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4th
Molecular Diagnostics
for Cancer Drug Development Meet the oncology and diagnostic experts you need to deliver better, safer drugs to market quicker
25th – 28th June 2012, Boston 31 expert speakers including
Benefits of attending • Hear pioneering insights on successful companion diagnostic development from Pfizer on Xalkori and Genentech on Zelboraf to understand the key to developing and commercializing a personalized medicine • Ensure you’re up to date with the evolving regulatory framework for CDx development and approval, and the impact of policy and legislation on personalized medicine • Get a comprehensive overview of the latest technologies to advance oncology personalized medicine and how to apply them in drug development, including next-gen sequencing and CTCs • Advance your organization’s capabilities to deliver a personalized medicine to market by sharing best practice in end to end drug and diagnostic development from discovery to commercialization with the leaders in oncology personalized medicine • Meet and network with the world’s authorities from big pharmaceutical companies, the most innovative biotechs, pioneering research institutions and leading diagnostic developers to form new business critical partnerships • Develop a comprehensive strategy for integration of predictive biomarkers into your drug development and ensure translation of novel biomarkers to approved diagnostics
Interactive Pre-Conference Workshops: 25th June 2012 A) Integrating the Regulatory and Clinical Trial Practices for MDx within Cancer Drug Development Eric Lawson, Managing Director, Critical Perspectives B) Overcoming Challenges in Identifying and Managing Enabling Partnerships in Oncology Molecular Diagnostics Dr John Bloom, President, Bloom Consulting Services & Special Government Employee, FDA C) Utilizing Next Generation Sequencing in Diagnostic Medicine and Drug Development Dr Nazneen Aziz, Director of Molecular Medicine, Transformation Program Office, College of American Pathologists
Dr Richard Buller Vice President, Translational Oncology Pfizer Dr Mitch Raponi Senior Director, Molecular Diagnostics & Translational Medicine Clovis Oncology Dr Miu Chau Global Head, Companion Diagnostics Operations Genentech Dr Funda Meric-Bernstam Medical Director, Institute of Personalized Cancer Therapy MD Anderson Cancer Center Dr Deborah Ricci Director, Oncology Biomarkers Johnson & Johnson Dr Barbara Conley Associate Director, Cancer Diagnosis Program National Cancer Institute Dr Leonard Reyno Chief Medical Officer, Oncology Astellas Pharma Dr Samir Hanash Program Head, Molecular Diagnostics Fred Hutchinson Cancer Research Centre Dr Sonia Pearson-White Scientific Program Manager, Oncology The Biomarkers Consortium
Expertise partners
Dr Tharak Rao Head of Medical Group, Molecular Diagnostics Novartis
Tel: +1 212 537 5898
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Email: info@hansonwade.com
www.moleculardiagnostics-cancer.com
4th Molecular Diagnostics for Cancer Drug Development
Benefits of attending $42 billion - The expected value of the personalized medicine market by 2015*. Oncology drug and diagnostic developers are expected to reap most of these rewards, but only if they can meet the challenges of targeting treatments to molecularly selected patient sub groups.
Boston
25th – 28th June 2012
Hear what previous Hanson Wade attendees have to say “The best molecular Dx meeting I have attended in several years”
After two high-profile companion diagnostic approvals in 2011, the race is hotting up amongst oncology drug developers to develop the next personalized cancer therapeutic. At the 4th Molecular Diagnostics for Cancer Drug Development meeting you will hear directly from key project leaders of Zelboraf and Xalkori. You will find out how Pfizer and Genentech overcame the scientific and commercial hurdles of targeting a drug to a specific patient subpopulation, and how this has paved the way for other drug developers to follow suit. However, as these two stories demonstrate, there are many challenges to overcome first. Not least because of the complexity of expertise required for biomarker-based drug development. Think: • Regulation • Biomarker identification • Sample acquisition & management • Technology/platform selection • Assay development
• Clinical validation • Partner selection • Clinical trial design • Drug-diagnostic co-commercialization • Reimbursement
The 4th Molecular Diagnostics for Cancer Drug Development meeting is designed to provide you with the information and contacts you need to overcome these challenges and develop your own comprehensive strategy for successfully developing personalized medicines. The meeting will profile those at the cutting edge of personalized medicine in oncology to give you a thorough review of best practice in end to end drug and diagnostic development from discovery to commercialization. Your peers, current competitors and future partners will be there. Will you? *By Marketwire, Februrary 2, 2012 http://www.sys-con.com/node/2152661
Over 15 hours of dedicated networking time Molecular Diagnostics for Cancer Drug Development isn’t just about fantastic presentations delivered by world leading experts. It’s also about you engaging with the people you need to meet, to deliver real value to your science and business. Speed Networking A revolutionary and highly valued way to meet fellow conference attendees in a 60 minute session. Bring lots of business cards! Morning of day one. Networking Dinner A fantastic opportunity for in depth discussion in a relaxed, informal and entertaining event at a great local restaurant. End of day one. 1to1 Networking Use speed networking and the first 2 days to arrange 1to1 Networking meetings. Get extended face time with drug and diagnostic developers in a relaxed informal environment. End of day two. Drinks Reception A perfect opportunity to relax and unwind with your peers in a casual setting. Meet the people you need to speak to. End of day two.
