TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580 DISRUPTIVE INNOVATIONS 3RD ANNUAL DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS CHALLENGING THE STATUS QUO WITH BOLD IDEAS TO CHANGE THE PACE OF CLINCIAL TRIALS SEPTEMBER 19 - 20, 2013 THE FAIRMONT COPLEY PLAZA, BOSTON, MA Craig H. Lipset, MBA Head of Clinical Innovation, R&D Pfizer, Inc. Jeff Kasher, PhD VP, Clinical Trial: Materials, Implementation and Transportation Eli Lilly John Orloff, MD SVP, Global Development & CMO Novartis Pharma AG Andreas Koester, MD, PhD VP, Clinical Trial Innovation & External Alliances Janssen Healthcare Innovation CO-CHAIRED BY Keynote Fireside Chat with Krishna Yeshwant, MD General Partner Google Ventures NEW FOR 2013 THOUGHT PROVOKING CASE STUDIES MIT Clinical Trial Hackathon Results with Zen Chu Faculty Director & Entrepreneur in Residence MIT Disruptive Thinkers with John J. Whyte, MD, MPH Chief Medical Expert and VP, Health & Medical Education Discovery Channel How Not to Do a Traditional Clinical Trial with Genzyme Innovation in Alternative Clinical Settings: The Walgreens-Novartis Collaboration with Novartis & Walgreens An Interview Series of Disruptive Thinkers with Medimmune, Center for Connected Health & VA Boston Healthcare Follow us on Twitter @ConferenceForum #DPharm Organized by Lead Sponsor Supporting Partners Executive Sponsors
Transcript
TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580
DISRUPTIVE INNOVATIONS3RD ANNUAL DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS
CHALLENGING THE STATUS QUO WITH BOLD IDEAS TO CHANGE THE PACE OF CLINCIAL TRIALS
SEPTEMBER 19 - 20, 2013 THE FAIRMONT COPLEY PLAZA, BOSTON, MA
Craig H. Lipset, MBAHead of Clinical Innovation, R&DPfizer, Inc.
Jeff Kasher, PhDVP, Clinical Trial: Materials, Implementation and TransportationEli Lilly
John Orloff, MDSVP, Global Development & CMONovartis Pharma AG
TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580
Each year, dozens of conferences and meetings are held to discuss specific challenges within clinical trials. Many events are tactical in nature, focusing independently on topics ranging from financing approaches, protocol design, partnering models between sponsors and clinical trial sites, technology trade shows, etc. By focusing on narrow aspects of clinical trials, past conferences have not effectively taken the necessary high-level, systemic view needed to identify innovations that can leapfrog inefficiencies in clinical trials.
The Conference Forum is presenting the 3rd Annual Disruptive Innovations to Advance Clinical Trials event. This conference is designed for drug development innovative thinkers who are determined to re-invent clinical trials. It is an outcomes-focused program that not only delves deeply into the key strategic factors impeding clinical trial productivity, but also connects change makers who can share current solutions, propose new solutions and commit to testing them and share the results. This conference is designed to be engaging in a highly informative format, similar to the style of TED events.
Focus & Objectives• This is a TED-style event showcasing innovations and
leading practioners in Pharma R&D with a focus on clinical research as well as innovative leaders from other industries.
• We strive to underscore the promise and challenge of innovation in advancing drug development.
• We strive to innovate a new model and find collaborations to get therapeutics to patients faster.
• We address how we can better apply the full spectrum of clinical research options and utilize insights more appropriately.
• We are dedicated to designing creative solutions and finding a way to implement them.
Jamie Freedman, MD, PhDSVP, Global Clinical DevelopmentMedimmune
Dalvir Gill, PhDCEOTransCelerate
Todd GriscoVP, Retail StrategyWalgreens
Thomas GrundstromVice President, Integrated Processes and TechnologiesQuintiles
Jeff Kasher, PhDVP, Clinical Trial: Materials, Implementation and TransportationEli Lilly
DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS OVERVIEW
OVERVIEW
2
SPEAKING FACULTY
DPharm is the definitive event for innovators in the clinical trial space. The entire conference introduces novel and bold approaches to help attendees think radically different about how we do clinical trials.
TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580
7:45 amBreakfast & Registration
8:30 amChairsʼ Welcome & Opening Address: Avoiding the Trap of Incremental ChangeHow can we be disruptive to change the pace of clinical trials to meet patient needs? What kinds of leadership do we want and need to support disruption and innovation? What is the job description for innovation as a discipline? Our chairs open the 2013 event addressing these questions and more.
