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

28th-30th January 2014, Boston

Control Your Next-Gen Data
Discover Clinically Actionable Biomarkers
Personalize Medical Care
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

Tel: +44 (0)203 141 8707

Email: join@hansonwade.com

www.clinicalgenomics-usa.com
Boston

28th-30th January 2014
From past attendees

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

“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

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

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

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

Complete Genomics

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

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.

Actelion

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

Best wishes and hope to see you in Boston.

Seth Crosby
Director, Partnerships & Alliances
Washington University School
of Medicine
Chairman of Clinical Genomics 2014

Tel: +44 (0)203 141 8707

Email: join@hansonwade.com

“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

www.clinicalgenomics-usa.com
Boston

28th-30th January 2014

Speakers

Kelci Miclaus
Research Statistician Developer
JMP Life Sciences, SAS
Association

Brian Dougherty
Translational Genomics Lead
AstraZeneca

Catherine Brownstein
Research Sequencing
Project Manager
Boston Children’s Hopital

Jun Li
Senior Research Investigator
Bristol-Myers Squibb

Sanjay Rakhade
Director, Global Clinical
Development
Genzyme

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

Joe Monforte
Independent Consultant

David Smith
Professor, Laboratory of
Medicine & Pathology
Mayo Clinic

Ken Chang
Clinical Assay Development &
Outsourcing Lead
Merck

Saumya Pant
Clinical Development
Research Fellow
Merck

Sunita Badola
Senior Manager, Translational
Medicine
Millennium

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

Matthew Lebo
Assistant Laboratory Director
Partners Healthcare

Mollie Roth
Managing Partner
PGx Consulting

Pia Gargiulo
Independent Consultant

Nadeem Sarwar
Senior Director, Worldwide
Clinical Research, Pfizer

Mitchell Martin
Director, Predictive Medicine,
Oncology
Regeneron

Oscar Puig
Biomarker & Experimental
Medicine Leader
Roche

Justin Klekota
Scientist II
Takeda

Shashikant Kulkarni
Head, Clinical Genomics
Washington 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.”
Seth Crosby
Director, Partnerships & Alliances
Washington University School
of Medicine

Tel: +44 (0)203 141 8707

Integrated DNA Technologies

Email: join@hansonwade.com

www.clinicalgenomics-usa.com
Boston

28th-30th January 2014

Conference Workshops
Workshop A: Incorporating NGS into Companion Diagnostics

Date: 28th January 2014, Time: 9 - 12

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.

Workshop Leaders
Matthew Lebo
Assistant Laboratory Director,
Whole Genome Sequencing
Partners Healthcare Center for
Personalized Genetic Medicine

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

•	

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.

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

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


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

•	

Workshop Leaders
David Smith
Professor, Laboratory of
Medicine  Pathology
Mayo Clinic
The laboratory of David Smith uses the most cuttingedge 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.

The clinical vision for sequencing platforms

•	

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.

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

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.

 See next page for more conference workshops

Tel: +44 (0)203 141 8707

Email: join@hansonwade.com

www.clinicalgenomics-usa.com
Boston

28th-30th January 2014

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

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

Workshop Leaders

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

Mollie Roth
Managing Partner
PGx Consulting

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.

Joe Monforte
Independent Consultant

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 Gargiuli
Independent Consultant

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

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.

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.

Media Partners

Tel: +44 (0)203 141 8707

Email: join@hansonwade.com

www.clinicalgenomics-usa.com
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 RD 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

Tel: +44 (0)203 141 8707

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 Forum
An 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

Email: join@hansonwade.com

www.clinicalgenomics-usa.com
Boston

Day 2 - 30th January 2014
Making the Case for Genomics in Clinical Medicine

08.00	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

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

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 RD
to ensure each clinical candidate has a complimentary
biomarker when it reaches the clinic
	
Brian Dougherty, Translational Genomics Lead,
AstraZeneca

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

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

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

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

Tel: +44 (0)203 141 8707

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

Email: join@hansonwade.com

www.clinicalgenomics-usa.com
Boston

28th-30th January 2014

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

Spotlight Partner
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.

Why Sponsor Clinical Genomics 2014?
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.

What Options are Available?

Who Should Sponsor?

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.

Tel: +44 (0)203 141 8707

Email: join@hansonwade.com

Sequencing Companies
Genomic CROs

Genomic Data Storage  Analysis Software Companies
Diagnostics Developers
Target Discovery Companies

For information on sponsorship,
please contact Diane McKenna at:
sponsor@hansonwade.com or call
+44 (0) 20 3141 8746

If you have any questions about the program, contact:
izzy.scott-moncrieff@hansonwade.com
For media and marketing queries, contact:
craig.love@hansonwade.com

www.clinicalgenomics-usa.com
Boston

28th-30th January 2014

SPX

Priority code:
Event Prices

Register
Tel: +1 (212) 357 5898
Email: info@hansonwade.com

Package

Register before
Friday 6th December
2013*

Standard
Prices*

2 day conference
+ 3 workshops

$3698
(save $500)

$3898
(save $300)

Team Discounts

2 day conference
+ 2 workshops

$3197
(save $400)

$3597

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

2 day conference
+ 1 workshop

$2698
(save $300)

$2998

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

2 day conference

$2199
(save $200)

$2399

Workshops (each)

$599

$599

Mail: Hanson Wade
304 Park Avenue South, 11th Floor
New York, NY 10010

Venue and Accommodation
Hyatt Regency Boston
1 Ave De Lafayette, Boston, MA 02111, United States
Accommodation
Overnight accommodation is not included in the registration
fee, however accommodation options will be sent out with your
confirmation email upon registering.

