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| 12370 | 2019 Industry-Provided Assets | table td{padding:5px;} Assets in this table are alphabetized by mechanism of action. These compounds and biologics have undergone significant preclinical and safety testing in humans. 2019 Table of Assets Code Number & Link to More Information Mechanism of Action Original Development Indication(s) Route of Administration Formulation Available (CNS Penetrant+) AZD1656 (PDF - 114KB) Glucokinase (GK) activator Type 2 Diabetes Oral (No/Low CNS) AZD2014 (PDF - 93KB) Vistuserib Dual mTORC1 and mTORC2 inhibitor Oncology Oral (No/Low CNS) AZD5213 (PDF - 114KB) Histamine receptor 3 (H3) antagonist (inverse agonist) Neuro Oral (CNS) AZD5904 (PDF - 112KB) Myeloperoxidase (MPO) inhibitor Multiple sclerosis (MS), and Chronic obstructive pulmonary disease (COPD) Oral (No/Low CNS) RDEA119 Refametinib (PDF - 73KB) MEK1/2 inhibitor Oncology Oral (Low CNS) ZD4054 (PDF - 78KB) zibotentan Endothelin type A (ETA) antagonist Oncology Oral (Low CNS) PF-04995274 (PDF - 138KB) 5-Hydroxytryptamine 4 receptor (5-HT4) partial agonist Gastroesophageal reflux disease Alzheimer's disease Oral (Yes) CE-224535 (PDF - 203KB) Purinergic receptor 2 antagonist Rheumatoid arthritis Osteoarthritis Oral JNJ-18038683 (PDF - 67KB) 5-Hydroxytryptamine 7 receptor (5-HT7) antagonist Major depressive disorder Oral (Yes) JNJ-39269646 (PDF - 34KB) Fast dissociating D2/D3/5-HT6 antagonist Schizophrenia Bipolar depression Oral (Yes) | 2019 Industry-Provided Assets | 2019 Industry-Provided Assets | ||||||
| 12214 | RDCRN Program FOA Frequently Asked Questions | The FAQs below address RFA-TR-18-020: Rare Diseases Clinical Research Consortia(link is external) for the RDCRN and RFA-18-021: Data Management and Coordinating Center(link is external) for the RDCRN. RFA-TR-18-020: Rare Diseases Clinical Research Consortia (RDCRC) What is the purpose of this Funding Opportunity Announcement? This is a reissue of RFA-TR-13-002. What are the major changes? What qualifies as a rare disease for the RDCRN? How many rare diseases must be represented in the application? It is the intent of the NIH to not support individual RDCRCs for more than 15 years (three awards) after awards are made under this FOA. As such, may a grantee who has been funded for three awards still apply? Duration of funding will be determined by the “grant number." What is the grant number? What is “clinical trial readiness”? What is a clinical trial liaison? Is there additional space allotted for the progress report for renewals, or does the progress report need to be included within the overall page limitation of the application? Do applicants need to include letters of support for each section, or is one broad letter that covers all sections acceptable? Is the Career Enhancement Program just for pre-docs? Does “pre-doc” include either M.D.s or Ph.D.s? The RFA states no more than $1 million in direct costs/year (see below). Does that mean that Consortium Indirect Costs do NOT count towards the $1 million per year? What can be included in the Appendix? Is it true that the RDCRN Data Management and Coordinating Center (DMCC) will no longer convene the Data and Safety Monitoring Board (DSMB)? For the multi-center consortia, is it best to identify the specific sites and individuals in the overall portion? Should individuals in multi-center consortia be listed as co-PIs? Can individuals at multi-center consortia be at institutions outside the U.S? Is the Career Enhancement component intended to focus on rare diseases in general or should it focus on the specific rare diseases of the consortium? Is there any extra space allocated for Progress Reports? If a project currently uses a central IRB, can it continue using that same IRB or does it have to use SmartIRB? For the longitudinal study, will all the data be housed within the DMCC and is there a budget consideration that will need to be put into that project? Regarding the provided cloud services, will the data ingress/egress, storage, IO, processing, etc. be paid by NCATS? Can individual clinical research projects fall under or be funded by different institutes (e.g., cognitive endpoint relevant to NIMH or NINDS and tumor predisposition related to NCI)? Do sub-award/consortium Facilities and Administrative (F&A) costs count towards the directs costs? Large phase 3 trials are not allowed, but is a proof of concept trial that involves two – three centers allowed? For the Career Enhancement Core, it is necessary to support predoctoral, postdoctoral and clinical fellows? What about junior faculty? As the DMCC will no longer provide audits, what are the requirements for site audits and is it expected the U54 budget will include payment for the audits? NEW (August 2018): What happens if an applicant tries to submit a component that is not listed in the FOA (e.g., Statistics Core)? RFA-18-021: Data Management and Coordinating Center (DMCC) What is the purpose of this Funding Opportunity Announcement? This is a reissue of RFA-TR-13-003. What are the major changes? Is the abstract Specific Aims page included in the capped number of pages in the research section, or is that page additional? Will the External Advisory Committee be convened (and budgeted for) by the RDCRN? Will the External Scientific Panel be convened by NCATS? Should we include compensation for the ESP members in our RDCRC budget? Is it true that the RDCRN Data Management and Coordinating Center (DMCC) will no longer convene the Data and Safety Monitoring Board (DSMB)? For the longitudinal study, will all the data be housed within the DMCC and is there a budget consideration that will need to be put into that project? Regarding the provided cloud services, will the data ingress/egress, storage, IO, processing, etc. be paid by NCATS? Do sub-award/consortium Facilities and Administrative (F&A) costs count towards the directs costs? As the DMCC will no longer provide audits, what are the requirements for site audits and is it expected the U54 budget will include payment for the audits? NEW (August 2018): What happens if an applicant tries to submit a component that is not listed in the FOA (e.g., Statistics Core)? RFA-TR-18-020: Rare Diseases Clinical Research Consortia (RDCRC) What is the purpose of this Funding Opportunity Announcement? The primary purpose of the RDCRCs is to advance the diagnosis, management and treatment of rare diseases with a focus on clinical trial readiness. This is a reissue of RFA-TR-13-002. What are the major changes? There is an increased focus on clinical research (no animal models are allowed) and clinical trial readiness. There is an increased focus on incorporation of input from patients and stakeholders. Multiple-Program Directors/Principal Investigators are allowed. Applications must include a minimum of two, and a maximum of five Clinical Research Projects. What qualifies as a rare disease for the RDCRN? Each RDCRC application must indicate at least three different rare diseases. For the purpose of this program, a rare disease may include: Disorders – abnormal physical or mental conditions or ailments. Syndromes – group of symptoms that occur together, or a condition characterized by a set of associated symptoms. Diseases – a disorder of structure or function that affects a specific location and is not simply a result of physical injury. Manifestations – symptom or sign of an ailment. Conditions – a particular state of being that