Pediatric Preclinical Testing Consortium

Slides:

Advertisements

Similar presentations

Investigator Responsibilities in Clinical Research

Advertisements

Role of the Statistician and the Bioinformatics Scientist in Cancer Clinical Trials Larry Rubinstein, PhD Biometric Research Branch, NCI International.

Safety and Extrapolation Steven Hirschfeld, MD PhD Office of Cellular, Tissue and Gene Therapy Center for Biologics Evaluation and Research FDA.

Overview of Mentored K Awards Shawna V. Hudson, PhD Assistant Professor of Family Medicine and Community Health UMDNJ-RWJMS The Cancer Institute of New.

The Role of Preclinical Models to Identify Novel Therapeutics in Rare Cancers Peter J. Houghton, Ph.D. St. Jude Children’s Research Hospital.

July 15, :00 – 11:00 Introduction to Clinical Research: Research Funding and Career Development Michael B. Amey Associate Dean Office of Research.

Michael Birrer, PI, Director, Gynecologic Medical Oncology, MGH Lari Wenzel, Co-PI, Prof. of Medicine, University of California, Irvine

February 25, 2014 SERIES 4, SESSION 2 OF AAPLS APPLICANTS & ADMINISTRATORS PREAWARD LUNCHEON SERIES Material Transfer and Confidentiality Agreements.

Oncology Pediatric Initiatives Richard Pazdur, MD Director, Division of Oncology Drug Products.

Academic Clinical Trial Do’s & Don’ts for Partnering with Pharma CCAF San Diego, CA April 14, 2014 J. Eric Bubbers, Ph.D.

Translation of Anti-CD22 Monoclonal Antibodies for the Treatment of Lymphoma Joseph M. Tuscano, M.D. Associate Professor of Medicine Department of Internal.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH Working with FDA: Biological Products and Clinical Development U.S. DEPARTMENT.

Supported by: Georgia Department of Human Resources, National Center for Minority Health and Health Disparity (NCMHD), and the Medical College of Georgia.

CALGB Informational Session June 22, 2007 David Hurd, MD Interim Chair Data Audit Committee.

TYPE 2 TRANSLATIONAL RESEARCH 2009 GRANT PROGRAMS UW Institute for Clinical and Translational Research (ICTR) Community-Academic Partnership Core (CAP)

Jeff Bond AMT Grant and Proposals Director. Research Opportunities Reserved for Small Business Reserved for Small Business SMALL BUSINESS INNOVATION RESEARCH.

1 The Cancer Consortium Deborah Schrag, MD (PI) Caprice Christian Greenberg, MD, MPH Brigham and Women’s Hospital Dana-Farber Cancer Institute.

CTEP IND LOI Review and Approval Process. Study Proposals Letter of Intent May be sent in response to solicitation May be sent by investigator with interesting.

Partnering with Federal Labs: A Panel Discussion FLC Mid-Atlantic Region Annual Meeting October 24, 2007.

Clinical Trials in PKU Georgianne Arnold, MD Professor of Pediatrics

SARC Developmental Therapeutics Committee Update Chand Khanna Open Science: Biology to Therapy” SARC Developmental Therapeutics Committee Update Chand.

DCB New Grantee Workshop: Post-Award Administration of Grants Brett Hodgkins Team Leader National Cancer Institute Office of Grants Administration.

SARC Career Development Award Program Richard Gorlick, MD Lee Helman, MD.

Investigational Drugs in the hospital. + What is Investigational Drug? Investigational or experimental drugs are new drugs that have not yet been approved.

ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP inhibitor, Niraparib and Temozolomide in Patients with Previously Treated,

How can we work together? Partnering with Industry: An Investigator’s Perspective Robert L. Coleman, MD M. D. Anderson Cancer Center.

DCB New Grantee Workshop: Post-Award Administration of Grants Brett Hodgkins Team Leader National Cancer Institute Office of Grants Administration.

Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

SARC: Participation and Protocol / Concept Review Robert Maki, MD PhD Memorial Sloan-Kettering Cancer Center.

Slide 1 Community Networks to Reduce Cancer Health Disparities Pre-Application Conference May 26, 2004 Bethesda, MD Kenneth C. Chu, PhD Chief, Disparities.

Preclinical Guidelines: Development of Radioprotective/Mitigative Agents Departments of Dermatology & Radiation Oncology University of Rochester Medical.

DCB New Grantee Workshop: Post-Award Administration of Grants Brett Hodgkins Team Leader National Cancer Institute Office of Grants Administration.

