Next Generation Dx Summit
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The co-development of drugs and diagnostics requires a new business model to fit the realities of the emerging marketplace. There are compelling examples demonstrating the enormous potential from exploiting the pairing of diagnostic tests that determine individual responsiveness to therapeutic options. However, many practical barriers need to be faced before this can become a streamlined path for new products to emerge. In the future, it is clear that many pharmaceuticals will require a companion diagnostic. This conference will shed light on this new movement promising significant patient benefits, healthcare cost savings, and revenue opportunities.

 

WEDNESDAY, AUGUST 25 

11:00 am-12:00 pm Registration

  

 

PLENARY KEYNOTE SESSION 

SHAPING THE FUTURE OF CANCER PATHWAY-BASED MEDICINE 

(Shared session with Trends in Cancer Diagnostics) 

12:15 pm Chairperson’s Remarks 

Harry Glorikian, Managing Partner, Scientia Advisors 

12:20 Comprehensive Cancer Genome Diagnostics in the Era of Targeted Therapy 

Jeffrey S. Ross, M.D., Cyrus Strong Merrill Professor & Chair, Department of Pathology & Laboratory Medicine, Albany Medical College and Foundation Medicine 

The integration of multigene predictors and molecular diagnostics into the selection, administration, dosing and monitoring of the use of anti-cancer drugs has continued to impact the both current oncology practice and the discovery and clinical development of new anti-cancer drugs. Comprehensive cancer genome diagnostics and continued in depth sequencing of the human cancer cell genome have uncovered a variety of genetic mutations, translocations and amplifications that are playing major roles in the continuing discovery of novel drug – test combinations and have resulted in critical changes in the selection and dosage of anti-neoplastic agents already on the market.

12:50 Emerging Stakeholders in Personalized Medicine 

Harry Glorikian, Managing Partner of Scientia Advisors 

Personalized medicine represents a fundamental shift in the healthcare industry at a time when change is needed most. The unacceptable cost and efficacy of today’s drugs is driving pharmacogenomic tests’ strong value proposition to patients, physicians and payors. In fact, the allure of this new paradigm to create additional value and new growth opportunities is attracting new players, ranging from drug distributers to pharmacy benefits managers to entirely new enterprises (e.g. genomic benefits managers) into the fray. This talk will provide an overview of the space, today’s active players and an overview of newly active players that are shaping the future of a new healthcare ecosystem.

  


1:20 Luncheon Presentation
(Sponsorship Available) or Lunch on Your Own 

 

UNDERSTANDING THE PROCESS 

2:10 Chairperson’s Remarks 

Robert Yocher Robert E. Yocher, M.H.Sc., RAC, FRAPS, Vice President, Regulatory Affairs and Corporate Quality Compliance, Genzyme Corporation 






2:15 Immunohistochemistry and Companion Diagnostics--Know Your Target, Start Early, Fail Often
 

Robert DunstanRobert Dunstan, Ph.D., Distinguished Investigator, PCDS, Biogen Idec 

Immunohistochemistry (IHC) is often the first method considered for a companion diagnostic for solid tumors, especially for antibody-based therapies. However FDA-approved IHC assays are far from robust. This asks the question whether IHC assays be designed that can be used for accurate prognostic or predictive biomarker development?

 

2:45 The PMC Public Policy Efforts on Companion Diagnostics 

Robert Yocher Robert E. Yocher, M.H.Sc., RAC, FRAPS, Vice President, Regulatory Affairs and Corporate Quality Compliance, Genzyme Corporation 

This talk will enumerate how an extremely diverse group of major stakeholders came together to guide policy and provide comprehensive input to one of the most requested FDA guidance documents to date.




3:15 Evidence Based Evaluation of New Molecular Diagnostic Tests – Going for the Gold
 

Steven Gutman Steve Gutman, Ph.D., Technology Evaluation Center, Associate Director, Blue Cross and Blue Shield Association 

While all diagnostic tests can be important, pharmacogenomic tests developed in conjunction with new drug development or for already available drugs are particularly important because the benefit and risks of the diagnostic test become inextricably linked to those of the drug. While the requisites for good method evaluation have now been well defined in the ACCE and EGAPP models, making good evidence based decisions remains a complex and challenging process. There is no substitute for good data and good science in making the right decisions on the proper use of new test.


3:45 Networking Refreshment Break, Exhibit & Poster Viewing
 

4:30 New Challenges in Health Economics and Reimbursement 

Chawla_Anita-_ADX Anita J. Chawla, Ph.D., Vice President, Analysis Group 

In the emerging evidence-based marketplace of drugs and diagnostics, clinical evidence alone is no longer sufficient for reimbursement. Successful companies need to develop a robust evidence package, built on a solid foundation of outcomes data--including data that demonstrate value, or benefits versus costs. This presentation will examine the challenges diagnostic companies face in conducting rigorous studies to collect such data, and provide a case study review examining where molecular diagnostic tests have been successful -- and where they have failed.


