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Paediatric Product Development

Development and delivery of age-appropriate formulations

Traditional drug development has predominantly focused on the development of drug products for an adult population, which has led to the off-label use of conventional dosage forms in paediatrics. This often involved manipulating the dosage form (i.e. cutting tablets or opening capsules) to enable delivery to children and infants bringing unknown safety issues.

Recent changes in the regulations framework now requires the pharmaceutical industry to design and develop age appropriate formulations and perform clinical trials involving paediatrics, in addition to the development and approval of the drug product for adults. Inadequate progress in the paediatric product assessment can lead to delays or rejection of the approval for the primary adult indication.

Seda offers a service that is unique in this landscape. A complete handover and transformation of your molecule by providing end-to-end CMC and regulatory support and consultancy for paediatric medicine development including:

  • An understanding of the global regulations on paediatric development
  • Guidance on development, selection and/or appropriateness of the formulation being developed for
    the designated age range
  • Guidance on excipient selection e.g. GRAS (Generally Regarded As Safe), paediatric specific.
  • Identification and management of CDMO/CRO with experience in manufacturing paediatric
    formulations and devices
  • Sourcing and management of taste masking technologies from third party contract service providers
  • Biopharmaceutical assessment of paediatric products including bridging between adult and
    paediatric formulations
  • PK-PD modelling of all paediatric age groups
  • Recommendations on regulatory strategies and authoring & reviews of PIPs (Paediatric Investigation Plans)

Related Publication

Evaluation Of Emerging And Existing Taste Masking Technologies For Paediatric Drug Development

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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.

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    Expect a reply typically within 48 hours.

    Expertise:

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

    Marcel de Matas

    BSc (Hons) PhD FRSC CChem

    Director & Co-Founder

    Marcel de Matas

    BSc (Hons) PhD FRSC CChem

    Director & Co-Founder

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    Marcel has a track record in a range of management and senior scientific positions in industry and academia. Most recently he was a Principal Scientist in Product Design and Innovation at AstraZeneca, where he was responsible for introducing the latest science, new technologies (advanced drug delivery and manufacturing) and product design thinking into the Product Development group.

    Marcel has led technical activities, provided project leadership and has managed product development teams responsible for the delivery of drug projects from initial concept design through late stage development, regulatory submission and launch (including advanced drug delivery systems). He has led teams at the drug discovery-development interface, assessing the level of chemistry manufacturing and controls (CMC) technical risk and defining product design strategies in early development. Project experience has covered projects across a range of disease and therapy areas with substantial experience in the oncology field.

    Ask me a question

      Expect a reply typically within 48 hours.

      Expertise:

      • Oral Drug Delivery
      • Paediatric Product Development
      • Complex Parenterals

      Shanoo Buhdheo

      BSc (Hons)

      Principal Scientist

      Shanoo Buhdheo

      BSc (Hons)

      Principal Scientist

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      Shanoo is an experienced pharmaceutical development scientist with many years’ experience in large pharma and the biotech sector. She has a particular interest in biopharmaceutics, development of clinically relevant in vitro tests and the development of products for paediatrics.

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        Expect a reply typically within 48 hours.