The Big Ten cancer centers have united · The Big Ten cancer centers have united ... Dr. Susan Goodin is executive director, ... Vijaya Bhatt, MD Krishna Gundabolu, MD

The Big Ten cancer centershave united

to transform the conduct of cancer research through collaborative,

hypothesis-driven, highly translational oncology trials that leverage

the scientific and clinical expertise of Big Ten universities.

The Big Ten Cancer Research Consortium creates a unique

team-research culture to drive science rapidly from ideas to

treatment-changing paradigms. Within this innovative environment,

today’s research leaders collaborate with and mentor the research

leaders of tomorrow with the unified goal of improving the lives

of all patients with cancer.

Concepts must meet all of the below criteria to be approved for development:

• BTCRC studies can be Phase II or earlier. The BTCRC will not conduct industry-sponsored Phase III studies.

• Sponsor Investigator is from a BTCRC member institution.

• Studies should include a translational component that involves core or basic science lab.

• At a minimum, studies should include baseline whole blood for PBMC DNA/RNA, pre- and post-treatment serum and plasma. Archived FFPE tumor tissue will be collected and mandatory from all consenting sub-jects and will be available for future use by the BTCRC.

• The study involves mentorship of junior faculty by senior faculty.

• The study includes multi-disciplinary research and/or cross-collabora-tion between BTCRC institutions in the trial design whenever appropri-ate.

• BTCRC institutions will own the data from the study.

• The Sponsor Investigator has identified potential funders.

NOTE: It is preferable that concepts be brought to the BTCRC prior to budget discussions.

• All subjects accrued should be from the BTCRC and non-academic sites which have entered into site agreements with BTCRC Administra-tive Headquarters or sub-contracts with BTCRC institutions. Non-BT-CRC academic sites should not participate in BTCRC studies.

Research Criteria

Executive Officer — Susan Goodin, PharmDDr. Susan Goodin is executive director, statewide affairs at Rutgers Cancer Institute of New Jersey and professor of medicine at Rutgers Robert Wood Johnson Medical School. She possesses more than 20 years of clinical research lead-ership experience including serving as deputy director of op-erations, associate director of clinical trials and therapeutics, and director of the Division of Pharmaceutical Sciences at the Cancer Institute of New Jersey. She played a key role in the establishment of the Cancer Institute’s clinical practice and designed its clinical research infrastructure, including the Center’s research office, research pharmacy, and protocol review and monitoring system and is a founding co-leader of the Can-cer Institute of New Jersey’s statewide clinical trials network that includes 15 hospitals under the Center’s clinical research infrastructure. Dr. Goodin works closely with BTCRC administrative headquarters, pharmaceutical partners, and other physicians and researchers to carry out the consortium’s mission. She serves as the primary spokesperson and representative for the consortium at meetings and events with funders and professional organizations, and commu-nicates regularly with BTCRC cancer center directors and the steering commit-tee regarding key issues, challenges, and opportunities facing the consortium.

Steering CommitteeThe BTCRC Steering Committee is composed of one researcher from each member institution. The Steering Committee meets on a regular basis to review activities of the consortium and decide matters of policy. The Steering Committee determines the criteria for approving concepts for development with the Big Ten CRC. Committee members (pictured left to right) include:

Oana C. Danciu (Illinois), Bert H. O’Neil, MD (Indiana), Mohammed Milhem, MBBS (Iowa), Eric R. Fearon, MD, PhD (Michigan), Anas Al-Janadi, MD (Michigan State), Robert A. Kratzke, MD (Minnesota)

Apar K. Ganti, MD (Nebraska), Al B. Benson III, MD (Northwestern), Chandra P. Belani, MD (Penn State), Andrew D. Mesecar, PhD (Purdue), Mark N. Stein, MD (Rutgers), Ruth O’Regan, MD (Wisconsin)

Leadership

Clinical Trial Working Groups

Bone Marrow / Stem Cell Transplant Working Group

Indiana University Melvin and Bren Simon Cancer Center

Sharif Farag, MD, PhD

University of Iowa Holden Comprehensive Cancer Center

Umar Farooq, MD

University of Michigan Comprehensive Cancer Center

Brian Lee Parkin, MD

Masonic Cancer Center, University of Minnesota

Claudio Brunstein, MD, PhD

Fred & Pamela Buffett Cancer Center (University of Nebraska)

