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Father Robert Mitchell, a noted Catholic priest and philosopher, once wrote of the difference between “like” and “love.” Father Mitchell believes that “like” is an uncontrollable emotion, a reflexive response to our experience of another individual and the way we interact with

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

them. According to Father Mitchell “liking” somebody or “disliking” them is as uncontrollable as the color of our eyes or the color of our hair.

“Love” on the other hand in Father Mitchell’s world is a choice, an active decision based on the type of relationship we choose to h

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

Examples of combination products may in

ave with another individual. Father Mitchell states that while we may respect some individuals very often we will neither like nor love them. Similarly Father Mitchell believes that there are many people who we like intrinsically. Our experience of them and our interactions w

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

ith them lead us to the inevitable response of genuinely liking these people, yet we choice not to love them. As Father Mitchell states it is nice if we like them as well but we can choose to love somebody, in other words care for them as an individual and more importantly care

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

what happens to them, even without respecting or liking them as a person.

It is this final paradox, loving without liking, that Father Mitchell believes is the reason love is the ultimate “energizing” emotion. It is energizing because love is an active choice decision that we

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

Combination pro

make to not only extend a relationship to someone else but to take control of ourselves and our lives. For Father Mitchell to love is the ultimate empowerment.

Another Catholic priest and philosopher, Father Dan Schulte, offered a functional definition of love:

"Love is a uni

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

fying response between two people who care for and have said 'Yes' to each others total being. It implies mutual respect, freedom and trust, and seeks the happiness and fulfillment of each other as a common goal."

For love to be the basic building block of resilience it must 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

ot only be a choice as Father Mitchell has stated but it must also fulfill all of the basic tenants of Father Schulte’s definition.

"Love is a unifying response ..."

In this phrase Father Schulte has encapsulates the most basic essence of the choice to love as well as its grea

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

test hurdle. Love is a unifying response binding the person making the love decision to the person who is the recipient of that gift. It unites these two individuals creating something that is greater than the sum of its two parts.

"... who care for and have said 'Yes' to eac

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

h other's total being."

Father Schulte echoes Father Mitchell's sentiment that love here is a choice, a choice to accept ones partner in a relationship exactly as they are. No conditions, no qualifications, no equivocation.

It has been said that "no one self can see ones self

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

through the eyes of another." If this is true then Father Schulte’s definition holds that much more power as a building block of resilience. When we love another and enter into that "unifying" relationship we not only see ourselves as we are but find acceptance of ourselves as

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

Following aspects would a

we are, not the way we wish we could be. It is through this acceptance that we can come first to respect ourselves then to like ourselves and finally we can make the active choice to love ourselves in the same way that we love others.

"It implies mutual respect, freedom and t

dd to the challenges in developing combination products:

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

rust ..."

Father Schulte emphasizes that the choice to love grows from the roots of respect. To love ourselves we must first respect ourselves. It is from this self-respect that Father Mitchell's emotional response to like ourselves springs. Similarly, since if we are to lov

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

e another person we must first respect them. That respect grows from absolute and unconditional acceptance. Once respect is manifest it demonstrates itself through trust. Trust like love is an active decision. Paraphrasing Father Mitchell, "we do not choose to like, that is a

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

n uncontrollable emotional response. But we do choose to trust (love)."

"... and seek the happiness and fulfillment of each other as a common goal."

Finally, Father Schulte reminds us that the choice to love is an active ongoing and demonstrative choice. We manifest this cho

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

ce to love through the goals that we have for the relationship. If our goals for the relationship are completely focused upon ourselves then the relationship may represent respect and even like but it is clearly not love. It does not contribute to our resilience.

If, on the o

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

Professional from academic institutions, pharmaceutical industries, health care indust

ther hand, our goal of the relationship is strictly to please another person and does not include ourselves actively within the relationship then again it may represent respect and even like but it is not love. It does not contribute to our resilience.

For a relationship to ac

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

tively demonstrate love it must balance our own self-interests with our desire to be selfless. If love is unifying response and therefore the love relationship becomes a true individual a sum of the two people who choose to share the relationship the contribution of love as a b

.

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

asic building block of resilience is that by choosing to create this love relationship we choose to create a reservoir of resilience for two.

The four forms of resilience are all based on this simple emotion, love. Whether it is our physical resilience, our emotional resilienc

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

Companies that provide selfless information through particip

e, our relationship resilience, or our spiritual resilience each requires that we make the active decision to love in order to build that resilience; to fill that canteen. Similarly, we thus fill our 40,000-gallon bathtub of resilience with this basic element of resilience, love

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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