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Molecular Medicine Tri-conference Break-Out Sessions
Wednesday, February 25
5:00 – 6:00pm
In the Exhibit Hall

The concurrent roundtable discussions open to all attendees, sponsors, exhibitors, and speakers provide a forum for discussing key issues and meeting potential partners. This unique opportunity brings together attendees from all tracks. Plan to take part and be able to explore the topics in- depth.

Please pick a topic of your choice and sign up on the message board next to the registration desk by Wednesday at 1:00pm. Then at 5:00 find your table in the exhibit hall and join in.

TRACK 1: MOLECULAR DIAGNOSTICS

Overcoming Integration Hurdles for Rapid Testing
Moderator: Katherine Tynan, Consultant

  • Intellectual Property and freedom to operate challenges

  • Simplification of delivery

  • Integration of sample prep with amplification and detection, and other platforms

  • Identifying applications for decentralized, “simplified” tests

Value-Based Pricing for Molecular Diagnostics
Moderator: Michael Stocum, MS, Managing Director, Personalized Medicine Partners, LLC 

  • Optimizing therapeutic and molecular diagnostic combinations to improve outcomes

  • Evaluating where novel diagnostics may better inform treatment decisions

  • Demonstrating higher efficacy and/or lower risk of side effects of therapeutic regimens

  • Investigating current standard of care and where inefficiencies exist in healthcare delivery

  • Generating and utilizing clinical data to inform pricing and reimbursement decisions 

Preventative Genomic Medicine
Moderator: Vance Vanier, M.D., Chief Medical Officer, Navigenics and Partner, Mohr Davidow Ventures

  • The promise and current state of preventive genomic medicine

  • Physician and patient interest

  • Clinical data published and forthcoming

  • Policy, educational, regulatory, and legal issues

Biomarker Partnerships in Companion Diagnostics 
Moderator: Brian T. Edmonds, Ph.D., Principal Investigator, Integrative Biology/ Global External Research & Development, Lilly Corporate Center 

  • Role of partners in biomarker assay development 

  • How are deals structured? Who should you partner with? 

  • Process of commercializing assays different from commercializing drugs 

  • Use of companion diagnostics in drug differentiation, dose setting and safety profile

Advanced Screening Protocols for Early Detection of Lung Cancer
Moderator: Paul Billings, M.D., Ph.D., President and Chief Executive Officer, CELLective Dx Corporation

  • What is status of early detection technology?

  • What is the evidence that early detection can improve patient care? Ovarian and lung, get cancer below certain size, it will be curable

  • How well does early detection alter the system? False positive, primary cancer who is providing data and care? How will they adapt to large # of patients?

  • Modalities for work up for clinical group: Initial screen, initial diagnosis

Use of Biomarkers to Make Go / No-go Decisions – Are We Ready?
Moderator: Edward A. Smith, Ph.D., President & Chief Executive Officer, Predictive Biomarker Sciences Inc

  • How pharmaceutical companies utilize biomarker information on internal decision making for drug development programs

  • Validity of the biomarker

  • Tolerance of risk 

  • How biomarker data should be interpreted and used

TRACK 2: MASTERING MEDICINAL CHEMISTRY

Outsourcing Strategies
Moderator: Alex Kiselyov, Ph.D., President of Chemistry, deCODE Chemistry

  • Choosing successful partnerships

  • Choosing geographies

  • How much, how little

  • Communication

  • ROI

Fragment Based Screening 
Moderator: Noeris Salam, Ph.D., Application Scientist, Schrodinger Inc.

  • FBDD as a platform for medicinal chemistry 

  • FBDD inspired fresh approaches in lead generation (small, soluble)

  • Optimization of fragment hits

  • Facing the challenge of applying FBDD when structural information is not available

Blood-Brain Barrier
Moderator: Douglas K. Spracklin, Ph.D., Director, Biotransformation & Enzymology, Pfizer Inc.

  • Experimental approaches (in vitro/in vivo) available for screening for brain penetration

  • The application of in vivo models used to study the BBB

TRACK 3: STEM CELLS CONGRESS

Menstrual Stem Cells – A Novel Source of Cells
Moderator: Julie Allickson, Ph.D., Vice President Laboratory Operations, R&D, Cryo-Cell International, Inc.

  • Introduction on the menstrual stem cell 

  • Cell procurement methods and cell processing

  • Cell characteristics including cell phenotype (adult and embryonic cell surface markers)

  • Cell Culture proliferative capacity including doubling time

  • Cell longevity demonstrated by cell passages in culture and telomerase activity

  • Safety Studies

  • Cell capability for differentiation

  • Pre-clinical studies

Cell Therapies: Preparing the Case for Reimbursability 
Moderator: Lee Buckler, B.E.d, LLB, Principal, Cell Therapy Group 

  • How do insurers view cell therapies now? 

