Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 1 of 66 PageID #: 10161
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GUARDANT HEALTH, INC.,
`
`Plaintiff,
`
`v.
`
`FOUNDATION MEDICINE, INC.,
`
`Defendant.
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`
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`
`
`C. A. No. 20-cv-01580-LPS
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`
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`DECLARATION OF NEAL D. SHORE, M.D., F.A.C.S., C.P.I.
`
`I, Neal D. Shore, hereby declare:
`
`1.
`
`I am currently the Medical Director of the Carolina Urologic Research Center and
`
`practice with Atlantic Urology Clinics in Myrtle Beach, South Carolina. As I further explain
`
`below, I have extensive experience treating patients with urologic cancer, including prostate,
`
`kidney, and bladder cancer. Additionally, I have significant experience using FoundationOne®
`
`Liquid CDx in treating cancer patients and in connection with clinical trials. I also have experience
`
`using Guardant360® CDx, offered by Guardant Health, Inc. (“Guardant”).
`
`2.
`
`I have been asked by Defendant Foundation Medicine, Inc. (“Foundation
`
`Medicine” or “FMI”) to provide my perspective as a treating physician regarding the use of
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`FoundationOne® Liquid CDx to treat cancer patients, and how FoundationOne® Liquid CDx
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`compares with Guardant360® CDx. The opinions and perspectives I offer herein are my own and
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`based on my personal knowledge and experience.
`
`3.
`
`Based on my personal experience as a treating physician, using comprehensive
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`genomic assays enables me to create more tailored treatment plans for my patients, including
`
`matching patients to clinical trials based on rare mutations identified by FMI’s liquid tests. It is
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`

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`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 2 of 66 PageID #: 10162
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`important for me to be able to continue to choose FoundationOne® Liquid CDx when I deem that
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`it may be advantageous for my patients. It is therefore my opinion that it is in the best interest of
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`patients suffering from cancer that FoundationOne® Liquid CDx remains as an available treatment
`
`option.
`
`I.
`
`Qualifications
`
`4.
`
`I received my medical degree from Duke University School of Medicine in 1984.
`
`Afterwards, I completed a six-month clinical research fellowship in Pretoria, South Africa, and
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`then completed my General Surgery/Urology training at New York Hospital Cornell Medical
`
`Center and at Memorial Sloan-Kettering Cancer Center in New York City. A copy of my
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`curriculum vitae is attached as Exhibit A.
`
`5.
`
`I am board certified in Urology and a Certified Physician Investigator (CPI). I am
`
`also a Fellow of the American College of Surgeons (FACS).
`
`6.
`
` I have conducted over 400 clinical trials, focusing mainly on genitourinary
`
`oncology. In particular, I have served as principal investigator in several clinical trials and studies
`
`involving various genomic molecular tests, and have been actively involved in educational
`
`programming for genomic profiling within the urologic communities.
`
`7.
`
`I have also served as an investigator, consultant, and advisor for a wide range of
`
`biotechnology and pharmaceutical research companies, including Myriad, Ambry Genetics,
`
`Invitae, Amgen, Abbvie, BMS, Dendreon, AstraZeneca, Exact Sciences (formerly Genomic
`
`Health), FerGene, Janssen, Pfizer, Merck, Sanofi, Tolmar, and Myovant.
`
`8.
`
`At Atlantic Urology Clinics, and as the Medical Director of the Carolina Urologic
`
`Research Center, I diagnose and treat patients suffering from advanced prostate cancer. I have
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`used both FoundationOne® Liquid CDx and Guardant360® CDx with patients who are not
`
`enrolled in any clinical trial or study.
`
`2
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`

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`9.
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`In addition to my clinical experience, I currently serve and have served on a wide
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`variety of Government Boards, Professional Association Boards, and Medical Boards, including,
`
`but not limited to, the Duke Global Health Initiative Advisor Board, the Cancer Support
`
`Community Professional Advisory Board, the Society of Urologic Oncology Board of Directors,
`
`the Bladder Cancer Advocacy Network Board of Directors, and many others. I also serve as the
`
`National Urology Research Director for Genesis Care US.
`
`10.
`
`I have authored more than 200 peer-reviewed publications and numerous book
`
`chapters, and have served on the editorial boards of Reviews in Urology, Urology Times,
`
`Chemotherapy Advisor, OncLive, PLOS ONE (Academic Editor), Urology Practice, World
`
`Journal of Urology, and Everyday Urology-Oncology.
`
`II.
`
`Benefits of FoundationOne® Liquid CDx
`
`11.
`
`I have been ordering genomic testing for my patients consistently over the last five
`
`years, both in prescribing treatment for cancer patients in my practice and as part of various clinical
`
`trials. Based on my experience, I have found that different genomic tests may be appropriate for
`
`different uses and different patients. For example, I have found certain tests suitable for molecular
`
`profiling for newly diagnosed prostate cancer patients, while other tests are more suited to
`
`assessing late stage cancers or even germline testing.
`
`12.
`
`Compared to other types of cancer, therapeutic options for urologic cancers are
`
`often particularly underfunded and under researched. One of the reasons I have participated in
`
`various clinical trials utilizing FoundationOne® Liquid CDx and Guardant360® CDx was to help
`
`ensure that more lifesaving research is done for urologic cancer patients in particular.
`
`13.
`
`A recent positive development in the treatment of urologic cancers was the approval
`
`in May 2020 by FDA of two poly (ADP-ribose) polymerase (“PARP”) inhibitors for men with
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`metastatic castration-resistant prostate cancer (mCRPC) who have certain genomic mutations. The
`
`3
`
`