Jeff Kasher, PhDVP, Clinical Trial: Materials, Implementation and Transportation, Eli Lilly
Andreas Koester, MD, PhDVP, Clinical Trial Innovation & External Alliances, Janssen, Pharmaceutical Companies of Johnson & Johnson
Craig Lipset, MBAHead of Clinical Innovation, R&D, Pfizer Inc.
John Orloff, MDSVP, Global Development & CMO, Novartis Pharma AG
8:45 amHow Not to Do a Traditional Clinical TrialCan we have clinical trials with out expensive infrastructure while, engaging the patient and generating credible clinical data? In our opening session, Dr Lee shares his story in designing a non-traditional clinical trial to reduce infrastructure, engage patients and generate credible clinical data.
Andrew Lee, MDSVP, Global Clinical Operations, Genzyme
9:15 amInnovation in Alternative Clinical Settings: The Walgreens-Novartis Collaboration
This session presents an example of innovation in an alternative clinical setting. Our presenters address:
• How to further drive clinical trials into the community
• How to make research participation easier for patients and providers
• The technology to make it possible
• Overcoming barriers
John Orloff, MDSVP, Global Development & CMO, Novartis Pharma AG
Todd GriscoVP, Retail Strategy, Walgreens
Joris Van Dam, PhDTranslational Sciences Strategic Project Leader, Novartis Institutes for Biomedical Research
10:00 amKeynote Fireside Chat with Google Ventures
Dr Krishna Yeshwant is a physician, programmer, and entrepreneur who has been working with Google Ventures since its inception. As a physician and life science investor, Dr Yeshwant has a unique perspective on a wide range of new approaches to disrupt drug development. In this fireside keynote chat we will discuss:
• How attractive for VC investors is the notion of disruptive innovation in drug development?
• New approaches to using social and mobile technologies
• How can these new platforms impact drug development?
• How big data can revolutionize healthcare and in particular the current clinical trial model; what are some of the concerns?
Krishna Yeshwant, MD, MBAGeneral Partner, Google Ventures
10:40 amNetworking Break
• Meet with Exhibiting Companies
• One-on-One Meeting Space Available
• Soap Box Presentations
11:15 amInnovation in Regulatory
Regulatory changes to support innovation is happening and our FDA presenter gives us an update on:
• Implementation barriers
• Enrichment strategies
• Safety and Innovation Act
• Patient center initiatives
• Engaging patients in the process from IND
• Approvals after Phase II
Anne Meeker O’ConnellActing Division Director, Good Clinical Practice Compliance, U.S. Food and Drug Administration
DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS AGENDA
TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580
11:45 amAn Interview with TransCelerate’s CEO on Progress & Disruption
TransCelerate BioPharma with the support of ten major biopharmaceutical companies has a mission to develop shared industry research and development solutions to simplify and accelerate the delivery of innovative products to patients. Our co-chairs discuss with the CEO of TransCelerate the following:
• The road map on initiatives and where TranCelerate is going
• How TransCelerate is supporting and implementing initiatives
• Cross industry collaborations on sharing data and what does this really mean for pharma, CROs and Sites?
• What are the shared solutions to kill drugs faster?
• What’s been disruptive?
• What is the end game and when is it going to deliver results
Dalvir Gill, PhDCEO, TransCelerate BioPharma Inc.
12:15 pmPatient eConsent Pilot Results
Paper based consenting is a suboptimal model, resulting in error prone documentation and a non-patient centric delivery of concepts critical to the clinical research process. This session will provide an overview of the business case, rollout and lessons learned from a pilot deployment of multimedia eConsents on the iPAD.
• Clarify the issues related to paper based consents
• Learn about the key lynchpins to success
• Envision the roadmap for the future of this technology and process
• Get ahead of audit findings
• How to improve successful adoption by your organization
Joseph Kim, MBAClinical Operations Director, Shire
12:40 pmLuncheon
2:00 pmAn Interview Series of Disruptive Thinkers hosted by Craig Lipset, Pfizer
Our co-chair Craig Lipset, MBA, Head of Clinical Innovation, Research & Development, Pfizer Inc. interviews the following disruptive thinkers:
Jamie Freedman, MD, PhD, SVP, Global Clinical Development, Medimmune discusses disruptive initiatives on how new technologies are helping informative early Go/No Go decisions in drug development.
