HIGH THROUGHPUT TESTING CAPABILITIES FOR RAPID SCREENING OF COMPUTATIONAL CANDIDATES IN DRUG DEVELOPMENT AND RAPID RESPONSE

REQUEST FOR INFORMATION HIGH THROUGHPUT TESTING CAPABILITIES FOR RAPID SCREENING OF COMPUTATIONAL CANDIDATES IN DRUG DEVELOPMENT AND RAPID RESPONSE Objective: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies (JPEO-CBRND EB) is seeking information on the available capabilities and willingness of private entities (academic, non-profit and commercial) to collaborate with the Government in the areas listed below. Background: The Department of Defense is leveraging computational approaches and modeling to accelerate and reduce developmental risks in product development. These approaches require robust and potentially high-throughput approaches to data generation to build the required models, as well as a highly efficient screening approaches and processes to facilitate product downselection and characterization. In general, these approaches will be implemented in a program that seeks to develop biologics-based medical countermeasures to address a broad threat space, and in some cases, these capabilities could be leveraged during future rapid responses to unanticipated threats. Requirements: The purpose of this RFI is to solicit information on capabilities to rapidly develop a range of assays, produce biologics test materials, determine protein structure, and test materials against pathogens and toxins (potentially requiring biosafety levels 2, 3 and 4). Examples include the generation of DNA and protein test articles and efficient determination of binding, physicochemical characterization, pseudoneutralization and neutralization, affinity, enzyme kinetics, antibody titers, glycoprofiling, manufacturing process data and others. Innovative material generation technologies and high throughput testing/screening approaches are of interest. Performance Objectives: Generation of large datasets to build and validate computational models. Models will be generated that enable rapid discovery, design (across a large number of critical quality attributes), manufacturing process development, and formulations for candidate medical countermeasures. In order to generate the large amount of data needed to create the models, the government is interested in high-throughput, cost effective approaches that can be leveraged to model characteristics and effects of biologics molecules (e.g., antibodies, vaccines, and enzymes). Screening of large numbers of computationally designed medical countermeasures using relatively standard characterization approaches to select candidates and/or inform further computational designs. This capability will require the ability to rapidly and efficiently produce large numbers of test samples developed during computational discovery/design campaigns, and develop and implement a range of assays to characterize those samples. This could involve screening against a broad range of targets (r-proteins, bacteria, viruses, toxins, etc.) at various biosafety levels. It is anticipated that hundreds of samples will require characterization in each computational batch, which could require high-throughput approaches. Screening of pre-clinical and clinical samples. In addition to assessment during discovery/design phase, the government is interested in a capability to test samples that originate from preclinical (animal) and clinical testing. The goal is to leverage similar approaches to facilitate further downselection, refinement, and to feed model building. Generation of protein structures. The availability of protein structures for both the target and the medical countermeasures are often critical for computational discovery and design. There is a significant interest in capabilities that can rapidly assess protein structures, with accuracy required for computational model-based predictions to be made. Manufacturing process development, process controls, and efficient product release. There is significant interest in innovative approaches to bioreactor control using computational approaches such as digital twins. The intent is to develop control strategies that significantly reduce or eliminate the need for process development, reduce the probability of run failure, increase the product yield of a run, precisely control product quality attributes, and facilitate rapid product release. Rapid experimental prediction/validation of antibody/vaccine/enzyme targets. Experimental approaches to rapid target determination (e.g., neutralizing epitopes, etc.) are of interest. Capabilities that are tied primarily to pathogen characterization in terms of pathogen biology and disease natural history are of secondary interest. Capabilities related to small molecule drug development are not of interest for this RFI unless they are also applicable to the biologics space. The Respondents shall provide the following in response to this RFI, not to exceed 11 pages in total: Company Description (2 page maximum) Provide a brief description of company history, alliances and funding emphasizing experience in the application of high throughput testing/screening capability to drug development Discuss any data rights assertions anticipated for the high throughput testing/screening capability (Freedom to operate, patent application status, issued or licensed intellectual property) High throughput Testing/Screening Capability Description (5 page maximum) Description and discussion of any or all of the capabilities described in the Performance Objectives section. Innovative approaches that address the overarching program goals that do not precisely match the above Performance Objectives can be included. Discussion of the throughput of the described system(s) or approach(es), including the projected size and types of dataset that could be generated. Discussion of the maturity of the proposed approaches, including previous demonstrated use, and any relevant FDA regulatory exposure. Willingness to support an extended campaign of medical countermeasure development across broad threat space. General description and status of equipment/supplies that are required for material generation and the testing/screening capability. Potential risks or liabilities that are associated with high throughput testing/screening capability application and maintenance, if known. Any associated intellectual property rights or patent coverage Administration: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by COB on 10 May 2022. Responses should be sent by e-mail to: contact@example.gov, and contact@example.gov, with Subject Line of Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI the first choice for an acquisition vehicle, if appropriate, will be the Medical CBRN Defense Consortium (MCDC) Other Transaction Agreement (OTA). Respondents not already members of the consortium are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at contact@example.gov and view the Medical Countermeasures Broad Agency Announcement (BAA) in SAM.gov, keywords MCS-BAA-17-01. For questions related to this RFI, please e-mail to: contact@example.gov, and contact@example.gov. The Point of Contact for this RFI is Lee A. Hess at contact@example.gov.