2015 annual review · pdf file · 2017-07-14innovative precision medicine trial,...
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Innovative Precision Medicine Trial, Lung-MAP,Expands Across NationâMore than 700 sites activatedâ210 patients enrolled May 19, 2015 – Friends Creates Momentum for
Enhancing Patient Input and Regulatory InnovationLeaders from advocacy, industry, science, academiaand government discuss pressing issues with FDAleadership and develop framework for patient input
June 10, 2015 – Friends Convenes Multi-stakeholderForum Exploring Rate-limiting Steps in ManufacturingReadiness for Breakthrough Drug Development
September 9, 2015 – Friends Charts Blueprint forPersonalized MedicineFriends partners with Alexandria Real Estate Equities tohost forum addressing how genetic databases alterresearch
Friends Plays Key Role in House 21st Century Cures Act
âFebruary 23, 2015 – Friends holds congressionalbriefing on 21st Century Cures Act
âMay 21, 2015 – House Energy & CommerceCommittee unanimously passes bill
âJuly 10, 2015 – Bill passes House
JANUARY
FEBRUARY
MAY
JUNE
SEPTEMBER
Breakthrough Continues to Revolutionize DrugDevelopmentFriends was pivotal in creating the designation, movingit from an idea to reality in just 13 months. Since theprogram began there have been:â384 breakthrough therapy designation requestsâ118 designations grantedâ39 FDA approvalsâ30 approvals for novel indications
Within the last year there were:â34 cancer drugs that received the designationâ21 breakthrough cancer drugs approved
October 22, 2015 – Friends Celebrates IncredibleLeaders, AccomplishmentsFriends honors Marlene Malek, Rep. Diana DeGette(D-CO) and Rep. Fred Upton (R-MI) at 19th AnnualCancer Leadership Awards Reception; NIH Dir.Francis Collins surprises attendees through song “If Not Now, Tell Me When”
November 12, 2015 – Friends Partners with PrevisionPolicy to Launch Biopharma CongressKeynotes delivered by CMS Acting Administrator AndySlavitt and FDA CDER Dir. Janet Woodcock; Former FDACommissioners Margaret Hamburg and Mark McClellandiscuss future of FDA with Ellen Sigal
November 17, 2015 – 8th Friends-Brookings AnnualMeetingCaliff makes first appearance post-Senate confirmationhearing; meeting sought recommendations to:âIntegrate new measures of tumor response into drug
development programsâDevelop a framework to improve use of expansion
cohorts to support drug approvalsâFacilitate incorporation of patient reported outcomes
into drug development and support improvedcollaboration between government and sponsorsOCTOBER
NOVEMBER
DECEMBER
Breakthrough Designations by
Therapeutic Categories
Other20.8%
Rare InheritedDisorders
13.2%
Cancer49.1%
InfectiousDisease14.2%
Cardiovascular2.8%
About Friends Friends Board of Directors
BOARD OF DIRECTORS
Pennie Abramson, Ph.D. (h.c.)President’s Circle, TheWeizmann Institute of Science
Carolyn “Bo” AldigePresident & Founder, PreventCancer Foundation
Anna Barker, Ph.D. Professor & Director,Transformative HealthcareNetworks, Arizona StateUniversity
Christopher W. HansenPresident, American CancerSociety Cancer Action Network
Sherry Lansing Chief Executive Officer, TheSherry Lansing Foundation
Catherine Ann Stevens, J.D.Partner, Mayer Brown LLP
Mary WoolleyPresident, Research!America
Robert C. Young, M.D.President, RCYMedicine
ExECuTIvE COMMITTEE
Ellen v. Sigal, Ph.D.Chair & Founder, Friends ofCancer Research
Marlene Malek, R.N.President, Friends of CancerResearch
Barbara Duffy Stewart, M.P.H.Executive Director, Association of American Cancer Institutes
Sudip S. Parikh, Ph.D.Vice President & GeneralManager, Health & Analytics,Battelle Memorial Institute
Margaret Foti, Ph.D., M.D. (h.c.)Chief Executive Officer, AmericanAssociation for Cancer Research
Jonathan LeffPartner, Deerfield Management
Joel S. MarcusChairman, Chief Executive, andFounder, Alexandria Real EstateEquities, Inc., Alexandria VentureInvestments
David MitchellPartner, GMMB
Richard Schilsky, M.D.Chief Medical Officer, AmericanSociety of Clinical Oncology
Jeff Allen, Ph.D., Executive Director
Ryan Hohman, J.D., Managing Director, Policy and Public Affairs
Heather Chaney, Managing Director, Program Administration
Berrett Stradford, Director, External Affairs
Samantha Roberts, Ph.D., Director, Scientific Affairs
Marina Kozak, Ph.D., Science Policy Analyst
Mark Stewart, Ph.D., Science Policy Analyst
Michael Shea, Policy Research Associate
Joe Patterson, Public Affairs Associate
Alexi Turbow, Public Affairs Associate
Linda Ostermann, Administrative Coordinator
Thank you to all of the Friends staff and collaborators whocontribute to our work.
