Profiles of Our Network of Oncology Drug Development Experts

Over 25 years’ industry experience in oncology, across all phases of clinical development, more than 20 of which have been in translational medicine developing new therapies for first time in human evaluation. Instrumental in implementing, Project Optimus complaint, novel study designs (adaptive, modular, basket etc.) to enable rapid and efficient evaluation of initial safety, dose and indicative efficacy utilizing for example, biomarkers and PK/PD approaches, where appropriate.

Extensive regulatory authority experience in most global regions for pre-trial advice, accelerated pathways as well as study related safety and data reviews. Extensively published (circa. 100 publications) and holding two honorary academic positions.

More than 20 years’ clinical research experience with extensive knowledge of the design and analysis of early phase oncology clinical trials. Provided statistical input and analysis to numerous clinical trials as well as strategic input to many oncology drug development programs.

Designed studies and undertook regulatory defense with the FDA, EMA, TGA and MHRA of the statistical approaches for a development program which went from start of Phase I to NDA submission within 3 years. For the last 6 years has been supporting biotech companies with clinical trials designs and project strategy as well as ongoing data review and interpretation.

More than 30 years’ pharmaceutical industry regulatory affairs experience culminating in the position of global regulatory affairs director in oncology at a global top 10 pharmaceutical company. Regulatory authority experience across global regions. More recently supporting biotech companies with regulatory agency advice at pre-IND meetings (PIND) and obtaining accelerated development approvals.

Eight years leading a nonclinical toxicology consultancy business with 60 staff and a global client base. Previously, over 20 years of toxicology and drug development experience at a major pharmaceutical company ultimately as part of the drug safety and oncology leadership teams. Overarching responsibility for the oncology project portfolio of small molecules, biologics, proteins and oligonucleotides. With an in-depth understanding of drug discovery and drug development process, has been directly involved in bringing over 35 new candidate drugs to clinical trials and six to marketing approval. With this extensive experience brings an innovative, science-led, and pragmatic approach to the design and delivery of nonclinical safety programs.

More than 25 years’ pharmaceutical development experience across large pharma, academia and biotech industries. Leadership of technical activities, projects and development teams and responsibility for delivery of oncology drug projects from initial concept design through late-stage development, regulatory submission, and launch (including advanced drug delivery systems). Experienced 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 trials across a range of therapy areas including gene and cellular therapy, bio specifics, mRNA vaccines.

Specialist in cancer drug discovery with more than 30 years’ experience in the pharmaceutical industry providing scientific and project leadership for small molecule and biotherapeutic approaches. A research background in cell and molecular biology with experience across all stages of Oncology drug discovery from target selection, lead identification and optimization, to supporting regulatory submission. Evaluation of licensing opportunities and provision of translational science strategy for clinical phase drug candidates.

More than 20 years’ experience of clinical trial design and delivery, regulatory submission and approval in the pharmaceutical industry with a primary focus in oncology. Extensive regulatory submissions experience within the US, EU, Asia and other markets, led delivery of the safety components of submissions. ODAC and OE Presentations and responses. Pharmacovigilance expertise across clinical safety ensuring collaboration between clinical and pharmacovigilance teams. Oversight of investigator study strategy and programs, strategic development of lifecycle management plans. Now supplemented by experience of study design and delivery of first-in-human studies in oncology, respiratory and healthy volunteer settings supporting biotech clients.

More than 25 years’ industry drug development and project management experience. Expertise in strategic delivery of preclinical studies and programs by effective and collaborative leadership of global project teams. Proactively drive optimum project development goals, to scope, on time and on budget with agreed tolerances. Provide insights into trial design and provide guidance around optimal clinical operation execution. Will be your key contact at Catalyst to help drive the strategy and delivery of science-based decision-making for your project, listening to exactly what you need to the success of your project.