healthtech.com/dps

Part of Cambridge Healthtech Institute’s

October 13-16, 2009Hyatt Harborside Hotel | Boston, MA

Cambridge Healthtech Insti tute 250 First Avenue, Suite 300, Needham, MA 02494, USATelephone: 781-972-5400 or toll-free in the U.S. 888-999-6288 Fax: 781-972-5425 • www.healthtech.com

Presentations By:John Arrowsmith, Ph.D.Pfi zer Global Research and Development

Albert Bellibas, M.D.Pharmahelpline International

Daniel Bradley, Ph.D., Millennium The Takeda Oncology Co

Neil Bodick, M.D., Ph.D.Deloitte Consulting

Stephen Donahue, M.D.Ore Pharmaceuticals

Alan Evans, Ph.D.McGill University

Josi Holz, M.D.Ablynx NV

Patrick McConville, Ph.D.Charles River

Phillip MillerThomson Reuters CMR Intl

Sashi Nadanaciva, Ph.D.Pfi zer Global, R&D Groton Labs

Ken PhelpsCamargo Pharmaceutical Services

Terri A. Roberson, MT (ASCP), MBAEli Lilly and Company

Victor Sandor, M.D.AstraZeneca Pharmaceuticals

Rumin Zhang, Ph.D.Schering-Plough Research Institute

What You Will Gain: Build a More Effective Drug Discovery and Development Process•

Reduce Risk and Later-Stage Attrition•

Case Studies of New Proof-Of-Concept Approaches and Programs•

Measure Targets, Pathways and Impacts•

Implement New Drug Development Process Models•

Discover the Latest Early Proof-Of-Concept Approaches, • Techniques and Technologies

Register by July 24 and SAVE up to $350!

October 13-14, 2009 Hyatt Harborside Hotel

Boston, MA

Organized by:

PROOF OF CONCEPT

Featuring a Pre-Conference Short Course: Tuesday, October 13Predicting Outcomes in Pre-Clinical Development

Cambridge Healthtech Institute’s Second Annual

Better Early Decision-Making for a More Effective Drug Development Process

Corporate Sponsors:

Online:healthtech.com/dps

Email: reg@healthtech.com

Fax: 781-972-54252

Scientifi c Advisory Committee:Terri A. Roberson, MT (ASCP), M.B.A., Manager, Chorus Operations, Eli Lilly and CompanyStephen Donahue, M.D., Senior Vice President, Clinical Development, Ore Pharmaceuticals, Inc.

8:30-9:00 am Short Course Registration and Morning Coffee

MORNING PRE-CONFERENCE SHORT COURSE9:00 am to 12:00 pm

Predicting Outcomes in Pre-Clinical DevelopmentJohn Arrowsmith, Ph.D., Executive Director and Head, Competitive Intelligence, Pfi zer Global Research and Development Phillip Miller, Manager, Product Strategy, Thomson Reuters CMR IntlThe course will explore some of the fundamental factors that go into a PO decision. It will analyze the underlying science that drives those decisions and how to infl uence investments and behaviors to make more of the right choices and fewer of wrong choices. *Separate Registration Required

12:00-1:25 pm Main Conference Registration

Main Program

DAY ONE: TUESDAY, OCTOBER 13, 2009

CASE STUDIES OF ACCELERATED PROOF-OF-CONCEPT PROGRAMS AND APPROACHES

1:25 Chairperson’s Opening RemarksTerri A. Roberson, MT (ASCP), M.B.A., Manager, Chorus Operations, Eli Lilly and Company

1:30 Eli Lilly’s Chorus Program: The Continuing Evolution of Accelerated Drug Development

Joel Scherer, M.D., Managing Director, ChorusChorus was created in 2002 as a strategic early phase R&D pilot focused on improving productivity (virtual development, limit parallel processing, cutting edge IT platform), and has evolved into an alternative R&D engine to move molecules through the LRL early phase pipeline. The group now numbers ap-proximately 30 and handles about 20% of the Lilly early development portfolio. The challenges of managing the growth and maturation of this unique group while maintaining its productivity advantages and identity will be discussed.

