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

ong>making him look bad. We talked over several ways to deal with the situation. My client acknowledged that he knew that some of the options he was considering, though tempting, were vengeful and acc

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

Examples of combination products may in

satory, and would just escalate the tension. He said that he knew he needed to "get his head in the right place" before initiating any discussion. I call this psyching yourself up for the inte

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

action.

What this means is getting your mindset to a place that allows you to approach, listen and interact with the other person from a place of curiosity and self-responsibility, rather tha

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

accusation and blaming. Just how do you psyche yourself up to be there? Wouldn't that just be fooling yourself? What if they ARE out to get you? That's an understandable response.

Your thoughts and conclusio

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

Combination pro

s about the situation may be right on target. But you can't really know for sure until you talk to the person about it. And even if it turns out that you are right, even if they never admit it, approaching the

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

situation in a non-accusatory way will more likely salvage the relationship. And even if you don't necessarily want to salvage the relationship, you will have spoken my truth in a way that is

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

respectful to all parties, even if you believe the other person does not deserve it. So, how do you do that? Below you will find seven key points for psyching yourself up for that difficult conversatio

.

As difficult as these questions may be to answer, take some time to think about your responses. These questions are not meant to get you to back off or take sole responsibility fo

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

what went wrong in the interaction. They are meant to get you to a place where you can compassionately express your concerns and are open to the other person's side of it. Ask yourself:

1.

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

>What do I like about the other person? Does the individual have any redeeming qualities that I can admit, e.g. the person may be picky, but can her passion for attention-to-detail be

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

Following aspects would a

channeled productively into our collaborative efforts?

2. In what ways might this person be right about this situation? Has she touched on something I don't want to

dd to the challenges in developing combination products:

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

dmit I'm responsible for? Maybe I really should have communicated sooner. And even if I don't think so, would it be that difficult to communicate more often or in more detail?

3. Is there mor

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

than one explanation for the other person's behavior? For instance, is she lashing out because she is threatened by my expertise or knowledge? This is not an excuse but an explanation that may help d

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ffuse the intensity of my anger, feeling of betrayal, etc.

4. What assumptions am I making? Do I know she talked about me behind my back?

5. Where might I be wrong? You know, I've been building this

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

story without really checking with her on facts and motivations.

6. What do I value about the relationship? Well, she's not going away. We're going to be working together for

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

Professional from academic institutions, pharmaceutical industries, health care indust

the length of this project, and we need each other's unique expertise.

7. What is the goal? What do I have control over? I know. The only thing I really hav

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

control over is what I do with this. I need to be clear on my intention for the discussion, and my own standards for myself.

Now, you're all ready, right? Don't expect to do this perfectly. Even

.

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

a little effort can make a difference.

Now that you've "gotten your head in the right place," check out the elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

_t.html">next step, where you will learn key techniques for following through on conducting a potentially difficult interaction.

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