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Breakout Discussions in the Exhibit Hall
February 21, 2012
5:20-6:20pm 

 

Concurrent problem solving breakout discussions, open to all attendees, speakers, sponsors, and exhibitors, provide a forum for discussing key issues and meeting potential collaborators. Plan to take part and explore these topics in-depth. Please pick a topic of your choice, find your table and join in.

DIAGNOSTICS CHANNEL 

Drug, Test and Lab
Moderator: Mollie Roth, J.D., COO, Diaceutics  

  • How services are delivered
  • The need for real time reporting
  • Quality control and external quality assurance programs
  • Procedures for standardization
  • Making access to the test seamless and ensuring clear, standardized reporting

Cancer, a Molecular Pathology
Moderator: Harry Glorikian, Scientia Advisors
Has the time come where we can treat cancer for what it is – a molecular disease rather than an anatomic malady?

  • Enabling technologies (e.g., NGS)
  • Key hurdles

 

* Regulators – Following its recent guidance on companion diagnostics, could the FDA approve a molecular indication (e.g., EML4/ALK cancers vs. NSCLC with EML4/ALK)?
* Reimbursers – How should novel diagnostics –or off-label drug use in the interim– be reimbursed?
* Pharma – Can pan-cancer clinical trials be developed?

  • Impact of potential changes in cancer care

 

* On the FDA – How will the organization react?
* On pharma and emerging diagnostics players – How will they build a sustainable business  model?

Clinical Utility: Where Regulatory and Reimbursement Meet
Moderator: Mya Thomae, CEO, Myraqa
Regulations and payer policies are in constant flux, especially with regard to lab-developed tests (LDTs). In this panel, experts from both domains will discuss a strategy that rises to both challenges by emphasizing proof of clinical value.

Outsourcing FDA: Regulated Diagnostic Product Development
Moderator: Gary Madsen, Ph.D., Biotech Resolutions, LLC 

  • Share successes and failures when outsourcing product development (assay development, v&v, clinical trials, etc.)
  • What are areas of unmet need having high potential for outsourcing activities?  Why?
  • What areas are of the most concern when outsourcing?
  • Are there areas that will NEVER be outsourced?
  • Is there a trend toward more or less outsourcing of development activities?  Why?

Translating Novel Biomarker Discoveries to the Clinical Lab
Moderator: David Bourne, Senior Director, Business Development, Luminex Molecular Diagnostics 

  • How will stakeholders deal with the next wave of diagnostic discoveries
  • Selecting a technology and platform, and downstream considerations
  • LDT or IVD kit 
  • Outlook for LDT’s in the next 2 – 3 years

Hire Right the First Time: Interview Techniques That Work
Moderator: Tara Kochis, President, Slone Partners   

  • Learn from recruiting experts
  • Must ask interview questions
  • How to probe and understand a candidate's motivation and why this matters
  • Why do people leave good jobs and how can knowing this help you retain your top talent

Maximizing Results Despite Small Sample Size 
Moderator: David A. Eberhard, M.D., Ph.D., Associate Professor, Comprehensive Cancer Center and Research Associate Professor, Pathology & Lab Medicine, University of North Carolina, Chapel Hill  

From Data to Diagnosis: NGS in the Clinic 
Moderator: Fuad Gwadry, Bioinformatics Consultant  

Adoption of WGS in the Clinic: Hurdles and Potential Solutions 
Moderator: Katherine Tynan, Business Development & Strategic Consulting, Tynan Consulting LLC  

  • Reimbursement
  • Regulatory
  • Physician education
  • Biological understanding
  • Ethics, privacy, and technology

Developments in Diagnostics Enabling Personalized Medicine
Moderator: Harald Kraushaar, Ph.D., Vice President & Head of Business Development, BioSciences, Sony DADC 

  • Genomic testing: LDTs and IVD diagnostics
  • Microarrays vs. whole genome sequencing
  • Is sensitivity a driver for new diagnostics for PM?
  • Unmet needs and upcoming solutions

Integrative Genomics Approaches for Personalized Medicine
Moderator: Ilya Kupershmidt, Co-founder and Vice President of Products, NextBio 

  • Strategic integration of NGS in translational research and the clinic
  • Genomic biomarkers in drug development: optimizing patient stratification in clinical trials
  • When to seq- a cure: clinical indications for targeted or whole genome sequencing

Cancer, a Molecular Pathology
Moderator: Harry Glorikian, Scientia Advisors
Has the time come where we can treat cancer for what it is – a molecular disease rather than an anatomic malady?

