Advice You - Business

Chapter 7 of 14

We liken this approach to something that is done in the stock market by many exce

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

ptionally talented traders. The most notable that comes to mind is that of Sir John Templeton. F

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

Examples of combination products may in

or decades, he had a very simple philosophy. That was to buy things when they were out of favor o

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

when no one else thought they had any value. This mindset resulted in vast fortunes for his inve

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

stors in The Templeton Funds, as well as for himself. He stuck to his philosophy and it paid off.

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

Combination pro

If you stick to and use the same approach, you to can win big at the celebrity endorser game.

We

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

constantly follow the rule of acquiring athletes who are out of favor or who are in their dormant

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

state, in terms of professional sports seasons. It has worked for us for sixteen years and it wil

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

l work for you. I can’t tell you how many calls we have had over the years saying, “things are de

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

d, I will do anything for just about any price.” Wait until the season starts and everything chan

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

ges. Timing is everything when looking for a celebrity endorser, just like location is everything

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

Following aspects would a

when looking into real estate. Just recently, I had a call from a football player asking if I ha

dd to the challenges in developing combination products:

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

anything needing endorsements. What do you think his price would be and how willing would he be

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

to do a super job because he doesn’t have one now?

Most of the celebrity endorsers we work with (

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

nes you can work with, too) are extremely flexible when it comes to timing and advance bookings.

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

The trick is to plan your celebrity endorsed event months in advance. This will give you the bene

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

Professional from academic institutions, pharmaceutical industries, health care indust

it of having something pre-planned but also securing the best deal. When the celebrity endorser i

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

s sitting around doing nothing…like in the off-season…it is prime time to strike. They aren’t look

.

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

ng into the future, just the fact that they need bookings now, and in most cases, you and your com

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

Companies that provide selfless information through particip

pany can secure great deals at a discount. We constantly do this to secure the best possible deal

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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