POSTPONED 

7:30 am Registration & Networking Breakfast

8:20 am Chair’s Opening Remarks

Showcasing the Future of Precision Medicine: Cutting-Edge Advances Across Biomarkers & CDx

8:30 am Clinical Biomarker Strategy With a Complex Immunomodulator: The Must-Haves & the Nice-To-Haves On a Limited Budget

  • Thomas Kleen Chief Scientific Officer, Immodulon Therapeutics

Synopsis

  • Identification and validation of circulatory immunological biomarkers in cancer patients remains a major challenge during clinical trials and assessment of
    therapeutic responses
  • Novel technologies and classic immunological biomarkers each offer benefits and challenges that should be evaluated before their use
  •  A sample clinical biomarker strategy for IMM-101 a multitargeted immunomodulator of the innate and adaptive immune system will be presented

9:00 am Lauching a Companion Diagnostic: Research & Development Through Commercialization

Synopsis

  • Evaluating the key considerations for being day one ready – a focus on PD-L1
  • PIK3CA cast study – discussing the full spectrum of CDx development from bench to bedside
  •  Perspectives on lessons learned and future paradigms for diagnostic development

9:30 am Details shortly confirming

10:00 am Delivering Successful Companion Diagnostics Programs: A Large Global Central Laboratory’s Experience

  • Alan Wookey Global Head, Companion Diagnostics, Q2 Solutions

Synopsis

  • Describing some of the trends in the data to support companion diagnostic submissions and approval, seen by a Central Laboratory, that is supporting over 100 CDx clinical trials
  • Other approaches required to maximize the potential of predictive biomarker assays, given the small number of CDx approvals since the first 20 years ago
  • Trends and best practice will be described on how CDx assays are supporting clinical development in China

10:30 am Panel Discussion: Women in Precision Medicine

  • Corinne Dannan Executive Vice President, Pharma BU, Board Member, HalioDx
  • Joanne Hackett Chief Commercial Officer, Genomics England
  • Kathryn Becker Head, Global Scientific Affairs, Innovation & Companion Diagnostics, Abbott Molecular

Synopsis

With a shortage of female representation in senior healthcare positions, this discussion is designed to engage, inform and connect the community on how we can advance female career progression. Get involved in this session and help create inclusive working environments to recognize and champion the achievements of all.

11:15 am Speed Networking & Morning Refreshments

Optimizing Preclinical Trials to Inform Clinical Development

Enhancing Business Models, Collaborations & Partnerships

11.45 Utilising Innovation for Early Detection of Scleroderma

  • Involving patients in creating new diagnostics
  • Digital innovation and collaboration to develop early detection tools
  • Collaboration across industry for common goals in diagnostics and early detection

Fatima Sulaiman, Head, Research & Services,
Scleroderma & Raynaud’s UK

11.45 A Large Pharma Perspective: Sourcing & Collaborating with Dx to Maximize Global Footprint

  • Developing international partnerships from the EU to Japan for suitable diagnostics for novel therapeutics
  • An overview on the impact of IVDR on drug-Dx codevelopment and maintaining regulatory compliance
  • Ensuring maximal clinical uptake and commercialisation

Pierre Lao-Sirieix, Associate Director & Diagnostic Expert, AstraZeneca

12.15 Understanding Disease Mechanisms & Response Outcomes Through Biomarker Analyses: A Case Study in NSCLC & Treatment With Pembrolizumab

  •  Uncovering biomarker selection to better predict responders and non-responders
  •  Disease mechanisms and response pathways based on biomarker analyses in context of monotherapy and combination treatment options
  • Tying it all together: How these findings inform future drug development and trial design

Ellie Corigliano, Global Director Medical Affairs, Oncology, Thoracic & Pan Tumor Biomarkers & Diagnostics, Oncology Global Medical Affairs, Merck & Co

12.15 Clinical Trial Assay & CDx Development in the Era of Precision Medicine: Planning for Success

  • Regulatory considerations for assay development, validation & commercialisation
  • Choosing the right diagnostic partner: Experience, ability to deliver, transparency & trust
  • Biomarker led Clinical Trial Assay & Companion Diagnostic development & validation challenges
  • Case Study showcasing a recent Almac Biomarker Programme with a large Global Pharma partner

