`
`David George Frame, Pharm.D.
`Hematology/Oncology/BMT Clinical Specialist
`University of Michigan Health System
`
`Assistant Professor of Pharmacy
`University of Michigan
`Ann Arbor, MI
`
`BUSINESS ADDRESS:
`
`University of Michigan Medical Center
`1500 E MEDICAL CENTER DRIVE
`Department of Pharmacy UH B2D30 I
`Ann Arbor, MI
`e-mail: dframe@med.umich.edu
`
`HOME ADDRESS:
`
`7313 Ridge Line Circle
`Dexter, MI 48130
`Phone: (734)426-7789
`
`BIRTHPLACE:
`
`Belleville, TL, USA
`
`LICENSURE:
`
`Michigan, Illinois
`
`EDUCATION:
`1978-1 982
`1982-1986
`1986-1990
`1990-1993
`1993-1994
`1994-1995
`
`Belleville Township High School West, Belleville, Illinois
`St. Louis University, St. Louis, Missouri (B.S. Chemistry)
`Wayne State University, Detroit, Michigan ( Grad. School Biochemistry)
`Wayne State University, Detroit, Michigan (B.S. Pharmacy)
`Wayne State University, Detroit, Michigan (Pharm.D.)
`Fellowship (Oncology), University of Illinois at Chicago
`
`ACADEMIC APPOINTMENTS:
`1986-1988
`Research Assistant, Endocrinology, St. Louis University School of Medicine
`Faculty (Biochemistry) Wayne State University School of Medicine
`1989-1994
`1995- Present
`Associate Clinical Professor of Pharmacy, University of Illinois at Chicago
`1995- Present
`Associate Clinical Professor of Pharmacy, Midwestern College of Pharmacy
`Assistant Professor of Medicine, Rush University
`2002-2005
`2003-2006
`Assistant Professor of Pharmacology, Rush University Medical School
`Assistant Professor of Pharmacy, University of Michigan
`2005- Present
`
`UNIVERSITY OF MICHIGAN APPOINTMENTS:
`Committee- Pharm.D Investigations
`2006- Present
`2005- Present
`Committee- Quality Control BMT
`
`PROFESSIONAL EXPERIENCE:
`1991-1992
`Pharmacy Intern, Conununity Pharmacy,
`Pharmacist and Intern, Children's Hospital of Michigan, Detroit, Michigan
`1990-1994
`1996- 1997
`Oncology Consultant, Copley Memorial Hospital, Aurora, Illinois
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1024
`
`Exh. 1024, Page 1 of 8
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`
`
`1995-1999
`
`1999-2005
`
`Hematology/Oncology Clinical Specialist, RUSH-Presbyterian-St. Luke's Medical Center, Chicago,
`Illinois
`Director of Clinical Hematology/Oncology Pharmacy Services and Research, RUSH-Presbyterian-St.
