James B. Bussel

A. GENERAL INFORMATION

Weill Medical College of Cornell University,

1300 York Avenue, P-695

New York, NY 10065

B. EDUCATIONAL BACKGROUND

Institution name, city & state	Year Awarded
Columbia College of Physicians and Surgeons	1975
Yale University, Cum Laude	1971

C. PROFESSIONAL POSITIONS AND EMPLOYMENT

Post-doctoral training including residency/fellowship

Institution name, city and state	Dates
Pediatric Hematology/Oncology 1980 - 1981	1980-1981
Pediatric Hematology/Oncology New York Hospital-Cornell University Medical Center and Memorial Sloan-Kettering Cancer Center, New York, New York	1978-1981
Cincinnati Children's Hospital, Cincinnati, Ohio	1976-1978
Cincinnati Children's Hospital, Cincinnati, Ohio	1975-1976

Academic positions (teaching and research)

Institution name, city and state	Dates
Cornell University Medical College, New York, New York	1981-1982
Cornell University Medical College, New York, NY	1982 – 1988
Weill Medical College of Cornell University	1988 – 2000
Weill Medical College of Cornell University, New York	2000 –Present
Weill Medical College of Cornell University, New York	2000 – Present
Weill Medical College of Cornell University, New York	2004 - Present

Hospital positions (attending physician, if applicable)

Institution name, city and state	Dates
New York Presbyterian Hospital, New York	2000 - Present
Memorial Hospital for Cancer and Allied Diseases, New York	1991 - Present
Lenox Hill Hospital, New York	1989 – Present
New York Hospital, New York	1981 – 1988 1989 – 1999

D. LICENSURE, BOARD CERTIFICATION, MALPRACTICE (if applicable)

Licensure

State	Number	Date of Issue	Date of last registration
New York	#135038	July, 1978	February, 2012

DEA number:	AB1397632
NPI Number	1063509156

Board Certification

Name of specialty

Board Certificate #

Date of Certification

American Board of Pediatrics

9/6/79

American Board of Pediatric

Hematology/Oncology

1/11/81

Malpractice insurance

Do you have Malpractice insurance? Yes

Name of Provider: MCIC Vermont, Inc.

Premiums paid by: (self/ group/ institution (give name of group/institution)

**E. PROFESSIONAL MEMBERSHIPS (medical and scientific societies)**

Name of Organization	Dates held
Society for Pediatric Research	1987 - Present
International Society of Thrombosis and Hemostasis	1985 - Present
New York County Medical Society	1984 - Present
American Federation of Clinical Research	1984 - 1994
American Society of Hematology	1984 - Present
Society for Pediatric Hematology/Oncology	1983 - Present
Society for the Study of Blood, New York	1982 - 2009
American Association for the Advancement of Science	1984 - 1986

F. HONORS AND AWARDS

Name of award	Date awarded
Co-Chairman of Blood Club Meeting Society of the Pediatric Research Society Anaheim California	1989
Abstract Reviewer and Session Moderator Society of Pediatric Research, Hematology, Anaheim, California	1989
Session moderator, Pediatric Research Meeting, Section on Neonatal Hematology, New Orleans	1997
Symposium Chairman, First Annual Meeting of American Society for Pediatric Hematology/Oncology	1990
Invited Consultant of Canadian Pediatric ITP Group	1991, 1992
10th Edward Pratt Lecturer, Cincinnati Children's Hospital	1995
Abstract Reviewer and Session Moderator Immunohematology Section of American Society of Hematology Meeting	1987
Speaker Education Session American Society Hematology: A. HIV-related Thrombocytopenia 1990 B. Fetal and Neonatal Immune Cytopenias 1994 C. ITP	1990 1994 1997,2000, 2001, 2004, 2007
Chairman Corporate symposium on ITP at ASH (Super Friday)	1999, 2000, 2001, 2002, 2003, 2004, 2005
Chair, Education Session on Platelets at ASH	2000
Abstract Reviewer for ASH Platelet Section	2000, 2003, 2005, 2007
Honorary Chairman of Children’s Blood Foundation New Projects Group Event	1992
Alpha Award of the American Blood Resources Association for Contributions in Immunohematology	1998
Chairman of ITP Meeting to Discuss Splenectomy Sparing Strategy, Boca Raton, Florida	1998
Speaker, The Henry Kunkel Society 11^thAnnual Meeting, Kunkel Society Symposium, Rockefeller University, New York, New York.	2003
Selection as 1 of 15 representatives of American Society of Hematology for SPARKII 1/20/03	2003
Inclusion in both the 3^rdedition of America’s Top Doctors and Top Doctors: New York Metro Area	2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010
Reviewer, Thrasher Research Fund	2006
Reviewer, NIH Clinical Hematology Special Emphasis Panel	2006
22nd Ratnoff Professor of Hematology at Case Western President, New York Society for the Study of Blood Canadian Blood Services Intramural Grant Competition Reviewer Dacie Lectureship	2008 2007-09 2009 2011
King Faisal International Prize for Medicine (the Arab Nobel Prize)	2012