  • What must cell therapy companies do now to position their therapies for reimbursement when they hit the market?

The Epigenetic Landscape of Human Embryonic Stem Cells
Moderator: Mark Levenstein, Ph.D., CDI Bioscience
The unique status of hESC, their ability to self-renew indefinitely and to develop into any cell type in the body, drives their promotion as a therapeutic Rosetta Stone. This informal discussion will go beyond the morphological and genetic characteristics of pluripotent cells and focus on their epigenetic state. Discussion topics include:

  • Chromatin modifications

  • DNA methylation

  • small RNAs

  • imprinting 

  • How epigenetic analyses can aid in the characterization of reprogrammed (iPS) cells

TRACK 5: PRECLINICAL DRUG SAFETY

Accelerating Technology Adoption in Preclinical Drug Safety
Moderator: Jack Reynolds, DVM, Chairman of the Advisory Board, The Drug Safety Executive Council 

  • How much does the 'Not Invented Here' mentality inhibit new technology assessment/implementation in your organization?

  • What can be done to lower the barriers for new technology or novel platform adoption? 

  • Can we simplify the technology evaluation process?

  • Collaborative projects - is this the solution?

Animal Models and Idiosyncratic Toxicity
Co-Moderators: John R. Senior, M.D., Associate Director for Science, Offi ce of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration; and 
Paul B. Watkins, M.D., Director of Hamner/U.N.C. Center for Drug SafetyScience, University of North Carolina at Chapel Hill

  • Should current animal testing focus on outliers rather than mean responses (as is the case in assessing toxicity in clinical trials)

  • What is the potential of various animal models proposed to mimic idiosyncratic adverse drug reactions (eg. genetically modified mice, panels of inbred but genetically diverse mice)

  • Are these efforts just killing more harmless drugs?

Translational Safety Biomarkers
Moderator: William B. Mattes, Ph.D., D.A.B.T., Director of Toxicology, The Critical Path Institute

  • Recently the FDA and EMEA have qualified seven new biomarkers for sensitive detection of drug-induced kidney injury. How do other safety biomarkers, applicable both in a non-clinical and in a clinical setting, improve the progression of candidates in drug development from discovery through clinical studies?

  • What other approaches and technologies may be applied for addressing safety issues at the preclinical-Phase 1 interface?

Evaluating and Improving Pre-Clinical Models 
Moderator: Vivek Kadambi, Ph.D., Senior Director, Drug Safety Evaluation, Millennium Pharmaceuticals

  • How predictive are animal models of human response?

  • What are the “validation” criteria for animal models?

  • What assays can be done in in vitro models?

  • How can human adverse reactions be predicted?

  • How to address variability in animal models?

Cardiotoxicity Assays for Preclinical Screening
Co-Moderators:
Craig T. January, M.D., Ph.D., Professor, Division of Cardiovascular, Medicine, University of Wisconsin-Madison
Blake D. Anson, Ph.D., Director hERG Screening Services, Cellular Dynamics International, Inc

  • Limitations of current assays

  • New technologies on the horizon

  • Adopting new technologies into your screening programs

TRACK 6: PRECLINICAL DEVELOPMENT OF BIOLOGICS

Pre Clinical Development of Vaccines - Experiences in Developing the Next Generation of Vaccines for Infectious Diseases
Moderator: Sue Clarke, CIBiol, Head of Project Management, ImmBio

  • Understanding your product mode of action - Heat shock protein complexes and Fc fusion proteins
  • Complex products - defining a draft specification
  • Rationales for efficacy and safety testing
  • Surrogate molecules and end points
  • New paradigms - regulatory "buy-in"

Critical Information to Consider When Designing a Toxicology Program for a Novel Biological
Moderators: Lauren Black, Ph.D., Senior Scientific Advisor, Navigator Services, Charles River Laboratories
Gilles Gallant, B. Pharm, Ph.D., Vice President, Clinical Oncology, Human Genome Sciences

Points to Consider When Selecting Animal Models for Use in Discovery Research
Moderator: Richard G. Peterson, Ph.D., EVP Research and Development, PreClinOmics, Inc.