`Luke's Medical Center (now Rush University Medical Center), Chicago, Illinois
`Responsibilities include:
`• Oversee of all clinical pharamcy oncology services (outpatient clinic,
`service, bone marrow transplant service)
`• Palli.ative care team member
`• Pain monitoring and control
`• Hematology/Oncology patient outcomes monitoring
`• Anti-infective monitoring for appropriateness and outcomes
`• Cancer Institute research internal review board member
`• Writing, Collaborating, and Consulting on Clinical Hematology/Oncology/BMT
`research protocols
`• Member of Hospital Cancer Committee
`• QA/QI committee co-chair for pharmacy and nursing
`• Development of Anticoagulation service for inpatients as well as outpatient for hip and
`knee replacements
`• Development of an inpatient anticoagulation consult service
`• Development of an anticoagunation research group
`
`inpatient floor
`
`2003-2005
`
`Assistant Professor of Pharmacology, Rush University Medica l Center
`• Teaching Pharmacology for second year medical students (General Principles,
`Kinetics, Rheumatology, lmmunosuppressives, Oncology, Anticoagulation, Nausea
`and Vomiting)
`• Teaching Masters and Ph.D. students (Kinetics, Oncology, Anti-infectives,
`Anticoagulation, GI)
`
`2005- present
`
`Assistant Professor of Pharmacy, Clinical Hematology/Oncology/BMT Specialist,
`University of Michigan
`
`PROFESSIONAL SOCIETIES:
`1990- 1994
`Academy of Students of Pharmacy
`1990- 1994
`Michigan Pharmacists Association
`1991-1994
`Southeastern Michigan Society of Hospital Pharmacists
`1993- Present
`American College of Clinical Pharmacy
`1994- Present
`American Society of Health System Pharmacists
`1998- Pr.esent
`American Society of Clinical Oncology
`1998- Pr·esent
`International Society of Oncology Pharmacists -Publications, Education and Research Committees
`2004- Present
`Hematology/Oncology Pharmacy Association (HOPA)-, Research Committee
`
`ACADEMIC HONORS AND A WARDS:
`1984-1986
`Phi Lambda Epsilon Honor Society, St. Louis University
`1985-1986
`St. Louis University President Advisory Board
`1985
`Monsanto Research Fellowship, St. Louis University
`1986-1987
`Toyota Fellowship, Wayne State University
`
`Exh. 1024, Page 2 of 8
`
`
`
`1986
`1986
`1986
`1988- 1989
`1989-1991
`1991
`1991
`1992
`1992
`1992
`1992
`1993
`1993
`1993- 1994
`1993- 1994
`1999
`1999
`
`Graduated Magna Cum Laude, St. Louis University
`The Marcus Research Award, St. Louis University
`Alpha Epsilon Delta Honor Society, St. Louis University
`Graduate Research Assistantship, Wayne State University
`Public Health National Research Service Award
`Schering Future Pharmacist Award
`Wayne County Pharmaceutical Society Scholarship
`Allen and Hanbury's Scholarship Award
`Pharmacy Alumni Association Scholarship
`Rho Chi National Honor Society
`Wayne State University Pharmacy Curriculum Committee
`Wayne State Pharmacy Class President
`Eli Lilly Achievement A ward
`Wayne State University Graduate School Scholarship
`Michigan Healtlh Care Education and Research Scholarship
`RUSH Medical Center Team of the Year Award
`American Society of Health System Pharmacists Drug Research Award
`
`RESEARCH EXPERIENCE:
`Molecular Biology:
`Apoptosis
`Carcinogenesis
`
`Chemistry/Biochemistry:
`Oligonucleotide synthesis in solution and solid phase
`Palladium catalysis reactions
`
`Kinetics:
`Kinetics of Valsartan in Renal Failure
`Interaction of Itraconazole and Phenytoin
`Kinetics of Gengraf- a cyclosporine formulation
`Kinetics of Rituximab in CLL
`
`Quality of Life:
`Quality of life in patients with hypertension
`Antiemetic Outcome studies in oncology and Post-operatively
