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A friend of mine recently bought a fitness center franchise and she is miserable. She learned that when the center is empty she goes stir-crazy. She likes to have people around her all of the time and can't stand the quiet of the afternoon. On the other hand, my best friend is an engineer an

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

d he happily works at home alone. Some people are outgoing, some enjoy keeping to themselves and others prefer a little of both. In fact, you can classify people into four basic personality types or behavioral styles.

Look around your office and see if you see any of these people. We'll cal

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

Examples of combination products may in

l the first person Dave. Dave likes immediate results and tends not to listen to details before making decisions. He acts quickly and often cuts people off mid-sentence. Or how about Ingrid? Ingrid is optimistic and looks for the best in everyone. She enjoys conversations, networking events

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

nd spreads her influence using her charismatic style. Then there is Stan. Stan is very predictable and patient. He is very loyal to the organization and listens attentively. And finally, we have Catherine. Catherine is interested in accuracy and details. She enjoys working alone and prefers

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

to use diplomacy to solve problems rather than direct confrontation. Each of these people demonstrates one of the four primary behavioral styles:

Dominance: Direct and Decisive. D's are strong-willed, strong-minded people who like accepting challenges, taking action, and getting imm

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

Combination pro

diate results.

Influence: Optimistic and Outgoing. I's are "people people" who like participating on teams, sharing ideas, and energizing and entertaining others.

Steadiness: Sympathetic and Cooperative. S's are helpful people who like working behind the scenes, performing in

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

consistent and predictable ways, and being good listeners.

Conscientiousness: Concerned and Correct. C's are sticklers for quality and like planning ahead, employing systematic approaches, and checking and re-checking for accuracy.

Let's look at Dave first. He fits into 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

he Dominance behavioral style. Dave likes to question the status quo, make quick decisions and solve problems. He is comfortable in an environment that includes power and authority, freedom from supervision and working with a variety of activities. He does have trouble understanding that peo

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

le need people and sometimes has trouble identifying with the group. We need people like Dave because he moves things forward. To be most effective, Dave needs people who can handle the details he often overlooks.

Now on to Ingrid. She's interested in making a favorable impression and enjoy

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

s entertaining friends, coworkers and clients - she easily fits into the Influence style. She is articulate and prefers to talk about her ideas rather than present them in writing. Ingrid enjoys group activities on and off the job and is comfortable talking with just about anyone. Since she

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

always sees the best in people, Ingrid can have trouble making objective evaluations of people and situations. She does not like a lot of details and can appear a little disorganized. But we all benefit from people like Ingrid who encourage us to open up and communicate. She contributes to a

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

Following aspects would a

creative, outgoing and positive working environment. Ingrid needs people who enjoy every-day routines and tasks because these things make her uncomfortable. Stan is more of a steady person. He is extremely patient, likes to help other people and finishes everything he starts. Stan's daily r

dd to the challenges in developing combination products:

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

outine rarely changes; in fact, he doesn't handle sudden changes well at all. Stan is part of the glue that keeps an organization together. Without people like Stan the office or household can be chaotic. Yet Stan's love of routine can slow things down in a fast-paced environment that requir

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

s quick decisions and action.

Catherine is our conscientious person. She's similar to Stan but even more detailed oriented. She thinks analytically, is diplomatic with people and uses a critical approach to analyzing performance. She enjoys working in an environment where she knows what is

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

expected and why. She enjoys mentoring others and using her expertise. Sometimes Catherine can slow projects down by paying too much attention to detail and may seem negative at times. She has a knack for pointing out everything that can go wrong with a project, product or venture. It's impo

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

tant to have people like Catherine because they can see potential problems. Catherine needs to work with people who can help her see the big picture and get her to move when she gets stuck.

So what's the answer? Who is most effective? The answer is that each of us is effective with differen

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

Professional from academic institutions, pharmaceutical industries, health care indust

t people, problems, situations and careers; we each have our own style. So how do you find out what your style is? Behavioral styles are determined using a 28 question survey called the DiSC Profile Indi

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

viduals complete the survey using the self-scored paper booklet or the online version. Online profile results can be used to generate group reports used by organizations to get a better understanding of the organizational culture.

There are several uses for this type of profile. Organizatio

.

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

s use DiSC to improve communication, build effective teams and help people reach their full capabilities. Some also find it valuable in helping sales and customer service people understand different cust

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

omer types. DiSC was developed to offer a practical, self-directed approach with a lot of flexibility. Whether you want to promote more effective communication, build successful teams or just find out what your personality type is the DiSC profile is one of the most effective tools available

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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