Clinical Trials for Molecularly Targeted Cancer Drugs

Venue: Boston

Location: Boston, Massachusetts, United States

Event Date/Time: Sep 25, 2002 End Date/Time: Sep 27, 2002
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There are now a plethora of novel, molecularly targeted agents currently in clinical trials, reflecting our increased comprehension of the complex pathogenesis of cancer. In addition, there is a growing realization that to effectively maximize clinical benefit, clinicians will need to use multi-pronged approaches that employ a combination of agents targeting several different important oncogenic mechanisms. It has also become evident that the standard cytotoxic drug development paradigm has limited applicability for these innovative agents as a consequence of the inherent differences in expected clinical outcomes and toxicities.

Successfully guiding these agents through clinical development and surmounting the regulatory hurdles has proved extremely challenging. However, several of these novel agents have now demonstrated their potential for improving patient outcomes and gained regulatory approval. There are also new challenges and regulatory issues that we face as we begin to move from the acute treatment paradigms of cytotoxic agents to potentially managing cancer as chronic disease.

To specifically address these new challenges, the Institute for International Research presents "Clinical Trials for Molecularly Targeted Cancer Drugs", which is the successor to our Annual Clinical Trials for Anti Cancer Drugs conference. The mission of this conference is to provide attendees with the key insights and critical information that will enable them to effectively optimize novel, anti-cancer drug development strategies and clinical trial designs. To successfully provide these broad perspectives, a tag team approach, pairing industry and academic experts, will be the forum used to highlight the critical issues in translational research, exploratory development, clinical trial design, and the translational issues associated with each of the key mechanism-based approaches. Day Two topics include discussions of: biomarkers and surrogate endpoints, dose selection, dosing considerations for combination therapy, chemoprevention, critical go/ no-go criteria, pharmacogenomics/molecular phenotyping, and imaging technologies. Panel discussions expand on dosing and biomarker issues and provide the forum for further exploring important perspectives on these key subjects.

Day Three provides the opportunity to review and update you on the current status of clinical translation and clinical assessment challenges associated with the development of drugs with targeted mechanisms of action. Therapeutic classes covered include: signal transduction inhibitors, cell cycle inhibitors, anti-angiogenic agents, and immunotherapeutic agents. In addition, strategic regulatory and clinical strategies are discussed. These presentations are given by industry leaders together with highly regarded members of the scientific and medical community.

Day One: Three Pre-Conference Workshops

Strategies for Early Clinical Trial Design for Cancer Drugs reviews traditional statistical methodologies used in Phase I and Phase II oncology trials with a focus on their application to novel cancer drugs. This workshop is designed for Biostatisticians, Directors of Regulatory Affairs, and Medical Directors
Assessing Combinations of Cytotoxic and Non Cytotoxic Cancer Therapies explores the scientific validation and mechanistic viability of drug combinations, utilizing molecular pathology to guide drug selection and treatment, overcoming cytotoxic resistance, and study designs for combination toxicology studies. This workshop is designed for Clinical Pharmacologists, Vice Presidents of Translational Research/Pre-Clinical Development, and Medical Directors.
Strategies for Meeting Recruitment Rates and Overcoming Patient Enrollment Obstacles explores crucial issues in site selection, effective study designs, specific regional issues in running global trials, enrollment-enhancing strategies, and managing protocol testing procedures at the site level. This workshop is designed for Clinical Research Managers, Clinical Research Physicians, and Director of Clinical Operations.