EDUCATION:
| M.D. |
The
Johns Hopkins School of Medicine, Baltimore, MD (1984) |
| B.A. |
German
and Biology, Middlebury College, Middlebury, VT (1980) |
EXPERIENCE:
CURRENT
POSITION Feb. 2008 to present: |
|
Senior
Clinical Consultant, Biologics
Consulting Group, Inc., Chapel Hill, NC. |
| |
|
|
| Apr.
2005 to Jan. 2008 |
|
Vice
President of Drug Development, Biolex Therapeutics,
Inc., Pittsboro, NC.
Direction
of pharmacology, toxicology and clinical development
activities for all Biolex products including:
- BLX-883
human interferon alpha 2b
- Locteron
(controlled-release interferon alfa 2b)
- Responsible for developing toxicology program
to support clinical development, direction of
clinical trials (phases 1 and 2) and for creation
of clinical development program leading to licensing
of Locteron for the treatment of chronic hepatitis
C.
- BLX-155
(Plasmin).
- Responsible
for developing toxicology program to support clinical
development of Plasmin in multiple indications.
- Responsible
for creating clinical strategy for licensing program
for Plasmin.
- Responsible
for designing clinical trials of Plasmin in multiple
indications.
- Other
Proteins:
- Responsible
for clinical evaluation of proteins for possible
in-licensing or in-house development.
|
| |
|
|
| Sep.
2001 to Mar. 2005 |
|
Director,
Global Clinical Strategy Biologics Division, Global
Strategic Marketing / Vascular, Intensive Care, Respiratory
and Immunology, Bayer HealthCare, LLC, Research Triangle
Park NC.
- Global
clinical strategist for Plasmin
- Worked
with marketing and opinion leaders in US, EU and
Japan to identify optimal licensing indications
and trial designs
- Developed
an international advisory board of experts in
interventional radiology, cardiology, hematology
and vascular surgery - met every 6 months
- Obtained
agreement with FDA on phase I trial design
- Global
clinical strategist for Alpha-1-Antitrypsin (AAT)
- Developed
licensing strategies for a new version of plasma-derived
AAT for 2 indications: congenital AAT deficiency
(intravenous) and cystic fibrosis (aerosol)
- Wrote
position paper on novel primary endpoint for licensing
trial of aerosolized AAT for FDA and EMEA
- Clinical
representative on transgenic AAT collaboration
with PPL, Lt
- Designed
and oversaw a phase II study of recAAT by aerosol
administration in patients with congenital A1AT
deficiency
- Developed
3 expert panels and held teleconferences with FDA
regarding the outcome of this trial
- Created
the Alpha-1-antitrypsin Laurell's Training Awards
(ALTA) Program to bring young researchers into the
field of A1AT investigation
- Sserved
as Bayer representative on the grant review committee
with 5 European physician opinion leaders
- First
2 awardees presented at Bayer-sponsored symposium
at 2004 European Respiratory Society meeting in
Glasgow, September, 2004
- Director
of ADAPT (Alpha-1-antitrypsin Detection and Assessment
Programme of Therapy) involving researchers in the
US and UK; developed
a registry of patients for conducting clinical trials
and gathering natural history information to facilitate
licensing trials in congenital AAT deficiency; held
meetings every 6 months with consultants and selected
Bayer representatives
- Developed
expert group for assistance in designing / selecting
aerosol devices for delivering AAT by aerosol in
cystic fibrosis, meetings held in May and July of
2003 and in October, 2004
- Global
clinical strategist for IGIV-C
- Developed
international advisory board of opinion leaders
to assess a new indication and design a phase
III clinical trial for licensing in Chronic Inflammatory
Demyelinating Polyneuropathy (CIPD)
- Worked
with clinical development team in negotiations
with and to gain agreement with FDA on phase III
trial design in CIDP
- Program
Director: GRIP: Gamunex (IGIV-C) Research Initiative
Program - to facilitate phase IV research and
assess potential new indications
- Developed
North American experts group to debate options
for licensing clinical trials of IVIG in the area
of renal transplantation, then to design a pivotal
trial
- Global
clinical strategist for Albumin
- Developed
international opinion leader / advisory committee
for assessment of potential new indications for
albumin and development of a clinical trials program
for life-cycle management
- Held
experts meeting regarding the risks of aluminum
in albumin products; led to preparation of a paper
for publication
- Global
clinical strategist: Other
- Clinical
evaluator of possible pipe-line development and
in-licensing of products for development - assess
clinical need / feasibility of trials and licensing
|
| |
|
|
| Apr.
1999 to Sep. 2001 |
|
Director,
International Clinical Projects, Biologics Division,
Bayer Corporation, Research Triangle Park, NC.
