Todd Christopher Furesz
**** ******** ***** **. *****, MO 63146
314-***-**** or **********@*****.***
EDUCATION
****-**** **. ****’s University, San Antonio, Texas; B.S. in Biological Sciences, minor in Chemistry
ACADEMIC DISTINCTIONS
1986-1987 Alumni Scholarship, St. Mary’s University, San Antonio, Texas
WORK EXPERIENCE
2008-Present Clinical Trials Consultant, Furesz Clinical Trials Consulting, St. Louis, Missouri
Worked directly with clients as a consultant on clinical trials. Tasks included training sites/coordinators at investigator meetings (topics included: Good Clinical Practices, How to maximize study enrollment, Dealing with difficult Inclusion/Exclusion criteria, Lessons learned in 20+ years of research from CRC/CRA point of view), business development for sites/obtaining clinical trials for PIs, setting up clinical research sites at offices that were formally private practice doctor's offices, creating source documents, advising on budgets, monitoring/auditing research sites, contributing author to protocols, advising on creation of case report forms, modifying research pharmacy to handle investigational product for trials in multiple therapeutic areas, expertise and training of staff to conduct trials as clinical research coordinators/sub-investigators. Worked as a CRA doing on site co-monitoring and auditing of clinical trials.
2008-2009 Director of Clinical Research, Midwest Clinical Research, LLC, St. Louis, Missouri.
Study Management-Worked directly with CROs and Pharmaceutical companies to attract studies for site, and served as site contact in site selection visit, initiation and close out visits for all studies. Reviewed contract language and negotiated budgets for all studies, created source documents when not provided by sponsor, and maintained/submitted all regulatory documents for study. Attended investigator meetings and trained research staff in all aspects of protocol. Listed on 1572 as sub-investigator on most studies. Invoiced sponsors and prepared monthly research reports. Reported directly to PI. Supervised two clinical research coordinators and receptionist.
Patient Recruitment- Responsible for subject recruitment. Used in-house, patient database. Used media contacts to purchase and place TV, radio and print ads. Created advertising for Patient Recruitment. Order general and study supplies for site. Primary contact for IRB.
2006-2008 Research Coordinator, A & A Pain Institute of St. Louis, St. Louis, Missouri:
Study Management- Served as Coordinator for Phase II-IV clinical studies in Pain Management. Worked directly with CROs and Pharmaceutical companies to attract studies for site, and served as site contact in site selection visit, initiation and close out visits for all studies. Reviewed contract language and negotiated budgets for all studies, created source documents when not provided by sponsor, and maintained/submitted all regulatory documents for study. Attended investigator meetings and trained research staff in all aspects of protocol. Listed on 1572 as sub-investigator on most studies. Completed paper documentation and eCRFs. Invoiced sponsors and prepared monthly research reports. Reported directly to PI. Supervised an Adult Nurse Practitioner and Study RN. Helped obtain DEA Schedule 1 license and acted as primary site contact for DEA.
Patient Recruitment- Responsible for subject recruitment (averaged 140% of contracted number of subjects while at site, #1 in enrollment on multiple studies). Used in-house, patient database. Used media contacts to purchase and place TV, radio and print ads. Created advertising for Patient Recruitment. Rater for MADRS (and other scales). Scheduled all subject visits. Order all supplies pertaining to visits. Evaluated subjects at visits, including but not limited to: conduct informed consent, obtain vital signs, ECGs, subject questionnaires, palm pilot or IVRS diary review, process and ship lab samples. Dispensed study drug and maintained accurate study drug logs. Worked with Scheduled 1 -5 medications. Processed subject stipends and answered all non-medical queries. Primary contact for IRB.
2002-2005 Research Coordinator, St. Charles Psychiatric Associates, Midwest Research Group; St. Charles, Missouri
Duties as Clinical Research Coordinator at St. Charles Psychiatric Associates/Midwest Research Group:
Study Management Served as coordinator for Phase I-IV clinical studies in CNS. Worked directly with CROs and Pharmaceutical companies to attract studies for site. Primary contact in site selection, initiation and close out visits. Reviewed contract language and negotiated budgets for all studies, created source documents when not provided by sponsor, as well as maintained and submitted all regulatory documents for study. Attended investigator meetings and trained research staff in all aspects of protocol. Listed on 1572 as sub-investigator on most studies. Completed paper documentation and eCRFs. Invoiced sponsors and prepared monthly research reports. Reported directly to PI. Supervised 3 coordinators in my department.