G. INSTITUTIONAL/HOSPITAL AFFILIATION

Primary Hospital Affiliation:	New York Presbyterian Hospital – Weill Medical College of Cornell University
Other Hospital Affiliations:	Memorial Sloan-Kettering Cancer Center

H. EMPLOYMENT STATUS

I. CURRENT AND PAST INSTITUTIONAL RESPONSIBILITIES AND PERCENT EFFORT

FELLOWS

Organizes the divisional teaching conferences with the fellows, as well as being an active participant: with at least monthly case conferences or didactic conferences on special topics. Inpatient Service Attending for 3 months per year and in the Outpatient Division, 3 days per week one-on-one with the Fellows. In addition, he gives two lectures per year to the adult hematology fellows and interacts with them on a regular basis as well as with the maternal fetal medicine fellows. I have had three ITP fellows over the past 8 years: Nichola Cooper, M.D., Specialty Registrar, University College Hospital, London; Marc Michel, M.D., Attending Hematologist Hopital Henri Mondor, Paris; Lemke Page, M.D., Pysch Resident, Netherlands; Beth Psaila, M.D., Specialist Registrar, Haematology Hammersmith Hospital; Mariana Pinheiro, Resident at Jacobi Medical Center; Sarah Barsam, Weill Cornell Medical College visiting fellow.

RESIDENTS
Attends Pediatric Morning Report on a monthly basis. Give approximately six noon conferences/year and helps to organize the rest of the topics for the other members of the Division to provide. On the Hematology Selective, I work one-on-one with the rotating junior residents 2-3 days per week. takes an active role in recruiting and suggesting speakers for pediatric grand rounds. gives at least 2 lectures per year to the obstetrical residents as part of their core lecture series and 1-2 lectures per year to the Pathology residents.

MEDICAL STUDENTS

For 3 years, I had participated in the problem based learning classes. More recently I have been a substitute. In addition, I have precepted summer students and, for 5 years had precepted 1st and 2nd year students for 1/2 day once per week in the Outpatient Department.

EXTRAMURAL TEACHING

I deliver an average of one lecture every 2 weeks outside the New York Hospital-Cornell Medical Center for various Grand Rounds or other sessions. In 2001 I presented the discussion of ITP in the Education Session at ASH (American Society of Hematology) for the second year in a row. I chaired the ITP symposium on super Friday at ASH in 2002 for the fourth year in a row. I presented studies in the Pediatric and Perinatal Hemostasis and Platelet Immunology Subcommittees of the International Committee of Thrombosis and Hemostasis, in the 2001 meeting in Paris and the 2002 meeting in Boston. I am a co-chair of both sub-committees. In addition to being visiting professor at a number of institutions, I give his yearly grand rounds at Weill-Cornell in Pediatrics and at several of the affiliated network hospitals. I was a visiting professor in Hematology at the NIH in November 2000, in January 2001 at Yale, and at Duke in September 2002.

Date

I continue to see > 40% of all patient visits to the Outpatient Department of the Division of Hematology Oncology. This includes at least this percentage of the new patient visits seen by a physician and reflects consultation on > 150 new patients per year, > 50 of whom have other hematologic disorders, and > 100 of whom have ITP. ITP visits include both children and adults, pregnant women, pregnant women with an affected fetus as a result of allo-anti-platelet antibodies, and HIV-related thrombocytopenia. On average, at least 25 ITP patients are seen per week, of whom at least 5-10 receive treatments of one type or another, virtually all of which are delivered by IV infusion or SC injection.

Patients come for consultation from many parts of the US, Canada, and abroad including Europe, the mid East, Asia, and South America. An increasing percentage of referrals come from the internet by patients who request access to studies of ITP and identify us as the leading center in the US. In addition, at least 50% of our physician referrals to the ITP center come via other hematologists, asking for help with their difficult cases.

Dates

I am involved in the administration of the Fellows' rotation at New York Hospital and meets regularly with the Memorial Sloan Kettering Staff to help oversee the Fellowship program. I interview and participate actively in the selection process of Fellows. In addition, I am involved in the Transfusion Committee of the Department of Pediatrics and in the Scientific Advisory Committee of the Pediatric CRC. I am the representative for Pediatrics on the Cornell Billing Compliance Committee. Finally, I am participating as a mentor for the K12 Multidisciplinary Clinical Research Career Development (post-doctoral) Award, and for the related T32 pre-doctoral Clinical Research Training Program.

The ITP Society of the Children’s Blood Foundation continues to be active and productive. They support my work and have honored me at their yearly event. I serve on the fund-raising committee of CBF.

I am on the editorial board of the Journal of Maternal Fetal medicine, and Hematology. I review manuscripts for many journals including Blood and the New England Journal of Medicine. I review grants ad hoc for the NIH, Canadian Red Cross, and for other agencies, i.e. the March of Dimes, as well.

Dates

The Center has evolved as the national and international leader in clinical trials in ITP (see table). We have reported the largest number of ITP patients and the largest number of fetal and neonatal alloimmune thrombocytopenia patients in treatment trials. Typically, well over 100 patients per year are enrolled in one or more trials. Clinical research treatment trials are often linked to studies involving the pathobiology of ITP, so information is acquired about the disease, in addition to its treatment.