  • Animal size-amount of drug available to do the experiment and amount of blood available for analysis

  • Endpoints that need to be measured-amount of blood/tissues needed, availability of assay, and ability of a CRO/collaborator to measure

  • Appropriate disease models for efficacy work

  • Appropriateness of non-disease models for efficacy work

  • Costs of the animals and experiments

TRACK 7: TRANSLATIONAL MEDICINE

Evaluating and Improving Pre-Clinical Models 
Moderator: Vivek Kadambi, Ph.D., Senior Director, Drug Safety Evaluation, Millennium Pharmaceuticals

  • How predictive are animal models of human response?

  • What are the “validation” criteria for animal models?

  • What assays can be done in in vitro models?

  • How can human adverse reactions be predicted?

  • How to address variability in animal models?

Optimizing Translation to FIH Studies 
Moderator: Kailash Swarna, Ph.D., Executive Director, Research & Development, Amgen, Inc.

  • How predictive are pre-clinical models of human response?

  • What are the effective dose selection strategies?

  • What are the roles of biomarkers in FIH studies?

  • What technologies are most useful in optimizing translation to FIH studies?

Biomarkers for Go/No-Go Decision Making 
Moderator: To be Announced

  • Has there been sufficient ROI on biomarkers and enabling technologies in drug development?

  • How is ROI estimated and measured? 

  • Which types of biomarkers should be developed at various stages in the drug pipeline? 

  • What strategies help translate biomarkers from preclinical to clinical development? 

  • What type of biomarker data should lead to terminating a target or a compound? What type of data should lead to increased investment in a compound? 

  • Where is the value of using biomarkers in decision making?

TRACK 8: CANCER PROFILING AND PATHWAYS

Taking Account of the Limitations of Biomarker Discovery in Cancer
Moderator: Zoltan Szallasi, M.D., Senior Research Scientist, Children's Hospital, Boston, USA, Professor, Danish Technical Uiniversity, Lyngby, Denmark

  • Are we ready to face the limitations of genome scale screening based biomarker discovery?

  • Worst and best case scenarios: the variables are not independent and this should give us cautious hope if we know how to take advantage of it 

  • Can we optimize the efficiency of genome scale screening based biomarker discovery in cancer technical and cohort design related issues

DNA Copy Number Variation and Cancer Susceptibility
Moderator: David Malkin, M.D., Co-Director of the Cancer Genetics Program, University of Toronto’s Hospital for Sick Children 

  • How can DNA Copy Number variation be used to enhance molecular profiling of cancer susceptibility?

  • What genetic mechanisms explain the development of copy number variable regions of DNA?

  • What is the relationship of copy number variable regions and specific target 'cancer genes' in the carcinogenic process?

Epigenetics and MicroRNA
Moderators: Dalia Cohen, Ph.D., Chief Scientific Officer, Rosetta Genomics Inc. and Enal Razvi, Ph.D., System Biosciences SBI 

  • Role of epigenetics and microRNAs in cancer and differentiation—exploring the connections

  • Impact of epigenetics and microRNA on the expanding stem cells research and regenerative medicine efforts

  • How to commercialize upon the microRNA space?

  • What about epigenetics? The current landscape and what value it offers for diagnostics/therapeutics in the future

Expression Profiles for Individual Tumors
Moderator: Craig N. Giroux, Ph.D., Associate Professor, Research, Karmanos Cancer Institute, Wayne State University

  • How can we best use static snapshots (gene signatures) of a moving target (dynamic tumor progression) to guide cancer treatment?

  • How do we deal with tumor heterogeneity and its confounding effects on our ability to distinguish driver from passenger effects in tumor progression?

  • Can we define an individual tumor expression profile (private variation) or must we settle for a sub-type classification (common variation)?

  • How do we score a gene expression signature: statistical metrics or network topology?

TRACK 9: ADOPTING INTEGRATED R&D INFORMATICS SYSTEMS

Translational Informatics
Moderator: John Russell, Executive Editor, Bio-IT World 

  • When you’re new to the translational informatics game, where’s the best place to start?

  • If you’re well into a project, how are you measuring results?

  • What organizational barriers and what technology challenges should you expect?

  • What’s the best approach for getting budget for new products?

  • How much of the enabling technology (hardware and software) can you buy and how much do you have to build yourself?

  • Does anyone have favorite tools in use today, and what make them effective?

Knowledge Management 
Moderator: Susan Ward, Ph.D., Executive Advisor, Biotechnology & Pharma

  • How to capture, integrate, and make data accessible when and to whom it is needed

  • Capture and integrate gene-related information, & distribute the data across the company

  • Optimal or realistic decision making 

Effective Integration Strategies
Moderator: Joseph A. Cerro, President & Founder, Schooner Group LLC

  • Driving Productivity

  • Driving Workflows

  • Managing resources

  • Managing costs

TRACK 10: CANCER MOLECULAR MARKERS

Taking Account of the Limitations of Biomarker Discovery in Cancer
Moderator: Zoltan Szallasi, M.D., Senior Research Scientist, Children's Hospital, Boston, USA, Professor, Danish Technical Uiniversity, Lyngby, Denmark

  • Are we ready to face the limitations of genome scale screening based biomarker discovery?