  • Enabling technologies (e.g., NGS)
  • Key hurdles
  • Regulators – Following its recent guidance on companion diagnostics, could the FDA approve a molecular indication (e.g., EML4/ALK cancers vs. NSCLC with EML4/ALK)?
  • Reimbursers – How should novel diagnostics –or off-label drug use in the interim– be reimbursed?
  • Pharma – Can pan-cancer clinical trials be developed?
  • Impact of potential changes in cancer care
  • On the FDA – How will the organization react?
  • On pharma and emerging diagnostics players – How will they build a sustainable business model?

Maximizing Results Despite Small Sample Size
Moderator: David A. Eberhard, M.D., Ph.D., Associate Professor, Comprehensive Cancer Center and Research Associate Professor, Pathology & Lab Medicine, University of North Carolina, Chapel Hill 

From Data to Diagnosis: NGS in the Clinic
Moderator: Fuad Gwadry, Bioinformatics Consultant 

Adoption of WGS in the Clinic: Hurdles and Potential Solutions
Moderator: Katherine Tynan, Business Development & Strategic Consulting, Tynan Consulting LLC 

  • Reimbursement
  • Regulatory
  • Physician education
  • Biological understanding
  • Ethics, privacy, and technology

Developments in Diagnostics: Enabling Personalized Medicine
Moderator: Harald Kraushaar, Ph.D., Vice President & Head of Business Development, BioSciences, Sony DADC 

  • Genomic testing: LDTs and IVD diagnostics
  • Microarrays vs. whole genome sequencing
  • Is sensitivity a driver for new diagnostics for PM?
  • Unmet needs and upcoming solutions

Innovative Techniques for Characterization of CTCs
Moderator: John F. Zhong, Ph.D., Assistant Professor, Pathology; Director, Bioinformatics, Gene Therapy Laboratories, University of Southern California School of Medicine 

  • Which cell is a CTC
  • Define CTC with biomarker, DNA mutation or transcriptome
  • Heterogeneity of CTC population
  • Dynamic changes of CTC population for treatment evaluation
  • Challenge of CTC molecular analysis

CTCs: Value for Diagnostics, Therapeutics, and Cancer Personalized Medicine
Moderator: Enal Razvi, Ph.D., Biotechnology Analyst 

  • CTCs in various cancer types, their origin, and role in metastasis
  • CTC isolation and characterization tools & technologies
  • CTCs in cancer personalized medicine: diagnostic and therapeutic optimization
  • Emerging trends and themes in the CTCs marketplace

Characterization of CTCs
Moderator: Yvon E. Cayre, M.D., D.Sci., Professor, Pierre and Marie Curie University; CSO, ScreenCell 

  • Value of enumeration
  • CTCs and tumor initiating cells
  • CTCs and treatment monitoring

“Lost in Translation” – How to Turn Candidate Biomarkers into Validated Diagnostic Tests?
Moderator: Yuling Luo, Ph.D., Founder, President & CEO, Advanced Cell Diagnostics, Inc. 

  • What are the current and new ways to validate biomarkers?
  • What are the main issues in analytical and clinical validation of biomarker assays?
  • What are the issues with various sample sources (e.g. blood, tissue) for biomarker analysis?
  • What is the impact of cellular and tissue context on biomarker analysis and clinical utility?
  • What is the impact of quantitation on biomarker analysis and clinical utility?
  • How simple and robust should a clinical diagnostic test be?

Innovative Techniques for Characterization of CTCs
Moderator: John F. Zhong, Ph.D., Assistant Professor, Pathology; Director, Bioinformatics, Gene Therapy Laboratories, University of Southern California School of Medicine 

  • Which cell is a CTC
  • Define CTC with biomarker, DNA mutation or transcriptome
  • Heterogeneity of CTC population
  • Dynamic changes of CTC population for treatment evaluation
  • Challenge of CTC molecular analysis

CTCs: Value for Diagnostics, Therapeutics, and Cancer Personalized Medicine
Moderator: Enal Razvi, Ph.D., Biotechnology Analyst 

  • CTCs in various cancer types, their origin, and role in metastasis
  • CTC isolation and characterization tools & technologies
  • CTCs in cancer personalized medicine: diagnostic and therapeutic optimization
  • Emerging trends and themes in the CTCs marketplace

