CURRICULUM VITAE
`
`
`Contact Information:
`David Gortler, Pharm.D. FCCP
`(203) 772-1309
`
`E-mail: david.gortler@gmail.com
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`Georgetown University, Associate Professor of Pharmacology:
`July 2010 - CURRENT
`• Associate Professor, lecturer and thesis advisor to graduate level pharmacology and
`medical students in various therapeutic areas.
`• Research advisor for Medical and Pharmacology Ph.D. students.
`• See website at Georgetown University for details.
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`Journal Editorial Boards:
`Journal of Pharmacology & Clinical Toxicology: 2012 – CURRENT
`Journal of Drug Research and Development: 2013 – CURRENT
`• Editor for submitted articles on the topics of: investigational medicine, adverse
`events and case reports in the area of clinical pharmacology, drug-induced QT
`prolongation, cardiovascular pharmacology, pharmacokinetics and dynamics, drug
`delivery and metabolism, pharmacology of the vascular and central nervous system,
`et cetera.
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`US Food and Drug Administration, (FDA) Medical Officer/ Senior Analyst:
`December 2007 – December 2010
`Division of Metabolism and Endocrinology Products (DEMP)
`Office of Drug Evaluation, Office of New Drugs.
`• Lead reviewer responsible for various safety and efficacy analyses of clinical study
`proposals, reports, product labeling BLAs, NDAs, INDs, new protocols and protocol
`amendments.
`• Lead medical officer for the SEARCH trial: “Study of the Effectiveness of Additional
`Reductions in Cholesterol and Homocysteine” addressing the safety and efficacy of
`simvastatin 80mg.
`• Lead efficacy medical officer for the Livalo (pitavastatin) NDA.
`• Prepared written summaries and formal presentations of safety and efficacy of
`protocols and package labeling for interdisciplinary reviewers and division directors.
`• Advised sponsors on the suitability of drug development plans and clinical trials were
`adequate and well-controlled, and sufficient to support the efficacy and safety of
`drugs under investigation, based on the available data.
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`• Reviewed post-marketing safety reports, databases and safety submissions to
`determine if there were potential issues that required further evaluation or product
`labeling changes.
`• Provided advice and direction to pharmaceutical sponsors and investigators on the
`design of clinical studies.
`• Compiled data to prepare special reports related to the work of the Division and
`analyzed background data pertinent to FDA programs.
`• Assessed New Drug Applications, supplements and pre-clinical applications based
`on the most recent version of FDA guidance documents and The Code of Federal
`Regulations.
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`Yale University, Assistant Professor of Pharmacology:
`January 2004 – January 2008:
`Assistant Professor (Timothy Dwight College Fellow, Chubb Fellow)
`Department of Pharmacology,
`Yale School of Medicine
`• Lectured on graduate level clinical pharmacology for medical, physician assistant and
`pharmacology Ph.D. students. Lectures and discussions include cardiology, metabolic
`diseases, obesity, alcohol pharmacology/neuropharmacology, drug development, drugs
`of abuse, among others.
`• Research advisor for Medical, Physician Assistant and Pharmacology Ph.D. students.
`Thesis committees and participation in rotation guidance.
`• Clinical investigation analyzing and standardizing drug therapy during surgical
`procedures including carotid endarterectomy and carotid stenting procedures.
`• Clinical investigation on compounds which have the potential to modulate endogenous
`cholesterol levels.
`• Basic science research exploring various hemodynamic cell signaling pathways related
`to vascular wall thickening, inflammation, plaque stabilization, migration and the non-
`random localization of atherosclerotic plaques in the vasculature.
`• Faculty member of the Yale University Center for Bioethics, Research Ethics working
`group and Research Ethics writing group.
`Involved in multiple interdisciplinary scientific and research collaborations as well as
`various academic presentations to the faculty.
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`•
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`Pharmaceutical Industry: Merck Inc. Vioxx Litigation Consultant and Expert Witness:
`January 2005 - December 2007
`Expert witness and consultant on the clinical use of drugs and basic science
`pharmacology Williams and Connolly LLP and Fulbright & Jaworski LLP
`• Applied expertise to research, consult and deliver expert witness services to
`litigators defending Merck Inc. in Vioxx litigation.
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`• Used clinical pharmacology and basic science research to give a comprehensive
`interpretation of scientific publications related to vascular occlusion and
`thrombosis.
`• Performed an independent and comprehensive search and examination of the
`medical literature as pertaining to the defendant’s case.
`• Communicated directly with publication authors on studies as necessary to
`clarify detail and endpoints.
`• Provided independent opinion in a detailed and heavily referenced publication-
`style report.
`• Provided additional reports in an easy to understand format for the expert as well
`as the lay individual.
