Support Development
Resume:
JOSE MANUEL GALLO
Philadelphia, PA 19103
Email: **********@*******.***/ Phone: 267-***-****
SUMMARY-PROFESSIONAL EXPERIENCE
• Ph.D. in Statistics
• 28 yrs. in the industry; at least 20 of these at pharmaceutical companies
• 20+ years in a managerial role; either as a Director, Sr. Director or VP of
Biostatistics or Biometrics; on 3 occasions responsible for leading the creation/
development of such departments.
• Responsible for overseeing Biostatisticians, SAS Programmers, Clinical Data
Managers; and on one occasion also led the Regulatory Affairs and Medical Writing
depts.
• Significant experience addressing submissions (to both the FDA and the EMA); over
14 submissions, most of these NDAs. Primarily for new drugs to address cancer;
but also significant work in Gastrointestinal (e.g., lead biostatistician in the
OTC Prilosec submission), Inflammatory, Cardiovascular, and CNS.
• Over 20 years of experience providing biostatistical support in the Oncology
therapeutic area.
• Significant experience communicating statistical methodology/ results to non-
statisticians.
• 34 years of experience using SAS.
• Conducted some of the pioneering work associated with the development of exact
statistical tests for mixed models when you have unbalanced data [see Chapter 6
of the textbook – Statistical Tests for Mixed Linear Models (Khuri, A., Mathew,
T., Sinha, B.; 1998, Wiley & Sons)].
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Independent Statistical Consultant (September 2013-Present)
While searching for a permanent job position; I have been providing statistical consultation to start-up and small pharmaceutical companies in the Pennsylvania/ New Jersey region.
The work has consisted of proving statistical input in protocol development; developing or reviewing Statistical Analysis Plans (SAPs), reviewing the statistical related input provided in Clinical Study Reports (CSRs); and advising groups on the statistical options to consider as a basis for approval.
The submission related advisement looks at assessing such issues as considering whether to use as a basis for approval demonstrating superiority or non-inferiority. What makes sense when and the statistical methodology that is involved.
United Biosource Corporation (May 2012-August 2013)
Senior Director, Statistics & Statistical Programming
Due to organizational restructuring-position eliminated
Primarily responsible for directing the responsibilities associated with the Statistics & Statistical Programming groups.
Responsibilities included:
• Managing client related-support
• Directing a staff that included biostatisticians and statistical programmers
• Leading the department’s hiring process
• Conducing the staff’s evaluations
• Leading and conducting the department’s development activities; i.e., development of required templates, Standard Operating Procedures (SOPs), and other related activities
• Assigning individuals to the different client-related projects; these primarily focused on protocol development, developing the Statistical Analysis Plans (SAPs), developing the Clinical Study Reports (CSRs), other submission related work, and supporting publications
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Onyx Pharmaceuticals Inc. (October 2010-February 2012)
Sr. Director of Biostatistics
Key responsibilities included:
• Developing the Biostatistics department
o Assessing/ overseeing the department’s personnel
o Defining job descriptions
o Leading the department’s hiring activities
o Leading the development of the operational guidelines and Standard Operating Procedures (SOPs) required
o Defining/ establishing the Statistical Drug Development-Related Strategies
• Responsible for establishing and implementing guidelines for effective cross-departmental processes
• Leading all of the Biostatistics support associated with addressing the tasks in the clinical development of new drugs for Cancer
• Developing strategic statistical approaches to improve the design and analysis of drug development clinical trials
• Supporting the statistical responsibilities of the assigned clinical studies; such as addressing the development of protocols; developing the corresponding Statistical Plan (SAP); and providing the necessary input for developing the Clinical Study Reports (CSRs)
• Addressing the statistical support required in the ongoing non-clinical studies
• Proving the statistical support needed in publication-related work
• Interacting with the other leaders of Biometrics (Statistical Programming and Clinical Data Management), Clinical Development, and Regulatory Affairs to identify operational guidelines and how Biostatistics could improve on its responsibilities
Independent Statistical Consultant (July 2009-August 2010)
This consultation work basically involved addressing trial design issues, developing the statistical section of protocols, reviewing developed Statistical Analysis Plans (SAPs), and reviewing the statistical input provided to Clinical Study Reports (CSRs) that were under development.