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`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 4 of 66 PageID #: 10164
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`first of these two approved PARP inhibitors is Lynparza® (olaparib), which is indicated for the
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`treatment of patients with deleterious or suspected deleterious germline or somatic homologous
`
`recombination repair (HRR) gene-mutated mCRPC who have progressed following prior
`
`treatment with enzalutamide or abiraterone. Ex. 8. The other approved PARP inhibitor is
`
`Rubraca® (rucaparib), which is indicated for the treatment of patients with a deleterious BRCA
`
`mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer
`
`(mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based
`
`chemotherapy. Ex. 3. In order for a patient to be selected for treatment with either olaparib or
`
`rucaparib, the patient must first be determined to have particular genomic mutations. Ex. 8, at 1;1
`
`Ex. 3, at 2.
`
`14.
`
`Specifically, selection of patients for treatment with Lynparza® for prostate cancer
`
`is based on the presence of deleterious or suspected deleterious HRR gene mutations in tissue or
`
`blood samples, including (in tissue) ATMm, BRCA1m, BRCA2m, BARD1m, BRIP1m, CDK12m,
`
`CHEK1m, CHEK2m, FANCLm, PALB2m, RAD51Bm, RAD51Cm, RAD51Dm, and RAD54Lm;
`
`and (in blood), gBRCA1m and gBRCA2m. Ex. 8, at 1. The FDA label for Lynparza® states that
`
`in order to determine the presence of these mutations, selection should be done based on an FDA-
`
`approved companion diagnostic (a “CDx”) for olaparib. Id.
`
`15.
`
`FoundationOne® Liquid CDx is approved by FDA to specifically identify patients
`
`who may benefit from treatment with Lynparza® for prostate cancer. Ex. 5, at 2; Ex. 7; Ex. 6. On
`
`the other hand, Guardant360® CDx does not have FDA approval as a companion diagnostic for
`
`olaparib or for any FDA-approved therapies for prostate cancer. Ex. 9, at 12-13; Ex. 2, at 1. As a
`
`
`1 All exhibits referred to herein are attached to the Appendix in Support of Foundation Medicine’s Brief in Opposition
`to Guardant’s Motion for Preliminary Injunction.
`
`4
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`

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`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 5 of 66 PageID #: 10165
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`
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`result, patients and physicians may have less confidence in relying on Guardant360® CDx’s
`
`testing results to select patients for treatment with olaparib.
`
`16.
`
`Likewise, selection of patients for treatment with Rubraca® for prostate cancer is
`
`based on the presence of a deleterious BRCA mutation (germline and/or somatic) in plasma
`
`specimens. Ex. 3, at 2. The FDA label for Rubraca® states that in order to determine the presence
`
`of these mutations, selection should be done based on an FDA-approved CDx for rucaparib. Id.
`
`If FoundationOne® Liquid CDx test is not utilized then patients may also encounter third party
`
`payor denials on the cost of the treatment as well as the non-approved test.
`
`17.
`
`FoundationOne® Liquid CDx is approved by FDA to specifically identify patients
`
`who may benefit from treatment with Rubraca® for prostate cancer. Ex. 5, at 2, Ex. 4, at 1. On
`
`the other hand, Guardant360® CDx does not have FDA approval as a companion diagnostic for
`
`rucaparib or for any FDA-approved therapies for prostate cancer. Ex. 9, at 12-13; Ex. 2, at 1. As
`
`a result, patients and physicians may have less confidence in relying on Guardant360® CDx’s
`
`testing results to select patients for treatment with rucaparib.
`
`18.
`
`Because of the differences in approval between FoundationOne® Liquid CDx and
`
`Guardant360® CDx for use with FDA-approved therapies, it is my opinion that removing
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`FoundationOne® Liquid CDx as an option would be a significant disservice to patient care.
`
`19.
`
`Additionally, it is my opinion that having multiple testing options available is better
`
`for physicians and patients overall. In my experience, more testing options leads to more
`
`competition, which prompts companies to continually develop and improve testing at the most
`
`accessible price point. Competition also leads to testing providers offering better patient education
`
`for doctors and medical professionals. Competition among testing options also advances
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`molecular profiling overall and allows for a more comprehensive analysis of a patient’s particular
`
`5
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`

