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ACE Case Study
| To find out more about the CRADA, please review the following: | |
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FDA Federal Register E6-1918 - CRADA with Conformia |
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Conformia CRADA Overview Presentation |
Food and Drug Administration
Conformia Software Inc. is collaborating with the Food and Drug Administration (FDA) under a Cooperative Research and Development Agreement (CRADA) to get a better understanding of the factors that influence pharmaceutical development. Sponsored by the FDA’s Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Sciences (OPS), the FDA-Conformia CRADA is a research study entitled: “A Survey of Pharmaceutical Needs” designed to uncover the challenges and bottlenecks faced by pharmaceutical and biotechnology companies in bringing new drugs to market.The factors of focus will include:
- Commercialization Processes
- Quality by Design, PAT, Design Space
- ICHQ8, Q9 Q10
- Collaboration
- Communication/Decision Making
- Information Bottlenecks
- FDA Perception
PROJECT OBJECTIVES:
- Interview 9 pharmaceutical and biotechnology companies to understand the difficulties they have encountered in their pharmaceutical development processes. (Pilot Group_
- Concurrently review guidance and regulatory requirements that impact the pharmaceutical and biotechnology drug development process.
- While maintaining the confidentiality of individual responses, evaluate the potential impact of changes in guidance documents and regulatory requirements that may have an effect on the time and resources required by firms to complete pharmaceutical development.
- Communicate research findings to the U.S. pharmaceutical industry through publications and workshops with the aim of enhancing understanding of factors that may impact on pharmaceutical development and regulatory or other changes that might be helpful.
- Expand Pilot Group to 25 Companies.
Background
This CRADA Research Agenda will focus on along with following FDA initiatives: (1) Critical Path Initiatives (2) Quality Systems Infrastructure and Design (3) ICH Q8 Guidelines on Pharmaceutical Development and (4) Pharmaceutical cGMPs for the 21st Century – A Risk Based Approach. At the completion of the study Conformia will disseminate the research agenda, findings, and FDA comments to all participants and make the findings available to the public through publication(s) of findings. Conformia will summarize the findings in a manner that is consistent with the protection of all participating company identities. By disseminating this research to pharmaceutical and related companies, the limited resources used to complete this research on both FDA and Conformia’s side can be leveraged to provide benefit to pharmaceutical companies, and ultimately the public. The intended use of these findings is to improve the understanding of the factors contributing to problems drug companies face in efficiently bringing to market better therapeutics, particularly with respect to product development, process development, analytical testing and commercial manufacturing. (i.e. industrialization of new therapeutics on the Critical Path of Drug Development).
CRADA Scope Maps directly with FDA Initiative:
Critical Path CRADA outputs are contributing to Industrialization Track
Description of Study
Through this project, attention will be paid to why drugs that could help the public are not coming to market as fast and as efficiently as possible. Through the findings, presentations, future state case study, and discussion with FDA, more clarity will emerge as to why it is taking the time it is taking now to bring high quality products to market, i.e., whether companies are misinterpreting guidelines, whether FDA is /isn’t getting the data they need, and improving understanding around "what " the root causes are that could be addressed to enable the public to receive better quality drugs in a more efficient manner.FDA will have the opportunity to learn where the regulatory process can be improved and what the implications are of the current state of affairs for companies in trying to meet submissions requirements. Also, more effective means of gathering relevant data (as opposed to volumes of data) will be explored. Through the CRADA, FDA will also help shape and refine the existing research agenda topics such that those areas that are also of concern to FDA will be prioritized in Conformia’s research.
Conformia will conduct a research study with nine companies, blinded to the FDA, ranging in size and type of products produced (proprietary small and large molecule based products, generics, and biotechnology products). The research will provide insights into:
- Existing root causes of bottlenecks in the drug development process resulting from inadequate information capture;
- Types of infrastructure and processes which will be necessary in order for companies to implement closed loop, continuous improvement, quality by design and risk based approach to new drug development;
- Expectations of future guidance from the agency that might better assist companies in successfully gaining approval for new drugs as fast and effectively as possible.
The proposed study will occur over a 3 year period and the output will be a series of reports that will be made available to the public.
This CRADA will extend Conformia’s preliminary research to uncover the challenges companies face in managing information associated with bringing new drugs to market. The research will shed light on the current state and explore what a future state could look like.
Conformia plans to share research findings at various stages of the 3 year study and gain feedback from FDA subject matter experts on "blind company" specific areas of question. Conformia will be able to receive clarity on areas of guidance that are unclear, as well as on the research that is emerging: Are these findings specific to a company, or are they "trends" that are occurring across the industry?
EXPECTED TANGIBLE RESULTS
Through collaboration with FDA, Conformia will gain feedback from a cross section of subject matter experts as needed, who have knowledge of science and risk based, systematic approaches to drug development, leading to IND, BLA, NDA submissions. Conformia will also gain feedback from FDA on relevant data and guidance involved in producing high quality drug products. Working with the FDA, Conformia has the best chance of getting correct interpretations and industry feedback and correctly understanding the guidance set forth by FDA.Through the research, FDA hopes to gain important insights in meeting the goals for its Pharmaceutical cGMPs for the 21st Century and critical path initiatives. A major component of the critical path to market of new pharmaceuticals is the time taken in pharmaceutical development. Of particular interest to FDA are what kinds of steps it can take to help companies reduce time spent in pharmaceutical development and speed the adoption of new technologies (like Process Analytic Technologies) which are aimed at producing higher quality products as well as reducing product cost. For example, the CRADA research will help FDA to determine modifications to current guidance and what new guidance may be needed to meet these objectives.
Conformia will summarize both the relevant research findings as well as the relevant FDA comments in a publication (or publications). Publication will be distributed to pharmaceutical companies interested in the report. Workshops or seminars will also be conducted by Conformia in conjunction with appropriate FDA involvement based on the outcome of the research.
CONFIDENTIALITY
To protect the rights of individuals and companies involved, the study will be blinded to FDA, including any identifying information on the companies selected for participation in the study. FDA’s input into the selection process will be limited to the general criteria used for selection, i.e., large versus small firms, biotech versus other firms. Because of the large number of firms in each category in the U.S., it will be impossible to identify specific firms. Furthermore, results of the survey will be aggregated and summarized in reports before sharing with FDA. No data identifying individuals from companies will be provided to FDA. Through these procedures, Conformia is committed to maintaining the protection of individuals and companies involved in the study.How to get involved
To begin the application process, please download and complete the documents found below, and return Conformia via the contact points below.• Conformia FDA CRADA - Confidential Disclosure Agreement
• Conformia FDA CRADA - Informed Consent
• Conformia FDA CRADA - Interview Panel List Workbook Master
Conformia Office of the CRADA Personnel
Anjali Kataria, Principle Investigator(408) 625-3800
akataria@conformia.com
Sam Venugopal, Co-Investigator
(408) 625-3800
svenugopal@conformia.com
Conformia Software
Attn: Office of the CRADA
150 N. Mathilda Ave. Suite 202
Sunnyvale, CA 94086
Tel: 408-625-3800
Fax: 408-625-3801