E-Folder - Business

Team Building Question:

What are some disadvantages of self

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

directed work teams?

The Team Doc Says…

The advantages do

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

Examples of combination products may in

outweigh the disadvantages in my opinion, but some of the disadvantages

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

can be:

More meetings
Teams are made up of group

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

s of people (no secret here!) which requires that they get together oft

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

Combination pro

en to discuss team business. Provide them with the training they need s

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

their meetings will be more than a gathering of people.

Longer

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

decision-making process
When one person makes all the decisions

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

, it can be done in a heartbeat. When several people are required to pr

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

vide input and discussion the pros and cons before making a decision, i

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

t can take some time. Equip your teams with decision-making tools so th

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

Following aspects would a

at the process is not agonizing for them.

A dip in productivity

dd to the challenges in developing combination products:

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

before it takes off in a positive direction
Things around your c

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

ompany will be very different. After you begin your journey, you may ev

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

en begin to wonder why you started in the first place! Be patient, the

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

ains will come — and typically they will be big gains.

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

Professional from academic institutions, pharmaceutical industries, health care indust
>
Ensure that your organization is really ready to provide the infra
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
structure and support needed by teams to accomplish their work. If the
.

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
rganization merely calls a work group a team and doesn't provide critic
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
al training and support, you’ll have a major mess on your hands.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

E-Folder - Are Self Directed Work Teams For You?

Related Articles: