On March 31, 2020, the U.S. Food & Drug Administration (FDA) introduced a specially designed “emergency program”—dubbed the Coronavirus Treatment Acceleration Program (CTAP)—to provide patients with faster access to new COVID-19 treatments. The CTAP allows FDA to “move new therapies to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”
Given the rapidly increasing rate of COVID-19 confirmed cases and fatalities in the United States, efforts to streamline FDA processes may prove crucial to uncovering and delivering viable treatments.
To read the full text of this Duane Morris Alert, please visit the firm website.
By Patrick C. Gallagher, Ph.D. and Sandra G. Stoneman
Emerging growth biotechnology companies often need to rely on third-party vendors and collaborators to fuel their research and development efforts. These vendors and collaborators may perform crucial aspects of the R&D process, such as candidate screening, assay development and validation, and lead generation. To enable this work, biotechnology companies may be required to share their “secret sauce” (or the building blocks to an eventual secret sauce), like antibodies and their targets. The following recommendations should be taken to account when working with third parties to balance the need to advance R&D with limited internal capacity and the need to maintain confidentiality of trade secrets and other proprietary information:
- Strong work-product language—Ensure the contract has strong invention assignment and “work-for-hire” language. Consider calling out specific antibodies and their targets as your “background intellectual property” or your materials.
- Confidentiality—Confidentiality obligations in the contract for trade secrets should survive for so long as the information qualifies as a trade secret under applicable law.
- Subcontracting—Limit the ability of the vendor or collaborator to use subcontractors. Understand the full supply chain and work flow, and the companies involved in each step. For example, often vendors and collaborators want the ability to assign/subcontract to affiliates. If that affiliate not qualified, this could present regulatory and IP protection issues. Make sure you know who will actually have access to your confidential information and proprietary biological material.
- Material transfer—If biological material is being transferred, consider entering into a separate “material transfer agreement” because most contract service agreements may not adequately address protections around sharing of material, and each time biological material is shared there likely will be specific limitations that will be appropriate to specify for the vendor. At a minimum, ensure the contract limits the scope and nature of what the vendor is allowed to do with the biological material. Also ensure that the contract requires return of all physical materials (often, the return obligations only apply to confidential information), and prohibits copying or replication except to the extent necessary for the contracted work.
- Diligence your vendor or collaborator—ask for references, visit their location, periodically exercise audit and inspection rights under the contract.
It almost goes without saying that if a company is going to outsource R&D functions, there is some inherent risk that cannot be eliminated, but a good deal of the risk can be mitigated.
This was originally published in the Food and Drug Law Institute’s Update magazine.
Patient-focused drug development and the selection and development of Clinical Outcome Assessments (COA) continue to be a focus for the U.S. Food and Drug Administration (FDA). At the same time, we continue to see an increase in technology available at our fingertips and on our wrists. As electronic capture of data becomes more robust and systems to ensure its integrity are put into place, FDA has started to embrace electronic clinical outcome assessments (eCOA). This increase opens up a plethora of new data sources that can be used to facilitate and enhance clinical trials, including the use of a study subject’s own devices (a/k/a “bring your own device” (BYOD)). This article discusses eCOA, BYOD, and FDA’s guidance on their use in clinical studies.
For the full article by Frederick R. Ball, Carolyn A. Alenci and Sandra Stoneman, visit the Duane Morris LLP website.