- Planned
life-cycle management programs for non-hemophilia
biologics (IVIG, Alpha-1-antitrypsin [AAT] Albumin,
Antithrombin III)
- Developed
licensing strategy for new indication for AT III (heparin
resistance in cardiopulmonary bypass)
- Planned
clinical development for new products (Plasmin, transgenic
AAT)
- Developed
budgets (out to 5 years) for clinical trials for the
above programs
- Developed
regulatory licensing strategy for transgenic AAT for
the treatment of congenital AAT deficiency; including
presentations to FDA and EMEA
- Worked
with research and development in the assessment of
potential new drugs for internal development or in-licensing.
|
| |
|
|
| May
1998 to Mar. 1999 |
|
Associate
Director, Scientific Studies, Pharmaceutical Division,
Bayer Corporation, West Haven, CT.
- Chair,
Biologics Phase IV program: set up multidisciplinary
internal committee to review and award grants for
Phase IV research for Biologics in the US (IVIG, AAT,
Kogenate, Albumin and Antithrombin III)
|
| |
|
|
| Jul
1997 to May 1998 |
|
Associate
Professor (Joint Appointment), Division of Hematology/Oncology,
Department of Internal Medicine, Department of Pathology,
University of Virginia, Charlottesville, Virginia. |
| |
|
|
| Jul
1995 to May 1998 |
|
Director,
Hemostasis and Thrombosis Clinic, University of
Virginia Health Sciences Center, Charlottesville, Virginia. |
| |
|
|
| Jul
1994 to May 1998 |
|
Consultant,
Veterans Administration Medical Center, Salem, Virginia. |
| |
|
|
| May 1992 to Jun 1997 |
|
Assistant
Professor (Joint Appointment), Division of Hematology/Oncology,
Department of Internal Medicine, Department of Pathology,
University of Virginia, Charlottesville, Virginia. |
| |
|
|
| May
1991 to Apr. 1992 |
|
Instructor (Joint Appointment), Division of Hematology/Oncology,
Department of Internal Medicine, Department of Pathology,
University of Virginia, Charlottesville, Virginia. |
| |
|
|
| Nov.
1990 to May 1998 |
|
Associate
Director, Special Coagulation Laboratory Department
of Pathology
University of Virginia Health Sciences Center, Charlottesville,
Virginia.
|
|
Residency and Fellowship Training
| 1984
1987 |
Resident
in Internal Medicine
The Johns Hopkins Hospital, Baltimore, MD
Program Director: Victor A. McKusick, M.D.
|
| 1987-1990 |
Fellow,
Division of Hematology/Oncology
University of VA School of Medicine
Charlottesville, VA
Program Director: Peter J. Quesenberry, M.D.
|
Honors
and Awards
| 2007 |
Biolex
Award for Excellence |
| 2003 |
PPTA
Albumin Committee: Special Appreciation Award |
| 2003 |
Bayer
Special Recognition Award |
| 2001 |
PPTA
Albumin Committee: Special Appreciation Award |
| 1984 |
Phi
Beta Kappa - Middlebury College |
| 1984 |
Summa
Cum Laude - Middlebury College |
Certifications
and Licensures
| Certifications |
| November,
1995 |
Academy
of Clinical and Applied Thrombosis, Hemostasis and
Vascular Medicine - Diplomate |
| November,
1990 |
American
Board of Internal Medicine
Certification in Hematology
|
| September,
1988 |
American
Board of Internal Medicine
Certification in Internal Medicine
|
| December,
1985 |
FLEX
- Federation Licensing Examination |
Licensure |
| Prior:
MD, VA, Connecticut |
| None
currently active |
Clinical
Activities (1992 - 1998)
- Attending
- 1-3 months per year on inpatient Hematology/Oncology
Service
- Attending
- 2-4 months per year - Hematology Consultation Service
- Attending
- 12 months per year - Coagulation Consultation Service
- Outpatient
clinic two 1/2 days per week - patients with disorders
of hemostasis and thrombosis, also general non-malignant
Hematology
- Bone
marrow aspiration review - 2-5 months per year
- Daily
Special Coagulation Laboratory - work rounds with
Clinical Pathology Residents - year-round
Teaching
| December,
1997 |
"The
Role of Hypercoagulable States in Dermatology"
Dermatology Grand Rounds |
| November,
1997 |
"Role
of the PT and aPTT in Interventional Radiology"
Radiology Grand Rounds |
| November,
1997 |
"Update
on Lupus Anticoagulant Testing" Rheumatology
Grand Rounds |
| October,
1997 |
"Disorders
