Clinical genomics spx

Control Your Next-Gen Data

Discover Clinically Actionable Biomarkers

Personalize Medical Care

28th-30th January 2014, Boston

22 Expert Speakers Including:

Nadeem Sarwar Senior Director, Worldwide Clinical Research Pfizer

Rong Chen Director, Clinical Research Mount Sinai School of Medicine

Sanjay Rakhade Director, Global Clinical Development Genzyme

Oscar Puig Biomarker & Experimental Medicine Leader Roche

Birgit Funke Director, Clinical R&D Laboratory for Molecular Medicine Partners Healthcare

Book early and save up to $500

“That was the best event I have ever attended…You have a committed customer from this point onwards”

Sanofi

Tel: +44 (0)203 141 8707 Email: [email protected] www.clinicalgenomics-usa.com

Boston 28th-30th January 2014


Chairman of Clinical Genomics 2014

Seth CrosbyDirector, Partnerships & AlliancesWashington University School of Medicine

A Welcome From The Chairman

Dear Colleague,

Genomic information is changing and challenging the practice of medicine…

Clinical genomics. Many from pharma and research institutes alike are calling it a ‘genetics revolution’. The era of personalized genomic health that is no longer simply a pipe-dream.

You know sequencing isn’t a painless process. But there are solutions out there. Clinical Genomics 2014 will uncover success stories from the pioneers selecting the right drug for the patient based on their genomic targets.

Why do I think you should attend? Just a few reasons…

1. You can discover novel methods for cracking the clinical data bottleneck with new data from Pfizer, Boston Children’s Hospital and AstraZeneca

2. Find out what technologies are out there for you to use in clinical trials. Mayo Clinic, Merck and Harvard Medical School let you into their trade secrets…

3. You will hear the strategies that Roche, Millennium and Regeneron use for their biomarker discovery, development and delivery in the clinic

4. Bristol-Myers Squibb, Takeda and Partners Healthcare will help you explore the clinical diagnostic landscape, and the role that NGS can play when implementing an effective strategy in the lab

5. Networking! Benefit from the unique format of Clinical Genomics 2014 and take part in the interactive workshops, speed networking and round table discussions available to make the most of your time

Whatever your motivations, Clinical Genomics 2014 will give you clarity on exactly how NGS can be applied in a clinical setting. Integrating molecular details into day-to-day patient decision-making processes.

We need to start asking the right questions from clinical data: will it help in creating new drug discovery programs? Will it help with biomarker discovery? Will it help with patient stratification?

There is a huge translational gap that needs to be closed if we are to make any headway. If we want to get this right, we need to break the silos and start communicating.

Best wishes and hope to see you in Boston.

From past attendees

“This is the best conference I have ever gone to…I have already recommended people in my group to go next year.”

AVEO

“I thought that conference was well organized, sessions were well planned and we had a good mix of academic & pharma speakers. So overall, the conference was a great success.”

GSK

“I enjoyed the meeting very much. The size was ideal to encourage communication and networking.”

Complete Genomics

“All very motivated, well spoken speakers. Very good presentations overall. Topics were well selected.”

Actelion

“It exceeded my expectations. The talks were high quality and the interaction among participants was excellent.”

Genentech

“Whoever designed the structure of this summit deserves a credit. Lots of thought has been put in to organising and selection of topics. Kudos to the organizing team.”

Coldstream Laboratories



Kelci MiclausResearch Statistician DeveloperJMP Life Sciences, SAS Association

Catherine BrownsteinResearch Sequencing Project ManagerBoston Children’s Hopital

Brian DoughertyTranslational Genomics LeadAstraZeneca

Speakers

Joe MonforteIndependent Consultant

Birgit FunkeDirector, Clinical R&D Laboratory for Molecular Medicine Harvard Medical School

Sanjay RakhadeDirector, Global Clinical DevelopmentGenzyme

Jun LiSenior Research InvestigatorBristol-Myers Squibb

Rong ChenDirector, Clinical Genome InformaticsMount Sinai School of Medicine

Pia GargiuloIndependent Consultant

Mollie RothManaging PartnerPGx Consulting

Matthew LeboAssistant Laboratory DirectorPartners Healthcare

David SmithProfessor, Laboratory of Medicine & PathologyMayo Clinic

Ken ChangClinical Assay Development & Outsourcing Lead Merck

Sunita BadolaSenior Manager, Translational MedicineMillennium

Saumya PantClinical Development Research FellowMerck

Nadeem SarwarSenior Director, Worldwide Clinical Research, Pfizer

Mitchell MartinDirector, Predictive Medicine, OncologyRegeneron

Oscar PuigBiomarker & Experimental Medicine LeaderRoche

Justin KlekotaScientist IITakeda

Shashikant KulkarniHead, Clinical GenomicsWashington University School of Medicine

Seth CrosbyDirector, Partnerships & AlliancesWashington University School of Medicine

“You did a great job bringing together some bright minds. I got two full days of exposure to information I will benefit from.”