limits/restricts something else. A rare disease is a condition affecting fewer than 200,000 individuals in the United States. How many rare diseases must be represented in the application? At least three different rare diseases must be included in the application. It is the intent of the NIH to not support individual RDCRCs for more than 15 years (three awards) after awards are made under this FOA. As such, may a grantee who has been funded for three awards still apply? Yes. All applicants are eligible to apply to this FOA and to be considered for funding. At the end of the funding cycle of awards made under this FOA, applicants with three or more consecutive award segments (which likely equates to 15 or more years of funding) will not be eligible to apply or receive further support under this FOA. Duration of funding will be determined by the “grant number." What is the grant number? The grant number is the number that is assigned to a grant upon initial submission of the application. The serial number (underlined as follows) of the grant does not change through the life of the grant - 5 U54 TR 123456 - 15. The support years (underlined as follows) do change 5 U54 TR 123456 15. This number indicates the grant is in its fifteenth year of support. Please reference the following URL for tips on how to decipher NIH grant numbers: https://era.nih.gov/sites/default/files/Deciphering_NIH_Application.pdf(link is external). What is “clinical trial readiness"? Different groups may be at differing levels of scientific maturity within their research programs; therefore, different studies may be needed to move closer to be ready to conduct clinical trials in the near or distant future. For the purposes of this Request for Applications (RFA), clinical trial readiness includes studies that validate clinical research tools that can include biomarkers or clinical outcome assessment measures that are fit-for-purpose within a defined context of use relevant to the clinical trials. Clinical trial readiness studies also may propose to expand the knowledge of disease natural history necessary for clinical trial design and can include characteristics for stratification or determining inclusion and exclusion criteria; the stage of disease progression that may be responsive to treatment; and data needed for determining sample size through power calculations. What is a clinical trial liaison? The Administrative Core will have a Clinical Team Liaison. This individual will be a trained clinical investigator who will ensure a mutually supportive interaction between the scientists (who are often located at different sites) conducting clinical research. Is there additional space allotted for the progress report for renewals, or does the progress report need to be included within the overall page limitation of the application? Per Page M-95 of the Multi-Project Instructions for NIH and Other PHS Agencies - Forms Version E Series, The Progress Report falls within the Research Strategy and is therefore included in the page limits for the Research Strategy. Do not include a list of publications, patents or other printed materials in the Progress Report. That information will be included in the “Progress Report Publication List” attachment. Please refer to the Multi-Project Instructions(link is external) for more information. Do applicants need to include letters of support for each section, or is one broad letter that covers all sections acceptable? The Multi-Project (M) Instructions in the SF424 (R&R) Application Guide provide important information regarding the content of the letters. The letter should clearly state what is being provided. Please follow the instructions in the FOA regarding placement of the letters. Note that reviewers are assigned to individual components. Reviewers will be instructed to check the overall section for any letters “missing” from that component. https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-18-020.html(link is external) (Overall) Letters of Support: Applicants must provide letters from the appropriate high-ranking institutional official(s) from the lead institution and partnering institutions that…. (Administrative Core) Letters of Support: Only letters of support specific to the Administrative Core should be attached to this section. (Clinical Research Project) Letters of Support: Only letters of support specific to each Clinical Research Project should be attached to this section. Provide letters of collaboration from individuals who will contribute in a substantive, meaningful way to the scientific development or execution of the clinical research project, whether or not salaries are requested. (Pilot/Feasibility Core) Letters of Support: Only letters of support specific to the Pilot/Feasibility Core should be attached to this section. Letters from high-level institution official(s) (e.g., Dean of the School of Medicine, President, and Vice President for Research) should state the institutional support. There is no cost sharing requirement under this FOA. Indication of institutional commitment to the success of the program will be considered positively in the programmatic evaluation of applications. Examples for such support may include ensuring adequate access to facilities. (Career Enhancement Core) Letters of Support: Only letters of support specific to the Career Enhancement Core should be attached to this section. Letters from high-level institution official(s) (e.g., Dean of the School of Medicine, President, and Vice President for Research) should state the institutional support. There is no cost sharing requirement under this FOA. Indication of institutional commitment to the success of the program will be considered positively in the programmatic evaluation of applications. Examples for such support may include ensuring adequate access to facilities. Is the Career Enhancement Program just for pre-docs? Per the FOA, each Rare Diseases Clinical Research Consortia (RDCRC) should provide a Career Enhancement Program to provide support for career enhancement-related expenses for predoctoral, postdoctoral and/or clinical fellow as well as support for activities that enhance the institution's environment for the education of students/post-docs and early-stage investigators in rare diseases research. Does “pre-doc” include either M.D.s or Ph.D.s? Both M.D.s and Ph.D.s may be included. The RFA states no more than $1 million in direct costs/year (see below). Does that mean that Consortium Indirect Costs do NOT count towards the $1 million per year? Correct. Consortium indirect costs do not count towards the direct costs limitation. The National Institutes of Health (NIH) have a long-standing policy to exclude consortium Facilities and Administrative (F&A) costs when determining whether an application falls within specified direct cost limits (see NOT-OD-05-004(link is external)). What can be included in the Appendix? Per FOA RFA-TR-18-021(link is external) & RFA-TR-18-020(link is external): Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-126.html(link is external) Beginning with applications submitted to the NIH, the Agency for Healthcare Research and Quality, or the National Institute for Occupational Safety and Health for due dates on or after January 25, 2018, unless specified otherwise in the FOA, the only allowable Appendix materials are: Blank data collection forms, blank survey forms and blank questionnaire forms -- or screenshots thereof. Simple