Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 1 of 15 PageID #: 7065
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
`
`GUARDANT HEALTH, INC.,
`
`Plaintiff,
`
`V.
`
`FOUNDATION MEDICINE, fNC.,
`
`Defendant.
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`)
`)
`)
`)
`)
`)
`)
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`C. A. No. 20-cv-01580-LPS
`
`DECLARATION OF MARTIN DIETRICH, M.D. PHO.
`
`I, Martin Dietrich. hereby declare as follows:
`
`I.
`
`I am a physician at Florida Cancer Spec_ialists & Research Institute. and hold a
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`faculty appointment at the University of Central Florida in Orlando as an assistant professor of
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`medicine. I have held these positions since May 2020. I specialize in the treatment of patients
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`with lung cancer. I also consult regularly on patients who have a genetic predisposing syndrome.
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`resulting in, for example, ovarian, breast or prostate cancer.
`
`2.
`
`I have been asked by Foundation Medicine, Inc. ("FMI'') to provide my perspective
`
`as a treating physician regarding my extensive experience using FoundationOne® Liquid CDx as
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`a component of patient treatment. I have also treated patients using Guardant360® COx. and also
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`have been asked to provide my opinions regarding how FoundationOne® Liquid COx compares
`
`with Guardant360® CDx.
`
`3.
`
`Based on my personal expenence as a treating physician and usmg both
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`FoundationOne® Liquid CDx and Guardant360® CDx. FoundationOne® Liquid CDx is a unique
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`comprehensive genomic profiling test that allows me to create more tailored treatment plans for
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`my patients, including by matching patients to clinical trials based on rare mutations identified by
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 2 of 15 PageID #: 7066
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`the test. Because of its status as a companion diagnostic ("CDx" ), which I explain further below,
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`1 believe that it is important for my practice and my patients that I have the option to choose
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`FoundationOne® Liquid CDx when I deem it advantageous for my patients. Its status as a CDx ,
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`which means the test has been validated by FDA, gives me confidence that I am selecting the most
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`effective therapy for my patients. I believe that it is crucial for patients that physicians have access
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`to FoundationOne® Liquid CDx.
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`4.
`
`The opinions expressed herein are my own and are based on my personal
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`knowledge and experience.
`
`I.
`
`Education and Qualifications
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`5.
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`I received my medical degree and doctorate in cancer biology from the German
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`Cancer Research Center, Heidelberg, Germany in 2006, Magna Cum Laude, and completed a
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`doctorate in molecular genetics from the University of Texas Southwestern Graduate School in
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`20 I 0. I also studied at the University of Massachusetts Medical School in 2004-2005 for my third
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`year of medical school as a Fulbright Scholar.
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`I completed postdoctoral training at the MD
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`Anderson Cancer Center in Houston, Texas in the Department of Stem Cell Transplantation.
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`between 2005 and 2007. I completed my internship and residency at the Department of Internal
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`Medicine Parkland Memorial Hospital, University of Texas Southwestern Medical Center, Dallas.
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`Texas, between 2010 and 2012. I also completed fellowships in Hematology/Oncology in the
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`physician-scientist training track at the University of Texas Southwestern Track as a T32 scholar
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`of the National Cancer Institute between 2012 and 2016. A copy of my curriculum vitae is attached
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`as Exhibit A.
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`6.
`
`I am a board certified physician in internal medicine and medical oncology.
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`In
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`2016, I became a Fellow of the American College of Physicians. In my practice, I address all
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`2
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 3 of 15 PageID #: 7067
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`aspects of hematologic and oncologic care. with a research interest in the treatment of lung cancer,
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`along with genetic evaluation and counseling of somatic and hereditary conditions.
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`7.
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`In addition to my clinical experience, 1 currently serve in. and have held, a wide
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`variety of leadership roles on several professional organizations. These roles include, but are not
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`limited to. Lead of the Molecular Tumor Board of AdventHealth Cancer Institute. in Orlando.
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`Florida, and previous Chair of the Pharmacy & Therapeutics Committee at Memorial Cancer
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`Institute, in Hollywood, Florida.
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`I am also a member of several professional organizations.
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`including, but not limited to, the American Society of Hematology. the American Society of
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`Clinical Oncology, and the American Academy of Cancer Research.
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`8.
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`I have authored nineteen peer-reviewed articles, and have served as reviewer for
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`several journals, including Journal of Thoracic Oncology and JAMA Oncology.
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`9.