2:00 Moment – Coordination of the Work in a Distributed Environment

Neil Bodick, M.D., Ph.D., Chief Operating Offi cer, Flexion Therapeutics As the organizational model for pharmaceutical innovation evolves beyond the monolithic institutions that dominated the modern industry, and as early stage partnering takes on greater signifi cance in value generation, there is an associated redistribution of the work of pharmaceutical development within and particularly across organizations. As large R&D organizations reconfi gure in-ternal operations and become more involved with external relationships, a need emerges for a common representation of work that serves to both maintain the integrity of the workfl ow in a distributed environment and provide bases for portfolio-wide optimization. In the past, pharmaceutical companies have made large investments in both enterprise management systems and project manage-ment technologies. And while these systems undoubtedly confer benefi t, they do not, by enlarge, provide deep representation of the work itself. MomentTM is a novel management system developed at Flexion Therapeutics that does provide a deep representation of the work. In particular:

The data model underlying Moment comprises a set of abstractions that • relate strongly to the fundamental elements of work; The system explicitly represent the absorption of risk as a product of work • and as such provides a basis for portfolio optimization;Moment is anchored in time with the capability to rapidly reconfi gure plans • with the emergence of new data;The Moment accountability model may be distributed over multiple organiza-• tions;Provision is made for communication or sequestration of proprietary materi-• als among multiple organizations.

The data model underlying Moment will be described and the operation of interface will be demonstrated.

2:30 Networking Refreshment Break with Exhibit and Poster Viewing

PROOF-OF-CONCEPT APPROACHES, PROCESSES AND TECHNOLOGIES

3:10 Sponsored Presentation (Opportunities Available)

3:40 Predicting Outcomes in Pre-Clinical Development at Pfi zer

John Arrowsmith, Ph.D., Executive Director and Head, Competitive Intelligence, Pfi zer Global Research and Development Phase II survival is the weakest link in the development continuum and is a key driver of the low industry wide R&D productivity that Pharma is currently experiencing. Despite increasing Phase I and Phase II portfolios over recent years, the industry struggles with the conversion of these into Phase II starts. Benchmark data showing a greater than twofold increase in the number of compounds failing at the POC hurdle over that last 3-5yrs. Pfi zer has imple-mented a simple process to harvest learning’s from positive and negative POC decisions that has led to key insights that will signifi cantly increase the POC success rate and avoid the expenditure of resources on projects that would inevitably have failed.

4:10 Pharmacology Guided Drug Development: An Innovative Approach for Earlier Go/No-Go Decisions

Albert Bellibas, M.D., President, Pharmahelpline InternationalNo matter what NME we are trying to develop, we are either interacting with a receptor, a drug transporter or an enzyme activity in the biological systems. Therefore, even before a desired therapeutic effect is achieved, there is a pharmacological change or a “response” that has occurred. Monitoring these responses at the cellular or molecular level can provide guidance in order to understand the likelihood of success for any NME before conducting expen-sive and time consuming large clinical trials. This pharmacological approach coupled with an understanding of the pathophysiology of targeted disease and advanced biomarkers/imaging techniques will be discussed and case studies will be presented.

4:40 Effective Use of Translational Imaging for Early Indication of Treatment Response in Oncology

Patrick McConville, Ph.D., Director, Global Discovery Imaging, Discovery and Imaging Services, Charles River Imaging technologies are being increasingly adopted in the pharmaceutical industry to accelerate drug discovery. The effective use of imaging tech-nologies can enable early, more predictive endpoints that are also clinically translatable. This presentation will focus on key in vivo imaging technologies, such as 18-FLT PET, diffusion MRI, and 1H magnetic resonance spectroscopy (MRS), and the critical advantages they offer for oncology research and drug discovery. Optimization of their effectiveness in pre-clinical imaging will be a key part of the presentation, including study design, data analysis, and data interpretation issues.

5:10 Networking Reception with Sponsored by Exhibit and Poster Viewing

6:10 Close of Day One

DAY TWO: WEDNESDAY, OCTOBER 14, 2009

7:45 am Continental Breakfast Presentation Sponsored by505(b)(2): Not Just for Modifi cations of Approved Drugs

Ken Phelps, President & Chief Executive Offi cer, Camargo Pharmaceutical ServicesHistorically, most sponsors have used the 505(b)(2) pathway to make improvements to existing approved drugs. Yet, the regulations state that a 505(b)(2) can be used for any drug product where pivotal information is not conducted by the applicant. Thus, even a new chemical entity can be approved under 505(b)(2). This understanding will open up a vast source of potential drug products for development over the next decade. This session will review the regulatory requirements for a 505 (b)(2) NDA and the kinds of information that may be used in support of an NDA submission, as well as the process needed to gain FDA buy-in to the 505 (b)(2) development plan and some of the products currently being developed without a U.S.-approved reference drug.