Commercializing CTC technologies
Moderator: John A. Viator, Ph.D., Associate Professor, Biological Engineering and Dermatology, University of Missouri 

  • Protecting your technology
  • Licensing your technology from an academic institution
  • Funding your venture

Characterization of CTCs
Moderator: Yvon E. Cayre, M.D., D.Sci., Professor, Pierre and Marie Curie University; CSO, ScreenCell 

  • Value of enumeration
  • CTCs and tumor initiating cells
  • CTCs and treatment monitoring

“Lost in Translation” – How to Turn Candidate Biomarkers into Validated Diagnostic Tests?
Moderator: Yuling Luo, Ph.D., Founder, President & CEO, Advanced Cell Diagnostics, Inc. 

  • What are the current and new ways to validate biomarkers?
  • What are the main issues in analytical and clinical validation of biomarker assays?
  • What are the issues with various sample sources (e.g. blood, tissue) for biomarker analysis?
  • What is the impact of cellular and tissue context on biomarker analysis and clinical utility?
  • What is the impact of quantitation on biomarker analysis and clinical utility?
  • How simple and robust should a clinical diagnostic test be?

Integrative Genomics Approaches for Personalized Medicine
Moderator: Ilya Kupershmidt, Co-founder and Vice President of Products, NextBio 

  • Strategic integration of NGS in translational research and the clinic
  • Genomic biomarkers in drug development: optimizing patient stratification in clinical trials
  • When to seq- a cure: clinical indications for targeted or whole genome sequencing

Integration of Sequencing Technologies to the Clinic
Moderator: Stephen Kingsmore, M.B., Ch.B., BAO, D.Sc., FRCPath, Director, Center for Pediatric Genomic Medicine, Children’s Mercy Hospital 

DTC Genetic Tests for Common Complex Diseases
Moderator: Nazneen Aziz, Ph.D., Director, Molecular Medicine, Transformation Program Office, College of American Pathologists 

Advances in Non Invasive Genetic Testing
Moderator: Charles Cantor, Ph.D., CSO, Sequenom, Inc. 

DRUG DISCOVERY & DEVELOPMENT CHANNEL 

Fragment-Based Screening
Moderator: Daniel A. Erlanson, Ph.D., Carmot Therapeutics, Inc. 

  • What screening techniques are best for finding fragments? How many orthogonal techniques are needed?
  • How much structural information is needed to advance fragments? Can fragments be advanced without knowing the structure of the co-complex?
  • What makes a good fragment – ligand efficiency, structure, novelty, chemical tractability, SAR?
  • At what point in a lead finding campaign should fragment-based lead discovery enter the picture – from the start of a program, or when all else fails?
  • Once fragments are identified, how can they be further elaborated – growing, merging, linking, library design, other?

Property-Based Design
Moderator: Darren McKerrecher, Associate Director, Medicinal Chemistry & Project Leader, Cardiovascular & Gastrointestinal Innovative Medicines Unit, AstraZeneca 

  • What do we mean by property-based design...which properties do we most need to control?
  • At what stage in a drug discovery program is property-based design most effective?
  • Does property-based design reduce attrition, or just identify failures faster?
  • How do we continue to allow ourselves the benefit of serendipity within a property-based design paradigm?
  • What are good examples of successful property-based design?

Allosteric Modulators
Moderator to be Announced 

Kinase Drug Discovery
Moderator: Jean Cui, Ph.D., Associate Research Fellow, Oncology Medicinal Chemistry, Pfizer Global R&D 

  • Considerations for kinase selectivity:  
  • Assays for the evaluation of kinase selectivity 
  • Design principles for kinase selectivity 
  • Successful examples of highly selective kinase drugs 
  • Drug-like properties of kinase inhibitors 
  • Non-ATP competitive kinase inhibitors 

 

The Use of NGS in Cancer Diagnostics – Challenges in Moving from Research into the Clinic
Moderator: Jeffrey M. Otto, Ph.D.,  M.B.A., National Director, Catholic Health Initiative's Center for Translational Research
- Is there demonstrated clinical evidence suggesting an improvement over existing alternatives?
- Who should pay for the test? Payors? Patients? Providers?
- 85% of cancer care is delivered in community hospitals – how to drive adoption when existing molecular diagnostics are under-utilized?
- Is NGS, while a strong research tool, not a viable platform for routine molecular diagnostics?

