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Jane Theaker was VP of Science and Technology Development for LGC Genomics and had responsibility for R&D within the Genomics Division. She previously worked at QIAGEN Ltd in Manchester UK where she headed up the Early Phase Development Group. It was here that she and her Team took multiple qPCR companion diagnostic assays, such as Kras and EGFR from initial user needs through to a robust assay ready for verification with blue-chip pharma partners, under FDA design control. Prior to this, she worked at AstraZeneca within the R&D Genetics function where she developed and evaluated genetic technologies such as whole genome amplification and NGS in support of drug development. She is a co-inventor of Scorpions primers which she developed while at Zeneca diagnostics. After her degree in Biochemistry, she started her scientific career in the NHS within a Clinical Biochemistry laboratory, which she credits with teaching her “the reality ” of diagnostics in clinical practice.
Sue brings over 25 years of pharmaceutical expertise gained through a combination of Global Pharma (14 years at AstraZeneca), NHS Pharmacy (9 year) and most recently Pharma Consultancy (4 years). Throughout her career, Sue has been inspired to apply her scientific understanding to solving complex commercial and business challenges. Within AstraZeneca Global, Sue was at the forefront of the market access and pricing capability build; driving payer value demonstration into the heart of development and lifecycle execution. Sue has first-hand experience gaining payer insights and testing value propositions facilitating payer interviews and advisory panels, as well as experience navigating Global, Regional, and Local company interactions.
Clive has over 25 years experience in regulatory affairs, working in global and European roles across all stages of the product life cycle and covering variety of therapeutic areas. He developed his interest in companion diagnostics working on anti-rheumatoid drugs targeting HLA DR antigens at AstraZeneca and went on to establish personalised healthcare as a core element of the corporate strategy. He also played a major role, both within AstraZeneca and through EFPIA, in promoting an understanding of the evolving regulatory framework for the development of precision medicines, particularly in areas outside of oncology. Since January 2017, Clive has worked with academic groups, start-ups and pharma companies to navigate the regulatory environment for drug and companion diagnostic development in order to harness innovative science.
Marie exploits her years of immunological experience to support immuno-oncology programmes evaluating immune biomarkers of drug efficacy, mode of action, patient selection and patient safety. With over 30 years of experience in both academic and pharma industry developing specialist knowledge in oncology, toxicology, allergy and dermatology, she is able to support a range of immunology projects from preclinical research through to clinical studies including immuno-oncology drug discovery and biomarker development. Her experience is reflected in her extensive publication record and her many invitations to present and chair at international scientific meetings. Her excellent communication skills allow her to convey complex concepts to multidisciplinary teams and lead collaborative scientific projects delivering data for clinical projects.
Rachael is an experienced statistician specialising in clinical trial design and analysis involving precision medicines and companion-diagnostic drug as well as medical device development.
She has extensive experience of clinical trials in oncology and other therapeutic areas based on sixteen years of working across all phases of drug discovery and development at AstraZeneca. Including, leading the statistical contribution to the design, analysis and interpretation for the accelerated global regulatory authority submissions for cancer precision medicine TAGRISSO (osimertinib).
Glen has extensive experience in developing cancer therapies and precision medicines from previously serving as a Senior Medical Director in Oncology in AstraZeneca to representative roles for several Academic and Regulatory Alliances/’Think Tanks’ including honorary Professor of Translational Medicine in the Department of Oncology at the University of Sheffield.
Glen graduated from the Royal Free Hospital School of Medicine, London, spending 5 years in basic surgical training in the National Health Service. He joined large Pharma in 1997, and has experience in all phases of clinical development within Oncology. Since 2002 he has been involved in translational medicine and has been accountable for the early development of small molecule anti-cancer precision medicines.
Andy has over 13 years experience in the pharmaceutical and biotech industry. His expertise in business development operations allows scouting, evaluating and transacting both in-bound and out-bound strategic options for companies. He has a deep therapy area experience in cardiovascular and metabolism and has experience in developing precision medicine strategies for stem cell, gene therapy, mAb or complex biologics as well as small molecules to enhance market access considerations for these drugs.
Emma’s extensive scientific expertise, communication and project management capabilities enables her to drive forward and deliver workable, robust solutions to support the clinical development and commercialisation of precision medicines.
Having over 15 years experience in the pharmaceutical industry, Emma has supported many precision medicine projects (such as Iressa) at all stages of development. This includes assay development and implementation for AstraZeneca’s clinical studies, as well as diagnostic partner management (CROs and Diagnostic companies) for diagnostic assay development. Emma is process driven ensuring robust practices are in place to ensure high quality, reliable clinical biomarker data is produced.
Grace’s extensive scientific experience, project management and working knowledge of quality standards and systems enables her to deliver comprehensive diagnostic support for clinical development of precision medicines and support diagnostic implementation post- launch.