Online:healthtech.com/dps

Email: reg@healthtech.com

Fax: 781-972-5425 3

CASE STUDIES OF ACCELERATING PROOF-OF-CONCEPT

8:30 Chairperson’s Opening Remarks

8:40 Translational Research in the Development of Novel Nanobody-Based Therapies

Josi Holz, M.D., Chief Medical Offi cer, Ablynx NVNanobodies are a novel class of antibody derived therapeutic proteins. Be-cause of their small size, unique structure and extreme stability, nanobodies combine the advantages of conventional antibody therapeutics with the key features of small molecule drugs. This talk will illustrate in a case study for an anti-vWF Nanobody how the translation of results in pre-clinical develop-ment (e.g. use of biomarker, PK and PD modeling) into clinical development accelerated the achievement of proof-of-concept. The presented case study illustrates the rapid advancement of a novel protein drug from target identifi ca-tion to completion of phase I with biological proof-of-concept in the clinic in less than 4 years.

9:10 Imaging Biomarkers in Early-Phase CNS StudiesAlan Evans, Ph.D., Professor, Neurology & Neurosurgery, Montreal Neurological Institute, McGill UniversityImaging biomarkers based on the quantitative analysis of MRI and PET im-ages are increasingly utilized in early-phase studies of CNS diseases, such as Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis. The com-bination of data from structural, functional, molecular imaging studies provide new insight into the biodistribution, mechanism-of-action, and effi cacy of novel therapeutic agents for CNS diseases. This presentation will discuss the use of advanced imaging biomarkers to allow for earlier go/no go decision making, as well as for more effi cient and cost-effective early phase studies.

9:40 Reducing Attrition due to Hepatotoxicity through Early Safety Assessments of Mitochondrial Dysfunction

Sashi Nadanaciva, Ph.D., Principal Scientist, Compound Safety Prediction, Pfi zer Global R&D Groton LabsRecent retrospective analysis of drugs which have received black-box warn-ings and drugs which have been withdrawn due to post-market safety issues has revealed that mitochondrial dysfunction is a key factor in hepatotoxicity. The mechanisms by which drug-induced mitochondrial dysfunction occurs and the high-throughput in vitro screening methods being used to identify this type of impairment, in order to reduce compound attrition, will be discussed.

10:10 Networking Coffee Break with Exhibit and Poster Viewing

10:50 Sponsored Presentation (Opportunities Available)

11:20 Biomarkers in Early Stage Drug Development: Challenges and Opportunities – The Changing Face of Early Drug Development at AstraZeneca

Victor Sandor, M.D., Global Product Head, Executive Director, Oncology, Clinical Development, AstraZeneca Pharmaceuticals (Tentative)The talk will focus on the practical use of biomarkers in drug development. It will focus on specifi c examples of how various biomarkers that cover the spectrum of biological changes that make cells malignant (growth factor signalling, angiogenesis, metastasis and genetic plasticity) were used in real development programs at AstraZeneca to make decisions to either move a drug forward or to stop development. In addition, issues related to how these markers were developed and validated will be reviewed.

11:50 Panel Discussion with Speakers

12:10 pm Lunch Presentation (Opportunity Available) or Lunch on Own

1:25 Chairperson’s Remarks

1:30 Translational Imaging in Drug Discovery and Development

Daniel Bradley, Ph.D., Scientist II, Millennium The Takeda Oncology Co.Imaging is becoming well recognized as a keystone technology internally or collaboratively for many large pharmaceutical companies across multiple disease functions in early discovery molecular imaging and translational bio-marker development. DCE- & DWI- MRI and FDG- & FLT- PET are well recog-nized examples of translational imaging biomarkers deployed in oncology drug discovery and development. The use of translational imaging in pre-clinical

drug discovery is more so to qualify the value of the biomarker than discon-tinue a therapeutic; or at least contextualize the importance of the imaging biomarker when used to measure the effect of a novel therapeutic develop-ment. The presentation will focus on a number of examples where imaging in drug discovery can aid in clinical deployment and a number of the factors that must be considered when appropriately ‘translating’.

2:00 Mechanisms to Reduce Cost in Getting to Clinical Proof-of-Concept

Stephen Donahue, M.D., Senior Vice President, Clinical Development, Ore PharmaceuticalsA number of options have evolved over the years that provide the drug devel-oper effective routes to clinical proof-of-concept. Some of these can save the sponsoring pharmaceutical company resources.

We will examine some of the basic routes to cost reduction involving:

Focus on critical path; appreciated but diffi cult to implement• Selection of study designs; re-examination of the pilot study• Selection of indication; consideration of the demonstration indication• Relieving the proof-of-concept teams of some of the practices of phase 3 programs• Partnering before proof-of-concept•

These routes will be presented with attention to items of interest to the small company or the large pharmaceutical company.

