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Several years ago, I took over the supervision of a section in a Public Agency. I was a newbie in management, enthusiastic, and excited about the opportunity that lay before me. I was informed by my manager that I had a problem employee on my team. He described her as

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

unpleasant, resistant, not a team player and told me that I would have my hands full managing her. He stated that she had been forced upon him by another department and now we had to deal with her. I listened and filed his comments.

Within the first few months,I met wi

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

Examples of combination products may in

th each of my team and talked with them about my philosophy, expectations I had for the department, and engaged them in discussion about their future career plans. The problem employee was not very forthcoming and I sensed the resistance that I had been warned about. Th

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

oughout the next year, I continued to engage her in conversation, even if she was noncommittal. I paid close attention to her work product. In my observation, I noticed that she was exceptionally bright and productive. But her demeanor had led my manager and others to f

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

orm a negative opinion.

I began to look for special projects, that were in alignment with her skills and assigned them to her. She excelled beyond my expectations with each project. At one point, she began coming to me with suggestions for projects that she wanted to

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

Combination pro

manage. I had discovered a diamond in the rough. I suspected that she was a long term public employee who had not had the right management support to be successful. She had been given a tag of problem employee and put in the corner to waste away. What a disservice to he

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

r and the agency.

Over the years, as we worked together our relationship continued to build as one of mutual trust, respect and support. I continued to promote her abilities to others whenever the opportunity arose. She continued to be an asset to the company.

Managin

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

g your company's most valuable resource (people) can provide challenging and rewarding opportunities for your own professional development and growth. The manager must find creative solutions to promote the best in each of their employees. Mentoring employees who suffer

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

from agency attention deficit requires that the mentor use techniques which provide measured success for both the agency and the individual.

Communicate your expectations to employees

Communication is a basic practice that should be an ongoing interchange betwe

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

en managers and their work teams. Establishing a communication model that allows employees to understand what you expect from them and in turn what they can expect from you, sets the foundation for trust building in the workplace. Meeting with employees to outline your

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

management philosophy, style, and expectations sets the work relationship ground rules, opens the lines of communication, and gives the employee an opportunity to share their vision and perspectives.

Don't believe what you hear about someone

Relationships in th

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

Following aspects would a

e workplace are complicated, limited, and not necessarily the best method of defining the real person. Individual relationships are unique from person to person and new managers should be wary of any press about their employees, negative or positive, until they have had

dd to the challenges in developing combination products:

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

time to do an independent assessment of employees' skill set and performance. As with any story there are always two sides. The employee/organization relationship is no different.

Promote and seek the best in people

What we look for is often what we see. Manag

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

rs need to look for the best in our people and give them the opportunity to be the best. Our role is to put our employees in situations to diminish their weaknesses and promote their strengths. Identifying projects for an employee that will give them a chance to let the

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

ir strengths be highlighted is a professional ego boost. If we look for and expect the best we are often successful and are rewarded with a desired result.

Don't step up and then step off

Managing under challenge requires consistent, sustained, repeated positiv

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

e behavior on the part of the manager. If you identify an employee who may benefit from attention and support don't take on the task and then back off when something else becomes more interesting or distracting. You must be in it to win it. Remember working with a perso

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

Professional from academic institutions, pharmaceutical industries, health care indust

who has had a history of negative press and behavior as a result, takes caution and care. The commitment must be on the part of the manager to stay focused on highlighting the abilities of the employee. If you give up there is a cost to you, the agency and the employee

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

. Your professional creditability will be compromised, the agency will continue to support a mediocre performance, and the employee will take another hit to their professional self-esteem.

As managers, we have the responsibility to promote, encourage and support the po

.

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

itive development of our team members. Even the most challenged employee can receive the benefit of good management strategies. Employees who are in situations where they have been overlooked often times have skills, abilities and resources that are untapped and under a

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

Companies that provide selfless information through particip

ppreciated. It just takes a committed professional to unleash the potential that is trapped inside. After all, as managers, isn't that our role to enhance the overall performance of the agency. What better way to do it than by changing organizations one person at a time

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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