During 2000-2005 the Center initiated and participated in a number of trials. These included management of patients at all stages of ITP.

As the Principal Investigator, we initiated a study of anti-CD40ligand with IDEC’s anti-CD40 ligand involving retreatment of patients whose platelet counts have fallen after responding to the Biogen antiCD40 ligand.

As PI, this lead to a randomized multicenter study of anti-CD40L in refractory ITP for which we were the leading enroller.

Similarly as PI of a multicenter, multicontinent study, we completed an IVIG study with Bayer that was a randomized trial of two types of IVIG as well as a separate follow up study of more rapid infusion rates with a novel IVIG. In this and in studies of IV anti-D, we continue to explore platelet turnover and platelet destruction. In addition, we have explored newer measurements of platelet numbers, specifically of large platelets and platelet granularity, as part of a study supported by Bayer Diagnostics. We also began to collaborate on Fc Receptor interactions following intravenous immunoglobulin infusions.

We have finished our prospective study of Intracranial Hemorrhage in ITP. We have now accrued 39 cases, with the goal of seeing what leads to development of intracranial hemorrhage and how we can identify these patients in time to prevent the ICH.

We have completed a prospective study with IV anti-D infusion, licensed in the US in 1995 largely as a result of our center’s efforts, to see if patients, by receiving periodic anti-D as treatment of their platelets, will eventually improve enough on their own to avoid splenectomy. This was published in Blood, March 2002.

In 2001 in the British Journal of Hematology we published a manuscript comparing 75 mcg/kg to 50 mcg/kg of IV anti-D as the initial treatment of ITP. The data show that the platelet count increases significantly faster (overnight) with 75 mcg/kg. This has changed treatment because it allows IV anti-D to be used as treatment for acute ITP at diagnosis in both children and adults.

We have completed a study looking at cytokine production post infusion in the patients in the anti-D studies described above and have compared 2 doses of IV anti-D 50 vs. 75, and IV anti-D to IVIG at different time points before, during, and after initial infusions. This will be helpful in clarifying some of the mechanisms of effect of IVIG and of IV anti-D.

We are finishing a study of intravascular hemolysis following IV anti-D. Anti-D binds to red cells and is thought to operate almost exclusively via splenic removal of antibody-coated red cells (extravascular). This study involves the distinction of intravascular from extravascular hemolysis. The reason for the study is the very low incidence of a very serious complication of anti-D: intravascular hemolysis. This has resulted in renal failure in at least 4 patients. The focus will be on the pre and post infusion determination of a number of parameters of hemolysis in order to better understand mechanism and identify ways of pre-treatment identification of risk.

We published an IL 11 Trial in ITP in the American Journal of Hematology in 2001. It was a negative study.

We have published a study of 57 adult patients who received rituxan treatment of their ITP and also a separate study of 8 children with ITP. We are intending to participate in future studies in children and adults especially in those patients who do not respond to standard dose rituxan. This, like the anti-CD40ligand trial, promises to be very exciting for the treatment of refractory ITP. We have also conducted and plan to perform additional studies to see if we can better understand and predict response.

Our long-term outcome of splenectomy study with our collaborators in Israel appeared in the American Journal of Hematology in 2003.

We published in 2001 a study on the prediction of splenectomy outcome. This involves the usefulness of pre-operative response to IVIG and to IV anti-D as predictors of the subsequent response to splenectomy and on the relationship of the responses to the two treatments.

We have pursued a multi-agent, five drug treatment protocol for ITP intended to provide efficacy in refractory cases at a minimum of toxicity. We have enrolled 35 patients in this informal study and are in the process of reporting the outcome including efficacy and toxicity. The goal is to evaluate the short and long term effects of a multi-agent therapy that is intended to be non-toxic and effective.

Refractory ITP patients have an increased expression of MDR, the multi-drug resistance gene and this may explain in part acquired resistance to treatment. We published this study in the British Journal of Hematology.

We have continued a collaboration in ITP in which we are doing T cell spectratyping at the NIH with Drs. Fogarty and Dunbar. This study was published last year.

We continue our studies of infectious etiologies of ITP having published a study of H Pylori and a study of CMV.

We have begun our fourth multicenter study of alloimmune thrombocytopenia and have enrolled > 30 patients in the past 1+ year. We are writing up the previous study.

We have begun new studies of:

Thrombopoietin-agonist treatment of refractory ITP with exciting results
national registry of amegakaryocytic thrombocytopenias and other non-immune thrombocytopenias and thrombocytopathies
microchimerism as connected with fetal blood sampling

I am the PI of the Cornell-Columbia site of the clinical NIH Clinical Trial Network

J. EXTRAMURAL PROFESSIONAL RESPONSIBILITIES

International Committee of Thrombosis and Hemostasis:

Perinatal Subcommitte, Co-Chairman: 1988-1990, 1998 - 2002
Platelet Immunology Subcommittee: Chairman 1992 - 1995; Co-Chairman 1990-1992, 1995 - Present