`Pain Outcome Monitoring
`Supportive care management
`
`Anticoagulation
`Kinetics of anti-Xa and outcomes with Lovenox in renal insufficient patients
`
`Hematology/Oncology
`Supportive care protocols- Nausea and Vomiting, Anemia, GVHD, Bone Health
`Development of Infection and Antifungal Guidelines
`Annual Nursing Training- Nausea and Vomiting
`
`SELECT PRESENTATIONS:
`2015
`American Managed Care Pharmacy- Annual Meeting
`"Managed Care Considerations in Multiple Myeloma"
`
`2015
`
`Hematology/Oncology Pharmacy Association Annual Meeting
`"Immunotherapy in Oncology"
`
`Exh. 1024, Page 3 of 8
`
`
`
`2014
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`2 104
`
`2013
`
`2011
`
`2009
`
`2008
`
`2007
`
`2006
`
`2006
`
`2005
`
`2004
`
`2004
`
`2003
`
`2003
`
`2003
`
`2002
`
`Hematology Oncology Pharmacy Association Northeast Annual Meeting
`"Updates in Bone Marrow Transplant"
`
`University of Jllinois Annual Oncology Updates
`"Updates in Hemophilia, ITP and Aplastic Anemia"
`
`Hematology Oncology Pharmacy Association Northeast Annual Meeting
`"Updates in Multiple Myeloma"
`
`American Society of Blood and Marrow Transplant- Annual Meeting San Diego
`"The Rationale and Role of Reduced Intensity Transplants"
`
`Hematology Oncology Pharmacy Association- Annual Meeting Salt Lake City
`"Pharmacogenomics in Oncology"
`
`American Society of Health System Pharmacists- Annual Meeting San Francisco
`"Pharmacy Considerations and Updates in CML"
`
`Hematology/Oncology Pharmacy Association- Annual Meeting Denver, CO
`"Mechanisms of Oral Tyrosine J(jnase Inhibitors"
`
`American Society of Managed Care Annual Meeting- San Diego
`"New Therapies and Economics in CML"
`
`Asia Pacific Oncology Pharmacy Congress- Thailand
`''Treatments Options in Anemia"
`" Targeted Therapies In Cancer"
`" PharmacogenetEcs and Cancer"
`
`International Society of Oncology Pharmacy Practicioners- Kuala Lampur
`" Pharmacogenomics in Oncology"
`"New Therapeutic Targets"
`
`American Society of Health System Pharmacists- Midyear Meeting
`"DNA methylation- A New Therapeutic Target"
`"Antiemetics: New Therapeutic Rationales and Cost Effectiveness"
`
`Making a Difference in Oncology National Meeting
`"Making Sense out of Anti-sense"
`"Gallium: New Therapy for Resistant Hypercalcemia"
`
`Making a Difference in Oncology National Meeting- Phoenix
`"Updates in Breast and Lung Cancer"
`"Apoptosis, Angiogenesis and Second Messengers"
`
`Focus on Fungal Infection International Meeting- Maui
`"New Preventative Strategies in Antifungal Therapy"- Presentation
`"Low dose liposomal amphotericin is effective in prevention of fungal infections in allogeneic
`transplant"- abstract
`bone marrow
`
`Supportive Care in Cancer International Meeting- Bermuda
`"Erythropoeitic agents: What do we really !know?"
`
`International Society of Oncology Pharmacists International Meeting- Vancouver 2002
`"Apoptosis: A new target in Oncology Therapeutics"
`"Cell Cycle and New Therapeutic Targets in Oncology"
`
`Exh. 1024, Page 4 of 8
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`
`
`2001
`
`2000
`
`2000
`
`1999
`
`1998
`
`1998
`
`1998
`
`1998
`
`1996
`
`1996
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`P UBLICATIONS:
`
`April 1993
`
`May 1989
`
`April, 1997
`
`June, 1998
`
`endometriosis"
`
`October, 1998
`
`December, 1999
`
`Oncology Nursing Society- Chicago Chapter
`"Updates on New Drugs in Oncology"
`
`Australian Clinical Society of Oncology National Meeting- Adelaide
`" Oncology agents with new molecular mechanisms"
`" Monoclonal anLibodies in cancer"
`" Update on current phase I and II oncology trials"
`