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`genomic profile. These advancements in molecular profiling are particularly useful in clinical
`
`trials, where the option of having different genomic tests with different coverage of genes is
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`especially helpful to understanding the efficacies of developing therapies. All cancers have a
`
`genomic component to them and doctors and scientists are just starting to understand the
`
`appropriate approved drug indications for various genetic alterations. Only through additional
`
`recognition of gene alteration and drug types will doctors be able to find the correct and most
`
`suitable types of therapies for patients.
`
`20.
`
`For all of the above reasons, it is important for me to be able to continue to have
`
`the choice to order FoundationOne® Liquid CDx for my patients.
`
`
`
`
`
`6
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`

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`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 7 of 66 PageID #: 10167
`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 7 of 66 PageID #: 10167
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`I declare under penalty of perjury under the laws of the United States that the foregoing
`
`and the content ofmy Declaration are true and correct to the best ofmy knowledge. Executed this
`
`23rd day of February 2021 in Myrtle Beach, South Carolina.
`
`NfiLéZ/Q 3 g)
`
`eal Shore, M.D.
`
`

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`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 8 of 66 PageID #: 10168
`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 8 of 66 PageID #: 10168
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`EXHIBIT A
`
`EXHIBIT A
`
`

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`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 9 of 66 PageID #: 10169
`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 9 of 66 PageID #: 10169
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`Signature: gm g E
`Date: 4& g M20
`
`NEAL D. SHORE, MD, FACS, CPI
`
`Carolina Urologic Research Center/Atlantic Urology Clinics
`
`823 82nd Parkway, Suite B
`
`Myrtle Beach, SC 29572
`
`W (843) 449-1010
`
`C (843) 455-1220
`
`nah“I‘Ltfrittggitilfttggul
`
`11:31)01"3@fllmllillgfisfiglll
`
`
`
`: ca ml 1 n a [I I'U logmmma rd) ten. te r. m m'
`
`
`
`
`
`httpflw \evwdmavtlmgmticu rologrvt‘l i nicsu mtg
`
`E53 ii 5: All Q N
`
`Residency:
`
`The New York Hospital-Cornell Medical Center
`
`Urology: July 1986 — July 1990
`
`Chief Resident: July 1989—1990
`
`General Surgery: July 1984 — July 1986
`
`Residency included a 6-month surgical rotation at
`
`Memorial Sloan-Kettering Cancer Center
`
`Graduate Research:
`
`University of Pretoria School of Medicine
`
`Pretoria, R. S. A., January to June 1984
`
`Medical School:
`
`Duke University School of Medicine, Durham, North Carolina
`
`Graduated: M.D., 1984
`
`College:
`
`Duke University
`
`Majors: Public Policy Sciences/ US History
`
`Graduated Ma gna Cum Laude: BA 1980
`
`Early Identification Program: Awarded acceptance as a sophomore
`to Duke University School of Medicine
`
`High School:
`
`Rutgers Preparatory School, Somerset, New Jersey
`Graduated Cum Laude: 1976
`
`

`

`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 10 of 66 PageID #: 10170
`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 10 of 66 PageID #: 10170
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`Neal]1") SlmchED1ACIS
`% % $
`
`EMPLQYMENT
`
`Carolina Urologic Research Center
`
`Medical Director
`
`2000—present
`
`Atlantic Urology Clinics, LLC
`
`Clinical Urology Practice
`
`1994-present
`
`Myrtle Beach, South Carolina
`
`Atlantic Urology Clinics
`
`Managing Partner
`
`2007-2012
`
`DASHKO, LLC
`
`Founding Member
`
`2015-present
`
`CUSP, LLC
`
`Founding Member
`
`2011-present
`
`21st Century Oncology
`
`National Urology Research Dir.
`
`2011—present
`
`Urology Oncology Consortium, LLC Founding Member
`
`2008-2013
`
`Morristown, New Jersey
`
`Clinical Urology Practice
`
`1990-1994
`
`“C E NS U RE
`
`Certified Physician Investigator, (CPI), and February 2005 to present
`
`Board Certified, American Board of Urology - February 1992 to present
`
`Recertified, American Board of Urology - December 1999; September 2009
`
`National Board of Medical Examiners - July 1985
`
`Fellow, American College Surgeons — 1994 to present
`
`New York # 164254
`
`New Jersey # 54695
`South Carolina # 17316
`
`DEA # 352176116
`
`GQVERNMENT BQARDS
`
`Genitourinary Cancer Scientific Steering Committee (GUSC), National Cancer Institute,
`2009-2012
`
`0 Early Detection Cancer Research Network, member 2003-2012
`0 Molecular Diagnostics (Mol Dx), SME 2013 to present
`0 NCI/NIH: Novel Therapeutics for Non-Muscle Invasive Bladder Cancer — Bladder Task
`Force Clinical Trials Planning Meeting (CTPM) March , 2015
`
`2 I P a g e.
`
`