of Hemostasis in Liver Disease" Gastroenterology/Hepatology
Research Conference |
| October,
1997 |
"Approach
to the Diagnosis and Management of Bleeding Disorders"
Anesthesiology Grand Rounds |
| September,
1997 |
"Update
on Approach to Diagnosis and Management of Bleeding
Disorders" Surgery Grand Rounds |
| September,
1997 |
"Stroke
and the Hypercoagulable States" Neurology Grand
Rounds |
| September,
1997 |
"Approach
to Diagnosis and Treatment of Inherited and Acquired
Bleeding Disorders" Dentistry Grand Rounds |
| September,
1997 |
"Update
on Approach to Diagnosis and Management of Bleeding
Disorders" Neurosurgery Grand Rounds |
| March,
1997 |
"Diagnosis
and Management of Inherited and Acquired Coagulation
Disorders" Plastic Surgery Grand Rounds |
| September,
1996 |
"Outpatient
Management of Deep Vein Thrombosis" Medical
Grounds |
| August,
1996 |
"Emergency
Room Management of Deep Vein Thrombosis" Department
of Emergency Medicine Rounds |
| 1996
- 1998 |
Lectures
on Hemostasis, Thrombosis and Platelets: 3 hours
annually, 1st year students, WV School of Osteopathic
Medicine |
| November,
1995 |
"Regulation
of Alpha-2-antiplasmin" Department of Pathology
Research Seminar |
| October,
1995 |
"Diagnosis
and Management of Bleeding Disorders" Department
of Dentistry Rounds |
| October,
1995 |
"Treatment
of Acquired Coagulation Disorders" Department
of Anesthesiology Grand Rounds |
| September,
1995 |
"Update
on Hypercoagulability: Activated Protein C Resistance"
Medical Grand Rounds |
| September,
1995 |
"Clinical
and Laboratory Aspects of Hemostasis" Department
of Anesthesiology Grand Rounds |
| September,
1994 |
"Use
of Antithrombin III Concentrates in the Management
of DIC" Critical Care Grand Rounds |
| August,
1994 |
"Management
of Acquired Antithrombin III Deficiency" Department
of Medicine Grand Rounds |
| May,
1994 |
"Clinical
Uses of Low Molecular Weight Heparins" Department
of Medicine Grand Rounds |
| August,
1993 |
"The
INR: International Normalized Ratio" Thoracic/Cardiovascular
Surgery Rounds |
| June,
1993 |
"Lupus
Anticoagulant" Lupus Clinic Conference, Rheumatology
Division |
| February,
1993 |
"Introduction
to the INR" INR Research Group Meeting |
| January,
1993 |
"The
Hypercoagulable States" Neurology Grand Grounds |
| December,
1992 |
"Clinical
and Laboratory Aspects of Hemostasis" General
Surgery Grand Rounds |
| September,
1992 |
"Approach
to the Bleeding Patient" Acute Care Conference
for Internal Medicine Housestaff |
| August,
1992 |
"Introduction
to Hemostasis" Department of Dentistry Rounds |
| August,
1992 |
"Acquired
Hemophilia" Department of Medicine Grand Rounds,
University of VA |
| August,
1992 |
"Introduction
to Hemostasis" Lecture to Hematology/Oncology
Outpatient Clinic Nursing Staff |
| February,
1991 |
"Anticoagulation
and Procedures" Department of Medicine Grand
Rounds, University of VA |
| May,
1990 |
"Bleeding
Disorders in the ICU" Critical Care Grand Rounds,
University of VA |
| 1992
- 1998 |
"Introduction
to Anemia." One hour lecture to 3rd year medical
students; 2-3 times per year |
| 1992
- 1998 |
Pathology
course for second year medical students. Two to
four 1-hour lectures on hemostasis and thrombosis,
fibrinolysis and platelets. |
| 1988
- 1990 |
Two
hour lecture on "Anemia;" School of Nursing;
nurse practitioner students |
| 1988
- 1998 |
Physical
Diagnosis, School of Medicine; 2nd year medical
students; 5 two hour sessions |
| Spring
1989, 1990 and 1992 |
Physical
Diagnosis Course; School of Medicine; 1st year medical
students; two hours per week for six weeks |
| July,
1989 - May, 1998 |
Coagulation
Conference: Departments of Pathology and Internal
Medicine; one hour per week; year round; directed
at teaching Hematology/Oncology fellows and Clinical
Pathology residents; all aspects of hemostasis and
thrombosis with particular attention to laboratory
evaluation with clinical correlations |
Industry
Training
| September,
2005 |
"Outsourcing
for Small and Medium-Sized Biotechs" (2 Days)
IBC |
| April,
2005 |
"Biological
Drug Development" (2 Days) PERI |
| February,
2005 |
"Follow
