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There is no substitute for soliciting the opinions of the executive team, the people who will be most affected by change or its absence. However, often the answers to complicated questions don’t lie within those most affected. Frequently the CEO will n

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

eed to look outside the organization for advice and wisdom. Sometimes this comes for a Board of Directors, a body of individuals that has the duty of influencing a company’s direction. Members of this board have a fiduciary responsibility to represent

; 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 shareholders by making pivotal decisions.

Advisory Boards, on the other hand, do not vote, nor do they have fiduciary obligations. Rather, as the name implies, they exist for the sole purpose of advising the CEO and executive team. Small companie

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, family owned companies, and organizations that do not have a board of directors often find that advisory boards can be helpful in assisting the leadership, but sometimes companies find that they benefit from both kinds of boards.

In the last decade

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

dvisory boards have been rather commonplace in the Silicon Valley, particularly for new ventures. However, even though they are relatively inexpensive and easy to form, outside this arena, advisory boards are a valuable, but much underused asset in hel

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

Combination pro

ping companies handle change. Advisory boards are unencumbered by compliance and other business issues specific to boards of directors, and they can provide the CEO and executive team the benefits of experience, expert knowledge, contacts and credibili

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

ty that will help them navigate the future of their companies. An effective advisory board can provide expertise that a small company cannot usually afford in full time employees, and it can offer ongoing personal support to those who have the lonely p

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

osition of CEO.

How do they get started? Because they are free from the regulatory restrictions that shape a board of directors, advisory boards vary greatly in composition and function. Advisory board members are usually chosen for their expertise,

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

xperience, and knowledge. A well-balanced advisory board will include 4-7 individuals who have a background in one of the critical areas that affects the business: finance, operations, human resources, business development, marketing, sales, and indus

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

try issues. They will be people who are candid, objective, and independent, not friends who will tell the leader what he or she wants to hear.

Recruitment of qualified members usually occurs through acquaintances, either directly known to the CEO or k

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

nown to existing advisory board members. Some members contribute their time for the pleasure of the stimulation of being involved in cutting edge discussions, but more often, participants are compensated by an annual stipend, stock options, or an hourl

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

Following aspects would a

y fee. According to Corporate Governance, the main attraction for being on a board is the intellectual adventure, the chance to meet with outstanding peers and to discuss issues of the future. It is an honor to be invited, and high quality people attr

dd to the challenges in developing combination products:

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

ct other quality people.

The purpose of an advisory board is self-evident: it gives advice. So, the members should be good listeners who offer dispassionate analysis about the challenges the company is facing. They should be sounding boards for the

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

CEO who is struggling with decisions related to anything and everything that touches the company. If they can quickly get to the core of complicated problems, they can offer the leadership a new perspective for understanding implications and consequenc

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

es.

For best results, the members’ advice needs to be both strategic and tactical. They can assist by anchoring decisions in the company’s vision, mission, and values, but they can also offer specific, step-by-step plans for carrying out plans. They

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

need to be able to separate important from unimportant issues so that they can encourage the leadership to focus their energies, time, and resources on those initiatives that will have the most impact. In short, a successful advisory board will be able

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

Professional from academic institutions, pharmaceutical industries, health care indust

to help the CEO see a bigger picture when the temptation is to be distracted by the day-to-day problems of running a company.

This relationship is not one sided, however. The CEO has responsibilities too. First, she or he will usually be directly inv

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

olved in the recruitment of qualified members. Then, the CEO will need to set meetings well ahead of time and set agendas for the meetings. Most advisory boards have two to three meetings a year, but others meet every quarter. With a start up venture

.

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

, the board may meet monthly until things are under way. Usually the meetings of the entire board will be half a day or a full day, but often CEO’s find that they need specific advice from individual members more often. Whatever the needs of the compa

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

Companies that provide selfless information through particip

ny are, the effectiveness of the advisory board is enhanced when expectations are clear on both sides, and the board and leadership can concentrate on the challenges of helping the company’s employees handle change, even if it is unexpected or unwelcome

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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