Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I work for a small start-up biotechnology company where I head up business development and partnering. We do not have a formal RA group, so a lot of the regulatory responsibility falls upon me. To be honest, I have enjoyed reading and learning the regulations and it's made more informed at my full-time responsibility.

We are going to embark on a single-center Phase 2a study in health volunteers. We have contracted a major CRO to run our study and we will be in the clinic shortly. I'd like to mention that we have an active IND. When I file the Phase 2a protocol, I'll obviously have to file a Form 1571. I am beginning to question whether or not I have been correctly filling out Field 16 of Form 1571. We do not have a physician employed on staff and we have been putting the name of one of our executive officers (a Ph.D.) in this field. It occurs to me that we probably should put the name of the PI from our CRO (the PI that's on the 1572) in Field 16. We have transferred medical oversight to the CRO.

Is my line of thinking correct?

Dear Anonymous,



------------------------------
Suzanne Sensabaugh
President and Principal Consultant
Hartmannwillner LLC
Washington DC
United States
------------------------------

Original Message:
Sent: 16-May-2017 12:03
From: Anonymous Member
Subject: Form 1571 Question

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I work for a small start-up biotechnology company where I head up business development and partnering. We do not have a formal RA group, so a lot of the regulatory responsibility falls upon me. To be honest, I have enjoyed reading and learning the regulations and it's made more informed at my full-time responsibility.

We are going to embark on a single-center Phase 2a study in health volunteers. We have contracted a major CRO to run our study and we will be in the clinic shortly. I'd like to mention that we have an active IND. When I file the Phase 2a protocol, I'll obviously have to file a Form 1571. I am beginning to question whether or not I have been correctly filling out Field 16 of Form 1571. We do not have a physician employed on staff and we have been putting the name of one of our executive officers (a Ph.D.) in this field. It occurs to me that we probably should put the name of the PI from our CRO (the PI that's on the 1572) in Field 16. We have transferred medical oversight to the CRO.

Is my line of thinking correct?

Dear anonymous,

I agree with most of the replies posted to your inquiry.  Field box # 16 is intended to identify the person or persons responsible for the review and assessment of safety of the drug/biologic under clinical investigation.  Since you have contracted with a CRO,
you should be identifying the assigned medical monitor from the CRO, unless your company has a medically trained person assigned for this responsibility.  Also, please do not underestimate your assigned responsibilities as a study sponsor and as the regulatory representative. Although you have transferred most responsibilities for study conduct to the CRO, your company remains ultimately responsible for the safety of subjects and data integrity. One further point of clarity. You have referred to a PI at the CRO. Usually phase 2 studies are performed at independent study sites who assigns a PI to perform the study (screen subjects, enroll subjects, treat subjects, report, evaluate lab data, adverse events etc.), while the CRO is responsible oversight of the conduct of the study and the collection and reporting of clinical data derived from the study.

If you need further guidance about your responsibilities, I would be please to assist you.

------------------------------
Michael Trapani
Senior Consultant
Biologics Consulting Group, Inc.
Monroe Township NJ
United States
------------------------------

Original Message:
Sent: 17-May-2017 06:07
From: Suzanne Sensabaugh
Subject: Form 1571 Question

Dear Anonymous,

Field 16 of the Form FDA 1571 is the person who is responsible under the regulations for review and evaluation of information relevant to the safety of the drug. I expect this is your PI from your CRO rather than an executive director of the company. So it would be appropriate to put the contact information for this PI in Field 16.

Sincerely yours, Suzanne

------------------------------
Suzanne Sensabaugh
President and Principal Consultant
Hartmannwillner LLC
Washington DC
United States
------------------------------

Original Message:
Sent: 16-May-2017 12:03
From: Anonymous Member
Subject: Form 1571 Question

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I work for a small start-up biotechnology company where I head up business development and partnering. We do not have a formal RA group, so a lot of the regulatory responsibility falls upon me. To be honest, I have enjoyed reading and learning the regulations and it's made more informed at my full-time responsibility.

We are going to embark on a single-center Phase 2a study in health volunteers. We have contracted a major CRO to run our study and we will be in the clinic shortly. I'd like to mention that we have an active IND. When I file the Phase 2a protocol, I'll obviously have to file a Form 1571. I am beginning to question whether or not I have been correctly filling out Field 16 of Form 1571. We do not have a physician employed on staff and we have been putting the name of one of our executive officers (a Ph.D.) in this field. It occurs to me that we probably should put the name of the PI from our CRO (the PI that's on the 1572) in Field 16. We have transferred medical oversight to the CRO.

Is my line of thinking correct?

Dear Anonymous - it is perfectly acceptable to put the name of the person medically and/or the safety officer responsible at the CRO in Box 16.  I take it that you will include with the 1571 a transfer of obligations list with the 1571 that will show that the CRO is responsible for safety evaluations.  There is also no problem with putting your executive with the PhD as long as that person will take responsibility for evaluation of safety of the product.

Glen

------------------------------
Glen Park
Scynexis, Inc.
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 16-May-2017 12:03
From: Anonymous Member
Subject: Form 1571 Question

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I work for a small start-up biotechnology company where I head up business development and partnering. We do not have a formal RA group, so a lot of the regulatory responsibility falls upon me. To be honest, I have enjoyed reading and learning the regulations and it's made more informed at my full-time responsibility.

