pharmaceutical product development
Experienced multi-disciplinary team providing flexible service options to deliver cost-effective and pragmatic development of pharmaceutical products to Phase 2b. S2PD supports clients in the following areas:
Drug Development Planning Project Management
S2PD has an experienced in-house drug development team to help clients with preclinical and early stage clinical phases. Our extensive experience in the space enables us to formulate plans and anticipate potential contingencies required. We know that work is often outsourced at short-notice with tight deliverable deadlines and sometimes with limited resources. S2PD will work with clients to define timelines, scope and resources required.
Drug Candidate Selection
We advise and project manage the work-streams to permit selection of clinical development candidates. This includes in-vitro and in-vivo studies to establish pharmacology, efficacy, absorption, metabolism, excretion, toxicology (ADMET). Typically, we are asked to work on a short-list of drug candidates to identify/prioritise development candidates via selected CRO partners. Our programmes are designed to quickly identify potential lead candidates saving clients considerable time, resources and money. S2PD can also provide 2nd opinion having considerable experience in this area for small and biologic molecules.
Preclinical Drug Development
Having a coherent preclinical drug development strategy can help significantly in the clinical development stages. S2PD has experienced preclinical experts who can tailor the preclinical packages according to the specific characteristics of the drug candidate and in line with the regulatory framework. We can consider preclinical drug development with future regulatory, CMC and QA from an early stage so as to easily transition into clinical stages of drug development.
Preclinical Project Management
S2PD provides a full project management service across all phases of development to phase 2b. In-house preclinical expertise includes toxicologists who can cover their drug development aspects such as safety pharmacology, genotoxicity, reproductive toxicology etc. S2PD preclinical specialists will shortlist selected CROs for clients and upon agreement, will take project management responsibility for the study. Several of our preclinical specialists are from a CRO background and have extensive networks to call upon for placing carefully designed studies and negotiating appropriate study costs.
Technical Due Diligence Support
S2PD has been asked to undertake technical due diligence on drug developments by sponsors looking to license products. Reviews of preclinical, regulatory, CMC and clinical data would form part of the review. We are often asked to support such due diligence with subsequent design of further product development work streams.
Preclinical Regulatory Documentation
S2PD have supported clients in the preparation of preclinical reports and documents necessary for regulatory submissions.
Chemistry, Manufacturing Control (CMC)
S2PD believes having a CMC strategy is critical for efficient and timely development of drugs in early-stage preclinical. Study drug material considerations need to be taken into account at an early stage in preparation for preclinical and first-in-man studies. Depending on indication, clinical opinion, and product data, S2PD can advise formulation pathways or further work requirements in terms of drug characterisation or further studies. S2PD provides a bespoke service to clients dependent on client requirements and can include trial drug management through our CROs, CMC plan development etc. Additional CMC services include:
- CMC Regulatory Affairs – to support regulatory requirements to phase IIb
- CMC Project Management
- Contract Manufacturing Organisation – selection
Contract Research Organisation – selection management thereof including contract, documentation, reporting etc.
Investor Support for Early Stage Drug Medical Device Development
In our opinion, it is business critical to develop a robust regulatory strategy for drug development from early preclinical through to the clinical phases. In this way, you can optimise the programme with defined milestones, cost-effective resource allocations and streamlined development timelines.
S2PD offers early stage drug development companies extensive expertise in developing both therapeutics from early preclinical to phase 2 programmes and medical devices.
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