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Q. My performance review was disappointing, although I’ve had two promotions in the last four yea

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

rs. My boss said I needed to work on showing more leadership skills when I’m working on a team. W

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

Examples of combination products may in

en I try to pin him down for a discussion, he brushes me aside.

A. As you move up the ladder, yo

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

’ll be expected to work on your own, with less and less feedback and direction.

A lack of feed

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

ack can be a sign that you’re trusted and respected. You’re expected to read between the lines

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

Combination pro

nd interpret unwritten signals.

Start with these three questions:

Q1. What is your company’s cu

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

ture around performance reviews?

In some cultures, you’re expected to take a negative review in

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

stride. Responding will be viewed as defensive and insecure behavior. Other cultures value disc

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

ssion and at least the appearance of openness.

Q2. What signals are you sending?

Your boss ne

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

ds to know that you’re willing to talk tough. You can say something like, “Don’t worry about h

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

rting my feelings. Just share with me anytime, even if it’s something small.” Then act on your

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

Following aspects would a

romise.

You might say, “I’m happy with my review – just trying to learn. Can you give me some

dd to the challenges in developing combination products:

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

specific examples of situations where I could have demonstrated more leadership? And examples o

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

what you’re looking for?”

Q3. What’s the unwritten message?

Your boss may be absolutely deligh

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

ted with your performance, but the rules (formal or informal) require him to include negative a

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

ong with positive feedback. So he threw in some comments about leadership, which don’t amount t

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

Professional from academic institutions, pharmaceutical industries, health care indust

much.

The key is to take your performance review in context. If you’re receiving tangible rec

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

gnition – increased responsibility, invitations to key meetings, attention from major players –

.

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

you’ll appear insecure if you worry about your performance review. But if you’re getting warni

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

Companies that provide selfless information through particip

g signals – missed meetings, weaker assignments – you need to understand what’s really going on

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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