understand functionality to interpret disease causality ......vedanta biosciences nicholas schork...

June 28th-30th, 2016 Boston, MA

20+ Expert Speakers Include:

Partner:

David Cook Executive Vice President of R&D & Chief Scientific Officer Seres Therapeutics

Jeffrey Riley Chief Executive Officer, President & Director Synthetic Biologics

Bernat Olle Co-Founder, Chief Executive Officer, Member of BOD Vedanta Biosciences

James Collins Termeer Professor of Medical Engineering & Science MIT

Matthew Steele Primary Reviewer & RPM FDA

Pierre Belichard Chief Executive Officer Enterome

Jim Brown Director, Computational Biology GSK

David Berry General Partner Flagship Ventures

Jackie Papkoff Vice President, Immunology Scientific Innovation Johnson & Johnson

Understand Functionality to Interpret Disease CausalityValidate Targets to Accelerate Translational SuccessDemonstrate Clinical Efficacy & Commercial Viability

www.microbiome-summit.com

Book now and save up to $800

June 28th-30th, 2016 Boston, MA

Researched & Developed by:

Tel: +1 212 537 5898 | Email: [email protected]

Tel: +1 212 537 5898 Email: [email protected]


Microbiome Drug Development Summit Boston, MA | June 28th-30th, 2016

The first end-to-end summit dedicated solely to translational microbiome drug developmentAt this critical moment in the field’s history, the Microbiome Drug Development Summit will provide you with the complete toolkit to overcome the barriers of entry to this dynamic field and tailor your research and investment to seize the clinical utility and commercial opportunity within the microbiome.

Utilizing a discussion, case study and networking-driven agenda, the Microbiome Drug Development Summit will ensure that those harnessing the functionality of the microbiome will translate this exciting science into clinical breakthroughs and commercially-viable therapies.

Specifically designed for those who are looking to break into the field through partnerships, investment and research, as well as the pioneers, this years summit will focus on translational drug development in a chronological format that drills down into distinct therapeutic approaches.

As fundamental scientific understanding, investment and clinical successes are poised to advance at an ever increasing rate, now is the time to ensure that you become part of the microbiome revolution.

Industry PioneersWith an industry-defining speaker faculty, join the field’s pioneers as well as its most exciting innovators to ensure you can translate the key microbiome breakthroughs to empower your strategy and research.

Establish clinical efficacy by learning from the front-running biotech, early adopters from large pharma, biggest investors and leading translational academics.

Welcome to the Microbiome Drug Development Summit 2016As microbiome research races into the clinical mainstream, the Microbiome Drug Development Summit 2016 will ensure that you don’t miss out on the next big drug development opportunity. Accelerate translational research and deliver to market the next generation of safe, effective and commercially viable microbiome therapeutics.

Interactive FormatsCollaboratively learn, network and have in-depth discussions around the crucial topics in this emerging collaborative ecosystem.

Panel sessions, roundtables, speed networking, workshops will provide you with a multitude of opportunities to have in-depth discussions around the greatest drug development challenges and opportunities in order to maximize the therapeutic potential of the microbiome.

Drug DevelopmentCase studies on high throughput screening, NGS, clinical trial design, scaling-up manufacturing, regulatory approval and many more specific challenges will be debated to ensure you are fully primed for innovative R&D success.

Discuss fecal transplantation, cocktails of microorganisms, small molecules and gene-editing, and overcome the specific challenges related to the current and future generations of therapies.