Patient Recruitment Responsible for subject recruitment (averaged 125% of contracted number of subjects while at site, #1 in enrollment on multiple studies). Used in-house, patient database. Used media contacts to purchase and place TV, radio and print ads. Created advertising for Patient Recruitment. Back Up Rater for MADRS (and other scales). Scheduled all subject visits. Ordered all supplies pertaining to visits. Evaluated subjects at visits, including but not limited to: conduct informed consent, obtain vital signs, ECGs, subject questionnaires, palm pilot or IVRS diary review, process and ship lab samples. Dispensed study drug and maintained accurate study drug logs. Worked with Scheduled 2 -5 medications. Processed subject stipends and answered all non-medical queries. Primary contact for IRB.
1999-2002 Senior Research Technician, Washington University School of Medicine, Department of Pediatrics, St. Louis, Missouri
Responsibilities at Washington University Medical School/Pediatrics included but were not limited to the following areas. Ran basic research lab in pediatrics; planning, designing and conducting bench research experiments in same lab for fifteen years. Ordered all supplies. General lab skills include but are not limited to: Lowry protein assay, preparation of basal and microvillous membranes of human placenta, cell culture experience with BeWo cancer cells and primary placenta trophoblasts. Gave presentations to group and developmental biology division in Pediatrics. Wrote and co-authored abstracts and manuscripts for publication. Designed and developed the flip tray transport experiment technique for cell culture. Reported directly to PI. Supervised summer interns.
1993-1999 Medical Research Technologist, Washington University School of Medicine, Department of Pediatrics, St. Louis, Missouri
1988-1993 Medical Research Technician, Washington University School of Medicine, Department of Pediatrics, St. Louis, Missouri
1986-1987 Laboratory Teaching Assistant, St. Mary’s University, Genetics and Molecular Biology Labs
PUBLICATIONS
1. Furesz, T.C., A.J. Moe, and C.H. Smith: Two cationic amino acid transport systems in human placental basal plasma membranes. American Journal of Physiology 261 (Cell Physiol. 30): C246-C252, 1991.
2. Kulanthaivel, P., T.C. Furesz, A.J. Moe, C.H. Smith, V.B. Mahesh, F.H. Leibach, and V. Ganapathy: Human placental synctiotrophoblast expresses two pharmacologically distinguishable types of Na+-H+ exchangers, NHE-1 in the maternal-facing (brush border) membrane and NHE-2 in the fetal-facing (basal) membrane. Biochemical Journal 284:33-38, 1992.
3. Furesz, T.C., C.H. Smith, and A.J. Moe: ASC system activity is altered by development of cell polarity in trophoblast from human placenta. American Journal of Physiology 265 (Cell Physiol. 34): C212-C217, 1993.
4. Moe, A.J., T.C. Furesz, and C.H. Smith: Functional characterization of L-alanine transport in a placental choriocarcinoma cell line (BeWo). Placenta 15:797-802, 1994.
5. Furesz, T.C., A.J. Moe, and C.H. Smith: Lysine uptake by human placental microvillous membrane, comparison of system y+ with basal membrane. American Journal of Physiology 268 (Cell Physiol. 37): C755-C761, 1995.
6. Fang, J.G., T.C. Furesz, R.S. Laurent, C.H. Smith, M.E. Fant: Spatial polarization of insulin and insulin-like growth factor (IGF) receptors on human synctiotrophoblast cell membranes. Pediatric Research 41:258-265, 1997.
7. Furesz, T.C. and C.H. Smith: Identification of two leucine sensitive lysine transport activities in human placental basal membrane. Placenta 18:649-655, 1997.
8. Way, B.A., T.C. Furesz, J.K. Schwarz, A.J. Moe and C.H. Smith: Sodium-independent lysine uptake by the BeWo choriocarcinoma cell line. Placenta 19:323-328, 1998.
9. Kamath S.G., T.C. Furesz, B.A. Way and C.H. Smith: Identification of three cationic amino acid transporters in placental trophoblast: cloning, expression and characterization of hCAT-1. Journal of Membrane Biology 171:55-62, 1999.
