Enabling Technologies Consortium™ (ETC) Partner Frequently Asked Questions and Answers (FAQ)
We have created a list of Frequently Asked Questions from our collaboration partners. If you do not see the answer to your question here, please contact us.
What are the purpose and scope of the ETC?
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.
What are the origins of ETC?
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).
What are the origins of ETC?
See our Members page for a list of current consortium members.
How does one become a member of ETC?
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 2018 the membership fee is $20,000. Interested parties should contact us for more information.
What kinds of projects are in scope for the ETC? What are pre-competitive technologies?
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.” 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.
How are project teams assembled and how are costs shared?
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.
Do members not participating in a given project get access to the results? When are results shared outside the ETC organization?
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.
Are members of ETC obligated to purchase products coming from ETC projects?
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.
How are new projects launched? What is the RFI/RFP process and why is this needed?
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 and identify an external partner for collaboration. The 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.
Will ETC consider other mechanisms for launching a project?
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.
Do companies responding to an RFI need a non-disclosure agreement (NDA) with ETC? How does ETC ensure that trade secrets shared in these discussions will not be disseminated?
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.
Are the responses to an RFI/RFP shared among respondents?
No. Only members within ETC view responses to an RFI/RFP; responses to an RFI/RFP are not shared among different respondents.
What is the process for asking questions about an RFI prior to submitting a response?
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.
What is a typical timeline for an ETC project from RFI to completion?
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.
What do vendors get from participation in ETC projects?
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.
Who will own intellectual property, patents, data, etc. resulting from ETC projects?
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.
Will ETC conduct, or support the conduction of, a market study around a proposed project?
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.