`

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`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 11 of 66 PageID #: 10171
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`Neal D. Shore, MD FA CS
`awry
`
`PROFESSIONAL ASSOCIATEON BOARDS
`
`Duke Global Health Initiative(DGHI) Advisor Board, 2020—
`
`Cancer Support Community Professional Advisory Board,2020-
`
`MEDICAL BOARDg
`
`Society for Immunotherapy of Cancer (SITC) Prostate Committee 2018- present
`Large Urology Group Practice Association, Immediate Past President 2018-Present
`Large Urology Group Practice Association, President 2016 - 2018
`Large Urology Group Practice Association, Executive Committee Secretary 2013 - 2014
`Large Urology Group Practice Association, Board of Directors, 2008 - present
`Society of Urologic Oncology, Executive Board of Directors, 2009 - present
`Society of Urologic Oncology, Clinical Trials Consortium Board of Directors, 2008 - present
`Society of Urologic Oncology, Clinical Trials Consortium Secretary Treasurer, 2014 -2018
`Bladder Cancer Advocacy Network (BCAN), Board of Directors, 2017 - present
`
`AUA Data Committee 2012-present
`
`AUA Committee on Male Health, September 2009-2012
`South Carolina Urology Executive Committee, Member at Large, 2011-2013
`Prostate Conditions Education Council, Board of Directors, 2009-present
`Zero ~ The Project to End Prostate Cancer: National Medical Advisory Board, August 2008 —2010.
`Urology TimeS/Modem Medicine Website M15141) mimimcdicuucom Monthly blog;
`Dr. Shore’s blog. Initiated June, 2008 — 2010; 2013-present.
`Medical Director, US Too, Prostate Cancer Support Group, Myrtle Beach, SC, 1999 — present
`
`STEERHN§ COMMITTEE MEMBER
`
`Society for Immunotherapy of Cancer, Prostate Cancer Task Force, 2014 to present
`PROTEUS PCR3011 Radical Prostatectomy Trial 2019 to present
`
`Bayer DaroAcT 20609 Castrate Resistant Prostate Cancer Trial 2019 to present
`
`Escalate MCRPC Trial 2019 to present
`
`ORIC—101-02 MCRPC Trial 2019 to present
`
`Modra MCRPC Trial 2019 to present
`
`Merck 3475-676 NMIBC Trial 2019 to present
`BMS CA2099UT NMIBC Trial 2019 to present
`Merck V937-O12 NMIBC Trial 2019 to present
`Cold Genesys CG203C NMIBC Trial 2019 to present
`
`Predict Dendreon Prostate Cancer Registry, 2013 to 2019
`
`Innocrin (Viamet) Phase II trial, 2013 to 2019
`
`Sequoia Ecoli Vaccine Trial, 2013 to 2019
`Metastatic Castrate Resistant Prostate Cancer Registry (Astellas), 2013 to 2019
`
`Progenics, DSM, 2016 to 2018
`ODM-201— M0 Castrate Resistant Prostate Cancer Trial, 2014 to 2018
`
`COMMUNITY BOARDS
`
`Brookgreen Gardens, President’s Council, 2000-present
`
`3|Ii’age
`
`