Integrated DNA Technologies



Conference Workshops

Workshop Leaders

Matthew LeboAssistant Laboratory Director, Whole Genome Sequencing Partners Healthcare Center for Personalized Genetic Medicine

Workshop A: Incorporating NGS into Companion Diagnostics Date: 28th January 2014, Time: 9 - 12

As a director in a clinical diagnostics laboratory, Matt is responsible for the interpretation and reporting of large gene panel tests – with a special focus in cardiomyopathy – and the development of next-generation sequencing tests, including clinical genome/exome sequencing.

As a member of the IT team at Partners, Matt also works on the development of GeneInsight Suite, an innovative software platform for molecular laboratories, clinics, and EHR systems that manages variant, gene, and disease annotations and the integration of that information into patient reports.

> See next page for more conference workshops

As the costs of NGS decreases, the opportunity to use personalized genomics in clinical studies has become more accessible than ever. And the development of genomic sequencing methods could help to rapidly identify genetic alterations which may serve as targets for new diagnostic tests.

But how can we ensure we are maximizing the returns on investment for these technologies and achieving the best results we can for patient selection?

This session will explore how you can realistically make NGS an integral part of your personalized medicine strategies:

• Find out how identify and evaluate cancer-causing mutations using sophisticated sequencing technologies

• Explore the possibilities of NGS to identify new targets for clinically relevant companion diagnostic tests

• Evaluate what NGS technologies and services are available to you to successfully to optimize your patient population approaches

Workshop Leaders

Workshop B: Next Generation Sequencing Platforms for the Clinic Date: 28th January 2014, Time: 12.30 - 3.30

Next Generation sequencing is poised to make a significant impact upon clinical practice. While the first clinical applications of NGS will most probably be small gene panels, within the next few years this technology will become integrated into routine clinical practice.

This will still include the small gene panels, but will also include, much larger gene panels (such as the one that is used by Foundation Medicine for Cancer Treatment), whole exome sequencing, whole genome sequencing, transcriptome sequencing and maybe even methylation sequencing…

Each of these different applications has its own unique set of challenges, suggesting that there may not be a single sequencing platform that can meet all these needs.

This workshop will be an enlightening introduction to NGS technology – present and future. What should you use? Why should you use it?

Attend this session for…

• A brief history of NGS: Where have we come from, and where are we going?

• A review of each of the available and soon to be available platforms: their strengths, their weaknesses, and which clinical application each is best suited for

• The clinical vision for sequencing platforms

• A presentation from laboratories already using NGS as a routine part of clinical practice

The laboratory of David Smith uses the most cutting-edge genomic technologies to better understand the molecular alterations that underlie cancer development. David is also the chairman of the Technology Assessment Committee, which works for the Center for Individualized Medicine at Mayo Clinic. The goal of this committee is to evaluate new technologies that could have a significant impact on research and its clinical translation.

Perhaps the most exciting technology has been the recent advancements in DNA sequencing, which now make it possible to completely sequence a person’s entire genome for just a few thousand dollars.

David SmithProfessor, Laboratory of Medicine & Pathology Mayo Clinic

“Excellent cross section of core science, regulatory, commercialization and project management from both pharma and diagnostic companies. Very educational” Eli Lilly



Join our Linkedin group and enjoy discussions with the online community in the run up to the meeting. Just search Linkedin groups for Clinical Genomics

Join the discussion and Tweet about the event using #ClinicalGenomics

Media Partners

As we move closer towards integrating Next Gen Sequencing into clinical practice, we continue to face numerous hurdles across the developmental lifespan from early R&D through application in clinical trials through to understanding how to drive commercial success of these tests in the targeted therapy space.

