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New Frontiers in Cancer Drug Development Agenda
Drug Discovery & Development Week 2009: August 3-6, 2009· The World Trade Center Boston and Seaport Hotel · Boston, MA
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Pre-Conference Workshop - Tuesday, August 4, 2009
Biomarkers and Companion Diagnostics for Cancer Therapy
1:00
Workshop Chair Opening Remarks
1:10
Companion Diagnostics and Biomarkers in Developing Cancer Therapeutics: The Emergence of Targeted Therapies and Strategies to Improve Clinical Trial Design
Functional genomics and proteomics approaches provide the basis for transforming medicine from the current disease-centric to a patient-centric approach. As the technologies become validated, clinical applications emerge that change drug development and will lead to individualized medicine. Strategies to improve cancer clinical trial design and to identify targeted therapies and biomarkers will be presented.
Towia A. Libermann, Associate Professor of Medicine, Beth Israel Deaconess Medical Center and Director, BIDMC Genomics and Proteomics Center
1:40
VEGF Pathway Response Biomarkers Using Population-based Preclinical Models
We present a unique preclinical platform that queries entire populations of genetically engineered tumor models for drug response. Like human tumors, these tumors exhibit variation in response to our phase 2 VEGFRi AV-951. The resulting novel response biomarker derived from this platform is currently being evaluated in ongoing clinical studies.
Murray O. Robinson, Ph.D., Senior Vice President, Oncology, AVEO Pharmaceuticals, Inc.
2:10
Levels of Evidence to Consider for Biomarker Adoption
Ideally patient stratification biomarkers would be implemented prior to randomization of pivotal trials allowing a prospective evaluation of the biomarker(s). However, that may not always occur due to a sufficient understanding of the mechanisms of resistance to therapy being elucidated later in the clinical trial process rather than early. The various factors one needs to consider will be presented through example in this presentation.
Speaker: TBA
2:40
Networking Break in Exhibit & Poster Hall
3:15
Using and Developing Companion Diagnostics and Biomarkers for Cancer Therapeutics
Biomarkers have a critical role in increasing the efficiency of the drug development process. This presentation will review the recent impact of biomarkers in confirming mechanism of action, exploring PK/PD interactions, defining dose, and in developing companion diagnostics for novel oncology therapies. Examples of biomarker applications in our current oncology development pipeline will also be discussed.
Nicholas C. Dracopoli, Ph.D., Vice President, Biomarkers, Centocor R&D, Johnson & Johnson
3:45
Biomarker Strategies for Developing Novel Cancer Therapeutics
Today's oncology candidate drugs target molecular entities and pathways that can be assessed using sophisticated enabling technologies. As markers, these can be used to demonstrate proof of concept, stratify/select clinical trial subjects, predict response and, occasionally, as a companion diagnostic. Approaches to managing the development challenges these present will be reviewed.
John C Bloom, Ph.D., Executive Director, Diagnostic and Experimental Medicine, Eli Lilly and Company
Strategic Discussion Group
4:15
The Reality of Implementation and Regulatory Pathways for Biomarkers and Companion Diagnostics in Cancer: What is the Right Approach?
- What is the regulatory path for biomarkers and companion diagnostics in cancer?
- When to engage diagnostic companies to transition a biomarker to a companion diagnostic?
- If a companion diagnostic is developed, will people use it? What is the reality of implementation of companion diagnostics in the clinical setting?
Panelists:
Richard A. Bender, M.D., Vice President and Chief Medical Officer, Agendia BV
Walter H. Koch, Ph.D., Vice President, Global Research, Roche Molecular Systems, Inc.