Use of Retrospective and Prospectively collected samples for the discovery and validation of Biomarkers
Moderator: Rao Mulpuri, Ph.D. M.B.A., Director of Scientific Operations, Catholic Health Initiative's Center for Translational Research
a) Ethical, Privacy and consenting challenges
b) Challenges in using previously collected samples – how to normalize the data for sample quality
c) Clinical and genomic data integration challenges – define best practices

How do you Facilitate Excellence in Translational Research in an Academic Setting?
Moderator: Michael Kalos, Ph.D., Director, Translational and Correlative Studies Laboratory, University of Pennsylvania School of Medicine

How Can We Define the Appropriate Patient Population Early in Drug Discovery?
Moderator: Joerg Heyer, Ph.D., Director, Genetic Models, Translational Research, AVEO Pharmaceuticals

  • Effects of translational medicine on increasing patient population knowledge
  • Informatics approaches
  • Pharmacogenomics, clinical data, and more

Forging New Regulatory Pathways for Delivery of Personalized Medicine
Moderator: Linda Burdette, Ph.D., Director, Drug Regulatory Affairs, F. Hoffmann-La Roche, Inc.
-  Brainstorm new regulatory pathways to facilitate co-development of drug/diagnostics
-  Explore areas where additional FDA guidance is needed for co-development of drug/diagnostics
-  Propose incentives for innovation and risk-based approaches to contemporaneous development of drug/diagnostics

To Randomize or Not to Randomize in Oncology Phase 2 Clinical TrialsModerator: Ionel Mitrica, Ph.D., Director, Clinical Development, Oncology, GlaxoSmithKline
-  Review experience with/bias toward Phase 2 single-arm trials (SATs) vs randomized controlled trials (RCTs) in roundtable participants’ institutions
-  Review some of the pros and cons for SATs vs RCTs, and when one or the other may make more sense
-  Discuss the role of RCTs in early oncology drug development

Genomic Based Approach to Cancer Clinical TrialsModerator: Apostolia-Maria Tsimberidou, M.D., Ph.D., Associate Professor, Department of Investigational Cancer Therapeutics, University of Texas, MD Anderson Cancer Center
-  Optimization of molecular profiling: challenges
-  Development of novel targeted agents
-  Collaboration and exchange of information regarding molecular profiling and treatment selection

Network Pharmacology for Cancer Drug Discovery: Are We There Yet?
Moderator: Asfar S. Azmi, Ph.D., Research Associate, Pathology, Karmanos Cancer Institute, Wayne State University 

It’s Never Too Early to De-Risk Your Lead Compounds!
Moderator:Glenn Short, Ph.D., Director, Discovery Sciences, Zalicus, Inc.
·Cell-based approaches to de-risking potential lead compounds in discovery phase
·Utility of cell-based disease models
·Assay strategies for indication selection, target/mechanism i.d. and triage for potential lead molecules

  

INFORMATICS CHANNEL 

Standardizing External Data
Moderator: Sandor Szalma, Head, External Innovation, Research & Development IT, J&J Pharmaceutical Research & Development, LLC 

  • What is external data? Who needs it anyway?
  • Standards – pre-competitive collaboration or competitive advantage?
  • Who should drive standards development?
  • Best practices for standards development? Large groups or small groups?
  • Adopting standards – what if the “standard” does not cover my use case?
  • The devil is in the detail – or is it?

Translational Informatics
Moderator: Shoibal Datta, Ph.D., Associate Director, R&D Information Technology, Therapeutic Areas & Translational Medicine, Biogen Idec, Inc. 

Informatics for Biologics
Moderator to be Announced 

  

CANCER CHANNEL 

Cancer, a Molecular Pathology
Moderator: Harry Glorikian, Scientia Advisors
Has the time come where we can treat cancer for what it is – a molecular disease rather than an anatomic malady?

  • Enabling technologies (e.g., NGS)
  • Key hurdles
  • Regulators – Following its recent guidance on companion diagnostics, could the FDA approve a molecular indication (e.g., EML4/ALK cancers vs. NSCLC with EML4/ALK)?
  • Reimbursers – How should novel diagnostics –or off-label drug use in the interim– be reimbursed?
  • Pharma – Can pan-cancer clinical trials be developed?
  • Impact of potential changes in cancer care
  • On the FDA – How will the organization react?
  • On pharma and emerging diagnostics players – How will they build a sustainable business model?

