience. Prior to joining Seda he was Vice President, Global Product Development at AstraZeneca, leading a group of over 350 scientists and engineers in the development of all products, manufacturing processes and analytical methods for the AstraZeneca small molecule portfolio.

AstraZeneca Global Product Development has centres in the UK, Sweden, US and China and a network of partnerships with colleagues all over the world and under Paul’s stewardship registered 10 global products.

At AstraZeneca Paul was accountable for the Drug Product CMC component of all Due Diligence assessments and was CMC lead on several multibillion dollar acquisitions. In addition, Paul is a visiting Professor of Pharmaceutics at the University of Manchester, UK and founder of the North West Centre for Drug Delivery (NoWCADD) at the University.

He is a proven senior manager and strategic leader in Pharmaceutical Development with experience across geographical boundaries. Passionate about the development of individual and group capabilities and the application of innovation and scientific rigour to bring new medicinal products to market.

He is recognised within the Industry and with Regulatory Agencies as a driving force in the establishment and realisation of best practice in CMC Quality by Design.

Ask me a question

    Expect a reply typically within 48 hours.

    Expertise:

    • DMPK and Dose Selection
    • Oral Drug Delivery
    • Complex Parenterals
    • Pharmacokinetic Modelling
    • Clinical Pharmacology

    Wang Wang Lee

    MPharm (Hons) PhD GPhC

    Principal Scientist

    Wang Wang Lee

    MPharm (Hons) PhD GPhC

    Principal Scientist

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    Wang Wang Lee is a GPhC registered pharmacist with a PhD in Pharmaceutical Sciences and MBA from the University of Strathclyde. She has deep industry and academic experience particularly in the areas of biopharmaceutics and product development. Her expertise in early and late stage development, risk assessing and mitigating the development challenges has helped clients transition compounds into the clinic from discovery. Most recently, she is interested in DMPK and clinical pharmacology projects for poorly solubles and complex parenterals.

    Ask me a question

      Expect a reply typically within 48 hours.

      Expertise:

      • Oral Drug Delivery
      • Complex Parenterals
      • Regulatory CMC

      Nicola Parisi

      MSc PhD

      Principal Scientist

      Nicola Parisi

      MSc PhD

      Principal Scientist

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      Nicola holds a MSc in Pharmaceutical Chemistry from the University of Messina and a PhD in Pharmaceutics from UCL School of Pharmacy. He is an accomplished Formulation Scientist with 9+ years’ experience in the field and roles at AstraZeneca and GlaxoSmithKline. He additionally holds a qualification from the Association for Project Management (PFQ). He is expert in planning, leading and managing clinical drug product development projects and has a deep understanding of change control, risk and stakeholder management processes.

      Ask me a question

        Expect a reply typically within 48 hours.