Non-iLab, JHU SKCCC Core Facilities

Overview of JHU SKCCC, Non-iLab Cores

This is a listing of SKCCC Cores which have not yet implemented iLab. As these cores implement the iLab management program they will move from this listing to the cores active in iLabs.

The core service listing includes contact information for each core. Click on the core website to access the core.

Leadership

To update or edit information please contact Jeff Smith

Contacts

Name	Role	Phone	Email	Location
Erika Weaver			eweave10@jhmi.edu

JHU SKCCC, Non-iLab Cores' Service Listing

Name	Description	Price
SKCCC Oncology Tissue Services	Tissue Microarray Construction - Contact Helen Fedor 410 614-1660 Immunostaining/FISH Slide Scanning - Contact Kristen Lecksell 410 502-7452 Histology Services - Contact Bonnie Gambichler 410 502-3358 Website: http://tmalab.jhmi.edu	Inquire
SKCCC Bioinformatics Consultation	This Core is not active in iLab. To access this core please click here: SKCCC Bioinformatics Shared Resource (BISR) The SKCCC Bioinformatics Shared Resource (BISR) provides comprehensive consultation and expertise regarding data acquisition, statistical quality control, data mining/visualization, and development of innovative, customized bioinformatics methodologies The BISR provides high-quality expertise in the areas of computational molecular biology, bioinformatics, and computing-intensive statistical genetics. The resource comprises faculty and support staff able to support data acquisition (including study design, feasibility of objectives, availability of public-access genomic information, data storage, and data annotation), statistical quality control (including artifact detection, preprocessing, and normalization of data from genomic technologies), data analysis (including visualization, modeling, inference and interpretation), and development of innovative customized bioinformatics tools, and education. Contact Information: Director: Leslie Cope, Ph.D., Director Manager: Alisa Moore Phone: 410-955-4884	Inquire
SKCCC Biostatistics Shared Resources (BiostaSR)	This core is not active in iLab. To access this core please click here: SKCCC Biostatistics Shared Resources (BiostaSR) The goal of the Biostatistics Shared Resource (BiostatSR) is to ensure that study designs, data monitoring, and analyses use state-of-the-art methods. BiostatSR provides consultation and expertise regarding study design (including validity of the overall design, feasibility of meeting objectives, sample size and projection of study duration), recommendations for and development of key infrastructure (data management and computer systems support), data analysis, preparation of reports and assistance with manuscript writing, and development of new biostatistical methods if required by the project. Location 550 Building 11th Floor Members Gary L. Rosner, Sc.D., Director Peng Huang, Ph. D. Biostatistician Chenguang Wang, Ph.D., Biostatistician Hao Wang, Ph.D., Biostatistician Marianna Zahurak, M.S., Principal Biostatistician Zhe Zhang, M.S., Senior Biostatistician Amanda Blackford, Sc.M., Biostatistician Hua-Ling Tsai, Sc.M., Biostatistician Services Biostatistical services for design and analysis are available to all clinical and laboratory investigators in the Cancer Center. Specifically, faculty and staff in the Shared Resource consult and provide expertise in the following areas: Study design, ensuring feasibility and appropriateness with respect to stated study objectives. Input is provided during the conceptualization and/or design stages of the study. Protocol writing, ensuring that there are clear and consistent definitions in the protocol of study objectives, eligibility criteria, statistical plans, primary analysis endpoint, evaluation criteria (such as toxicity and response definitions), and guidelines for removal of patients from study. New study design, developing novel study designs when necessary to achieve specific objectives. Protocol Review and Monitoring, through membership in the Protocol Review and Monitoring Committee and the Safety Monitoring Committee. BiostatSR members evaluate and, when appropriate, provide constructive criticism to all clinical research studies. Guidance and participation in interim study monitoring, implementing plans for interim monitoring and analyses of study data and reporting progress in the Protocol Status Report. BiostatSR members often contribute to decisions regarding the conduct of studies, either as a formal member of a Monitoring Committee or on an informal ad hocbasis. Data analysis, designing, performing, authoring, and presenting statistical analyses. Quality control, establishing and conducting quality control and study monitoring procedures. Manuscript preparation, co-authoring articles and abstracts based on study results. Grant preparation, providing advice and support to SKCCC investigators preparing grant applications. Education, teaching clinical research methods to oncology fellows. Biostatistical research, carrying out relevant methodologic research in support of clinical trials, preclinical studies, and basic science experiments within SKCCC. Contact Gary L. Rosner, Sc.D., Resource Director Alisa Moore, Resource Contact 410-955-4884	Inquire
