References - Travel and Leisure

I’ve been blessed to travel to many beautiful and inspiring places in the world, and always, I come away with a deeper appreciation for the cul

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

ture, the people, and the environment. Knowing this, Peru was first on my list of dream destinations. For years I’d heard and read about Mach

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

Examples of combination products may in

Picchu and wanted experience it myself. My opportunity came when I was asked to lead a Peru trip.

Since returning, people ask me…. “So, how

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

as Peru?” “Tell me about Machu Picchu.” Words don’t easily come to express the experience. Sometimes a place has the power to move you profo

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

ndly–to change you from the inside out. Peru is such a place.

So my response to their question usually goes something like this: Together, 18

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

Combination pro

xtraordinary women trekked through Peru by plane, bus, boat and train. We explored the beauty and history of the capital city of Lima, and the

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

nfluence of Spanish rule over Peru’s ancient cultures. We visited charming Cusco, also known as the Navel of the World... the center of the In

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

ca Empire with its advanced hydraulic engineering, agricultural techniques, marvelous architecture, textiles, ceramics and ironworks. The magn

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

ficence of the Sacred Valley of the Andes Mountains impressed us all. We experienced the thrill of rafting the rapids of the Urubamba River.

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

fter traveling south to Lake Titicaca, the world’s highest navigable lake at 12,500 feet above sea level, we walked on the man-made floating is

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

ands of Uros, created from cane where families actually live. Taquille Island is like arriving on a Mediterranean island, hot sunshine, blue l

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

Following aspects would a

ke, exotic flowers, warm, intriguing people. We discovered pisco sours, incredible cuisine... we shopped for our beautiful baby alpaca gifts a

dd to the challenges in developing combination products:

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

d hand made treasures created by these beautiful Peruvian people. This was our exquisite itinerary. Some of my fondest memories are of the incr

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

dible women I traveled with, who felt more like old friends than new travel companions.

More than anything though, I’ll remember... Machu Picc

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

hu. In all of my travels, this is the most remarkable place I have ever visited. I’d seen all the pictures, studied the Inca history, but not

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

ing prepared me for the magic and energy of this place.

The day after our guided group tour of Machu Picchu, many of us arose in the wee hours

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

Professional from academic institutions, pharmaceutical industries, health care indust

of the morning to go back and spend time alone among the ancient ruins. In one of those precious, once in a lifetime moments, I watched the su

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

crest, moving mist and shadows to reveal the sacred and mysterious city of Machu Picchu. What is the truth of this magical place, and what is

.

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

legend? What was its purpose? How did the Incas create such perfection? Then again, why?

Months later, Machu Picchu continues to move me fro

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

Companies that provide selfless information through particip

the inside out. I’ll keep asking the questions and see what I discover. Perhaps I may need another trip back to Peru for further exploration

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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