lists of interview questions. For clarification, these blank forms and lists are not and do not include items such as: data, data compilations, lists of variables or acronyms, data analyses, publications, manuals, instructions, descriptions or drawings/figures/diagrams of data collection methods or machines/devices. Blank informed consent/assent forms Other items only if they are specified in the FOA as allowable Appendix materials Some FOAs further restrict allowable appendix materials and/or may specify that some materials listed above must be provided in another part of the application. Applications submitted to those FOAs must follow instructions in the FOA and must not put those items in the Appendix. No other items are allowed in the Appendix. Simply relocating disallowed materials to other parts of the application will result in a noncompliant application unless they are items specified in the FOA as optional or required for those other sections of the application. Consequence for Submitting Disallowed Materials: Applications submitted for due dates on or after January 25, 2018, will be withdrawn as noncompliant if they are submitted with Appendix materials that are not specified in this Notice (NOT-OD-18-126(link is external)) or specified in the individual FOA as allowed or required. Is it true that the RDCRN Data Management and Coordinating Center (DMCC) will no longer convene the Data and Safety Monitoring Board (DSMB)? Per both FOAs, if DSMB services are required, they may be requested from the DMCC -- but only if no alternate source exists -- for RDCRC clinical trials or pilot studies that meet program requirements. To be eligible for the DMCC services, clinical trials or pilot studies must be of greater than minimal risk. The RDCRN will only provide DSMB services in the following circumstances. If DSMB services are required, they may be requested from the DMCC only if no alternate source exists. To be eligible for the DMCC services, clinical trials or pilot studies must be of greater than minimal risk and include one or more of the following: Protocol designs that allow for modifications to the trial or statistical procedures of the trial after its initiation, such as an adaptive design; Plan to evaluate novel technology or an intervention for which prior data (e.g., preclinical toxicology or from a related compound) suggest the intervention under study has the potential to induce a potentially severe or unacceptable toxicity; Objective to provide definitive information about the effectiveness or safety of the intervention (e.g., a Phase 3 or efficacy trial, such as a trial intended to support product registration); Ethics-driven need to stop the study early if the primary question is addressed, for futility, or for other pre-specified reasons. For the multi-center consortia, is it best to identify the specific sites and individuals in the overall portion? List all performance sites and individuals that apply to the specific component of the application. Should individuals in multi-center consortia be listed as co-PIs? The term “co-PI” is inaccurate. There are multiple PIs and there are co-investigators. The roles and responsibilities of both are described below. The appropriate designation of a role is based on the responsibilities of the individual as they related to accomplishing the goals of the project. https://grants.nih.gov/grants/multi_pi/overview.htm(link is external) https://grants.nih.gov/grants/multi_pi/faq.htm#2954(link is external) The Program Director/Principal Investigator (PD/PI) is defined as the individual(s) judged by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. The applicant organization may designate multiple individuals as PD/PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the applicant organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program including the submission of all required reports. The presence of more than one identified PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI. The Co-Investigator (collaborator) may be employed by, or be affiliated with, the applicant/recipient organization or another organization participating in the project under a consortium agreement. A Co-Investigator typically devotes a specified percentage of time to the project and is considered senior/key personnel(link is external). The designation of a Co-Investigator, if applicable, does not affect the PD/PI's roles and responsibilities as specified in the NIH Grants Policy Statement(link is external), nor is it a role implying multiple PD/PI. Can individuals at multi-center consortia be at institutions outside the U.S? Foreign components, as defined in the NIH Grants Policy Statement(link is external), are allowed. Is the Career Enhancement component intended to focus on rare diseases in general or should it focus on the specific rare diseases of the consortium? This is up to the discretion of the investigator. Is there any extra space allocated for Progress Reports? The progress report falls within the Research strategy and is therefore included in the page limits of the Research Strategy. However, A “Progress Report Publication List” attachment is required for renewal applications. If a project currently uses a central IRB, can it continue using that same IRB or does it have to use SmartIRB? The investigators are strongly encouraged to use SmartIRB. For the longitudinal study, will all the data be housed within the DMCC and is there a budget consideration that will need to be put into that project? NCATS/RDCRN will only maintain and pay for Management and Governance of the IaaS and PaaS services Federated Access and Authorization Services Cloud Engineering and DevOps Support Domain Name Services Container Image Store Centralized Logging Services for production systems Centralized Monitoring Services for production systems Source Control Backups for all production systems and instances Regarding the provided cloud services, will the data ingress/egress, storage, IO, processing, etc. be paid by NCATS? Each individual center is responsible for the choice of the cloud provider along with all relevant charges for running the system on the cloud instance needs to be budgeted and provided in the application. Can individual clinical research projects fall under or be funded by different institutes (e.g., cognitive endpoint relevant to NIMH or NINDS and tumor predisposition related to NCI)? In the past multiple NIH institutes have funded single RDCRCs. Do sub-award/consortium Facilities and Administrative (F&A) costs count towards the directs costs? NIH policy provides for the exclusion of consortium/contractual F&A costs when determining if an applicant is in compliance with a direct cost limitation. However, the full cost of subaward/consortium in the Subawards/Consortium Costs field must be included (M.300 - R&R Budget Form, Section F. Other Direct Costs, Question 5). Large phase 3 trials are not allowed, but is a proof of concept trial that involves two – three centers allowed? Any interventional clinical trials proposed as part of a RDCRC must be Phase 1, or early stage proof-of-concept trials. Such clinical trials should be designed to provide specific data that will be necessary to design a subsequent definitive efficacy trial. The proposed clinical trial must address questions that, when answered, will optimize the design of a subsequent definitive clinical trial rather than simply address the clinical question