Jude O’Donnell, Head, Regulatory Strategy, Almac Diagnostic Services

12:45 pm Networking Lunch

Maximizing Clinical Outcomes with Next Generation Technology

Enhancing Business Models, Collaborations & Partnerships

1.45 Accelerating Precision Oncology Therapeutic Development

  • To accelerate therapeutic development every patient in a health system should have a genomic test
  •  Each patient should have the novel treatment options accompanied with robust clinical data so we learn from every patient
  • We need to share data globally to gain knowledge

Andrew Biankin, Director GPOL, ICGC & Precision-Panc, Regius Professor of Surgery, University of Glasgow

1.45 How Can Academia & Industry Play Better Together?: Improving the Pathway From Biomarker Discovery to Commercialisation

  •  Less than 1% of biomarkers end up being clinically adopted
  •  Our research suggests many fail due to the way the early research is carried out
  • There are ways we can improve how Academia and Industry work together to improve the field and maximise the chances of Biomarker success

Christopher Peters, Clinical Senior Lecturer & Consultant
Upper GI Surgeon, Imperial College London

2:15 Multiplex Biomarker Strategies That Drive Successful Drug Development Programmes

  •  Current challenges faced by CDx programs and the potential benefits of multiplex-based technologies
  • New high throughput whole slide multiplex platform designed to support clinical implementations and the demands of aggressive CDx programs
  •  Identifying complex phenotypes within the tumor microenvironment through the colocalization of multiple markers on individual cell compartments

Katir Patel, Associate Director, Biomarker Strategy & Applications, Ultivue

2:15 Uniting Against Diseases: Technology Powered Partnerships to Accelerate Precision Health

  • Building partnerships and modular solutions is our way to respond to constant biomarker innovative change
  • What kind of partnerships is Illumina forging and why
  • How we see the future and where/when you can count on us

Coralie Mansukoski, Programme Manager, EMEA Pharma Development, Illumina

2.45 Utilizing Liquid Biopsies in Cancer Immunotherapy Clinical Trials

  • Background to Achilles Therapeutics and Adoptive Cell Therapy Outlining the scope of the Translational Science Programme
  • How and why we are using different liquid biopsies within our Programme

Michael Epstein, Team Leader, Translational Science, Achilles Therapeutics

2.35 Interactive Session: Maximising Market Access With Effective Internal Strategies

This is your chance to have a discussion on your lessons learned, discuss how you will implement changes moving forward and maybe even identify a new prospective partnership ahead of the coffee break!

Key topics to be discussed:

  • Streamlining biomarker-CDx co development with effective Rx-Dx partnerships
  • How can we reduce turnaround time from development to market?
  • Deploying effective sales teams for particular geographical markets

Revolutionising the Standard of Care for Complex & Rare Diseases

3:15 pm Afternoon Refreshments

3:45 pm Precision Medicine Outside Oncology: Where Are We Now & Where Are We Going?

  • Rob Hastings Precision Medicine Portfolio Lead, Cardiovascular, Renal & Metabolism, AstraZeneca

Synopsis

  • The current position of precision medicine within pharma development. Describing different approaches to patient selection and trial design with internal and external examples. Highlight examples of where companion diagnostics are being developed as a classical precision medicine approach
  • Diagnostics to support clinical trials and non-precision medicines as a path to increasing knowledge and interest internally
  • What can we learn from oncology and what is different. Companion diagnostics as important outside oncology but complementary/conduit diagnostics more so. Stronger focus on point of care
  • The scale of the task to align and engage stakeholders (patients, clinicians, labs, payers in particular). A collaborative approach is needed and we need to act now

4:15 pm Translatable Biomarkers in Gene Therapy for Huntington Disease: Innovative Approaches & Learnings from Pre-Clinic to the Clinic

Synopsis

  • Many challenges are associated to finding adequate efficacy/response biomarkers in neurodegenerative disorders
  •  Novel approaches can be tested in adequate models of disease, and in the case of gene therapies, biomarkers may need to be tailored
  • Candidate biomarkers to follow-up efficacy of a gene therapy for Huntington Disease will be addressed, highlighting the experience learnt from preclinical models, ranging from biofluid biomarkers to imaging modalities

4:45 pm Panel Discussion: Precision Medicine Beyond Oncology

Synopsis

  • What lessons can be learned from oncology to accelerate complex and rare disease drug development?
  • What strategies exist to overcome challenges associated with small population groups?
  •  How are diagnostics currently being applied in non-oncology disease indications?

5:30 pm Chair’s Closing Remarks

5:35 pm End of Day 1