SKCCC Cell Processing & Gene Therapy (CPGT)	This core is not active in iLab. To access this core click here: cGMP Facility for Manufacturing Vacines for Clinical Trials The SKCCC Cell Processing and Gene Therapy Core (CPGT) manufactures clinical grade biotherapeutic material for Phase I/II clinical gene therapy trials. The CPGT is composed of three components: a 400 square foot Process Optimization Lab (POL), a 400 square foot Materials Management/QC laboratory, and an 1800 square foot cGMP facility comprised of 4 manufacturing suites, a general processing area, storage, gown in and gown out areas. The POL is shared by the Cellular Therapy Core (CTC); all labs operate under shared management and oversight. This facility supports the entire Johns Hopkins community in the translation of research concepts to human somatic cell and gene therapy clinical trials The services of the Core are to: Produce expanded cell-therapy and gene-therapy based biotherapeutic products for Phase I and II clinical studies employing current Good Manufacturing Practices (cGMP) as required by federal regulations, Manufacture novel biological oncolytic agents and clinical grade biotherapeutic reagents that require cGMP, as mandated by the FDA, Serve as a regulatory resource to the JHUSOM in the preparation of cell and gene-therapy based INDs, and Provide quality oversight, education and initiation of Good Laboratory Practices (GLP) in SKCCC cores and laboratories. Contact: Medical Director: Ivan Borrello, M.D. Resource Director: Victor Lemas, Ph.D. Phone: 410-614-5411	Inquire
SKCCC Cell Therapy Laboratory	This core is not active in iLabs. To access this core please click here: Description The SKCCC Cell Therapy Laboratory is a clinical laboratory located in the Weinberg Cancer Center. The restricted-access laboratory manufactures cell therapy products regulated under the FDA’s Good Tissue Practice regulations as well as products manufactured for Phase I/II clinical trials prepared under FDA Investigation New Drug regulations. Location Weinberg 2450 Members Ivan Borrello, M.D., Medical Director Vic Lemas, Ph.D., Facility Director Janice Davis-Sproul, MAS, Facility Manager Services This Core services include technology transfer from the research laboratory to the clinical setting, scale up and validation studies. The staff within this laboratory has extensive experience in all aspects of cellular therapy including cGMP Phase I/II manufacturing for autologous products, cGTP manufacturing of blood and bone marrow for transplantation, stem cell biology expertise, immunotherapy expertise and clinical experience in transplantation and cellular therapies. There is extensive QA/QC and regulatory experience for the development of products and compliance with FDA regulations. Staff in this core also provide assistance in the preparation of regulatory documents including IND applications. Contact Ivan Borrello, M.D., Medical Director Vic Lemas, Ph.D., Facility Director Janice Davis-Sproul, MAS, Facility Manager Telephone number 410-955-2354	Inquire
SKCCC Research Pharmacy	This core is not active in iLab. To access this core please click here: The Research Pharmacy assists clinical research efforts in the SKCCC through a variety of integrated services. The investigational drug pharmacist works with the research team in study design, blinding methods, randomization, drug and placebo formulation, cost analysis, and inventory management. Pharmacists participate in protocol review and assist investigators in protocol development prior to submission to the SKCCC CRC (PRMS). The pharmacy monitors all investigational trials involving drug therapy. This monitoring involves protocol review, medication preparation, drug accountability, staff/patient education and quality assurance. Pharmacists, are part of a patient care team and help the investigators by ensuring each patient's drug therapy is in compliance with the written investigational protocol. Additionally pharmacists assure that patients are not started on investigational drug therapy until patient consent has been obtained. The pharmacy monitors patient eligibility, checks dose escalation criteria for all studies, reviews or prepares standardized order forms for new studies, reviews or prepares investigational drug data sheets, reviews or prepares patient education materials and monitors patient compliance of oral investigational agents. The pharmacy participates in audits conducted by the study sponsors and the Food and Drug Administration. The pharmacy works closely with the quality assurance and performance improvement groups of the Center and JHH Pharmacy to improve policies and operations regarding chemotherapy safety and regulatory compliance. The Research Pharmacy has spent significant time in the development and implementation of process to assure an efficient process for the development of medication order sets for both CPOE and paper orders. The process was developed with input from the JHH Pharmacy Informatics team, the oncology pharmacy Clinical Specialist group, and designated members of the CRO. This process has been in place for about 18 months, and has required both close evaluation and modification since implementation. Additionally, these pharmacists work with the research team in developing and reviewing all order sets for patients receiving therapy on a clinical trial. The Research Pharmacy provides both informal and formal education for all pharmacy personnel that provide pharmaceutical care for individuals on clinical trials at the SKCCC. The Research Pharmacy staff has worked with the JHH Oncology Pharmacy team to determine educational needs regarding clinical trials, investigational drug services and oncology drug development. Educations strategies have included development of a staff newsletter to provide written information regarding new clinical trials or changes in processes for the Research Pharmacy. Education is presented to the staff as a collaborated effort with the Research Pharmacy staff and the JHH Oncology Pharmacy staff. These efforts have initially focused on pharmacist members of the team, but is currently expanding to the technical staff. Contact: Phone: 410-955-8138 Email: oncpharmacy@jhmi.edu	Inquire