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Hear From the Experts




Overcome the clinical challenges specific to microbiome drug development including clinical trial design, scaling up and industrial manufacturing

Advance the commerciality of your microbiome targeting therapies with guidance on intellectual property, go-to-market strategy and reimbursement

Top 10 Reasons to Attend Microbiome Drug Development Summit 2016:

Build solutions for the translational approaches, high throughput screening, mouse models and computational model development

Understand how to overcome the barriers of entry for big pharma through analyzing partnership models and what needs to be “resized” for large drug developers to succeed

Progress your microbiome research from correlative hypotheses to causative understanding that delve deeper into strain-specific knowledge

Validate driver biomarkers in microbiome-related disease progression to develop robust translational and clinical experiments and protocols

Anticipate the evolving regulatory landscape facing microbiome therapies to ensure that you are up to date with the latest discussions with the FDA and abroad

Secure funding for your organization by understanding what investors are looking for when deciding where to invest

Breakthrough the NGS data analytical challenges to uncover a deeper and broader array of validated therapy targets

Gain appreciation for the translational applications of microbiomes outside of the gut including the skin, vaginal and oral microbiomes

Rodolphe Clerval Chief Business Officer Enterome

Colleen Cutcliffe Chief Executive Officer & Co-Founder Whole Biome

Nick Conley Chief Executive Officer EpiBiome

“This will be the event for leading drug developers to learn from latest case studies and detailed discussion with the goal of accelerating translational and clinical research of microbiome targeting drug candidates.”

“This Summit is different in that it is entirely devoted to microbiome drug development. It’s designed to allow active participation from both biotech and large pharma and focuses on the key areas of commercialization and science.”

“The program for this Summit really stands out for me. It mixes interactive discussion-led sessions and data-driven case studies and is specifically focused on advancing microbiome drug development.”




Speakers

Mark Bodmer Chief Scientific Officer & President of R&D Evelo Biosciences

Matthew Steele Primary Reviewer & RPM FDA

Jim Brown Director, Computational Biology GSK

Pierre Belichard Chief Executive Officer Enterome

Ran Blekhman Assistant Professor University of Minnesota

James Collins Termeer Professor of Medical Engineering & Science MIT

Nick Conley Chief Executive Officer EpiBiome

David Cook Executive Vice President of R&D & Chief Scientific Officer Seres Therapeutics

Colleen Cutcliffe Chief Executive Officer & Co-Founder Whole Biome

Susan Finston Chief Executive Officer Amrita Therapeutics

David Steinberg Co-Founder & Executive Vice President, Company Creation Puretech Ventures

Jeffrey Riley Chief Executive Officer, President & Director Synthetic Biologics

Jackie Papkoff Vice President, Immunology Scientific Innovation Johnson & Johnson

Larry Weiss Chief Medical Officer AOBiome

Bruce Roberts Chief Scientific Officer Vedanta Biosciences

Nicholas Schork Professor & Director, Human Biology J. Craig Venter Institute

Greg Sieczkiewicz Managing Director, Chief IP Counsel MPM Capital

Mark Smith Research Director & Co-Founder OpenBiome

Rodolphe Clerval Chief Business Officer Enterome

This is the first conference I have been to that is so relevant and applicable directly to my role. I love the interactive elements and the networking opportunities. The contacts I have made are well worth the cost of the conference. Topics timely, excellent speakers.

Past Hanson Wade Attendee

David Berry General Partner Flagship Ventures

Isabelle de CremouixPresident & Chief Executive OfficerSeventure Partners

Bernat Olle Co-Founder, Chief Executive Officer, Member of BOD Vedanta Biosciences

Conference Day One Wednesday June 29th 20168.00 Registration & Breakfast

09.00 Chairman’s Opening RemarksLarry Weiss, Chief Medical Officer, AOBiome

Harnessing the Microbiome for Therapeutic Development

9.10 State of Address: The Evolution of Drug Development Targeting the Microbiome• A brief look at the recent history of harnessing the microbiome for

therapeutic targets• Understand what the key breakthroughs have been along this

journey and what is needed to accelerate this progress further• A look at the key research and case studies that have opened the

flood gates for microbiome R&D and what is needed to fuel further investment

David Cook, Executive Vice President of R&D & Chief Scientific Officer, Seres Therapeutics

9.40 Pioneer’s Panel: Building a Roadmap to Microbiome Drug Development Success• What are the key success factors that have already led us to this

point on our journey?