on Protein Pharmaceuticals" (2 1/2 days) Drug
Information Association |
| February,
2005 |
"Investigator
Initiated Studies" (2 days) PERI |
| November,
2004 |
"Update
on International Regulatory Issues related to Drug
Development" (2 days) Barnett International |
| October,
2004 |
"Thought
Leaders and Key Opinion Leader (KOLs)" (2 days)
Center for Business Intelligence |
| January,
2004 |
"Phase
IV Clinical Trials" (2 days) Barnett International |
| November,
2003 |
"Expedited
Drug Approval Pathways" (2 days)Barnett International |
| February,
2003 |
"Improving
Product Development in a Changing World" (2
days) Scripps Clinic |
| November,
2001 |
"Statistical
Concepts for Non-Statisticians" (2 days) Barnett
International |
| October,
2001 |
"Conducting
Clinical Trials Under ICH GCP" (2 days) Barnett
International |
| May,
2001 |
"Delivery
of Drugs by Inhalation" (1 day) Henry Stewart
Conference / Georgetown University |
| October,
2000 |
"Clinical
Trials 2000 Conference" USDA-sponsored (2 days);
Pharmaceutical Quality Institute |
| October,
1999 |
"Preclinical
and Clinical Development of Biologic Therapeutics:
Focus on Pharmacokinetics and Pharmacodynamics"
FDA/CBER-sponsored (3 days) Georgetown University |
| July,
1998 |
"Monitoring
Clinical Drug Studies: Beginner" (3 days) Barnett
International |
Scientific
Activities
| 2003-present |
Manuscript
reviewer for Journal of Thrombosis and Hemostasis |
| 1996-1997 |
President,
VA Society of Hematology/Oncology |
| Jul.
1996 - May 1998 |
Program
Co-Director, Hematology/Oncology Fellowship Training
Program |
| 1994
- 1998 |
Contributing
Editor, Yearbook of Clinical Pathology and Laboratory
Medicine |
| Jul
1994 - Aug. 1996 |
Co-Principal
Investigator, National Institutes of Health - Hematology
Training Grant 5 T32 DK07509-10. |
| Apr.
1994 - Jul. 1996 |
Program
Director, Hematology/Oncology Fellowship Training
Program |
| 1993
- 1998 |
Coordinator,
Medical Resident Hematology/Oncology Consult Elective |
| Apr.
1992 - May 1998 |
Medical
Director, University of VA Adult Hemophilia Treatment
Center |
| 1993
- 1998 |
Coordinator,
Medical Student Clinical Hematology/Oncology Elective |
| 1992
- 1993 |
Member,
Residency Program Review Committee, Department of
Pathology |
| Jan.
1992 - May 1998 |
Internal
Medicine representative, University of VA Health
Sciences Center Transfusion Committee. |
| Jul.
1991 - May 1998 |
Appointee,
State of VA Hemophilia Advisory Committee |
| Jul.
1991 - May 1998 |
Member,
Medical and Scientific Advisory Committee; United
VA Chapter of the National Hemophilia Foundation |
| 1991
- 1998 |
American
Journal of Clinical Pathology, American Journal
of Medical Sciences, Anesthesiology, Clinical Chemistry,
Annals of Pharmacotherapy, Blood Coagulation and
Fibrinolysis, Journal of Critical Illness, Journal
of Neurosurgery, Journal of Urology, Nephron, Southern
Medical Journal |
Invited
Lectures
| February
20, 2007 |
"Antithrombin
III in the ICU: Failure to Launch" Society
of Critical Care Medicine, Orlando, FL. |
| September
23, 2004 |
"Coagulopathies
and DIC" Neurology Critical Care Conference,
Charlottesville, VA. |
| September
10, 2004 |
"ALTA
Program" Evening Symposium, European Respiratory
Society, Glasgow, Scotland. |
| April
4, 2000 |
"Antithrombin
Concentrates: Role in Cardiopulmonary Bypass"
Surgery Grand Rounds, Washington Hospital Center,
Washington, DC. |
| September
19, 1998 |
"Bigger
Isn't Always Better: Clinical Uses of Low Molecular
Weight Heparins" Coagulation Continuing Medical
Education Course, Medical College of VA, Richmond,
VA. |
| September
18, 1998 |
"Hypercoagulable
Disorders: Diagnosis and Treatment" The Charles
J. Tegtmeyer, MD, Memorial Continuing Medical Education
Course, Charlottesville, VA. |
| September
18, 1998 |
"Low
Molecular Weight Heparins for Treatment and Prophylaxis
for Venous Thromboembolic Disease" The Charles
J. Tegtmeyer, MD, Memorial Continuing Medical Education
Course, Charlottesville, VA. |
| May
2, 1998 |
"Low
Molecular Weight Heparin, New Treatment" 46th
Annual Scientific Assembly of the WV Chapter of