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`I have served as a consultant for both FM! and Guardant Health. The last time I
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`was contracted to consult with Guardant Health was in 2019 as part of an advisory board.
`
`IL
`
`Benefits of FoundationOne® Liquid CDx
`
`I 0.
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`In my practice, I use genomic testing in order to help me evaluate treatment options
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`for patients. Genomic testing allows me to learn everything I can about the specific type of tumor
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`that each patient has in order to prescribe the most effective and safe treatments. Depending on
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`the genomic test I use, I will learn different facts about the patient's disease. Certain types of
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`genomic tests will tell me more information about a patient's cancer, as opposed to other tests that
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`are better suited for different tumor types and different stages in the disease progression.
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`11.
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`One specific type of genomic test that I use to learn the most effective and safe
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`treatments for my patients are Companion Diagnostic tests ('"CDx"). FDA validation as a CDx is
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`a direct link between a diagnostic and therapeutic treatment. When FDA labels a test as a CDx, it
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`_l
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 4 of 15 PageID #: 7068
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`means that FDA has determined that the test has been validated and effectively determines
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`mutation type and an effective therapy for that mutation type. The CDx label gives me confidence
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`that I am using the best treatment options for my patients.
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`12.
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`FDA granted FoundationOne® Liquid CDx this status to identify patients who may
`
`benefit from therapies connected to four tumor types: non-small cell lung cancer ("NSCLC').
`
`prostate cancer, ovarian cancer, and breast cancer. Ex. 4, at Table 1. 1
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`13.
`
`In my practice, I treat patients with NSCLC and consult on patients whose cancer
`
`has a genetic component, such as some types of prostate, ovarian, and breast cancer. Four possible
`
`therapies for NSCLC are Alecensa® (alectinib), Iressa® (gefitinib), Tagrisso® (osimertinib), and
`
`Tarceva® (erlotinib). Two possible therapies for prostate cancer are Lynparza® (olaparib) and
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`Rubraca® (rucaparib ). Rubraca® (rucaparib) is also one possible therapy for ovarian cancer. One
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`possible treatment for breast cancer is Piqray® (alpelisib). Patient selection for each of these
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`therapies requires detection of the specific mutations with an FDA approved test. See Ex. 3, Ex.
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`8, Ex. 10; Ex. 11 ; Ex. 12; Ex. 13; Ex. 14.
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`14.
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`In order for me to most effectively treat patients with NSCLC, prostate, ovarian,
`
`and breast cancer, it is important that the full range of possible treatments be available.
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`FoundationOne® Liquid CDx is an FDA-approved test to identify patients who may benefit from
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`treatment with Alecensa® (alectinib), Iressa® (gefitinib), Tagrisso® (osimertinib), and Tarceva®
`
`(erlotinib) for NSCLC, Lynparza® (olaparib) and Rubraca® (rucaparib) for prostate cancer,
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`Rubraca® (rucaparib) for ovarian cancer, and Piqray® (alpelisib) for breast cancer. See Ex. 5.
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`15.
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`It is my opinion that FoundationOne® Liquid CDx is critical to my practice because
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`it allows me to prescribe the treatment with the best chance of success for my patients.
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`1 All exhibits referred to herein are attached to the Appendix in Support of FM l's Brief in Opposition to Guardan!'s
`Motion for Preliminary Injunction.
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`4
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 5 of 15 PageID #: 7069
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`Guardant360® CDx does not have FDA approval as a companion diagnostic for alectinib,
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`gefitinib, erlotinib. olaparib, rucaparib. or alpelisib. Guardant360® CDx also. more generally,
`
`does not have FDA approval as a companion diagnostic for any FDA-approved therapies for
`
`prostate cancer, ovarian cancer or breast cancer. Thus, I and other physicians cannot rely on
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`Guardant360® CDx's testing results to select patients for treatment with alectinib, gefitinib,
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`erlotinib, olaparib, rucaparib, or alpelisib. ln my opinion, when choosing a therapy for the patient,
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`FDA approval as a CDx is as important as the approval and characteristics of the indicated therapy
`
`itself.
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`16.
`
`Having more than one company that offers comprehensive liquid biopsy testing is
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`good for patients. Validating competition is in the best interest of patients and providers.
`
`17.
`
`For all of the reasons that I state above, it is my preference to have the option to
`
`test patients with FoundationOne® Liquid CDx. For all the reasons above. the possibility of
`
`having FoundationOne® Liquid CDx removed from the market is concerning.