  • Worst and best case scenarios: the variables are not independent and this should give us cautious hope if we know how to take advantage of it 

  • Can we optimize the efficiency of genome scale screening based biomarker discovery in cancer technical and cohort design related issues

DNA Copy Number Variation and Cancer Susceptibility
Moderator: David Malkin, M.D., Co-Director of the Cancer Genetics Program, University of Toronto’s Hospital for Sick Children 

  • How can DNA Copy Number variation be used to enhance molecular profiling of cancer susceptibility?

  • What genetic mechanisms explain the development of copy number variable regions of DNA?

  • What is the relationship of copy number variable regions and specific target 'cancer genes' in the carcinogenic process?

Epigenetics and MicroRNA
Moderators: Dalia Cohen, Ph.D., Chief Scientific Officer, Rosetta Genomics Inc. and Enal Razvi, Ph.D., System Biosciences SBI 

  • Role of epigenetics and microRNAs in cancer and differentiation—exploring the connections

  • Impact of epigenetics and microRNA on the expanding stem cells research and regenerative medicine efforts

  • How to commercialize upon the microRNA space?

  • What about epigenetics? The current landscape and what value it offers for diagnostics/therapeutics in the future

Expression Profiles for Individual Tumors
Moderator: Craig N. Giroux, Ph.D., Associate Professor, Research, Karmanos Cancer Institute, Wayne State University

  • How can we best use static snapshots (gene signatures) of a moving target (dynamic tumor progression) to guide cancer treatment?

  • How do we deal with tumor heterogeneity and its confounding effects on our ability to distinguish driver from passenger effects in tumor progression?

  • Can we define an individual tumor expression profile (private variation) or must we settle for a sub-type classification (common variation)?

  • How do we score a gene expression signature: statistical metrics or network topology?

TRACK 11: COMPANION DIAGNOSTICS

Biomarker Partnerships in Companion Diagnostics 
Moderator: Brian T. Edmonds, Ph.D., Principal Investigator, Integrative Biology/ Global External Research & Development, Lilly Corporate Center 

  • Role of partners in biomarker assay development 

  • How are deals structured? Who should you partner with? 

  • Process of commercializing assays different from commercializing drugs 

  • Use of companion diagnostics in drug differentiation, dose setting and safety profile

Value-Based Pricing for Molecular Diagnostics
Moderator: Michael Stocum, MS, Managing Director, Personalized Medicine Partners, LLC 

  • Optimizing therapeutic and molecular diagnostic combinations to improve outcomes

  • Evaluating where novel diagnostics may better inform treatment decisions

  • Demonstrating higher efficacy and/or lower risk of side effects of therapeutic regimens

  • Investigating current standard of care and where inefficiencies exist in healthcare delivery

  • Generating and utilizing clinical data to inform pricing and reimbursement decisions 

Preventative Genomic Medicine
Moderator: Vance Vanier, M.D., Chief Medical Officer, Navigenics and Partner, Mohr Davidow Ventures

  • The promise and current state of preventive genomic medicine

  • Physician and patient interest

  • Clinical data published and forthcoming

  • Policy, educational, regulatory, and legal issues

Taking Account of the Limitations of Biomarker Discovery in Cancer
Moderator: Zoltan Szallasi, M.D., Senior Research Scientist, Children's Hospital, Boston, USA, Professor, Danish Technical Uiniversity, Lyngby, Denmark

  • Are we ready to face the limitations of genome scale screening based biomarker discovery?

  • Worst and best case scenarios: the variables are not independent and this should give us cautious hope if we know how to take advantage of it 

  • Can we optimize the efficiency of genome scale screening based biomarker discovery in cancer technical and cohort design related issues

Expression Profiles for Individual Tumors
Moderator: Craig N. Giroux, Ph.D., Associate Professor, Research, Karmanos Cancer Institute, Wayne State University

  • How can we best use static snapshots (gene signatures) of a moving target (dynamic tumor progression) to guide cancer treatment?

  • How do we deal with tumor heterogeneity and its confounding effects on our ability to distinguish driver from passenger effects in tumor progression?

  • Can we define an individual tumor expression profile (private variation) or must we settle for a sub-type classification (common variation)?

  • How do we score a gene expression signature: statistical metrics or network topology?


 


 

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