Jerry Lanchbury, Ph.D., Executive Vice President of Research and Development, Myriad Genetics (Tentatively Confirmed)
Steven Shak, M.D., Chief Medical Officer, Genomic Health (Invited)
5:15
Close of Workshop and Proceed to Plenary Keynote
Plenary Keynote
5:20
Keynote Introduction
Osamu Sato, Ph.D., Director & Head of Medical Writing Group, Daiichi-Sankyo Co., Ltd., Japan
5:25
Global Pharma Innovator: Daiichi Sankyo's Challenge to Build a Competitive Pharmaceutical Company in the Global Market
The current challenge for Japanese pharmaceutical companies to stay competitive in the global marketplace, is to expand product offerings and sales and increase R&D and clinical development capabilities in the U.S., Europe and other markets outside of Japan. This presentation will discuss Daiichi Sankyo's vision and strategy for transforming itself from a Japan-based pharmaceutical company to a truly global pharmaceutical player. Recent implementations of this strategy including the incorporation of Ranbaxy (India) and U3 Pharma (Germany) into the Daiichi Sankyo family will be discussed.
Takashi Shoda, President and CEO, Daiichi Sankyo Co., Ltd., Japan
6:00
Cocktail Reception in Exhibit & Poster Hall
Main Conference - Wednesday, August 5, 2009
7:30
Registration and Coffee
8:30
Conference Chair Opening Remarks
Lyuba Varticovski, M.D., Staff, Cancer Research Center, National Cancer Institute
Understanding and Exploiting the Role of Cancer Stem Cells in Drug Development
8:40
Targeting Cancer Stem Cells
Cancer stem cells are thought to mediate tumor initiation, metastasis, and recurrence. We have isolated and characterized CSCs from a variety of major tumor types and have found that these cells are preferentially resistant to many current therapies. As part of our effort to develop novel agents targeting CSCs, we have developed an anti-DLL4 antibody that blocks Notch signaling. Anti-DLL4 inhibits tumor growth through multiple mechanisms including a reduction in CSC frequency.
Timothy Hoey, Ph.D., Vice President, Cancer Biology, OncoMed Pharmaceuticals, Inc.
9:05
Drug Discovery Approaches in Self-Renewal Pathways that Drive Cancer Stem Cells
Effective treatments for disease recurrence are a major area of unmet need in cancer. Recent progress in defining tumor cell populations that have stem cell properties provides new insight on the mechanisms that initiate, drive and maintain tumor growth. The canonical self renewal pathways defined by Wnt, Hedgehog and Notch are frequently activated in tumors and drive stem cell behavior. For many years these pathways have been refractory to small molecule drug discovery. I will discuss novel approaches to targeting these pathways.
Speaker: TBA
9:30
Selection and Expansion of Stem-like Cells from Solid Tumors Based on Growth and Survival Properties: Cell Surface Antigens Useful as Drug Targets
The CSC hypothesis has important implications for drug development and cancer treatment. Most CSC studies use cell populations enriched using prospectively defined markers. We have used defined media to select subpopulations of cells from solid tumors, including colon and prostate, which are capable of self-renewal and form well differentiated tumors. These cell lines can be used to develop and screen drug candidates and to further characterize gene and cell surface marker expression. Preclinical and clinical data from two projects…a novel target/Mab and a set of novel Mabs to a known target… that we find on our stem or progenitor cells and cancer stem cells will be presented.
Jenny P. Mather, M.D., Ph.D., Senior Vice President, Cancer Stem Cell Research, MacroGenics, Inc.
9:55
Developing Drug Candidates Directed to Cancer Stem Cell Targets: Preclinical and Clinical Update
Stemline Therapeutics, a clinical stage biopharmaceutical company, is developing a broad portfolio of small molecule and biologic compounds directed to cancer stem cell targets of both solid and hematological cancers. Stemline has built its pipeline through a combination of acquisition and internal discovery. Stemline has also developed several novel cancer stem cell focused drug discovery platforms, including a proprietary high throughput screen ("StemScreen®-2"), which the Company has utilized to identify multiple anti-cancer stem cell compounds. Emerging data from the Company's multiple cancer stem cell projects, including its IL-3R and Notch directed programs as well as its discovery platform, will be presented.
Ivan Bergstein, M.D., CEO, Stemline Therapeutics, Inc.
10:20
Networking Refreshment Break in Poster & Exhibit Hall
11:00
Targeting the Hedgehog Pathway in Cancer Treatment
Hedgehog (Hh) pathway activity plays a crucial role in embryonic development and tissue homeostasis. Mutations of the pathway effector genes and increased Hh ligand expression have been identified in human tumors. Inhibition of the Hh pathway has resulted in clinical benefit for patients with tumors driven by activated Hh pathway.