VP, Translational Oncology Pfizer
“Outstanding meeting with first class speakers. I learned a lot and I will certainly recommend the meeting to my colleagues….” Director, Oncology Business Opportunities Sanofi
“One of the best meetings I’ve attended. Outstanding!” Director Merck
“Highly informative discussion, appropriately focused with attendance and contribution from key opinion leaders. Great networking opportunity” Director, Molecular Sciences Amgen
“An excellent view of the landscape with well integrated content from pharma, dx, clinical research and agency perspectives. This has been one of the best commercial meetings I have attended in memory” Advanced Cell Diagnostics
“Successful in bringing together pharma and diagnostics for information sharing, discussion and networking. Very informative, good representation, great networking”
Search groups for: Molecular Diagnostics for Cancer Drug Development to join the online community
Tel: +1 212 537 5898
Fax: +1 212 537 5898
Email: info@hansonwade.com
www.moleculardiagnostics-cancer.com
Abbott Molecular
4th Molecular Diagnostics for Cancer Drug Development
Boston
25th – 28th June 2012
Workshop A: Integrating the Regulatory and Clinical Trial Practices for MDx within Cancer Drug Development It’s finally happening - after months of discussion on personalized medicine and CDx, the much anticipated FDA guidance was finally released and we’ve already seen the first CDx products take advantage of this. But the question still remains: How well does the guidance meet the needs of industry? And how will these two real product experiences affect the evolving industry practices? This workshop will focus on the major regulatory issues that concern diagnostic and pharmaceutical partners during co-development, including: • Integration of the development process: Latest trends on companion diagnostic development for cancer drugs • Coordination of clinical trials: Examples of companion diagnostic development with cancer drug development • FDA review of both products: What can you do to ensure effective and timely review of both products? • Expected future proposed FDA draft guidance for both drug and diagnostic industries This expert session will present these topics using case studies from drug and diagnostic developers. At the end of the workshop, you will gain a clear perspective on how to shape your internal company practices to be aligned with the FDA’s latest thought process.
Date: 25th June 2012 Time: 9am-12pm Workshop leader Eric Lawson Managing Director Critical Perspectives Mr. Lawson has over two decades of experience in research, design, compliance management, and regulatory sciences for novel medical products. Eric directs personalized medicine and diagnostics RA/QS consulting for Critical Perspectives. He previously served with Voisin Consulting Life Sciences providing strategic consulting worldwide in the IVD arena, and guided FDA preparations and LDT regulatory safeguards for Metamark Genetics. Eric also co-founded and served as chairman of the Companion Diagnostics Working Group, sponsored by AMDM (the Association of Medical Diagnostics Manufacturers).
Workshop B: Overcoming Challenges in Identifying and Managing Enabling Partnerships in Oncology Molecular Diagnostics
Date: 25th June 2012 Time: 12.30pm-3.30pm
This workshop will focus on how the need for strategic partnerships and collaborations has evolved in the areas of translational biomarker research, the molecular profiling of oncology clinical trial patients and the parallel development of drugs and companion diagnostics. Discussion will focus on: • How such markers are being used to predict efficacy, safety, disease progression and predisposition to specific disorders • The disparate challenges and attributes of the major stakeholders involved (pharma, vendors, academia, regulators, etc.) • The evolving regulatory and technical challenges that pharma sponsors face in the co-development of drugs and diagnostics • The dynamic nature of the analytical platforms involved, as applied to tissue-based and non-solid matrices • Considerations for the successful development and management of strategic partnerships in a rapidly changing environment Perspectives of pharmaceutical sponsors, diagnostic manufacturers, service providers, research collaborators and regulators will be shared through informal facilitated discussion.
Dr Bloom has 29 years of experience in the pharmaceutical industry with leadership roles in preclinical and clinical drug development. He is regarded as an expert in developing phase-appropriate biomarker strategies for drug development, with emphasis on tailoring to individual patients needs, defining technical probability of success and product differentiation. As part of this work he established the Diagnostic and Experimental Medicine Division at Lilly accountable for the above. He is a recognized expert in the development of companion diagnostics in an R&D setting with an extensive track record in partnering.
Workshop C: Utilizing Next Generation Sequencing in Diagnostic Medicine and Drug Development
Date: 25th June 2012 Time: 4pm-7pm
The rapid evolution of NGS technologies presents significant opportunities and challenges for researchers, clinicians and the pharmaceutical industry for improving health outcomes, particularly with respect to an increased emphasis on companion diagnostics and personalized medicine. Adoption of NGS in the clinical laboratory setting requires the adoption of many processes and procedures, such as the analytic and clinical validation of the test, CLIA/CAP certification, standards for reference materials for proficiency testing, and questions regarding reimbursement, informed consent and intellectual property. This workshop will help you and your company find answers to the following key questions: • What is practically needed for clinical adoption of NGS as a diagnostic test? E.g. regulatory and professional standards, development, availability, and access to reference materials, and the laboratory professional’s role for ensuring high quality test results that are useful for informing clinical decision making • How will NGS technology impact the pharma industry and the drug development process? • What is the estimated time frame by when NGS will be adopted in clinical trials? • What measures are being taken by the pharmaceutical industry to prepare for this technology as it moves into clinical diagnostics?
Tel: +1 212 537 5898
Fax: +1 212 537 5898
Workshop leader Dr John Bloom President, Bloom Consulting Services & Special Government Employee, FDA
Workshop leader Dr Nazneen Aziz Director of Molecular Medicine, Transformation Program Office College of American Pathologists Dr. Nazneen Aziz is the Director of Molecular Medicine in the Transformation Program Office at the College of American Pathologists. In her prior positions, Dr. Aziz was Vice President of Research and Development at Interleukin Genetics, Vice President of External Research at Point Therapeutics and Director of Translational Research at Novartis Institute of Biomedical Research. In her industry career, she has focused on biomarker and genetic test development and development of drugs for cancer and diabetes. Prior to joining the biotechnology industry, she was Assistant Professor at Harvard Medical School.
