Immuno-Oncology Xchange EAST COAST 2018

Immuno-Oncology

Time

Titles and Bullets

Facilitator

9:00am – 10:00am

Developing predictive biomarkers for immunotherapies to identify mechanisms of resistance

Clinically relevant model systems assays to predict biomarkers of resistance and activity
Patient selection biomarkers and stratification to enhance clinical benefit
Understanding failure of response to PD1 treatment to enable viable combinations

Roopa Srinivasan

Senior Director, Head of Translational Research, Immuno-Oncology R&D
GlaxoSmithKline

10:30am – 11:30am

Can proteomics enable immuno-oncology biomarker discovery?

The use of Thermal Proteome Profiling to map cellular pathways
Direct and indirect target engagement quantification
Predictive biomarker identification and validation.

Michael Dabrowski

Chief Executive Officer
Pelago Bioscience

12:00pm – 1:00pm

Bridging the knowledge gap between real-world adaptation of I-O treatments and reliable biomarkers to ensure safe and effective use of this therapy class

Potential value of biomarkers for different purposes in I-O
Proper identification and qualification of biomarkers in I-O
Where is the gap, using PD-L1 as an example, and how can it be filled?

Abdel Halim

Vice President, Translational Medicine, Biomarkers & Diagnostics
Celldex Therapeutics

3:15pm – 4:15pm

Identifying and validating predictive biomarkers for combined immunotherapy and targeted therapy

How do targeted proteomic biomarkers of treatment efficacy tell us what genetics alone cannot?
How can we develop fast high-specificity diagnostic assays for protein drug targets?
How can we use multiplexed pathway-driven proteomics and metabolomics panels to identify treatment targets and mechanisms of resistance?
How does reproducible protein quantitation, with isoform and phosphorylation information, help avoid validation pitfalls?
How do we gain insight by going beyond cytokine levels?

Christoph Borchers

Chief Scientific Officer,
MRM Proteomics

4:20pm – 5:20pm

Challenges and opportunities for pharmacodynamic biomarkers in IO to help inform clinical dosing decisions

How to tackle a 10x problem – identifying biomarkers for response
Microbiome Yes / No, when and how
Tumor-based markers: TILs, mutational load, T-cell repertoire
Biomarkers for toxicity?
Interaction tumor and microenvironment

Stefan Scherer

Vice President, Head Early Development, Strategy & Innovation,
Novartis

Translational research

Time

Titles and Bullets

Facilitator

9:00am – 10:00am

How to select right translational models to quantitatively monitor and characterize IO therapeutic agents

Is there a biased focus toward the improvement of patient selection schemes and is this helping or impeding our progress?
No model is perfect: How do we apply “fit-for-purpose” validation of current models to immunotherapy drug development?
Emerging immune biomarker technologies and the vision for quantification (from high throughput genomics to immune monitoring cytometry).

Maria Karasarides

Executive Director, Immuno-Oncology
Regeneron Pharmaceuticals

12:00pm – 1:00pm

What are the differentiators between the various Antibody platforms?

Why do antibodies from animals dominate the commercial and clinical pipelines?
What drives the selection of an antibody technology?

Bjorn Hock

Vice President
Biologics Technologies & Development
Ferring

10:30am – 11:30am

Technology for effective translational research

Mechanism of action/proof of biology
Modeling clinical response (efficacy)
Deficiencies/strengths in existing models

Mark Paris

Associate Director, Translational Applications
Mitra Biotech

12:00pm – 1:00pm

Evaluating the efficacy of human PD-1 targeting antibodies in humanised mouse models

Which subsets of immune cells provide the best indicator of the mechanism of action in these model systems?
How closely do the cell populations actually reflect and correlate to human immune cells?
What do the next generation of mouse models look like?
Which new IO targets are the leading candidates for development and validation by these models?
How does the FDA and other regulatory agencies view the mouse model as part of a pre-clinical data package?

William Hearl

President & Chief Executive Officer
Immunomic Therapeutics

4:20pm – 5:20pm

How to better predict anti-tumor efficacy and toxicity associated with immune cells genetically engineered with CARs and TCRs

Are in vitro assays predictive of CAR/TCR efficacy and toxicity in patients?
Are animal models useful in understanding CAR/TCR efficacy and toxicity?
If in vitro and animal models are not predictive of T cell efficacy and safety, how does the field choose clinical candidates for their trials?

Ildiko Csiki

Vice President, Clinical Development, Immuno-Oncology
Inovio Pharmaceuticals

Clinical trials

Time

Titles and Bullets

Facilitator

9:00am – 10:00am

Developing new clinical endpoints for immuno-oncology studies

How has our thinking of the mechanism of action of immune agents changed our thinking of clinical endpoints in general?
What does the tail of the survival curves (PFS and OS) how we should define “clinical benefit?”
What is the optimal study design with which to define a maximally tolerated or biologically effective dose?
How can we leverage predictive biomarkers into our studies now?

Jeffrey Skolnik

Vice President Clinical Development
Inovio Pharmaceuticals

10:30am – 11:30am

Using predictive analytics to accelerate the success of your clinical operations

Why have true leading indicators of clinical trial performance not been routinely captured?
How can you use predictive analytics to better select and manage clinical service vendors?
What can you do to Increase investor, investigator, and internal confidence in your ability to meet deadlines and budgets?
Where can you make changes that advance your ability to recruit and retain patients.
Why is creating a data-driven clinical operations culture important, why you don’t have one, and how can you get one?

