Tag Archive: Biologics

Lab Resources


The ICTR laboratories provide coordinated help across several related programs, all focused on the foundational components required to effectively translate new drugs, biologics, vaccines, devices, biomarkers and diagnostics into clinical trials and eventually clinical practice. Biologics Translational Program This lab offers: Biologic product development and testing Consultative support for biologic development Preclinical testing to clinical production for early phase clinical testing Good Manufacturing Practices (GMP) facility and expertise to produce and maintain (stability testing Cell lines Gene vectors Antibodies Peptides Contact: Vic Lemas, PhD Lab Leader 410-614-5411 | mvlemas@jhmi.edu Ruth Karron, MD Lab Leader 410-614-0319 | rkarron1@jhmi.edu Submit a Connection […]

Investigational Drug and Biologics Research


To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. FDA Formal Meeting Requests FDA Formal Meeting Request Guidance and Template FDA Formal Meeting Request Blank Template IND Exemption Request IND Exemption Request Guidance IND Application IND Application Guidance and Template for Drug Products IND Application Blank Template for Drug Products IND Application Guidance Template for Biologic (Somatic Cell Therapy) Products IND Application Blank Template for Biologic (Somatic Cell Therapy) Products Letters of Authorization/Right of Reference for INDs Letter of Authorization Guidance and Template for Drug Master Files Letter of Authorization Guidance and Template for Investigational […]

Drug and Device Resources


The information resources compiled at the various links below are available for use by all investigators and project teams at no cost. Through these documents, the Research Navigators can provide answers to general regulatory questions as well as access to a list of Frequently Asked Questions, templates, and other guidance documents. The list of informational resources will continue to grow as the DDRS develops. **EFFECTIVE IMMEDIATELY** CBER’S new mailing address: U.S. Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue W071, G112 Silver Spring, MD 20993-0002 Please disregard any other address for […]

Drug and Device Resource Service (DDRS)


The Drug and Device Resource Service (DDRS) provides Johns Hopkins University investigators and project teams access to resources needed to help manage the development and use of investigational drugs and devices in research. The DDRS is comprised of an investigational drug, biologics, and device information repository (Resources). DDRS Consultation Service This service includes a complimentary eight-hour consultation for those seeking a higher level of assistance with managing the regulatory requirements of their research projects. For assistance, please submit an ICTR Connection Request . Read more. Drug and Device Resources The information resources compiled at the various links below are available […]