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Advice Pool - When Being A Facilitator DOESN'T Help
I talked with a group of internal consultants last week - they felt they had to wear too many hats in their work. They had to be consultants, facilitators, coaches and trainers - sometimes in the same one-hour
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
session. They weren't always sure what role to be in and they felt that all this role-switching was draining them and was decreasing their credibility and effectiveness.
After learning a bit more, I suggeste
After learning a bit more, I suggeste
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
d two things to them:
1) At times they were trying to serve as facilitators when another role would have been more helpful to their clients; and
2) It wasn't switching roles that was causing them trouble - i
1) At times they were trying to serve as facilitators when another role would have been more helpful to their clients; and
2) It wasn't switching roles that was causing them trouble - i
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
was how they were doing it.
I'm suggesting the same may apply to you.
First, let's look at when you and your client group are better off if you don't serve as a facilitator. My colleagues and I have identif
I'm suggesting the same may apply to you.
First, let's look at when you and your client group are better off if you don't serve as a facilitator. My colleagues and I have identif
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ied five different facilitative roles you might fill as you work with a group - facilitator, facilitative consultant, facilitative coach, facilitative trainer, and facilitative leader. All of the roles enable
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
you to use the same core values and ground rules to help a group improve the way it works together, but only the facilitator role requires that you withhold your content information or expertise from the group
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
(what we call being "substantively neutral").
If the group is discussing how to improve sales and you have expertise on the topic or unique information because of your position in the organization, you don't
If the group is discussing how to improve sales and you have expertise on the topic or unique information because of your position in the organization, you don't
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
share any of it. If you don't need to share any content information with the group and if you're not a group member, you can be a facilitator.
But you lose credibility and reduce your effectiveness if you cal
But you lose credibility and reduce your effectiveness if you cal
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
l yourself a facilitator and then start sharing content information, begin offering expertise on the content, or have a stake in the outcome of the conversation. Some group members will feel you are trying to
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
eddle in their work and some will feel you are favoring others' points of view. In short, you are no longer neutral and you've overstepped your bounds.
But there are times when you need to be involved in the
But there are times when you need to be involved in the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
content of the group conversation at the same time you are helping improve its process. There are also times when you have relevant expertise. That's when you use the other roles. All of these other roles allo
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
w you to be involved in the content and still use your facilitative skills.
-If you're a member of the group, you are a facilitative leader. In my definition, you're a facilitative leader as long as you are u
-If you're a member of the group, you are a facilitative leader. In my definition, you're a facilitative leader as long as you are u
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ing the Skilled Facilitator core values and skills while working in your group - even if you're simply a team member.
-If you're not a member of the group and you're helping them solve a problem or address an
-If you're not a member of the group and you're helping them solve a problem or address an
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
d opportunity, you are a facilitative consultant. This role is ideal if you're an OD consultant. It's also great if you're an HR manager and need to share your HR perspective on the group's topic.
-If you nee
-If you nee
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
d to formally teach the group some knowledge or skills, you are a facilitative trainer - you use your facilitative skills to help improve the learning process.
-If you are working one-on-one, you are a facili
-If you are working one-on-one, you are a facili
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ative coach.
In my experience, it's fine - often best - to switch roles to help a group get results; how you do this greatly affects the results you can get for your clients. Here are some guidelines for esta
In my experience, it's fine - often best - to switch roles to help a group get results; how you do this greatly affects the results you can get for your clients. Here are some guidelines for esta
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
blishing and switching roles:
1. Select the appropriate role(s) given what the situation calls for.
2. Reach agreement with your client about the role(s) you will fill to help them, and how you'll switch bet
1. Select the appropriate role(s) given what the situation calls for.
2. Reach agreement with your client about the role(s) you will fill to help them, and how you'll switch bet
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ween them. Give them some examples so they know exactly what this will look like.
3. Before you switch roles, tell the group so they understand what you are doing and explain why you're making the shift.
4.
3. Before you switch roles, tell the group so they understand what you are doing and explain why you're making the shift.
4.
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
f you need to switch to a facilitative role that you haven't obtained agreement on, re-contract on the spot before you fill that role.
If you select the appropriate facilitative roles and explicitly switch am
If you select the appropriate facilitative roles and explicitly switch am
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ong them with permission, you'll bring all of your expertise - content and process - to your clients' challenges.
What do you think? If you'd like to share your thoughts, please email me.
© 2005 Roger Schwar
What do you think? If you'd like to share your thoughts, please email me.
© 2005 Roger Schwar
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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