Maximizing Results Despite Small Sample Size
Moderator: David A. Eberhard, M.D., Ph.D., Associate Professor, Comprehensive Cancer Center and Research Associate Professor, Pathology & Lab Medicine, University of North Carolina, Chapel Hill 

From Data to Diagnosis: NGS in the Clinic
Moderator: Fuad Gwadry, Bioinformatics Consultant 

Adoption of WGS in the Clinic: Hurdles and Potential Solutions
Moderator: Katherine Tynan, Business Development & Strategic Consulting, Tynan Consulting LLC 

  • Reimbursement
  • Regulatory
  • Physician education
  • Biological understanding
  • Ethics, privacy, and technology

Developments in Diagnostics: Enabling Personalized Medicine
Moderator: Harald Kraushaar, Ph.D., Vice President & Head of Business Development, BioSciences, Sony DADC 

  • Genomic testing: LDTs and IVD diagnostics
  • Microarrays vs. whole genome sequencing
  • Is sensitivity a driver for new diagnostics for PM?
  • Unmet needs and upcoming solutions

Innovative Techniques for Characterization of CTCs
Moderator: John F. Zhong, Ph.D., Assistant Professor, Pathology; Director, Bioinformatics, Gene Therapy Laboratories, University of Southern California School of Medicine 

  • Which cell is a CTC
  • Define CTC with biomarker, DNA mutation or transcriptome
  • Heterogeneity of CTC population
  • Dynamic changes of CTC population for treatment evaluation
  • Challenge of CTC molecular analysis

CTCs: Value for Diagnostics, Therapeutics, and Cancer Personalized Medicine
Moderator: Enal Razvi, Ph.D., Biotechnology Analyst 

  • CTCs in various cancer types, their origin, and role in metastasis
  • CTC isolation and characterization tools & technologies
  • CTCs in cancer personalized medicine: diagnostic and therapeutic optimization
  • Emerging trends and themes in the CTCs marketplace

Characterization of CTCs
Moderator: Yvon E. Cayre, M.D., D.Sci., Professor, Pierre and Marie Curie University; CSO, ScreenCell 

  • Value of enumeration
  • CTCs and tumor initiating cells
  • CTCs and treatment monitoring

“Lost in Translation” – How to Turn Candidate Biomarkers into Validated Diagnostic Tests?
Moderator: Yuling Luo, Ph.D., Founder, President & CEO, Advanced Cell Diagnostics, Inc. 

  • What are the current and new ways to validate biomarkers?
  • What are the main issues in analytical and clinical validation of biomarker assays?
  • What are the issues with various sample sources (e.g. blood, tissue) for biomarker analysis?
  • What is the impact of cellular and tissue context on biomarker analysis and clinical utility?
  • What is the impact of quantitation on biomarker analysis and clinical utility?
  • How simple and robust should a clinical diagnostic test be?

Innovative Techniques for Characterization of CTCs
Moderator: John F. Zhong, Ph.D., Assistant Professor, Pathology; Director, Bioinformatics, Gene Therapy Laboratories, University of Southern California School of Medicine 

  • Which cell is a CTC
  • Define CTC with biomarker, DNA mutation or transcriptome
  • Heterogeneity of CTC population
  • Dynamic changes of CTC population for treatment evaluation
  • Challenge of CTC molecular analysis

CTCs: Value for Diagnostics, Therapeutics, and Cancer Personalized Medicine
Moderator: Enal Razvi, Ph.D., Biotechnology Analyst 

  • CTCs in various cancer types, their origin, and role in metastasis
  • CTC isolation and characterization tools & technologies
  • CTCs in cancer personalized medicine: diagnostic and therapeutic optimization
  • Emerging trends and themes in the CTCs marketplace

Commercializing CTC technologies
Moderator: John A. Viator, Ph.D., Associate Professor, Biological Engineering and Dermatology, University of Missouri 

  • Protecting your technology
  • Licensing your technology from an academic institution
  • Funding your venture

Characterization of CTCs
Moderator: Yvon E. Cayre, M.D., D.Sci., Professor, Pierre and Marie Curie University; CSO, ScreenCell 

  • Value of enumeration
  • CTCs and tumor initiating cells
  • CTCs and treatment monitoring

“Lost in Translation” – How to Turn Candidate Biomarkers into Validated Diagnostic Tests?
Moderator: Yuling Luo, Ph.D., Founder, President & CEO, Advanced Cell Diagnostics, Inc. 