• What are the key scientific breakthrough’s needed to further accelerate microbiome drug development?

• How do we cut through the “noise” in the microbiome to identify true disease casualty?

• What needs to be realized from a commercial standpoint to facilitate marketed success?

• What do we need to see from the regulatory agencies to help build the roadmap to success?

• How do we look to increase funding and investment in the field?

• What are we expecting to learn at Microbiome Drug Development Summit 2016?

David Cook, Executive Vice President of R&D & Chief Scientific Officer, Seres Therapeutics

Bernat Olle, Co-Founder, Chief Executive Officer, Member of BOD, Vedanta Biosciences

Jeffrey Riley, Chief Executive Officer, President & Director, Synthetic Biologics

Pierre Belichard, Chief Executive Officer, Enterome

David Berry, General Partner, Flagship Ventures

10.20 Speed Networking & Morning Refreshments

High Throughput Screening & Pre-Clinical Modeling

11.40 Next Generation Sequencing and the Microbiome• Understand how next generation sequencing was one of the crucial

step changes to open up translational microbiome research and development

• What have been the scientific breakthroughs with the application of NGS to the microbiome?

• Understand how we are looking to breakthrough the data analytical bottleneck to accelerate the application of this technology even further

Colleen Cutcliffe, Chief Executive Officer & Co-Founder, Whole Biome

12.10 Designing Mouse Models to Improve Microbiome Drug Translation • A look at the major challenges for designing mouse models for

microbiome based drug development• This presentation will showcase how research groups looking to

overcome challenges of colonizing mice with human microbiome• What is the future of gnobiotic mouse models for microbiome

drug development?

Nick Conley, Chief Executive Officer, EpiBiome




12.40 Networking Lunch

Translating Scientific Potential into Clinical Results

2.10 Design of Efficient Clinical Trials Leveraging the Microbiome• Understand how patients can be optimally selected for clinical trials

on the basis of their microbiome profiles• Understand how more efficient clinical trial designs can be achieved

repeatedly sampling the microbiome over time• Understand how patient-oriented trials targeting the microbiome

can be pursued that result in general biological insights as well as cater to individual patient needs

Nicholas Schork, Professor & Director, Human Biology, J. Craig Venter Institute

2.40 Generation and Development of Defined Microbial Drug Products• Selection of combinations of bacterial strains based on

functional characterization• Optimization of consortia composition via bioinformatics analysis

and pharmacologic evaluation• Scale-up, manufacture and characterization of defined products

Bruce Roberts, Chief Scientific Officer, Vedanta Biosciences

3.10 Panel Session: Building the Future Microbiome Drug Development Protocol • What are the key manufacturing hurdles that need to be overcome

to scale-up microbiome drug development?• How can big pharma best influence the drug development “machine”

for the microbiome?• How early should we be thinking about commercialization of

microbiome products?• What are we looking for with CRO partners in this space?• How do we ensure that drug development is built for long-term

sustainable success?• Will there ever be a “master protocol” of conducting drug

development with the microbiome?• How much of a hurdle are drug delivery challenges with microbiome

targeting therapies?


Colleen Cutcliffe, Chief Executive Officer & Co-Founder, Whole Biome

Bruce Roberts, Chief Scientific Officer, Vedanta Biosciences

Nicholas Schork, Professor & Director, Human Biology, J. Craig Venter Institute

3.40 Afternoon Refreshments

Breakout Roundtables: Seizing the Microbiome

Mark Bodmer, Chief Scientific Officer & President, R&D, Evelo Biosciences


• Microbiome and Cancer – What are the emerging applications of the microbiome into oncology and immuno-oncology research and development?

• Regulating Microbiome Therapies – What are the current and future regulatory landscapes for microbiome-harnessing therapeutic development?