This workshop will address key issues across this lifespan, including:

• The underlying data, how it will be maintained and updated and who owns it

• The regulatory impediments based upon the constantly shifting data underlying NGS tests

• Internal barriers to success of NGS inherent in the pharma and diagnostic business models

• Obtaining reimbursement for tests that potentially provide broader data than strictly required to guide use of specific drugs

• Educating physicians and patients about NGS and what it means to their practice and health

Interactive discussions will be driven by use of realistic hypotheticals designed to demonstrate tangible issues and address specific concerns in the NGS space.

Workshop LeadersMollie RothManaging Partner PGx Consulting

Joe MonforteIndependent Consultant

Pia GargiuliIndependent Consultant

An attorney by training, Mollie is the Managing Partner of PGx Consulting, which provides customized, personalized medicine specific business services to the pharmaceutical, biotech and diagnostic industries in the personalized medicine space.

Joe is a leading expert in genomics and molecular analysis, with an emphasis on PCR and multiple generations of sequencing. His experience ranges from molecular chemistry and analytical platform development, through full-scale diagnostic development and deployment in the clinical setting.

Pia has led teams in the novel development, deployment, and delivery of companion diagnostic programs focusing on the broad technical utility and uptake of commercialization models for both the pharmaceutical and diagnostic industries. She has over 15 years’ experience in industry and academia with a strong focus in Oncology.

Workshop C: Issues with Developing and Implementing NGS Technologies: A Lifespan Review

Date: 28th January 2014, Time: 4 - 7


Boston Day 1 - 29th January 2014

Clinical Genomics in the Age of Next Generation Sequencing 08.00 Registration & Breakfast

08.50 Chair’s Opening Remarks Genomics in the Clinic: Where are we now, and where do we want to be? Seth Crosby, Director, Partnerships & Alliances, Washington University School of Medicine

High-Throughput Genomic Technology in Research and Clinical Trials: What Choice is the Right Choice?

09.00 The HPV Epidemic: Understanding it’s Role in the Evolution of Oropharyngeal Cancer• How HPV is responsible for the explosion in the cases of

OPSCC in spite of decreased incidence of smoking in the United States

• How the role of HPV in the development of OPSCC is distinct from its’ well characterized role in cervical cancer

• The power of mate-pair sequencing to determine the precise status of HPV in OPSCC

David Smith, Professor, Laboratory of Medicine & Pathology, Mayo Clinic

09.30 From Genes to Genomes - Implementing NGS in the Clinic• Discussing how next generation sequencing technologies

have revolutionized diagnostic testing• Benefits and challenges of current NGS tests - gene

panels and exome/genome• Impact of expanded testing on result interpretation -

variant assessment as the new bottle neck in genomics Birgit Funke, Director, Clinical R&D Laboratory for

Molecular Medicine, Harvard Medical School

10.00 Speed Networking

11.00 Morning Refreshments

Cracking the Clinical Data Interpretation Bottleneck for Medical Decision Making

11.30 Implementation and Integration of NGS Services at Boston Children’s Hospital• New initiatives at Boston Children’s Hospital to increase

the clinical utility of NGS data• Faster and more accurate diagnosis through NGS results

in targeted prescribing and increased possibilities for investigational therapies

• Case studies from the past 12 months demonstrating how BCH has reduced the obstacles between rare disease research and clinical discovery

Catherine Brownstein, Research Sequencing Project Manager, Boston Children’s Hospital

12.00 PANEL SESSION: Sequencing is the Easy Bit. But now how do we Make Sense of the Data?• Solving the clinical puzzle: a discussion of novel

computational techniques for implementing patient selection and diagnostic strategies

• Whole genome studies and translational bioinformatics: what does all this data mean?

(Moderator) Catherine Brownstein, Research Sequencing Project Manager, Boston Children’s Hospital; Nadeem Sarwar, Senior Director, Worldwide Clinical Research, Pfizer; Jun Li, Senior Research Investigator, Bristol-Myers Squibb; David Smith, Professor, Laboratory of Medicine & Pathology, Mayo Clinic

12.30 Clinically Actionable Results through Discovery and Prediction• Next Generation Sequencing Whole-Genome, Exome,

RNA-Seq analysis• Integrated genomic analysis• Biomarker discovery• Clinical subgroup analysis