with lower power. For the Career Enhancement Core, it is necessary to support predoctoral, postdoctoral and clinical fellows? What about junior faculty? Each RDCRC should provide a Career Enhancement Program to provide support for career enhancement-related expenses for predoctoral, postdoctoral and/or clinical fellow as well as support for activities that enhance the institution's environment for the education of students/post-docs and early-stage investigators in rare diseases research. As nationally recognized consortia in rare diseases research, the RDCRCs are expected to play a leadership role in the career enhancement of new researchers for the rare diseases field and contribute to the development of future research leaders. Each RDCRC should provide a Career Enhancement Program to provide support for career enhancement-related expenses for predoctoral, postdoctoral and/or clinical fellow as well as support for activities that enhance the institution's environment for the education of students/post-docs and early-stage investigators in rare diseases research. Leveraging existing career enhancement programs and exploring sponsorship opportunities are encouraged. This program may propose activities that enhance the career enhancement environment through specialized coursework, a seminar program, retreats for presentation of students/post-doc research, journal clubs or other activities that contribute to the preparation of junior investigators for careers in rare diseases research. Exposure to research at other RDCRCs is also encouraged through exchange programs, short-term career enhancement opportunities or visits to learn new research approaches. As the DMCC will no longer provide audits, what are the requirements for site audits and is it expected the U54 budget will include payment for the audits? The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm(link is external) and in the application instructions (SF424 (R&R) and PHS 398). What happens if an applicant tries to submit a component that is not listed in the FOA (e.g., Statistics Core)? It will not be accepted by the system. ASSIST will limit applications to the components listed in the FOA. Back to top RFA-18-021: Data Management and Coordinating Center (DMCC) What is the purpose of this Funding Opportunity Announcement? The primary purpose of the DMCC is threefold, with each function of equal importance. The DMCC: Provides clinical research and data management support to the individual RDCRCs. Coordinates activities across the RDCRN and helps establish an identity for the network as a rare diseases resource. Serves as a conduit of information related to the rare diseases research being conducted within the network to both the research community and the general public. This is a reissue of RFA-TR-13-003. What are the major changes? The activity code has been changed from a U01 (Research Project – Cooperative Agreements) to a U2C (Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements). There are now three primary areas of focus for the DMCC: Data Management: To support and enhance a collaborative informatics community for the RDCRN. Clinical Research: To serve as a Network resource, providing expertise and consulting to the RDCRCs in areas including, but not limited to, Protocol Development and Management, Biostatistics, Study Designs and support in establishing single IRBs. Engagement and Dissemination: To work collaboratively with the RDCRCs and the Coalition of Patient Advocacy Groups (CPAG), the Engagement and Dissemination Core will develop a broad RDCRN outreach plan for the consortium. The DMCC Data Management Core will provide Cloud Computing Services and Engineering Support provisioned by the Information Resources Technology Branch (ITRB), NCATS. RDCRN participants will be required to share their data within the DMCC. Is the abstract Specific Aims page included in the capped number of pages in the research section, or is that page additional? Per the FOA: The Specific Aims page does not count towards the total page limit. Per the application guidance(link is external), for all Activity Codes that use an application form with the Specific Aims section (including each component of a multi-component application), the specific aims are limited to one page. Page Limitations Component Types Research Strategy/Program Plan Page Limits Overall 6 Administrative Core 12 Data Management Core 12 Clinical Research Core 12 Engagement and Dissemination Core 12 Additional page limits described in the SF424 Application Guide and the Table of Page Limits(link is external) must be followed. Will the External Advisory Committee be convened (and budgeted for) by the RDCRN? Will the External Scientific Panel be convened by NCATS? Should we include compensation for the ESP members in our RDCRC budget? The External Advisory Committee (EAC) will be convened and budgeted for by the individual RDCRC. Per both FOAs, The EAC should meet in person or electronically at least once a year, beginning in the first or second year of the award. The External Scientific Panel (ESP) will be convened by NIH program officials. Per both FOAs, the ESP will be named by NIH program officials and will serve in advisory capacity by reviewing RDCRN activities and making recommendations to the Network Steering Committee and the NIH regarding process and substantive issues that arise during Network operations. Is it true that the RDCRN Data Management and Coordinating Center (DMCC) will no longer convene the Data and Safety Monitoring Board (DSMB)? Per both FOAs, if DSMB services are required, they may be requested from the DMCC -- but only if no alternate source exists -- for RDCRC clinical trials or pilot studies that meet program requirements. To be eligible for the DMCC services, clinical trials or pilot studies must be of greater than minimal risk. The RDCRN will only provide DSMB services in the following circumstances. If DSMB services are required, they may be requested from the DMCC only if no alternate source exists. To be eligible for the DMCC services, clinical trials or pilot studies must be of greater than minimal risk and include one or more of the following: Protocol designs that allow for modifications to the trial or statistical procedures of the trial after its initiation, such as an adaptive design; Plan to evaluate novel technology or an intervention for which prior data (e.g., preclinical toxicology or from a related compound) suggest the intervention under study has the potential to induce a potentially severe or unacceptable toxicity; Objective to provide definitive information about the effectiveness or safety of the intervention (e.g., a Phase 3 or efficacy trial, such as a trial intended to support product registration); Ethics-driven need to stop the study early if the primary question is addressed, for futility, or for other pre-specified reasons. For the longitudinal study, will all the data be housed within the DMCC and is there a budget consideration that will need to be put into that project? NCATS/RDCRN will only maintain and pay for Management and Governance of the IaaS and PaaS services Federated Access and Authorization Services Cloud Engineering and DevOps Support Domain Name Services Container Image Store Centralized Logging Services for production systems Centralized Monitoring Services for production systems Source Control Backups for all production systems and instances Regarding the provided