All Frequently Asked Questions
New projects primarily come about through preliminary discussion and agreement within ETC working groups that there is sufficient cross-industry interest in a potential project to assemble a team of interested researchers to explore a new project
The Project team creates a Request for Information (RFI) outlining the project scope and requirement. Following approval from the Board of Directors, the RFI is published via our website and circulated to recipients on our mailing lists and to potential collaboration partners to identify interested parties. Responses to the RFI along with interviews with potential collaborators are used to select partners to participate in the Request for Proposals (RFP) process or used to select a collaboration partner. Ultimately an agreement between ETC and the external partner is created to define the terms of the collaboration. The RFI/RFP process helps to ensure the open and fair selection of collaboration partners.
o Yes, please the consortium will consider project suggestions received via email or via the “Project Proposal Form” on our website.
ETC members on the project and the collaborator will work together to scope the project priorities and capture these in a SOW, which will specify the project deliverables, timeline, payment schedule, fixed cost in US dollars to ETC, etc.
Due to the volume of requests, ETC cannot schedule meetings with individual parties to address questions. ETC requests all interested collaborators to submit questions via the email specified in the RFI/RFP. ETC sets a deadline to submit questions to the consortium before responding. ETC will answer these questions promptly and send responses to the interested collaborator. ETC will also anonymize the questions and post them publicly on the website
The delivery timeline will be discussed in detail after a collaborator has been selected, but please include a proposed timeline in your response.
Following submission of RFI/RFP responses, the team will evaluate proposals and send further questions for clarification as needed before selecting a collaborator. A virtual or an in-person scoping workshop may also be scheduled with the selected vendor to further refine the proposal and project.
Only members within ETC view responses to an RFI/RFP; responses to an RFI/RFP are not shared among different respondents.
In general, from the time the RFI/RFP is released until project start is approximately 6-12 months but that can be faster or slower depending on the project. The timeline depends on a lot of factors but primarily driven on how quickly a Statement of Work (SOW) can be created and agreed upon by both parties. Once that process has made enough progress the ETC Secretariat will work with the collaborator on the Development Agreement.
The project duration should be proposed by the 3rd party, based upon the time they believe they need to complete the project. Projects in ETC typically last 1-3 years with options to execute additional phases of work through new SOWs after the completion of the initial SOW.
This is unknown at this stage in the process. ETC may decide to scope a project with one of the I respondents or issue a second request. This RFI/RFP process is scheduled to conclude on the specified due date for responses on the RFI/RFP.
Individuals from ETC will be comprised of representatives from ETC member companies participating in the project. The frequency and need for meetings between ETC participants and the collaborator will be determined in the project plan. Typically, ETC and the collaborator meet either monthly or quarterly at a minimum to get product updates from the collaborator, but more frequent meetings are possible if needed.
Yes, the Enabling Technologies Consortium is open to a phased project approach.
Typically, the project sponsors are known during the scoping phase with the collaborator but will be formalized at the time the internal ETC Project Charter is sent for signature. For all projects, the 3rd party collaborator has regular meetings with the project sponsors, usually on a monthly or quarterly basis in order to report on progress, receive input/feedback, and get additional information.
The internal project charter is the agreement signed by all ETC members participating in the project. It provides details about the project (e.g., timelines, costs, deliverables), budget requested, terms/conditions negotiated with the 3rd party. The Charter serves as the basis for the Development Agreement and Non-Disclosure Agreement between ETC and the 3rd party collaborator. The Charter, Development Agreement and Non-Disclosure Agreement all use template language which was been reviewed and approved by ETC members to accelerate the process.
The purpose of the Enabling Technologies Consortium is to foster collaboration on issues related to pharmaceutical chemistry, manufacturing, and control with the goal of identifying, developing, evaluating and improving scientific technologies that enable the rapid and efficient discovery, development, and manufacturing of pharmaceuticals. While the current scope of the consortium is predominantly focused on Chemistry Manufacturing and Controls, the organization has been established with a view to allow for future expansion into other areas in pharmaceutical research and development.
