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Companion Diagnostics (CDX) Symposium

Evolution of Best Practices and Collaborations

WHEN

December 6-7, 2017

WHERE

New Jersey Hospital Association
Princeton, NJ

Demonstrating the Value of Companion Diagnostics for Precision Biologics and Drugs

Assessing impact on Safety, Efficacy, Outcomes, and Economic Value in Oncology and other Therapeutic Areas

Event Focus
Companion diagnostics and related assays have been used to indicate drug treatments in clinical trials and for marketed products for several years. Long enough that data for CDx-drug pairs can now be compared with treatments used broadly (no CDx) for the same indication. Not only must CDx-drug pairs demonstrate therapeutic utility, business partnerships and alliances (pharma, diagnostics, CRO companies) must realize net financial benefits. In this symposium, examples of the impact of CDx to improve safety, efficacy, outcomes, and economic value will be presented and discussed.

CALL FOR ABSTRACTS FOR SESSION TOPICS

Please send your submitted abstract and abstract title to tfare@planetconnect.com with your full name, job title, organization (e.g., company, university, etc), a short bio, email address, and telephone number.

1. Importance of CDx for Biologics and Small Molecule Drugs – therapeutic and market value

  1. Economic qualification of CDx and precision medicine – Stratification, Safety, Efficacy, Cost-effectiveness, QALYs, etc.
  2. Critical roles of alliance management to ensure value throughout value chain to the clinic
  3. Considerations in using CDx to indicate and differentiate drugs (biologics, small molecules)
    1. Differentiating products in a rapidly growing sector
    2. Assays to determine markers for biologics, small molecule, combination therapies
    3. Assays for markers to differentiate Biologics vs biologics (e.g., Keytruda, Opdivo, Tecentriq)
    4. Liquid biopsies and exosomes as sources for novel biomarkers and diagnostics
    5. Panels of CDx (gene-, mRNA, protein-, metabolite-based, etc.)
    6. CDx role in identifying new indications for currently marketed drugs or drugs in trials
    7. Strategies for long-term vs short-term investments (CDx, complementary Dx, LDTs, and clinical assays)
  4. Challenges of finding novel biomarkers to differentiate emerging products
  5. Differentiating personalized, precision, companion, complementary as terms of the art

2. Technologies to identify markers

  1. Profiling samples using Genomics, Proteomics, Metabolomics, Lipidomics to identify signature panels for CDx indications
  2. NGS to profile and identify candidate signatures
  3. Portfolio of assays and reagents – antibodies, gene profiles, cells
  4. CTCs and related liquid biopsy assays (oncology and others)
  5. Technologies for precision engagement of drugs with targets
  6. Informatics to identify and vet biomarkers for selection in clinical diagnostics
  7. Image IHC and ISH for BMx clinical sample analysis

3. Evolving CDx from animal models: From proof of concept (POC) to generating BMx candidates; drug dosing; and response tracking

  1. How animal models expedite co-development of drug-CDx pairs
  2. Testing and use of CDx in huMouse models and platforms for ImmOnc, Infectious Disease, etc
  3. Choosing and testing with the best animal models to expedite drug-biomarker progress

4. Informatics for analyzing Big Data sets

  1. Deep Learning for Translational and Precision Biologics
    1. Pattern recognition for data trends – response to treatment, potential for new indications in trials
    2. Data visualization tools
    3. Hypothesis generation
  2. Classification, regression, and other methods to identify responders
  3. Achieving statistical significance for rare/ultra-rare and infectious diseases
  4. Text mining from caregivers’ notes (EHRs), patients’ diaries (e-notes)

5. Regulatory

  1. Filing and prosecution
  2. Guidance on CDx, LDTs

Panel (45min to 1 hour)

  1. BD&L (Business Development and Licensing) in Biologics for drug candidates, technologies, and applications
    1. Identifying opportunities, arranging the first meeting, creating trust
    2. Due diligence – homework before the deal
    3. Defining terms and conditions – from draft to final agreement
    4. Strategies and lessons learned to close the deal

Guidelines:

  • You may submit an abstract for more than one talk type: Oral Presentation, Product Theater, Workshop.
  • All contributed abstracts must be submitted through our web site. No faxed, e-mailed, or mailed abstracts will be accepted (exception by permission).
  • All abstracts must be less than 250 words.
  • All abstracts will be acknowledged via e-mail.
  • Please provide the title, an abstract, the list of authors (designate presenter), and a photo and bio for the presenter.
  • State which Topic Area your abstract addresses.
  • Submission deadline is Friday, August 4, 2017.
  • All abstracts will be reviewed by the event committee.
  • Exhibitors whose abstract is approved will be acknowledged as presenters.
  • Presenting authors of contributed abstracts will be notified by August 18, 2017 of the status of the abstract and its session assignment.
  • Presenting authors must register for the symposium by Oct. 15th
  • All talks must be given in-person.
  • Suppliers: There are no fees for presentations or Product Theater Presentations if you have an exhibit booth.
  • There is a fee to hold a workshop.

Submit Your Abstract

Click to submit

Benefits Of Attending & Who Should Attend

 

Attendees will hear speakers address topics covering the following areas:

  • Tools and techniques to validate CDx-drug pairs
  • Examples of business cases as models for future offerings
  • Growth potential of complementary diagnostics
  • Trade-offs between LDTs and CDx pathways
  • Competitive advantages for drugs with a companion assays
  • Strategies for successful partnerships enabling development through marketing
  • Alliance management among pharma, diagnostic, and CRO partners
  • Tactics for drafting and closing deals for CDx-drug pairs

 

 

We welcome researchers in biotechnology organizations ranging from start-up companies to leading-edge suppliers to non-profit institutions. Functions of attendees range from development to post-marketing surveillance with biomarkers (development) and diagnostics (market offerings).

Professionals in biopharma, biotech, academics, government, diagnostics, and CROs are all invited to register:

  • VPs in Translational Medicine and related functions
  • Executive/Senior Directors
  • Laboratory and Technology Directors
  • Project Managers (technical, logistical, and transitioning projects to partners)
  • Technology leaders and researchers (assays, platforms, informatics)
  • Researchers in assays, diagnostics (basic, development, validation, execution)
  • Allied VP, Executive/Senior Directors, Directors, and Associates in licensing and regulatory

 

Committee Members

 

Anka Ehrhardt, BMS

Bonnie Lafleur, HTG

Donald Very, Helomics

Warren Glaab, Merck

 

 

 

Kellie Howard, Covance

John Mudgett, JsM BioScience

John Thompson, BMS

Mark Roberts, Covance

 

 

Matthew J Marton, Merck

Sarah Hersey, Celgene

Sean Ferree, Nanostring

Russell Weiner, Daiichi Sankyo

 

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