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The trials involved were primarily Phase I and III clinical trials addressing drug development at small or start-up pharmaceutical companies.
As a result of my extensive experience of working on regulatory submissions and interacting with the regulatory agencies I was also asked during this period for advice on how to best address issues raised by the FDA (or if a European submission, with the EMA).
The work here included a short-term assignment to C-TASC; through Smith-Hanley. C-TASC had been focused on providing Biometric support to government agencies like the NIH and wanted to expand its horizon to support pharmaceutical related work. Given my significant experience in the pharmaceutical companies; C-TASC hired me to identify and develop the processes/ components that would be needed to achieve this objective.
Primary responsibilities:
• Provide information to the biotech-pharmaceutical companies about C-TASC and how the company could help them address their clinical development needs in an efficacious and timely fashion
• Develop the resources within C-TASC that would be needed to provide this new support by reviewing the current capabilities of the company in terms of the biostatistical, SAS programming, and clinical data management capabilities and then identifying/ proposing how these needed to be modified
• Develop or modify the required SOPs; and develop the SAP and Mock Tables/ Listings/ Figures templates that were going to be employed to provide this support in an efficient and timely fashion
• In addition, I took on some of the ongoing government agency-related work that C-TASC was currently addressing
Therakos-Johnson & Johnson (October 2006-June 2009)
Director, Biometrics
Company Closed Down
Developed and led a Biometrics department that supported the ongoing clinical research associated with assessing the efficacy/ safety of Extracorporeal Photopheresis (ECP) in different therapeutic areas.
Assessed department personnel needs in terms of personnel, proceeded with the hiring activities involved, if needed
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Identified software/ hardware needs
Led the development of Standard Operating Procedures (SOPs) for the 3 groups in the department, i.e., for Biostatistics, SAS Programming, and Clinical Data Management;
Worked on defining for the company the “correct” operating procedures for interacting with Biometrics with regards to work associated with clinical trials and the development of manuscripts;
Proactively participated in interactions with the FDA and the EMA to gain approval to utilize a meta-analysis on results from either the literature and/or trials conducted at key investigational sites; in order to demonstrate the clinical benefit of ECP in fighting chronic Graft versus Host Disease
(GvHD). Both regulatory agencies requested a SAP that would specify in
detail how this meta-analysis would be conducted and I proceeded with
developing such SAP.
Wrote and directed the development of the statistical sections of relevant
documents and/or the statistical documents involved in reporting the
trials; and results of these (Protocols, Statistical Analysis Plans, other).
The trials involved were in the areas of Rheumatoid Arthritis; Crohn’s
Disease; Acute GvHD, Chronic GvHD, and Prevention GvHD.
Led the efforts to resolve existing database issues
Provided the statistical support needed in the development of manuscripts, posters, and scientific talks
Managed the support provided by CROs to Biometrics
GPC-Biotech Inc. (November 2005-October 2006)
Senior Director, Statistics and Data Management
Led the Statistical and Data Management support in
The development of the department
Addressing the immediate responsibilities associated with the company’s key NDA submission, i.e., working on the tasks related to the Phase III trial where our compound, Satraplatin, was being assessed as a 2nd line therapy for patients with Hormone Refractory Prostate Cancer. In particular, the work involved:
Finalizing the corresponding Statistical Analysis Plan (SAP)
Resolving issues associated with the database development process.
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Addressing the differences existing between the views that the European regulatory group (the EMA) and the FDA have in terms of this trial
Developing the Briefing document for the FDA meeting scheduled to discuss the results of the trial
Received an award from GPC-Biotech for my efforts/contributions in the development of this NDA submission;
Investigated/ led the efforts to assess potential CRO candidates for database management support;
Led and worked on the statistical support required for all existing trials;
Led the effort to develop Standard Operating Procedures (SOPs) for Statistics and Data Management
EXIMIAS Pharmaceutical (April, 2003-September2005)
Vice-President, Biometrics
Company Closed Down
Built and developed the Biometrics Division (consisting of Biostatistics, Clinical Data Management (CDM), and SAS Programming) of this liver cancer drug development focused pharmaceutical company.