`

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`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 12 of 66 PageID #: 10172
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`Neal E.) Sham-2, M!) F A (:78
`®%@
`
`Chief of Staff, Grand Strand Regional Medical Center, Myrtle Beach, SC, January 2001 to
`
`January 2002
`Vice Chief of Staff, Grand Strand Regional Medical Center, Myrtle Beach, SC, January 2000
`
`to January 2001
`Secretary/Treasurer Medical Staff, Grand Strand Regional Medical Center, Myrtle Beach,
`
`SC, January 1999 to January 2001
`Chairman, Department of Surgery, Grand Strand Regional Medical Center, Myrtle Beach,
`
`SC, January 1997 to January 1998
`Chairman, Carolina Lithotripsy, LLC, Myrtle Beach, SC, January 1997 to January 2004
`Medical Advisory Committee, South Strand Ambulatory Care Center, Myrtle Beach, SC,
`1997 to 2002
`
`Vice Chairman, Department of Surgery, Grand Strand Regional Medical Center, Myrtle
`Beach, SC, 1996 to 1997
`
`Big Brothers Horry County, Board of Directors, 1998-1999
`Burroughs & Chapin Art Museum, Board of Directors, 2000-2002
`Sertoma Club, Board of Directors, President 2000-2001
`
`JOURNAL REVIEWER
`
`Annals of Urology
`
`Asian Journal of Andrology
`
`British Journal of Urology
`Canadian Journal of Urology
`Cancer Control
`
`Cancer Drug Resistance
`Clinical Cancer Research: American Association for Cancer Research
`
`Clinical Genitourinary Cancer
`Cochrane Prostatic Diseases and Urologic Cancers Group
`
`Combining Immunotherapy and Radiation for Prostate Cancer
`Critical Reviews in Oncology / Hematology
`
`Current Medical Research & Opinion
`Cytotherapy: The Journal of Cell Therapy
`European Urology
`Expert Opinion On Pharmacotherapy
`
`Hospital Practice
`International Journal of Molecular Science
`
`International Journal of Radiation Biology
`Journal of Bone Oncology
`Journal of OncoPathology
`
`Journal of Urology
`
`New England Journal Medicine
`
`Oncology
`Pharmaceutical Biotechnology
`
`Practice Update
`Prostate Cancer
`
`4|I’age
`
`

`

`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 13 of 66 PageID #: 10173
`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 13 of 66 PageID #: 10173
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`Neal [3. Show, MIT) F A (:8
`@%w
`
`o
`
`0
`
`0
`
`Prostate Cancer and Prostatic Diseases
`
`Prostate Cancer: Incorporating Genomic Biomarkers In Prostate Cancer Decisions
`
`Postgraduate Medicine
`
`0 Radiation Oncology
`
`0 Therapeutic Advances in Urology
`
`0 Urology, The Gold Journal
`
`0 Urologic Oncology
`0 World Journal of Urology
`0 Yonsei Medical Journal
`
`GRANT REVIEWER
`
`0 California Institute for Regenerative Medicine (CIRM)
`0 National Science Foundation Poland
`
`0
`
`Swiss National Science Foundation
`
`EDITORIAL BOARDS
`
`o Annals of Urology, 2014
`0 World Journal of Urology, 2017
`o Annals of Hematology & Oncology, 2015
`
`0 Urology Times, 1999-Present
`o Chemotherapy Advisor, 2012-Present
`
`0 Current Urology Reports, 2011-Present
`- OncLive, 2011-Present
`
`0 Asian Journal of Andrology, 2012-Present
`
`0 Urology Practice, 2014-Present
`o
`PLOS One, 2014-Present
`
`- Developments in Clinical Oncology, 2014—Present
`
`0 Urologists in Cancer Care, 2013-Present
`
`0 Everyday Urology, Editor, 2016-Present
`o
`Prostate Cancer Foundation Patient Guide Editorial Board, 2018-Present
`
`HQSPlTAL AFFILIATIONS
`
`Parkway Surgery Center
`
`827 82nd Parkway
`
`Myrtle Beach, South Carolina 29572
`
`October, 2001 to present
`
`Grand Strand Regional Medical Center
`
`November, 1994 to present
`
`809 82nd Parkway
`
`Myrtle Beach, South Carolina 29572
`
`Loris Hospital
`3655 Mitchell
`
`Loris, South Carolina 29569
`
`5 | P a g e
`
`April, 2003 to present
`
`

