Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all
I am looking for regulatory consultant or CRO with expertise in regulatory review of promotional material for biologics in the US. I need someone who is specialized in this area. Do any of you have experience in using consultants for this specific type of task, or do you use only in-house resources? What are the down-side of using consultant / CRO compared to in-house?
Thanks!

Hi Anon.

While I don't work currently in biologics, I can provide some of my insight on these issues I think more generally.  My preference has always been to keep decision making on things like promo materials in-house.  Couple of key reasons:

1. Many consultants tend to be more "risk averse" because they have a certain level of specific individual liability if they provide you with answers or advice that is less than accurate or that might not be completely updated.
2. No consultant, in my opinion, can ever truly understand the risk posture of any individual company that they do not currently work for.  This is not a negative in any way - just a statement of fact because the consultant is typically not around the business enough to truly understand what the business is willing to risk and where the business might "draw that line" never to be crossed.
3. Ultimately, the company will always own the information on their own product(s) so even if I depend on a highly skilled, highly credentialed, highly experienced consultant, if there are any problems with the document or the advertisement or anything - it is still ultimately my neck in the noose.

Before all of my consultant friends throw daggers at me, let me say explicitly that I believe there is a very necessary place for consultants in the industry.  Often we need specific information or experience or simply just an extra set of eyes for making sure the industry is moving in the right direction.  More importantly the good consultants I have dealt with also bring the "best practices" mindset to their consultancies which has helped me significantly in some instance and I hope that they have also been able to glean some ideas from my processes to help other companies they work with in their businesses.​

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 30-Jan-2019 09:27
From: Anonymous Member
Subject: Regulatory review of promotional material

This message was posted by a user wishing to remain anonymous

Hi all
I am looking for regulatory consultant or CRO with expertise in regulatory review of promotional material for biologics in the US. I need someone who is specialized in this area. Do any of you have experience in using consultants for this specific type of task, or do you use only in-house resources? What are the down-side of using consultant / CRO compared to in-house?
Thanks!

At really small companies I have used consultants, but if possible I prefer to keep in house. Even when done in-house, I tend to use consultants periodically for the "lay of the land" - what is evolving around FDA expectations, what the industry broadly is doing etc, but it usually works better to deal with the specifics in-house. Why? A couple reasons.

1) in house personnel only work with their products, so they can know them, and their related scientific data, much better than an outside person;
2) an in-house person has a much better feel for the company's "risk comfort" level and ability to balance regulatory risks with other risks, be they business, safety etc etc. It is prohibitively hard for someone who is not involved in the day to day business of the company to get a feel for this and this is probably the most important reason.
3) understanding of the background behind any unique regulatory commitments or situations - be it negotiations and concerns in the pre-market process, post-market safety situation etc

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 30-Jan-2019 09:27
From: Anonymous Member
Subject: Regulatory review of promotional material

This message was posted by a user wishing to remain anonymous

Hi all
I am looking for regulatory consultant or CRO with expertise in regulatory review of promotional material for biologics in the US. I need someone who is specialized in this area. Do any of you have experience in using consultants for this specific type of task, or do you use only in-house resources? What are the down-side of using consultant / CRO compared to in-house?
Thanks!

I agree with you Ginger and for all the reasons that you mentioned. My experience with consultants would be when we have peak volumes and tight timelines. A consultant in that field and expertise within an established process (Advertising Review Committee, weekly review cycles, etc.) and environment can hit the ground running to help out with deliverables. 

Just out of curiosity: a quick look on Linkedin shows about 750k professionals with "Regulatory Affairs" as title and about 40k only with title containing "Advertising and Promo" specifically. Further search with "biologics" shows very few still so this should give an indication of how many people have this expertise in general.

------------------------------
Jennifer Ng Ain Kin
WW Regulatory Affairs, Advertising and Promotion
Santa Clara CA
United States
------------------------------

Original Message:
Sent: 31-Jan-2019 11:08
From: Ginger Glaser
Subject: Regulatory review of promotional material

At really small companies I have used consultants, but if possible I prefer to keep in house. Even when done in-house, I tend to use consultants periodically for the "lay of the land" - what is evolving around FDA expectations, what the industry broadly is doing etc, but it usually works better to deal with the specifics in-house. Why? A couple reasons.

1) in house personnel only work with their products, so they can know them, and their related scientific data, much better than an outside person;
2) an in-house person has a much better feel for the company's "risk comfort" level and ability to balance regulatory risks with other risks, be they business, safety etc etc. It is prohibitively hard for someone who is not involved in the day to day business of the company to get a feel for this and this is probably the most important reason.
3) understanding of the background behind any unique regulatory commitments or situations - be it negotiations and concerns in the pre-market process, post-market safety situation etc

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 30-Jan-2019 09:27
From: Anonymous Member
Subject: Regulatory review of promotional material

This message was posted by a user wishing to remain anonymous

Hi all
I am looking for regulatory consultant or CRO with expertise in regulatory review of promotional material for biologics in the US. I need someone who is specialized in this area. Do any of you have experience in using consultants for this specific type of task, or do you use only in-house resources? What are the down-side of using consultant / CRO compared to in-house?
Thanks!

