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Cases - Board Committees-Is Your New Small Organization Ready For The Next Step?
When a new nonprofit is created, the founder or founder(s) generally recruit a small group of people they know and trust to help get things going. These people often wear many hats ranging from janitor to baker to teacher's aide to board member.
As the organization begins to grow up, the lines become clearer between serving on the
As the organization begins to grow up, the lines become clearer between serving on 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
Board and volunteering in the program or office, though people will often continue to serve in multiple roles.
Up to this point the Board typically has 4-8, maybe 10, members and most discussions and decisions are made by the group as a whole or default to whomever is closest to the daily operations. Eventually, the Board realizes
Up to this point the Board typically has 4-8, maybe 10, members and most discussions and decisions are made by the group as a whole or default to whomever is closest to the daily operations. Eventually, the Board realizes
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
hat in order to increase the impact of the organization, it needs to extend its efforts beyond its initial program efforts. That generally means more emphasis on fund raising, finances, marketing, and evaluation (proving that the organization is good at what it does).
For many organizations, this is when the discussion turns to rec
For many organizations, this is when the discussion turns to rec
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
uiting board members with skills that complement the founding group and exploring an effective committee structure. For a small organization, Board committees can support the staff in key roles or actually do the work until funds are available for a staff person.
Committees are great when they work and a terrible burden and experie
Committees are great when they work and a terrible burden and experie
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ce when they don't. My philosophy on committees has evolved over time – I offer four key insights:
1) Committees should be formed around the current needs of the organization, not out of a Board book that says "every board should have X, Y, and Z committees."
It is too common for a well-meaning board member to use a board
1) Committees should be formed around the current needs of the organization, not out of a Board book that says "every board should have X, Y, and Z committees."
It is too common for a well-meaning board member to use a board
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
book or their experience with another organization to create a board structure for your organization. While there are many committees that most organizations have in common, your first venture into committee work can be overwhelming if you try to catch up with a mature organization too quickly.
I suggest an organization look first
I suggest an organization look first
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
o their mission and strategic plan. What needs to be accomplished? Where are you focusing most of your efforts over the next one to two years? Where can the board's work best benefit the organization? Common initial committees might be one that is externally focused - perhaps Marketing, PR, Fund Raising and one that is more internal
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
y focused, perhaps finance and developing board policies. This assumes that the Board officers are already acting as, at least, an informal Executive Committee handling Exec Dir evaluation and review and orientation of new board members. Using this approach, each committee can identify what it needs in new members and skills and wor
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
with the other board members to find and recruit those people.
The next committee is typically charged with program evaluation or planning and evaluation. This group helps define what "Success" is for the organization and how well you are doing.
2) With the exception of an all-volunteer organization, committees should exist to
The next committee is typically charged with program evaluation or planning and evaluation. This group helps define what "Success" is for the organization and how well you are doing.
2) With the exception of an all-volunteer organization, committees should exist to
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
complement staff roles and responsibilities, not duplicate or mirror them.
For very small organizations, committees may take the place of staff efforts - either until a staff person is hired or for the long-term if the organization expects to remain small. In this case, committee responsibility descriptions may look very simil
For very small organizations, committees may take the place of staff efforts - either until a staff person is hired or for the long-term if the organization expects to remain small. In this case, committee responsibility descriptions may look very simil
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
r to staff job descriptions.
But in most organizations, the Board committees play a role in helping the board, staff, and organization become more effective – not to do the work. Board members can help provide objectivity in the evaluation of service delivery or the development of external communications. They can also help connect
But in most organizations, the Board committees play a role in helping the board, staff, and organization become more effective – not to do the work. Board members can help provide objectivity in the evaluation of service delivery or the development of external communications. They can also help connect
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
the organization to people, companies, and resources that might not be accessible to staff members directly.
For example, the Program Committee or Program Evaluation Committee should focus on answering questions like – “What are we trying to accomplish? “and “Are our programs having the impact we want?”. The Finance Committee focus
For example, the Program Committee or Program Evaluation Committee should focus on answering questions like – “What are we trying to accomplish? “and “Are our programs having the impact we want?”. The Finance Committee focus
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
s on ensuring that internal controls are in place to reduce the likelihood of fraud or theft and on identifying the risks to the organization and making sure that appropriate insurance and loss prevention strategies are in place.
Typically, the committee, with a staff member, works to develop a plan and then decide who will turn th
Typically, the committee, with a staff member, works to develop a plan and then decide who will turn th
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
e plan into action. In an organization with few or no staff, the committee members become the primary implementers. In an organization with staff, the staff often leads the implementation with committee members playing critical roles in reviewing progress, adding specific expertise, and making connections with people, funders, other
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
nonprofits, business, or government that can help the organization reach its goals.
3) Board members aren't truly engaged unless they are responsible for doing something outside the routine Board meetings - so I think almost all boards should have some committees.
An unfortunate truth of board service is that we typically t
3) Board members aren't truly engaged unless they are responsible for doing something outside the routine Board meetings - so I think almost all boards should have some committees.
An unfortunate truth of board service is that we typically t
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
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
ll prospective board members that we will not expect much of their time and then we are upset if they don't do more than the absolute minimum.
If your board meets quarterly, it can be hard to get board members to think about you more than 6-8 hours a year (when they are sitting in board meetings). If you meet monthly, it can be har
If your board meets quarterly, it can be hard to get board members to think about you more than 6-8 hours a year (when they are sitting in board meetings). If you meet monthly, it can be har
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
to keep attendance up because so little of consequence happens in the 30 days between each meeting.
If board members can be engaged in a committee that is doing work that they feel is interesting and worthwhile, and that allows them to use their skills in ways they enjoy, you will build bonds between board members, increase buy-in
If board members can be engaged in a committee that is doing work that they feel is interesting and worthwhile, and that allows them to use their skills in ways they enjoy, you will build bonds between board members, increase buy-in
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to the organization, and get more accomplished.
4) Task Forces (short-term committees) create energy and work to quick completion of a defined outcome. Standing committees with poorly defined responsibilities frustrate Board members and waste their time attempting to be productive.
I have found one effective way to launch
4) Task Forces (short-term committees) create energy and work to quick completion of a defined outcome. Standing committees with poorly defined responsibilities frustrate Board members and waste their time attempting to be productive.
I have found one effective way to launch
.
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
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
committees is to treat them as short-term task forces with a distinct project to complete. For example, a Marketing/PR committee might start by putting on a new event or getting out a regular newsletter. I have found that efforts like “assembling a 3 year marketing plan” do not create much energy because no one has seen anything act
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ally happen.
After the initial success, the group can more easily define the additional skills and people it needs on the team and who is the natural leader. Some groups might work effectively in a task-to-task basis on an on-going basis. Others, like finance, usually define more of a regular routine to their meetings and schedules
After the initial success, the group can more easily define the additional skills and people it needs on the team and who is the natural leader. Some groups might work effectively in a task-to-task basis on an on-going basis. Others, like finance, usually define more of a regular routine to their meetings and schedules
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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