With 15 years experience in AstraZeneca, Grace has supported the diagnostic testing for clinical trials, leading the clinical implementation of a range of diagnostic tests including FISH and tissue based diagnostics at global testing sites in USA, Europe and Asia. This has included training, monitoring and trouble shooting to ensure consistent, high quality results across testing sites resulting in submission ready results to support simultaneous drug and diagnostic approval.
Stephen is a successful serial biotechnology entrepreneur in the precision medicine field. He serves as a Director and CEO of Permaitha Health and is the former CEO of DxS, an innovator in the field of personalised medicine, developing and manufacturing companion diagnostics. DxS was was sold to QIAGEN BV. DxS pioneered the use of molecular diagnostic tests such as KRAS and EGFR mutation analysis to predict the use of novel cancer therapies. In 2009, DxS was acquired by QIAGEN and Stephen became Vice President of Personalised Healthcare, responsible for developing companion diagnostic partnerships with the pharma industry. Prior to his leading role at DxS, Stephen worked for 20 years in various senior positions in the diagnostic divisions of AstraZeneca and ICI.
John is an excellent communicator and influencer with a wealth of experience in drug discovery, drug development and considerable expertise in precision medicine strategies and companion diagnostics delivery, particularly in the oncology setting. His appreciable contribution to the successful LYNPARZA companion diagnostic pre-market approval FDA submission was recently recognised as a recipient of an AstraZeneca’s CEO award for exceptional delivery.
John has over 30 years of scientific and project leadership experience in large pharma and biotech in roles which have include Head of Department for Molecular Virology at Roche, Respiratory and Inflammation Bioscience Director and Head of R&D Genetics at AstraZeneca. In his most recent role as Diagnostic Expert, John developed and led implementation of the precision medicine strategy for early satge clinical studies with a small molecule asset developed by AstraZeneca for the treatment of prostate and breast cancer.
Bob is a regulatory strategist with over 30 years experience in drug development. He has extensive experience across the development continuum from research through commercialisation, leading regulatory projects throughout the product lifecycle. He has led projects in wide range of therapeutic areas through EU centralised and mutual recognition procedures and global development programmes, contributing to the successful development and approval of more than 16 medicines. He has a strong interest in the impact of regulation on the development of precision medicines and global healthcare policy matters.
Bob previously served as VP Global Regulatory Affairs at AstraZeneca with responsibility for Oncology, Infection and Personalised Healthcare. He has held senior leadership roles at Pfizer, Wellcome and Zambon. Bob also serves as the Chief Regulatory Officer at Kinapse and President of TOPRA.
Bob has extensive experience in the field of precision medicines from creating the Global Personalised Healthcare & Biomarkers function in AstraZeneca to serving as the Chief Medical Officer of Oxford Gene Technology.
Bob has played leading roles in the development of significant medicines in the CNS and oncology therapeutic areas, maintaining a special interest in clinical pharmacology, biomarkers and patient segmentation. Robert served as VP & Head, Personalised HealthCare & Biomarkers, VP & Head, Neuroscience Therapeutic Area, Head of Clinical Pharmacology & Experimental Medicine at AstraZeneca. He was also a member of the R&D Leadership Team at AstraZeneca. After retiring from AstraZeneca in 2012, Bob continued his interest in patient stratification and diagnostics, becoming Chief Medical Officer of Oxford Gene Technology.
Gillian capitalises on her precision medicine development expertise to deliver successful diagnostic solutions for deployment in the clinic for a range of disease areas and devise strategies to overcome barriers to testing for companion or complementary diagnostics. With over 25 years of academic, diagnostic and predominantly large pharma experience, having contributed to numerous personalised healthcare programs, including three successfully launched stratified medicines, Gillian is able to see the big strategic picture whilst retaining focus on the important operational detail.
Previous projects include designing and delivering post-launch initiatives to improve the quality of diagnostic testing in support of Iressa, Lynparza and Tagrisso, pre-launch activities, including field force training, to ensure diagnostics are synchronised with medicine approval, and generating diagnostic data in support of numerous phase 2 and 3 clinical studies requiring patient stratification.
Ansar’s extensive expertise in precision medicine development, approval and commercialisation has enabled him to initiate and lead global projects in a wide range of therapeutic areas across R&D and Commercial for both large Pharma and Biotech companies, with particular expertise on launch readiness and optimising uptake of novel medicines alongside companion diagnostics.
Ansar has over 15 years experience working in this field, having supported the development, approval and commercialisation at senior leadership level of 8 medicines including cancer precision medicines Lynparza and Iressa at AstraZeneca, laying the foundations for future precision medicine development and commercialization strategies. Ansar has won marketing awards for diagnostic campaigns he led to drive diagnostic testing for precision medicines in various countries.