Chia Portera, M.D., Ph.D., Assistant Medical Director, Exploratory Clinical Development, Genentech BioOncology
Strategic Discussion Group
11:30
Cancer Stem Cells
- Is there a difference between a cancer stem cell and a tumor initiating cell?
- Defining molecular and functional characteristics of cancer stem cells
- Understanding mechanisms of resistance of cancer stem cells
- What is the best way to target tumor stem cells?
Moderator: Lyuba Varticovski, M.D., Staff, Cancer Research Center, National Cancer Institute
Conference Keynote
(open to all attendees and exhibit hall visitors)
12:00
From Empiric to Specific: How Can We Translate Science into Cancer Treatments and Get it Right More Reliably?
Conventional anticancer cytotoxic therapy is highly empiric, and while a subset of patients benefit, the relative therapeutic index of these agents is amongst the lowest of any systemic drugs used in medicine. By understanding the huge variety of cancers, and validating more fully the leads coming from basic discovery biology, clinical oncology stands poised to recreate the field of translational and clinical research in a way that takes advantage of "personalized medicine" approaches to increase the success and the relative impact of new investigational therapies. Lessons learned from the development of successful "targeted therapies" such as imatinib, sunitinib, nilotinib, and dasatinib, as well as other targeted agents, will be summarized to help point the way in which collaborative research models can be developed which support rapid discovery and development of highly effective new anticancer agents based on the best science and clinical insights.
George D. Demetri, M.D., Director, Ludwig Center at Dana-Farber/Harvard Cancer Center and Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute
12:30
Networking Luncheon in Exhibit & Poster Hall
New Approaches for Targeting Cancer
1:45
The Lin28 Oncogene and Pluripotency Factor is a Potential Target in Cancer Stem Cells
Members of the let-7 microRNA family are emerging as promoters of differentiation in development and as tumor suppressors in cancer. The microRNA binding proteins Lin28 and Lin28B were recently identified as potent suppressors of let-7 processing, positioning them as oncogenes and stem cell reprogramming factors. Indeed, several reports have demonstrated the importance of let-7 and Lin28 in human cancer and normal stem cell function. Exploring this intersection of microRNAs, cancer, and pluripotency opens new avenues for the pharmacologic enhancement of regeneration and suppression of cancer stem cells.
Hao Zhu, M.D., Post-Doctoral Fellow in the lab of George Q. Daley, Department of Hematology/Oncology, Dana-Farber Cancer Institute and Children's Hospital of Boston
2:10
A New Paradigm for Translational Cancer Research: Targeting Endocrine Factors and Real Human Tumors
This presentation will discuss research focused on identifying systemic and endocrine factors that contribute to tumor progression. As a consequence of this work, an in vivo model system to study the growth of human tumor surgical specimens that otherwise did not form successful xenografts, has been developed. Ultimately, the ability to target endocrine factors and to study real human tumor specimens holds the hope of designing new cancer therapies.
Sandra S. McAllister, Ph.D., Postdoctoral Associate, Robert Weinberg Laboratory, Whitehead Institute for Biomedical Research
2:35
AMG 386, an Anti-Angiogenic Agent Targeting the Angiopoietin-Tie2 Pathway
This presentation will provide preclinical and clinical updates on the status of AMG 386, a peptibody (peptide-Fc fusion protein) that binds to and inhibits angiopoietin 1 and 2. It is being investigated as a cancer treatment and is currently in phase 2 clinical trials.
Jon Oliner, M.D., Ph.D., Scientific Director, Oncology Research, Amgen, Inc.
3:00
Targeting Chromatin Modifying Enzymes as an Epigenetic Therapy for Cancer
Deregulation of gene expression caused by genetic and epigenetic mechanisms that affect key cellular control pathways is a hallmark of human cancers. Chromatin modifying enzymes like histone and DNA methyltransferases have been identified as important epigenetic regulators of chromatin function and resultant changes in gene expression. The pharmacological inhibition of these enzymes by small molecule compounds offers an attractive therapeutic approach in which changes of the epigenetic modification landscape cause an inactivation of cancer-related genes and reactivation of tumor suppressor genes.