the American Academy of Family Physicians, Charleston,
WV. |
| April
9, 1998 |
"Low
Molecular Weight Heparins: Role in the Treatment
of Thromboembolism" Shenandoah Memorial Hospital
Continuing Medical Education Conference, Woodstock,
VA. |
| March
31, 1998 |
"Update
on the Use of Low Molecular Weight Heparins"
Medical Grand Rounds, Porstmouth Naval Hospital,
Portsmouth, VA. |
| March
13, 1998 |
"Low
Molecular Weight Heparins: Indications and Contraindications"
Roanoke Memorial Hospital 49th Annual Postgraduate
Program, Roanoke, VA. |
| March
6, 1998 |
"Outpatient
Treatment of Venous Thromboembolism" Salem
Veterans Administration Hospital Medical Staff Conference,
Salem, VA. |
| March
6, 1998 |
"Review
of Hemostasis" Roanoke Memorial Hospital Grand
Rounds, Roanoke, VA. |
| February
27, 1998 |
"Use
of Low Molecular Weight Heparins in the Prevention
of Thromboembolism" Mary Washington Hospital
Medical Staff Conference, Fredericksburg, VA. |
| February
24, 1998 |
"Update
on the Treatment of Deep Vein Thrombosis and Pulmonary
Embolism" Lewis-Gale Clinic Continuing Medical
Education Program, Salem, VA. |
| February
19, 1998 |
"Use
of Low Molecular Weight Heparin in Unstable Angina
and Arterial Thrombosis" Bluefield Regional
Medical Center Continuing Medical Education Program,
Bluefield, WV. |
| November
20, 1997 |
"Use
of Low Molecular Weight Heparin for the Treatment
of Deep Vein Thrombosis" Sentara VA Beach Hospital
Continuing Medical Education Course, VA Beach, VA. |
| November
8, 1997 |
"Outpatient
Treatment of Deep Vein Thrombosis with Low Molecular
Weight Heparin" Scientific Session of the Annual
Meeting of the Medical Society of VA, Hot Springs,
VA. |
| October
14, 1997 |
"New
Agents in the Treatment of Thrombosis" Annual
Update in Clinical Medicine, Charlottesville, VA. |
| June
26, 1997 |
"Use
of Low Molecular Weight Heparin in the Treatment
of Deep Vein Thrombosis" Bluefield Medical
Society Continuing Medical Education Conference,
Bluefield, WV |
| April
14, 1997 |
"Update
on Hemostasis and Thrombosis" Hematology Rounds,
Veterans Administration Hospital, Salem, VA. |
| April
14, 1997 |
"Case
Studies in Hemostasis and Thrombosis" Annual
Meeting of VA Society of Medical Technology, Roanoke,
VA. |
| March
27, 1997 |
"Outpatient
Treatment of Deep Vein Thrombosis with Low Molecular
Weight Heparin" Medical Staff Rounds, Pulaski
General Hospital, Pulaski, VA. |
| November
7, 1996 |
"Antithrombin
III in the Treatment of Disseminated Intravascular
Coagulation" Baylor Division of Hematology
Conference, Houston, TX. |
| August
28, 1996 |
"Treatment
of Disseminated Intravascular Coagulation: Role
of Antithrombin III Concentrates" Hematology/Oncology
Grand Rounds, University of Miami Medical Center,
Miami, FL. |
| July
30, 1996 |
"Role
of Antithrombin III in the Treatment of Disseminated
Intravascular Coagulation" Critical Care Grand
Rounds, Howard University Medical Center, Washington,
DC. |
| July
17, 1996 |
"Update
on the Management of Disseminated Intravascular
Coagulation" Winchester Medical Center Grand
Rounds, Winchester, VA. |
| April
26, 1996 |
"Update
on Hypercoagulable States: Activated Protein C Resistance"
Medical Grand Rounds, Roanoke Memorial Hospital,
Roanoke, VA. |
| April
23, 1996 |
"Antithrombin
III Concentrates: Use in the Treatment of Disseminated
Intravascular Coagulation" Intensive Care Clinical
Conference, St. Louis, MO. |
| April
23, 1996 |
"Role
of Antithrombin III in the Treatment of Disseminated
Intravascular Coagulation" Medical Grand Rounds,
Baptist Medical Center, Kansas City, KS. |
| April
4, 1996 |
"Update
on the Treatment of Inherited Bleeding Disorders"
Medical Grand Rounds, Bethesda Naval Hospital, Bethesda,
MD |
| March
2, 1996 |
"Treatment
of Acquired Coagulation Disorders" Augusta
Medical Center Grand Rounds, Fishersville, VA |
| December
20, 1995 |
"Update
on Hypercoagulable States: Activated Protein C Resistance"
Medical Grand Rounds, Winchester Medical Center,
Winchester, VA. |
| November
8, 1995 |
"Treatment
of Disseminated Intravascular Coagulation: the Role
of Antithrombin III Concentrates" Medical Grand