Email: info@hansonwade.com
www.moleculardiagnostics-cancer.com
4th Molecular Diagnostics for Cancer Drug Development Keynote Session
Panel Session
25th – 28th June 2012
Networking Session
Tuesday 26th June 2012
Day 1 08.00 Registration, coffee and networking 09.00 Chairman’s opening remarks Dr Richard Buller, Vice President, Translational Oncology, Pfizer
Learning from Recent CDx Approval Case Studies in Oncology 09.05 The Amazing Adventures of Xalkori® (crizotinib) from Met to ALK Inhibitor and Onward • CDx development for low prevalence of disease populations • Kicking off: LDT or IUO and which one? • Overcoming dual labeling, marketing, and post-approval issues Dr Richard Buller, Vice President, Translational Oncology, Pfizer 09.35 The Development of Zelboraf: The Opportunity and Challenge of Personalized Medicine • US approval of vemurafenib (Zelboraf®, PLX4032) in BRAFV600E mutation-positive unresectable or metastatic melanoma: A landmark in personalizing the treatment of melanoma • Challenges encountered in the co-development of the drug and diagnostic (cobas BRAF V600 mutation test) and lessons learned Dr Flavia Borellini, Senior Director, Life Cycle Leader, Zelboraf™, Genentech 10.05
Boston
Speed Networking session
Practical Considerations for Successfully Developing Personalized Medicines in Oncology 2.30 Improving the Efficiency and Effectiveness of Drug and Diagnostic Development Programs: The Myriad RBM Approach 3.00 A Stakeholder-Driven Approach to Improving the Evidence Base for Molecular Diagnostics in Cancer • Understand what types of studies provide adequate evidence for clinical and reimbursement decision making • How companies and researchers can plan beyond FDA approval Dr Patricia Deverka, Senior Research Director, Center for Medical Technology Policy (CMTP) 3.30 Accessing Molecular Profiling and Companion Diagnostic Development Capabilities in a Rapidly Evolving Vendor Environment • Overcoming the logistical, operational and technical challenges in real-time pre- and post-treatment profiling of patients • Addressing the challenges for drug sponsors and diagnostic companies to work together to develop companion diagnostics • Summary of key learnings from the pre-conference workshop Dr John Bloom, President, Bloom Consulting Services & Special Government Employee, FDA
11.00 Morning refreshments
Understanding the Latest in Regulation and Legislation for Personalized Medicine and Companion Diagnostics 11.30 FDA Guidance and Companion Diagnostic Development: The Pharma/Diagnostic Experience • Recent experiences of development and approval of diagnostics at Johnson & Johnson • Ensuring a smooth and efficient approval process • Key lessons learned from working with regulators Dr Debra Rasmussen, Senior Director, Regulatory Affairs, Johnson & Johnson 12.00 Latest Updates in CDx Regulation • Understanding the major regulatory issues concerning diagnostic and pharmaceutical partners during co-development • Review of expected future FDA draft guidance for Dx/Rx • Ensuring effective and timely review of both products • Summary of key learnings from the pre-conference workshop Eric Lawson, Managing Director, Critical Perspectives 12.30 Lunch 1.30 Understanding How Policy and Legislation Affects Personalized Medicine and Companion Diagnostics • Overview of barriers to personalized medicine • Current policies in development to address barriers • Examination of legislative solutions and opportunities for them Mark A. Kass, Partner, Nixon Peabody 2.00 Extended Q&A Session: What Does it Take to Get a CDx Approved and On to the Market? Dr Debra Rasmussen, Senior Director, Regulatory Affairs, Johnson & Johnson Dr Flavia Borellini, Senior Director, Life Cycle Leader, Zelboraf™, Genentech Eric Lawson, Managing Director, Critical Perspectives Dr John Bloom, President, Bloom Consulting Services & Special Government Employee, FDA
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4.00 Afternoon refreshments 4.30 Molecular Characterization of Cancer Patients to Accelerate Personalized Medicine: MD Anderson Cancer Center Case Study • Strategies for molecular characterization for advanced cancer • Discovery of biomarkers of response and resistance • Challenges and opportunities Dr Funda Meric-Bernstam, Medical Director, Institute of Personalized Cancer Therapy, MD Anderson Cancer Center
Guidance on General Principles for Successful Companion Diagnostics Development I 5.00 Global Insights from Historical and Current Case Studies in Companion Diagnostics • Key factors driving current and evolving strategies for CDx • Understanding current and emerging platforms impacting CDx • Managing a CDx and therapeutic product portfolio to maximize probability of success in the US market Michael Stocum, President & Founder, Personalized Medicine Partners 5.30 Examining and Overcoming the Challenges of Companion Diagnostics in Pharmaceutical Development • Broad considerations for successful CDx test development • Exploring regulatory options involving CDx development • CDx qualification in clinical studies: Challenges and options Dr Tharak Rao, Head of Medical Group, Molecular Diagnostics, Novartis 6.00 Chairman’s closing remarks 7.30
Networking Dinner The summit dinner will take place in a local venue. Share discussions with your peers and enjoy a relaxing and informal dinner in comfortable surroundings. Good food, good wine, good company.