We are going to embark on a single-center Phase 2a study in health volunteers. We have contracted a major CRO to run our study and we will be in the clinic shortly. I'd like to mention that we have an active IND. When I file the Phase 2a protocol, I'll obviously have to file a Form 1571. I am beginning to question whether or not I have been correctly filling out Field 16 of Form 1571. We do not have a physician employed on staff and we have been putting the name of one of our executive officers (a Ph.D.) in this field. It occurs to me that we probably should put the name of the PI from our CRO (the PI that's on the 1572) in Field 16. We have transferred medical oversight to the CRO.

Is my line of thinking correct?

Original Message------

Dear Anonymous - it is perfectly acceptable to put the name of the person medically and/or the safety officer responsible at the CRO in Box 16.  I take it that you will include with the 1571 a transfer of obligations list with the 1571 that will show that the CRO is responsible for safety evaluations.  There is also no problem with putting your executive with the PhD as long as that person will take responsibility for evaluation of safety of the product.

Glen

------------------------------
Glen Park
Scynexis, Inc.
Jersey City NJ
United States
------------------------------

Original Message------

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I work for a small start-up biotechnology company where I head up business development and partnering. We do not have a formal RA group, so a lot of the regulatory responsibility falls upon me. To be honest, I have enjoyed reading and learning the regulations and it's made more informed at my full-time responsibility.

We are going to embark on a single-center Phase 2a study in health volunteers. We have contracted a major CRO to run our study and we will be in the clinic shortly. I'd like to mention that we have an active IND. When I file the Phase 2a protocol, I'll obviously have to file a Form 1571. I am beginning to question whether or not I have been correctly filling out Field 16 of Form 1571. We do not have a physician employed on staff and we have been putting the name of one of our executive officers (a Ph.D.) in this field. It occurs to me that we probably should put the name of the PI from our CRO (the PI that's on the 1572) in Field 16. We have transferred medical oversight to the CRO.

Is my line of thinking correct?

Yes - you are correct that the 1571 should state who is doing the safety monitoring.
Don't forget to also include the "Transfer of Regulatory Obligations" - it may be an extensive list that can be a separate attachment. It goes with Box 14...

Good luck

------------------------------
Shannon Wehrendt RAC, MA
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 16-May-2017 12:03
From: Anonymous Member
Subject: Form 1571 Question

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I work for a small start-up biotechnology company where I head up business development and partnering. We do not have a formal RA group, so a lot of the regulatory responsibility falls upon me. To be honest, I have enjoyed reading and learning the regulations and it's made more informed at my full-time responsibility.

We are going to embark on a single-center Phase 2a study in health volunteers. We have contracted a major CRO to run our study and we will be in the clinic shortly. I'd like to mention that we have an active IND. When I file the Phase 2a protocol, I'll obviously have to file a Form 1571. I am beginning to question whether or not I have been correctly filling out Field 16 of Form 1571. We do not have a physician employed on staff and we have been putting the name of one of our executive officers (a Ph.D.) in this field. It occurs to me that we probably should put the name of the PI from our CRO (the PI that's on the 1572) in Field 16. We have transferred medical oversight to the CRO.

Is my line of thinking correct?

I will chime in to agree that the CRO probably has a medical monitor assigned to your study.  If so, this person's name should be entered in this field. 

Whether or not the CRO is going to provide medical monitoring (or any other service) depends on what is in your agreement with the CRO.  If your agreement does not include medical monitoring (or any other service), the CRO is not obligated to provide it.  In that case, you should find someone medically qualified to review the adverse event data.  You can probably find individuals on LinkedIn who offer this service, but if the CRO will provide it, that's often more efficient.  I would have expected the CRO to include this service in your agreement as a matter of course, because then they get paid to do it (how do you think they became "major"?), leaving it to you to decline it if you don't want them to provide it.

CROs are critical suppliers and should be evaluated, selected, and managed as such.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 16-May-2017 12:03
From: Anonymous Member
Subject: Form 1571 Question

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I work for a small start-up biotechnology company where I head up business development and partnering. We do not have a formal RA group, so a lot of the regulatory responsibility falls upon me. To be honest, I have enjoyed reading and learning the regulations and it's made more informed at my full-time responsibility.

We are going to embark on a single-center Phase 2a study in health volunteers. We have contracted a major CRO to run our study and we will be in the clinic shortly. I'd like to mention that we have an active IND. When I file the Phase 2a protocol, I'll obviously have to file a Form 1571. I am beginning to question whether or not I have been correctly filling out Field 16 of Form 1571. We do not have a physician employed on staff and we have been putting the name of one of our executive officers (a Ph.D.) in this field. It occurs to me that we probably should put the name of the PI from our CRO (the PI that's on the 1572) in Field 16. We have transferred medical oversight to the CRO.

Is my line of thinking correct?

Original Message------

I will chime in to agree that the CRO probably has a medical monitor assigned to your study.  If so, this person's name should be entered in this field. 

Whether or not the CRO is going to provide medical monitoring (or any other service) depends on what is in your agreement with the CRO.  If your agreement does not include medical monitoring (or any other service), the CRO is not obligated to provide it.  In that case, you should find someone medically qualified to review the adverse event data.  You can probably find individuals on LinkedIn who offer this service, but if the CRO will provide it, that's often more efficient.  I would have expected the CRO to include this service in your agreement as a matter of course, because then they get paid to do it (how do you think they became "major"?), leaving it to you to decline it if you don't want them to provide it.

CROs are critical suppliers and should be evaluated, selected, and managed as such.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------