`International Society of Oncology Pharmacists International Meeting-Prague
`"Pharmacokinetics of the Taxanes"
`
`Oncology Nursing Society- Chicago Chapter-
`"New oral chemotherapy drugs"
`
`Oncology Nursing Society- National Meeting
`"Hypercoagulation in Oncology Patients"
`
`University of Iowa Oncology Grand Rounds
`"Antiemetics and Supportive Care in Oncology"
`
`Memorial Sloan Kettering- Pharmacy Grand Rounds
`" Updates in Antifungal therapy and use in Oncology"
`
`Missouri Chapter ASHP
`"Updates i1i Oncology therapeutics- new targets and mechanisms"
`
`American Society of Health System Pharmacists- Midyear Meeting
`"Mechanisms of Resistance in the Treatment of Breast Cancer"
`
`American Society of Health System Pharmacists- Midyear Meeting
`" Liposomes: an overview of drug products with an emphasis on anthracyclines"
`
`Platform presentation for American College of Clinical Pharmacy
`"Gender and racial dufferences in the usage of thrombolytic agents in acute
`myocardial infarction"
`
`Abstract for the American Association for Cancer Research
`"Automated chemical synthesis of oligonucleotides containing site-
`specifically incorporated acetylaminofluorene adducts"
`
`KeePosted
`" Liposomes: Drug Delivery Tools"
`
`Fertility and Sterility
`" Spontaneous apoptosis of endometrial tissue is impaired in women with
`
`Archives of Internal Medicine
`"Efficacy of Ondansetron vs Prochloperazine in Post Operative Nausea and
`Vomiting after Total Hip or Knee Relacement"
`
`Bone Marrow Transplantation
`" Intra vesicular instillation of E-aminocaproic acid for patients with adenovirus-
`induced hemorrhagic cystitis"
`
`Exh. 1024, Page 5 of 8
`
`
`
`April, 2000
`
`Abstract for American Society of Clinical Oncology
`"Incidence and management of pain in a university hospital"
`
`December, 2000
`
`Abstract for American Society of Hematology
`"Neutropenic fever guideUnes and outcomes in a university hospital"
`
`January 2003
`
`Pharmacotherapy
`"Cox-2 Inhibitors in Oncology"
`
`May 2003
`
`Dec 2006
`
`June 2007
`
`Abstract at American Society of CUnical Oncology
`""Gleevec associated with Breast cancer: A case series report"
`
`Frame D. Chronic myeloid leukemia: standard treatment options. Am J Health Syst
`Pharm. 2006 Dec I ;63(23 Suppl 8):S I 0-4.
`
`Savona MR. Newton D. Frame D. Levine JE. Mineishi S. Kaul DR. Low-dose cidofovir
`treatment of BK virus-associated hemorrhagic cystitis in recipients of hematopoietic stem
`cell transplant. Bone Manow Transplantation 2007; 39(12):783-787
`
`October 2007
`
`Frame D. New strategies in controlling drug resistance. Journal of Managed Care Pharmacy
`2007; 13(8 Suppl A): 13-7
`
`December 2007
`
`September 2009
`
`Frame D. New strategies in controlling drug resistance in chronic myeloid leukemia.
`American Journal of Health-System Pharmacy 2007; 64(24 Suppl15):S16-21
`Frame D. Alternative dosing schedules for methylation inhibitors in MDS
`treatment. Managed Care 2009; 18( I I Suppl 9): 15-9
`
`December 2009
`
`Pogue JM. DePestel DD. Kaul DR. Khaled Y. Frame DG. Systemic absorption of oral
`vancomycin in a peripheral blood stem cell transplant patient with severe graft-versus-host
`disease of the gastrointestinal tract. Transplant Infectious Disease 2009; I I (5):467-70.
`
`February 20 l 0
`
`October 201 I
`
`February 2012
`
`Sept2014
`
`Oct 2104
`
`Frame DG. Best Practice Management of ONV in Oncology Patients: I. Physiology and
`Treatment of CINV Multiple Neurotransmitters and Receptors and the Need for
`Combination Therapeutic Approaches. Support Oncol 20l0;8(suppl 1):5- 9
`
`Magenau J. Tobai H. Pawarode A. Braun T. Peres E. Reddy P. Kitko C. Choi S. Yanik G.