`
`I declare under penalty of perjury under the laws of the United States that the foregoing
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`and the content of my Declaration are true and correct to the best of my knowledge. Executed
`this 2, S th day of February 2021 , in Orlando, Florida.
`
`u
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`5
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 6 of 15 PageID #: 7070
`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 6 of 15 PageID #: 7070
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`EXHIBIT A
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`EXHIBIT A
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 7 of 15 PageID #: 7071
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`CURRICULUM VITAE
`Martin F. Dietrich, MD, PhD
`
`
`PERSONAL INFORMATION
`
`Name:
`
`Current Position :
`Since 05/2020
`
`
`
`MARTIN F. DIETRICH, MD, PhD
`
`Florida Cancer Specialists & Research Institute
`Hematology / Medical Oncology
`Assistant Professor of Internal Medicine
`University of Central Florida College of Medicine
`
`805 Currency Circle
`Lake Mary, FL 32746
`
`
`
`Martin.Dietrich@FLCancer.com
`
`O : (407) 804 – 6133 | C : (214) 202 - 2650
`
`
`
`(866) 447 – 9143
`
`U.S.A.
`
`Fellowship, Division of Hematology / Oncology
`Physician-Scientist Training Program (Medical Oncology / Cancer Genetics)
`Harold Simmons Comprehensive Cancer Center
`University of Texas Southwestern Medical Center, Dallas, TX
`
`
`Work Address :
`
`
`
`
`Email :
`
`Phone :
`
`Fax :
`
`Citizenship :
`
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`CLINICAL EDUCATION
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`2012 – 2016
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`
`
`
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`
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`2010 – 2012
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`POSTDOCTORAL TRAINING
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`2014 – 2016
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`2005 – 2007
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` Internship and Residency, Department of Internal Medicine
` Parkland Memorial Hospital and
` University of Texas Southwestern Medical Center, Dallas, TX
`
`
`
`
`
`
`
`
`Ruth L. Kirschstein T32 Postdoctoral Scholarship
`Genomic KRAS pathway analysis in Non-small cell lung cancer
`Dept. of Cell Biology, PI : Dr. Michael White
`
`MD Anderson Cancer Center, Houston, TX
`Dept. of Stem Cell Transplantation, Chair : Dr. Richard Champlin
`
`
`
`1
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 8 of 15 PageID #: 7072
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`CURRICULUM VITAE
`Martin F. Dietrich, MD, PhD
`
`
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`GRADUATE EDUCATION
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`2007 – 2010
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`2002 – 2006
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`
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`University of Texas Southwestern, Dallas, TX
`Doctor of Philosophy, Molecular Genetics
`“The Tumor Suppressor LRP1b in Receptor Signal Modulation”
`Supervisors : Dr. John Minna, Dr. Joachim Herz
`
`Germany Cancer Research Center (dkfz), Heidelberg, Germany
`Doctor medicinae (Dr. med.) Degree in Cancer Biology (Magna cum laude).
`Supervisors : Professor Christof von Kalle, Professor Dr. Harald zur Hausen
`
`
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`MEDICAL EDUCATION
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`2002 – 2006
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`
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`2004 – 2005
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`
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`2000 – 2002
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`PROFESSIONAL LICENSE AND BOARD CERTIFICATIONS
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`2016 – 2026 Board Certification (ABIM ID : 339476) in Medical Oncology
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`2013 – 2023 Board Certification (ABIM ID : 339476) in Internal Medicine
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`2016 – 2022 Florida Medical License ME128710 (2016 – 01/2022)
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`2010 – 2017 Texas Medical License P3879(2010 – 2017)
`
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`FACULTY APPOINTMENTS
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`2018 – current Assistant Professor of Internal Medicine
`
`University of Central Florida College of Medicine, Lake Nona, FL
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`
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`
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`Ruprecht-Karls-University Heidelberg, Germany
`Doctor of Medicine with Thesis (Magna cum laude)
`
`University of Massachusetts Medical School Worcester, MA
`3rd year Medical Student as Fulbright Scholar
`
`
`
`
`Friedrich-Wilhelms-University Bonn, Germany
`Pre-medical Education (Physikum)
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`
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`2
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 9 of 15 PageID #: 7073
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`CURRICULUM VITAE
`Martin F. Dietrich, MD, PhD
`
`Staff Physician, Department of Internal Medicine
`Veterans’ Administration Hospital, Dallas, TX
`
`Staff Physician, Department of Emergency Medicine
`Veterans’ Administration Hospital, Dallas, TX
`
`
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`2016 – 2019 Clinical Assistant Professor of Internal Medicine
`