Please select your choice of Workshop:

A

B

C

There is a 40% discount available for not-for-profit institutions.
For more information please email: register@hansonwade.com

*All discount offers (including team discounts) require payment at the time of registration to receive any discount. ‘Early Bird’ discounts require payment at time of registration and
on or before the cut-off date to receive any discount. All discount offers cannot be combined with any other offer. The conference fee includes lunch, refreshments and course
documentation. The fee does not include travel or hotel accommodation.

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Tel: +44 (0)203 141 8707

Email: join@hansonwade.com

www.clinicalgenomics-usa.com

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Clinical genomics spx

  • 1. 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 28th-30th January 2014, Boston Control Your Next-Gen Data Discover Clinically Actionable Biomarkers Personalize Medical Care 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 Tel: +44 (0)203 141 8707 Email: join@hansonwade.com www.clinicalgenomics-usa.com
  • 2. Boston 28th-30th January 2014 From past attendees 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 “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 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 “I enjoyed the meeting very much. The size was ideal to encourage communication and networking.” 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 Complete Genomics “All very motivated, well spoken speakers. Very good presentations overall. Topics were well selected.” 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. Actelion “It exceeded my expectations. The talks were high quality and the interaction among participants was excellent.” Genentech Best wishes and hope to see you in Boston. Seth Crosby Director, Partnerships & Alliances Washington University School of Medicine Chairman of Clinical Genomics 2014 Tel: +44 (0)203 141 8707 Email: join@hansonwade.com “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 www.clinicalgenomics-usa.com
  • 3. Boston 28th-30th January 2014 Speakers Kelci Miclaus Research Statistician Developer JMP Life Sciences, SAS Association Brian Dougherty Translational Genomics Lead AstraZeneca Catherine Brownstein Research Sequencing Project Manager Boston Children’s Hopital Jun Li Senior Research Investigator Bristol-Myers Squibb Sanjay Rakhade Director, Global Clinical Development Genzyme Birgit Funke Director, Clinical R&D Laboratory for Molecular Medicine Harvard Medical School Joe Monforte Independent Consultant David Smith Professor, Laboratory of Medicine & Pathology Mayo Clinic Ken Chang Clinical Assay Development & Outsourcing Lead Merck Saumya Pant Clinical Development Research Fellow Merck Sunita Badola Senior Manager, Translational Medicine Millennium Rong Chen Director, Clinical Genome Informatics Mount Sinai School of Medicine Matthew Lebo Assistant Laboratory Director Partners Healthcare Mollie Roth Managing Partner PGx Consulting Pia Gargiulo Independent Consultant Nadeem Sarwar Senior Director, Worldwide Clinical Research, Pfizer Mitchell Martin Director, Predictive Medicine, Oncology Regeneron Oscar Puig Biomarker & Experimental Medicine Leader Roche Justin Klekota Scientist II Takeda Shashikant Kulkarni Head, Clinical Genomics Washington 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.” Seth Crosby Director, Partnerships & Alliances Washington University School of Medicine Tel: +44 (0)203 141 8707 Integrated DNA Technologies Email: join@hansonwade.com www.clinicalgenomics-usa.com
  • 4. Boston 28th-30th January 2014 Conference Workshops Workshop A: Incorporating NGS into Companion Diagnostics Date: 28th January 2014, Time: 9 - 12 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. Workshop Leaders Matthew Lebo Assistant Laboratory Director, Whole Genome Sequencing Partners Healthcare Center for Personalized Genetic Medicine 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 • 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. Evaluate what NGS technologies and services are available to you to successfully to optimize your patient population approaches “Excellent cross section of core science, regulatory, commercialization and project management from both pharma and diagnostic companies. Very educational” Eli Lilly 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 • Workshop Leaders David Smith Professor, Laboratory of Medicine Pathology Mayo Clinic The laboratory of David Smith uses the most cuttingedge 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. The clinical vision for sequencing platforms • 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. A presentation from laboratories already using NGS as a routine part of clinical practice 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. See next page for more conference workshops Tel: +44 (0)203 141 8707 Email: join@hansonwade.com www.clinicalgenomics-usa.com
  • 5. Boston 28th-30th January 2014 Workshop C: Issues with Developing and Implementing NGS Technologies: A Lifespan Review Date: 28th January 2014, Time: 4 - 7 Workshop Leaders As we move closer towards integrating Next Gen Sequencing into clinical practice, we continue to face numerous hurdles across the developmental lifespan from early RD through application in clinical trials through to understanding how to drive commercial success of these tests in the targeted therapy space. Mollie Roth Managing Partner PGx Consulting 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. Joe Monforte Independent Consultant 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 Gargiuli Independent Consultant 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 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. 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. Media Partners Tel: +44 (0)203 141 8707 Email: join@hansonwade.com www.clinicalgenomics-usa.com