Search available services: View: by category alphabetically

Name	Description	Price
▼ ► SKCCC Bioinformatics Shared Resource (BISR) (1)
SKCCC Bioinformatics Consultation	This Core is not active in iLab. To access this core please click here: SKCCC Bioinformatics Shared Resource (BISR) The SKCCC Bioinformatics Shared Resource (BISR) provides comprehensive consultation and expertise regarding data acquisition, statistical quality control, data mining/visualization, and development of innovative, customized bioinformatics methodologies The BISR provides high-quality expertise in the areas of computational molecular biology, bioinformatics, and computing-intensive statistical genetics. The resource comprises faculty and support staff able to support data acquisition (including study design, feasibility of objectives, availability of public-access genomic information, data storage, and data annotation), statistical quality control (including artifact detection, preprocessing, and normalization of data from genomic technologies), data analysis (including visualization, modeling, inference and interpretation), and development of innovative customized bioinformatics tools, and education. Contact Information: Director: Leslie Cope, Ph.D., Director Manager: Alisa Moore Phone: 410-955-4884	Inquire
▼ ► SKCCC Biostatistics Shared Resources (BiostaSR) (1)
Name	Description	Price
SKCCC Biostatistics Shared Resources (BiostaSR)	This core is not active in iLab. To access this core please click here: SKCCC Biostatistics Shared Resources (BiostaSR) The goal of the Biostatistics Shared Resource (BiostatSR) is to ensure that study designs, data monitoring, and analyses use state-of-the-art methods. BiostatSR provides consultation and expertise regarding study design (including validity of the overall design, feasibility of meeting objectives, sample size and projection of study duration), recommendations for and development of key infrastructure (data management and computer systems support), data analysis, preparation of reports and assistance with manuscript writing, and development of new biostatistical methods if required by the project. Location 550 Building 11th Floor Members Gary L. Rosner, Sc.D., Director Peng Huang, Ph. D. Biostatistician Chenguang Wang, Ph.D., Biostatistician Hao Wang, Ph.D., Biostatistician Marianna Zahurak, M.S., Principal Biostatistician Zhe Zhang, M.S., Senior Biostatistician Amanda Blackford, Sc.M., Biostatistician Hua-Ling Tsai, Sc.M., Biostatistician Services Biostatistical services for design and analysis are available to all clinical and laboratory investigators in the Cancer Center. Specifically, faculty and staff in the Shared Resource consult and provide expertise in the following areas: Study design, ensuring feasibility and appropriateness with respect to stated study objectives. Input is provided during the conceptualization and/or design stages of the study. Protocol writing, ensuring that there are clear and consistent definitions in the protocol of study objectives, eligibility criteria, statistical plans, primary analysis endpoint, evaluation criteria (such as toxicity and response definitions), and guidelines for removal of patients from study. New study design, developing novel study designs when necessary to achieve specific objectives. Protocol Review and Monitoring, through membership in the Protocol Review and Monitoring Committee and the Safety Monitoring Committee. BiostatSR members evaluate and, when appropriate, provide constructive criticism to all clinical research studies. Guidance and participation in interim study monitoring, implementing plans for interim monitoring and analyses of study data and reporting progress in the Protocol Status Report. BiostatSR members often contribute to decisions