`

`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 14 of 66 PageID #: 10174
`Case 1:20-cv-01580-LPS Document 35 Filed 02/26/21 Page 14 of 66 PagelD #: 10174
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`Neal E). Shore, Mi.) FA (375:3
`%@%
`
`Waccamaw Hospital
`
`4070 Hwy 17 Bypass South
`
`Murrells Inlet, South Carolina 29576
`
`May, 2004 to present
`
`A$S®CIATIONS/CERTEFICATEONS
`
`Society of Urologic Oncology, elected 2008
`
`0 American College of Surgeons Fellow, elected 1993
`0 American Society of Clinical Oncology
`
`0 American Urological Association
`
`0 ACRP/APPI: January 7, 2005 to present
`
`0 Morley Foundation, Clinical Trials Training for Medical Professionals: October, 2002
`0
`South Carolina Medical Society
`
`CME PRESENTATIONS
`
`AUA/ASCO/EAU/ESMO
`
`-
`
`Evaluation of an immunotherapeutic DNA-vaccine in biochemically relapsed prostate cancer. Neal
`
`Shore, MD. 2018 ASCO Annual Meeting. Poster Session, Abstract #5078. Chicago, IL. June
`2nd, 201 8
`
`o
`
`Interim Analysis of an Open Label Phase II Study of Enzalutamide and Radium RA 233
`
`dichloride in symptomatic, metastatic castration-resistant prostate cancer patients.
`Moderated Poster Session. San Francisco, CA. May 215‘, 2018.
`o A New Paradigm in Urothelial Cancer: The Convergence of Immuno-oncology 8: Urology.
`
`Ashish, M. Kamat, MD, MBBS; Arjun V. Balar, MD; Robert Dreicer, MD, MS, MACP, FASCO;
`
`Neal D. Shore, MD, FACS. AUA 2018 San Francisco, CA. May 20‘“, 2018.
`
`0 Annual Board of Urology Town Hall Meeting. Faculty Panel with Audience Q 8: A. AUA
`
`It
`
`0
`
`2018. San Francisco, CA. May 20th, 2018.
`
`16th IPF Introductions and AUA PCA Programs. Neal Shore, MD, 4th Year as Co-Chair. AUA
`
`2018. San Francisco, CA. May 20th, 2018.
`
`Science and Stories: Navigating the Prostate Cancer Landscape Urologists at the Intersection
`
`of Emerging Evidence and Patient Centric Care. Robert Dreicer, MD, MS, MACP, FASCO;
`Oliver Sartor, MD; Michael S. Cookson, MD, MMHC; Neal D. Shore, MD, FACS. AUA 2018
`
`San Francisco, CA. May 19*“, 2018.
`- Non-Metastatic CRPC: Is it a Real Entity? And What do SPARTAN and PROSPER tell us about
`therapeutic approaches? Association Espanol Urology Synopsis. Neal Shore, MD and Eric
`Smell, MD. AUA 2018. San Francisco, CA. May 19th, 2018.
`I New Directions in Nonmetastatc CRPC: Perspectives on the Latest Data for Urologists. Neal
`D. Shore, MD FACS; Fred Saad, MD, FRCS; Daniel Petrylak, MD. AUA 2018 San Francisco,
`
`CA. May 18th, 2018.
`
`o A 17—Gene Assay Drives High Active Surveillance Persistence in Clinically Low-Risk Prostate
`
`Cancer: 1 Year Results from a 1,200 Patient Perspective Observational Trial. AUA 2018.
`
`Moderated Poster Session. San Francisco, CA. May 18th, 2018.
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`Neai D. Slxizre, Mi) F A C555
`saw
`
`it
`
`o
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`0
`
`The PROSPER trial: chemotherapy-related endpoints in patients with nonmetastatic
`
`castration-resistant prostate cancer treated with enzalutamide. AUA 2018. Oral Podium. San
`
`Francisco, CA. May 18th, 2018.
`Immunotherapy for the Urologist: Basic Principles, Adverse Effects & Drug Delivery.
`Neal ShOre, MD, et al. AUA Course, San Francisco, CA, May 18, 2018.
`Survival Outcomes of Pre-Metastatic Castration-Resistant Prostate Cancer and the Burden
`
`of Developing Metastasis: A Systematic Literature Review. Neal D. Shore, Gershwinder
`Rai, Karim Fizazi, et al. ASCO Annual Meeting. Poster Session B, Abstract #293. San
`
`Francisco, CA. February 9th, 2018.
`
`o
`
`Real—World Study of Enzalutamide and Abiraterone Acetate (with Prednisone)
`Tolerability (REAACT): Results. Neal D. Shore, Daniel R. Saltzstein, Paul R. Sieber, et al.
`Poster Session B, Abstract #296. San Francisco, CA. February 9th, 2018.
`a A Phase 1b/2 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, Combined with
`Enzalutamide (E) or Abiraterone/Prednisone (A/P) in Patients with Metastatic Castration
`
