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There's a lot to think about when you need to initiate a difficult interaction -- the kind of discussion that is required when a colleague is taking credit for your ideas, is not delivering on their part or is just plain making you look bad.

Before proceeding you might want to check out my article on helping to "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

://artemispath.typepad.com/eborders/2004/09/psyching_yourse.html">get your head in the right place," which is a process to help you get to a place where you can compassionately express your concern and remain open to the other person's side of it.

Once you've gotten yourself in the right frame of mind, it's time to plan the actual discussion. For the purposes of this

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

exercise, we'll call the colleague that we'll be interacting with, Jackie. Keep in mind that the goals for this process include: a) learning more about Jackie's perspective (even if you don't like it), b) approaching her in a way that is respectful of you both, and c) for the troubling behavior to stop.

1. Request time and attention.

Rather than just dro

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

p by and ask Jackie, "Can I talk to you?" it can help to first to ask her for 15-20 minutes of her time. This way she knows you want to have a substantive conversation and you know Jackie is willing to invest the time in this conversation. If she says yes, but seems rushed or preoccupied, ask if there is a better time, and nail down a time/day for an appointment. If Jackie says that this ti

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

me is fine, you can reflect to her that she seems preoccupied, and that you'll just make an appointment. You can make choices here. Even if she insists that you stay, you can defer the conversation at any time, if you are feeling you do not have her attention. You deserve it.

2. Come from curiosity and humility.

The interaction I just described in tip #1

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

can escalate quickly if you come across as demanding, accusatory, condescending or defensive. It is important to balance your right to express your concern, and respect that Jackie perhaps has a valid point of view too. If you want to increase the chances the relationship will be preserved, you will want to approach the reconciliation process in a way that does not create

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

more tension.

3. Express your positive intention.

Tell Jackie why you are there, and give her a reason to want to be there too. For instance,

"Jackie, there something that has been happening between us that has been bothering me. I value working with you and want to continue to make that work. So, I didn't want to draw any conclusions about what I've ex

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

perienced, without talking to you."

4. Describe the troubling behavior specifically.

"Jackie, I notice that after I agree to a particular task at a project meeting, you ask me the next day if I've gotten started on it."

It's important to use neutral, not loaded, language, so the interaction isn't intensified unnecessarily. Describe facts, not opinions or

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

interpretations at this point.

5. Check your assumption.

This is the time to offer your interpretation. At the same time you want to give Jackie room to offer an explanation and/or save face. This step might go like this.

"It's happened more than once and I'm left feeling like I've done something that makes you think I can't be counted

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

on to follow-through. I don't want to assume that though. I thought I should check it out with you. Can you tell me about this?"

6. Listen.

This is important... stop speaking for a few moments. Endure some awkward silence if you really want to hear an answer. You may hear just about anything, such as,

a. "I don't know what you're talking

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

bout."

b. "I'm so sorry I've left you feeling that way. I guess I'm just feeling under the gun given this is a high-visibility project."

c. "You're right. I do feel like I have to keep after you to get things done."

Here's where tip #7 comes in handy.

7. Own what is yours, no more, no less.

Reminder - be curious and humble!!

(Below are potential responses

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

to guide you, which correspond with Jackie's responses above.)

a. "I'm glad that you consider me someone you can count on then. Is there some other reason you check with me regularly?"

b. "I appreciate you sharing that with me. What can I do to relieve some of your concern?"

c. "What is it that I do that makes you feel that way?"

More for item c. Listen

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

. If necessary, follow with, "Is there a specific experience that brought you to that conclusion?" Listen more. Then if appropriate, "What can I do from now on to remedy that?"

You don't have to get her to admit that she is micromanaging. Consider instead what you are learning from the exchange.

8. Use a backup plan if necessary.
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
>

If the discussion just continues down the path of Jackie's responses 6a or 6c, without producing anything helpful, you can always wrap it up with something like this.

"Our relationship is important to me, and I needed you to know I was feeling this way. I would rather share this with you than keep it from you, to increase our chances of working together better. Thank yo
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
u for your time."

Though not completely satisfying, at least you more clearly know what you can expect from Jackie. And, don't give up all hope. I have found that even when someone like Jackie will not acknowledge anything is amiss, that she will stop the behavior, particularly if I check in with her occasionally over time, regarding the same concern.

9. Make plan
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
s to move forward.

If it IS a fruitful interchange, suggest how you can go forward. Possibilities include:

Ask her what she would like you to do differently from now on.

Offer what you are willing to do.

Express what you would like her to do.

Only agree to what you really are willing to do.

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
i>Don't be afraid to offer a counter-proposal.
Tell Jackie you need time to think about a particular request, if necessary.

Plan to regroup together at a later time.

10. Solidify agreement and offer thanks.

Be sure to summarize. This may include articulating:

Agreemen
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t on how to go forward, including what actions each of you will take as a result of this discussion.
Agreement to not let an issue exist between you for so long next time.

Your appreciation for the other person's honesty, willingness to be open, and time.

If you feel Jackie is just "going along" with you to avoid what
.

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
might be an uncomfortable exchange for her, and she does not follow through with her agreements, you can always follow up with tip #8 eventually.

Though these comments may feel awkward or sound silly at first, remember that it takes time to change your behavior. Practice your response - in front of a mirror, with a friend or even into a tape recorder - until the wo
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
rds, and the feelings behind them, seem natural to you. The point is to be able to approach the situation in a way that is mostly likely going to result in a mutually agreeable resolution, without allowing the other person's potentially resistant responses to derail you. We can all use practice doing that!

Copyright 2002-2006, Mary C. Schaefer, all rights reserved

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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