Rounds, Trinity Lutheran Hospital, Kansas City,
MO. |
| November
7, 1995 |
"Update
on the Prophylaxis and Treatment of Deep Vein Thrombosis"
Hospital Grand Rounds, Richmond Memorial Hospital,
Richmond, VA. |
| October
8, 1995 |
"Treatment
of Disseminated Intravascular Coagulation: the Role
of Antithrombin III Concentrates" Critical
Care Continuing Medical Education Program, Syracuse,
NY. |
| September
11, 1995 |
"Treatment
of Disseminated Intravascular Coagulation: the Role
of Antithrombin III Concentrates" Critical
Care Grand Rounds, Hahneman University, Philadelphia,
PA. |
| June
10, 1995 |
"The
Use of Natural Anticoagulants to Normalize Hemostasis
in Disseminated Intravascular Coagulation"
New Concepts in Critical Care Medicine Conference,
Georgetown University, Washington, DC |
| May
2, 1995 |
"Management
of Disseminated Intravascular Coagulation"
Department of Medicine Grand Rounds, Washington
General Hospital, Washington, DC. |
| March
9, 1995 |
"Update
on the Prophylaxis and Treatment of Deep Vein Thrombosis"
Bluefield Medical Society Continuing Medical Education
Program, Bluefield, WV. |
| February
7, 1995 |
"Prophylaxis
and Treatment of Deep Vein Thrombosis" Martha
Jefferson Hospital Continuing Medical Education
Program, Charlottesville, VA. |
| January
27, 1995 |
"Update
on the Prophylaxis and Treatment of Deep Vein Thrombosis"
Continuing Medical Education Conference, Health
South Medical Center, Richmond, VA. |
| January
21, 1995 |
"Antithrombin
III: Mechanisms of Regulation of Hemostasis and
its Therapeutic Role in the Treatment of DIC"
Current Concepts in Hemostasis and Thrombosis, University
of California - Davis, Sacramento, CA. |
| January
20, 1995 |
"The
Role of Antithrombin III in Disseminated Intravascular
Coagulation" Critical Care Medicine Conference,
San Francisco General Hospital, San Francisco, CA. |
| January
20, 1995 |
"Antithrombin
III: Mechanisms of Regulation of Hemostasis and
its Therapeutic Role in the Treatment of DIC"
Intensive Care Unit Morning Conference, University
of California - San Francisco, San Francisco, CA. |
| January
19, 1995 |
"Antithrombin
III: Role in the Management of DIC" Anesthesia
Clinical Conference, San Francisco, CA. |
| December
8, 1994 |
"Clinical
Use of Low Molecular Weight Heparin" Orthopaedic
Surgery Group, Roanoke, VA. |
| November
22, 1994 |
"DIC
and Sepsis: Role of Antithrombin III" Allegheny
General Hospital, Pittsburgh, PA. |
| October
22, 1994 |
"Thrombophilia
and Acquired Complex Deficiencies of Antithrombin,
Protein C and Protein S" National Antithrombin
Investigators Conference, Phoenix, AZ. |
| October
3, 1994 |
"Management
of Disseminated Intravascular Coagulation: Role
of Antithrombin III Concentrates" Hematology
Grand Rounds, The Johns Hopkins Hospital, Baltimore,
MD |
| September
9, 1994 |
"Antithrombin
III Concentrate and the Management of DIC"
Critical Care Grand Rounds, Mount Sinai Medical
Center, New York, NY. |
| September
7, 1994 |
"Management
of DIC:Present and Future" Medical Grand Rounds,
St. Luke's/Roosevelt Hospital, New York, NY. |
| September
7, 1994 |
"Management
of Disseminated Intravascular Coagulation: Role
of Antithrombin III Concentrates" Critical
Care Grand Rounds, St. Luke's/Roosevelt Hospital,
New York, NY. |
| August
18, 1994 |
"Recent
Developments in the Management of Disseminated Intravascular
Coagulation." Department of Medicine Grand
Rounds, Albany School of Medicine, Albany, NY. |
| July
14, 1994 |
"Deep
Vein Thrombosis: Update on Treatment and Prophylaxis"
Medical Ground Rounds, Southside General Hospital,
Petersburg, VA. |
| June
25, 1994 |
"Clinical
Experience in the Management of Acquired Antithrombin
III Deficiency" Current Topics in Hematology/Oncology
Conference, Washington, DC. |
| May
18, 1994 |
"Overview
of Hemostasis and Thrombosis" Conference on
the Contribution of Coagulation Abnormalities to
Sepsis. Williamsburg, VA. |
| May
11, 1994 |
"Deep
Vein Thrombosis: Update on Treatment and Prophylaxis"
Rockingham Memorial Hospital Continuing Medical
Education Course, Harrisonburg, VA. |
| December