Hired the required personnel
Defined and designed the department’s strategy in order to meet the company’s corporate goals
o The primary focus was to submit the company’s first NDA-if approved this would have been the first approved drug for patients with Hepatocellular Carcinoma (HCC)
o Developed the strategy needed to address the objectives under very limited resources and tight timelines
Provided the leadership needed in defining the responsibilities of each group within Biometrics in relationship to the tasks (and corresponding timelines) that needed to be addressed by each.
Very proactively involved with the objectives and tasks at hand; for instance, engineered an alternative approval strategy basing the approval on non-inferiority rather than superiority.
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Direct hands-on responsibilities on all of the required biostatistical
support; i.e., developing the statistical section of the protocols, developing
the corresponding Statistical Analysis Plans (SAPS), conducting the
statistical analysis; proactively participating in FDA related meetings, and
addressing all of the Data Safety Monitoring Board (DSMB) statistical
responsibilities.
Actively involved with the Medical Affairs Division, in terms of providing statistical support in their submission of abstracts, papers, and posters.
AstraZeneca LP (1997-2003)
Director-Biostatistics Project Team Leader (Oncology)
Key responsibilities included addressing the clinical trials related to new emerging products in oncology.
Managed direct/ indirect reports; and the external support provided from CROs
Led the biostatistical support in a number of submissions to the FDA. These included:
CASODEX sNDA. For treating patients with early stage non-metastatic Prostate Cancer.
ARIMIDEX IND. For treating males with Hypogonadotropic Hypogonadism having no underlined primary testicular or pituitary pathology.
FASLODEX NDA. For the treatment of postmenopausal women with advanced breast cancer following endocrine therapy.
Over-the-Counter (OTC) PRILOSEC NDA.
PRILOSEC Pediatric sNDA
ENTOCORT CIR Capsules to use in Crohn’s Disease NDA
Received awards in relationship to the work produced on these submissions
Significant experience working with overseas colleagues
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Cancer Institute of New Jersey (1995-1997)
Director, Biostatistics
Primary responsibility was to establish a Biostatistics Division and define the process by which the biostatistical support would be provided
Responsible for supporting the basic scientists and clinical investigators in all the design and analysis issues associated with their trials. Primarily Phase I-II oncology trials
Prepared the department for a successful assessment by the National Cancer Institute (NCI); an assessment needed to have the institute designated as a cancer treatment center by the NCI.
Parke-Davis Pharmaceuticals (1994-1995)
Senior Research Statistician II;
Responsible for the statistical design and analysis of cardiovascular trials. In particular, for trials associated with the ATORVASTATIN (LIPITOR) NDA.
American Cyanamid, Lederle Laboratories (1992-1994)
Senior Research Statistician
Responsible for providing the statistical support in cardiovascular related trials
Provided the statistical support needed in the development of a new dioxolane dicarboxylate derivative of phenethanolamine; the tasks involved addressed the NDA related submission work.
Directed the statistical support needed in a number of Phase IV studies involving sustained release formulation of verapamil hydrochloride for use in adults with essential hypertension.
Shands Hospital at the University of Florida (1986-1992)
Head/ Senior Statistician;
Key responsibility was to create/ develop the division that would provide the statistical support to the hospital administration.
Responsibilities also included managing direct/ indirect reports, and directing the statistical support provided by the hospital.
Played a key role in the biostatistical support provided to the Bone Marrow Transplant Unit (in particular in relationship to ongoing neuroblastoma cancer studies).
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EDUCATION
Graduate Studies University of Florida
Ph.D. in Statistics
Dissertation: Derivation of Exact Tests for Testing the Random and Fixed
Effects in Unbalanced Mixed Linear Models
Master of Statistics
Baccalaureate Studies University of Florida
BS in Mathematics
Continuing Education
Attended a course at the University of Reading (England) - Dose Escalation Procedures in Phase I Clinical Trials (Instructors: Drs. John Whitehead and Yinghui Zhou). September 24-25 2001.
Participated in a summer workshop at the University of Pennsylvania - Survival Analysis Using the SAS System (Instructor: Dr. Paul Allison). August 1998.
Attended a software short course at USC - Modelling and Data Analysis in Pharmacokinetics and Pharmacodynamics Using ADAPT II. May 1996.