A special thanks to:
Friends of Cancer Research (Friends) drivescollaboration among partners from everyhealthcare sector to power advances in science,policy and regulation that speed life-savingtreatments to patients.
During the past 20 years, Friends has beeninstrumental in the creation and implementationof policies ensuring patients receive the besttreatments in the fastest and safest way possible.We’ve been successful to date due to our abilityto convene the right people at the right time andput forth revolutionary, yet realistic ideas.
As we embark on this milestone year, we lookforward to continuing this critical work with ourtrusted partners and continue to lead the way inevolving cancer research and treatment.
2015 Publications
The articles below were created either entirely byor with input from Friends of Cancer Researchand published in 2015.
âThe role of nonrandomized trials in the evaluationof oncology drugs. Clinical Pharmacology andTherapeutics, May 2015.
âImproving evidence developed from population-level experience with targeted agents. ClinicalPharmacology and Therapeutics, May 2015.
âModernizing Measurement of Tumor Response toTherapy: Application to Immunotherapeutics.2015 Conference on Clinical Cancer Research.
âCapturing Symptomatic Adverse Events From thePatients’ Perspective: The Potential Role of theNational Cancer Institute’s PRO-CTCAEMeasurement System. 2015 Conference onClinical Cancer Research.
âThe Blurring of Phase 1, 2 and 3 Trials inOncology: Expansion Cohorts in Phase 1 Trials.2015 Conference on Clinical Cancer Research.
âExamining Manufacturing Readiness forBreakthrough Drug Development. AmericanAssociation of Pharmaceutical Scientists.PharmSciTech, November 2015.
âEnhancing Use of Patient-Centered Data inRegulatory Decision-Making. Friends of CancerResearch and Burroughs Wellcome Fund. 2015.
âRegulatory decision-making meets the real world.Science Translational Medicine, November 2015.
Supporters
INNOvATORS
Alexandria Real Estate Equities Inc /Alexandria Venture Investments
Amgen
AstraZeneca
Bayer HealthCare
Bristol-Myers Squibb Company
Celgene Corporation
Eli Lilly and Company
Genentech
Janssen Pharmaceuticals, Inc.
Marlene and Fred Malek
Merck & Co., Inc.
Novartis PharmaceuticalsCorporation
Pfizer Inc
PhRMA
Ellen and Gerry Sigal
Takeda Oncology
CHAMPIONS
Abbvie
The Abramson Family Foundation
American Association for CancerResearch
American Cancer Society
American Society of Clinical Oncology
Boehringer Ingelheim Pharmaceuticals
EMD Serono
Foundation for the National Institutesof Health
Foundation Medicine Inc.
Gilead
Ken and Virginia Grunley
Helsinn Therapeutics
Illumina
Johnson & Johnson
The Kovler Foundation – Peter andJudy Kovler
Onyx Pharmaceuticals Inc.
Pharmacyclics Inc.
Resnick Family Foundation, Inc.
PARTNERS
The Rona and Jeffrey AbramsonFoundation
ADP Foundation, Inc.
Association of American CancerInstitutes
Battelle
Burroughs Wellcome Fund
Greenleaf Health LLC
Interstate Hotels and Resorts
Lionsgate
The Meltzer Group
Miller & Long Company, Inc.
National Patient AdvocateFoundation
Prevision Policy
The Abe & Kathryn SelskyFoundation Inc.
Klara and Larry Silverstein
Vertex Pharmaceuticals
A note from the Executive Director
On behalf of Friends of Cancer Research, I would like to thank all of our supporters andcollaborators for your steadfast commitment to our mission. We’ve made great strides in developingnew models to enhance science and innovation.