Leonard D’Avolio, PhD, Assoc. Center Director, VA Boston Healthcare System on a trial simplification approach through the example of running randomized diabetes clinical trials at point-of-care with the VA EMR. How can we translate this approach to investigational drugs and in other settings to merge care delivery with clinical research at the point of care?
Joseph Kvedar, MD, Director, Center for Connected Health on leveraging existing and emerging tools to conduct trials remotely.
Michael Cantor, MD, Senior Director, Clinical Informatics & Innovation, Pfizer addresses the following questions: What if we could bring together all of the control arm data from our various studies to create a rich and clean database of natural disease progression? How could this resource be used to better design and plan studies? What if we could then bring together the control arm data across research sponsors to create a vast new data resource? Would we still need the same size control arms for future trials?
3:15 pmNetworking Break
• Meet with Exhibiting Companies
• One-on-One Meeting Space Available
3:30 pmThe 2nd Annual Quick Fire Disruptive Technology Presentations in an “American Idol” Format
This section of the program features several short, but impactful presentations by technology disruptive developers and services. Two panels of judges will ask questions and challenge our presenters to tell us how their technologies and services are advancing clinical development. At the conclusion of the session, an award will be given to the most disruptive presenter.
Judges:
Deirdre BeVardVP, Development Operations, Endo Pharmaceuticals
5
AGENDA DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS
Jeff Kasher, PhDVP, Clinical Trial: Materials, Implementation and Transportation, Eli LillyAndreas Koester, MD, PhDVP, Clinical Trial Innovation & External Alliances, Janssen, Pharmaceutical Companies of Johnson & Johnson
Craig Lipset, MBAHead of Clinical Innovation, Research & Development, Pfizer Inc.
Presenting companies to date:Archimedes Spaulding Clinical
CRF Health TrialReach
Cytel Trifecta
Greenphire Verified Clinical Trials
iTrials VIS
Quintiles
5:30 pmNetworking Reception
8:00 amBreakfast
8:45 amChairsʼ Welcome & RecapJeff Kasher, PhDVP, Clinical Trial: Materials, Implementation and Transportation, Eli Lilly
Andreas Koester, MD, PhDVP, Clinical Trial Innovation & External Alliances, Janssen, Pharmaceutical Companies of Johnson & Johnson
Craig Lipset, MBAHead of Clinical Innovation, R&D, Pfizer Inc.
John Orloff, MDSVP, Global Development & CMO, Novartis Pharma AG
9:00 amMIT Hackathon Results to Barriers in Clinical Trials
The Founder of MIT’s Hacking Medicine program will present the results from our Barriers to Clinical Trials Hackathon, including themes, process, solutions and which ideas gained the most traction as viable solutions and ventures.
Zen Chu, MBAFaculty Director and Entrepreneur-In-Residence, MIT
9:45 amVIP Guest Session: The Mobile Banking Revolution in Africa: What can Drug Developers Learn from this Extraordinary Example of Disruption?
Bernhard Warner is a reporter who writes about disruptive innovation across a multitude of industries for Bloomberg Businessweek and other publications. In this session, Mr Warner will tell us about one of the greatest examples of disruption transforming Africa. Following his insightful story, Dr Andrew Lee, SVP, Global Clinical Operations, Genzyme will join Mr Warner in an open discussion on what we can learn and apply to clinical trials.
Bernhard WarnerReporter, Columnist, Bloomberg Business Week
Andrew Lee, MDSVP, Global Clinical Operations, Genzyme
10:30 amExecuting Disruptive Innovation: What You Need to Know and Do to Have Breakthrough Performance
Peter J. Valenti III, MBAformerly EVP and Global President, Vision Care, Bausch + Lomb
Jennifer ZimmerPartner, Insigniam
11:00 amNetworking Break
• Meet with Exhibiting Companies
• One-on-One Meeting Space Available
11:30 amDiscovery Channel Interview Series
John J. Whyte, MD, MPH, Chief Medical Expert & VP, Health and Medical Education, Discovery Channel interviews prominent healthcare voices disrupting thought and leadership to advance health care.
DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS AGENDA
TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580
Interviews:
Jeff Carroll, PhD, Patient Advocate, is a prominent scientific researcher in the field of Huntington’s Disease. He is also a public advocate for families affected by the disease, and co-founder of the HD research news platform HD Buzz. His life and work were the subject of a 2011 Gemini award nominated CBC documentary feature. Jeff Carroll is an Assistant Professor of Neuroscience in the Department of Psychology, Western Washington University.
Jules T. Mitchel, PhD, MBA, President, Target Health and John Orloff, MD, SVP, Global Development & CMO, Novartis Pharma AG discuss eSourcing and other technologies to bring innovation to life and how we can use fewer patients in clinical trials.
2012 presenters, Elise Felicione, MPH, Director, Clinical Trial Innovation, Janssen, Pharmaceutical Companies of Johnson & Johnson and Mike Luker, Director, Clinical Research, Eli Lilly discuss where they are a year later with their Cross-Pharma Pre-Competitive Investigator Databank Project.
12:40 pmLuncheon
1:45 pmDisruptive Case Study on Next Generation Clinical Monitoring
Eugene PatinHead of US Clinical Operations, Novartis
2:15 pmThe Pfizer Blue Button Project: Engaging Patients by Sharing Electronic Clinical Data
In 2013 Pfizer will launch the Pfizer Blue Button Project, a first-of-it’s-kind initiative enabling patients who have participated in clinical trials the opportunity to download their individual clinical data. Using the Blue Button standard launched by the White House, patients will be empowered to use the data to improve their overall health and wellness, from sharing with healthcare providers to powering clinical risk assessments. In this session Pfizer will share more on why they have launched this initiative, initial learnings, and where the project may go if successful.
3:00 pmThe Investigator POV: What Disruption is Needed to Achieve Better Relationships
After DPharm 2012, it was highly requested to hear the voice of the investigator to help us candidly understand
what is needed to greatly improve our relationship with them. This interview style session with investigators addresses:
• What do we have to do to bring investigators back?
• What are the new ways we can attract investigators?
• Solutions to every day site challenges
• Thoughts on protocol writing
• What would make a great relationship?
Moderated by:
Andreas Koester, MD, PhDVP, Clinical Trial Innovation & External Alliances, Janssen, Pharmaceutical Companies of Johnson & Johnson
Christine PierrePresident, Society for Clinical Research Sites
Investigators:
Jeff Kingsley, DOInvestigator & CEO, SERRG, Inc.
Michael Koren, MDInvestigator & Founder, Florida Physicians and Research Associates
Jeffrey Rosen, MDMedical Director, Clinical Research of South Florida
3:45 pmClinical Trial Visit of the Future: Interactive SessionThis session will simulate a future clinical trial visit using emerging technologies followed by a discussion on opportunities and challenges to include patient access, recruitment and retention. Also discussed will be uses of novel technologies in clinical trials and regulatory/patient safety implications.
Craig H. Lipset, MBAHead of Clinical Innovation, Worldwide Research and Development, Pfizer Inc, United States
Tomasz Sablinski, MD, PhDFounder & CEO, Transparency Life Sciences
Komathi StemSenior Director, Product Development, Innovation Lead, Genentech, A Member of the Roche Group, United States
4:45 pmConference Concludes
AGENDA DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS
TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580
Global Clinical Trials takes place the day before the Disruptive Innovations to Advance Clinical Trials event on September 18, 2013. A special rate is available for those interested in attending both events. See page 10 for details.
