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Team management in the context of setting tasks, prioritizing, monitoring progress, agreeing and setting performance measures is all relatively straightforward.

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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

lk about Leadership, Development, Empowerment and Having Fun

Being responsible for a team, large or small, is a serious business. Getting the best out of people takes creativity, guidance and perseverance. if our team members lose focus, fai

; 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 to achieve the group's goals and objectives, we should be held accountable. What am I saying? You knew that when you took on the job. Didn't you?

Only you know your team (Or at least you should).

This article cannot comment on a special

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

team situation you may have. However, what it can do is focus on maximizing the benefit you get every time you get together with your team(s).

Examples of Spending Time Together

Departmental Meetings

Task Force

Special Projec

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

Team

Training Session

Workshops

Team Briefing

Product Review

Customer Visits

Focused Improvement Group

I'm sure you can add more. However, you've guessed it - any setting where there is a sens

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

Combination pro

e of purpose, common goals, and a desire to achieve success by being part of your particular team.

Any of the above examples can be highly motivating, rewarding, and productive. They can also be time consuming and costly. have you ever measured how much tim

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

e you spend in a 'team setting'? Have you ever calculated the cost to the business?

Wasting time and resources is definitely one of my pet hates. And, yet, I'm probably as guilty as the next person - losing focus, digressing, being reactive instead of proac

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

ive - even simply just having a bad day.

However, let's keep things in perspective.

As a team, be single minded in achieving the common goals through that shared sense of Purpose and Direction, through that shared Vision BUT don't get boring i

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

n the process.

For me, a key attribute of good leadership is having team members who

Enjoy being part of your team

Have a strong desire to contribute

Believe their contribution is valued

Want to develop the team not

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

just themselves

Are recognized outside the team for their achievement

Have fun

All of that isn't as daunting as it may seem.

So, again, in the context of leadership and maximizing the value and benefit to be gained from a team setti

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

g, what are some of the positive things we can do as team leaders?

Suggestions

Publish agendas or session flows in advance with enough time for team members (including yourself) to prepare for that team session. Why not invite inclusions to

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

Following aspects would a

the agenda.

If the session is going to be a long one, break it up into manageable sections, take breaks. Be creative, have some fun, do some exercises. I personally would not go more than 50 minutes, an hour, before taking a break.

Introduce quick 15-20 m

dd to the challenges in developing combination products:

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

inute training sessions any meaningful and contextual topic or theme. e.g. Giving and Receiving Feedback, Brainstorming, Setting S.M.A.R.T. Objectives. Empower team members by a) Have each team member prepare and deliver the training session and b) Have anoth

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

er team member facilitate the training session.

Deliberately have a non-context topic or theme on the agenda but, again, one that will add value and benefit participants - e.g. invite a technical expert or different functional / departmental head to give a 15

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

20 minute presentation on what and why they do what they do (This can be as good as having an actual break).

Before the formal session starts, get each team member to 'dump' - get rid of all the stuff in their head that's going to prevent them from focusing o

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

n the task(s) in hand. Caution team members need to feel safe and comfortable to do this. It also needs to be carefully led so it does not get out of control. Most importantly, it needs to comply with the team's agreed ground rules that were

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

Professional from academic institutions, pharmaceutical industries, health care indust

set at the formation of the team.

Continually develop individuals - give others the opportunity to prepare and publish the agenda for the next team session, empower them to lead and facilitate the session and to write the follow-up review afterwards ( apart

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

rom anything else, it gives you a rest! ). Further development can be achieved by inviting other team members to provide constructive feedback - with the knowledge that they too will be given the same developmental opportunity and will also be receiving 'cons

.

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

tructive' feedback.

Have fun and celebrate successes. Take time out, have a bbq, have a picnic, supply the supper when the team session's a late one.

Lead by example at all times. Show the team that your business, their business is a seriou

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

Companies that provide selfless information through particip

s one with specific goals and expected results BUT the best way to achieve success is through ongoing individual and team development, empowering others to succeed and having fun along the way.

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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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Sometimes, achievement is simpler than most make it out to be. You can act as if you are fully prepared and even very experienced at public speaking or negotiation or effective private communication, whatever the day requires you to do.

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When we see a slew of equally bad slides from different people in the same organization, we’re fairly certain that the company has a slew of workers in a Presentation Regulations Department working feverishly to hamstring any attempt by an employee to make their slides understandable, much less compelling.

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