  • What are the current and new ways to validate biomarkers?
  • What are the main issues in analytical and clinical validation of biomarker assays?
  • What are the issues with various sample sources (e.g. blood, tissue) for biomarker analysis?
  • What is the impact of cellular and tissue context on biomarker analysis and clinical utility?
  • What is the impact of quantitation on biomarker analysis and clinical utility?
  • How simple and robust should a clinical diagnostic test be?

Forging New Regulatory Pathways for Delivery of Personalized Medicine
Moderator: Linda Burdette, Ph.D., Director, Drug Regulatory Affairs, F. Hoffmann-La Roche, Inc.
-  Brainstorm new regulatory pathways to facilitate co-development of drug/diagnostics
-  Explore areas where additional FDA guidance is needed for co-development of drug/diagnostics
-  Propose incentives for innovation and risk-based approaches to contemporaneous development of drug/diagnostics

To Randomize or Not to Randomize in Oncology Phase 2 Clinical TrialsModerator: Ionel Mitrica, Ph.D., Director, Clinical Development, Oncology, GlaxoSmithKline
-  Review experience with/bias toward Phase 2 single-arm trials (SATs) vs randomized controlled trials (RCTs) in roundtable participants’ institutions
-  Review some of the pros and cons for SATs vs RCTs, and when one or the other may make more sense
-  Discuss the role of RCTs in early oncology drug development

Genomic Based Approach to Cancer Clinical TrialsModerator: Apostolia-Maria Tsimberidou, M.D., Ph.D., Associate Professor, Department of Investigational Cancer Therapeutics, University of Texas, MD Anderson Cancer Center
-  Optimization of molecular profiling: challenges
-  Development of novel targeted agents
-  Collaboration and exchange of information regarding molecular profiling and treatment selection

Developing Antibody Drug Conjugates
Moderator: Puja Sapra, Ph.D., Director, Bioconjugates, Oncology Research Unit, Pfizer Biotherapeutics 

  • Novel approaches to find targets
  • Novel payloads beyond tubulin inhibitors and DNA binders
  • Site specific conjugation approaches: Hope or hype
  • Precision medicine for ADCs: biomarker assays (IHCs, imaging, CTCs etc)
  • Investment in translational biology: from preclinical to clinic
  • Beyond whole antibody-drug conjugates: smaller fragments, other approaches

Technological Challenges with Antibody Drug Conjugates
Moderator: Ho Sung Cho, Ph.D., Chief Technical Officer, Ambrx 

  • Determining the best combination of warhead and target
  • Selection of right linker technology for the product
  • Ensuring uptake, internalization and activation of the product
  • Ensuring specificity to tumor cells and not normal ones
  • In vitro studies and in animal models
    • Selection of good predictive biomarkers
    • Challenges with optimizing performance
    • Challenges with toxicity
  • Challenges with characterization (heterogeneous) and comparability

Measures to Improve ADC Linkers
Moderator: Bob Lutz, Ph.D., VP, Translational R&D, ImmunoGen, Inc. 

  • Development of payload and linker technology
  • Is linker stability the property of importance?
  • Impact of linker on the safety profile of the ADC

Challenges of Targeting Cancer Stem Cells
Moderator: Norman J. Maitland, Ph.D., Chief Scientific Officer, Procure Therapeutics Ltd 

  • How cancer stem cells differ from normal stem cells and other cancer cells
  • Approaches to the identification and evaluation of new cancer stem cell targets
  • Payloads that overcome the enhanced resistance of cancer stem cells
  • Issues to do with selection of animal model
  • Concerns to do with delivery and clearance
  • Potential safety issues
  • Strategy for entering clinical trials
  • Demonstration clinical benefit

Finding the right targets
Moderator: Patrick A. Baeuerle, Ph.D., CSO, Senior Vice President, R&D, Micromet, Inc. 

  • Targets for dual ligand or receptor blockers
  • How to select target combinations
  • Targets for T- or NK cell-engaging antibodies
  • How to achieve a therapeutic window

Pre-clinical Assessment for Prediction of Clinical Success for Cancer Biologics
Moderator: Gary Starling, Ph.D., Director, GPRD Discovery, Oncology Biologics, Abbott Biotherapeutics Corp. 

  • Development of pre-clinical models to reflect the human tumour
  • Pre-clinical parameters that are translatable from animals to humans
  • Decision making based on pre-clinical safety and efficacy studies
  • Using PD biomarkers to determine dose
  • New tools to help translational research.
  • Phase one safety and tolerability
  • Regulatory Concerns