regarding the conduct of studies, either as a formal member of a Monitoring Committee or on an informal ad hocbasis. Data analysis, designing, performing, authoring, and presenting statistical analyses. Quality control, establishing and conducting quality control and study monitoring procedures. Manuscript preparation, co-authoring articles and abstracts based on study results. Grant preparation, providing advice and support to SKCCC investigators preparing grant applications. Education, teaching clinical research methods to oncology fellows. Biostatistical research, carrying out relevant methodologic research in support of clinical trials, preclinical studies, and basic science experiments within SKCCC. Contact Gary L. Rosner, Sc.D., Resource Director Alisa Moore, Resource Contact 410-955-4884	Inquire
▼ ► SKCCC Cell Processing & Gene Therapy (CPGT) (1)
Name	Description	Price
SKCCC Cell Processing & Gene Therapy (CPGT)	This core is not active in iLab. To access this core click here: cGMP Facility for Manufacturing Vacines for Clinical Trials The SKCCC Cell Processing and Gene Therapy Core (CPGT) manufactures clinical grade biotherapeutic material for Phase I/II clinical gene therapy trials. The CPGT is composed of three components: a 400 square foot Process Optimization Lab (POL), a 400 square foot Materials Management/QC laboratory, and an 1800 square foot cGMP facility comprised of 4 manufacturing suites, a general processing area, storage, gown in and gown out areas. The POL is shared by the Cellular Therapy Core (CTC); all labs operate under shared management and oversight. This facility supports the entire Johns Hopkins community in the translation of research concepts to human somatic cell and gene therapy clinical trials The services of the Core are to: Produce expanded cell-therapy and gene-therapy based biotherapeutic products for Phase I and II clinical studies employing current Good Manufacturing Practices (cGMP) as required by federal regulations, Manufacture novel biological oncolytic agents and clinical grade biotherapeutic reagents that require cGMP, as mandated by the FDA, Serve as a regulatory resource to the JHUSOM in the preparation of cell and gene-therapy based INDs, and Provide quality oversight, education and initiation of Good Laboratory Practices (GLP) in SKCCC cores and laboratories. Contact: Medical Director: Ivan Borrello, M.D. Resource Director: Victor Lemas, Ph.D. Phone: 410-614-5411	Inquire
▼ ► SKCCC Cell Therapy Laboratory (1)
Name	Description	Price
SKCCC Cell Therapy Laboratory	This core is not active in iLabs. To access this core please click here: Description The SKCCC Cell Therapy Laboratory is a clinical laboratory located in the Weinberg Cancer Center. The restricted-access laboratory manufactures cell therapy products regulated under the FDA’s Good Tissue Practice regulations as well as products manufactured for Phase I/II clinical trials prepared under FDA Investigation New Drug regulations. Location Weinberg 2450 Members Ivan Borrello, M.D., Medical Director Vic Lemas, Ph.D., Facility Director Janice Davis-Sproul, MAS, Facility Manager Services This Core services include technology transfer from the research laboratory to the clinical setting, scale up and validation studies. The staff within this laboratory has extensive experience in all aspects of cellular therapy including cGMP Phase I/II manufacturing for autologous products, cGTP manufacturing of blood and bone marrow for transplantation, stem cell biology expertise, immunotherapy expertise and clinical experience in transplantation and cellular therapies. There is extensive QA/QC and regulatory experience for the development of products and compliance with FDA regulations. Staff in this core also provide assistance in the preparation of regulatory documents including IND applications. Contact Ivan Borrello, M.D., Medical Director Vic Lemas, Ph.D., Facility Director Janice Davis-Sproul, MAS, Facility Manager Telephone number 410-955-2354	Inquire