`Resistant Prostate Cancer (mCRPC). Mary-Ellen Taplin, Arif Hussain, Neal D. Shore, et
`al. ASCO Annual Meeting. Poster Session E, Abstract #TPS398. San Francisco, CA.
`February 9th, 2018.
`0 Evaluation of the MiCheck MIA Rest Performance in Differentiating Aggressive from
`
`Non-Aggressive Prostate Cancer: The MiCheck-Ol Prospective Trial. Neal D. Shore,
`Christopher Michael Pieczonka, Ralph Jonathan Henderson, et al. ASCO Annual Meeting.
`Poster Session A, Abstract #TP8152. San Francisco, CA. February 8th, 2018.
`
`0 Association of Prostate-Specific Antigen (PSA) Trajectories with Risk for Metastasis and
`Mortality in Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC). Sophia Li,
`Zhijie Ding, Neal D. Shore, et al. ASCO Annual Meeting. Poster Session A, Abstract #27.
`San Francisco, CA. February 8th, 2018.
`PROSPER: A Phase 3, Randomized, Double-Blind, Placebo (PBO)-Controlled Study of
`
`o
`
`Enzalutamide (ENZA) in Men with Nonmetastatic Castration-Resistant Prostate Cancer
`
`(M0 CRPC). Maha Hussain, Karim Fizazi, Neal D. Shore, et a1. ASCO Annual Meeting.
`
`Poster Session A, Abstract #3. San Francisco, CA. February 8th, 2018.
`Predict: Evaluation of Baseline Characteristics Predictive of Distant Metastases in Patients
`
`-
`
`with Castration-Resistant Prostate Cancer—Updated Data. Stephen J. Freedland,
`Matthew R. Smith, Neal D. Shore. ASCO Annual Meeting. Poster Session A, Abstract #253.
`
`San Francisco, CA. February 8th, 2018.
`
`0 Hepatic Effects Assessed by Review of Safety Data in Enzalutamide Castration-Resistant
`Prostate Cancer (CRPC) Trials. Tomasz M. Beer, Simon Chowdhury, Neal D. Shore. ASCO
`Annual Meeting. Poster Session A, Abstract #199. San Francisco, CA. February 8th, 2018.
`Immune Response Results From Vesigenurtacel—L (HS-410) In Combination With BCG
`From A Randomized Phase 2 Trial In Patients With Non-Muscle Invasive Bladder Cancer
`
`o
`
`(NMIBC). Poster Session. Gary D. Steinberg MD, Neal D. Shore, MD, et al. 2017 ASCO
`Annual Meeting. McCormick Place. Chicago, Illinois. June 2017.
`0 Minnesota Urological Society, Inc. Spring Seminar. Neal Shore, MD. Minnesota Medical
`Association. Minnesota, April 1, 2017.
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`7 I I) a g e.
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`-
`
`Prospective Study of a 17-GENE RT—PCR-Based Assay for Prediction of High Risk
`Pathology at Radical Prostatectomy. Poster Session (Board #B23). Neal Shore, MD.
`
`Genitourinary Cancers Symposium. Orlando, Florida. February 16‘“, 2017.
`o A Clinical Trial for the Safety and Immunogenicity of a DNA-based Immunotherapy in
`Men with Biochemically (PSA) Relapsed Prostate Cancer. Poster Session (Board #D15).
`Neal Shore, MD. Genitourinary Cancers Symposium. Orlando, Florida. February 16th,
`2017.
`
`o
`
`Is There a Role for Urologists Managing CRPC? Neal Shore, MD, FACS, NYU School of
`Medicine Faculty, Surgical, Pharmacological and Technological Advances in Urology,
`New York, NY, December 8, 2016.
`
`0 Advanced Prostate Cancer: Managing the Spectrum of Disease. Course Faculty: Daniel W.
`Lin, MD, David F Penson, MD, MPH, Neal D. Shore, MD, FACS, et. Al. AUA Course,
`
`Chicago IL, September 24, 2016, Washington DC, December 10, 2016.
`0 Optimizing Bladder Disease Management. Chair: Neal D. Shore, MD. 2016 LUGPA CME
`Session. November 2016.
`
`o Long-Term Safety and Antitumor Activity of ODM-201 in Chemotherapy and CYP17-
`Inhibitor Na'ive Patients from the Arades and the Arafor Trials. Neal Shore, et al. AUA
`
`Annual Meeting Podium Session 32-06. San Diego, CA. May 8, 2016.
`o Testosterone Lowering, PSA Response and Quality of Life in Patients with Advanced
`Hormone Sensitive Prostate Cancer Receiving TAK-385, an Oral GnRH Antagonist: Phase
`
`2 Interim Analysis. Neal Shore, et a1. AUA Annual Meeting Podium Session 28-01. San
`
`Diego, CA. May 8, 2016.
`0 Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia with
`Connective Water Vapor Energy Ablation: Preserved Erectile and Ejaculatory Function.
`Kevin McVary, Steven Gange, Neal Shore, et al. AUA Annual Meeting Podium Session