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`Pfizer Inc., Investigational Medicine Scientist
`November 2001 - December 2004
`Investigational Medicine Research Scientist
`Clinical Research and Development,
`Pfizer Inc., Groton/ New London, CT
`• Responsible for designing, implementing and driving the process of state-of-the-art
`clinical pharmacology studies for multiple early and full development compounds.
`• Designed and composed Phase 1 and 2 protocols and study reports for first-in-human
`studies, multiple dose studies, food effect studies, dose escalation studies, drug
`interaction studies and dose bioequivalence studies.
`• CRO negotiations, supervision and management
`• Responsible for study implementation including:
`• Chairing study team meetings
`• Managing a multidisciplinary operational group: (clinical research associate,
`project assistant, medical monitor, assay coordinator, biometrician, data
`manager)
`• CRO selection, study initiation, clinical safety monitoring
`• Projecting study budgets and recognizing/ implementing areas of cost savings
`in study design and conduct.
`• Contributor to Early Clinical Development Plans of early phase compounds
`• Ad hoc presenter of various clinical, scientific and protocol related topics.
`
`Postdoctoral Training: Yale University Vascular Medicine/ Pharmacology Fellowship:
`December 1999-January 2002:
`Vascular and Cardiovascular Medicine Postdoctoral Fellowship
`Department of Surgery, Section of Vascular Surgery,
`Yale School of Medicine
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`• Basic Science research related clinically to cholesterol, arteriosclerosis, intimal
`hyperplasia, diabetes and hypertension.
`• Clinical Research: Coordinator for multiple clinical trials assessing efficacy in
`atherosclerosis and hypertension. Responsible for GCP adherence. Screened
`and managed patients or subjects in studies.
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`Basic Science Pharmacology Research Fellowship, Yale University (Laboratory activities):
`December 1999 to January 2002:
`Vascular and Cardiovascular Medicine Research Fellowship, Yale School of Medicine
`• Studied the effect of atherosclerosis, diabetic levels of glucose isomers, and
`their effects on endothelial and smooth muscle cells.
`• Red wine polyphenols, (with emphasis on resveretrol and quercetin) and
`their role in atherosclerotic disease. Studied smooth muscle migration and
`cell cycle analysis as related to atheroma formation.
`• Cyclic strain induced activation of pro-survival cascades in bovine aortic
`endothelial cells and bovine aortic smooth muscle cells.
`• The effects of cyclic strain on the phosphorylation of AKT and BAD
`in vascular endothelial and smooth muscle cells.
`• The effects of cyclic strain on the rate and extent of apoptosis in
`vascular endothelial and smooth muscle cells.
`• The effects of cyclic strain on transcription factor NF[k]B in vascular
`endothelial and smooth muscle cells.
`• The significance of cytoskeleton integrity in mechanical stress induced
`signal transduction in bovine aortic endothelial cells.
`• Cyclic strain induced activation of the GTPase RhoA.
`• The effects of cytochalasin B on cyclic strain induced activation of
`MAPK.
`• The effects of galvanotaxis on vascular endothelial and smooth muscle cells.
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`Yale University Fellowship, Clinical Research Activities (Continued):
`Vascular and Cardiovascular Medicine Research Fellowship, Yale School of Medicine
`• Clinical research investigator/coordinator in charge of screening patients
`upon verification of diagnosis.
`• Applied GCP standards for all patient follow-up and monitoring of safety
`and efficacy parameters.
`• Served as the primary or secondary contact at Yale University for listed
`investigational drug trials.
`• Responsible for protocol adherence, study drug accountability, compliance
`assessment, and adverse event assessment.
`• Responsible for regulating compliance with investigational compound
`sponsor and the University Human Investigation Committee.
`• Designed and conducted research projects exploring the molecular
`mechanisms of hypertension and diabetes in association with cholesterol
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`plaque formation and intimal hyperplasia as related to hemodynamics.
`• Worked under an annually renewed NIH (RO1 HL 47345-05) and VA Merit
`Review Grant.
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`Postdoctoral Training: Specialty Residency: Yale-New Haven Hospital:
`July 1999-January 2000:
`Clinical and Investigational Drug Information Residency (ASHP Accredited)
`The Yale-New Haven Hospital. New Haven, CT
`• Performed extensive literature research on complex questions regarding drugs
`and pharmacotherapy.
`• Worked with the Yale University Investigational Drug Service on managing the
`approximately 200+ drug trials at Yale University.
`• Responsible for providing Yale physicians with information on medication use
`(drug-drug interactions, pharmacologic mechanism, unapproved uses, et cetera)
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`Postdoctoral Training: General Residency: Columbia Presbyterian
`July 1998 to July 1999
`General Clinical Pharmacy Practice Residency (ASHP Accredited)
`The Valley Hospital (affiliate of Columbia Presbyterian Medical Center)
`Ridgewood, NJ
`• Special emphasis in cardiac and psychiatric pharmacology
`• Pharmacy and Therapeutics Committee member (addressing disease state
`management protocol and hospital formulary issues)
`Investigational New Drug Review Committee member. Worked with private
`industry to set up clinical trials in several patient populations.
