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

ETC membership is limited to companies engaged in the development of new chemical or molecular entities for the prevention, diagnosis, or treatment of disease with at least one active Clinical Trial Application.

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 and fund their project fee account.

Active participants in ETC do not have direct interactions with the ICH. However, individuals within ETC member companies can be identified to facilitate an interaction if appropriate.

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.

Joint proposals from multiple academic institutions and/or commercial organizations will be considered. However, for keeping the execution of the collaboration agreement the simplest the preference is that one institution/organization acts as the primary and have the other be a collaborator/subcontractor. If this is not possible, ETC will provide a multi-way collaboration agreement.

Yes, you can include them in your proposal. ETC recommends/prefers that the collaborator treat their partner(s) as subcontractors/service providers so that the agreements and negotiations are only between ETC and the collaborator, with the collaborator responsible for ensuring that their partner(s) adhere to the terms set forth in the agreement.  However, if this isn’t possible, we can contract with multiple parties. 

Yes, individual project sponsors (i.e., members of ETC) are welcome to collaborate with commercial vendors outside of an ETC project if they so choose to.  The benefits for conducting a project within ETC vs. multiple, individual project sponsors include: collective requirements, single development agreement vs. multi-party agreement, sponsor funding dollars go farther since costs are split over multiple sponsors.  

Yes.  You can sub-contract out any of the work for a project with ETC.  ETC will execute the contract with the 3rd party selected for the project. The 3rd party should include it its budget request to ETC any project costs to be paid to the sub-contractor. The 3rd party would be responsible for payments to the sub-contractor, any delays, or issues relating to the subcontracted work.  

In general, ETC members participating on this project will be available to provide Subject Matter Expertise to support the collaboration through piloting, testing, helping with development, analyzing data, providing feedback, etc. The exact details and support requests from ETC members should be included in the proposal and can be discussed in more detail as part of the proposal evaluation process. Note, typically any samples provided by ETC are non-proprietary, off the shelf samples; if a vendor requires or an ETC member wishes to provide proprietary samples for evaluation, that will be handled and discussed with the individual members as part of the project scoping process.

Unless specified in an RFI/RFP, the funding available for projects isnot determined up front.  Project budgets are dependent on the project proposals received along with interest from ETC members in pursuing a particular project. Respondents should estimate the cost of the project and the total funding sought from ETC.  Historically ETC funding has been in the $0 – $450,000 range spread over 1-3 yrs. but there is no hard limit on the amount of funding.  Once a project is scoped out and a Statement of Work available, the ETC members will determine if there is sufficient interest to fund a particular project and meet the requested funding amount.  The funding provided by ETC to a commercial vendor should be considered seed funding to supplement the total development costs, with the collaboration investing as well since with most projects, all commercialization rights will reside with the collaborator and ETC will not assume ownership of any intellectual property (IP) developed by the collaborator or expect royalties from future commercial sales.

No, the budget for this project has not been set and will be based upon the selected proposal and the interest of ETC members to fund a given proposal

There are no official limits on what the RFP funding can be spent on other than expenses should be related to the project. However, ETC likely will not fund line items related to patent or trademark filings, marketing, or other expenses not directly related to technology development or the project deliverables.

A respondent may include “Indirect costs” in their budget. If a proposal is selected, ETC may further negotiate the total costs to align with available funding being provided by ETC members. Please note that “Direct Costs” in the ETC context includes items such as faculty salaries, postdoctoral and student fellowships, supplies, equipment, travel, etc. It is important that whatever budget proposed represents the final fixed cost to ETC inclusive of any indirect costs.

The budget will be based upon the selected proposal and the interest of ETC members to fund a given proposal. If the available budget is less than what was requested, ETC will look to negotiate the costs to align with the available budget; this negotiation could include reduction of direct costs, indirect costs or scope of the project. Respondents are encouraged to provide a budget that will satisfy the requirements and requested deliverables specified in the RFP.

