Advice Pool - Relationships

All of us have an occasional bad day. However, there are two fundamental reasons a relationship [busin

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

ess or personal] gets chronically out of synch.

The first is Vision and the second is Value

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

Examples of combination products may in

.

A real life example...

Anne and Jason work together. For a time the partnership seem

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

s to be a match made in heaven. Jason is out developing new prospects while Anne uses her skills to co

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

pile powerful proposals that Jason closes almost every time. Their production has soared over the past

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

Combination pro

six months, but Anne is unhappy!

What happened?...

Anne is feeling more and more like an

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

assistant instead of a partner. After some probing Jason admits that he prefers working solo with a dy

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

amite assistant [how he increasingly views Anne] to support him.

The long and the short of it is, Ann

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

and Jason's Vision & Values are not in synch - if only they'd known this earlier!

To be a little

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

more specific...

Vision includes hopes, dreams and long-term objectives [again, this appli

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

s to business and personal relationships equally.] We all have a vision even if at a very covert, unsp

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

Following aspects would a

ken level.

Values includes basic principles, norms, standards and ethics an individual lives b

dd to the challenges in developing combination products:

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

y, both consciously and unconsciously.

To be in synch a partnership must have...

1. A common,

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

well defined vision [long-term goals] that guides monthly, weekly, and daily planning and activities.

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

2. A compatible set of values [ethics, standards and principles] that all on the team live by day by d

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

ay, week in and week out.

It is absolutely critical... to identify where you and your partne

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

Professional from academic institutions, pharmaceutical industries, health care indust

stand with regards to both your vision and your values to assure a solid, productive and fun business

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

or life partnership. This is the number one cause it seems for partnership failure.

CHALLENGE...
.

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
b>

- Sit down this week and review your personal goals and standards

- Call a meeting with your part
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
er to address your partnership's goals and standards.

Remember, Life is short figure it out and enjoy

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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Advice Pool - Relationship Out of Synch? 2 Secrets to Get Back on the Same Page

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