▼ ► SKCCC Research Pharmacy (1)
Name	Description	Price
SKCCC Research Pharmacy	This core is not active in iLab. To access this core please click here: The Research Pharmacy assists clinical research efforts in the SKCCC through a variety of integrated services. The investigational drug pharmacist works with the research team in study design, blinding methods, randomization, drug and placebo formulation, cost analysis, and inventory management. Pharmacists participate in protocol review and assist investigators in protocol development prior to submission to the SKCCC CRC (PRMS). The pharmacy monitors all investigational trials involving drug therapy. This monitoring involves protocol review, medication preparation, drug accountability, staff/patient education and quality assurance. Pharmacists, are part of a patient care team and help the investigators by ensuring each patient's drug therapy is in compliance with the written investigational protocol. Additionally pharmacists assure that patients are not started on investigational drug therapy until patient consent has been obtained. The pharmacy monitors patient eligibility, checks dose escalation criteria for all studies, reviews or prepares standardized order forms for new studies, reviews or prepares investigational drug data sheets, reviews or prepares patient education materials and monitors patient compliance of oral investigational agents. The pharmacy participates in audits conducted by the study sponsors and the Food and Drug Administration. The pharmacy works closely with the quality assurance and performance improvement groups of the Center and JHH Pharmacy to improve policies and operations regarding chemotherapy safety and regulatory compliance. The Research Pharmacy has spent significant time in the development and implementation of process to assure an efficient process for the development of medication order sets for both CPOE and paper orders. The process was developed with input from the JHH Pharmacy Informatics team, the oncology pharmacy Clinical Specialist group, and designated members of the CRO. This process has been in place for about 18 months, and has required both close evaluation and modification since implementation. Additionally, these pharmacists work with the research team in developing and reviewing all order sets for patients receiving therapy on a clinical trial. The Research Pharmacy provides both informal and formal education for all pharmacy personnel that provide pharmaceutical care for individuals on clinical trials at the SKCCC. The Research Pharmacy staff has worked with the JHH Oncology Pharmacy team to determine educational needs regarding clinical trials, investigational drug services and oncology drug development. Educations strategies have included development of a staff newsletter to provide written information regarding new clinical trials or changes in processes for the Research Pharmacy. Education is presented to the staff as a collaborated effort with the Research Pharmacy staff and the JHH Oncology Pharmacy staff. These efforts have initially focused on pharmacist members of the team, but is currently expanding to the technical staff. Contact: Phone: 410-955-8138 Email: oncpharmacy@jhmi.edu	Inquire
▼ ► unclassified (1)
Name	Description	Price
SKCCC Oncology Tissue Services	Tissue Microarray Construction - Contact Helen Fedor 410 614-1660 Immunostaining/FISH Slide Scanning - Contact Kristen Lecksell 410 502-7452 Histology Services - Contact Bonnie Gambichler 410 502-3358 Website: http://tmalab.jhmi.edu	Inquire