Email: info@hansonwade.com
www.moleculardiagnostics-cancer.com
4th Molecular Diagnostics for Cancer Drug Development Keynote Session
Panel Session
25th – 28th June 2012
Networking Session
Wednesday 27th June 2012
Day 2 08.00 Registration, coffee and networking 09.00 Chairman’s opening remarks Dr Theresa Zhang, Associate Director, Exploratory and Translational Sciences, Merck
Next Generation Sequencing Applications in Oncology Personalized Medicine and Drug Development 09.05 Next Generation Sequencing: Transitioning from Research to the Clinics and Standards for Laboratory Accreditation • Overcoming the hurdles to adoption of NGS in the clinical laboratory setting, including analytic validation of the test, CLIA/CAP certification, standards for reference material and proficiency testing • Review of laboratory accreditation standards being developed Dr Nazneen Aziz, Director of Molecular Medicine, Transformation Program Office, College of American Pathologists 09.35 Mutation Identification and Validation: Application of Exome Sequencing in Cancer Personalized Medicine • Annotating functions of novel sequence variants with NGS • Identifying biomarkers predictive of drug response in model systems • Translating biomarkers derived from preclinical models to the clinic Dr Theresa Zhang, Associate Director, Exploratory and Translational Sciences, Merck 10.05 Deep Sequencing for DNA Diagnostics Using Next-Generation Sequencing and COLD-PCR • Boosting next generation sequencing sensitivity for detection of rare, low-abundance mutations (e.g. in clinical cancer samples) • Sample preparation to magnify mutations prior to sequencing • Boosting confidence in the results of targeted re-sequencing in cancer samples and validating border-line sequence variants Dr G. Mike Makrigiorgos, Professor & Director of Medical Physics & Biophysics, Director of DNA Technology laboratory, Dana-Farber Cancer Institute, Harvard 10.35 Morning refreshments
Improving Biomarker Discovery and Development in Oncology: New Methodology and Technology 11.05 Exome Sequencing of Cancer Cell-lines: Mutation Identification and Applications in Cancer Drug Discovery & Development • Exome sequencing: Identifying genomic alterations costeffectively • Strategies for using exome data in cancer drug discovery and biomarker identification Dr Han Chang, Principal Scientist, Bioinformatics, Bristol-Myers Squibb 11.35 Multiplexed Tissue Biomarkers: Revealing Disease Profiles Dr Clifford Hoyt, Divisional VP, Tissue Applications and Collaborations, PerkinElmer 11.45 Next Gen Models and Pathway Bioinformatics for Biomarker Discovery in the VEGF Pathway • Response prediction for tivozanib: A potent selective VEGFR TKI with positive P3 data in RCC • Overcoming biomarker challenges for complex mechanisms, e.g. angiogenesis • Using pathway bioinformatics to create robust multigene biomarkers Dr Murray Robinson, Senior Vice President, Translational Medicine, Oncology, AVEO Pharmaceuticals
Tel: +1 212 537 5898
Boston
Fax: +1 212 537 5898
12.15 The Wide World of Circulating Markers for Cancer Applications • Exploring the potential of circulating cancer markers: From DNA to RNA and proteins to metabolites • Selecting appropriate technologies and samples to fast track the development of markers: A road map from discovery to validation Dr Samir Hanash, Program Head, Molecular Diagnostics, Fred Hutchinson Cancer Research Centre 12.45 Lunch 2.00 Patient Selection Biomarkers: Targeting the Tumor and Microenvironment • Signaling pathways as a rich source of biomarkers whether your target is tumor-specific or in the microenvironment • Contrasting biomarker strategies between tumor cell specific pathways (PI3K) and the microenvironment (endosialin/TEM-1) • Using mutiplexed assays to determine a single cut-point Dr Christina Coughlin, Senior Director, Clinical Development and Translational Medicine, Morphotek 2.30 Extended Q&A Session: Exploring the New Opportunities for Molecular Profiling in Oncology: When, Where, How, What? Dr Deborah Ricci, Director, Oncology Biomarkers, Johnson & Johnson Dr Samir Hanash, Program Head, Molecular Diagnostics, Fred Hutchinson Cancer Research Centre Dr Han Chang, Principal Scientist, Bioinformatics, Bristol-Myers Squibb Dr Nazneen Aziz, Director of Molecular Medicine, Transformation Program Office, College of American Pathologists 3.00 Afternoon refreshments
Translating Biomarkers from Research to the Clinic and Achieving Assay Validation 3.30 Oncology Translational Science at Eisai: Towards Personalized Medicine • Development of predictive/response biomarker hypotheses via systems biology in preclinical translational research • Overcoming the key challenges to implementing pharmacogenomic approaches in systems biology in translational science • Testing preclinically developed biomarker hypothesis in early clinical trials to develop a strategy for companion diagnostics Dr Yasuhiro Funahashi, Senior Director, Biomarkers and Personalized Medicine, Eisai 4.00 From Research Lab to a Validated Biomarker Assay for Clinical Trials: What the Researcher Needs to Consider • Defining the intended use of the assay: Clinical need and competitive existing assays • Analytical validation of single and multi-analyte assays • Clinical validity: Relating the test to the outcome of interest • Assessing clinical utility and addressing regulatory issues Dr Barbara Conley, Associate Director, Cancer Diagnosis Program, National Cancer Institute 4.30 Chairman’s closing remarks 4.35
1 to 1 Networking
6.30
Drinks Reception
Email: info@hansonwade.com
www.moleculardiagnostics-cancer.com
4th Molecular Diagnostics for Cancer Drug Development Keynote Session
Panel Session
25th – 28th June 2012
Networking Session
Thursday 28th June 2012
Day 3 12.05 Lunch
08.00 Registration, coffee and networking 09.00 Chairman’s opening remarks Dr Miu Chau, Global Head, Companion Diagnostics Operations, Genentech
Advanced Biomarker Strategies to Accelerate Clinical Development and Achieve Patient Stratification 09.05 Accelerating Clinical Trials in the Context of Personalized Medicine: A Consortium Case Study • Innovations in clinical trial design to accelerate drug and biomarker development • Incorporating biomarker strategies into an adaptive clinical trial paradigm • Collaborative clinical trial design using a public-private partnership Dr Sonia Pearson-White, Scientific Program Manager, Oncology, The Biomarkers Consortium 09.35 Clinical Validation of Predictive Biomarkers and Consequences of Genetic Dynamics for Personalized Medicine • Comprehensive strategy and tactics for integration of predictive biomarkers into late stage oncology clinical development • Novel adaptive designs which provide continuous validation of predictive biomarkers against clinical benefit • Personalized medicine treatment strategies incorporating genetic heterogeneity and change Dr Robert Beckman, Executive Director, Clinical Development Oncology, Daiichi Sankyo 10.05 Morning refreshments