`• Anticoagulation and Hypertension clinic team member.
`• Twice-weekly clinic and patient assessment with appropriate dosage and
`lifestyle recommendations.
`• Residency project: “Standardizing Hyperlipidemia Treatment in Postoperative
`Cardiac Patients.” Meta-analysis cohort funded with a grant from Merck
`Pharmaceuticals.
`Assistant Clinical Instructor, Department of Pharmacy Practice,
`Rutgers College of Pharmacy, Piscataway, NJ
`Assistant Clinical Instructor, Bergen Community College,
`Department of Nursing, Paramus, NJ
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`Clinical Coordinator Gaylord Hospital and Hill Health Center: New Haven, CT
`January 2005 - January 2008
`Clinical Duties
`Operated a drug-monitoring clinic for hypercholesterolemia, hypertension, diabetes and
`warfarin. Identified and resolved pharmacy-related patient care problems by implementing
`collaborative, cooperative, communicative, interdependent relationships with medical staff.
`Supervised and/or performed the following duties in a hospital and/or ambulatory care setting:
`• Recommended appropriate evidence-based therapeutic regimens based on provider diagnoses.
`• Designed and implemented evidence-based drug monitoring plans.
`• Monitored patient progress via laboratory assessments, physical signs and assessments and
`made dosing decisions as necessary.
`• Formally presented and coordinated pharmacy clinic issues and updates with hospital staff.
`• Designed and implemented forms for patient drug-monitoring activity.
`•
`Integrated thorough and effective communication techniques in interviews with patients, in
`assessing:
`1. Medication is used with no medical indication
`2. Diagnosis for which there is no medication prescribed
`3. Appropriateness of medication for a particular medical condition
`4.
`Immunization regimen completeness
`5. Current medication therapy regimen and inappropriate (dose, dosage form, duration,
`schedule, route of administration, method of administration)
`6. Therapeutic duplication
`7. Medication allergies
`8. Clinically significant drug-drug, drug-disease, drug-nutrient interactions or potential for
`such interactions
`9. Medical therapy interference by social, recreational, nonprescription, or nontraditional
`drug use.
`10. Patient benefit of prescribed medication therapy
`11. Patient understanding of medication therapy
`12. Compliance with medication regimen
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`Administrative Duties
`• Addressed Medicare billing reimbursement paperwork, cost-saving implementations and
`miscellaneous other budget/billing duties. Cover director’s duties or meetings in her
`absence as needed.
`• Participated and department preparation for various aspects of accreditation, legal,
`regulatory agency requirements, and committees.
`• Participated in the pharmacy department's budget planning processes.
`• Attend and presented in P&T committee meetings, best-practice meetings as well as other
`various leadership and pharmacy-department related meetings.
`• Established professional pharmacist-patient and pharmacist-caregiver relationships in an
`ambulatory care setting.
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`• Collected and analyzed patient pharmacotherapy information and related medication data as
`related to coordinating an ambulatory care drug monitoring pharmacy clinic.
`• Recommended appropriate evidence-based therapeutic regimens based on provider
`diagnoses.
`• Designed and implementing evidence-based drug monitoring plans.
`• Monitored patient progress via laboratory assessments, physical signs and assessments and
`make dosing decisions as necessary.
`• Designed and implement documentation forms for patient drug-monitoring activity.
`•
`Integrated effective communication techniques in interviews with patients, caregivers,
`healthcare professionals in order to meet patient care needs.
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`Medline Publications:
`David Gortler, Felix J.V. Schlösser, Bart E. Muhs, Michael E Nelson, Alan Dardik
`Periprocedural Drug Therapy in Carotid Artery Stenting: The Need for More Evidence.
`Vasc med. 2008 Nov-Dec;16(6):303-9.
`
`Tiffany T Fancher, Akihito Muto, Dania Magri, David Gortler, Toshiya Nishibe and Alan
`Dardik Control of Blood Vessel Identity: From Embryo to Adult (COVER STORY) Ann
`Vasc dis Vol. 11 (2008) pp.28-34
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`Felix J.V. Schlösser, Frans L. Moll; David Gortler, Bart E. Muhs. The Promise of MR for
`TEVAR and EVAR: Obtaining both force and anatomic imaging and how this might affect
`endovascular repair. Endovasc Today March 2008, 62-67
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`David Gortler, Stephen Maloney; Reuben Rutland, Tormod Westvik; Akihito Muto, Fabio A.