This message was posted by a user wishing to remain anonymous

Dear Ginger
Thank you very much for your insights. I am in a really small company, and currently we do not have the in-house regulatory expertise in this area, nor do we have enough work for a full time position. I thus probably will take the chance with a regulatory consultant to begin with. I have been looking around, but it seems pretty hard to find expert consultants for this type of work; do you know how I can search for this / where to look?
Much appreciated!
Best, Ricky
Original Message:
Sent: 31-Jan-2019 11:08
From: Ginger Glaser
Subject: Regulatory review of promotional material

At really small companies I have used consultants, but if possible I prefer to keep in house. Even when done in-house, I tend to use consultants periodically for the "lay of the land" - what is evolving around FDA expectations, what the industry broadly is doing etc, but it usually works better to deal with the specifics in-house. Why? A couple reasons.

1) in house personnel only work with their products, so they can know them, and their related scientific data, much better than an outside person;
2) an in-house person has a much better feel for the company's "risk comfort" level and ability to balance regulatory risks with other risks, be they business, safety etc etc. It is prohibitively hard for someone who is not involved in the day to day business of the company to get a feel for this and this is probably the most important reason.
3) understanding of the background behind any unique regulatory commitments or situations - be it negotiations and concerns in the pre-market process, post-market safety situation etc

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 30-Jan-2019 09:27
From: Anonymous Member
Subject: Regulatory review of promotional material

This message was posted by a user wishing to remain anonymous

Hi all
I am looking for regulatory consultant or CRO with expertise in regulatory review of promotional material for biologics in the US. I need someone who is specialized in this area. Do any of you have experience in using consultants for this specific type of task, or do you use only in-house resources? What are the down-side of using consultant / CRO compared to in-house?
Thanks!

Hello Ricky,

Please feel free to tap me for Ad/Promo Regulatory Consultants with extensive review experience interacting with OPDP. I have a network of these folks.

Hope this helps,
Lindsey

------------------------------
Lindsey Summers, MBA
Director, Pharmaceutical Consulting Division Green Key Resources, LLC
Denver, CO
Direct: 720.543.8692
Mobile: 303.437.0391
lsummers@greenkeyllc.com
www.linkedin.com/in/lindseysummers

http://www.greenkeyllc.com/ph/

Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

*Receive up to1500 for referring a colleague*

Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.
------------------------------

Original Message:
Sent: 01-Feb-2019 04:24
From: Anonymous Member
Subject: Regulatory review of promotional material

This message was posted by a user wishing to remain anonymous

Dear Ginger
Thank you very much for your insights. I am in a really small company, and currently we do not have the in-house regulatory expertise in this area, nor do we have enough work for a full time position. I thus probably will take the chance with a regulatory consultant to begin with. I have been looking around, but it seems pretty hard to find expert consultants for this type of work; do you know how I can search for this / where to look?
Much appreciated!
Best, Ricky
Original Message:
Sent: 31-Jan-2019 11:08
From: Ginger Glaser
Subject: Regulatory review of promotional material

At really small companies I have used consultants, but if possible I prefer to keep in house. Even when done in-house, I tend to use consultants periodically for the "lay of the land" - what is evolving around FDA expectations, what the industry broadly is doing etc, but it usually works better to deal with the specifics in-house. Why? A couple reasons.

1) in house personnel only work with their products, so they can know them, and their related scientific data, much better than an outside person;
2) an in-house person has a much better feel for the company's "risk comfort" level and ability to balance regulatory risks with other risks, be they business, safety etc etc. It is prohibitively hard for someone who is not involved in the day to day business of the company to get a feel for this and this is probably the most important reason.
3) understanding of the background behind any unique regulatory commitments or situations - be it negotiations and concerns in the pre-market process, post-market safety situation etc

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 30-Jan-2019 09:27
From: Anonymous Member
Subject: Regulatory review of promotional material

This message was posted by a user wishing to remain anonymous

Hi all
I am looking for regulatory consultant or CRO with expertise in regulatory review of promotional material for biologics in the US. I need someone who is specialized in this area. Do any of you have experience in using consultants for this specific type of task, or do you use only in-house resources? What are the down-side of using consultant / CRO compared to in-house?
Thanks!

I sit on several professional committees made up of one person with a legal, medical, and regulatory background. This LMR committee reviews all promotional material, sales training, labeling, TV and radio ads, and any other labeling that is used in the company. I would recommend you may wish to try this. This is not a solicitation and I will be happy to furnish any information to help you get started.