Patrick Trojer, Ph.D., Senior Scientist, Constellation Pharmaceuticals
Technology Workshop
3:25
Genotype-correlated Phenotypic Drug Discovery- OncoPanel™
Oncopanel comprises of a compendium of a large panel of human tumor-derived cell lines from different origins with broad genetic heterogeneity and a sensitive High Content Analysis method for comparing proliferation or cytotoxicity across genotypes. We have developed a panel of 240 human cell lines with genetic information available on the genome copy number, mRNA expression data and gene mutation. The media and culture conditions, cell fixation and High Content Analysis are standardized and optimized so that the genetic heterogeneity of the cell line will be responsible for the results obtained. We generate simultaneous data for each compound at 10 concentrations in triplicates resulting in precise IC50/EC50 values for analysis and comparison. Results from a case study will be presented to depict the very robust data quality. Also, data with known inhibitors will be presented using a smaller subset of the cells.
Usha Warrior, Ph.D., Technical Director, In Vitro Pharmacology, MDS Pharma Services
3:50
Networking Refreshment Break in Exhibit & Poster Hall
POINT/COUNTERPOINT: Innovation Starvation in Oncology Drug Development: Implications for R&D Strategies
POINT: The industry is changing and the current approach to first-in-class innovation in oncology isn't working.
4:30
Is There Evidence that First-in-class Innovation in Oncology is Dwindling?
- How will this impact R&D pipelines, revenues and patients?
- What effects might scarcer innovation have on the competitive landscape in cancer drug development?
John Herrmann, Ph.D., Executive Director, Search & Evaluation (Oncology), EMD Serono (U.S. Division of Merck Serono)
COUNTERPOINT: Novel target discovery platforms are feeding innovation in oncology
4:55
FunctionFIRST: A Novel Antibody/Target Discovery Platform
Unlike traditional drug discovery approaches where an inhibitor is made to a pre-selected target and subsequently tested for efficacy, the FuntionFIRST approach identifies antibodies that inhibit cancer cell but not normal cell viability in vitro and in vivo before target identification. Examples and merits of this strategy will be discussed.
Daniel S. Pereira, Ph.D., Vice President, Head of Research, Pharma Research Toronto, Hoffmann-La Roche Ltd., Canada
6:00
Attendee Networking Dinner
Join fellow attendees of the New Frontiers in Cancer Drug Development conference for dinner. Space is limited and an additional fee applies. Check box on registration form to sign up.
Main Conference - Thursday, August 6, 2009
8:30
Conference Chair Opening Remarks
Helen Chen, M.D., Associate Branch Chief, Cancer Therapy Evaluation Program, National Cancer Institute
Combination Cancer Therapies and Multi-Targeting Strategies for Novel Therapeutics
8:35
Combination of Molecularly Targeted Agents: Opportunities and Challenges
Combination of molecularly targeted agents has the potential to overcome molecular complexity of cancer and improve the therapeutic outcome in patients. Challenges for clinical evaluation of novel combinations are however unprecedented. This presentation will review the critical elements of a rational strategy as well as experience with NCI-sponsored clinical trials for targeted agent combinations. Scientific and intellectual property issues and possible means of overcoming these barriers will be discussed.
Helen Chen, M.D., Associate Branch Chief, Cancer Therapy Evaluation Program, National Cancer Institute
Featured Presentation
9:05
The Evolving Treatment Paradigm in Multiple Myeloma
Thalidomide, lenalidomide, bortezomib, and Doxil provided the framework for six new FDA approved treatments for multiple myeloma, extending the median survival from three to seven years. Preclinical models are informing rational design of combination of novel and conventional agents to enhance response, overcome drug resistance, and further improve patient outcome.