`Kudo, Alan Dardik. Adjunctive Pharmacologic Use in Carotid Endarterectomy: A Review Vasc
`med. 2006;14(2):93-102.
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`Masae Haga, Alan Chen, David Gortler, Alan Dardik, Bauer Sumpio. Shear stress and
`cyclic strain may suppress apoptosis in endothelial cells by different pathways.
`Endothelium. 2003;10(3):149-57.
`
`Alan Chen, David Gortler, Sashi Kilaru, Omar Araim, Spiros Frangos, Bauer Sumpio,
`Cyclic strain activates the pro-survival AKT protein kinase in bovine vascular smooth
`muscle cells. Surgery 2001;130:378-81.
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`Sashi Kilaru, Spiros Frangos, David Gortler, Alan Chen, Bauer Sumpio, Nicotine: a
`review of its role in atherogenesis. Journal of the American College of Surgeons. 2001
`Nov;193(5):538-46.
`
`Alan Chen, Omar Araim, Spiros Frangos, David Gortler Bauer Sumpio, Cyclic strain
`activates the pro-survival Akt protein kinase and BAD in bovine vascular endothelial cells
`Surgery
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`Alan Chen, David Gortler, Spiros Frangos, Omar Araim, Ajay Dhadwal, Gabriel Di
`Luozzo, Sashi Kilaru, Bauer Sumpio, The role of cyctoskeletal integrity in cyclic strain-
`induced activation of MAPK. Journal of Vasc Surg
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`All Manuscripts, Publications, Presentations & Abstracts:
`All manuscripts, publications, presentations and abstracts are listed in search engines such as
`Google primarily under “gortler, ds” (for David S. Gortler)
`Additional publications may also be found under “gortler, d” “d gortler” and “ds gortler.”
`Full list available upon request.
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`Clinical Research / Investigational Drug Studies:
`1. Chief Clinical Coordinator for Protocol Number 223 (SH-TPV-0005) Astra-Zeneca A
`Double Blind, Efficacy and Safety Study of the Oral Thrombin Inhibitor, H376/95 versus
`Standard Therapy [Enoxaparin and Warfarin] in patents with Acute Symptomatic Deep
`Vein Thrombosis with or without Pulmonary Embolism (THRIVE V)
`
`2. Assistant Clinical Coordinator for Protocol Number KGF-2-WHO4 Human Genome
`Sciences A Randomized, Double Blinded, Parallel-Group, Placebo-controlled, Multicenter
`Study to Evaluate the Efficacy and Safety of Repifermin (KGF-2) in Subjects With Venous
`Ulcers
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`3. Assistant Clinical Coordinator for Protocol Number196-98-201-01 Otsuka America
`Pharmaceuticals Inc. A Twelve-Week Randomized, Double-Blind, Multicenter Study of the
`Safety and Efficacy of Three Oral Doses of OPC-28326 Versus Placebo Tablets in Patients
`With Intermittent Claudication Secondary to Peripheral Arterial Disease.
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`4. Assistant Clinical Coordinator for Protocol Number NAT-990133, Amgen
`Pharmaceuticals. Safety Pharmacokinetics and Pharmacodynamics of Novel acting
`Thrombolytics for initial Treatment of Chronic Peripheral Arterial Occlusion.
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`Education, Professional Memberships and Licensure:
`Doctor of Pharmacy University of Arizona: Tucson, AZ
`PharmD conferred 1998
`Fellow of the American College of Chest Physicians (FCCP) 2007 - present
`Fellow of the American Society of Consultant Pharmacists (FASCP) 2005 - 2011
`Drug Information Association 2002-2005
`Fellow of The American Society of Clinical Pharmacology and Therapeutics 2003-present
`American Society of Health System Pharmacy Member 1994-2002
`Arizona State Board of Pharmacy License #S11993.
`Connecticut State Board of Pharmacy License #09257.
`Pharmacotherapy National Provider Identifier (NPI): 1962692681
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`Proficient in the Following Laboratory Techniques and Processes:
`Acrylamide Gel Electrophoresis
`Gel Shift Assays
`Nucleic Acid Purification and Extractions
`Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
`Enzyme-Linked Immunosorbent (ELISA) Assays
`Terminal Deoxynucleotidyl-Transferase-mediated dUTP Nick End Labeling (TUNEL)
`Immunoprecipitation
`In Vitro Kinase Assays
`Zymography
`Southern/Northern/Western Blotting
`Autoradiography/ECL detection
`Restriction Digests/Mapping
`Cell Proliferation Assays
`Cell/Tissue Culture
`Transfection technologies and reporter assays
`Cryopreservation and cryothawing
`Cell cloning
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`Hobbies and Personal Interests:
`Ham radio call sign: KB1PIO
`Vintage automobile enthusiast
`Precision distance rifle shooting
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