`Florida International University, Miami, FL
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`PROFESSIONAL HOSPITAL AND ADMINISTRATIVE APPOINTMENTS
`
`2018 – 2020 Attending Physician, Hematology/Oncology
`
`AdventHealth Cancer Institute, Orlando, FL
`
`2016 – 2018 Attending Physician, Hematology/Oncology
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`Memorial Hospital, Pembroke Pines, FL
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`2013 – 2016 Attending Physician, Internal Medicine
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`Parkland Memorial and UT Southwestern University Hospitals, Dallas, TX
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`2012 – 2016
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`2012 – 2016
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`
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`LEADERSHIP ROLES AND MEMBERSHIPS IN PROFESSIONAL ORGANIZATIONS
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`2018 – 2020 Lead, Molecular Tumor Board
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`AdventHealth Cancer Institute, Orlando, FL
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`2018 – 2020 Member, VIA Pathway Committees
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`Non-small cell lung cancer, melanoma
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`2018 – 2020 Member, Protocol Review Committee
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`AdventHealth Cancer Institute, Orlando, FL
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`2016 – 2018 Chair, Pharmacy & Therapeutics Committee
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`Memorial Cancer Institute, Hollywood, FL
`
`2016 – current Professional Expert Advisor, JP Morgan Healthcare Division
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`2016 – current Peer Reviewer, Journal of Thoracic Oncology, JAMA Oncology
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`
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`2016 – current Member, CARG Geriatric Research Group
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`2016 – current Member, Florida Society of Clinical Oncology (FLASCO)
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`3
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 10 of 15 PageID #: 7074
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`CURRICULUM VITAE
`Martin F. Dietrich, MD, PhD
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`On-Time Doctor Award, vitals.com
`
`Fellow, American College of Physicians
`
`Guardian of Excellence Award, Memorial Health
`
`
`
`
`
`
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`University of Texas Southwestern Dean’s Academic Excellence Award
`
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`2012 – current Member, American Society of Hematology (ASH)
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`2011 – current Member, American Society of Clinical Oncology (ASCO)
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`2008 – current Member, American Academy of Cancer Research
`
`
`HONORS AND AWARDS
`
`2017 – 2019 Compassionate Doctor Recognition, vitals.com
`
`
`2017
`
`
`2016
`
`2016
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`2014 – 2016 National Cancer Institute (NCI) Ruth L. Kirschstein T32 Grant
`
`2010
`
`2008 – 2010 Marshall Fund (European Recovery Program) Academic Scholarship
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`2007 – 2010 Boehringer Ingelheim Foundation Postdoctoral Scholarship
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`2005 – 2007 German Academic Exchange Service (DAAD) Exchange Scholarship
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`2004 – 2006 Fulbright Foundation Scholarship / Travel Grant
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`2004 – 2005
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`2002 – 2010 German National Merit Foundation (Studienstiftung) Scholarship
`
`
`CONTINUING MEDICAL EDUCATION AND INVITED LECTURES (Excerpt)
`
`04/2020
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`
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`03/2020
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`03/2020
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`State of Baden-Wuerttemberg Academic Scholarship
`
`Community Oncology Alliance, Invited Panel Discussant Orlando, FL
`Molecular Testing in the Community Setting
`
`Novartis National Meeting, Invited Speaker, Orlando, FL
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`USCAP Meeting, Invited Speaker, Los Angeles, CA
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`4
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 11 of 15 PageID #: 7075
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`CURRICULUM VITAE
`Martin F. Dietrich, MD, PhD
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`Sanofi Genzyme, Invited Speaker for Video Lecture Series
`Management of PD-1 Inhibitor related side effects
`
`Foundation Medicine, Member, Longitudinal Advisory Board.
`
`Bristol Myers Squibb VAP National Meeting, Orlando, FL
`
`HOPA Meeting, Invited Speaker, Orlando, FL
`“Changing landscapes in Her2-directed targeted therapies”
`
`Oncology Pathways Conference, Invited Speaker, Boston, MA
`
`AdventHealth GynOncology Conference, Invited Speaker, Orlando, FL
`Molecular Testing in Gynecological Malignancies
`
`Regeneron National Meeting, Invited Speaker, Kissimmee, FL
`
`Best of ASCO, Invited Speaker, Orlando, FL
`
`Best of ASCO, Invited Speaker, Philadelphia, PA
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`Puma Biotechnology, Faculty Chair Advisory Board, Philadelphia, PA
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`AstraZeneca EGFR Steering Committee Member.