The ETC was founded in 2015 following several years of discussion between scientists from various pharmaceutical companies, as an evolution of the ETC® Working group formed within the Active Pharmaceutical Ingredient (API) Leadership group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium).
See our Members page for a list of current consortium members.
Any company with an active new drug application (NDA) can become a member of the consortium. All members must agree to the established Bylaws and Antitrust Guidelines, execute the ETC® Membership Agreement and Operating Agreement, and pay the annual membership fee. For 2023 the membership fee is $25,000. Interested parties should contact us for more information.
The focus of the consortium is on pre-competitive technologies, where pre-competitive is defined here “as collaborations between multiple pharmaceutical companies and third parties designed to produce an efficiency-enhancing advancement or refinement that will ultimately be made broadly available to the public, either through publication, commercialization of a new product, or other means.”[1] Consequently, the development of technologies that are intended to be held as a trade secret by one or more ETC member companies is out of scope for ETC. Projects within the consortium can include the development of new instruments, reagents, computer models or general research workflows, and can involve collaborations between groups of ETC member companies and vendors, academics or government laboratories. Projects with external parties can be zero cost collaborations and sometimes involve ETC funding.
Project teams consist of cross-pharma groups of subject matter experts, thereby ensuring a thorough vetting of new solutions and input on key gaps, desired features or ranking of priorities that is representative of the entire industry, rather than a single company. Project costs are shared among participating companies, leading to significant cost savings. Participation in individual projects is based on interest; not all members are required to participate in each project.
Member companies not participating in a given project receive periodic progress reports, and upon project completion, the outcome of all projects is made available to the entire pharmaceutical industry and other interested parties via scientific publications, the commercialization of new products by vendors and other appropriate mechanisms.
No, any collaboration agreement executed with a vendor or other third party will not include any terms or conditions related to obligation to purchase products. ETC members participating in development projects with external vendors will be obligated to fulfill the terms of the collaboration agreement with that vendor, but once the project is completed, each ETC member can make whatever product-buying decision it deems best for their company.
No, any collaboration agreement executed with a vendor or other third party will not include any terms or conditions related to obligation to purchase products. ETC members participating in development projects with external vendors will be obligated to fulfill the terms of the collaboration agreement with that vendor, but once the project is completed, each ETC member can make whatever product-buying decision it deems best for their company.
The consortium will consider other mechanisms, but the primary path for beginning a project is described above. Please contact us if you have further questions.
As indicated in each RFI, initial responses to RFIs should contain only high level discussions of product development efforts and should not contain trade secrets or confidential information. As the RFI process advances to the RFP stage and as a collaboration partner is selected, ETC does have the ability to create an NDA to ensure that confidential information shared with the project team is not shared more widely.
No. Only members within ETC view responses to an RFI/RFP; responses to an RFI/RFP are not shared among different respondents.
ETC sets a deadline for interested collaborators to submit questions on an RFI to the consortium before responding. ETC will answer these questions promptly and send responses to the interested collaborator. ETC will also anonymize the questions and post them publicly on the website.
It is too early in the ETC history to answer this authoritatively, but there is a mixture of projects of varying complexity, some of which could be completed within 6 months, and others that may take 2 years or more. At this time, we estimate that a 9-18 month timeline will be typical.
The ETC hopes to provide an avenue for streamlined access to the consolidated input from a cross-pharma group of key customers on product design/desired features, etc. In addition, in some projects, ETC project teams can provide project funding, help with the evaluation of prototypes, and provide feedback on design improvements.
The contract for each ETC project will detail licensing, copyrights, ownership of IP, software, prototypes, etc. It should be noted that it is the intention of ETC not to retain IP when engaging in collaborations with third parties in order to allow these new technologies to be commercialized.
No, ETC as an organization will not conduct, support, or participate in a market study. Any third party is welcome to conduct their own market study around any public solicitation by ETC for their own benefit.