RELATED EXPERIENCE
Invited by the National Cancer Institute (NCI) to review/ assess projects from the Portland Medical Center in Portland, Oregon: “Expression and Manipulation of Novel TNF-Receptor in Cancer”; and “Generation of Antigen-Specific Anti-Tumor Immunity in a Marine Mammary Tumor Model”. February 1998.
Invited by the NCI to be a member of the Special Emphasis Panel created to review and evaluate oncology related research proposals. August 1997.
Invited by the National Cancer Institute (NCI) to be the statistical reviewer of the Program Project Application - “Vectors for Cancer Gene Therapy” from the University of Alabama at Birmingham. Sept. 1996.
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TEACHING EXPERIENCE
Adjunct Assistant Professor; Department of Environmental and Community
Medicine, University of Medicine and Dentistry of New Jersey (UMDNJ)-Robert
Wood Johnson Medical School. March 1997-July 1997.
Workshop; Institute for Health, Health Care Policy, and Ageing Research-Rutgers University. Invited to conduct a presentation on power analysis in relationship to clinical trial designs. May 1, 1997
Adjunct Faculty; University of Florida, College of Nursing, 1990-1991.
PROGRAMMING LANGUAGES
33 years of experience with SAS/ over 4 years with BMDP/ SPSS
Other software languages include: WORD/ WordPerfect/ Power-Point
AWARDS
Oncology Therapeutic Area Recognition Award for contributions to the
Emerging Products in Oncology Therapeutic Area. (AstraZeneca-July 2002).
Special Achievement Award from the FASLODEX US Product Team for contributions made in the New Drug Application (NDA) - FASLODEX (for the treatment of Breast Cancer). (AstraZeneca - July 2001).
Received an award from AstraZeneca for the statistical support provided in the Supplemental New Drug Application (sNDA) - CASODEX (for the treatment of early stage non-metastatic prostate cancer). This sNDA was submitted to the FDA – December 2001.
PROFESSIONAL AFFILIATIONS
American Statistical Association
Drug Information Association (DIA)
Society for Clinical Trials
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KEY PUBLICATIONS
Articles
Flowers M., Apperley J., Besien K., Elmaagacli A., Grigg A., Reddy V., Bacigalupo A., Kolb H., Bouzas L., Michallet M., Knobler R., Parenti D., Gallo J., Greinix H. (2008). A multicenter prospective phase II randomized study of extracorporeal photopheresis for treatment chronic graft-versus-host disease. Blood.
Gish R, PoC, Lucian L, Ruff P, Feld R, Croitoru A, Feun L, Jeziorski K, Leighton J, Knox J, Gallo J, Kennealey G (2007). A phase III randomized controlled trial comparing the survival of patients with unresectable hepatocellular carcinoma treated with nolatrexed or doxorubicin. Journal of Clinical Oncology, Volume 25, No 21 3069-3075.
Sieber P, Keiller D, Kahnoski R, Garcias-Vargas J, Gallo J, and McFadden S
(2003). Bicalutamide (‘CASODEX’) 150 mg maintains bone mineral density
during monotherapy for localized or locally advanced prostate cancer. Journal of
Urology.
Huhn R, Radwanski E, Gallo J, et al. (1997). Pharmacodynamics of subcutaneous recombinant human interleukin-10 in healthy volunteers. Clinical Pharmacology and Therapeutics, in press.
Gross S, Tomlinson B, and Gallo J. (1993). Efficacy of public sponsored
healthcare for children with cancer. Cancer Research, Therapy and Control 3.
Graham-Pole J, Gallo J, et al. (1991) Myeloblative chemoradiotherapy and
autologous bone marrow transplant for neuroblastoma patients: Factors affecting engraftment. Blood 78:1607-1614.
Guin P, Gallo J, and Hudson A. (1991). The efficacy of six-heel pressure reducing devices. DECUBITUS 4:15-23.
Gallo J and Khuri A. (1990). Exact tests for the random and fixed effects in an unbalanced two-way cross classification mixed model. Biometrics. 46:1087-1095. Presented at Annual Meeting, American Statistical Association, 1987. Cited in textbook: Statistical Tests for Mixed Linear Models (Khuri, A., Mathew, T., Sinha, B.) Wiley 1998.