10. Fang J., T.C. Furesz, C.H. Smith and M.E. Fant: IGF binding protein-1 (IGFBP-1) is preferentially associated with the fetal-facing basal surface of the synciotrophoblast in the human placenta. Journal of Growth Hormone and IGF Research, 9:438-444, 1999.
11. Kakuda R., F.H., Leibach, T.C. Furesz, C.H. Smith and V. Ganapathy: Polarazed distribution of interleukin-1 receptors and their role in the regulation of the serotonin transporter in placenta. Journal of Pharmacology and Experimental Therapeutics 292:1032-1041, 2000.
12. Cariappa, R., E. Heath-Monnig, T.C. Furesz, S.G. Kamath and C.H. Smith: Stable polarized expression of hCAT-1 in an epithelial cell line. Journal of Membrane Biology 186:23-30, 2002.
13. Furesz, T.C., E. Heath-Monnig, S.G. Kamath and C.H. Smith: Lysine uptake by cloned hCAT-2B: comparison with cloned hCAT-1 and with trophoblast surface membranes. Journal of Membrane Biology 189:27-33, 2002.
14. Nelson, D.M., S.D. Smith, T.C. Furesz, Y.Sadovsky, V. Ganapathy, C.A. Parvin, and C.H. Smith: Hypoxia reduces the expression and function of system A amino acid transporters in cultured term human trophoblasts. 284:C310-C315, American Journal of Physiology 2003.
ABSTRACTS/PRESENTATIONS
1. Smith, C.H., T.C. Furesz, and L.K. Kelley: Cationic amino acid transport in the basal membrane of human placenta. FASEB J. 4:A1966, 1990.
2. Kulanthaivel, P., F.H. Leibach, V.B. Mahesh, C.H. Smith, T.C. Furesz and V. Ganapathy: Placental synciotrophoblast expresses two types of Na+-H+ exchangers, one in the brush border membrane (BBM) and the other in the basal membrane (BM). FASEB J.5:A759, 1991.
3. Furesz, T.C., C.H. Smith, K.S. Wein and A.J. Moe: Alanine transport systems of trophoblast primary cultures from term human placenta. FASEB J. 6:A534, 1992.
4. Smith, C.H., T.C. Furesz and A.J. Moe: Lysine transport in microvillous membrane of term human placenta. Placenta 14:A.71, 1993.
5. Way, B.A., J.K. Schwarz, T.C. Furesz and C.H. Smith: Lysine transport systems in a placental choriocarcinoma cell line (BeWo). FASEB J.9(3):A307, 1995.
6. Fang, J., T. Furesz, R.S. Laurent, C.H. Smith and M.E. Fant: Spacial polarization of IGF binding sites on the syncytiotrophoblast cell membrane. Pediatric Research 37(4):61A, 1995.
7. Fang, J., T. Furesz, R.S. Laurent, C.H. Smith and M.E. Fant: IGF receptors and IGF binding proteins are associated with distinct surfaces of the syncytiotrophoblast cell membrane. Presented at the International Congress of Endocrology. San Francisco, CA. June 12-15, 1996.
8. Fang, J., T. Furesz, C.H. Smith and M.E. Fant: IGFs regulate neutral amino acid transport systems by distinct signaling pathways in the BeWo choriocarcinoma cell line (b30 clone). Presented at the 79th Annual Meeting of the Endocrine Society. Minneapolis, MN. June, 1997.
9. Smith, C.H., S.G. Kamath, T.C. Furesz, B.A. Way: Cloning, expression and characterization of a cationic amino acid transporter from the placental choriocarcinoma cell line (BeWo). Presented at 1997 FASEB Summer Research Conference. Copper Mountain, CO, July 27-August 1, 1997.
10. Kamath, S.G., T.C. Furesz, B.A. Way and C.H. Smith: Cationic amino acid transporters hCAT-1 and hCAT-2B in human placental trophoblast. FASEB J. 12 (5): A1044, 1998.
11. Fang, J., T. Furesz, C.H. Smith and M.E. Fant: IGF binding protein-1 (IGFBP-1) is uniquely associated with the fetal-facing basal surface of the syncytiotrophoblast in human placenta. Presented at American Pediatric Society and Society of Pediatric Research Annual Meeting, New Orleans, LA, May 1-5, 1998.
