Main Subject - Business

In business, entrepreneurs have to understand that to make it to the "next level" it can never be a solo journey. All too often we attempt to do everything on our own

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

and fail to do what we're supposed to do, and that is stick to our strengths. Playing to your strengths and surrounding yourself with those who are stronger and smarte

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

Examples of combination products may in

then you in other areas doesn't make you obsolete, it makes you incredible.

Meriwether Lewis and William Clark were visionaries. They had a vision of blazing a trail

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

to the western coast of what we now call the United States of America. These two men didn’t decide one day to do something new all by themselves, but they surrounded t

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

emselves with experts, and lay persons. They also enlisted the assistance of the local Native Americans because of their expert knowledge of the land. This led to a su

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

Combination pro

cessful expedition, and the immortalization of these two men. The same goes on in business, one visionary (or two) arise with a magnificent idea, but they must surroun

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

themselves with the expertise of others to accomplish the task at hand, Lewis and Clark called them guides, we call them a Board.

There are generally two different k

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

nds of Boards. You have your Board of Directors, those placed in charge of the financial responsibilities who oversee the executive management team, and you have Advis

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

ry Boards, simply of sounding board for ideas with no responsibilities. Some Boards are ‘hands-on” taking an active approach to the management of a company, while othe

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

s are strictly oversees, meeting quarterly to be sure everything is in order.

No matter which it is, when selecting Board members, you have to be sure you are equippi

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

g yourself with those who can help catapult your company instead of those just looking for something else to place on their resume. This Board and the direction they c

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

Following aspects would a

ose for your company can determine the difference between success and failure. Discovering the Pacific Ocean or perishing in the Rocky Mountains. What are the criteria

dd to the challenges in developing combination products:

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

What makes separate a great Board member, from an average member? Let’s explore those together.

When selecting member take heed to more then their resumes and experi

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

nces. You want to explore their passion, drive, knowledge of your company, and their vision or lack there of. Can they see where your company is headed next year? Five

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

years? Or can they not see past their own nose? Even though you are the visionary of the company, you need people who can see long-term, who can think strategically, a

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

d who help navigate you through the wildernesses you may encounter. What are their strengths? You need a diverse Board of individuals, both in skill as well as gender,

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

Professional from academic institutions, pharmaceutical industries, health care indust

ethnicity, race, background, experience, and knowledge. It’s more then just industry experience; it’s also a willingness to be vested in the future of the company. Som

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

potential members could be the smartest people you will ever meet, but if they’re somewhere else when you need them to be where you are you have a problem; knowledge

.

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

ever makes up for absence.

So to all the entrepreneurs, Executive Directors, CEO’s and anyone looking to reach that “next level” in their business, be thorough in dec

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

Companies that provide selfless information through particip

ding who will help direct your company, take inventory of who you have, and never be timid about surrounding yourself with genius, it’ll just make you look even better

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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