- All abstracts will be acknowledged via e-mail, submission deadline is Friday, July 31st
- Presenting authors of contributed abstracts will be notified by August 14th of the status of the abstract and its session assignment.
- Presenting authors will receive a Free Attendee Pass – they should register for the symposium by October 15th
- You may submit an abstract for more than one talk type: Oral Presentation or Workshop.
- All abstracts must be less than 350 words.
- 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.
- All abstracts will be reviewed by the event committee.
- Exhibitors whose abstract is approved will be acknowledged as presenters.
- All talks must be given in-person.
- Suppliers: There are no fees for presentations if you have an exhibit booth.
- There is a fee to hold a workshop.
1. Importance of CDx for Biologics and Small Molecule Drugs – therapeutic and market value
- Economic qualification of CDx and precision medicine – Stratification, Safety, Efficacy, Cost-effectiveness, QALYs, etc.
- Critical roles of alliance management to ensure value throughout value chain to the clinic
- Considerations in using CDx to indicate and differentiate drugs (biologics, small molecules)
- Differentiating products in a rapidly growing sector
- Assays to determine markers for biologics, small molecule, combination therapies
- Assays for markers to differentiate Biologics vs biologics (e.g., Keytruda, Opdivo, Tecentriq)
- Liquid biopsies and exosomes as sources for novel biomarkers and diagnostics
- Panels of CDx (gene-, mRNA, protein-, metabolite-based, etc.)
- CDx role in identifying new indications for currently marketed drugs or drugs in trials
- Strategies for long-term vs short-term investments (CDx, complementary Dx, LDTs, and clinical assays)
- Challenges of finding novel biomarkers to differentiate emerging products
- Differentiating personalized, precision, companion, complementary as terms of the art
2. Technologies to identify markers
- Profiling samples using Genomics, Proteomics, Metabolomics, Lipidomics to identify signature panels for CDx indications
- NGS to profile and identify candidate signatures
- Portfolio of assays and reagents – antibodies, gene profiles, cells
- CTCs and related liquid biopsy assays (oncology and others)
- Technologies for precision engagement of drugs with targets
- Informatics to identify and vet biomarkers for selection in clinical diagnostics
- 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
- How animal models expedite co-development of drug-CDx pairs
- Testing and use of CDx in huMouse models and platforms for ImmOnc, Infectious Disease, etc
- Choosing and testing with the best animal models to expedite drug-biomarker progress
4. Informatics for analyzing Big Data sets
- Deep Learning for Translational and Precision Biologics
- Pattern recognition for data trends – response to treatment, potential for new indications in trials
- Data visualization tools
- Hypothesis generation
- Classification, regression, and other methods to identify responders
- Achieving statistical significance for rare/ultra-rare and infectious diseases
- Text mining from caregivers’ notes (EHRs), patients’ diaries (e-notes)
- Filing and prosecution
- Guidance on CDx, LDTs
There is also a Panel discussion that is available; panel time is 45 minutes to 1 hour:
BD&L (Business Development and Licensing) in Biologics for drug candidates, technologies, and applications
- Identifying opportunities, arranging the first meeting, creating trust
- Due diligence – homework before the deal
- Defining terms and conditions – from draft to final agreement
- Strategies and lessons learned to close the deal