Tag Archive: Biologics

Introduction to Drug Discovery Research


This course deals with various aspects of the drug discovery process including target identification, medicinal chemistry, in vitro and in vivo drug screening methods, pharmacokinetics, drug safety, and intellectual property management. While the main focus of the course is centered on small molecule-based drugs, one lecture covers the principles of biologics-based drugs given the increasing interests in this area. The last two lectures are devoted to case studies in which discovery of particular drugs will be discussed in detail to provide further insights into the process of drug discovery research. Each lecture is given by an expert on that respective subject with many years of drug … Continue reading

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   Click here to submit an ICTR Connection Request

Investigational Drug and Biologics Research


To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. Guidance and Templates 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 … Continue reading

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 … Continue reading

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) with a Project-Specific Consultation Service available for those who seek a higher level of assistance with management of the regulatory requirements of their research projects. *Please read the disclaimer. For assistance, please submit an ICTR Connection Request . To learn more about the consultation service and available resources, click the links below.