12. Smith, C.H., S.G. Kamath and T.C. Furesz: Identification of three cationic amino acid transporters in placental trophoblast: cloning, expression and characterization of hCAT-1. Presented at 1999 FASEB Summer Research Conference. Copper Mountain, CO, June 26-July 2, 1999.
13. Cariappa, R., E. Heath-Monnig, T.C. Furesz, S.G. Kamath and
C.H. Smith: Stable polarized expression of hCAT-1 in an epithelial cell line. Presented at Experimental Biology 2000, San Diego, CA, April 15-18, 2000.
14. Smith, S.D., T.C. Furesz, R. Levy, Y. Sadovsky, C.H. Smith and D.M. Nelson: Hypoxia changes the pattern of amino acid transport in cultured human trophoblast. Presented at the 14th Rochester Trophoblast Conference/Meeting of the Society of Investigation of Early Pregnancy Under the Auspices of Investigation of Placenta Associations, Rochester, NY, October 4-8, 2000.
15. Nelson, D.M., S.D. Smith, T.C. Furesz, E. Sadovsky, Y. Sadovsky, V. Ganapathy, C.A. Parvin, and C.H. Smith: Hypoxia reduces system A amino acid transport and down regulates gene expression for the hATA1 and hATA2 transporters in cultures of human trophoblast. Presented at 9th Conference of the European Placental Group. Sorrento, Italy September 19-23, 2001.
16. Furesz, T.C., E. Health-Monnig, S.G. Kamath, C.H. Smith: Lysine uptake by cloned hCAT-2B: comparison with hCAT-1 and with trophoblast surface membranes. Presented at Experimental Biology 2002, New Orleans, LA, April 20-24, 2002.
INVITED PRESENTATIONS
1. “Cancer Pain Studies from a Coordinator Perspective: Challenges and Solutions,” GW Pharmaceuticals Booster Meeting, Orlando, FL, February 21, 2008.
2. “Maximizing Enrollment” Presented at Valeant Pharmaceuticals of North America Booster Meeting, Les Vegas, NV, May 3, 2008.
RESEARCH COORDINATOR EXPERIENCE
1. X-Company-A Randomized Open-Label, Parallel-Group, Multi-Center Study to Assess the Efficacy, Cardiac Safety and Side Effect Profile of Two Different Antipsychotics in the Treatment of Schizoprenia and Schizoaffective Disorder, Co-Coordinator (2002).
2. X-Company-A Phase 1 Double Blind, Randomized, Placebo Controlled Inpatient Study of the Pharmacokinetics and Efficacy of a Slow-Release Formulation and a Medium-Release Formulation of Compound A in Patients with Schizophrenia or Schizoaffective Disorder, Co-Coordinator (2002).
3. X-Company-A Phase 3 Double Blind, Randomized, Parallel-Group, Placebo Controlled Study to Investigate the Safety and Efficacy of Compound A in Patients with Bipolar Depression, Co-Coordinator (2003).
4. X-Company-A Phase 3 Double Blind, Randomized, Parallel-Group, Placebo Controlled Study to Investigate the Safety and Efficacy of Compound A in Children and Adolescents with Major Depressive Disorder, Co-Coordinator (2003).
5. X-Company-An Open Label, Multi-Centered Study to Investigate the Efficacy and Tolerability of Compound A in Patients with Major Depression who were Intolerant of Prior Antidepressants, Coordinator (2003).
6. X-Company-A Phase 3 Double Blind, Randomized, Parallel-Group, Placebo Controlled Study to Investigate the Safety and Efficacy of Compound A for Treatment of Major Depressive Episodes in Adolescents with Attention Deficit Disorder and Comorbid Major Depression, Coordinator (2003)
7. X-Company-A Double Blind, Randomized, Parallel-Group, Placebo Controlled Study to Compare the Efficacy and Tolerability of Compound A and Compound B in patients with Major Depression, Coordinator (2003)
8. X-Company-A Phase 2 Double Blind, Randomized, Parallel Group, Placebo Controlled Study to Investigate the Safety and Efficacy of Compound A in Patients with Major Depression, Coordinator (2003.)
9. X-Company-A Double Blind, Randomized, Parallel Group, Placebo Controlled Study to Investigate the Safety and Efficacy of Compound A for Augmentation of SSRIs in Patients who had Failed to Respond to SSRI Monotherapy, Coordinator (2003).
10. X-Company-An Open Label, Multi-Centered Study to Investigate the Safety, Efficacy and Tolerability of Compound A for Prevention of Bipolar Episodes in Adults, Coordinator (2003)
11. X-Company-A Phase 3 Double Blind Multi-Center Placebo Controlled Study to Investigate the Safety and Efficacy of Compound A for Prevention of Psychotic Episodes in Patients with Schizophrenia, Back-up Coordinator (2004)
12. X-Company-An Open Label, Multi-Centered Study to Investigate the Safety, Efficacy and Tolerability of Compound A for Prevention of Bipolar Episodes in Adolescents, Coordinator (2004)
13. X-Company-A Phase 3 Open Label, Multi-Centered Study to Investigate the Safety and Efficacy of Compound A in Adults with ADHD, Coordinator (2004)
14. X-Company-A Phase 3 Double Blind Multi-Center Placebo Controlled Inpatient Study to Investigate the Safety and Efficacy of Compound A in Patients with Schizophrenia, Coordinator (2004)
15. X-Company-A Phase 3 Double Blind Multi-Center Placebo Controlled Study of a Triphasic Stimulant for the Treatment of Adults with ADHD, Coordinator (2004)
16. X-Company-A Phase 3 Multi-Center Open Label Extension Study of a Triphasic Stimulant for the Long Term Treatment of Adults with ADHD, Coordinator (2004)
17. X-Company-A Phase 3 Multi-Center Double Blind Placebo Controlled Study to Investigate the Efficacy of Compound A in Treating Agitation and Behavioral Disturbances in Patients with Dementia Receiving Ongoing Treatment with a Cholinesterase Inhibitor, Coordinator (2004)
18. X-Company-A Phase 3 Double Blind Multi-Center Placebo Controlled Study of the Safety and Efficacy of Compound A for the Prevention of Cardiovascular and Cerebrovascular Events, Coordinator (2005)
19. X-Company-A Phase 2 Multi-Center Placebo Controlled Study to Evaluate the Safety and Efficacy of Multiple Doses of Compound A for the Treatment of Generalized Anxiety Disorder, Coordinator (2005)
20. X-Company-A Phase 3 Multi-Center Double Blind Placebo Controlled Study to Evaluate the Safety and Efficacy of Compound A for Type 2 Bipolar Depression, Coordinator (2005)
21. X-Company-A Phase 3 Multi-Center Double Blind Placebo Controlled Study to Evaluate the Safety and Efficacy of Compound A for the Treatment of Child and Adolescent Depression, Coordinator (2005)
22. X-Company-A Phase 3 Multi-Center Double Blind Placebo Controlled Fixed Dose Study to Evaluate the Dose Response Relationship of a Triphasic Stimulant for Adult ADHD, Backup Coordinator (2005)
23. X-Company-A Phase 3 Multi-Center Double Blind Placebo Controlled Comparison of a SSRI, a NDRI and a Triple Reuptake Inhibitor for Adults with Major Depression, Coordinator (2005)
24. X-Company-A Phase 3 Multi-Center Double Blind Placebo Controlled Study of the Safety and Efficacy of Compound A for Adults with Type 1 or Type 2 Bipolar Depression, Coordinator (2005)
25. X-Company-A Phase 4 Multi-Center Double Blind Placebo Controlled Relapse Prevention Study of Compound A in Combination with Other Mood Stabilizers, Coordinator (2005)
26. X-Company-A Phase 2 Multi-Center Inpatient Study of the Safety and Efficacy of Various Doses of Compound A for Adults with Bipolar Mania, Coordinator (2005)
27. X-Company-A Phase 3 Randomized Double Blind Multi-Center Controlled Study to Investigate the Safety and Efficacy of a Dermal Patch in Patients with Postherpetic Neuralgia, Coordinator (2006)
28. X-Company-A Phase 2 Randomized Double Blind Multi-Center Placebo Controlled 2-Period Crossover Study to Investigate the Safety and Efficacy of Compound A in Patients with Postherpetic Neuralgia, Coordinator (2006)
29. X-Company-A Phase 3 Randomized Double Blind Multi-Center Placebo Controlled Study to Investigate the Safety and Efficacy of BID Dosing of Compound A in Patients with Diabetic Peripheral Neuropathy, Coordinator (2006)
30. X-Company-A Phase 3 Randomized Double-Blind Multi-Center Placebo Controlled Study to Investigate the Safety and Efficacy of QID and BID Dosing of Compound A in Patients with Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain, Backup Coordinator (2006)
31. X-Company-A Phase 3 Randomized Double Blind Multi-Center Controlled Study to Investigate the Safety and Efficacy of a Dermal Patch in Patients with Postherpetic Neuralgia, Coordinator (2006)
32. X-Company- A Phase 2 Compound A Dose-Range Finding Trial: A 16 Week, Randomized, Double-Blind, Placebo and Compound Controlled, Multi-Center Trial of Compound A in Patients with Postherpetic Neuralgia (PHN), Coordinator (2006).
33. X-Company- A Phase 2 Open Label Extension Trial Assessing the Safety and Tolerability of Compound A in Patients with Postherpetic Neuralgia (PHN), Coordinator (2006).
34. X-Company- A Phase 4 Randomized, Double Blind, Parallel-Group Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patients with or at High Risk for Cardiovascular Disease Comparing Compound A with Compound B and Compound C, Coordinator (2007).
35. X-Company-A Phase 2 Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Topical Compound A for the Treatment of Symptomatic Diabetic Peripheral Neuropathy, Coordinator (2007).
36. X-Company-A Phase 2B Long-Term, Randomized, Open-Label, Safety and Tolerability Trial Comparing Compound A with Routine Care in Patients with Chronic Painful Diabetic Peripheral Neuropathy (DPN), Coordinator (2007).
37. X-Company-A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of Compound A in Patients with Postherpetic Neuralgia (PHN) Concomitantly Treated with Compound B, Coordinator (2007).
38. X-Company-A Phase 2 Global, Multicenter, Randomized, Double Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Compound A, Compound B and Placebo in Subjects with Diabetic Neuropathic Pain, Coordinator (2007).
39. X-Company- A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy of Maximally Tolerated Doses of Compound A versus Placebo in Reducing Pain Associated with Post-Herpetic Neuralgia, Coordinator (2007).
40. X-Company-A Phase 2b Multi-center, Long Term, Open-Label Study of Compound A Administered Once Daily in Patients with Fibromyalgia, Coordinator, (2007).
41. X-Company- A Phase 2a Randomized, Double-Blind, Placebo-Controlled,Multicenter, Parallel Group, Proof of Concept Study of the Analgesic Effects of IV Compound A in Adult Patients with Post-Herpetic Neuralgia, Coordinator (2007).
42. X-Company- A Phase 2 Double-Blind, Randomized, Placebo Controlled, Parallel Group Dose-Range Exploration Study of Compound A (Schedule 1 Compound) in Relieving Pain in Patients with Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy, Coordinator (2007).
43. X-Company- A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Effificacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Adminstered as Allergen-Based TabletsOnce Daily to Adult Patients Suffering from Grass Pollen Rhinoconjuctivitis, Sub-I (2008).
44. X-Company- A Phase IV 12-Week, Randomized, Double Blind, Double-Dummy, Multi-Center Study Comparing the Efficacy and Safety of Compound A x 2 Actuations Twice Daily Versus Compound B x 2 Inhalations Twice Daily, in Adult and Adolescent African American Subjects with Asthma, Sub-I (2008).
45. X-Company- A Phase III Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study of the 12 Month Effect of Treatment with Once Daily Compound A on the Growth Velocity of Children, 3 to 9 Years of Age, with Perennial Allergic Rhinitis (PAR), Sub-I (2008).
46. X-Company-A Phase II, Multicenter, Randomized, Open-Label, Active-Control, Dose-Ranging Study of Compound A Given Via Continuous Subcutaneous Infusion in Subjects with Hepatitis C Virus Genotype 1 Infection, Coordinator (2009).
47. X-Company-A Three Year, Virology Follow up Study in Subjects Previously Treated with Compound A in Select Clinical Trials, Coordinator (2009).
48. X-Company-A Phase II, Randomized, Double-Blind, Placebo-Controlled Study if the effect of a single injection of Compound A on Reduction of Pain from Chronic Pancreatitis, Coordinator (2009).
49. X-Company-A Phase II Trial of Compound A in Interferon-Naïve Hepatitis C Patients, Coordinator (2009).
50. X-Company- A Phase IIb, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Compound A in Adults with Chronic Hepatitis C Virus Infection, Coordinator (2009).