Kelci Miclaus, Research Statistician, JMP Life Sciences, SAS Association

12.45 Networking Lunch

2.00 Driving Personalized Medicine and Clinical Diagnosis Using Genome Sequencing, Exome Sequencing and Integrative Genomics• Applying data from whole WES and WGS for diagnosis

and decision making in a clinical lab• Integrating and translating various molecular

measurements in the public repositories into biomarkers for the diagnosis of disease

• Discovery of causal variants, pathway, and mechanisms to illustrate human disease through integrative genomic

Rong Chen, Director, Clinical Genome Informatics, Mount Sinai School of Medicine

A New Paradigm for Drug Discovery: Integrating Clinical Data for Novel Drug Discovery Programs

2.30 Catalyzing the Translation of Genetic Signals into Therapeutic Targets• The evolution of the role of human genetics and related

sciences in medicines development: from traditionally reserved for late-phase “pharmacogenetic exploration” to application across all stages of the pipeline

• Discussing the role of the integration of different layers of robust human biology data

• Catalyzing translational value of human genetics “from insight to impact” to necessitate multi-disciplinary and multi-sector collaboration

Nadeem Sarwar, Senior Director, Worldwide Clinical Research, Pfizer

3.00 Afternoon Refreshment Break

3.30 Closing the Translational Gap: Using Patient Data to Educate and Guide us in Early Discovery Research• Setting up a center for genomics data that ensures

integrated data for laboratory management• A comprehensive genetics and functional genomics

approach to the annotation of genomes, and applying such methods to the validation of targets

Sanjay Rakhade, Director, Global Clinical Development, Genzyme

4.00 Regulatory Roundtable Discussion ForumAn exclusive session led by the speakers but with the content directed by you. This is the opportunity for leaders in the clinical genomics field to sit and discuss, off the record, what can be done to overcome the crippling regulatory hurdles. The roundtable forum agenda will be made up of queries submitted by the attendees of the meeting.

5.00 Regulatory Roundtable Presentations

5.30 Chair’s Closing Remarks

5.45 Networking Drinks Reception


Boston Day 2 - 30th January 2014

Making the Case for Genomics in Clinical Medicine08.00 Registration & Breakfast

08.50 Chair’s Opening Remarks Let’s Not Reinvent the Wheel with Clinical Genomics…What can we take from what’s been done before?

Seth Crosby, Director, Partnerships & Alliances, Washington University School of Medicine

Discover, Development & Delivery of Clinically Actionable Biomarkers

09.00 Establishing the Routine: Validating Biomarkers Through Clinical Research to Translate and Integrate into Clinical Practice• What stage have we got to in the clinic? Applying NGS for

biomarker development and subject stratification

• Securing strong predictive biomarkers to compliment products translating into clinical development

• Incorporating predictive biomarkers into early stage R&D to ensure each clinical candidate has a complimentary biomarker when it reaches the clinic

Brian Dougherty, Translational Genomics Lead, AstraZeneca

09.30 Clinical Genomics in Drug Response and Resistance• How do we use genomic tools to understand drug

response and resistance in clinical trials?• What clinical samples can be used? How do we get

them?• What are the limitations?

Oscar Puig, Biomarker & Experimental Medicine Leader, Roche

Integrated Clinical Genomics: New Horizons for Diagnostics and Biomarker Discovery

10.00 Next-Generation Clinical Genomic Profiling to Aid Clinical Diagnosis and Predict Outcomes• Design, validation and implementation of a

comprehensive mutation analysis of multiple cancer genes

• Constantly improving cost-effective, clinically actionable diagnostic markers

• Unveiling key genomic drivers, prognostic and diagnostic indicators in cancer

Shashi Kulkarni, Head, Clinical Genomics, Director, Cytogenomics and Molecular Pathology, Washington University School of Medicine

10.30 Morning Refreshment Break

11.00 Development and Validation of a Clinical Trial Patient Stratification Assay that Interrogates 27 Mutation Sites in MAPK Pathway Genes• Overcoming the technical challenges in the process of

developing and validating patient stratification assays • Using Next Generation sequencing to resolve discordant

calls between the SNPE mutation assay and Sanger sequencing

Ken Chang, Clinical Assay Development & Outsourcing Lead, Merck

11.30 PANEL SESSION: Is Personalized Medicine a Future Reality? Harnessing Clinical Data for Informed Patient Stratification

(Moderator) Oscar Puig, Biomarker & Experimental Medicine Leader, Roche; Mitchell Martin, Director, Predictive Medicine, Oncology, Regeneron; Justin Klekota, Scientist II, Takeda; Jun Li, Senior Research Investigator, Bristol-Myers Squibb

