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Abstract: Based on significant research, Entelechy has defined characteristics of effective teams.

Entelechy reviewed over 50 studies o

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

n high performance teams and compiled a list of high performance team characteristics. We grouped characteristics into eight categories

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

Examples of combination products may in

as indicated on the graphic below.

Participative Leadership

Aligned On Purpose And Vision

Task Focused
Shared Responsibility

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

>Innovative
Problem Solving
Strong Communication
Responsive
Self Monitoring

See if your team shares characteristics

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

of High Performance Teams. Circle the characteristics that describe your team; cross off those that don't describe your team.

PARTICIP

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

Combination pro

TIVE LEADERSHIP

Envisioning leadership and organizing leadership
Clear leadership role that is shared
Enables people to 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

ake choices
Shared norms
Shared values
Members drawn to the team
Team identity
Belonging/membership
Synerg

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

sm
Future focused

ALIGNED ON PURPOSE AND VISION

Common shared purpose
Clear shared vision
Self directing
High

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

orale
Team goals align with personal goals and organization goals
Problem solving, not laying blame
Clear, shared underst

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

nding of team members' roles

TASK FOCUSED

Challenging tasks
Individual accountability/ownership
Equality in workload

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

>Quality focus
Clear tasks and milestones
Mutual respect for ability
Commitment

SHARED RESPONSIBILITY

Shared decisi

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

Following aspects would a

on making
Rewards linked to team performance
Recognize expertise/value added in individuals
Cooperation
Clear standa

dd to the challenges in developing combination products:

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

ds of acceptable performance
Celebrates success
Clear authority and responsibility
Contribution
Members responsible

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

or team success

INNOVATIVE

Creative talents
May promote personal relationships
Respect for individuals
Empowered an

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

empowering

PROBLEM SOLVING

Upfront and direct; confronts issues not people
Trust
Clear decision-making process
Con

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

licts managed well
Freedom to express ideas
Freedom to share opinions

STRONG COMMUNICATION

Superb communication
Ope

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

Professional from academic institutions, pharmaceutical industries, health care indust

n communication
Openness
Clear communication channels
Share common language and terminology
External communications

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

Time managed well
Structure, purposeful meetings (facilitator, timekeeper, recorder, scribe)

RESPONSIVE

Unite/partner wit

.

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

other teams
Flexible
Outward focused
Focus on the customer
Allows risks and mistakes
Promotes group learning

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

Companies that provide selfless information through particip

ELF MONITORING

Self correcting; evaluates its own performance
Individuals pleased with work results
Assigns opposing view

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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