Advice Pool - Relationships

Sam, age 42, had never been married. It’s not that Sam had never fallen in love. But every time a relationship had started to move toward commitment, Sam ran.

When Sam’s loneliness became overwhelming

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

to him, he called me for help.

“I want to be in a relationship, yet every time I get close to someone, I run away. I’m not even sure what I’m so afraid of, but I must be terrified of something!”

“

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

Examples of combination products may in

am, what happens inside you when you like someone?” The following answer and resulting dialogue came out over time, but I’ve condensed it here.

“I think that if this person really knew me, she wouldn

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

t like me. I do all kinds of nice things for her so she will like me. Then after a while I start to feel trapped and I pull back. She gets upset about my pulling back and I then feel even more trappe

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

. Once she gets mad at me, I stop feeling in love with her. That’s when I decide she is not the right one for me. This has happened over and over.”

“So the first problem is that you believe that she w

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

Combination pro

n’t like you when she gets to know you. Out of your fear of rejection, you try to control how she feels about you by doing nice things for her. But then you feel trapped and your fear of engulfment –

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

of being controlled by her and losing yourself in the relationship – kicks in. Then you run. It sounds like your underlying fears of rejection and engulfment are controlling your life and not letting

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

you share love.”

“That’s exactly right! So what do I do about this?”

Sam was operating from core shame – the false belief that there was something basically wrong with him. As long as he believed that

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

e was inherently flawed and unlovable, he would fear rejection. Out of his fear of rejection, he would give himself up until he felt trapped, and then he would run.

The part of Sam that believed tha

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

he wasn’t good enough is his wounded self. The basis of the wounded self in all of us is our core shame false belief – the belief that we are inherently flawed. Our wounded self does not know that w

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

are a perfect child of God, an individual expression of the Divine. Because the wounded self operates out of false beliefs rather than from the truth of who we really are, it wants to control how pe

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

Following aspects would a

ople feel about us. Sam needed to develop a loving Adult part of himself – a part of himself connected to a spiritual Source of love and truth – in order to heal his core shame.

The Six Step Inner Bon

dd to the challenges in developing combination products:

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

ing process is a profound process for developing the loving Adult and for healing the fears and limiting beliefs of the wounded self. As Sam started to practice Inner Bonding, he slowly developed an

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

dult self who loved and valued his core Self, his true essence. As he developed this inner sense of personal power, he lost his fear of rejection. He saw that if a woman rejected him, it was because

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

f her fears rather than because of his inadequacy or unlovability. Because he stopped taking rejection personally, he stopped fearing it.

Once he stopped fearing rejection, he stopped giving himself u

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

in his attempt to control how a woman felt about him. Once he stopped giving himself up, he stopped feel trapped and engulfed in a relationship.

Over time, by consistently practicing the Six Steps of

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

Professional from academic institutions, pharmaceutical industries, health care indust

Inner Bonding, Sam developed a powerful inner loving Adult self and healed his fears of rejection and engulfment. Sam is now happily married with a child on the way.

This did not happen quickly. It

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

ook Sam time to heal his false beliefs about his own adequacy and lovability. It took time to develop a personal relationship with a spiritual Source of love and truth. It took time to be in truth wi

.

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

h a woman rather than being “nice” to try to control how she felt about him. It took time for him to feel safe in being himself. It took a couple of years of devoted inner work.

But if you were to ask

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

Companies that provide selfless information through particip

Sam if all the time it took was worth it, he would look at you with shining eyes and a huge grin and you would feel the joy within him. You would have no doubt that it was worth whatever time it took

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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