12.00 Lunch & Networking

1.30 Implementation of Genome Sequencing in a Clinical Diagnostic Laboratory• Identifying the appropriate datasets and approaches to

validate genome sequencing pipelines• Explaining important concepts that should be considered

when developing clinical reports based upon the results of genome sequencing

• Detailing our experiences offering genome sequencing in clinical care, including our support of the MedSeq project

Matthew Lebo, Assistant Laboratory Director, Partners Healthcare

2.00 Application of Novel Technologies for Better Patient Selection Strategies in Clinical Trials• Using next generation sequencing and microarray for

comprehensive characterization of cancer tumors• What challenges are presented by method of sample prep

and preservation? Sunita Badola, Senior Manager, Translational Medicine,

Millennium

2.30 Afternoon Refreshment Break

Medically Actionably Genomics: Clearing the Road to Routine Whole Genome Sequencing

3.00 Clinical Genomic Biomarker Assay Development: Technologies and Issues• Considerations in planning a clinical NGS based assay

• Challenges for NGS based assay translation to CDx

• Promise for the future with NGS clinical trial assays: no more “business as usual”

Saumya Pant, Clinical Development Research Fellow, Merck

3.30 PANEL SESSION: Incidental Findings or Good Medical Practice? Patient Choice, Patient Preference and Lab Responsibility

(Moderator) David Smith, Professor, Laboratory of Medicine & Pathology, Mayo Clinic; Sunita Badola, Senior Manager, Translational Medicine, Millennium; Nadeem Sarwar, Senior Director, Worldwide Clinical Research, Pfizer Matthew Lebo, Assistant Laboratory Director, Partners Healthcare

4.00 Chair’s Closing Remarks



As a service provider in this space you will be well aware that the field is expanding. Clinical Genomics 2014 is the opportunity to get a foot in the door, stay ahead of your competitors and present your capabilities to a captive audience of senior power buyers who are already primed to invest in this space.

It’s all about bringing together the leading scientists who are heading up the world’s most innovative and advanced clinical genomics programs to make progress happen.

Clinical Genomics 2014 provides a unique platform to access these decision makers; this forum doesn’t exist anywhere else in the world.

Imagine yourself presenting to a room full of drug developers and demonstrating how your technology and approach will help them apply NGS in a meaningful way to deliver commercial results. At Clinical Genomics 2014 you can position your company as the partner of choice.

Why Sponsor Clinical Genomics 2014?

For information on sponsorship, please contact Diane McKenna at: [email protected] or call +44 (0) 20 3141 8746

Scientific Presentation: Demonstrate thought leadership and present your message through a scientific presentation built into the agenda.

Private Lunch: Hosting a lunch with a pre-selected group of attendees is an excellent way to interact and impress prospective clients. This hugely personal networking opportunity gives you one-to-one access with a hand-picked audience selected by you.

Exhibition Booth: The best opportunity to showcase your company’s products, services and technology. All booths are in a central location, surrounded by all the networking functions and are ideally placed to allow you to interact with the attendees searching for solutions.

Innovation Panel: Ideal for up-and-coming companies who are looking to showcase their solutions. This is an excellent way to drive customers to your meeting area where relationships can be further forged or strengthened.

Bespoke sponsorship packages are available – we would be happy to discuss your specific requirements.

If you have any questions about the program, contact: [email protected]

For media and marketing queries, contact:[email protected]

Sequencing Companies

Genomic CROs

Genomic Data Storage & Analysis Software Companies

Diagnostics Developers

Target Discovery Companies

What Options are Available? Who Should Sponsor?

“Good meeting – great selection of speakers. The speed networking was very effective to connect with all participants.”

PwC

JMP® Genomics and JMP® Clinical software from SAS are customized for dynamic visualization of life sciences data, fueling discoveries from the earliest stages of molecular research to the final phases of drug development. They integrate powerful SAS®

Analytics with the graphical flexibility of JMP, putting multifaceted analysis options into the hands of all users, regardless of their statistical savvy.

Spotlight Partner

SPXBoston 28th-30th January 2014 Priority code:


• 10% discount – 3 delegates • 15% discount – 4 delegates • 20% discount – 5 or more delegates

Please note that discounts are only valid when three or more delegates from one company book and pay at the same time.

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Clinical genomics spx

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