5:00 Adoption of Companion Diagnostics by Industry and Academia
 

Tolias_Peter-_ADX Peter Tolias, Ph.D., Executive Director, Institute of Genomic Medicine; Research Director, The Autism Center; Professor, Department of Pediatrics, UMDNJ New Jersey Medical School 

Drug developers are facing unprecedented challenges in formulating new efficacious therapeutic products. The traditional model of developing medicine prescribed to a large segment of the available patient pool has been challenged by the reality that most blockbuster drugs have already been discovered. Another issue is an evolving regulatory process for increased safety and efficacy that has raised the bar for FDA approval. Both CLIA lab-developed and FDA-approved diagnostics represent a tool for drug developers to address these challenges by leveraging activities performed during drug development such as biomarker discovery, validation and clinical development and partnering with diagnostic companies to co-develop and launch drugs with companion tests. An instrumental role for successful market introduction and adoption of companion drugs and tests are academic medical centers that function as trial and educational sites to train medical students, fellows and physicians on how to best use the new technologies in clinical practice.

5:30 Break-Out Sessions 

The roundtable discussions open to all attendees, sponsors, exhibitors, and speakers provide a forum for discussing key issues and meeting potential partners. Plan to take part and explore the topics in-depth.

Evaluating Commercial Need for a Companion Diagnostic - How Do You Decide? 

Moderator: Charlie Raffin, CJR Advisors, LLC (formerly Vice President, Commercial Assessment, J&J) 

•          Some pundits believe every new drug needs a CDx - controversial position!  What do you think?
•          History shows drugs that didn't require a CDx (no regulatory mandate) still have them - causes & effects
•          Drug specific CDx tests - do they trump a "class effect" scenario?  Different commercial story!
•          Discuss examples of CDx tests that haven't caught on - payers have a lot more to say than regulators

Coping with Changing Evidence in a Changing Regulatory Environment - Is it Possible to Plan Ahead?

Moderator: Finley Austin, Ph.D., US Head, External Research and Innovation Environment, Roche Discovery Technologies 

•          Are the new plans to regulate LDTs a challenge or an opportunity?
•          Ideally, to know the PPV and NPV of a test to stratify patients a prospective trial randomizing biomarker + and - patients, is needed, are there situations, scientific or ethical, when this does not make sense?
•          Different stakeholders often view incomplete evidence differently: When it does not mean the same thing to regulators, clinicians, patients and payers, whose perspective should dominate?
•          Can retrospective analyses ever be used in place of a new prospective study?  Given the costs and time involved, when should I be collecting samples as a pre-cautionary measure?

To Partner or Not to Partner, That is the Question. The Dance between Pharma and Diagnostics Companies.Moderator: Brian T. Edmonds, Ph.D., Research Advisor, Global External Research & Development, Lilly Corporate Center•         Companion diagnostic tests are one way a pharma can differentiate its therapeutics from the competition. However, most pharma don't have a capability to develop commercial diagnostics. So what are the choices?
•          If you go internal and build capability, how do the parts interact?
•          If you collaborate through partnerships, how do you manage the different cultures?
•          In the end, what does "win/win" look like?

Health Economics and Evidence Development

Moderator: Anita J. Chawla, Ph.D., Vice President, Analysis Group 

•          What type of data will be required to communicate a strong value argument?
•          What are the implications for companion diagnostics research strategy and data collection?
•          How do you ultimately communicate the value of a companion diagnostic, based on health economics data?
•          How might the comparative effectiveness research agenda affect your strategy?

Companion Diagnostics- A Perspective from the Diagnostics Company

Moderator: Stephen Naylor, Ph.D., CEO and Chairman, Predictive Physiology & Medicine Inc. 

•          Who is the competition? Where is the focus? How do you make money?
•          What are the positions of the major stakeholders and how they view you, including pharma, payers and regulators?
•          Is there an emerging business model that is viable for Companion Diagnostic Companies?
•          How does the FDA or EMA view you? Is there a morass of red tape you have to navigate to get your product approved?

6:30 End of Day 

 

6:30 - 8:30 Dinner Short Course* 

(SC3) FUTURE OF POINT-OF-CARE PLATFORMS 

  • How are Dx POCT markets changing? 
  • Which platforms will win? What’s going to happen to the big box diagnostic companies? 
  • Hospital, MD offices, or home? 
  • What are the bottlenecks as markets change? 
  • Where will the new markets be and how will they be organized? 
  • What strategies make sense for Dx and POCT companies? 

Instructors: 

Keith F. Batchelder, Chief Executive Officer, Genomic Healthcare Strategies 

Peter S. Miller, Chief Operating Officer, Genomic Healthcare Strategies 


*Separate registration required. Click here for details.
 

 

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