As we embark on our 20th year, we look forward to continuing partnerships built on cutting-edgescience to create solutions that will change the cancer landscape.
Your support is vital to ensuring this work can continue.
With great appreciation,
Jeff Allen, Ph.D., Executive Director, Friends of Cancer Research
Miriam and Sandford AinJeff Allen and Kevin KenneyAnna BarkerGrace BenderThe Honorable and Mrs. Stuart BernsteinHarold BeznosBiotechnology Industry OrganizationKatherine and David BradleyHenry and Rachel BremC.R. Bard, Inc.Marcia CarlucciCBS CorporationCDWThe Honorable William and Mrs. Janet
CohenDana-Farber Cancer InstituteDeerfieldDick and Betsy DeVosMr. and Mrs. Richard DubinEdelmanAlvin and Joan EinbenderEplus, Inc.Diana and Michael David EpsteinSuellen EstrinLucy Fisher and Doug WickRobert and Shari Friedman
Suzy and Bob PencePeregrine Pharmaceuticals, Inc.Edwin and Linda PhelpsLeland and Mary PillsburyResearch!AmericaCatherine B. Reynolds FoundationMace and Joyce RothenbergVicki and Roger SantSidney Kimmel Comprehensive Cancer Center
at Johns Hopkins UniversityAnnie Simonian TotahMr. and Mrs. Albert H. SmallRobert H. Smith Family FoundationPaul G. SternCatherine StevensMichael and Leslie TiveUniversity of Kansas Cancer CenterUniversity of Maryland Greenbaum Cancer
CenterUniversity of Pittsburgh Cancer InstituteUniversity of Texas MD Anderson Cancer CenterGeorge Vande WoudeAndy and Madelyn von EschenbachVornado - Charles E. SmithSharon WeissLynne Zydowsky / Zydowsky Consultants
Norma Lee and Morton Funger - TheFunger Foundation Inc.
General DynamicsThe George Washington UniversityThe Honorable Joseph and Mrs. Alma
GildenhornJan and Ronald GreenbergHerbert Family FoundationRyan Hohman & Bradford RathgeberKids v CancerAnnette KirshnerKlein Financial CorporationSherry LansingLeukemia & Lymphoma SocietyLockton Companies, Inc.Fred and Britlan MalekJoel and Deborah MeiselAlan and Amy MeltzerMilken Family FoundationMK & AMoffitt Cancer Center & Research InstituteBarbara MoserNational Pharmaceutical CouncilMichelle and Chris OlsonOSU - The James Cancer HospitalOtsuka America Pharmaceutical, Inc.
ADvOCATES
Supporters
John AdelmanSusan AllenShalom BaranesSteven and Shari BloomAbigail BluntSusan and Dixon ButlerBridget CaraccioloCEO Roundtable on CancerHeather ChaneyDr. Tony and Robyn ColesRoger Cossack and Jane
HannawaySevasti DamesSusan DavisAnn DaytonAnita DaytonChip DigginsRichard and Judy DolingSamia FaroukiFasterCures
Joel and Barbara FinkelsteinStuart GellerGretchen GorogIra and Judith GottfriedAnne GradyLeonard GreenbergGerard and Pamela HeiberT. Patrick and Ann Marie HillWilhemina HolladayJacinta HurleyGail and Benjamin JacobsDianne KayFrank and Cathy KeatingDebra KirshnerMarina KozakBrendan and Leanna LalorClimis and Carol LascarisPaul LewisTom and Bonnie MillerDavid and Nicole Mitchell
PATRONS
Amy MuhlbergMary Ann and Scott
NordheimerMelanie and Larry NussdorfLinda OstermannJoe PattersonGeraldine PilzerPauline RandallRenay RegardieWilliam Regardie Living TrustSamantha RobertsMark and Elizabeth RogersEric and Kimberly RubinGenny and Fred RyanMatthew and Lynne ShankMargaret ShannonMary SingerBerrett StradfordCourtney StrausCarl Striler
Alexi TurbowUniversity of Miami Sylvester
Comprehensive Cancer CenterDaniel and Ann Von HoffGeoff WahlMarilyn and Hal WeinerRobert & Terri WeissAmbassador C. Howard WilkinsMyles Wittenstein Li YanRobert C. YoungNancy Zirkin
In-KindAlston + BirdDeerfield InstituteGCS, Inc.SIGAL ConstructionThe West Foundation