2:30 Networking Refreshment Break with Exhibit and Poster Viewing

3:10 Accelerating Proof-of-Concept Round Table DiscussionsModerator: Terri A. Roberson, MT (ASCP), M.B.A., Manager, Chorus Operations, Eli Lilly and CompanyAdditional Moderators to be Announced

3:40 Accelerating Proof-of-Concept – Report out of Round Table Discussions

Terri A. Roberson, MT (ASCP), M.B.A., Manager, Chorus Operations, Eli Lilly and Company

4:10 Towards a Mechanism of Action Informed Accelerated POC Model

Rumin Zhang, Ph.D., Senior Principal Scientist, New Lead Discovery, Schering-Plough Research InstituteProof-of-Concept (POC) studies must be designed with mechanism of action (MOA) in mind. We will explore the following questions: Can a biological target be kinetically differentiated from collaterial targets in an open system such as the human body? Are test compounds with a relevant range of kinetic attributes available to test the question of druggability? What mode of binding best ad-dress the underlying pathology?

4:40 Close of Accelerating Proof-of-Concept Conference

October 13-16, 2009Hyatt Harborside Hotel | Boston, MA

Visit our Website for Full Details: healthtech.com/dps

Conferences:

Finding New Routes to Success

PROOF OF CONCEPTDriving a More Productive Drug Development Pipeline

OF ACTIONDriving Pipeline Value through Understanding

Compounds, Targets, and Interactions

Media Partners:

Online:healthtech.com/dps

Email: reg@healthtech.com

Fax: 781-972-54254

Hotel & Travel Information

Conference Venue and Hotel: Hyatt Harborside Hotel101 Harborside DriveBoston, MA 02128Tel: 617-568-1234Fax: 617-568-8856

Discounted Room Rate: $205 s/dDiscounted Reservation Cut-off Date: September 14, 2009

Please visit our website to make your reservations online or call the hotel directly to reserve your sleeping accom-modations. Identify yourself as a Cambridge Healthtech Institute conference attendee to receive the reduced room rate. Reservations made after the cut-off date or after the group room block has been fi lled (whichever comes fi rst) will be accepted on a space-and-rate-availability basis. Rooms are limited, so please book early.

Flight Discounts:To receive a 5% or greater discount on all American Airline fl ights please use one of the following methods:

Call 1-800-433-1790 (authorization code A4819SS). •

Go online at www.aa.com (enter A4819SS in promotion • discount box).

Contact our designated travel agent, Wendy Levine, at • 1-800-336-5248 ext. 137.

Car Rental Discounts: Special discount rentals have been established with AVIS for this conference. Please call AVIS directly at 800-331-1600 and you must reference our Avis Worldwide Discount (AWD) Number J868190.

SPONSORSHIP & EXHIBIT INFORMATION

Your company has a unique opportunity to infl uence this major gathering of life science executives seeking technology services, solutions and strategies for enabling Drug Repositioning, determining Mechanism of Action of drug candidates, and obtaining early conformational studies that help them demonstrate early Proof-of-Concept.

Brand your company as a thought leader in systems and services for early drug discovery and development by participating as an active Sponsor. Presenting your solutions or services directly to our top-tier delegates can signifi cantly impact their purchasing and collaboration decisions and help you achieve your sales and business development objectives.

Opportunities include Agenda, Breakfast and Luncheon Presentations, or, you may pre-select and gain access to your the highest-level prospects through an Invitation-only VIP Dinner or function (limited availability).

CHI will support your Sponsorship and brand your company with strong marketing programs before, during and after these events. The earlier you secure your Sponsorship, the more opportunities.

To discuss your company’s objectives and participation options, please contact: Arnie Wolfson at 781-972-5431, awolfson@healthtech.com

Mail Registration to:C H I Cambridge Healthtech Institute250 First Avenue, Suite 300, Needham, MA 02494T: 781.972.5400 ● Toll-free in the U.S. 888.999.6288F: 781.972.5425 ● www.healthtech.com

Present a Poster and Save $50!Cambridge Healthtech Institute encourages attendees to gain further exposure by presenting their work in the poster sessions.

To secure a poster board and inclusion in the conference materials, your abstract must be submitted, approved and your registration paid in full by September 17, 2009. Register online, or by phone, fax or mail. Indicate that you would like to present a poster and you will receive abstract submission instructions via email.

