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Many nonprofit organizations contain term limits in their by-laws for members of their Boards of Trustees. Some of the Boards on which I have served have different provisions. On

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 provided for three year terms, with no more than three consecutive terms before the member was required to take at least one year off the Board. Another provided for annual term

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

Examples of combination products may in

, with no more than five years on the Board. Another allowed a Board member to serve for no more than a total of three terms of two years each.

There are a number of good reasons

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

for these provisions. They encourage new points of view, different mixes of ideas at the table, and expose the organization to more individuals within the community. However, th

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

re are also challenges that must be addressed when there are term limits, most having to do with the ongoing process of nominating qualified people to the Board. If nonprofits use

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

Combination pro

the checklist below, they will make the job of replacing Board members more efficient and more beneficial to fulfilling the mission of the organization.

1. Form a nominating comm

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

ttee. When there are too many people contributing to the selection, the process becomes encumbered. It is much more efficient to select three Board members to prepare a list of c

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

andidates to the entire Board for their selection.

2. Look for talents that are missing on the Board. Think about selecting an attorney, or an accountant, for example, to be able

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

to have their expertise as part of the Board decision-making process.

3. Look for diversity. Every nonprofit Board must account for the makeup of its constituency, and provide ad

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

equate representation on the Board. Select on the basis of fulfilling gaps in gender, race, age, economic circumstances, and geographic location.

4. Find people who are truly com

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

itted to the success of your organization. There are a lot of people who compile a list of their Board positions as if they were applying for a job. Make sure your candidate has

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

Following aspects would a

proven record in supporting the purpose of your nonprofit.

5. You must decide on whether you want to have a “rubber stamp” Board, or one that thrives on acrimony. There are plac

dd to the challenges in developing combination products:

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

es for both, and one is not necessarily preferable over the other. It is a matter of evaluating the strength of your Executive Director, and deciding whether you want to provide s

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

pport for their policies, or give them the benefit of contending with alternate points of view.

6. There are some good arguments for selecting people who will likely become or are

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

significant financial contributors to the organization. However, selection on the basis of honoring their support is no substitute for evaluating their potential contributions to

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

the decision-making process.

7. There should always be an “A” list and a “B” list. The “B” list should be arranged in order of preference. It is used to provide alternates in ca

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

Professional from academic institutions, pharmaceutical industries, health care indust

se any of the invitations to the “A” list are not accepted.

8. Institute an orientation program for new Board trustees. It is a daunting task for someone to acclimate themselves

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

o the culture of your Board, and giving them the opportunity to become familiar with your history, your facilities, your staff, and your current issues, will be very beneficial for

.

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

them and make them productive in shorter time.

9. When inviting a person to come on your Board, be very clear that yours, like most nonprofits, consider fundraising an essential

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

Companies that provide selfless information through particip

unction of each Board member.

If you adhere to these nine points, you will fulfill your nonprofit fiduciary obligations, as well as keeping your Board vital, active, and effective

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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