Kenneth C. Anderson, M.D., Chief, Division of Hematologic Neoplasia, Dana-Farber Cancer Institute and Kraft Family Professor of Medicine, Harvard Medical School
9:35
A Novel Approach to Combination Therapy through Cancer Network Disruption: Curis' Multi-Targeted Inhibitor Platform
Curis has developed an approach to accomplish the benefits of combination therapy through single small molecule Multi-Target Inhibitors (MTI) based upon novel chemical drug structures. The most advanced drug from the MTI platform, CUDC-101 is a highly potent, first-in-class, small molecule currently in dose escalation Phase 1, designed to specifically and synergistically target HDAC/EGFR/Her-2. The presentation will describe the underlying rationale for the MTI platform and describe preclinical in-vitro and in vivo data, including mechanism of action and demonstration of synergistic effects. The presentation will also present relevant clinical data, including does escalation observations and relevant biomarker data. This case study will exemplify Curis' multi-targeted approach to cancer drug development and the proposed advantages including aligned PK and potencies, better control of exposure and the promise of enhanced efficacy with a better tolerability and safety profile.
Daniel Passeri, President and CEO, Curis, Inc.
10:05
Interplay Between EGFR-TKI Resistance Mechanisms, EMT Biology and a Rationale for Multi-Targeting
Abstract not available at time of print.
David M. Epstein, Ph.D., Senior Vice President, Oncology Research, OSI Pharmaceuticals
10:35
Networking Refreshment Break
11:05
The Use of Genetically Engineered Mouse Lung Cancer Models to Assess Effectiveness of Targeted Therapeutic Combinations
To understand genetically the roles of the recently discovered B-RAF, HER2/NEU, KRAS, EGFR, ALK and PI3K mutations in lung cancer, my laboratory has generated various inducible bi- transgenic mice harboring these mutations. We have recently demonstrated that the activations of all these mutants in the lung epithelium are oncogenic in vivo as mice expressing these activated alleles develop lung tumors de novo. We have characterized these mice in detail and are now using them as unique platforms for testing various combination of targeted therapeutics that can produce dramatic responses in each type of these oncogene specific driven lung cancers.
Kwok-Kin Wong, M.D., Ph.D., Assistant Professor, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute and Harvard Medical School
11:35
Bevacizumab in Patients with Previously Treated Glioblastoma
Glioblastoma, a primary brain tumor with a dismal prognosis, is highly vascularized with overexpression of vascular endothelial growth factor (VEGF). In a Phase II study in patients with previously treated glioblastoma, treatment with bevacizumab, an anti-VEGF antibody, has demonstrated efficacy with a durable response rate.
Asha Das, M.D., Medical Director, BioOncology, Genentech
Strategic Discussion Group
12:05
Are Targeted Therapies Better than Non-Targeted Therapies?
- Lessons learned from the targeted therapy approach and what needs to be improved?
- Targeted therapies versus conventional therapies: what does the future hold?
- Combination cancer therapies…which combinations? How can companies work together?
- Approaches to combinations of targeted agents for cancer….can preclinical evaluations be extrapolated into clinical successes?
- What is the intelligent approach to choose multiple intervention points in cancer therapy?
Moderator: William N. Hait, M.D., Ph.D., Senior Vice President, Worldwide Head Oncology/Hematology R&D, Ortho Biotech Oncology R&D, The Johnson & Johnson Family of Companies
12:45
Networking Luncheon with Attendee/Speaker Chat Sessions
Informal roundtable discussions during the luncheon will be led by conference speakers. Grab your lunch, pick a topic, join a table and meet fellow attendees and conference speakers. Additional topics will be added. To suggest a discussion topic, Please contact us.
Extrapolating Preclinical Models to the Clinic
Discussion Leaders:
Murray Robinson, Ph.D., Senior Vice President, Oncology, AVEO Pharmaceuticals, Inc.
Kevin P. Foley, Ph.D., Director, In Vivo Pharmacology, Synta Pharmaceuticals Corp.