I am interested in presenting a poster at❏ Drug Repositioning Summit

❏ Accelerating Proof of Concept

❏ Mechanism of Action

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HOW TO REGISTER: Online: www.healthtech.com/dps Email: reg@healthtech.com Phone: 781-972-5400 Option 1 Fax: 781-972-5425

❏ Yes! Please register me for Drug Repositioning, Part of The Pipeline Success Summit PFC F REGISTRATION INFORMATION

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Email* Fax*Email is not a mandatory fi eld. However, by excluding your email you will not receive notifi cation about online access topre-conference presenter materials, conference updates, networking opportunitites and requested eNewsletters.

CONFERENCE PRICING Commercial Academic, Government, Hospital-affi liatedPRE-CONFERENCE SHORT COURSE ONLY – (October 13 am) Predicting Outcomes in Pre-Clinical Development ❏ $595 ❏ $295

SUMMIT PRICINGBEST VALUE!Includes Access to: Pre-conference Short Course (October 13),Drug Repositioning OR Accelerating Proof-of-Concept (October 13-14) , and Mechanism of Action (October 15-16) Early Registration Deadline until July 24, 2009 ❏ $1745 ❏ $875Advance Registration Deadline until September 11, 2009 ❏ $1895 ❏ $945Registrations after September 11, 2009 and onsite ❏ $2095 ❏ $1045

Please select the conference you will most likely attend on October 13-14: ❏ Drug Repositioning OR ❏ Accelerating Proof-of-Concept

INDIVIDUAL CONFERENCE – (October 13-14 OR October 15-16)Early Registration Deadline until July 24, 2009 ❏ $1245 ❏ $625Advance Registration Deadline until September 11, 2009 ❏ $1395 ❏ $695Registrations after September 11, 2009 and onsite ❏ $1595 ❏ $795

Please select the ONE conference you will most likely attend: ❏ Drug Repositioning (October 13-14)❏ Accelerating Proof-of-Concept (October 13-14) ❏ Mechanism of Action (October 15-16)

POSTER DISCOUNT ❏ $50 off ❏ $50 off

☛ REGISTER 3 - 4th IS FREE Individuals must register for the same conference or conference combination and submit completed registration form together for discount to apply. Please reproduce this registration form as needed.

GROUP DISCOUNTS AVAILABLE! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact David Cunningham at 781-972-5472.

❏ I cannot attend but would like to purchase the Pipeline Success Summit CD for $500 (plus shipping). Massachusetts delivery will include sales tax.❏ Please send information on exhibiting and opportunitites to present workshops.

PAYMENT INFORMATION❏ Enclosed is a check or money order payable to Cambridge Healthtech Institute, drawn on a U.S. bank, in U.S. currency.❏ Invoice me, but reserve my space with credit card information listed below.

Invoices unpaid two weeks prior to conference will be billed to credit card at full registration rate. Invoices must be paid in full and checks re-ceived by the deadline date to retain registration discount. If you plan to register on site, please check with CHI beforehand for space availibility.❏ Please charge: ❏ AMEX (15 digits) ❏ Visa (13-16 digits) ❏ MasterCard (16 digits)

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CHI Insight Pharma ReportsA series of diverse reports designed to keep life science professionals informed of the salient trends in pharmaceutical technology, business, clinical development, and therapeutic disease markets.For a detailed list of reports, visitInsightPharmaReports.com, or contact Rose LaRaia, rlaraia@healthtech.com, 781-972-5444.

Barnett Educational ServicesBarnett is a recognized leader in clinical education, training, and reference guides for life scienceprofessionals involved in the drug development process. For more information, visitwww.barnettinternational.com.

Additional Registration DetailsEach registration includes all conference sessions, posters and exhibits, food functions, and access to the conference proceedings link.

Handicapped Equal AccessIn accordance with the ADA, Cambridge Healthtech Institute is pleased to arrange special accommoda-tions for attendees with special needs. All requests for such assistance must be submitted in writing to CHI at least 30 days prior to the start of the meeting.

Substitution/Cancellation PolicyIn the event that you need to cancel a registration, you may:

Transfer your registration to a colleague within • your organization.

Credit your registration to another Cambridge • Healthtech Institute program.

Request a refund minus a $100 processing • fee per conference.

Request a refund minus the cost ($500) of • ordering a copy of the CD .

NOTE: Cancellations will only be accepted up to two weeks prior to the conference.Program and speakers are subject to change.

Video and or audio recording of any kind is prohibited onsite at all CHI events.

October 13-14, 2009 Hyatt Harborside Hotel

Boston, MA

Part of:

Cambridge Healthtech Institute’s Second Annual

PROOF OF CONCEPTBetter Early Decision-Making for a More Effective Drug Development Process