Vijaya Bhatt, MD Krishna Gundabolu, MD

Northwestern University Lurie Comprehensive Cancer Center

John P. Galvin, MD, MPH

Penn State Cancer Institute

Shin Mineishi, MD

Rutgers Cancer Institute of New Jersey

Dennis Cooper, MD

University of Wisconsin Carbone Cancer Center

Ryan Mattison, MD

Breast Working Group

University of Illinois Cancer Center

Lucy Chen, MDOana Danciu, MD

Kent Hoskins, MD


Maitri Kalra, MD Kathy D, Miller, MD


Jose Pablo Leone, MDSneha Phadke, DO

Rachna Raman, MBBSAlexandra Thomas, MD


Maria G. Castro, PhD Pedro R. Lowenstein, MD, PhD

Michigan State University Breslin Cancer Center

Harvey L. Bumpers, MD, FACS Deimante M. Tamkus, MD


Anne H. Blaes, MD David Potter, MD


Hamid Band, MD, PhDVimla Band, PhDJanina Baranowska-

Kortylewicz, PhD

Kenneth H. Cowan, MD, PhDElizabeth Reed, MDJames E. Talmadge, PhDPavankumar Tandra, MBBS


William J. Gradishar, MD


Alison L. Chetlen, DO Cristina I. Truica, MD


Nancy Chan, MDShridar Ganesan, MD, PhD

Kim M. Hirshfield, MD, PhDDeborah L. Toppmeyer, MD (co-chair)


Mark Burkard, MD, PhDLudmila Cavalcante, MDRuth O’Regan, MD

Murtuza M. Rampurwala, MDKari B. Wisinski, MD (co-chair)

Correlative Sciences Working Group


Yunlong Liu, PhD Christopher Stamatkin, PhD


Michael Henry, MD, PhD Kimberly Leslie, MD


J. Christine Ye, MD


Mark Klein, MDRobert Kratzke, MDEmil Lou, MD, PhD

Manish Patel, DOSubree Subramanian, PhD


Victoria M. Villaflor, MD

Purdue University Center for Cancer Research

Uma Aryal, PhD

Gastrointestinal Working Group


Rozina Chowdhery, MDDominic Ho, MD, PhD

Neeta K. Venepalli, MD


Bert H. O’Neil, MD Safi Shahda, MD


Laith Abushahin, MDDaniel J. Berg, MDGerald Clamon, MD

Joseph S. Dillon, MDJohn M. Watkins, MD


William R. Burns, MDClifford S. Cho, MDJohn Christopher Krauss, MDNeehar Parikh, MD

Oxana Rusher, MDVaibhav Sahai, MBBSSandra L. Wong, MD, MS


Anas Al-Janadi, MDBorys W. Hrinczenko, MD

Jatin Rana, MD


Wolfgang Gaertner, MDEmil Lou, MD, PhD

Rebecca Thomas, MD, MHSc


Lyudmyla Berim, MDJean L. Grem, MD

Kelsey Klute, MDJames K. Schwarz, MD


Al B. Benson III, MD (co-chair)Aparna Kalyan, MBBS

Mary F. Mulcahy, MDHalla S. Nimeiri, MBBS


Diane Hershock, MD, PhDYuxia Jia, MD, PhD

Nelson Yee, MD, PhD, Rph


Darren R. Carpizo, MD, PhDSalma Jabbour, MD (co-chair)

Edmund C. Lattime, PhDElizabeth A. Poplin, MD


Dustin A. Deming, MDDavid Kim, MDNoelle K. LoConte, MD

Sam J. Lubner, MDNataliya V. Uboha, MD, PhD

Genitourinary Working Group


Michael R. Abern, MDArkadiusz Dudek, MD, PhD

David J. Peace, MD


Costantine Albany, MDNabil Adra, MD

Hristos Kaimakliotis, MDRoberto Pili, MD


Sam Brancato, MD Yousef Zakharia, MD


Ajjai S. Alva, MD (co-chair)Pedro R. Lowenstein, MD, PhD

Alon Zadok Weizer, MDSarah Yentz, MD


Anas Al-Janadi, MD


Shilpa Gupta, MBBS Gautam Jha, MD


Ralph J. Hauke, MD, FACP James K. Schwarz, MD


Benedito Carneiro, MD, MSMaha Hussain, MB ChB

Joshua J. Meeks, MD, PhD


Joseph J. Drabick, MD, FACPSheldon L. Holder, MD, PhDMonika Joshi, MD

Mathew G. Kaag, MDSuzanne B. Merrill, MD


Chang-Deng Hu, MD, PhD


Anna Ferrari, MDRahul Parikh, MD

Eric A. Singer, MD, MAMark N. Stein, MD (co-chair)


David F. Jarrard, MDChristos Kyriakopoulos, MD

Glenn Liu, MD

Gynecologic Working Group


Rajul Kothari, MD Andras Ladanyi, MD, PhD


Michael J. Goodheart, MD Kimberly Leslie, MD


R. Kevin Reynolds, MD


John Risinger, PhD


Deanna Teoh, MD (co-chair)


John S. Davis, PhDJanina Baranowska-

Kortylewicz, PhD

Kerry Rodabaugh, MD


Daniela Matei, MD Mario Pineda, MD, PhD


Rebecca Phaeton, MD


Lorna Rodríguez, MD, PhD (co-chair)