Peter Malamis

Chief Executive Officer
CRO Analytics

12:00pm – 1:00pm

Highly complex early-phase studies with adaptive designs and multi-arm trials requires flexibility

What are the appropriate statistical designs for early phase IO phase 1 studies?
What are appropriate expansion rules and when should biopsies be mandated?
What should change when combinations are to be tested rather than monotherapy?
How do we advance IO agents in checkpoint-naive patients?

Teng Jin Ong

Vice President, Medical Affairs
Celgene

3:15pm – 4:15pm

Determining patient selection and eligibility

How can patient ineligibility rate be reduced by modification of entry criteria (prior IO therapy exposure, need for pathology samples, biomarker criteria)
What can be done to make it easier for patients to participate (financial burden, lifestyle impact)?
How to overcome physician nihilism (perceived barriers to study site referral, lack of trial knowledge)

Harish Dave

Chief Medical Officer
Accelovance Inc.

4:20pm – 5:20pm

Can OS still be measured given crossovers in trials? What measures best represent OS?

What role will PFS continue to play?
Some CPIs have been conditionally approved based on ORR: can a similar strategy also be pursued in an earlier setting?
Is there a need to validate some surrogate endpoints for OS to continue the development of immuno-oncology agents? What would be the most effective approach to do so? Would it still require to be indication specific?

Cristian Massachesi

Cristian Massachesi
Vice President Asset Team Leader,
Immuno-Oncology

Immunotherapies

Time

Titles and Bullets

Facilitator

9:00am – 10:00am

Where do cancer vaccines fit in the current landscape of immunotherapies? How to move them from “promising” to “effective”?

Overcoming the challenges posed by immune evasion
How to ensure continuous improvement in the algorithms for neoantigen vaccines?
Can posttranslational modifications be used as a vaccine target
Best approaches to identifying pharmacodynamics (PD) biomarkers to assess response
How to best determine when and what combination therapy is best to administer along with the vaccine

Cori Gorman

Vice President Precision Medicine & Manufacturing
Agenus Bio

12:00pm – 1:00pm

Developing CAR-T technologies to overcome immune evading mechanisms of tumours

What are the key tumor suppressive mechanisms that prevent CAR-T cell activity (e.g. immune checkpoints, cytokines, metabolism)?
How to design CAR T cells to resist the TME?
How to enhance CAR T cell activity and engage the host anti-tumor immune response?
How can CAR T cells be used to solve the problem of tumor heterogeneity?
What are the potential challenges with these approaches?

Charles Sentman

Professor, Microbiology & Immunology
Dartmouth Medical School

4:20pm – 5:20pm

Addressing optimal timing and sequencing of immune checkpoint inhibition

Does tumor burden impact response to immune checkpoint inhibitors (ICI)?
Does the timing of radiation therapy relative to ICI matter? Chemotherapy?
Will NeoAdj ICI improve outcomes in resectables tumors compared to adjuvant only?
What is the optimal duration of ICI for stage 4, stage 3 unresectable and in the adjuvant setting?

Kevin Horgan

Vice President, Global Medicine Leader – Immuno-Oncology
AstraZeneca

Combination Therapies

Time

Titles and Bullets

Facilitator

9:00am – 10:00am

Next generation I-O combinations for cancer

Is there a preferred agent capable of converting non-inflamed tumors into inflamed ones to synergize the activity of PD-1/ PD-L1 inhibtion?
How much preclinical evaluation is needed for new IO-combos?
How do we optimize trial design to evaluate optimal dose and schedule for combination agents, which may differ across distinct indications?
Are we ready to test triple I-O combinations?
What is the next I-O backbone agent to be tested beyond PD-1/PD-L1 blockade?

Andres Guiterrez

Chief Medical Officer
Oncolytics Biotech

10:30am – 11:30am

Implementing strategies to tackle resistance to anti-PD-1/PD-L1 therapies

Combination approaches to overcome primary resistance to PD-1/PD-L1
Combination approaches to address acquired resistance to PD-1/PD-L1
How should we define acquired resistance to PD-1/PD-L1?
Should PD-1/PD-L1 therapies be part of the combination regimen in the acquired resistance setting?

Patrick Mayes

Executive Director, Head of Immuno-Oncology Antibody Research
Incyte Corporation

12:00pm – 1:00pm

How to prioritise which combinations to use during development

As pre-clinical models in immune-oncology are poorly predictive of efficacy, what other measures should be used to determine appropriate combinations to develop?
How important is the regulatory requirement to demonstrate the contribution of each component in a combination?
Are data with combinations translatable across agents of the same class?
How will one combination be measured against another if not directly compared?

Harry Raftopoulos

Vice President, Translational Medicine – Immuno-Oncology
Bayer

3:15pm – 4:15pm

Rational design of combination approaches

Differential response versus amplification
Patient stratification and or biomarker ID (molecular, preclinical modelling)
Selecting/identifying complementary biology
Methods for predicting response ahead of clinical testing

Mark Paris

Associate Director, Translational Applications Mitra Biotech

4:20pm – 5:20pm

Strategies to optimize combination therapy

Triple combination approaches
Prevention of IR-AEs in PD1 /CTLA4 inhibitor combination
Prevention of IR-AEs and CIN in PD1/chemotherapy combination
Oral IO agents with shorter half lives to better manage IR-AEs

Ramon Mohanlal

Executive Vice President, Chief Medical Officer
BeyondSpring Pharmaceuticals

Immuno-Oncology Xchange EAST COAST 2018

Immuno-Oncology

Translational research

Clinical trials

Immunotherapies

Combination Therapies

Partners

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