Strategies to Exploit Epigenetic Mechanisms for Drug Discovery
Patrick Trojer, Ph.D., Senior Scientist, Constellation Pharmaceuticals
Functional Definition of a Companion Diagnostic: Strategies for Fit-for-Purpose Development
Discussion Leader: John C Bloom, Ph.D., Executive Director, Diagnostic and Experimental Medicine, Eli Lilly and Company
Combinations of Novel and Conventional Cancer Agents: Challenges and Opportunities
Discussion Leaders:
Kenneth C. Anderson, M.D., Chief, Division of Hematologic Neoplasia, Dana-Farber Cancer Institute and Kraft Family Professor of Medicine, Harvard Medical School
Helen Chen, M.D., Associate Branch Chief, Cancer Therapy Evaluation Program, National Cancer Institute
Translational Medicine: Predictive and Pharmacodynamic Biomarkers in Cancer Drug Development
Discussion Leader: Nicholas C. Dracopoli, Ph.D., Vice President, Biomarkers, Centocor R&D, Johnson & Johnson
Biomarker Clinical Utility: How Can Qualification of a Biomarker's Clinical Utility Be Determined? Prospective or Retrospective or a Combination?
Discussion Leader: Scott D. Patterson, Ph.D., Executive Director, Medical Sciences, Amgen, Inc.
Metastasis and Tumor Dormancy
Discussion Leader: Sandra S. McAllister, Ph.D., Postdoctoral Associate, Whitehead Institute for Biomedical Research
Translational Strategies for Cancer Drug Development
2:00
Turning Cancer Sequencing Data into Therapeutic Targets
It has become clear with the advent of high-throughput tumor sequencing projects that large volumes of genome-scale somatic mutation data will soon be generated for hundreds, if not thousands, of tumors. Statistical methods can be applied to detect evidence of positive selection of a mutated gene, but identification of potential therapeutic targets additionally requires functional validation. I will highlight examples of therapeutic targets identified in our cancer sequencing projects and discuss approaches to experimental evaluation of large-scale somatic mutation data.
Heidi Greulich, Ph.D., Instructor, Dana-Farber Cancer Institute and Visiting Scientist, The Broad Institute of MIT and Harvard
2:30
Effective Use of Animal Models during Preclinical Development of a Vascular Disrupting Agent
Advancing a cancer drug from preclinical studies into the clinic is a process fraught with challenges, not the least of which is the limited predictive power of animal models. However, such models can still play important roles in understanding drug mechanisms of action, selecting the optimum agent for further development, and validating clinically relevant biomarkers. We will discuss how animal models and bioimaging techniques were used to develop a novel vascular disrupting agent (VDA), STA-9584, which preferentially blocks blood flow in tumors relative to normal tissues, thereby inducing tumor hypoxia and necrosis. Compared to other VDAs, STA-9584 has an improved therapeutic index in preclinical models, and cardiovascular toxicity is predicted not to be dose-limiting.
Kevin P. Foley, Ph.D., Director, In Vivo Pharmacology, Synta Pharmaceuticals Corp.
3:00
Presentation Title TBD
3:30
Networking Refreshment Break
4:30
The Pharmacology Audit Trail: Connecting Discovery Research and Clinical Science in Oncology Drug Development
Oncology drug development in the age of molecularly targeted therapies requires the close integration of laboratory-based scientists and clinical investigators. One approach to improve collaborative decision-making in oncology drug development is the concept of the Pharmacological Audit Trail, first proposed by Workman and colleagues. The audit trail is a sequence of logical assessments examining the pharmacological behavior of an experimental agent. It encompasses evaluations of target expression, pharmacokinetics, pharmacodynamics, and biological and clinical activity in early clinical trials. This approach helps to organize strategic thinking and promotes rational decision making in oncology drug development. At its core is an emphasis on PK-PD model-based drug development. A thorough discussion of the audit trail and its application to the development of targeted oncological therapeutics will be described.
Chris H. Takimoto, M.D., Ph.D., Senior Director, Translational Medicine, Ortho Biotech Oncology R&D/Centocor R&D, Inc.
Strategic Discussion Group
5:00
Increasing Success in Oncology Drug Development
- Can disease models of cancer be improved?
- How can preclinical cancer research better support novel approaches to enable patient enrichment/selection, and combination strategies in clinical development?
- How can decision-making be improved in phase 2 oncology drug development to avoid phase 3 attrition?
Moderator: Vojo Vukovic, M.D., Ph.D., Vice President, Clinical Research, Synta Pharmaceuticals Corp.
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