Lisa Barroilhet, MDManish Patankar, PhD

Stephen L. Rose, MD

Head and Neck Working Group


Lawrence Feldman, MD Jonathan Moreira, MD


Greg Durm, MD


Muhammad Furqan, MD


Naomi Fujioka, MD Mark Klein, MD


Sung Kim, MD


Justine Y. Bruce, MD Randy Kimple, MD, PhD

Immunotherapy Working Group


Yousef Zakharia, MD


Ajjai Alva, MBBSOxana Rusher, MD

J. Christine Ye, MD


Manish Patel, DO


Apar Ganti, MD


John P. Galvin, MD, MPH


Diane Hershock, MD, PhD Hong Zheng, MD, PhD


Jyoti Malhotra, MD MPH Ann Silk, MD, MS


Glenn Liu, MD Doug McNeel, MD, PhD

Lymphoid Malignancies Working Group


David Peace, MD


H. Scott Boswell, MDLarry Cripe, MD

Hamid Sayar, MD


Thomas H. Carter, MD, PhDUmar Farooq, MDBrian Link, MD

Oana Paun, MDRupali Roy, MDGeorge Weiner, MD


Suma Devata, MDSami Malek, MDTycel Phillips, MD

Ryan Alan Wilcox, MDJ. Christine Ye, MD


Anas Al-Janadi, MD


Veronika Bachanova, MD, PhD (co-chair)Julie Chang, MD

Livia T. Hegerova, MD Aleksandr Lazaryan, MD (co-chair)


Gregory Bociek, MD Matthew Lunning, DO


Shuo Ma, MD, PhD Barbara Pro, MD


Muhammad Mir, MD, FACPNeil Palmisiano, MD

Jeffrey Pu, MD, PhD


Rajat Bannerji, MD, PhDJoseph Bertino, MD

Dennis Cooper, MDRahul Parikh, MD


Vaishalee P. Kenkre, MD

Melanoma/Cutaneous Oncology Working Group


Arkadiusz Dudek, MD Donald Wood, MD


Theodore Logan, MD


Mohammed Milhem, MBBS (co-chair)

Yousef Zakharia, MD


Maria G. Castro, PhDLeslie Anne Fecher, MDTimothy Johnson, MDChristopher Lao, MD (co-chair)

Pedro R. Lowenstein, MD, PhDFrank Worden, MDSandra L. Wong, MD, MS


Evidio Domingo-Musibay, MDPeter Lee, MD, PhD

Daniel Miller, MD


M. Anne Kessinger, MD Alissa Marr, MD


Sunandana Chandra, MD, MS (co-chair)

Jeffrey Sosman, MD


Joseph J. Drabick, MD, FACPDiane Hershock, MD, PhDAnna M. Leung, MDRogerio Izar Neves, MD, PhD

Colette Pameijer, MDGavin Robertson, PhDArati Sharma, PhD


Janice Mehnert, MDAnn Silk, MD

Frank Victor, MD Jeffrey Pu, MD, PhD


Mark Albertini, MD Douglas McNeel, MD, PhD

Multiple Myeloma Working Group


Pritesh Patel, MD


H. Scott Boswell, MDLarry Cripe, MDHamid Sayar, MD

Rebecca Silbermann, MDAttaya Suvannasankha, MD


Apollina Goel, PhD


Erica Campagnaro, MDCraig Cole, MD (co-chair)Sami Malek, MD

Tycel Phillips, MDJ. Christine Ye, MD


Matthew Lunning, DO


Raymond Hohl, MD, PhDMuhammad Mir, MD, FACP

Neil Palmasiano, MDJeffrey Pu, MD, PhD


Joseph Bertino, MD Rahul Parikh, MD


Natalie S. Callander, MD Aric C. Hall, MD

Myeloid Malignancies Working Group


Irum Khan, MD John Quigley, MD (co-chair)


H. Scott Boswell, MDBryan J. Brinda, PharmDLarry Cripe, MD

Heiko Konig, MD (co-chair)Robert P. Nelson, MDHeather O'Leary, PhD


Thomas H. Carter, MD, PhDRupali Roy, MD

Carlos E. Vigil, MD


Patrick William Burke, MDMaria G. Castro, PhDIvan Maillard, MD, PhDSami Malek, MD

Brian Lee Parkin, MDTycel Phillips, MDMoshe Talpaz, MD (co-chair)