cloud services, will the data ingress/egress, storage, IO, processing, etc. be paid by NCATS? Each individual center is responsible for the choice of the cloud provider along with all relevant charges for running the system on the cloud instance needs to be budgeted and provided in the application. Do sub-award/consortium Facilities and Administrative (F&A) costs count towards the directs costs? NIH policy provides for the exclusion of consortium/contractual F&A costs when determining if an applicant is in compliance with a direct cost limitation. However, the full cost of subaward/consortium in the Subawards/Consortium Costs field must be included (M.300 - R&R Budget Form, Section F. Other Direct Costs, Question 5). As the DMCC will no longer provide audits, what are the requirements for site audits and is it expected the U54 budget will include payment for the audits? The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm(link is external) and in the application instructions (SF424 (R&R) and PHS 398). What happens if an applicant tries to submit a component that is not listed in the FOA (e.g., Statistics Core)? It will not be accepted by the system. ASSIST will limit applications to the components listed in the FOA. | RDCRN Program FOA Frequently Asked Questions | RDCRN Program FOA Frequently Asked Questions | ||||||
| 12206 | NCATS Develops New Technique to Look Inside Cells Growing in 3-D | Computed 3-D rendition of a the cells in a tumor sphere model after applying a clearing protocol that enables measurements of fluorescence signal from cell nuclei stained with a fluorescent dye, deep inside the tissues. Many drugs that seem promising in the laboratory fail during testing in humans. One reason for this failure is that many laboratory tests use cells grown on a flat, two-dimensional (2-D) plastic surface, which is very different from the three-dimensional (3-D) environment in which cells grow in tissue and organs inside the body. A different growth environment might change how cells respond to drugs, and researchers are experimenting with testing drugs in the laboratory using cells that grow in tissue-like 3-D environments. One technique, which uses cells that have been stained with fluorescent materials that produce light that can be seen with a microscope, can inform researchers about cell behavior or disease. This technique works in laboratory tests when cells are grown in a 2-D environment, where cells are transparent, but it does not work as well in a denser, tissue-like 3-D environment. Current methods to make 3-D tissues transparent and enable cell imaging take too long and are too complicated to be useful for testing thousands of potential new drugs. Now, in work published in Scientific Reports, NCATS researchers have described a simple, fast process to make 3-D tissues transparent. They imaged tissue with a microscope and saw fluorescent signals coming from cells deep within the tissue. The team developed a computer algorithm that found the nucleus of each cell (where DNA is housed) almost as accurately as a human could — but about 3,000 times faster. The process is automated and eventually could be used to test large numbers of drugs. The new method enables many types of observations within 3-D growth environments, such as locating molecules inside a cell or finding damaged DNA, and it can do so quickly in thousands of cells in a tissue-like structure. Posted August 2018 | NCATS intramural experts have published research that outlines a simple, fast and automated process to make 3-D tissues transparent that could improve drug testing. | /sites/default/files/3d-computed-sphere_900x600.jpg | NCATS Develops New Technique to Look Inside Cells Growing in 3-D | NCATS intramural experts have published research that outlines a simple, fast and automated process to make 3-D tissues transparent that could improve drug testing. | /sites/default/files/3d-computed-sphere_900x600.jpg | NCATS Develops New Technique to Look Inside Cells Growing in 3-D | ||
| 12198 | NCATS HEAL Collaboration Opportunities | NCATS welcomes your HEAL-related proposals to advance promising compounds and human cell-based models through preclinical development as a team-based, research collaborations with NCATS’ intramural scientists in the Division of Preclinical Innovation. As research collaborators, you bring a wealth of background knowledge and a starting point for a particular translational project. NCATS scientists provide expertise and resources to transform those starting points into therapeutically useful tools, platforms, or investigational drugs. Approved projects result in formation of joint project teams that will work together to design and follow milestone-driven project plans to achieve pre-agreed to deliverables. Learn more about submitting a proposal for collaboration. | Collaboration Opportunities | Collaboration Opportunities | ||||||
| 12186 | NCATS Creates Drug Development Data Portal | Research scientist Damien Duveau, Ph.D., works on a chemical formula in the NCATS chemistry laboratory. (Daniel Soñé Photography) Drug development scientists frequently need to use a variety of data sources for their research, but information is not always complete and is rarely, if ever, in one place. Searching for and verifying the accuracy of data wastes valuable time. To help researchers find the information they need more easily, NCATS created a new online tool — NCATS Inxight: Drugs — that aggregates reliable, curated drug development data from multiple existing sources, all in one place. This open-access, easy-to-use and evolving online portal is designed to help researchers obtain the data needed to repurpose or advance drugs to address unmet medical needs by: Listing — as accurately as possible — all U.S.-approved prescription and over-the-counter drugs, U.S.-withdrawn drugs, drugs marketed globally, and investigational interventions. Supplying manually curated, referenced data on the method of action, targets and uses (approved and off-label) for nearly 10,000 drug substances. Providing the context of medical use, including names, synonyms, molecular targets, pharmacology, diseases and conditions, and marketed products containing the drug. Unlike other drug development databases, NCATS Inxight: Drugs offers a substantial amount of manually curated data from multiple independent, public sources. These include updated information from the NCATS Pharmaceutical Collection as well as data published from the Food and Drug Administration (FDA) for the first time. The FDA’s Substance Registration System, which supplies more than 100,000 data points in NCATS Inxight: Drugs, is built on software developed at NCATS through the collaborative ginas project. NCATS Inxight: Drugs is the only resource that: Uses a complete list of rigorously defined drug substances as its core dataset. Substances are defined according to the ISO 11238 standard and richly annotated with data from a variety of publicly available resources. Includes all types of pharmaceutical ingredients found in drug products: small molecule agents, antibodies, oligonucleotides and natural product extracts. Features, for each record, a rigorous scientific definition that complies with regulatory standards for substance identification. The NCATS Inxight: Drugs resource, which is updated regularly, uses novel algorithms developed at NCATS to enable automated data aggregation from nearly unlimited sources. Posted August 2018 | NCATS has created an online tool — NCATS Inxight: Drugs — that aggregates reliable, curated drug development data from multiple existing sources, all in one place. | /sites/default/files/inxight_1260x630.jpg | NCATS Creates Drug Development Data Portal | NCATS has created an online tool — NCATS Inxight: Drugs — that aggregates reliable, curated drug development data from multiple existing sources, all in one place. | /sites/default/files/inxight_1260x630.jpg | NCATS Creates Drug Development Data Portal | ||
