Useful Advices - Business

Consider this a new “condition of employment”. Professionals who choose

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

to manage their careers in the same old ways will find themselves in a p

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

Examples of combination products may in

ecarious position similar to the company who has become stagnant and ine

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

ffective -- ending up obsolete and unable to successfully compete. Here'

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

the top ten things you need to do:

1. Stay informed – follow current m

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

Combination pro

rket and industry dynamics. Identify and study target companies and thei

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

r toughest competition.

2. Understand the needs of the people/markets y

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

ur serve through research conducted on-line and in the field through net

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

orking.

3. Be a creative solution provider. Understand concerns and ant

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

icipate needs.

4. Think in specifics to communicate with clarity.

5. G

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

t connected –as a professional build strong, far reaching relationships

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

Following aspects would a

think 6-degrees of separation and create “buckets” or types of relation

dd to the challenges in developing combination products:

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

ships that include but are not limited to marketing, promotion, developm

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

nt, finance, collaboration and or mentors.

6. Build strategic alliances

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

and partnerships to expand potential business and learning opportunities

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

.

7. Make energy, enthusiasm and results the mainstay tools in your ski

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

Professional from academic institutions, pharmaceutical industries, health care indust

l set.

8. Continuously work to improve your oral and written communicat

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

on skills.

9. Take responsibility for positioning yourself for future o

.

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

pportunities within a three to five year window.

10. Make evaluation an

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

Companies that provide selfless information through particip

adjustment a consistent part of your professional development practices

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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Useful Advices - Top Ten Ways to Gain a Winning Competitive Edge

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