• Impact of the Microbiome Therapies on the Healthcare System – How do we anticipate what the changes from microbiome drug development will be on the healthcare system?

• Targeting the Microbiome Outside of the Gut – Where outside of the gut is microbiome expected to have the next biggest therapeutic impact?

• Chatham House Rules C-Level Roundtable – Exclusively for C-Level executives, utilize this closed-doors unrecorded session to discuss the latest and greatest personal challenges in microbiome drug development

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5.10 End of Day One




Conference Day Two Thursday June 30th 20168.00 Breakfast & Networking

9.00 Chairman’s Opening RemarksLarry Weiss, Chief Medical Officer, AOBiome

Proving Microbiome Disease Causation & Biomarker Validation

9.05 Synthetic Biology and Microbiome Engineering• Understand how synthetic biology is bringing together engineers, physicists and

biologists to model, design and construct biological circuits out of proteins, genes and bits of DNA, to use these circuits to rewire and reprogram microbiome organisms

• An in-depth look at the development of engineered microbes to detect and treat gut pathogens as well as other microbiome-related conditions

• Analyze the development of synthetic biology devices to modify and sculpt the microbiome for therapeutic purposes

James Collins, Termeer Professor of Medical Engineering & Science, MIT

9.35 The Microbiome in Respiratory Diseases• How might the lung microbiome play a role in the pathology of respiratory diseases?• Can we used the lung microbiome as biomarkers for patient stratification or response?• What is the potential for new therapeutics targeting the lung or gut microbiome?

Jim Brown, Director, Computational Biology, GSK

10.05 Biomarker Validation in Microbiome: SMAR1 Case Study• Understanding the therapeutic importance of targeting the “master-regulator”

SMAR1 biomarker• Demonstrating the value of the SMAR1 biomarker for development of a companion

diagnostic for patient identification for AT-01C therapy• Showcasing the effectiveness of AT-01C therapy with demonstrated tumor-shrinking,

anti-metastasis and anti-inflammatory activity in solid tumors

Susan Finston, Chief Executive Officer, Amrita Therapeutics

10.35 Morning Refreshments

Seizing the Opportunity: Big Pharma’s Role in Microbiome Drug Development

11.05 Partnering and Research Models of Big Pharma with the Microbiome• Understand the different partnership and investment models big pharma are employing• A look at how best to utilize your research approaches, internal expertise and business

models to develop a successful pharma-biotech relationship• Future dynamics of big pharma to facilitate new partnerships and research models

Rodolphe Clerval, Chief Business Officer, Enterome

11.35 Discovering New Disease Mechanisms and Immunology Therapeutic Strategies Through Exploring the Microbiome• Understand how microbiota interact at the interface of the immune system host

genetics and tissue environment• Perspectives on new opportunities and challenges in an exciting, emerging space:

how could discoveries in the microbiome translate to new therapeutic strategies?• Introduction to Janssen immunology and highlights of ongoing R&D activities and

collaborations in the microbiome space

Jackie Papkoff, Vice President, Immunology Scientific Innovation, Johnson & Johnson

12.05 Panel Session: How do we Continue to Advance Microbiome Drug Development with Big Pharma?• How can we lower the barriers of entry and demonstrate a path forward for big

pharma into microbiome drug development?• How do big pharma need to adapt their understanding of classical small molecule

drug discovery and development to the microbiome?• Has the microbiome horse already bolted? Have the first movers already got and

uncatchable advantage?• How best to set up and run “innovation”-style groups to harness the microbiome?• What are big pharma looking for when deciding who to partner with?• What about the future of small molecule drug development targeting the microbiome?• How can the big pharma “machine” be best used to accelerate microbiome R&D?