------------------------------
Robert Schiff PhD, RAC, CQA, FRAPS
CEO
Schiff & Company, Inc.
1120 Bloomfield Ave., Suite 103
West Caldwell, NJ 07006
rschiff13@aol.com
973-568-3361
------------------------------

Original Message:
Sent: 01-Feb-2019 04:24
From: Anonymous Member
Subject: Regulatory review of promotional material

This message was posted by a user wishing to remain anonymous

Dear Ginger
Thank you very much for your insights. I am in a really small company, and currently we do not have the in-house regulatory expertise in this area, nor do we have enough work for a full time position. I thus probably will take the chance with a regulatory consultant to begin with. I have been looking around, but it seems pretty hard to find expert consultants for this type of work; do you know how I can search for this / where to look?
Much appreciated!
Best, Ricky
Original Message:
Sent: 31-Jan-2019 11:08
From: Ginger Glaser
Subject: Regulatory review of promotional material

At really small companies I have used consultants, but if possible I prefer to keep in house. Even when done in-house, I tend to use consultants periodically for the "lay of the land" - what is evolving around FDA expectations, what the industry broadly is doing etc, but it usually works better to deal with the specifics in-house. Why? A couple reasons.

1) in house personnel only work with their products, so they can know them, and their related scientific data, much better than an outside person;
2) an in-house person has a much better feel for the company's "risk comfort" level and ability to balance regulatory risks with other risks, be they business, safety etc etc. It is prohibitively hard for someone who is not involved in the day to day business of the company to get a feel for this and this is probably the most important reason.
3) understanding of the background behind any unique regulatory commitments or situations - be it negotiations and concerns in the pre-market process, post-market safety situation etc

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 30-Jan-2019 09:27
From: Anonymous Member
Subject: Regulatory review of promotional material

This message was posted by a user wishing to remain anonymous

Hi all
I am looking for regulatory consultant or CRO with expertise in regulatory review of promotional material for biologics in the US. I need someone who is specialized in this area. Do any of you have experience in using consultants for this specific type of task, or do you use only in-house resources? What are the down-side of using consultant / CRO compared to in-house?
Thanks!

Original Message------

This message was posted by a user wishing to remain anonymous

Dear Ginger
Thank you very much for your insights. I am in a really small company, and currently we do not have the in-house regulatory expertise in this area, nor do we have enough work for a full time position. I thus probably will take the chance with a regulatory consultant to begin with. I have been looking around, but it seems pretty hard to find expert consultants for this type of work; do you know how I can search for this / where to look?
Much appreciated!
Best, Ricky

This message was posted by a user wishing to remain anonymous

I have been doing promotional review as a contractor for small companies (as few as 12 employees) for the last decade.  Most of the products have been biologics.  I had previously worked for a big Pharma company in the vaccines unit, so I was familiar with the biologics.  In two instances, I was meant to fill in temporarily because someone had left.  I am still working as a contractor 4 years later at one company because they are so happy with the fit and my work.  Another company has been using me as a contractor for over 3 years and sought special permission to keep me on the job after the company had indicated that the use of contractors should be discontinued.  They felt that I had a real knowledge of and feel for the issues related to the product, and I had been on the committee so long that I could bring a historical perspective to the decisions made previously.

I believe that I am serving the clients needs, not dictating to them what they should do.  I assess and analyze the situation and give them the best advice and recommendations that I can.  I always explain the basis for my advice and put it into context, e.g., is it a regulation or a Guidance that I am relying on to reach the conclusion.  We work in partnership, and I do not make the decision, the client does that.  I just support their decision-making by supplying knowledge and context.  

This sort of working relationship necessitates my interacting with several disciplines to get input, documents and perspectives.  While I am not "part of the company"  I have a deep knowledge of the product and people who I can call on to assist me with my analysis.  So I think using a contractor, the right contractor, can work.
Original Message:
Sent: 01-Feb-2019 04:24
From: Anonymous Member
Subject: Regulatory review of promotional material

This message was posted by a user wishing to remain anonymous

Dear Ginger
Thank you very much for your insights. I am in a really small company, and currently we do not have the in-house regulatory expertise in this area, nor do we have enough work for a full time position. I thus probably will take the chance with a regulatory consultant to begin with. I have been looking around, but it seems pretty hard to find expert consultants for this type of work; do you know how I can search for this / where to look?
Much appreciated!
Best, Ricky
Original Message:
Sent: 31-Jan-2019 11:08
From: Ginger Glaser
Subject: Regulatory review of promotional material

At really small companies I have used consultants, but if possible I prefer to keep in house. Even when done in-house, I tend to use consultants periodically for the "lay of the land" - what is evolving around FDA expectations, what the industry broadly is doing etc, but it usually works better to deal with the specifics in-house. Why? A couple reasons.

1) in house personnel only work with their products, so they can know them, and their related scientific data, much better than an outside person;
2) an in-house person has a much better feel for the company's "risk comfort" level and ability to balance regulatory risks with other risks, be they business, safety etc etc. It is prohibitively hard for someone who is not involved in the day to day business of the company to get a feel for this and this is probably the most important reason.
3) understanding of the background behind any unique regulatory commitments or situations - be it negotiations and concerns in the pre-market process, post-market safety situation etc

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 30-Jan-2019 09:27
From: Anonymous Member
Subject: Regulatory review of promotional material

This message was posted by a user wishing to remain anonymous

Hi all
I am looking for regulatory consultant or CRO with expertise in regulatory review of promotional material for biologics in the US. I need someone who is specialized in this area. Do any of you have experience in using consultants for this specific type of task, or do you use only in-house resources? What are the down-side of using consultant / CRO compared to in-house?
Thanks!

message deleted