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On this second anniversary of the Indonesian Tsunami, the principles of resilience have a poignant significance. While those rebuilding lives and countries commemorated the event with religious services, memorials, events of s

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

tate and moments of silence, I spent this day with a small group of medical students. These students came to Central Florida to donate their time and holiday vacation to help severely disabled children and their families.

Med

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

Examples of combination products may in

ical school is a grueling experience. These students receive little or no time off during the four years while spending 50 to 60 hours per week in class and clinic. Without any conscious realization, these medical students fou

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

nd a way to rebuild their own resilience.

The greatest statement of resilience that I have heard in my years of nutrition counseling, medicine, or disaster for response and recovery are drawn from the daily prayer of Alcoholi

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

cs Anonymous:

“Lord, grant me the strength to change the things I can change;

(physical resilience)

“The serenity to accept the things I cannot change;

(relationship resilience and emotional resilience).

“And, the wisdom

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

Combination pro

to know the difference.”

(spiritual resilience)

This simple prayer, or wise saying if you prefer, is not only itself a source of spiritual resilience, but the embodiment of the four canteens.

Once we have filled our four ca

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

nteens of resilience: Physical, relationship, emotional and spiritual we are ready to deal with life’s adversities, but it is how we draw from our canteens of resilience that determine whether we will suffer a disaster (our n

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

eds will exceed our resources) or that we will actually remain resilient (our resources will exceed our needs).

Although I have heard this prayer many times during my over quarter century of dealing with clients, patients and

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

corporations, it was never brought home better than as I watched my own daughter go through her personal recovery.

Tiffany had been hospitalized with her own health challenge and at a time when I was deployed to a disaster s

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

cene. Ordinarily I would have been released to go back home, however just the day before my daughter was hospitalized, the only other physician on the team had been called back also for an emergency and his was more grave tha

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

n mine.

So, for the first time in her life, Tiffany had to face a challenge without daddy by her side. Laura was there, as well as her older sister, Victoria and her brothers, Nicholas and Christopher. My mother, Jean, was

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

Following aspects would a

also steadfast at Tiffany’s side, but with all of this support and even if I had been there, Tiffany had to walk her road with only our emotional support.

Certainly the relationship resilience we provided, as well as the emot

dd to the challenges in developing combination products:

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

ional resilience helped Tiffany’s resources, helped pace her needs at every moment. Tiffany had been the only girl on an all boys’ football team in high school and was in excellent physical shape which provided her the physic

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

al resilience to bounce back from her hospitalization.

While Tiffany was well rooted in the spiritual and religious beliefs of her upbringing, they had never been personally tested for her. Once more, being in her late teens

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

and being like all other teenagers she had begun to question and challenge her own beliefs, internalizing was hers rather than a mirror reflection of what her parents had taught her.

It was during this period of challenging h

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

er own beliefs that she would be forced by necessity and by survival to believe, to state to herself that she believed even if she was not certain anymore and from that, draw her spiritual resilience.

I say with no modesty an

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

Professional from academic institutions, pharmaceutical industries, health care indust

d with the greatest of pride that Tiffany is the embodiment of the four canteens of resilience. She displayed physical resilience in the face of a life adversity. She drew emotional, her relationship and emotional resilience

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

from her family and friends. In the turmoil of early adulthood she found the inner peace and the well spring of strength that comes from believing that comes from the act of believing, from a full spiritual life that leads to

.

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

spiritual resilience.

In the end, resilience is just that easy. It is resilience that prevents an adverse event from becoming a disaster because it is through resilience that our resources always exceed our needs.

Your 40,

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

Companies that provide selfless information through particip

000 gallon bathtub provides you the resilience to deal with any adversity that life or business may send your way.

(Excerpted from my lecture series and book Avoiding Business Disasters: Lessons from the Disaster Field Office

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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