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`HOPA Annual Conference, Invited Speaker, Fort Worth, TX
`
`Novartis Advisory Board, Faculty Chair, Denver, CO
`BRAF directed therapy in NSCLC / Melanoma
`
`Best of ESMO, Conference Chair, Ft. Lauderdale, FL
`
`Best of ASCO, Conference Chair, Saint Louis, MO
`Updates in Lung Cancer.
`
`Best of ASCO, Invited Speaker, San Juan, PR
`Updates in Lung Cancer.
`
`Caris Precision Oncology Alliance, Member Lung Cancer Committee
`
`
`5
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`12/2019
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`
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`10/2019 –
`Current.
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`10/2019
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`10/2019
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`10/2019
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`10/2019
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`
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`09/2019
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`08/2018
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`07/2019
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`07/2019
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`06/2019 –
`Current.
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`04/2019
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`04/2019
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`
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`10/2017
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`07/2018
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`07/2018
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`01/2018-
`04/2020
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 12 of 15 PageID #: 7076
`
`CURRICULUM VITAE
`Martin F. Dietrich, MD, PhD
`
`AstraZeneca Precision Medicine Steering Committee.
`
`University of Southern Alabama, Invited Speaker Grand Rounds, Mobile, AL
`
`ASCO Precision Medicine Series, Bridgeport, NJ
`
`
`03/2017 –
`Ongoing.
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`03/2017
`
`10/2016
`
`
`PEER REVIEWED ARTICLES
`
`1. Ling X, Wang Y, Dietrich MF, Andreeff M, Arlinghaus RB. Vaccination with leukemia cells
`expressing cell-surface-associated GM-CSF blocks leukemia induction in immunocompetent mice.
`Oncogene. 2006 Jul 27;25(32):4483-90.
`
`2. Konopleva M, Contractor R, Tsao T, Samudio I, Ruvolo PP, Kitada S, et al. Mechanisms of
`apoptosis sensitivity and resistance to the BH3 mimetic ABT-737 in acute myeloid leukemia.
`Cancer Cell. 2006 Nov;10(5):375-88.
`
`3. Carter BZ, Mak DH, Schober WD, Dietrich MF, Pinilla C, Vassilev LT, et al. Triptolide
`sensitizes AML cells to TRAIL- induced apoptosis via decrease of XIAP and p53-mediated increase
`of DR5.
`Blood. 2008 Apr 1;111(7):3742-50.
`
`4. Ling X, Konopleva M, Zeng Z, Ruvolo V, Stephens LC, et al. The novel triterpenoid C-28 methyl
`ester of 2- cyano-3, 12-dioxoolen-1, 9-dien-28-oic acid inhibits metastatic murine breast tumor
`growth through inactivation of STAT3 signaling.
`Cancer Res. 2007 May 1;67(9):4210-8.
`
`5. Kidd S, Spaeth E, Dembinski JL, Dietrich M, Watson K, Klopp A, et al. Direct evidence of
`mesenchymal stem cell tropism for tumor and wounding microenvironments using in vivo
`bioluminescent imaging.
`Stem Cells. 2009 Oct;27(10):2614-23.
`
`6. Kidd S, Caldwell L, Dietrich M, Samudio I, Spaeth EL, Watson K, et al. Mesenchymal stromal
`cells alone or expressing interferon-beta suppress pancreatic tumors in vivo, an effect countered by
`antiinflammatory treatment.
`Cytotherapy. (2009) Sep;12(5):615-25.
`
`7. Dietrich MF, Karner CM, Johnson EB, Kappesser N, Tennert C, Percin F, et al. Lrp4 regulates
`initiation of ureteric budding and is crucial for kidney formation--a mouse model for Cenani-Lenz
`syndrome.
`PLoS One.5(4):e10418.
`
`
`
`6
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 13 of 15 PageID #: 7077
`
`CURRICULUM VITAE
`Martin F. Dietrich, MD, PhD
`
`
`8. Dietrich MF, van der Weyden L, Prosser HM, Bradley A, Herz J, Adams DJ. Ectodomains of
`the LDL receptor- related proteins LRP1b and LRP4 have anchorage independent functions in vivo.
`PLoS One.5(4):e9960.
`
`9. Dieckmann M, Dietrich MF, Herz J. Lipoprotein receptors--an evolutionarily ancient
`multifunctional receptor family.