Nelli Bejanyan, MD Celalettin Ustun, MD


Vijaya Bhatt, MBBS Krishna Gundabolu, MBBS


Seth J. Corey, MD, MPH John D. Crispino, PhD, MBA


David Claxton, MDMuhammad Mir, MD, FACPNeil Palmisiano, MD

Jeffrey Pu, MD, PhDHong Zheng, MD, PhD


Joseph Bertino, MD Rahul Parikh, MD


Aric Hall, MDMark B. Juckett, MD

Ryan Mattison, MD

Neuro-Oncology Working Group


Herbert H. Engelhard, MD, PhD


Edward J. Dropcho, MD


Mariko Sato, MD, PhD


Larry R. Junck, MD Denise Leung, MD, MSc


Stephen J. Haines, MD, FACSMatthew A. Hunt, MD, FRCSEmil Lou, MD, PhD

Elisabeth Neal, MDJohn E. Trusheim, MD


Michele R. Aizenberg, MD, FACSJanina Baranowska- Kortylewicz, PhD

Philip J. Bierman, MDNicole A. Shonka, MD


Priya U. Kumthekar, MD Jeffrey J. Raizer, MD


Dawit G. Aregawi, MDMichael J. Glantz, MD

Brad E. Zacharia, MD, MS


Susan M. Mendrysa, PhD

Thoracic Working Group


Arkadiusz Dudek, MD (co-chair)Lawrence Feldman, MDJonathan Moreira, MD

Ardaman Shergill, MDRobert A. Winn, MD


Gregory A. Durm, MDLawrence H. Einhorn, MD

Nasser H. Hanna, MD (co-chair)Shadia I. Jalal, MD


Bryan G. Allen, MD, PhDGerald Clamon, MD

Muhammad Furqan, MD


Kahled Aref Hassan, MDGregory P. Kalemkerian, MD

Bryan J. Schneider, MD


Borys W. Hrinczenko, MD


Naomi Fujioka, MDMark Klein, MDRobert A. Kratzke, MD

Emil Lou, MD, PhDManish R. Patel, DO


Surinder K. Batra, PhDApar K. Ganti, MD

Rudy P. Lackner, MDRussell B. Smith, MD


Nisha A. Mohindra, MD


Chandra P. Belani, MD Xin Liu, MD, PhD


Joseph Aisner, MDSalma Jabbour, MD

Jyoti Malhotra, MD, MPH


J. Scott Ferguson, MDTiciana B. Leal, MD

Anwaar Saeed, MDAnne M. Traynor, MD

Submitting concepts and joining working groups

To discuss protocols, submit an LOI, or join a clinical trial working group, please visit the Contact page on the BTCRC website: www.bigtencrc.org.

BTCRC Milestones

2011 2012 2013

October 2011Hoosier Cancer

Research Network (formerly Hoosier Oncology Group)

selected as administrative headquarters.

February 2013First membership contract executed;

first BTCRC in- person meeting held at Big Ten headquarters.

June 2013BTCRC

kickoff event in Chicago.September

2012First steering

committee call.

July 2011Discussions to

form the Big Ten Cancer Research

Consortium begin.

July 2012Ten cancer centers

commit to participate; steering committee mem-

bers appointed; Noah Hahn, MD, named interim

executive officer.

2014

May 2014Susan Goodin,

PharmD, named executive officer;

face-to-face meetings at ASCO.

October 2013First Clinical Trial Working Group

forms.

2015

Visit www.bigtencrc.org/news-developments/meetings-and-events/ for a calendar of upcoming meetings and teleconferences.

April 2015First subject enrolled

in a BTCRC trial.

July 2016First BTCRC trial

fully accrued, 6 months early

March 2015First BTCRC trial opens.

2016

21APR2017

Administrative Headquarters at Hoosier Cancer Research Network500 N. Meridian Street, Suite 100, Indianapolis, IN 46204

phone: 317-634-5842, ext. 19 | www.bigtencrc.org

The Big Ten Cancer Research Consortium Administrative Headquarters pro-vides comprehensive study support for multi-center trials, from conception and design through project completion and publication.

Administrative Headquarters

Research Development• LOI, protocol, and consent devel-

opment• Budget development• Statistical analysis planning• Interest survey assessment

Site Support Services• Contracting• Budget preparation/management• SAE reporting (site and industry)• Correlative sample management• IRB tracking• IRB continuing review tracking• IND management

Project Management• Feasibility surveys• Study procedure manuals• Site monitoring• Study drug storage

and distribution

Data Systems• Electronic Data Capture data-

base design and development• Data monitoring plan• Data management and validation• Data security and regulatory

management• Biorepository support• Data analysis

Contacts• Jessica Roy, CCRP, Director of Research Development

[email protected] • 317-634-5842, ext. 19• Anita Borek, MBA, MT (ASCP), Director of Business Development

[email protected] • 317-634-5842, ext. 48

Documents

The Big Ten cancer centers have united · The Big Ten cancer centers have united ... Dr. Susan Goodin is executive director, ... Vijaya Bhatt, MD Krishna Gundabolu, MD