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CTEP Interactions with Industry and the FDA

CTEP Interactions with Industry and the FDA. Dale Shoemaker, Ph.D. Sherry Ansher, Ph.D. Regulatory Affairs Branch Cancer Therapy Evaluation Program. CTEP.CANCER.GOV. Division of Cancer Treatment and Diagnosis. Office of the Director, DCTD Biometric Research Branch.

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CTEP Interactions with Industry and the FDA

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  1. CTEP Interactions with Industry and the FDA Dale Shoemaker, Ph.D. Sherry Ansher, Ph.D. Regulatory Affairs Branch Cancer Therapy Evaluation Program CTEP.CANCER.GOV

  2. Division of Cancer Treatment and Diagnosis Office of the Director, DCTD Biometric Research Branch Radiation Research Program Cancer Diagnosis Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Biomedical Imaging Program

  3. CANCER THERAPY EVALUATION PROGRAM Michaele Christian Protocol and Information Office Michael Montello Clinical Grants and Contracts Branch Roy Wu Clinical Investigations Branch Richard Kaplan Regulatory Affairs Branch Dale Shoemaker Investigational Drug Branch Louise Grochow Pharmaceutical Management Branch Alfred Fallavollita Clinical Trials Monitoring Branch Joan Mauer

  4. Our Mission The mission of the Cancer Therapy Evaluation Program (CTEP) is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. CTEP accomplishes this mission by funding an extensive national program of cancer research and by sponsoring clinical trials to evaluate new anti-cancer agents, with a particular emphasis on translational research to elucidate molecular targets and mechanisms of drug effects. Theory to Therapy

  5. Currently sponsors over 150 INDs. 9905 registered investigators at over 1950 institutions. Over 1000 active protocols. 500 new protocols/year. ~25,000 patients accrued/year. Over 80 collaborative agreements (CRADAs, CTAs, and CSAs) with pharmaceutical companies. The Cancer Therapy Evaluation Program (CTEP)

  6. Doing Battle Against Cancer - A Collaborative Effort • DCTD-NCI • Expedite pivotal trials • Exploratory studies • Other indications (tumor types) • Combination regimens of investigational agents from two or more sources • Alternative methods of drug administration Investigational Anticancer Agents • Pharmaceutical/Biotech Company • Pilot studies and pivotal trials leading to licensing Clinical Investigators IND and Clinical Trials Novel Cancer Therapies

  7. The Advantages of Collaborating with CTEP • CTEP Sponsors INDs. • CTEP provides a wide range of investigational agents for clinical trials in a variety of tumor types and disease settings. • Indemnification issues are addressed in collaborative agreements.

  8. Prepares and submits Investigational New Drug Applications (INDs). Reviews protocol LOIs, protocols, and protocol amendments. Liaison with FDA. Liaison with intramural and extramural investigators. Interacts with biotech and pharmaceutical companies. Prepares agreements for clinical development of agents. Coordinates company interactions with NCI and NCI investigators. Regulatory Affairs Branch

  9. Continued Clinical Grants and Contracts Branch • Serves as the contact for extramural investigators for administrative and scientific advice concerning clinical research grants, cooperative agreements and contracts. • Manages three Grant Programs in Clinical Oncology, Surgical Oncology, and Cancer Nutrition.

  10. Clinical Grants and Contracts Branch • Supports grants and cooperative agreements encompassing clinical agent development at the molecular, cellular and whole body levels as well as treatment regimen and methodology development. • Participates in the planning, implementation, and management of the early phase clinical trials contract and cooperative agreement programs, the Clinical Trials Cooperative Groups.

  11. Agents developed at NCI. Agents developed under NCI-funding agreements. Agents developed independently by universities or other academic or research institutions. Agents developed by biotech and pharmaceutical companies. Source of Agents for CTEP

  12. Pre-IND Meetings with FDA IND Filing Protocols and Amendments Monitoring of and reporting to FDA on adverse drug events Annual Reports to FDA Responses to FDA letters and phone inquiries Attendance and participation at meetings Requests to export agents to foreign investigators Participation in joint NCI-FDA sponsored conferences CTEP Activities as IND Sponsor

  13. NCI holds MF for all sites/investigators NCI approves all protocols Investigators must adhere to protocols Confidentiality and transfer limitations apply Institutions maintain ownership of investigator data and intellectual property Access to data provided to NCI and collaborating company(ies) Guidelines for NCI-Sponsored Trials

  14. Established in 1955 to test new cancer therapies and funded as grants Support mechanism changed to cooperative agreements in 1980 to highlight NCI’s participation in the program Funding for the group is a specific line item in the NCI budget that does not compete with the RPG pool Currently 12 groups which are funded by over 150 U10s and which receive about $125 million The Clinical Trials Cooperative Groups

  15. Conduct large multi-center trials Funding is independent of any specific trial and is mainly for data management Group structure consists of a headquarters / operations office, a biostatistical/data management office and the participating institutions Many of the institutions are funded as subcontracts by the operations office for enrolling patients Groups seek industry support for trials of high scientific merit to offset some of the costs not covered by funding Insurance companies are reimbursing some of patient care costs on group studies Clinical Trials Through the Cooperative Groups

  16. IND sponsorship Drug Supply Patents CTEP NCI Protocols Publications Adverse Event Reporting Data Rights Monitoring Clinical Trials Provisions for All CTEP Cooperative Agreements

  17. The Advantages of Collaborating with CTEP • Regulatory expertise. • Ability to evaluate agent in wide variety of tumor types and disease settings. • Expedite trials through extensive clinical trials network of cooperative groups, cancer centers, and phase 1 & 2 contracts. • Primary data concerning a particular agent are made available exclusively to NCI collaborator for that agent.

  18. A CTA may be appropriate when: Collaborator has strong patent position Collaborator has completed preclinical studies and IND-directed toxicology Collaborator will supply agent only Clinical Trials Agreement (CTA)

  19. Detailed agreement between the NCI and a pharmaceutical company (Collaborator) for the clinical co-development of an agent that:  usually stipulates terms for a much broader scope of research than a CTA.  usually encompasses preclinical development  usually includes funds from collaborator Cooperative Research andDevelopment Agreement (CRADA)

  20. Either NCI or collaborator will submit an IND Either may cross-reference an IND or Master File (MF) held by the other All information in INDs will be fully shared between NCI and collaborator Manufacturing data may be held confidential by collaborator Collaborative Clinical Development of Agents - INDs

  21. Patent rights. Data rights. Timely access to clinical trial data. Control and timely completion of clinical studies. Publications. Combination of investigational agents. Collaborative Therapeutics Development Between NCI and Industry - Issues and Challenges

  22. Terms of award to clinical sites include Intellectual Property Option to collaborator. This offers rights of first negotiation to collaborator who supplied Agent if there is an invention. Co-exclusivity for combination studies. Patent Rights

  23. Data Rights • Primary data generated in NCI-sponsored clinical trials are made available exclusively to NCI and the Collaborator. The FDA has the right to review the data. • Provisions included in terms of award and standard language in all protocols.

  24. Timely Access • CTEP is implementing a new electronic web-based clinical trials reporting system which should improve the speed with which data are available to Collaborators. • Arrangements are made to provide Collaborators with access to trial data through existing systems such as CDUS.

  25. Control Over Agent • Clinical development is a collaborative effort between the NCI and the Collaborator. All protocols are mutually agreeable to the NCI and the Collaborator. • Drug development plans are established jointly so that needs and interests of both parties are addressed. • All protocols are reviewed by CTEP and collaborators.

  26. Collaborators are given 30 days to review manuscripts prior to submission to assure that no confidential/proprietary information is released. An additional 30 days can be requested for patent filings only. Purpose: information but not censorship. Meeting Abstracts are sent as a courtesy to Collaborator prior to, or at the time of submission. Publications

  27. Data reduction. Preparation for the electronic filing of protocol, and e-INDs. Adverse Events Expedited Reporting System (AdEERS). Clinical Data Update System (CDUS). Expanded Participation Project. Clinical Trials Support Unit. Current Initiatives at CTEP

  28. Program information. Informatics initiatives - AdEERS, CDUS. Model agreements - CDA, CTA, CRADA and CRADA appendices. Standard protocol language - all protocols using an investigational agent supplied under a CTA or CRADA must incorporate the standard language which details publication rights, data access, and intellectual property. Terms of award option to collaborator for intellectual property. CTEP on the Web - CTEP.CANCER.GOV

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