Useful Advices - Business

Be clear about where you are now. Audit your strengths and areas for development

Wher

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

e do you want to be?

What needs to be done to eliminate the gap between your dream and

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

Examples of combination products may in

the reality?

Prioritize – Look for quick wins, consider those things which will have

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

maximum long term impact. Build solid foundations, think of sustainability!

Set chall

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

enging but realistic targets. Aim high.

Communicate the vision, and keep doing so. En

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

Combination pro

sure that all stake holders understand and subscribe to the vision.

Who do you need to

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

involve? How will you ensure they sign up to and stay committed to the vision?

Think

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

about the language you use – sound positive, if others think you are confident it can b

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

e achieved they will gain confidence too. Develop a “Can do” mentality within the staf

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

f. For every problem there is a solution, encourage others to see themselves as proble

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

m solvers not problem givers.

Create clear lines of communication which operate at eve

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

Following aspects would a

ry level and in all directions.

Break each priority down into small achievable steps,

dd to the challenges in developing combination products:

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

involve the team.

Who needs to do what – by when? Set a timetable

Identify the roles

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

and responsibilities for all staff; ensure that staff take ownership without creating

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

“jobs worth” approach.

Ensure that people are appropriately trained and that training

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

is updated.

Build in the monitoring and review process from the start so you can eval

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

Professional from academic institutions, pharmaceutical industries, health care indust

uate performance and be prepared to adjust as necessary. (By creating a culture of dev

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

elopment rather than blame huge potential will be released.)

Celebrate success; rememb

.

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

er to thank people for their contribution. The best leaders give credit to the team.

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

Companies that provide selfless information through particip

Develop professional honesty within the staff, constructive feed back can be invaluable

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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Not everyone has the leadership abilities of Jack Welch or Steve Jobs, but there are some things everyone in a leadership position can do to improve their relationship with their team. Mutual respect is vital to a leader’s ultimate success so it is important that these six tips are followed by all leaders.

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