1 Clayton Biotechnologies, Inc. One Riverway, Suite 1520 Houston, Texas Overview of Clayton Biotechnologies,

Letters of Intent (LOIs) Through the NCI’s Cancer Therapy Evaluation Program (CTEP) Dr. Patricia M. LoRusso, D.O. Karmanos Cancer Institute Wayne State.

Initiating phase 1 clinical trials in pediatric oncology National Cancer Institute Perspective Barry Anderson, MD, PhD Pediatric Section Cancer Therapy.

AAHRPP ACCREDITATION (Association for the Accreditation of Human Protection Programs)

Dinutuximab (ch14.18) for children with high-risk neuroblastoma

Enrollment and Monitoring Procedures for NCI Supported Clinical Trials Barry Anderson, MD, PhD Cancer Therapy Evaluation Program National Cancer Institute.

Role of the Drug Project Team in Formulating the Initial Development Plan of NCI-IND agents Jeff Moscow, MD IDB, CTEP.

Building a Research Core Road Map and Lessons Learned Scott A. LeMaire, MD Professor of Surgery and of Molecular Physiology and Biophysics Vice Chair for.

Understanding Clinical Trials – Part 2 Georgianne Arnold, MD Professor of Pediatrics University of Pittsburgh Medical Center Pittsburgh Children’s Hospital.

C-1 Pegfilgrastim (Neulasta  ) Oncologic Drugs Advisory Committee Pediatric Subcommittee October 20, 2005 Amgen Inc.

Prioritizing New Agents for Pediatric Oncology Evaluation Malcolm A. Smith, MD, PhD Cancer Therapy Evaluation Program National Cancer Institute May 2007.

CTEP Visiting Physician Externship Coordinator: Igor Espinoza-Delgado, M.D. NCI CTEP Investigational Drug Branch

The TJU Human Research Protection Program (HRPP): Part I – Which Entities/Offices are Involved ? J. Bruce Smith, MD, CIP.

NCI Initiatives to Develop Non-Clinical Models for Pediatric Oncology Malcolm A. Smith, MD, PhD 17 March 2004.

1 Impediments to Early Initiation of Pediatric Studies in a Clinical Oncology Drug Development Program A Large Pharmaceutical Company Perspective  Corporate.

Application of the 1998 Pediatric Rule to Oncology Steven Hirschfeld, MD PhD CDR U.S. Public Health Service Medical Officer Division of Oncology Drug Products.

Review of Research-Related Agreements Between Academic Institutions and Other Entities. Manoja Ratnayake Lecamwasam, PhD Intellectual Property and Innovation.

BioMarker Strategies biotrinity 2016 London April Functional Profiling to Guide Cancer Drug Development and Treatment Selection.

Division of Cancer Treatment and Diagnosis Presented By: Michael Difilippantonio, Ph.D. October 1, 2015.

Pediatric Preclinical Testing Consortium

AACR Genomics In Clinical Medicine Think Tank

Financing Small Firm Innovation in the United States

Pediatric Brain Tumors: The Need for “Pristine” Biologic and Clinical Data Roger J. Packer, MD Senior Vice-President Neuroscience and Behavioral Medicine.

Novartis Pediatric Drug Development Faculty Program

Sarah Leary, MD MS CBTTC 5/25/2016

Broadening Eligibility Criteria to Make Clinical Trials More Representative Joint Recommendations of the American Society of Clinical Oncology and Friends.

Small Business Programs (SBIR and STTR)

Learning About PET/CT Scans:

SPARC – Washington University LEAP Inventor Challenge Program RFP

From Bench to Clinical Applications: Money Talks

Investment Opportunity and

Understanding the alphabet soup from funding agencies

IND Review Process Seoul National University

Cindy Murray NP Princess Margaret Cancer Centre

Trial Funding and Engagement: The NIH Sponsored CTSA Program

Liver and Intestinal Organ Transplantation Committee Spring 2014

Cancer is a Challenge Cancer is common in humans – a public health problem ~1 of every 3 women will develop cancer ~1 of every 2 men will develop cancer.

National Pediatric Critical Care Collaborative Research Network

Presentation transcript:

Pediatric Preclinical Testing Consortium April 2018

PPTC Primary Objective The PPTC is designed to produce reliable preclinical in vivo data using genomically characterized patient-derived xenograft lines so that childhood cancer clinical researchers can better prioritize which agents to pursue in pediatric clinical trials. Effective prioritization of truly active agents for pediatric clinical testing is essential to future success in identifying more effective treatments for children with cancer.

History Pediatric Preclinical Testing Program (PPTP) received two 5-year awards from NCI PPTP awards were research contracts with Dr. Peter Houghton as PI St. Jude Children’s Research Hospital Nationwide Children’s Hospital Systematic approach to preclinical testing with in vivo focus More than 80 agents More than 50 pharmaceutical companies More than 70 publications

PPTC Niche The PPTC develops robust preclinical datasets for candidate agents using genomically characterized childhood cancer xenograft lines Complementary to other research activities: More basic research teams identify critical biological pathways and therapeutic targets Individual laboratories focus on mechanism of action (primarily in vitro experiments) Pharmaceutical companies develop agents for adult cancer markets Clinical research teams prioritize agents for clinical evaluation

Pediatric Preclinical Testing Consortium (PPTC) The PPTC is funded through a cooperative agreement. Testing is performed by highly qualified research programs that focus on specific childhood cancers. Coordination and data management/analysis is by the PPTC Coordinating Center. NCI has specific responsibilities in providing scientific, technical, and regulatory assistance, advice, and coordination within the Consortium. The NCI Program Director for PPTC is Dr. Malcolm Smith of Cancer Therapy Evaluation Program (CTEP) Dr. Beverly Teicher serves as an NCI Steering Committee representative NCI is responsible for negotiating Material Transfer Agreement (MTAs) with pharmaceutical companies.

PPTC Members Role Institution PI Coordinating Center Research Triangle Institute (RTI) Greg Gatto, PhD Sarcoma & Renal Greehey Children’s Cancer Research Institute Peter Houghton, PhD Raushan Kurmasheva, PhD Neuroblastoma Children’s Hospital of Philadelphia John Maris, MD Osteosarcoma MD Anderson Cancer Center Richard Gorlick, MD Leukemia Children’s Cancer Institute Australia Richard Lock, PhD CNS Baylor College of Medicine Xiao-Nan Li, MD, PhD

Coordinating Center Name Position Greg Gatto, PhD Principal Investigator and Project Director Steve Erickson, PhD Statistician John Guo, PhD Cindy McClintock Project Coordinator Rebecca Hipp Jeff Ambroso, PhD Toxicologist Sophie Li Data Management

PPTC Organization

PPTC Funding Total funding of approximately $2.7 million per year Testing of 6 to 10 new agents (or combinations of agents) annually across relevant, well-characterized preclinical models. Limited funding for PK/PD studies

Evaluating Agents Through PPTC Confidentiality agreement (if needed) Application (see application at http://www.ncipptc.org/application) Review by PPTC Steering Committee Research Plan developed by PPTC MTA with NCI (see http://www.ncipptc.org/documents) Provision of agent to PPTC Coordinating Center In vivo testing and analysis of results at relevant Research Program(s) Report for company with 8-12 months of drug receipt

Agents Tested by PPTC and Transitioned to the Clinic for Evaluation in Children with Cancer Alisertib (MLN8237) NTX-010 Selumetinib for BRAF-mutated low-grade astrocytoma Rapalog plus standard chemotherapy (for rhabdomyosarcoma) IGF-1R antibodies Eribulin Talazoparib (BMN 673) plus low-dose temozolomide

PPTC Material Transfer Agreements Company executes MTA with CTEP/NCI for provision of agent for Pediatric Preclinical Testing Consortium only. No other uses of agent under this MTA. NCI has executed MTAs with each of participating institutions and a collaboration agreement with the PPTC Coordinating Center No significant modifications to MTAs are accepted from companies; terms of institution MTAs and company MTAs are consistent Institution awards were based on acceptance of MTA terms

MTA Terms Use agent as provided without making any modifications to agent or attempting to analyze compound provided Institution indemnifies company for its use of material and data Company indemnifies institution for its use of data resulting from the project Reports provided to NCI at least quarterly Company granted right to use all data and results for any purpose

Publications and IP Issues 45 day company review of all manuscripts and 10 day abstract review Institution may not submit without written approval from CTEP to do so after any and all NCI and company comments are addressed NCI IP Option to Collaborator included in Institution MTA and Coordinating Center Collaboration Agreement. Company receives non-exclusive royalty free license to any invention for commercial purposes, and first option to negotiate an exclusive or co-exclusive royalty bearing license for commercial purposes. Company will cover patent prosecution and maintenance costs. Company has 3 months to notify institution of interest in obtaining an exclusive license. Extended time period to decide if invention will be useful. Unauthorized Use. Company receives a royalty-free exclusive or co-exclusive license. Company will cover patent prosecution and maintenance costs.