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How do I balance risk versus cost in my development plan?

At the early stages of development, one must determine the essential experiments to perform to de-risk any clinical studies and meet the regulatory requirements. Equally important is the ability to determine those experiments that can be delayed until the next value inflection so as to manage the spend profile. At Seda we have vast experience in making these judgements and can work with Clients to establish a bespoke development plan that addresses the needs of the molecule and the strategic drivers of the business. We never try to force fit your molecule in to a branded, template development approach. This will ensure that spend is managed without unnecessary delays to the project timeline.

How do I gain adequate exposure in pre-clinical studies?

At Seda we have extensive experience in selecting formulation compositions to optimise exposure in animal studies, particularly those in which large doses are given. Formulations and dosing vehicles are selected based on our knowledge of dosing precedents across a range of preclinical species and the ability of the vehicles to deliver compounds in a solubilised form for oral and parenteral administration. We also have strong expertise in development of long acting formulations for dosing by subcutaneous, intramuscular and intratumoral administration.

How do I accelerate my candidate to First in Human studies?

Seda has established a framework for the rapid, successful and cost-effective development of products for clinical studies in healthy volunteers and patients. Bespoke development strategies for first time in human studies are focused on an understanding of the clinical programme combined with a developability assessment based on compound physicochemical, physicomechanical, drug absorption and pharmacokinetic properties. This allows us to quickly select the most appropriate dosage form and delivery systems for your compound from a range of proven technologies whilst developing relevant analytical methodologies for testing of product quality.

How do I optimise exposure?

Seda has access to an extensive library of enabling technologies for ensuring that the optimal PK profile and bioavailability is achieved for every compound. This covers technologies for the oral delivery of compounds with low aqueous solubility including lipidic delivery systems, liquid and semi-solid filled capsules and amorphous solid dispersions. We also have the ability to rapidly assess the suitability of particle size reduction as a means of enhancing the rate and extent of drug absorption. For compounds requiring parenteral administration, we have significant experience in the development of long-acting injections including polymeric microparticles, in-situ forming systems and oily depots.

How do I predict a Human Dose?

Our in-house drug metabolism and pharmacokinetics (DMPK) experts can guide you in the prediction of human systemic pharmacokinetics parameters. This is coupled with knowledge of the concentration and duration of coverage needed at the target tissue. A crucial additional step is the application of our proprietary in silico absorption modelling software, Nora Max, which is used to predict the fraction of the administered dose that would be absorbed, based on the compound’s physicochemical properties and formulation attributes. Via this approach, Seda can guide you in the selection of an appropriate human dose / schedule, optimising time and costs involved in formulation development for human clinical studies.

What technologies are available for drug targeting and intracellular delivery?

The changing nature of (bio)pharmaceutical pipelines has seen an increasing interest in the development of complex medicines, in particular those administered by injection. This includes a growing appetite for the development of nanomedicines and colloidal systems, including those aimed at promoting the accumulation of molecules in specific target tissues and cells such as lipid, polymeric and inorganic nanoparticles. Seda has a strong track record of supporting research organisations, biotech businesses and drug delivery companies to navigate the journey for these most complex of pharmaceutical systems into the clinic, providing deep technical insights and an understanding of regulatory requirements.

What pharmacokinetic profile should we aim for?

Rather than focussing purely on dose strength, we encourage Clients to consider the desired PK profile for optimum formulation performance. As experts in pharmacokinetic-pharmacodynamic-outcome (PK-PD) and PBPK modelling, we can assist Clients in interrogating preclinical data and translating it to a target human PK profile and thus, optimal release profile for the drug product.

How do we bridge between formulations?

When formulation or manufacturing process changes are made during development, it is important to understand whether there will be any impact on clinical performance of the drug product. Clinically relevant differences in PK profile part way through a development programme may invalidate prior safety and efficacy data or may necessitate a dose adjustment. The stage of development defines how stringently the standards are applied. Supporting data can range from comparative dissolution testing and in silico modelling, to clinical relative bioavailability studies or formal bioequivalence studies. Seda will guide you through rational design of your drug product bridging strategy, allowing your programme to progress at optimal speed and cost.

How do we meet the requirements for paediatric development?

Changes in the regulations now require 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. Seda has in-house expertise and a network of external thought leaders in the provision of formulation development, in silico PK prediction, taste assessment, and regulatory authoring to help you design and deliver your paediatric development program.

How do we develop an appropriate Regulatory Control Strategy?

One of the fundamental tenets of Quality by Design is to ‘start with the end in mind’. The most effective way to approach this is to think about a final, holistic Control Strategy that will form the basis of your quality assurance at the point of Product Authorisation and to focus your development efforts on this goal. This will structure your assessment and management of risk, your product design goals (through a Quality Target Product Profile) and your analytical method development.
This approach can be applied, as appropriate, at any stage of development and will maximise the value of your development asset.

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