  • 6. 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 RD 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 Tel: +44 (0)203 141 8707 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 Forum An 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 Email: join@hansonwade.com www.clinicalgenomics-usa.com
  • 7. Boston Day 2 - 30th January 2014 Making the Case for Genomics in Clinical Medicine 08.00 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 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 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 RD to ensure each clinical candidate has a complimentary biomarker when it reaches the clinic Brian Dougherty, Translational Genomics Lead, AstraZeneca 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 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 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 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 Tel: +44 (0)203 141 8707 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 Email: join@hansonwade.com www.clinicalgenomics-usa.com
  • 8. Boston 28th-30th January 2014 “Good meeting – great selection of speakers. The speed networking was very effective to connect with all participants.” PwC Spotlight Partner 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. Why Sponsor Clinical Genomics 2014? 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. What Options are Available? Who Should Sponsor? 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. Tel: +44 (0)203 141 8707 Email: join@hansonwade.com Sequencing Companies Genomic CROs Genomic Data Storage Analysis Software Companies Diagnostics Developers Target Discovery Companies For information on sponsorship, please contact Diane McKenna at: sponsor@hansonwade.com or call +44 (0) 20 3141 8746 If you have any questions about the program, contact: izzy.scott-moncrieff@hansonwade.com For media and marketing queries, contact: craig.love@hansonwade.com www.clinicalgenomics-usa.com
  • 9. Boston 28th-30th January 2014 SPX Priority code: Event Prices Register Tel: +1 (212) 357 5898 Email: info@hansonwade.com Package Register before Friday 6th December 2013* Standard Prices* 2 day conference + 3 workshops $3698 (save $500) $3898 (save $300) Team Discounts 2 day conference + 2 workshops $3197 (save $400) $3597 • 10% discount – 3 delegates • 15% discount – 4 delegates • 20% discount – 5 or more delegates 2 day conference + 1 workshop $2698 (save $300) $2998 Please note that discounts are only valid when three or more delegates from one company book and pay at the same time. 2 day conference $2199 (save $200) $2399 Workshops (each) $599 $599 Mail: Hanson Wade 304 Park Avenue South, 11th Floor New York, NY 10010 Venue and Accommodation Hyatt Regency Boston 1 Ave De Lafayette, Boston, MA 02111, United States Accommodation Overnight accommodation is not included in the registration fee, however accommodation options will be sent out with your confirmation email upon registering. Please select your choice of Workshop: A B C There is a 40% discount available for not-for-profit institutions. For more information please email: register@hansonwade.com *All discount offers (including team discounts) require payment at the time of registration to receive any discount. ‘Early Bird’ discounts require payment at time of registration and on or before the cut-off date to receive any discount. All discount offers cannot be combined with any other offer. The conference fee includes lunch, refreshments and course documentation. The fee does not include travel or hotel accommodation. Delegate Details Title: Forename: Surname: Job Title: Company/Organization: Email: Direct Manager: Address: Country: Direct Telephone: Direct Fax: Mobile: Switchboard: Postcode: Signature: Date: Payment Details Number of delegates: Amount: $ Conference Documentation: Card No: Credit Card: Visa Valid from: / Mastercard Amex Expiry Date: / Cardholders name: Signature: Date: Card billing address: TERMS CONDITIONS Changes to Conference Agenda: Hanson Wade reserves the right to postpone or cancel an event, to change the location or alter the advertised speakers. Hanson Wade is not responsible for any loss or damage or costs incurred as a result of substitution, alteration, postponement or cancellation of an event for any reason and including causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade or industrial disputes, terrorism or hostilities. Data Protection: The personal information shown and/or provided by you will be held in a database. It may be used to keep you up to date with developments in your industry. Sometimes your details may be obtained or made available to third parties for marketing purposes. If you do not wish your details to be used for this purpose, please write to: Database Manager, Hanson Wade, Charter House, 13-15 Carteret Street, London SW1H 9DJ Hanson Wade Limited. Registered in England Wales. Company No: 6752216 Tel: +44 (0)203 141 8707 Email: join@hansonwade.com www.clinicalgenomics-usa.com Code: 4095 Full payment is due on registration. Cancellation and Substitution Policy: Cancellations must be received in writing. If the cancellation is received more than 14 days before the conference attendees will receive a full credit to a future conference. Cancellations received 14 days or less (including the fourteenth day) prior to the conference will be liable for the full fee. A substitution from the same organization can be made at any time.