51. X-Company- A Phase II, Randomized, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Compound A in Thrombocytopenic Subjects with Hepatitis C Virus (HCV) Infection who are otherwise Eligible to Initiate Antiviral Therapy, Coordinator (2009).
52. X-Company- A Phase II Single-Arm Study to Provide Compound A Treatment in Subjects with Chronic Hepatitis C Genotype 1 Deemed Non-responders to Peginterferon/Ribavirin in Previous X-Company Compound A Studies, Coordinator (2009).
53. X-Company-A Phase II Study of Compound A in Previously Untreated Subjects with Genotype 1 Chronic Hepatitis C, Coordinator (2009).
54. X-Company-A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Comparing 24 or 48 Weeks of Compound A, in Combination with Standard of Care, to 48 Weeks of Standard of Care for the Treatment of Genotype-1 Chronic Hepatitis C Virus (HCV) Infection, Coordinator (2009).
55. X-Company-A Phase III Safety and Efficacy Study of Compound A in Combination with Standard of Care in Subjects with Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment with Standard of Care, Coordinator (2009).
56. X-Company-A Phase 2B, Partially Blinded, Randomized Study in Treatment Naïve Subjects with HCV Genotype 1 to Compare the Efficacy, Safety, and Tolerability of Three Doses of Compound A Plus Ribavirin Given Bi-weekly in Comparison with PEG-Intron Plus Ribavirin Given Weekly, Coordinator (2009).
57. X-Company-A Phase II, Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects with Genotype 1 chronic Hepatitis C who Achieve an Extended Rapid Vial Response (eRVR) while Receiving Compound A and Standard of Care, Coordinator (2009).
58. X-Company-A Phase III, Safety and Efficacy Study of Compound A in Previously Untreated Subjects with Chronic Hepatitis C Genotype 1, Coordinator (2009).
59. X-Company-A Phase III, Safety and Efficacy Study of Compound A in Subjects with Chronic Hepatitits C Genotype 1 who Failed Prior Treatment with Standard of Care, Coordinator (2009).
60. X-Company-A Phase III Study of Two Dose Regimes of Compound A in Combination with Standard of Care in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C, Coordinator (2009).
61. X-Company-A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Compound A in Combination with Standard of Care in Treatment-Naïve Patients with Hepatitis C, Coordinator (2009).
62. X-Company-A Long-Term Follow-Up of Subjects in a Phase II or III Clinical Trial in which Compound A was Administered for the Treatment of Chronic Hepatitis C, Coordinator (2009).
63. X-Company-A Phase II, Randomized, Open Label, Multi-Center, Therapeutic Trial of the Efficacy, Immunogenicity, and Safety of Compound A, Combined with Pegylated Interferon plus Ribavirin Standard of Care Therapy versus Standard Care Alone and Compound A Salvage Standard of Care Failures, in Patients with Genotype 1 Chronic Hepatitis C Infection, Coordinator (2009).
64. X-Company-A Phase II, Randomized, Double-Blind, Controlled Evaluation of Compound A versus Compound B for the Treatment of Presumed Pre-core Mutant Chronic Hepatitis B, Coordinator (2009).
65. X- Company-A Phase II, Randomized, Double-Blind, Controlled Evaluation of Compound A versus Compound B for the Treatment of HBeAG Positive Chronic Hepatitis B, Coordinator (2009).
66. X-Company-A Phase II Rollover Protocol of Compound A in Combination with Standard of Care in Subjects Enrolled in the Control Group (Group Alpha) of Study Q, Study R and Study S Who did not Achieve of Maintain an Undetectable HCV RNA Level through Sustained Viral Response, Coordinator (2009).
67. X-Company-A Phase III Study of Compound A and Standard of Care for the Treatment of Chronic Hepatitis C in the Treatment-Naïve Subjects: A Comparison of Compound B Use versus Compound C Dose Reduction for the Management of Anemia, Coordinator (2010).
68. X-Company- A Phase II Open Label Trial of Standard of Care in Combination with Compound A in HCV Null-Responders, Coordinator (2010).
69. X-Company-A Phase IIa Blinded, Randomized, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of Compound A with Compound B, Compound C or Compound D each Administered Alone and in Combination with Standard of Care in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, Coordinator (2010).