Rodolphe Clerval, Chief Business Officer, Enterome

Jackie Papkoff, Vice President, Immunology Scientific Innovation, Johnson & Johnson

David Steinberg, Co-Founder & Executive Vice President, Company Creation, Puretech Ventures




12.35 Networking Lunch

Value Based Development: Commercialization of Microbiome Therapies

1.35 Regulation of Microbiota-Based Products• Understand how and why of regulation of microbiota-based products

by CBER at the FDA exists

• A look at the history, as well as the current regulatory paradigms for microbiota-based therapies

• Discussion on the general contents of a new IND and some of the resources available to help industry

Matthew Steele, Primary Reviewer & RPM, FDA

1.55 Understanding the Intellectual Property and Exclusivity Landscape of the Microbiome• Understand what the global microbiome IP landscape looks like and

how this is likely to change

• Challenges and opportunities of a shifting landscape of patentable subject matter

• The issues of complexity and degeneracy: what impact are strain differentiation challenges having on microbiome IP?

Greg Sieczkiewicz, Managing Director, Chief IP Counsel, MPM Capital

2.05 Panel Session: Commercializing Microbiome Drug Development• Blockbusters vs. Nichebusters: How will microbiome-targeted

therapeutics scale to the population level and how do we tailor study design to this approach?

• How can we draw on the experiences from disease areas that have already experienced commercial success that are now being targeted through the microbiome?

• What role should big pharma be playing to help commercialize the field?

• How do we build manufacturing processes into intellectual property conversations?

• What regulatory conversations need to take place to further advance microbiome therapy development?

• What information needs to be considered when discussing pricing of microbiome therapies?

• How do build strategies for true global commercialization of microbiome therapies?

Greg Sieczkiewicz, Managing Director, Chief IP Counsel, MPM Capital

Matthew Steele, Primary Reviewer & RPM, FDA

2.55 Afternoon Refreshments

Funding & Investing in the Microbiome

3.25 Panel Session: Will Microbiome Drug Development Live Up to the Hype and Deliver ROI?• What needs to be demonstrated to investors who are looking to fund

the space?

• How will moving past targeting C.difficile influence investment in the microbiome?

• Is a success for one company in the space truly a success for everyone?

• How do we manage expectations with regards to long development cycles in the space?

• How much mechanistic understanding will need to be uncovered to negate scepticisms from investors?

David Steinberg, Co-Founder & Executive Vice President, Company Creation, Puretech Ventures

David Berry, General Partner, Flagship Ventures

Isabelle de CremouixPresident & Chief Executive Officer

Seventure Partners

4.05 Chairman’s Closing Remarks & End of Summit




Conference Workshops

Workshop A: Fundamental Guide to Microbiome Drug Development

Workshop B: Targeting Cancer Through the Microbiome




Breaking into the field of microbiome drug development and turning this exciting science into successful therapies has a distinct set of entry challenges.

From next generation sequencing and high throughput screening to commercialization and regulatory approval, the barriers to entry for harnessing require in-depth understanding to overcome.

As the field of microbiome drug development rapidly advances into the clinical mainstream, now is the time to analyze the fields potential and decide how and where to conduct your research and partnerships.

Leave this workshop with:

• A comprehensive understanding of the major challenges and opportunities when breaking into microbiome drug development

• In-depth insight into the gaps in our fundamental scientific understanding of the microbiome and how these are acting as a bottleneck to commercial applications

• Detailed questions to take into the main conference to ensure that you get all the answers you need when deciding how you will look to invest in microbiome drug development

Date: Tuesday June 28th, 2016 Time: 9.00 - 12.00Mark Smith Research Director & Co-FounderOpenBiome

Nick Conley Chief Executive OfficerEpiBiome

The rapidly emerging relationship between the human microbiome and cancer is opening up scores of oncology and immuno-oncology therapeutic applications which harness the microbiome.

As our scientific understanding of the microbiome continues to rapidly improve, it is paramount that leading researchers in the space fully appreciate the most promising approaches to drug development in the space and envisage how this the relationship with cancer research will blossom.

As these two hot areas of research come together, now is the time to understand how we can continue to fuel this dynamic relationship.

