Small Phase 2 pharma pursuing oncology, stroke and potentially cerebral palsy indications. Need expert regulatory strategy part time but long term. 20 hours a month to start with variation expected. 2023 is a critical year for regulatory strategy- currently running a phase 2, sponsor had tried for a phase 2b transformation trial but FDA requested they stay with phase 2. Most likely will run a PK study due to FDA inquiries. Potential to seek fast track in 2023. Interest in European agency, might pursue study/approval pathway, particularly in the UK.
Required is a regulatory strategist with expertise in all relevant FDA guidance including fast track, as well as UK regulatory approval pathway experience, agency behavior and current thinking, ability to interact effectively with FDA and internal stakeholders, attend FDA meetings, oversee regulatory filings, perform regulatory writing as needed. It is particularly helpful if the expert understands the small pharma connections between regulatory compliance, small pharma funding needs, and bringing new, safe and effective medicines to patients who need them.
Hello! Sheila here, just wanted to provide an update. I’m speaking with the Sponsor tomorrow to collect feedback and ascertain next steps. Any questions or comments please don’t hesitate to reach out to me directly, otherwise I will come back with updates after the call tomorrow (Tues 2/21)
-sheila
Spoke with the sponsor today- they have had a couple of sudden fires to put out involving both the CSO and a different fire for the CEO, so have had to reschedule. Another key stakeholder will be out all of next week, so they are looking to reschedule for the week of March 6- please standby for those calendar items. I’ve also asked Whitney to include me in those emails to keep the communication loop. Till then, any questions or comments please let me know!
thanks
sheia
Hi there, Sheila here. I’ve pinged the sponsor to ask if they are ready to resume discussions, got this back from them yesterday, Monday March 6- “Thank you for touching base. We would definitely like to resume the interview process. Tuesday, Wednesday, and Thursday of next week is when we are shooting for. ”
You should be hearing from Whitney to schedule a call next week. I’ve asked Whitney to cc me on communications so I can see it’s all progressing. Any questions or comments please let me know!
Sincerely,
Sheila
Week of March 13 update! Client is still in the process of scheduling and interviewing potential candidates. There were four submitted, two have been spoken to thus far.
I touched base with Rong this week and got this back- “We are just swamped with clinical initiation and really hope to enroll soon. May I suggest the week of 3/27?” So looks like I should have further updates on this the week of March 27. Will keep you posted. In the meantime, any questions or comments please let me know.
thanks!
-sheila
Sheila here with an update on this regulatory strategist project opportunity. They spoke with 2 of the 4- my understanding is that all four were excellent, they simply started with two and felt confident they found what they needed between them. They are very time strapped so didn’t take it any further at this point. I have a call with them on Friday March 31 to hear their intentions for next steps, will report back then. Any questions or comments please let me know.
Hello from LifeSciHub with an update on this regulatory strategist project opportunity. They spoke with 2 of the 4- my understanding is that all four were excellent, they simply started with two and felt confident they found what they needed between them. They are very time strapped so didn’t take it any further at this point. I have a call with them on Friday March 31 to hear their intentions for next steps, will report back then. Any questions or comments please let me know.
-Sheila