15, 1993 |
"Clinical
Uses of Antithrombin III Concentrates" Medicine
Grand Rounds, Norfolk General Hospital, Norfolk,
VA. |
| October
7, 1993 |
"Approach
to the Patient with Mild Bleeding Symptoms"
20th Annual Recent Advances in Clinical Medicine,
University of VA, Charlottesville, VA. |
| August
31, 1993 |
"Hemostasis
and Thrombosis Update" a series of lectures
(3), Salem Veterans Administration Hospital, Salem,
VA. |
| January
20, 1993 |
"The
INR: To Use or Not to Use" VA Society of Medical
Technology, Fredericksburg, VA. |
| October
20, 1992 |
"Regulation
of Fibrinolysis" Clinical Hemostasis and Thrombosis
Rounds, Duke University, Durham, NC. |
| April
14, 1992 |
"Hemostasis
and Thrombosis" a series of lectures (6) given
as a day-long symposium; Salem Veterans Administration
Hospital, Salem, VA |
| October
11, 1991 |
"Evaluation
of Thrombotic Disorders" 18th Annual Recent
Advances in Clinical Medicine, University of VA,
Charlottesville, VA |
| January
17, 1991 |
"Fibrinolysis
and the Plasminogen Receptor" Texas A&M
University, Scott & White Clinic, Temple, Texas |
Memberships
in Professional Societies
| 2007
- present |
European
Association for the Study of Liver Diseases |
| 2006
- present |
Vascular
Access Society of the Americas |
| 2005
- present |
Drug
Information Association |
| 2002
- present |
Cardiovascular
and Interventional Radiology Society of Europe |
| 2001
- present |
European
Cystic Fibrosis Society |
| 2000
- present |
Society
of Interventional Radiology |
| 1999
- present |
European
Respiratory Society |
| 1999
- present |
American
Thoracic Society |
| 1998
- 2002 |
American
Association of Blood Banks |
| 1997
- present |
Fellow
of the Council on Arteriosclerosis, Thrombosis,
and Vascular Biology, of the American Heart Association |
| 1996
- present |
Academy
of Clinical Laboratory Physicians and Scientists |
| 1994
- 2004 |
International
Academy of Clinical and Applied Thrombosis/Hemostasis |
| 1993
- present |
International
Society on Thrombosis and Haemostasis |
| 1993
- present |
International
Society on Fibrinolysis |
| 1992
- present |
Fellow,
American College of Physicians |
| 1992
- 1997 |
American
Heart Association, Thrombosis Council |
| 1991
- present |
American
Society of Hematology |
| 1991
- 1998 |
Albemarle
County Medical Society |
| 1990
- 1998 |
Virginia
Chapter of the National Hemophilia Foundation |
| 1990
- 1993 |
Medical
Society of Virginia |
| 1989
- present |
National
Hemophilia Foundation |
| 1989
- 1998 |
American
Federation for Clinical Research |
Grant
Support
- NIH
Physician Scientist Award HL-02592. "Hepatic
Mechanisms in the Regulation of Fibrinolysis"
Principal Investigator. Funded 5/1/91 - 4/30/96 (5
years): $66,528 1st year; $419,288 total award.
- Cancer
Center Clinical Research Grant. "Low-dose Coumadin
for the Prevention of Thrombosis in Long-term Indwelling
Catheters in Patients with Malignancy" Funded
7/1/95-6/30/96; $20,000.
- Research
and Development Committee Grant, University of Virginia.
"Recombinant alpha-2-antiplasmin" Funded
7/1/97 - 6/30/98; $13,000.
Peer
Review Participation
- Site-visit
reviewer for NIH Program Project: University of Rochester,
February, 1993.
Publications:
Published
Manuscripts in Refereed Journals
- de Leede L, Humphries JE, Bechet A, van Hoogdalem
E, Verrijk R, Spencer D: Novel controlled-release
Lemna-derived interferon alpha2b (Locteron): Pharmacokinetics,
Pharmacodynamics and Tolerability in a phase I clinical
trial. J Interferon Cytokine Res: (in Press).
- Sadeghi
S, Marder VJ, Stewart D, Kong M, Humphries J, Baumbach
GA, Jesmok G: Safety of plasmin in the setting of
concomitant aspirin and heparin administration in
an animal model of bleeding. J Thromb Haemost 1:2621-2625,
2003.
- Winther
B, Gwaltney Jr JM, Humphries JE, Hendley JO: Cross-linked
fibrin in nasal fluid of patients with the common
cold. Clin Infect Dis 34:708-710, 2002.
- Stanley
TB, Humphries J, High KA, Stafford DW: Amino acids
responsible for reduced affinities of vitamin K-dependent
propeptides for the carboxylase. Biochemistry 38:15681-15687,
1999.