| 12181 | NIH-Supported Researchers Use Robots, Stem Cells to Produce Organ Models | A plate with testing chambers containing kidney organoids that were generated by robots from human stem cells. The different colors mark distinct segments of the kidney. (Freedman Lab/University of Washington Photo) To create an authentic environment in which to test drugs, researchers have increasingly used human stem cells — which can be manipulated to develop into diverse cell types — to build tiny 3-D tissue models called organoids, miniature versions of an organ that are grown in a laboratory and can mimic key features of a human organ’s structure and function. While they can have a wide range of potential uses in medical research, organoids can be challenging to grow reliably in large quantities. With support from the NCATS Tissue Chip for Drug Screening program and the National Institute of Diabetes and Digestive and Kidney Diseases, researchers at the University of Washington are seeking to address this challenge. In a study published in Cell Stem Cell, these investigators created an automated procedure for producing kidney organoids in bulk from stem cells for medical research. The investigators programmed robots to place stem cells into plates containing up to 384 miniature testing chambers and prodded the cells to develop into organoids over the course of 21 days. The researchers then analyzed the organoids to ensure that the organoids exhibited characteristics that represented a developing kidney in healthy or disease states. “This effort provided a reproducible organoid system that represents kidney function and is useful in testing drugs on a large scale and more efficiently,” said Danilo Tagle, Ph.D., NCATS acting deputy director and associate director for special initiatives. “One of the next steps is to bring these organoids into wider use, especially at NCATS for screening drugs and compounds against kidney diseases.” Posted August 2018 | NIH-supported researchers have developed an automated procedure to reliably grow 3-D tissue models called organoids in large quantities to test drugs on a large scale. | /sites/default/files/tissuechip-robot_organoids1260x630.jpg | Using Robots and Stem Cells to Produce Organ Models | NIH-supported researchers have developed an automated procedure to reliably grow 3-D tissue models called organoids in large quantities to test drugs on a large scale. | /sites/default/files/tissuechip-robot_organoids1260x630.jpg | Using Robots and Stem Cells to Produce Organ Models | ||
| 12104 | New NCATS-Supported Test Could Provide Faster Diagnosis of Deadly Disease | Method of detecting nucleic acids using three-dimensional paper microfluidic devices. A sample is loaded on the one dot on the left. It is dispersed into seven different locations for the multiplexed detection of seven pathogens and one location for the control. (GoDx Photo) Every year, diarrheal disease kills more than 1 million people, mostly children in the developing world. To treat the illness effectively, health care providers need to know its cause. Currently, a diagnosis requires sending a stool sample to a lab for expensive tests, then waiting to find out if the patient has a bacterial or viral infection, a parasite, or some other problem. By the time the results come back, the patient has missed days of potentially lifesaving treatment. To address this challenge, Chang Hee Kim, Ph.D., co-founded the biotechnology company GoDx with a mission to develop a simple paper test for diarrheal disease. The test does not need electricity and can detect seven common causes of diarrhea in less than 30 minutes. GoDx has a clinical cooperative research and development agreement to develop the product with Wendy A. Henderson, Ph.D., M.S.N., C.R.N.P., a digestive diseases researcher at NIH’s National Institute of Nursing Research (NINR). Data generated through that collaboration made it possible for Kim to apply for and receive a Phase 1 Small Business Innovation Research (SBIR) grant from NCATS in 2017. NCATS chose to fund the application because it supported the development of a platform technology that could be used to diagnose many different diseases. GoDx plans to apply the technology to urinary tract infections, sepsis and sexually transmitted infections, which all involve the rapid, multiplexed detection of pathogens at the point of care or point of need. The technology will enable syndromic testing in a pocket-sized package. SBIR Phase 1 funding supports small businesses in the early stages, when the companies are trying to make sure that their proposed research and development efforts will work and be worthwhile. “It’s so valuable that NCATS is willing to fund research and development for this early-stage technology,” Kim said. “At the beginning of technology development, it is very hard to find investors.” GoDx co-founder Chang Hee Kim, Ph.D., and NIH researcher Wendy A. Henderson, Ph.D., M.S.N., C.R.N.P., co-developed a new test for diarrheal disease. The Phase 1 SBIR funding made Kim eligible to take part in the I-Corps™ at NIH program, which provides mentoring and training for entrepreneurs. As part of I-Corps, Kim and his colleagues interviewed 130 patients, doctors and others about the test and received input about improving and distributing it. In July 2018, GoDx received Phase 2 SBIR funding from NCATS to continue test development. The next step is a study with NINR to try out the test on volunteers; anyone with diarrhea near Bethesda, Maryland, can sign up. At the same time, study participants’ stool samples will be tested via more traditional laboratory procedures. Comparing the two results will indicate whether the new test is accurate. “This is just one example of how NCATS’ SBIR funding can support translational research advances that have commercial as well as lifesaving potential,” said Lili Portilla, M.P.A., director of NCATS’ SBIR and Small Business Technology Transfer programs. Read more from The New Gastroenterologist. Posted August 2018 | NCATS’ Small Business Innovation Research program helps fund the development and analysis of a simple paper test for diarrheal disease. | /sites/default/files/sbir-godx_1260x630.jpg | NCATS-Supported Test Could Provide Faster Diagnosis of Deadly Disease | NCATS’ Small Business Innovation Research program helps fund the development and analysis of a simple paper test for diarrheal disease. | /sites/default/files/sbir-godx_1260x630.jpg | NCATS-Supported Test Could Provide Faster Diagnosis of Deadly Disease | ||
