Our services

Apex Biologics Consulting provides expert support to companies looking to develop novel biologics. It specialises in advising on the integrated technical development of all major classes of biologic medicines, including monoclonal antibodies (including fAbs and scFvs), PEGylated proteins and growth factors, as well as antibody drug conjugates and biosimilars.

Transitioning a new molecule through the clinic is a complex venture requiring high investment and an integrated approach to clinical supply, development of the pharmaceutical form, non-clinical evaluation to support the first dosing and technical development to reach the right quality for the right price. Investment in a sound programme of development ensuring full developability, minimising liabilities and knowing where and when to invest in CMC activities (especially avoiding unnecessary activities) is crucially important and this is where I can help.

I am passionate about developing state-of-the art medicines and it is my pleasure to offer the following support services:

• Strategic programme design and support covering all of the CMC requirements for new molecules entering the clinic, up to and including market authorisation

• Optimisation of costs and timelines to bring the fastest technical path; working with clinical and non-clinical line functions to bring the best overall outcome

• Evaluation of CMOs for the production of drug substance and drug product, due diligence and selection; review of service agreements; Apex brings expertise gained working with six of the top global biologics CMOs over a twenty year period.

• Tracking technical progress in order to support delivery on time, right-first-time

• Establishing budgetary requirements and programme financial analysis concurrent with technical risk management planning; high quality documentation to support rounds of funding and to inform your decision-making architecture

• Providing day-to-day state-of-the art technical and resource planning using MS Project, Project Web Application or Planisware to minimise the critical path

• M&A Due Diligence Support: expertise in on-site technical evaluation of manufacturing and development sites, products and technologies providing high quality assessment reports including post-acquisition development planning

• Candidate selection and developability assessment study design and evaluation including written assessment

• Analytical planning and control strategy design according to ICH guidelines including the evaluation of process changes, where applicable

• Establishment of quality Target Product Profiles

• Biosimilar development: design of physicochemical and biological similarity studies, similarity data evaluation and dossier authoring

• Upstream and downstream process development strategy and planning

• Troubleshooting quality issues, assembling risk mitigation strategies

• Formulation study design and pharmaceutical development strategy for a wide range of parenteral dosage forms

• Review of technical documentation such as manufacturing protocols, analytical validation protocols and reports, stability protocols and reports; design of stability protocols

• Supporting programme technical risk assessment and mitigation plans

• CMC dossier guidance, authoring and review of sections from IND/IMPD to BLA/MAA, drug substance and drug product, biosimilar and innovator medicinal products

• Scientific Advice Meetings with the EU and US competent authorities; preparation of CMC questions and briefing book sections, F2F and TC meeting support, evaluation of advice and follow-up activities

•  Support in the design, training and configuration of Microsoft's Project Enterprise environment for use in a pharmaceutical development setting 

• Change management; implementing new systems and processes including project governance, time sheet entry, project planning, milestone/milepost tracking, work allocation (resource demand versus availability), cost tracking and portfolio analysis