Leave this workshop with:

• A comprehensive understanding of the major breakthroughs in oncology research targeting the human microbiome

• In-depth insight into the latest and greatest scientific challenges and opportunities when looking to increase our fundamental understanding of the human microbiome in response to cancer

• A look at what future commercial microbiome-targeting cancer therapeutic products will look like

Date: Tuesday June 28th, 2016 Time: 1.00 - 4.00Ran Blekhman Assistant Professor

University of Minnesota

Mark BodmerChief Scientific Officer & President, R&DEvelo Biosciences

Snapshot of Attending Companies

Audience Breakdown

Become a Partner

Email: [email protected]

Contact

Mo Langhi Commercial Manager

Tel: +1 212 537 5898

Partnership Opportunities

The Microbiome Drug Development Summit 2016 is dedicated to translating ground-breaking science into clinically successful drug candidates, with the fields pioneers and most exciting newcomers in attendance.

As the field rapidly advances, these therapies are being poised as the next drug revolution that will require a collaborative ecosystem of service providers to succeed. The Microbiome Drug Development Summit enables the community to establish long term commercial partnerships to safeguard and deliver the current and future generations of microbiome targeting therapies.

Several opportunities exist to educate the industry on your products or services through speaking engagements, exhibition and branding, through which you will be able to connect to your future clients.

The BioCollective

The BioCollective is a collaborative that is revolutionizing microbiome healthcare by enabling individuals to be part of their own health solutions. Its collective nature and holistic, original approach sets us apart from others in the field. Serving both the scientific community and individuals, The BioCollective provides storage for personal microbiome samples that can be used later for the restoration of healthy microbiomes after disruptive events (surgery, antibiotic, radiation treatment, etc.) as well as develops single microbiome strains to supplement the restorative process. The collaborative also is an invaluable source for researchers to access data that can help propel scientific progress.

www.thebiocollective.com

Exhibitor




Director Level or Above 77%

Biotech

Large Pharma

Solution Providers

Academics & Not-for-Profits

Other, inc Investors

45%

20%

15%

10%

10%

Attendance By Sector

Prices & Discounts

Code: 6499

Venue

* ‘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.

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 organisation can be made at any time.

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.

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Terms & Conditions

Registerwww.microbiome-summit.com/register/


Mail: Hanson Wade 4th Floor, 52 Grosvenor Gardens, London, SW1W 0AU United Kingdom

• 10% discount – 3 delegates • 15% discount – 4 delegates • 20% discount – 5+ delegates

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

Team Discounts

Industry Register & Pay before Friday March 18th 2016Register & Pay before Friday April 22nd 2016

Register & Pay before Friday June 3rd 2016

Standard Prices

Conference + 2 Workshops $3297 (save $800) $3497 (save $600) $3697 (save $400) $3797 (save $300)

Conference + 1 Workshop $2698 (save $700) $2898 (save $500) $3098 (save $300) $3198 (save $200)

Conference Only $2099 (save $600) $2299 (save $400) $2499 (save $200) $2699

Workshops (each) $699

Academic Register & Pay before Friday March 18th 2016Register & Pay before Friday April 22nd 2016

Register & Pay before Friday June 3rd 2016

Standard Prices

Conference + 2 Workshops $2097 (save $500) $2197 (save $400) $2297 (save $300) $2397 (save $200)

Conference + 1 Workshop $1698 (save $400) $1798 (save $300) $1898 (save $200) $1998 (save $100)

Conference Only $1299 (save $300) $1399 (save $200) $1499 (save $100) $1599

Workshops (each) $499




Hyatt Regency Boston One Avenue de Lafayette, Boston, Massachusetts, USA, 02111

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Overnight accommodation is not included in the registration fee, however accommodation options will be sent out with your confirmation email upon registering.

understand functionality to interpret disease causality ......vedanta biosciences nicholas schork...

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