| 11775 | CTSA Program Researchers Partner with Barbershops to Cut High Blood Pressure | Translational Science Highlight NCATS’ Clinical and Translational Science Awards (CTSA) Program engages communities in research and promotes the integration of underserved populations to strengthen the quality and adoption of research results. When is a haircut more than a haircut? When it’s also the first step to cutting high blood pressure. Black men are more likely to die from complications of high blood pressure than any other group in the U.S. To tackle this disparity, researchers from the Smidt Heart Institute at Cedars-Sinai and the University of California, Los Angeles (UCLA), are pairing pharmacists with barbershops to offer high blood pressure care for customers. The results from a recent study published in the New England Journal of Medicine show this approach can dramatically lower blood pressure. “If we could expand and maintain this kind of blood pressure reduction for years, it would prevent an enormous number of strokes and heart attacks,” said Ronald Victor, M.D., a cardiologist and the director of the Hypertension Center in the Smidt Heart Institute. Victor led the six-month study with other investigators at UCLA’s Clinical and Translational Science Institute (CTSI), an NCATS Clinical and Translational Science Awards (CTSA) Program hub. A Previous Attempt Barbershop owner Eric Muhammad (left) takes the blood pressure of customer Marc Sims (right).(Smidt Heart Institute at Cedars-Sinai Medical Center Photo) Health outreach through barbershops is not new. In fact, Victor had tried a similar approach in Dallas, where barbers measured their customers’ blood pressure and encouraged those with high numbers to see their doctor. “There was a meager improvement in blood pressure,” Victor said. “It was really disappointing, and I wanted to understand why.” It turned out that when men in the study did see their doctors, blood pressure medication was rarely prescribed or increased. Despite decades of evidence about the benefits of these medications, many barriers to prescribing them persist, such as overwhelmed primary care offices and patients who are hesitant to start a new medication. Adding a Twist Victor suspected that pharmacists might be the missing link in his barbershop outreach. In most states, primary care providers can partner with pharmacists to care for patients through collaborative practice agreements. The agreements enable a pharmacist to prescribe or adjust certain medications on behalf of a doctor, and studies have shown this approach can improve health for people with high blood pressure. Victor took this model and added a twist in his latest study: Instead of sending barbershop patrons to pharmacists, he sent the pharmacists to the barbershop. The goal was to overcome yet another obstacle for black men: They are less likely than other groups to visit a doctor. “Mistrust of the medical system is alive and well today,” said C. Adair Blyler, Pharm.D., a pharmacist and co-author on the study. “We knew that if we wanted to stamp out this disparity, we had to bring the care to the men.” A Powerful Endorsement for the Pharmacists Some of the barbers in the study had watched their customers grow up. On average, the barbers had cut the men’s hair every two weeks for the past 10 years. “I’ve seen some of my patients over the course of many years, but not every two weeks,” Victor said. “The barbers’ endorsement was instrumental in encouraging men to participate and also encouraging them to stay with the program for its duration. None of this would have been possible without the trust the men had in their barbers — and the relationship they developed over time with the pharmacists.” CTSI’s Community Engagement Unit helped Victor and his colleagues recruit the first few barbershop owners. Fortunately, one of the first recruited was Eric Muhammad, who reached out to other barbers in the area to share his positive experience in the study. Muhammad and a postbaccalaureate student from UCLA ultimately recruited more than 50 black barbers who owned shops in the Los Angeles area. “Some of the barbers, and especially Eric, felt it was their mission to help take care of their community,” Blyler said. Muhammad’s work was so critical that he was included as a co-author on Victor’s study. A Lasting Change With 52 barbershops on board, the researchers randomly assigned each shop into the test group or the control group. As in the Dallas study, barbers in the control group talked to customers with high blood pressure about lifestyle changes and encouraged the men to see a doctor. In the test group, customers with high blood pressure met with a pharmacist at the shop. The pharmacists then prescribed high blood pressure medications as appropriate and followed up with the participants at future haircut appointments to check that the medications were working and not causing problems. “As health care workers in neighborhoods that we don’t live in, there was some wariness about our intentions,” Blyler said. “But pretty quickly, we were able to establish a rapport with patients.” The research team tracked both the control and test group participants’ blood pressure over the next six months. Men in the control group, who were encouraged to see their doctor, had slight improvements in blood pressure, although on average their blood pressure was still high after six months. But men in the test group, who met with a pharmacist at a barbershop, had large drops in their systolic blood pressure, from an average of 153 mmHg at the beginning of the study to 126 mmHg after six months. Normal systolic blood pressure is less than 120 mmHg. Translating Results to the Real World The initial pilot study in a Los Angeles suburb received support through the UCLA CTSI, and the promising results enabled Victor to obtain more funding from the National Heart, Lung, and Blood Institute for the larger study. Biostatisticians from CTSI also offered crucial input on designing both the pilot and the larger study and determining how to analyze the results. Victor now wants to see if his approach can lead to equally impressive results in other real-world settings. This includes determining the approach’s cost-effectiveness, which would be key to national implementation. To proceed, he is collaborating with insurers to conduct more pilot studies. He also believes the CTSA Program network of hubs provides a great opportunity to test the model with diverse populations across the country. This study offers valuable lessons on the potential impact of directly engaging communities and utilizing alternative health care delivery, through pharmacists, in nontraditional settings. Posted August 2018 | Researchers from Cedars-Sinai Medical Center and the University of California, Los Angeles, are pairing pharmacists with barbershops to lower customers’ blood pressure. | /sites/default/files/barbershop-hypertension_%201260x630.jpg | CTSA Program Partners with Barbershops to Cut High Blood Pressure | Researchers from Cedars-Sinai Medical Center and the University of California, Los Angeles, are pairing pharmacists with barbershops to lower customers’ blood pressure. | /sites/default/files/barbershop-hypertension_%201260x630.jpg | CTSA Program Partners with Barbershops to Cut High Blood Pressure | ||