Guidance on General Principles for Successful Companion Diagnostics Development II 10.35 Companion Diagnostics to Support the Oncology Pipeline: Recent Experiences from Genentech • Exploring the challenges involved in companion diagnostics development from partner selection to assay commercialization • How to implement companion diagnostic assays in pivotal studies • Implementing a companion diagnostics strategy into pipeline molecules • Learning from companion diagnostics examples – past and present Dr Miu Chau, Global Head, Companion Diagnostics Operations, Genentech 11.05 From Biomarker to Cleared/Approved Diagnostic: It’s Not Just Another Assay • Developing the right reagents: Not all reagents are created equal • Development and validation of the assay: Diagnostician’s view • What assay do we employ in the clinic and when? • Dx regulatory guidelines and pathways – 510(k) versus PMA Dr Daniel O’Shannessy, Director, Diagnostics Development, Morphotek
Companion Diagnostic Development in Oncology: Learning from Current Drug Programs 1.15 Developing Cancer Therapies for Specific Patient Subsets: A Clovis Oncology Case Study • Enabling personalized cancer drug development under ever shortening time-lines • Identifying the “right” diagnostic partner • CO-101 in low hENT1 cancer: A case study for drug/diagnostic co-development Dr Mitch Raponi, Senior Director, Molecular Diagnostics & Translational Medicine, Clovis Oncology 1.45 Biomarker Development for Antibody Drug Conjugates: From Target Validation to a Companion Diagnostic • Introduction to antibody maytansinoid conjugates • Clinical experience with immunohistochemistry companion diagnostics for antibody based therapeutics • Development of a calibrated immunohistochemistry assay used to estimate antigen expression patterns and levels in tissues • Assay development methods to screen patients enrolled in various phases of the clinical trial Dr Christina Carrigan, Scientist III and Group Leader, Immunohistochemistry, Translational Research, ImmunoGen 2.15 Afternoon refreshments 2.45 Mesothelin-ADC: A Case-Study in Early Development of a Companion Diagnostic • Collection of preclinical data to support clinical biomarker development • Integration of CDx development into oncology drug development • Trial design for patient stratification and biomarker validation Dr David Henderson, Principal Scientist, Clinical Pharmacology, Bayer Healthcare Pharmaceuticals 3.15 Clinical Case Study of the Development of a Targeted Antibody Therapy against PCSA in Metastatic Pancreas Cancer • Phase II clinical trial design when prevalence of target is unknown • Challenges of defining “target positive” patients • What if the target is both predictive and prognostic? • Implications for Phase III trial design and diagnostic development Dr Leonard Reyno, Chief Medical Officer, Oncology, Astellas Pharma 3.45 Chairman’s closing remarks
11.35 Critical Steps in Biomarker and Companion Diagnostics Development • Ensuring the right expertise: Gathering bioinformatics, computational biology and systems biology resources • Getting assay development right: How and where? • Developing a partnership strategy for biomarker discovery and CDx development Dr Anjan Thakurta, Senior Director, Translational Development Integration, Celgene
Tel: +1 212 537 5898
Boston
Fax: +1 212 537 5898
“This has been a very valuable event - a great conference to be informed of the importance and current issues related to molecular diagnostics. I am very glad I chose to attend, as it has been a wealth of information.”
Email: info@hansonwade.com
www.moleculardiagnostics-cancer.com
Scientist Immunogen
4th Molecular Diagnostics for Cancer Drug Development
Boston
25th – 28th June 2012
Speakers Dr Nazneen Aziz Director of Molecular Medicine, Transformation Program Office College of American Pathologists Dr. Nazneen Aziz is the Director of Molecular Medicine in the Transformation Program Office at the College of American Pathologists. In her prior positions, Dr. Aziz was Vice President of Research and Development at Interleukin Genetics, Vice President of External Research at Point Therapeutics and Director of Translational Research at Novartis Institute of Biomedical Research. Dr Richard Buller Vice President, Translational Oncology Pfizer Dr Richard Buller is Vice President, Head of Translational Oncology at Pfizer. His team is responsible for leading efforts to integrate biological and genetic insights from the laboratory into the design and execution of clinical trials as well as delivery of Companion Diagnostics for Pfizer oncology drugs.
Dr Barbara Conley Associate Director, Cancer Diagnosis Program National Cancer Institute
Robert Beckman, M.D. is an oncology clinical researcher and molecular biophysicist, whose goals are to develop cancer therapies and to improve the way cancer therapies are developed. He has played significant leadership roles in the development of new oncology clinical research groups at GlaxoSmithKline, Centocor, Merck Research Laboratories, and Daiichi Sankyo Pharmaceutical Development. Dr Christina Carrigan Scientist III and Group Leader, Immunohistochemistry, Translational Research ImmunoGen Dr Carrigan joined ImmunoGen in 2005 as part of a team focusing on the preclinical evaluation of new conjugate antibodies. In addition to this role, she is currently leading the immunohistochemistry sub team to investigate potential ADC targets, developing and validating biomarker assays, and overseeing tissue cross reactivity studies to support both preclinical and clinical programs. Dr Christina Coughlin Senior Director, Clinical Development and Translational Medicine Morphotek
Dr Barbara A. Conley is the Associate Director of the Cancer Diagnosis Program (CDP), National Cancer Institute. Her previous positions at NCI include Senior Investigator in the Clinical Investigation Branch, Chief of the CDP Diagnostics Research Branch, and Head, Aerodigestive Diseases. She has research interests in diagnostic markers, drug development, and cancers of the aerodigestive tract. Dr Samir Hanash Program Head, Molecular Diagnostics Fred Hutchinson Cancer Research Centre Dr Hanash is Program Head for Molecular Diagnostics at the Fred Hutchinson Cancer Research Center in Seattle, Washington. Dr. Hanash’s interests and expertise focus on the development and application of integrated approaches to the molecular profiling of cancer, with particular emphasis on proteomics. He is involved in a number of cohort studies to identify cancer risk factors and predictive markers.