8:00 amRegistration & Breakfast
8:30 amChair’s Opening
Christopher Gallen, MD, PhDCEO, SK BioPharmaceuticals
8:45 amRegulatory Update on Global Clinical TrialsModerator:Christopher Gallen, MD, PhDCEO, SK BioPharmaceuticals
Panelists:Debra S. Barker, MDCSO, Emerging Markets, Novartis
Agustin Melian, MDHead of Emerging Markets Clinical Development, Merck
Christine H. WangSenior Director Quality Systems, EnVivo Pharmaceuticals
9:30 amHow Companies Are Re-Thinking Global Clinical Trials/Partnering with Investigative Sites
Moderator:Laurie Halloran, BSN, MSPresident & CEO, Halloran Consulting Group
Panelists:Mitchell Katz, PhDExecutive Director, Medical Research Operations, Purdue Pharma LPTracy Michener, PharmDDirector, Global EAP/ REMS/ R&D Supported ISRs, Collaborative Science Research & Operations, Bristol-Myers SquibbJodie MorrisonCEO, Tokai PharmaceuticalsHassan MovahhedSVP, Global Development Operations, United TherapeuticsBarry Ticho, MD, PhDVP, Clinical Development, Biogen Idec
10:15 amNetworking Break
10:40 amGlobal Site Selection
11:00 amRisk Based Monitoring for Global Clinical TrialsThomas HaagIT Systems and Processes, Development QA, NovartisDeborah Manzo, MScOLSenior Director, Clinical Business Operations and Transformation, AbbVieJules Mitchel, PhD, MBAPresident & Co-Founder, Target HealthThomas GrundstromVP, Integrated Processes and Technologies, Quintiles
11:40 amCompetitors Unite to Create Standardized Training in Asia for Cost-Efficient Clinical TrialsJohn ConstantineExecutive Director & Dean, Merck Polytechnic InstituteChair, Asia Training Consortium
Speaker TBA, Trifecta
DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS PRE-CONFERENCE EVENTS
AGENDA - WEDNESDAY, SEPTEMBER 18, 2013
4TH ANNUAL
EXECUTING GLOBAL CLINICAL TRIALSREDUCING COMPLEXITIES IN GLOBAL CLINICAL TRIALS
SEPTEMBER 18, 2013 THE FAIRMONT COPLEY PLAZA, BOSTON, MA
TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580
Adaptive Trial Designs takes place the day before the Disruptive Innovations to Advance Clinical Trials event on September 18, 2013. A special rate is available for those interested in attending both events. See page 11 for details.
TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580
September 19 – 20, 2013Disruptive Innovations to Advance Clinical Trials
Early Bird - before August 2, 2013 $1,495
Standard - after August 2, 2013 $1,695
The conference fee includes the program, morning coffee/tea, reception, luncheons, and conference documentation.
Attend one of our specialized pre-conference events in addition to Disruptive Innovations for a reduced fee:
September 18, 2013Executing Global Clinical Trials $300
Adaptive Designs in Clinical Trials $150
To register, go to our website at www.theconferenceforum.org/conferences/disruptive-innovations/registration-pricing
Discount Programs
Group Registration – Receive a 10% discount off each registration when two or more colleagues from the same company register online.
Large group discounts available.
Please contact [email protected] or call 646-350-2580 for any questions on discount rates.
Payment Policy
Payment must be received in full by the event date. All discounts will be applied to the Conference-Only fee (excluding add-ons)‚ cannot be combined with any other offer‚ and must be paid in full at the time of conference.
Substitution and Cancellation Policy
If you are unable to attend and would like to register a substitute, please email [email protected]. Please ask your substitute to provide identification on-site.
If you need to cancel your registration, please note the following policies based on the start date of the event:
Ten or more business days prior: A full refund less the administration fee of $295, or a pass to another event valid for two years from the date of issue.
Less than ten business days prior: A pass to a future event for either yourself or a colleague from the same company valid for two years from the date of issue.
To cancel and receive a refund or pass, please email [email protected] or call 646-350-2580.
The Fairmont Copley Plaza Hotel138 St. James AvenueBoston, MA 02116617-267-5300www.fairmont.com/copley-plaza-boston/
For reservations, call 800-441-1414 or 617-267-5300 and ask for the Disrutpive Innovations group rate.
Centrally located in Boston’s historic Back Bay, The Fairmont Copley Plaza sits steps away from the Boston Public Library, Beacon Hill, and the Freedom Trail. The hotel is only a few blocks from Copley Place Mall and the boutiques of Newbury Street. The hotel recently went through a $20 million restoration project.
“Excellent! Real Disruption! Refreshing!”
- Thomas Krohn, Eli Lilly
“My colleague and I were last minute attendees at Dpharm, and we are so glad that we went. We felt at home among kindred spirits trying to accomplish something new, challenging, different, and disruptive.”
- Brendan Kelleher, Karmadata
“Kudos to the Conference Forum, Craig, John and Andreas for a truly fresh perspective on our industry. It has been very energizing and without tired topics. The format and content are top-notch and sophisticated. Well worth taking the time to attend.”
- Deirdre BeVard, Endo
“This conference was a very good mix of inspirational and specific nitty-gritty. WOW!”
- Veronica Ludensky, Takeda/Millenium
“Thank you! Excellent. The best conference I have attended in the last few years!”
- Maria Makarovskaya, Cubist Pharmaceuticals
REGISTRATION / VENUE DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS
