BRP update from the NCI Acting Director

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1 BRP update from the NCI Acting Director Douglas R. Lowy Acting Director, National Cancer Institute National Institutes of Health BRP Virtual Meeting May 9, 2017

2 NCI APPROPRIATIONS (in billions) $6 $5 $4 $3 $2 $1 $0 $4.82 $4.92 $4.95 $5.22 $5.39 FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 (projected) +$300 million for Cancer Moonshot

3 LONG TERM >15 years TRAINING A DIVERSE WORKFORCE BASIC RESEARCH RESEARCH PROJECT GRANTS (RPGs)

4 NCI/NIH BUDGET PROCESS FOR REGULAR APPROPRIATION STEP 1 STEP 2 STEP 3 STEP 4 White House OMB coordinates with federal agencies to formulate the President s budget proposal Congressional appropriations committees consider President s proposal & prepare legislation Congress reconciles & finalizes appropriations legislation & sends to the President President signs the appropriations bill into law making funds available for NIH & NCI FY 2017 FY 2018

5 NCI Virtual Drug Formulary Goal: To shorten time needed to initiate multi-agent drug combination trials. System: Provides PI s with investigational agents for investigator-held INDs. No NCI funding for trials Program: launched Jan 2017; currently 26 agents from 7 companies; for clinical and pre-clinical stuies; standardized agreement terms Time-line: 8 week turn-around time for Pharma review (approval or not) of proposals

6 NCI Virtual https//nciformulary.cancer.gov Drug Formulary

7 ICPC (International Cancer Proteogenome Consortium) 10 MOUs / 11 countries / 18 institutions DATA SHARING PLEDGE leading research centers that have pledged to make genomic & proteomic datasets available to the public to advance cancer care

8 CANCER MOONSHOT: AUTHORIZED FUNDING Fiscal Year Cures Dollars (in millions) Estimated First Year Awards (in millions) 2017 $300 $ $300 $ $400 $ $195 $ $195 $ $194 $ $216 $25

9 Many potential collaborations Possible collaborations with: Other Institutes/Agencies Private philanthropy Pharma/biotech Other countries International donors

11 Implementation of the Cancer Moonshot Blue Ribbon Panel Recommendations Blue Ribbon Panel Meeting Mary 9, 2017

12 Overall Goals of the Cancer Moonshot Accelerate progress in cancer, including prevention & screening From cutting edge research to wider uptake of standard of care Encourage greater cooperation and collaboration Within and between academia, government, and private sector Enhance data sharing (Presidential Memo 2016) 2

13 Blue Ribbon Panel Goals Identify major scientific opportunities that are poised to be accelerated by additional emphasis and funding Develop recommendations of opportunities that would be pursued through the Cancer Moonshot Final recommendations at 3

14 Blue Ribbon Panel Recommendations A. Network for direct patient engagement B. Cancer immunotherapy translational science network C. Therapeutic target identification to overcome drug resistance D. Creation of a national cancer data ecosystem E. Fusion oncoproteins in pediatric cancer F. Symptom management research G. Precision prevention and early detection H. Retrospective analysis of biospecimens from patients treated with standard of care I. Creation of human tumor atlas J. Development of new enabling technologies Cross Cutting Themes: Health disparities, prevention, technology development, data sharing, partnerships

15 Cancer Funding in 21 st Century Cures Act The cancer research portion is named the Beau Biden Cancer Moonshot Initiative $1.8 billion over 7 years $300 million for FY17 To support cancer research, such as the development of cancer vaccines, the development of more sensitive diagnostic tests for cancer, immunotherapy and the development of combination therapies, research that has the potential to transform the scientific field that has inherently higher risk, and that seeks to address major challenges associated with cancer.

16 $400 M $300 M $200 M $100 M Funding for Beau Biden Cancer Moonshot New NCI Moonshot Awards Beau Biden Cancer Moonshot Funding Fiscal Year Dollar in Millions 2017 $ $ $ $ $ $ $216 $0 FY 2017 FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 FY 2023

17 NCI s Approach for Accelerating Research Utilizing 21 st Cures Funding Initiate a large amount of new research in FY 2017 through FY Some grant awards will use multi-year funding authority, to cover outyear costs Additional efforts to accelerate research will be undertaken through: contracts with the cancer community managed through the Frederick National Laboratory for Cancer Research (FNLCR) core resources at FNLCR (estimated to be <$10M) Enable new grant awards from the 21 st Century Cures funds to be made in every year except for FY 2020 and FY The inability to make new awards in those two years results from the sharp decrease in Moonshot funds that starts in FY 2020

18 FY17 Implementation of Blue Ribbon Panel Recommendations: Laying the Groundwork Fusion Oncoproteins in pediatric cancer Gene Fusions in Pediatric Sarcomas (APRC) New Enabling Technologies APTRC supplement program Advancing new enabling technologies in cancer research PDX development centers Cancer Immunotherapy Biomarker development labs (CIMAC) for adult and pediatric; Canine immunotherapy Expand CIMAC to include pediatrics Autoimmune sequelae with NIAID Therapeutic Target Identification to Overcome Drug Resistance Prevention and Early Detection HPV trial Tobacco cessation supplements to Cancer Centers Symptom Management Research Oral anticancer agents

19 Beyond FY17: FY18 and FY19 Implementation of Blue Ribbon Panel Recommendations

20 Process for Implementation of BRP Recommendations BSA Implementation Steering Committee Implementation Coordinating Committee Implementation Partnership Committee Cancer Moonshot Implementation Teams Aligned with BRP Recommendations

21 Charge to Cancer Moonshot Implementation Teams Discuss approaches and develop initiatives for FY18 and FY19 that will achieve the goals of the Recommendation Identify opportunities in current landscape of existing initiatives that can be leveraged Seek input from others, including the cancer research community, advocates, and associations Work with the Partnership Committee to consider creating and/or leveraging partnerships (academia, industry, pharma, ) Provide oversight and coordination of the Team s funded initiatives (e.g managing awards, organizing meetings, providing supplements)

22 Outreach by Implementation Teams Requests for Information (RFI) AACR meeting Discussions with Working Group Co-chairs or members Workshops

23 Process for Implementation of BRP Recommendations BSA Implementation Steering Committee Implementation Coordinating Committee Implementation Partnership Committee Cancer Moonshot Implementation Teams (CMIT) Aligned with BRP Recommendations

24 Cancer Moonshot Implementation Timeline Steering Committee Coordinating Committee February Implementation Team Kickoff March April May June Concept Deadline BSA Concept Review CM Implementation Teams A. Network for Patient Engagement B. Cancer Immunotherapy Translational Science Network Bi. Pediatric Bii. Adult C. Therapeutics Target ID to Overcome Resistance D. Cancer Data Ecosystem E. Fusion Oncoproteins Childhood Cancers F. Symptom Management Research G. Prevention and Early Detection Gi. High Risk Cancers Gii. Prevention and Screening H. Retrospective Analysis of Biospecimens I. Generation of Human Tumor Atlases J. Development of New Cancer Technologies Outreach Events Webinars (F) Workshop RFI (Bi) (Gi) RFI (E) Meeting (Bii) Teleconference (Bii) Webinars (Gii) Workshop Session (H)

25 A B Recommendation Network for Direct Patient Engagement Immunotherapy Networks Concepts Under Development for FY18/FY19 Network for Direct Patient Engagement Rare Tumor Patient Engagement Network Concept Pediatric Immunotherapy Translational Science Network (PI-TSN) Immunotherapy Translational Science Network Cancer Immunoprevention Consortium Precision Immunogenomics Resource Adult Immunotherapy Network Hub C Target ID to Overcome Drug Resistance Cancer Therapy Resistance Networks D National Cancer Data Ecosystem Encrypted patient identifiers; Data Aggregator E Fusion Oncoproteins Collaborative Research Network for Fusion Oncoproteins in Childhood Cancers F Symptom Management Improving Management of symptoms Across Cancer Treatments (IMPACT) Implementation and Analysis of Patient Reported Outcome Version of the Common Terminology Criteria for Adverse Event Reportings (PRO-CTAE) in Cancer Clinical Trials Assessing Tolerability of Anti-Cancer Treatment G High Risk Cancers Inherited Cancer Syndromes Approaches to Identify and Care for Individuals with Inherited Cancer Syndromes Traceback: A proposed framework to increase identification and genetic counseling of BRCA1/2 mutation carriers through family-based outreach Prevention and Screening Scaling up Colorectral Cancer Screening & Follow-up to Enhance Service Systems H Retrospective Analysis of Biospecimens FY17 I Generation of Human Tumor Atlas Human Tumor Atlas Network Translational 3D Platform for Understanding the Tumor Ecosystem J Development of New Technologies FY17

26 Funding Mechanisms to Support Moonshot Activities Grants Traditional RO1, R21 Cooperative agreements for Networks with NCI involvement U01: Discrete circumscribe project U54: specialized, multidisciplinary center UM1: large-scale research activities with complex structure, e.g consortia, networks, programs Contracts Through Frederick National Labs to cancer community to provide support and resources for Moonshot activities

27 Questions? National Cancer Advisory Board February 15,

NCI Cancer Moonshot. Christine Siemon National Cancer Institute, NIH. November 30, 2017

NCI Cancer Moonshot. Christine Siemon National Cancer Institute, NIH. November 30, 2017 NCI Cancer Moonshot Christine Siemon National Cancer Institute, NIH November 30, 2017 Presidential Memo 2016 Overall Goals of the Cancer Moonshot Accelerate progress in cancer, including prevention & screening