Tel: +1 212 537 5898
Dr Robert Beckman Executive Director, Clinical Development Oncology Daiichi Sankyo
Dr Coughlin led the Translational Medicine team in Oncology at Wyeth, and she was an Asset Team Leader at Pfizer in the Early Development Group in Oncology before moving to Morphotek where she leads both the clinical development of a novel target, Endosialin/TEM-1 and the Translational Medicine efforts across the company’s pipeline.
Dr John Bloom President Bloom Consulting Services & Special Government Employee, FDA Dr Bloom has 29 years of experience in the pharmaceutical industry with leadership roles in preclinical and clinical drug development. He is regarded as an expert in developing phase-appropriate biomarker strategies for drug development, with emphasis on tailoring to individual patients needs, defining technical probability of success and product differentiation. Dr Han Chang Principal Scientist, Bioinformatics Bristol-Myers Squibb Dr. Han Chang is currently leading cancer genomics and next-gen sequencing efforts at Bristol-Myers Squibb Co. He has extensive experience of applying genomics technologies and bioinformatics to oncology and immunology drug discovery and development. Dr Han Chang received his Ph.D. from Harvard University and completed postdoctoral training at Stanford University.
Fax: +1 212 537 5898
Since 2009, Flavia has been globally responsible for the development, life cycle management and commercialization of vemurafenib (Zelboraf). Zelboraf was approved in August 2011 by the US FDA for the treatment of patients with BRAF V600E mutated unresectable or metastatic melanoma, together with its companion diagnostic, the cobas 4800 BRAF mutation test.
Dr Miu Chau Global Head, Companion Diagnostics Operations Genentech Dr. Chau heads up the companion diagnostics group in late stage development at Genentech. The companion diagnostics group leads the collaboration with diagnostics partners for late stage oncology and inflammation programs with a companion diagnostics component. Prior to joining Genentech Dr. Chau worked in the diagnostics industry for 10 years.
Dr Patricia Deverka Senior Research Director Center for Medical Technology Policy (CMTP)
Dr Yasuhiro Funahashi Senior Director, Biomarkers and Personalized Medicine Eisai
The Center for Medical Technology Policy is a private, non-profit organization that provides a trusted forum in which patients, clinicians, payers, manufacturers, and researchers can work together to design and implement prospective, real world studies to inform health care decisions. Dr Deverka’s current research responsibilities reflect her broad expertise in comparative effectiveness research, genomics and personalized medicine.
Dr Yasuhiro Funahashi is currently the Senior Director of Biomarkers & Personalized Medicine at Eisai. He has 22 years of experience in the Oncology drug development area and is currently promoting a systems biology approach in industry for both drug development and biomarker research, especially combining pharmacology data with pharmacogenomics and ‘Omics’ by applying bioinformatics analysis.
Mark A. Kass Partner Nixon Peabody
Dr David Henderson Principal Scientist, Clinical Pharmacology Bayer Healthcare Pharmaceuticals At Bayer, Dr Henderson investigates predictive (for potential companion diagnostic development) and pharmcodynamic biomarkers for small molecule and antibodybased drugs, as well as prognostic biomarkers. Prior to Bayer, Dr Henderson worked at Schering AG, where he performed research in oncology, gene therapy and pharmacogenomics.
Dr Flavia Borellini Senior Director, Life Cycle Leader, Zelboraf™ Genentech
For the past twenty years, Mark Kass has focused his practice on commercial transactions and corporate finance, particularly in the life sciences arena. He has handled collaboration agreements in the personalized medicine space, and has extensive experience in international transactions. He is a partner in the international law firm of Nixon Peabody, LLP.
Email: info@hansonwade.com
www.moleculardiagnostics-cancer.com
Eric Lawson Managing Director Critical Perspectives
Mr. Lawson has over two decades of experience in research, design, compliance management, and regulatory sciences for novel medical products. Eric directs personalized medicine and diagnostics RA/QS consulting for Critical Perspectives. He previously served with Voisin Consulting Life Sciences providing strategic consulting worldwide in the IVD arena.
4th Molecular Diagnostics for Cancer Drug Development
Boston
25th – 28th June 2012
Speakers Dr G. Mike Makrigiorgos Professor & Director of Medical Physics & Biophysics, Director of DNA Technology laboratory, Dana-Farber Cancer Institute, Harvard As Director of the DNA Technology Laboratory and the radiation preclinical facility at Dana Farber Cancer Institute, Boston, USA, Dr Makrigiorgos’ research interests include the development of novel DNA technologies for molecular diagnostics with application in Oncology. He is the inventor of several novel PCR-based techniques for molecular diagnostics. Dr Tharak Rao Head of Medical Group, Molecular Diagnostics Novartis
Dr Funda Meric-Bernstam Medical Director, Institute of Personalized Cancer Therapy, MD Anderson Cancer Center Dr Funda Meric-Bernstam is the Medical Director of the Institute for Personalized Cancer Therapy (IPCT) at MD Anderson Cancer Center. She is responsible for leading the clinical aspects of the IPCT, including developing collaborations with clinicians from all disciplines: From optimizing biospecimen collection, processing, and discovery to coordination of personalized cancer therapy trials and laboratory studies.
