MichBio, in partnership with BIO, is seeking participants to provide input for a first-of-its-kind survey tool on FDA/Sponsor Interactions During Drug Development.
Please read below to learn about what benefits will be made available to survey participants and how this information will serve to better inform policy initiatives designed to improve FDA and drug sponsor interactions during drug development. This is a new type of real-time survey initiative, and participants will have access to the survey tool 24 hours a day, 7 days a week so that responses can be updated on a continuous basis.
Participants will be asked to provide responses about individual clinical programs for products that are currently at any point from the pre-clinical testing phase through the clinical testing phase, prior to submission of an initial NDA/BLA (responses will be blinded, and aggregated; see Privacy Information below). We ask that a company representative be designated as the lead responder for each clinical program included in your response. YOU DO NOT HAVE TO BE A BIO MEMBER COMPANY TO PARTICIPATE.
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Your participation and input to this survey will serve 3 high-priority goals:
Enable BIO to inform FDA in “real time” about FDA-sponsor interactions during drug development, i.e., prior to submission of the initial NDA/BLA. Note that FDA has requested this type of data to help them identify and address problems, particularly those that result from inconsistencies between review divisions.
This information will be a key factor in BIO’s ability to:
Identify areas where policies, regulations, and practices are working well for sponsors and should not be changed; and
Identify areas where policies, regulations, and practices need improvement in order to make the process more efficient and effective.
This will serve to inform industry/FDA prescription drug user fee negotiations that will begin in 2015 and continue through 2017.
Benefits for Participants
Participants will be provided with, at minimum, an annual report on the survey results. BIO will analyze the data at least twice a year (summer and late fall) for the next few years.
Participants will be able to download their individual surveys and share them with other members of their company to discuss and compare notes. We encourage companies to have multiple participants, with each participant providing information on different clinical programs. It is to your company’s benefit to input all data so you may receive a comprehensive report.
Participants will be invited to exclusive webinars where BIO will discuss survey results and invite panelists from companies as well as other regulatory experts. During these webinars, survey participants will be able to submit questions and comments to BIO and other participants.
Protection of Privacy
This survey will be conducted and maintained by a third-party contractor that will be prohibited from sharing individual survey responses with anyone.
Participants will be instructed to not provide names of products or molecules.
Individual surveys can only be accessed with a user name and password. (It is up to each individual participant whether to share log-in information with other people in the company, to assist in filling out the survey or for other reasons.)
BIO will only have access to aggregated data. We will know which companies are participating but will not have access to individual responses. BIO will use e-mail addresses of participants solely for the purpose of reminders about the survey and inviting them to special events, such as those described above.
The third-party contractor will also ensure cyber protection of database.
If you have questions regarding the third-party contractor’s abilities to protect privacy please contact Merrill Raman at firstname.lastname@example.org.