| 11675 | Automated Chemical Synthesis Workshop Agenda — October 19-20, 2017 | Natcher Conference Center, National Institutes of Health, Bethesda, Maryland October 19, 2017 8:00 a.m.: Registration 8:30 a.m.: Welcome and Workshop Overview 8:45 a.m.: Opening Remarks Christopher P. Austin, M.D., Director, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH) 9:15 a.m.: Session 1: Current State of Automated Chemical Synthesis 9:15 a.m.: Session 1: Current State of Automated Chemical Synthesis Chair: Jon R. Lorsch, Ph.D., Director, National Institute of General Medical Sciences (NIGMS), NIH 9:20 a.m.: The DARPA Make-It Program: Fully Automated Small Molecule Synthesis Anne Fischer, Ph.D., Program Manager, Defense Sciences Office, Defense Advanced Research Projects Agency (DARPA) 9:30 a.m.: NIGMS’s Synthetic Efforts Towards Automation Pamela A. Marino, Ph.D., Chief, Division of Pharmacology, Physiology, and Biological Chemistry, NIGMS, NIH 9:40 a.m.: Integrating Automated Chemistry and Biology Using High-Information Content Experimentation Spencer Dreher, Ph.D., Principal Scientist, Chemistry, Catalysis and Automation, Merck Timothy Cernak, Ph.D., Associate Principal Scientist, Discovery Chemistry — Automation and Capabilities Enhancement, Merck 10:00 a.m.: The Natural Productome Project Martin Burke, Ph.D., Professor, Department of Chemistry, University of Illinois 10:20 a.m.: Break 10:30 a.m.: Automated System for Knowledge-Based Continuous Organic Synthesis Klavs Jensen, Ph.D., Professor, Department of Materials Science and Engineering, Massachusetts Institute of Technology (MIT) 10:50 a.m.: New Approaches to Synthesis: Chemical Assembly Systems and Radial Synthesis Kerry Gilmore, Ph.D., Group Leader, Biomolecular Systems and Microreactors as Tools for Organic Chemists, Max Planck Institute of Colloids and Interfaces 11:10 a.m.: Digitization of Chemistry and Artificial Intelligence Driven Discovery of Organic Synthesis Lee Cronin, Ph.D., Regius Chair of Chemistry, School of Chemistry, University of Glasgow 11:30 a.m.: Translational Chemistry Phil Baran, Ph.D., Darlene Shiley Chair in Chemistry and Professor of Chemistry, The Scripps Research Institute 11:50 a.m.: Lunch (on your own) 12:50 p.m.: Panel Discussion 1:50 p.m.: Break 2:00 p.m.: Session 2: New Chemistries and AS 2:00 p.m.: Session 2: New Chemistries and AS Co-Chairs: Pamela A. Marino, Ph.D., Chief, Division of Pharmacology, Physiology, and Biological Chemistry, NIGMS, NIH Anton Simeonov, Ph.D., Scientific Director, Division of Preclinical Innovation, NCATS, NIH 2:05 p.m.: A New Approach to Late-Stage Functionalization Stephen Buchwald, Ph.D., Professor, Department of Chemistry, MIT 2:25 p.m.: Computational Identification and Prioritization of a Natural Productome Parts List Jeffrey Skolnick, Ph.D., Professor, School of Biological Science, Georgia Institute of Technology 2:45 p.m.: What Is Known vs. Possible? Functionomics Through AS, AI, New Reactions and Step/Time Economy Paul Wender, Ph.D., Bergstrom Professor of Chemistry and Professor of Chemical and Systems Biology, Stanford University 3:05 p.m.: 25 Years of DNA-Encoded Chemistry: What Have We Learned About Library Design? Barry Morgan, Ph.D., Chief Scientific Officer, HitGen 3:25 p.m.: Break 3:35 p.m.: Panel Discussion 4:35 p.m.: Break 4:45 p.m.: Breakout Discussion (Rooms D and F1/F2) Moderators: Sitta Sittampalam, Ph.D., Senior Advisor to the Director, NCATS Jason Rohde, Ph.D., Research Scientist, Division of Preclinical Innovation, NCATS 5:45 p.m.: Summary of Day 1 and Adjournment October 20, 2017 8:30 a.m.: Session 3: Machine Learning/AI and AS 8:30 a.m.: Session 3: Machine Learning/AI and AS Co-Chairs: Sam Michael, Ph.D., Director, Automation and Compound Management, NCATS, NIH Alexander Godfrey, Ph.D., Automated Chemistry Consulting 8:35 a.m.: Active Machine Learning: An Automated Approach to Determine What to Synthesize Next Joshua D. Kangas, Ph.D., Research Scientist, School of Computer Science, Carnegie Mellon University 8:55 a.m.: AI-Driven Retrosynthetic Analysis Akihiro Kishimoto, Ph.D., Research Staff Member, IBM Research 9:15 a.m.: Machine Learning for Pathway Validation in Automated Synthesis Connor W. Coley, Graduate Student, MIT 9:35 a.m.: Break 9:50 a.m.: How Computers Design Synthesis: From Reaction Rules to Higher-Order Logic (WebEx Talk) Bartosz A. Grzybowski, Ph.D., Distinguished Professor, Ulsan National Institute of Science & Technology (UNIST) 10:10 a.m.: Retrosynthetic Software for Practicing Chemists: Results from the Bench Sarah Trice, Ph.D., Head of Commercial Development, MilliporeSigma 10:30 a.m.: Incorporation of Bioactivity Data: The Case of Tox21 Anton Simeonov, Ph.D., Scientific Director, Division of Preclinical Innovation, NCATS, NIH 10:50 a.m.: Breakout Discussion (Rooms D and F1/F2) Moderators: Sam Michael, Ph.D., Director, Automation and Compound Management, NCATS, NIH Alexander Godfrey, Ph.D., Automated Chemistry Consulting 11:50 a.m.: Lunch (on your own) 12:50 p.m.: Summary of Breakout Discussions, Sessions 1–3 1:45 p.m.: Break 2:00 p.m.: Session 4: Open Science 2:00 p.m.: Session 4: Open Science Chair: Christopher P. Austin, M.D., Director, NCATS, NIH 2:05 p.m.: Lilly Open Platform Technology and the Future of the AS Alan D. Palkowitz, Ph.D., Vice President, Discovery Chemistry Research and Technologies, Eli Lilly and Company 2:30 p.m.: Panel Discussion Danilo Tagle, Ph.D., Associate Director of Special Initiatives, NCATS, NIH Anne Fischer, Ph.D., Program Manager, Defense Sciences Office, DARPA Peter Seeberger, Ph.D., Director, Max Planck Institute for Colloids and Interfaces Alan D. Palkowitz, Ph.D., Vice President, Discovery Chemistry Research and Technologies, Eli Lilly and Company Mirielle Krier, Ph.D., Principal Scientist, Merck KGaA Nicola L. B. Pohl, Ph.D., Professor of Chemistry and Joan & Marvin Carmack Chair, Indiana University Darla Henderson, Ph.D., Assistant Director and Publisher, Open Access Programs, American Chemical Society Martin Hicks, Ph.D., Board of Management, Beilstein Institute for the Advancement of Chemical Sciences Jake Yeston, Ph.D., Deputy Editor, Physical Sciences Research, Science 3:30 p.m.: Break 3:45 p.m.: Summary Martin Hicks, Ph.D., Board of Management, Beilstein Institute for the Advancement of Chemical Sciences 4:00 p.m.: Adjournment | Automated Chemical Synthesis Workshop Agenda — October 19-20, 2018 | Automated Chemical Synthesis Workshop Agenda — October 19-20, 2018 | ||||||
| 11672 | Assay Guidance Workshop Agenda — February 3, 2018 | February 3, 2018 — 8:00 a.m. - 5:00 p.m. San Diego Convention Center, 111 W Harbor Drive, San Diego, CA 92101 8:00-8:45 a.m.: Strategies for Assay Selection and for the Development of Robust Biochemical Assays Nathan P. Coussens, Ph.D., NCATS/NIH 8:50-9:35 a.m.: Treating Cells as Reagents to Design Reproducible Screening Assays Terry Riss, Ph.D., Promega Corporation 9:45-10:00 a.m.: Beverage Break 10:00-10:45 a.m.: Assay Interpretation: Studies in Mechanisms and Methods in Assay Interferences Douglas Auld, Ph.D., Novartis Institutes for BioMedical Research 10:55-11:15 a.m.: Robust or Go Bust: An Introduction to the Assay Guidance Manual G. Sitta Sittampalam, Ph.D., NCATS/NIH 11:15-12:00 p.m.: Lunch 12:00-12:45 p.m.: Biophysical Approaches to Small Molecule Discovery and Validation Michelle Arkin, Ph.D., University of California, San Francisco 12:55-1:40 p.m.: In Vitro Toxicological Testing using a qHTS Platform Menghang Xia, Ph.D., NCATS/NIH 1:45-2:00 p.m.: Beverage Break 2:00-2:45 p.m.: In Vitro Assessments of ADME Properties of Lead Compounds Xin Xu, Ph.D., NCATS/NIH 2:55-3:40 p.m.: Basic Assay Statistics, Data Analysis and Rules of Thumb Thomas D.Y. Chung, Ph.D., Mayo Clinic 3:50-4:35 p.m.: System Suitability of In Vitro Screening Assays in Drug Discovery V. Devanarayan, Ph.D., Charles River 4:45-5:00 p.m.: Open Discussion | Assay Guidance Workshop Agenda — February 3, 2018 | Assay Guidance Workshop Agenda — February 3, 2018 |
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