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Mark has been in his current position for about a year. He is Vice President for Academic Affairs at a small liberal arts college in the Northeast. His boss is th

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

e president of the college, and his direct reports are the deans and directors of academic programs. His goal: to change a culture. In the one he's now in, there'

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

Examples of combination products may in

a fairly high degree of mistrust and behavior ranging from vaguely disrespectful to openly adversarial. Our colleagues and clients in higher education report tha

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

t this type of environment is common. The vision Mark holds is a culture of collaboration and appreciation for the important role each person has to play.

Recent

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

y, there was an upset, the kind of fire that happens in every organization. In the Computer Science program, the faculty had decided to raise standards for gradua

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

Combination pro

ion. Students who had begun the program were upset. Faculty felt strongly that the new standards were justified and necessary for the integrity of the program.

M

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

ark immediately arranged meetings with both the faculty and the students. The day before, one of the faculty members came in with concerns. He was tense and jitte

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

y, his body language indicating that he didn't trust that he would be supported.

That Tuesday, Mark met first with the faculty. He invited everyone to speak, giv

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

ng each his full attention. He listened from an attitude of inclusiveness and respect, and he listened for what was important to each person. He asked questions s

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

ourced from what he was hearing. Then he and the faculty met individually with each of the ten students involved, providing them with a status report and the oppo

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

tunity for input.

The end results:

- The faculty decided to allow students who had begun the program under one set of standards to finish under that same set.

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

Following aspects would a

The faculty felt validated and supported.

- The faculty felt that their standards had been upheld and the integrity of the program was in tact.

- The students

dd to the challenges in developing combination products:

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

felt heard and supported.

- The students were in agreement with the decisions about their grades.

Indications that the culture is changing:

- The faculty membe

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

who had come to Mark's office tense and concerned was visibly relaxed and indicated he felt supported.

- Instead of leaving him terse notes, one of his direct r

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

ports is coming in to speak with him when she has something to say.

- The Computer Science Program has undergone a great deal of turbulence, and the woman in cha

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

rge of it spoke to Mark's boss and acknowledged Mark's ability to navigate the challenges.

People are appreciating Mark's contributions - improving processes, in

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

Professional from academic institutions, pharmaceutical industries, health care indust

lusiveness, an orientation of collaboration, and his modeling of respect. The cornerstone to the progress, one of Mark's core strengths, is his listening. He is a

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

powerful model of leading by listening.

Your culture may not be as adversarial as the one Mark walked into - and it may have aspects of it. What's the thorny sit

.

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

uation in your workplace that could use some good old fashioned listening right now? Can you move into listening without knowing the outcome first, open to what m

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

Companies that provide selfless information through particip

ght develop? Can you go in knowing that you want the best possible outcome yet without attachment to what that might be? Give it a try and let us know how it goes

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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