Fran Brown Email & Phone Number

Danville, Ca, Us

San Francisco Bay Area

San Francisco

Responsible for driving cross functional due diligence/asset assessments for client projects. Responsible for providing strategic development input with an emphasis the design and implementation of clinical development plans leveraging Model Informed Discovery and Drug Development. pharmacology and translational medicine strategies and extending to population approaches and the development of exposure/response relationships

San Francisco Bay Area

A member of the D3 Management Team. Responsible for driving cross-functional due diligence/asset assessments for client projects. Responsible for providing strategic development input on client projects with an emphasis the design and implementation of clinical pharmacology and translational medicine strategies and extending to population approaches and the development of exposure/response relationships

Responsible for providing scientific support to the team through the evaluation, optimisation and presentation of scientific components of selected opportunities. Part of the globally renowned business consultancy, Results International, Results Healthcare provides strategic business advice and lead advisory corporate finance expertise to the healthcare industries. Results Healthcare has a dedicated team centred in London, providing international coverage utilising Results' offices in London, New York, Frankfurt, Munich, Dubai, Singapore, Tokyo, New Delhi and Sao Paulo. Results Healthcare advises on sell side transactions, buy side mandates; including public to private transactions, venture capital and private equity fund raising, MBOs, R&D site evaluations and divestments, company and product valuations, and licensing transactions

This initiative by the Wellcome Trust aims to provide Strategic Translation Award funding for applicants with innovative therapeutically relevant biology or chemistry so that they may embark on drug-like compound discovery and/or lead optimisation involving the disciplines of disease biology, medicinal chemistry and pharmacology. The goal is for funded projects to progress to a stage whereby there is sufficient evidence to make the project results, intellectual property and outcomes attractive to follow-on developers/investors who may be from the commercial or not-for- profit sectors. To achieve this it is expected that typical projects will deliver patentable, drug-like lead candidates, with optimised and favourable pharmacological, physicochemical, toxicological and metabolic characteristics.

Responsible for providing high quality development advice and support to clients by; supporting clients to visualise and define their development goals, providing input to customise development plans in meeting these goals, supporting clients to organise and mobilise their clinical development plans through outsourcing and project management activities with the overall intention to maximize efficiency and effectiveness of their project development .Responsible for assisting clients in the evaluation of their portfolios with a focus on risk management. Assisting clients in the evaluation of new in-licensing candidates including assessment of potential development strategies, costs and timelines. Assisting clients in putting together dossiers for out-licensing.

Responsible for all Research and Development activities for the transition of 3 global marketed products into Biovitrum’s organisation. This included the establishment of out-sourced pharmacovigilance and global regulatory networks integrated as part of Biovitrum’s infrastructure. The transfer and validation of safety databases and documentation to a 3rd party provider and the establishment through out-sourcing of a global call centre for pharmacovigilance, medical information and product complaints. The establishment through out-sourcing of a pharmacovigilance support structure for marketed products. The transfer of an extensive ongoing clinical program including transfer of study sites, databases, documentation, clinical trial supplies and clinical assay methodologies.

Responsible for delivery of clinical studies and programs according to agreed time, cost and budget. Responsible for defining and implementing outsourcing and data management strategies to meet Biovitrum’s future business needs. Responsible for ensuring sound strategic Clinical Development Plans (CDP) which deliver the required information both for regulatory requirements, internal decision making and provision to key stakeholders. Ensure support for the Clinical Program Leaders assigned to each project (planning, outsourcing, execution, communication and reporting of clinical trials). Track ongoing clinical activities with regard to timelines and budget.

Provide strategic direction and leadership to the Canadian Affiliate Clinical Development Group consisting of 75 individuals. Ensure that the Canadian organisation delivers its commitments with regard to Canadian participation in global phase 2, 3 and 4 clinical studies. Ensure that all studies are completed on time, in accordance with GCP, within budget and to good quality. Foster cross collaboration with the local business affiliate to promote early development of market opportunities. Ensure that the needs of the Canadian development organisation are represented at a global affiliate level. Ensure the professional development of staff, appropriate management of performance and recruitment of high quality individuals.

Line management responsibility for a team of 7 Basel based project team leaders. Responsible for ensuring consistent quality of the project leadership provided by the group to the organisation. To ensure the strategic quality of development proposals. To ensure appropriate input into the evaluation of in-licensing opportunities.To act as interface between discovery research and development, ensuring high quality, consistent development input to discovery projects. To ensure the early consideration of clinical development scenario’s designed to deliver early data on key risks associated with molecule, target or indication.

Provide leadership to a multidisciplinary global research and development teams to plan and implement optimal early development activities focussed on timely progression of compounds with appropriate risk assessment. To ensure that technical, pre-clinical, clinical and regulatory plans are defined through to registration.Ensure appropriate project planning and budgeting of all activities required to support planned strategy in early phase development. Ensure appropriate pre-clinical studies have been performed and that drug substance and drug product are available in a timely manner to support phase II program and beyond. To ensure that key meetings (e.g. pre-IND, advice, EOP2) with regulatory agencies are planned and implemented in line with project strategy.

Provide strategic Clinical Pharmacology input for emerging projects. Work with research teams in Switzerland and the UK in the period prior to clinical candidate selection to define the early clinical pharmacology project strategy, identify possible issues and look for ways to de-risk the further development. Asses the potential to use innovative EIH designs and implement prospective planning for the definition of PK/PD relationships within the phase I program.

Responsibility for the care and support of a team of 7 clinical pharmacologists. Although the role included administrative responsibilities, the primary focus of the position was to provide scientific and professional support and effective mentoring to enable individuals within the department to maximise their potential and ensure career development.

Responsibility for the design, analysis of the clinical pharmacology/pharmacokinetic components of the clinical development strategy to support NDA application and package labelling. Analysis and interpretation of all pharmacodynamic and pharmacokinetic data resulting from the defined program including; first in man studies; identification of concentration effect relationship; appropriate dose selection for phase II; definition of drug-drug interaction program and studies in special patient populations. The generation of all summary documentation pertaining to clinical pharmacology/ pharmacokinetics required for the US and European NDA filings for two new virology products. Following the submission of the dossier for one of these compounds there was extensive interaction with the regulatory authorities including participation at a US Advisory Committee and CPMP hearings as the pharmacokinetic/pharmacology expert for the sponsor.

Responsibility for the design, planning and implementation of clinical development program for a development compound (included phase I through to phase IV studies) to agreed upon timelines and budget. Negotiation of acceptable development plans with US and European Regulatory agencies. Planning, development and filing of registration dossiers in US and EU. The co-ordination and motivation of a team of experienced scientists from different cultural as well as functional backgrounds.

Phd, Pharmacokinetics

Bpharm, Pharmacy

Education record