`Biol Chem. Nov;391(11):1341-63
`
`10. Dietrich MF, Xing YS, Schiller JH. Response to crizotinib/erlotinib combination in a patient
`with a primary EGFR driven adenocarcinoma and a primary c-met amplified adenocarcinoma of the
`lung.
` Journal of Thoracic Oncology (2015) – 2015 May;10(5):e23-5.
`
`11. Dietrich MF, Cavuoti D, Landay M, Arriaga Y. Histological regression of Giant cell tumor of
`bone following Rank ligand inhibition.
`
`13. Beer AG, Zenzmaier C, Schreinlechner M, Haas J, Dietrich MF, Herz J, Marschang P.
`Expression of a recombinant full-length LRP1B receptor in human non-small cell lung cancer cells
`confirms the postulated growth-suppressing function of this large LDL receptor family member.
`Oncotarget. 2016 Oct 18;7.
`
`14. Ning N, Yan J, Dietrich MF, Xie XJ, Gerber DE. Institutional Scientific Review of Cancer
`Clinical Research Protocols: A Unique Requirement That Affects Activation Timelines.
`J Oncol Pract. 2017 Dec;13(12).
`
`15. Dietrich MF, Rolfo C, Reclusa P, Giallombardo P, Valentino A, Raez LE. Exosomes biology:
`Function and clinical implications in lung cancer.
`Cancer Translational Medicine, (2017), Volume 3, Issue 2 [p. 58-63].
`
`16. Reclusa P, Valentino A, Sirera R, Dietrich MF, Raez LE, Rolfo C. Circulating microRNAs and
`long noncoding RNAs: Liquid biomarkers in thoracic cancers.
`Cancer Translational Medicine, Year 2017, Volume 3, Issue 2 [p. 53-57]
`
`17. Dietrich MF, Gerber DE. Chemotherapy for Advanced Non-small Cell Lung Cancer.
`Cancer Treat Res. 2016; 170:119-49.
`
`18. Bartelt A, Behler-Janbeck F, Beil FT, Koehne T, Müller B, Schmidt T, Heine M, Ochs L, Yilmaz
`T, Dietrich MF, Tuckermann JP, Amling M, Herz J, Schinke T, Heeren J, Niemeier A. Lrp1 in
`osteoblasts controls osteoclast activity and protects against osteoporosis by limiting PDGF-RANKL
`signaling.
`Bone Res. 2018 Feb 26;6:4. Doi.
`
`
`
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`7
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 14 of 15 PageID #: 7078
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`CURRICULUM VITAE
`Martin F. Dietrich, MD, PhD
`
`
`
`19. Gerber DE, Socinski MA, Neal JW, Wakelee HA, Shirai K, Sequist LV, Rosovsky
`RP, Lilenbaum RC, Bastos BR, Huang C, Johnson ML, Hesketh PJ, Subramaniam DS, Dietrich
`MF, Chai F, Wang Y, Kazakin J, Schwartz B, Schiller JH, Brahmer JR, Kelly RJ. Randomized phase
`2 study of tivantinib plus erlotinib versus single-agent chemotherapy in previously treated KRAS
`mutant advanced non-small cell lung cancer.
`Lung Cancer. 2018 Mar;117:44-49.
`
`
`
`
`8
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`Case 1:20-cv-01580-LPS Document 36 Filed 02/26/21 Page 15 of 15 PageID #: 7079
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`CERTIFICATE OF SERVICE
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`I hereby certify that on February 26, 2021, I caused the foregoing to be electronically filed
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`with the Clerk of the Court using CM/ECF, which will send notification of such filing to all
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`registered participants.
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`I further certify that I caused copies of the foregoing document to be served on February
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`26, 2021, upon the following in the manner indicated:
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`Brian E. Farnan
`Michael J. Farnan
`FARNAN LLP
`919 North Market Street, 12th Floor
`Wilmington, DE 19801
`Attorneys for Plaintiff Guardant Health, Inc.
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`Edward R. Reines
`Derek C. Walter
`WEIL, GOTSHAL & MANGES LLP
`201 Redwood Shores Parkway
`Redwood Shores, CA 94065
`Attorneys for Plaintiff Guardant Health, Inc.
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`Garland T. Stephens
`Justin L. Constant
`WEIL, GOTSHAL & MANGES LLP
`700 Louisiana, Suite 1700
`Houston, TX 77002-2755
`Attorneys for Plaintiff Guardant Health, Inc.
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`/s/ Jeremy A. Tigan
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`Jeremy A. Tigan (#5239)
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