Advice You - Business

At some point in the development of most Non-Profit organizations, the question of whether they need an Executive Committee arises. Usually this is the result of one of the

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

following situations:

1) Board members have seen Executive Committees on other boards so they form one because "that's the way it's done".
2) The founding or domi

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

Examples of combination products may in

ant members of the board get frustrated with having the whole board in on every discussion and form the Executive Committee so they can make decisions faster – and “get thin

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 done”.
3) The Board finds themselves lacking direction and order and wants their work to be better coordinated.

What is Typical?

In many organizations, the E

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

ecutive Committee is composed of the Board Officers, often joined by the chairs of most or all board committees.

Typically, the defined role of the Executive Committee is t

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

Combination pro

:

1) Establish the agendas for Board meetings, in coordination with the Executive Director/CEO
2) Evaluate the Exec Director
3) Identify and groom future lea

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

ers
4) Make decisions for the Board if a situation arises where it is not practical to pull the entire board together. Specific authority is granted through the by-laws

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

of the organization.

Where Can It Go Wrong? What is the Downside of Having an Executive Committee?

One of the most common problems arises when real issues are discu

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

sed and decisions made at the Executive Committee meetings. Instead of framing the issues for discussion by the whole Board (or delegating to the appropriate committee), the

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

Executive Committee presents their conclusions to the Board and asks for approval (or even worse doesn't advise the Board). After a few rounds of this, the other Board membe

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

s feel left out and realize they are not able to contribute insight or leadership.

How Does the Governance Committee Work with the Executive Committee?

Many organiz

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

Following aspects would a

tions have seen the Nominating Committee evolve into a year-round role as the Governance Committee. Previously, a nominating group would meet a few times in preparation for

dd to the challenges in developing combination products:

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

ecruiting new Board members or electing Board officers. As the Governance Committee, they may take on the role of planning Board Retreats, charting Board meeting topics well

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

in advance, guiding new Board member orientation, and creating on-going opportunities for Board members to get better acquainted with each other and the organization. An eff

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

ctive Governance Committee can take over many of the roles shouldered by the traditional Executive Committee, making it easier for that group to retain a true leadership rol

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 Executive Committee as THE Decision Making Body

There are organizations that intentionally use the Executive Committee as a Board within a Board. If the full

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

Professional from academic institutions, pharmaceutical industries, health care indust

oard has more than 20-25 members, it often becomes impractical to get everyone together, and sufficiently informed, to make all board decisions. This structure can work if B

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

laws are appropriate and members are informed of the role they will be asked to play - either as a decision maker or more likely as a fund raiser or friend raiser. You see t

.

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

is structure most often in arts and culture organizations where board members are linked to the organization through its performances or work, not just their attendance at b

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

Companies that provide selfless information through particip

ard meetings.

In spite of many people forecasting the eventual demise of the Executive Committee, recent surveys show that virtually every effective Board claims to use one

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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