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Today, most of us have been involved in a team project, either as the leader or a contributor. The team concept, if structured properly, can be a very success

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

ful option for any company or organization. You’re able to pool a great variety of resources with various backgrounds and strengths to achieve a desired outco

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

Examples of combination products may in

me. However, there also needs to be a proper foundation set in order for a team to function effectively and efficiently. So, in this month’s article I want t

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

o share my own key learnings and observations on how you can use the team concept to bring about success.

Okay, you’ve been “appointed” as the team/project le

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

ader, now what do you need to do to lead your team to success. Here are important steps to take to move along the path to achievement and success:

1. D

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

Combination pro

evelop a team vision and clearly define roles

Start with a project kick-off meeting to accomplish this task and engage the support/sponsorship of an Executive

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

Team member

Ensure that the team vision and roles are agreed upon and committed to in writing

2. Establish project accountabilities and measurements

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

Develop a weekly or biweekly meeting schedule - This will allow for the team members to share their status, look for feedback and bring problems to the forefro

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

nt. Have an agenda with team member input distributed prior to the meeting and distribute meeting notes with action items as a follow to the meeting.

Impleme

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

nt a project tracker - Create a master project schedule with timelines. Make sure that the team member understands how any delays or changes impact the entire

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

project.

3. Let the team participants determine their own desired outcome

Hold each participant accountable for his/her own actions, progress and resu

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

Following aspects would a

lts - Again, have the team member commit to these items in writing

4. Define each team player’s desired rewards and the reward sought by the organizatio

dd to the challenges in developing combination products:

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

n

Ask that a member of the Executive team communicate the reward sought by the organization during the initial kick-off meeting. - This communiqu? should also

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

address the “What’s in it for me?” question for the team members

Then ask the team member to outline the personal and professional rewards he/she is seeking

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

5. Communicate progress

Ask that each member give a two-minute status report at each team meeting

Enforce the rule that when introducing a problem, th

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 team member must also offer a solution

Apprise the team participants of changes or updates in between meeting dates

6. Enroll stakeholders in the process

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

Professional from academic institutions, pharmaceutical industries, health care indust

Each team member must be responsible for gaining buy-in from stakeholders in his/her department

Ensure that stakeholders are aware of how this project impac

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

ts his/her role within the organization and why the company is seeking the success of the project

7. Have team sign-off on successful completion of proj

.

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

ect

The project isn’t complete until all team participants agree on a successful project completion!

Have each team member share his/her key learnings, what

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

Companies that provide selfless information through particip

worked well and recommendations for improvement

As the team leader acknowledge the strengths and accomplishments noted by each individual team member2005-04-2

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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