- Bishop
GG, Wiegman P, McNamara C, Din S, Sanders J, Hesselbacher
S, Feldman M, McPherson JA, Humphries JE, Hammarskjold
M-L, Gimple LW, Ragosta M, Powers ER, Dichek D, Owens
GK, Sarembock IJ: Local adenovirus-mediated delivery
of hirudin in a rabbit arterial injury model. J Vasc
Res 36:343-352, 1999.
- Ragosta
M, Karve M, Brezynski D, Humphries J, Sanders JM,
Sarembock IJ, Gimple LW, Powers ER: Effectiveness
of heparin in preventing thrombin generation and thrombin
activity in patients undergoing coronary intervention.
Am Heart J 137:250-257, 1999.
- Angel
JF, Matsumoto AH, Al Shammari M, Hagspiel KD, Spinosa
DJ, Humphries JE: Transcatheter regional urokinase
therapy in the management of inferior vena cava thrombosis.
J Vasc Intervent Radiol 9:917-925, 1998.
- Thome
LM, Gimple LW, Bachhuber BG, McNamara CA, Ragosta
M, Gertz SD, Powers ER, Owens GK, Humphries JE, Sarembock:
Early plus delayed hirudin reduces restenosis in the
atherosclerotic rabbit more than early administration
alone: potential implications for dosing of antithrombin
agents. Circulation 98:2301-2306, 1998.
- Volles
DF, Ancell CJ, Michael KA, Mullins DM, Humphries JE:
Establishing an institution-specific therapeutic range
for heparin. Am J Health-Syst Pharm 55:2002-2006,
1998.
- Prescott
R, Nakai H, Saenko EL, Scharrer I, Nilsson IM, Humphries
JE, Hurst D, Bray G, Scandella D: Recombinate and
Kogenate Study Groups: The inhibitor antibody response
is more complex in hemophilia A patients than in most
nonhemophiliacs with factor VIII autoantibodies. Blood
89:3663-3671, 1997.
- Butler
MD, Biscardi FH, Schain DC, Humphries JE, Blow O,
Spotnitz WD: Pulmonary resection for treatment of
cavitary pulmonary infarction. Ann Thorac Surg 63:849-850,
1997.
- Barry
WL, Gimple LW, Humphries JE, Powers ER, McCoy KW,
Sanders JM, Owens GK Sarembock IJ: Arterial thrombin
activity after angioplasty in an atherosclerotic rabbit
model. Time course and effect of hirudin. Circulation
94:88-93, 1996.
- Becker
DM, Philbrick JT, Bachhuber TL, Humphries JE: D-Dimer
testing and acute venous thromboembolism - a shortcut
to accurate diagnosis. Arch Intern Med 156:939-946,
1996.
- Kaatz
SS, White RH, Hill J, Mascha E, Humphries JE, Becker
DM: Accuracy of laboratory and portable monitor international
normalized ratio determinations. Comparison with a
criterion standard. Arch Intern Med 155:1861-1867,
1995.
- Bower
WA, Humphries JE: Failure of the synthetic androgen,
danazol, to increase protein S levels and prevent
thrombosis in a patient with severe protein S deficiency.
Haemostasis 25:144-148, 1995.
- Humphries
JE, Gonias SL, Pizzo SV, Williams ME: Life-long bleeding
diathesis: effect of liver transplantation. Am J Clin
Pathol 102:816-820, 1994.
- Humphries
JE, Acker MN, Pinkstone JE, Ruddy S: Bleeding in a
5-year-old associated with combined lupus anticoagulant
and prothrombin deficiency. Am J Ped Hem Onc 16:372-376,
1994.
- Humphries
JE, De La Cadena RA, Atkins TL, Colman RW, Gonias
SL: Interaction of high molecular weight kininogen
with plasminogen inhibits binding of plasminogen to
cell surfaces. Fibrinolysis 8:245-254, 1994.
- Page
JD, De La Cadena RA, Humphries JE, Colman RW: An autoantibody
to human plasma prekallikrein blocks the activation
of the contact system. Br J Haematol 87:81-86, 1994.
- Spiekermann
BF, Lake CL, Rich GF, Humphries JE: Normal activated
clotting time despite adequate anticoagulation with
ancrod (Arvin®) in a patient with heparin-associated
thrombocytopenia and thrombosis undergoing cardiopulmonary
bypass. Anesthesiology 80:686-688, 1994.
- Turner
JS, Redpath GT, Humphries JE, Gonias SL, VandenBerg
SR: Plasmin modulates the thrombin-evoked calcium
response in C6 glioma cells. Biochem J 297:175-179,
1994.
- Humphries
JE: Acquired antithrombin III deficiency: replacement
with antithrombin III concentrates in a patient with
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