`Frame D. Han·us A. Erba H. Kujawski L. Elenitoba-Johnson K. Sanks J. Jones D. Paczesny
`S. Ferrara J. Levine J. Mineishi S. Clofarabine and busulfan conditioning facilitates
`engraftment and provides significant antitumor activity in nonremission hematologic
`malignancies. Blood. 2011 ;118(15):4258-64
`
`Frame D, Martell A., Markstrom, D, Choi S, Couriel, D. Levetiracetam is efficacious for
`prevention of busulfan induced seizures. Biology of Blood and Marrow Transplantation
`20 12; 18, No.2, Supplement 2
`•
`•
`Chang L, Frame D , Braun T , Gatza E, Hanauer D, Zhao G, Magenau J, .Schultz K,
`Tokala H, Ferrara J, Levine J, Paczesny S, Reddy P, Choi S. *-Equal effort
`Engraftment Syndrome following allogeneic hematopoietic cell transplantation predicts poor
`outcomes. Bioi Blood Marrow Transplant. 2014 Sep;20(9): 1407-17
`
`Huang A, Marini B, FrameD, Aronoff D, Nagel J. Risk Factors for Recurrent Clostridium
`difficile Infection in Hematopoietic Stem Cell Transplant Recipients. Transplant Infectious
`Disease Transpllnfect Dis. 2014 Oct;16(5):744-50
`
`Exh. 1024, Page 6 of 8
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`March 20 15
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`May 2015
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`June 2015
`
`GRANTS:
`1993-1994
`
`1994- 1996
`
`1994-1996
`
`1999
`
`2004
`
`2004
`
`Baseline body mass index among children and adults under!!oing allo!!eneic hematopoietic
`cell transplantation: clinical characteristics and outcomes.
`Gleimer M, Li Y, Chang L, Paczesny S, Hanauer DA, Frame DG, Byersdorfer CA,
`Reddy PR, Braun TM, Choi SW. Bone Marrow Transplant. 2015 Mar;50(3):402- l 0
`
`Treatment of Dyslipidemia in Allogeneic Hematopoietic Stem Cell Transplant Patients.
`Marini BL, Choi SW, Byersdorfer CA, Cronin S, Frame DG.
`Biol Blood Marrow T ransplant. 2015 May;21 (5):809-820
`
`Allo!!eneic transplantation with myeloablative FluBu4 conditioning improves survival
`compared to reduced intensity FluBu2 conditioning for acute myeloid leukemia in remission.
`Magenau JM, Braun T , Reddy P, Parkin B, Pawarode A, Mineishi S, Choi S, Levine J, Li Y,
`Yanik G, Kitko C, Churay T, FrameD, Riwes MM, Harris A, Bixby D, Cour·iel DR,
`Goldstein SC. Ann Hematol. 2015 Jun;94(6): I 033-4 1
`
`Michigan Health Care Education and Research Grant
`"Gender and racial differences in the usage of thrombolytic agents in acute
`myocardial infarction"
`
`Un iversity of Illinois Research Board
`"Apoptosis and its role in chemotherapy"
`
`American College of Clinical Pharmacy
`"Apoptosis in chemomodulation and resistance in melanoma cells"
`
`Fujisawa
`" Evaluation of AmBisome as prophylactic therapy in Lung transplant recipients"
`
`Roche Pharmaceuticals
`"A Randomized, Double Blind Trial of High Dose Ondansetron vs Standard Dose Granisetron in
`patients With Breakthrough Nausea and Vomiting with Low Dose Ondansteron"
`
`Fujisawa
`"A Randomized, Double Blind Trial of I mgfkg vs 3 mg/kg Liposomal Amphotericin for Pre-Emptive
`Prevention of Fungal Infections after Allogeneic Stem Cell Transplant or Induction for Acute
`Myelogenous Leukemia"
`
`Other Interests:
`
`Scuba Diving, Baseball, Basketball, Bowling, Baseball Card Collecting, Theater,
`Symphony, Kidney Foundation, CDKLS
`
`References:
`
`Available on request
`
`Exh. 1024, Page 7 of 8
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`Exh. 1024, Page 8 of 8