Main Subject - Business

As a training manager, there are two important aspects to managing your people well: hiring, supervising, and motivati

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

ng (managing with your people) and building up corporate support for your department (managing for your people). Unfor

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

Examples of combination products may in

unately, training is not well understood by some executives, and its benefits can be hard to assess. Even a good train

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

ng manager’s department risks cuts by cost-conscious administrators convinced that training is an unnecessary expense.

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

In The Secret of My Success, a cinematic fairy tale about life in corporate America, Michael J. Fox gets scolded his f

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

Combination pro

rst day on the job for speaking to a senior executive: “Never consort with a suit unless the suit consorts with you fi

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

st.” As a training manager, however, you had better be prepared to consort with “the suits” from Day One. Managing for

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

your people is a pro-active strategy that constantly demands selling your department’s services and widening the base

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

f organizational support for the training function.

All of our experts agree that the actions of the manager of train

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

ng are critical to the department’s survival, and important for the long-term health and continuity of the organizatio

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

itself. In an era of cost cutting and corporate mergers/takeovers, a training manager must make sure his or her depar

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

Following aspects would a

ment is 1) visible, 2) credible and 3) perceived to be as integral to the organization’s growth as it really is. This

dd to the challenges in developing combination products:

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

an be accomplished by means of two different approaches that boil down to either response or outreach. Some managers f

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

nd it effective to combine some of each into a very personal brew. For example, Mary Belle GrosJacques, Trainer Coordi

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

ator at CH2M HILL, characterizes her department’s approach as essentially “reactive .[We] satisfy needs brought to us”

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

.Yet she also notes that “[we] try to think of needs they didn’t bring to us,” indicating that it is possible to respo

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

Professional from academic institutions, pharmaceutical industries, health care indust

d creatively by anticipating future needs, and using the feedback from existing programs to extrapolate new directions

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

Susan Warshauer, Manager of Training and Development Programs, at M.I.T., acts on the premise that building up organi

.

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

ational support “...takes a conscious strategy. Cultivate relationships with senior people, find out what they perceiv

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

Companies that provide selfless information through particip

as needs, and have a yearly process of needs assessment. Keep in touch with your community and be responsive to them.

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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