Dr Daniel O’Shannessy Director, Diagnostics Development Morphotek Daniel J. O’Shannessy is currently the Director of Diagnostics Development at Morphotek, an antibody-based oncology therapeutic subsidiary of Eisai, where he is responsible for the development, implementation, regulatory approval and commercialization of all diagnostic products. He has significant experience in a combination of scientific, business development and strategic planning roles within the diagnostic industry.
Dr Deborah Ricci Director, Oncology Biomarkers Johnson & Johnson Deborah Ricci joined Johnson & Johnson PRD in 2004 and is currently a Director in the Oncology Biomarkers group responsible for the development, implementation and execution of biomarker strategies in full development clinical trial. Notably, she was responsible for leading the biomarker related activities for Velcade and chairing the joint J&J and Millennium biomarker project working group.
Dr Raponi is currently responsible for designing and executing companion diagnostic strategies to support the development and commercialization of effective cancer therapeutics at Clovis Oncology. He previously spent 15 years at Johnson & Johnson, building biomarker and companion diagnostic programs within the diagnostics (Veridex and Ortho-Clinical Diagnostics) and pharmaceutical (Centocor OrthoBiotech) franchises. Dr Murray Robinson Senior Vice President, Translational Medicine, Oncology AVEO Pharmaceuticals Dr Murray Robinson joined AVEO in 2003 and led the development of the company’s core technology: Human Response Platform™ (HRP). In his current role as Senior Vice President, Translational Medicine, Dr Robinson leads the strategic integration of AVEO’s HRP into its clinical development and drug discovery programs, with a focus on AVEO’s lead program tivozanib.
Tel: +1 212 537 5898
Dr Leonard Reyno Chief Medical Officer, Oncology Astellas Pharma
Dr Rasmussen is currently a Senior Director of Regulatory Affairs at Johnson & Johnson, with responsibilities across the Johnson & Johnson family of companies, including both in drug development and diagnostics. Dr Rasmussen will be sharing her experiences of working with the FDA to obtain regulatory approval on day one of the conference.
Dr Reyno is Senior Vice President and Chief Medical Officer at Agensys, a wholly owned subsidiary of Astellas Pharma, Tokyo. He also serves as Chief Medical Officer for oncology at Astellas Pharma Global Development. In these roles he provides strategic input leadership to the clinical development of the Agensys and Astellas Oncology pipeline.
Michael Stocum President & Founder Personalized Medicine Partners Michael Stocum is Founder and Managing Director of Personalized Medicine Partners, LLC, a firm that provides strategic and operational support to biopharmaceutical and diagnostic companies as well as laboratory service providers in the development of integrated therapeutic and biomarker/companion diagnostic programs that form the basis of current and future personalized medicine products.
Dr Theresa Zhang Associate Director, Exploratory and Translational Sciences Merck Theresa Zhang obtained her PhD in Computational Biology from the University of Virginia and received her postdoctoral training at the Cold Spring Harbor Laboratories. She currently leads a group of scientists that focus on discovery of patient stratification biomarkers for targeted oncology compounds and combinations, as well as clinical translation and validation of the biomarkers.
Dr. Sonia Pearson-White is currently Scientific Program Manager for Oncology in the Biomarkers Consortium at the Foundation for the NIH, a non-profit. Dr. PearsonWhite’s largest current project is oversight and sponsorship of the I-SPY 2 TRIAL, An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy.
Dr Debra Rasmussen Senior Director, Regulatory Affairs Johnson & Johnson
Dr Mitch Raponi Senior Director, Molecular Diagnostics & Translational Medicine Clovis Oncology
Tharak Rao works in Molecular Diagnostics at Novartis where his roles include directing a medical group that oversees conduct of diagnostic clinical trials, and liaising with Novartis research and pharma partners to identify and transition general medicine focused biomarker opportunities into Molecular Diagnostics for further development as regulated diagnostic tests.
Dr Sonia Pearson-White Scientific Program Manager, Oncology The Biomarkers Consortium
Dr Anjan Thakurta Senior Director, Translational Development Integration Celgene Dr Thakurta has worked at the National Cancer Institute, AstraZeneca and Biogen Idec in various roles in cancer research and cancer drug development. Currently he is Senior Director of Translational Development Integration at Celgene, where he leads biomarker and companion diagnostics development efforts.
Meet other molecular diagnostics professionals before the meeting
Search groups for: Molecular Diagnostics for Cancer Drug Development to join the online community
Fax: +1 212 537 5898
Open to drug and diganosic developers, as well as other important stakeholders such as academics, payors and regulators, the group will provide a platform for all of the major stakeholders in the cancer biomarker and diagnostics space. The aim of the group is to make new contacts and have open discussion about issues currently halting progress. And to find solutions. We’ll also keep you posted on progress of our Personalized Medicine Events in USA, Europe and Asia.
Email: info@hansonwade.com
www.moleculardiagnostics-cancer.com
4th Molecular Diagnostics for Cancer Drug Development
Sponsorship opportunities
25th – 28th June 2012
Working with Hanson Wade
If your organization needs to raise profile, promote products and services or develop new partnership opportunities in the oncology personalized medicine and diagnostics space, contact: Miles Harley
Boston
tel: +44 (0)20 3141 8700 email: miles.harley@hansonwade.com
When you work with Hanson Wade you work with a partner focused on your success. Your investment in both time and money needs to generate a return. Our clients want that too and that’s why they work with us. They want to reach a targeted audience and eliminate wastage from their marketing activities. They work with us because we deliver results. We’re proud of this fact. Our research identifies ground breaking issues and allows you to influence industry thinking at an early stage. Our expertise is recognised and respected by the industry. And our events are focused, leading edge and attended by people looking for knowledge before making decisions.