`
`o
`
`0
`
`21-04. San Diego, CA. May 7, 2016.
`Prospective, Randomized, Blinded Study of Prostatic Urethral Lift (PUL): Four Year
`Results. Claus Roehrborn, Steven Gange, Neal Shore, et al. AUA Annual Meeting Podium
`
`Session 21-02. San Diego, CA. May 7, 2016.
`Integrated Results of Two Multicenter, Randomized, Placebo Controlled, Double Blind,
`Phase 3 Trials (SPI-611/612) of Single-Dose Intravesical Apaziquone Immediately
`Following Resection in Patients with Non-Muscle Invasive Bladder Cancer. Lawrence
`Karsh, Neal Shore, et al. AUA Annual Meeting Podium Session 11-07. San Diego, CA.
`
`May 7, 2016.
`0 Renal Function Before and After Cytoreductive Nephrectomy in a Phase 3 Randomized
`Clinical Trial. Erik Mayer, William Lowrance, Neal Shore, MD, et al. AUA Annual
`Meeting Podium Session 04-02. San Diego, CA. May 6, 2016.
`o The Role of the Urologist in CRPC Therapy. Neal Shore, MD, FACS, CPI. Winthrop
`University Hospital. CME. Urology Grand Rounds, Research 8: Academic Conference
`Center
`
`«-
`
`Patient-Centric Care: Translating Research to Results. Bone Metastases- Biology,
`Treatment, and Palliation (ARS) General Session 3: Silke Gillessen, MD, Neal D. Shore,
`
`8 |
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`\1 ca 1 [3. Slwm, MD 1 A {17‘s
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`MD, FACS, Kenneth]. Pienta, MD, Glenn Liu, MD, Matthew R. Smith, MD, PhD.
`
`0
`
`January 7-9, 2016 Genitourinary Cancers Symposium, San Francisco, California #GU16
`Impact of CCP test on personalizing treatment decisions: Results from a prospective
`registry of newly diagnosed prostate cancer patients. Poster Session. Neal D. Shore,
`February 2015. Genitourinary Cancers Symposium.
`0 A Primary Care Approach to Prostate Cancer—The Role of Shared Decision Making in
`Screening and Treatment, presented at the NACE Emerging Challenges in Primary Care
`Conference, Birmingham, Alabama, June 2015.
`o Metastatic Castration-Resistant Prostate Cancer: The Treatment Algorithm Redesigned.
`Course Faculty: Mark Soloway, MD, Adam Kibel, MD, Neal Shore, MD, FACS, et al. AUA
`Annual Meeting, Orlando, FL, May 19, 2014
`Improving Survival in Advanced Prostate Cancer: The Changing Role of the Urologist.
`Course Faculty: E. David Crawford, MD, Neal Shore, MD, FACS, Daniel P. Petrylak, MD.
`AUA Annual Meeting, Orlando, FL, May 17, 2014
`0 Advanced Prostate Cancer Care. Course Directors: Michael S. Cookson, MD, MMHC, Neal
`
`0
`
`D. Shore, MD, FACS. AUA/SUO Educational Series, Tampa, FL. November 23, 2013.
`Effect of denosumab on prolonging bone-metastasis free survival (BMFS) in men with
`nonmetastatic castrate-resistant prostate cancer (CRPC) presenting with aggressive PSA
`kinetics. Oral Abstract Session, Genitourinary Cancer (Prostate). ASCO Annual Meeting
`
`May 30—June 3, 2013.
`ARN—509 in men with high-risk nonmetastatic castration-resistant prostate cancer
`(CRPC). Oral Abstract Session A: Prostate Cancer (eQ&A). ASCO Annual Meeting May
`
`30—]une 3, 2013.
`
`Effect of denosumab on prolonging bone-metastasis-free survival (BMFS) in men with
`nonmetastatic castrate-resistant prostate cancer (CRPC) presenting with aggressive PSA
`kinetics. Oral Abstract Session A: Prostate Cancer. Neal D. Shore et al. ASCO Annual
`
`Meeting May 30-]une 3, 2013.
`Improving Survival in Advanced Prostate Cancer: The Changing Role of the Urologist.
`Neal D. Shore, MD, FACS, et al. 2013 AUA Annual Meeting, Independent Satellite
`
`Symposia, Faculty. May 7, 2013.
`Prostate Cancer: Advanced (I), Podium Session 14 Co-Moderators: Neal Shore, John
`
`0
`
`o
`
`0
`
`0
`
`o
`
`Phillips. 2013 AUA Annual Meeting, San Diego, CA. May 5, 2013.
`o Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer Patients without
`
`prior Chemotherapy-Interim Analysis of the COU-AA-302 Phase III trial. Neal D. Shore,
`et a1, Podium Presentation, 2013 AUA Annual Meeting, San Diego, CA. May 5, 2013.
`0 Analysis of Disease Control Related Outcomes from Six Comparative Randomized Clinical
`Tr