There is not a predefined or preferred cost sharing percentage dictated by ETC. As stated in the RFP, any funding provided by ETC should be considered seed funding towards the project with the collaborator investing as well. The respondent is responsible for determining how much they wish to invest in the project.

• Our antitrust guidelines prohibit ETC’s members from sharing their purchasing information (i.e., pricing, commitments) with ETC so we cannot comment on this nor will ETC seek to gather this information. Furthermore, ETC will not commit to the purchase of systems by its members following the conclusion of any project. Simply stated, each of our members makes its own purchasing decisions within their companies, with no influence or direction provided by ETC.
• The members of ETC who are participating in this project (listed in the RFI/RFP document) are the companies that initiated this project and could be potential customers of the commercial solution.  However, ETC does not have insight into the information you are requesting, as this is considered market research and as previous stated is something that is outside our scope of activities.

• With regards to interest outside the consortium, given that the projects are based upon the collective needs of the pharmaceutical community it is the goal for the technology derived from any ETC project to be broadly applicable to that community, not just those companies participating in the collaboration. Vendors are encouraged to reach out to any company they wish to conduct their own market research based on the individual input that company may choose to share.

The team is willing to receive a proposal for a product currently on the market. Existing capabilities should be indicated for each requirement in your response

Highly unlikely but given the number of ETC members involved in creating this RFI, it is likely that existing commercial solutions have one or more gaps in their current capabilities and are unable to 100% satisfy the requirements set forth in this RFI.  However, if an existing commercial product is identified that satisfies all the requirements specified then the RFI will have served its purpose and identified a commercial solution. 

Yes, a development instrument to allow ETC members on the project to test and evaluate the technology will likely be needed.  Making the instrument available to ETC members for testing can occur in several ways:  1) shipped and setup onsite at the each of the various companies; 2) setup in regional locations allowing companies to come onsite to test; or 3) system setup at your facility for ETC members to test onsite or send samples for testing.  

Access to proprietary compounds is likely to be company dependent. Certain companies will allow this with a suitable CDA in place, but in some cases, companies would prefer to assess the analytes on site with a beta-test system and share the data back with collaborator. This will be confirmed prior to commencement of any project.

The sharing of analytical data for marketing and white papers is possible but will be project dependent, especially if the project team is looking to present/publish on the project. These requests will be handled on a case-by-case basis.  3rd party collaborators will be invited to co-author/co-present on the project as well.   

The general intent for every ETC project is that the output eventually results in a new commercial product offering to the scientific community.  Through collaboration with multiple ETC members providing collective requirements and feedback to the 3rd party collaborator the goal is that the resulting technology will be fit for purpose and readily adoptable by the industry.  

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.

For projects done in collaboration with ETC, we typically execute our standard NDA with the 3rd party.

These will be supplied to the 3rd party is chosen for the project at the appropriate time.  

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.

While any funding requests can be included in the proposed budget and be considered by ETC, historically ETC has not funded line items related to IP.

It depends if the developed techniques are considered intellectual property or not.   Any IP developed by the collaborator as part of the project will reside with the 3rd party collaborator and it is up to the collaborator to decide how to license this IP unless licensing predetermined during scoping phase and stated in the Statement of Work (SOW) and/or development agreements.  It should be mentioned that ETC in conjunction with the 3rd party collaborator typically publishes the output of projects to peer reviewed journals which will contain the techniques used in the project.  These manuscripts are reviewed and approved by all parties before submission.

ETC has no preference on industrial partners involved during the development and prototyping stage to produce the final product regardless of ETC’s contribution.  It will be up to the collaborator to decide how the final product will be produced.  Typically, any IP developed as part of the project would reside with the collaborator unless any ETC member company IP was included in the project in order to provide the collaborator the greatest flexibility to bring the output of a project available to the greater scientific community as a commercial product offering.

ETC does not have insight into the information you are requesting, as this is considered market research and something that is outside our scope of activities.  The members of ETC who are participating in this project are the companies that are interested in this project and would be potential customers of the commercial solution.

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.