Expertise Partners Myriad RBM, Inc. is the world’s leading multiplexed immunoassay testing laboratory, providing comprehensive protein biomarker services based on its Multi-Analyte Profiling (MAP) technology platform. This platform provides pre-clinical and clinical researchers with reproducible and quantitative data for a few or hundreds of proteins in a cost-effective manner. All services are performed in our CLIA certified laboratory. As a guide to drug development researchers, Myriad RBM also offers Strategic Biomarker Services that include companion diagnostics, custom assay development, co-sponsored research programs, and innovative cell culture products. Myriad RBM’s facilities include the biomarker testing laboratory, located in Austin, TX; a multiplex immunoassay development and GMP kit manufacturing facility in Lake Placid, NY, and a cell culture manufacturing and services lab in Reutlingen Germany. Myriad RBM is a wholly owned subsidiary of Myriad Genetics, Inc. (MYGN), a leading molecular diagnostic company based in Salt Lake City, Utah which develops and markets novel predictive medicine, personalized medicine and prognostic medicine tests. www.rulesbasedmedicine.com QIAGEN aquired DxS, a personalized healthcare company in September 2009 to create a Center of Excellence in Companion Diagnostics. QIAGEN work with pharmaceutical companies to support development of targeted cancer therapies by providing biomarkers and companion diagnostics. Working primarily in oncology, their product portfolio includes real-time PCR assays for K-RAS, EGFR, B-RAF and PI3K genes, to aid doctors and drug companies select therapies for patients. QIAGEN is active in more than 15 partnerships with pharmaceutical and large biotech companies in the field of personalized healthcare, including Astra Zeneca, Merck, Amgen, Bristol-Myers Squibb/ImClone Systems, Boehringer-Ingelheim and Pfizer. www.qiagen.com Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, develops, manufactures, and markets instrument/reagent systems that automate tissue preparation and slide staining in clinical histology and drug discovery laboratories worldwide. The company’s Smart Systems for clinical labs are important tools used in the diagnosis and treatment of cancer and infectious diseases. Ventana drug discovery systems are used to accelerate the discovery of new drug targets and evaluate the safety of new drug compounds. In addition, the company offers premier workflow solutions designed to improve laboratory efficiency, providing safeguards to enhance the quality of healthcare. www.ventana.com
Solution Spotlight Partner
Featured Exhibitor
At PerkinElmer we’re taking action to create a better tomorrow. We share our customers’ commitment to finding answers to the mysteries of human and environmental health, and to helping make the promise of personalized medicine a reality. PerkinElmer is a premier provider of cutting-edge technologies and solutions enabling researchers to create more efficient and quicker life-saving and enhancing medicines and diagnostic tests. As a leading solutions innovator, PerkinElmer bridges the gap between in vitro assays and in vivo results, allowing researchers to translate their results into cures for human disease. Visit www.perkinelmer.com/lifesciences
Tel: +1 212 537 5898
Fax: +1 212 537 5898
Email: info@hansonwade.com
www.moleculardiagnostics-cancer.com
4th Molecular Diagnostics for Cancer Drug Development
Boston
25th – 28th June 2012
Priority Code:
WEB
Event prices
Register www.moleculardiagnostics-cancer.com Tel: +1 212 537 5898 Fax: +1 212 537 5898 Email: register@hasonwade.com
Mail: Hanson Wade 304 Park Avenue South 11th Floor New York, NY 10010
Team discounts • 10% discount – 3 delegates • 15% discount – 4 delegates • 20% discount – 5 or more delegates Please note that discounts are only valid when three or more delegates from one company book and pay at the same time.
Venue and accommodation Venue DoubleTree Suites by Hilton Hotel Boston, 400 Soldiers Field Road Boston, MA 02134-1893, United States Tel: 1-617-783-0090 Accommodation Overnight accommodation is not included in the registration fee, however accommodation options will be sent out with your confirmation email upon registering.
Purchase audio presentations If you are unable to attend the meeting in person or would like documentation in addition to your attendance you may purchase the audio recordings of the speaker presentations for $799. These will be sent to you on CD rom with all available presentation slides within 10 days of the meeting. Audio orders can only be processed on receipt of credit card details.
Package
First 50 registrants
Register and pay Register and pay before Friday before Friday Standard price 27th April 2012** 25th May 2012**
3 day conference + 3 workshops + networking dinner*
$4396 (SAVE $600)
$4496 (SAVE $500)
$4596 (SAVE $400)
$4696 (SAVE $300)
3 day conference + 2 workshops + networking dinner*
$3897 (SAVE $500)
$3987 (SAVE $400)
$4097 (SAVE $300)
$4397
3 day conference + 1 workshop + networking dinner*
$3398 (SAVE $400)
$3498 (SAVE $300)
$3598 (SAVE $200)
$3798
3 day conference + networking dinner*
$2899 (SAVE $300)
$2999 (SAVE $200)
$3099 (SAVE $100)
$3199
Interactive pre-conference workshop (each)
$599 B
Please select your choice of workshop: A
C
*All of the conference packages include networking dinner. If you would like to opt out please and $100 will be deducted from your package. tick here
Please note that not for profit organizations and academic institutions are entitled to substantial discounts. Please get in contact or visit: http://moleculardiagnostics-cancer.com/event-details/pricing-discounts **All discount offers (including team discounts) require payment at the time of registration to receive any discount. ‘Early Bird’ discounts require payment at time of registration and on or before the cut-off date to receive any discount. All discount offers cannot be combined with any other offer. The conference fee includes lunch, refreshments and course documentation. The fee does not include travel or hotel accommodation.
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