Jose Manuel Gallo Page 12
Gallo J, Macelderry R, and Khuri A. (1989). A SAS matrix software for testing the random effects in random models with unequal cell frequencies in the last stage. Proceedings of the SAS User's Group International Annual Meeting 1277-1282.
Abstracts
Gish R., Wadler S., Gallo J., Garcia-Vargas, J., Suplick G. Improved safety profile
of THYMITAQ in the ETHECC (Evaluation of THYMITAQ in Hepatocellular
Carcinoma) trial when compared to the safety of the phase II program in
unresectable hepatocellular carcinoma (uHCC). ASCO Annual Meeting–2004
Gallo J, Mok TSK, Garcia-Vargas J., Suplick G. THYMITAQ vs. doxorubicin, a
clinical update of a multi-center randomized phase II study (014) in ethnic Chinese
subjects with unresectable or metastatic hepatocellular carcinoma. ASCO Annual
Meeting – June 2004
Gish R., Feld R., Porter C., Hossfeld D., Ruff P., Tuan B., Knox J., Geddes C.,
Palmeieri S., Schmiegel W., Garcia-Vargas J., Suplick G., Senico P., Gallo J.
Safety of the Phase III ETHECC trial (Evaluation of THYMITAQ in HCC) vs. the
safety of the Phase II THYIMITAQ in HCC. Hepatocellular Carcinoma (HCC)
Meeting – September 2003 in Atlanta, Georgia
Gish R., Ruff P., Feld R., Porta C., Hossfeld D., Tuan B., Geddes C., Knox J.,
Schmiegel W., Palmeieri S., Garcia-Vargas J., Suplick G., Senico P., Gallo J.
Safety of the Phase III randomized study of THYMITAQ vs. Doxorubicin in
unresectable Hepatocellular Carcinoma (HCC): ETHECC Trial (Evaluation of
THYMITAQ in HCC) vs. safety of the Phase II program with THYIMITAQ. Submitted to AASLD Annual Meeting – October 24-28, 2003 in Boston, Mass.
Leder B.Z., Rohrer, J.L., Rubin S.D., Gallo, J., Finkelstein J.S. Aromatase
inhibition does not alter bone turnover, serum OPG, or bone density in elderly men
with mild hypertension. Submitted to the American Society of Bone and Mineral
Research for their 25th Annual Meeting - September 19-23, 2003 in Minneapolis,
Minnesota.
Saltzstein D., Cantewell A., Sieber P., Ross, J, Silvay-Mandeau O., Gallo J.
Prophylactic tamoxifen significantly reduces the incidence of bicalutamide-induced gynecomastia and breast pain. Submitted to SIU Congress for the September 12-
18, 2002 Meeting in Stockholm, Sweden.
Sieber P., Keiller D., Kahnoski R., Garcia-Vargas J., Gallo, J., McFadden, S. Bone
mineral density is maintained during bicalutamide (Casodex) treatment.
Accepted at ASCO May 18-21, 2002 Meeting in Orlando, Florida.
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Gallo, J. Exact tests for testing the effects in an unbalanced mixed model.
Journees Modeles Mixtes et Biometrie. Mixed Models in Biometry Conference –
Paris, France. January 24-25, 2002.
Posters
Porta C., Gish R., Patt Y., Suplick G., Gallo J. Demographics from the
ETHECC (Evaluation of THYMITAQ [nolatrexed] in the Hepatocellular Carcinoma [HCC] trial population. World Congress Gastrointestinal Cancer Conference. Barcelona, Spain. June15-18 2005
Porta C., Gish R., Patt Y., Suplick G., Gallo J. Improved safety profile of
nolatrexed dihydrochloride (THYMITAQ ) in the Phase III Hepatocellular
Carcinoma (HCC) trial when compared to the safety of the Phase II program.
World Congress Gastrointestinal Cancer Conference. Barcelona, Spain. June15-18
2005
Patt Y., Gish R., Garcia-Vargas J., Suplick G., Gallo J. Demographics from the
ETHECC© trial: A randomized comparison between THYMITAQ® and
Doxorubicin for the treatment of unresectable hepatocellular carcinoma (HCC) in terms of survival. International Society of Gastrointestinal Oncology (ISGIO)
Gastrointestinal Oncology Conference – July 2004.
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