Summary - Relationships

Many would agree there is a need for Black men and women to come together and work towards healing our relationships. Black people have the lowest marriage rates and the highest divorce rates. Where approxima

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

tely 60% of white adults marry, only 40% of Black adults marry. And only one-third of Black children grow up in two parent homes. Passing blame and point fingers only hinders our progress. We need to come to

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

Examples of combination products may in

gether and communicate openly and honestly to figure out ways to bridge the communication gap that destroys our relationships.

For the past three years, I have been involved with forming roundtable discussion

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

groups titled, 'Withholding the Ring' that addresses the low marriage rate among African Americans. I have met several Black women in their late thirties and even early forties that are worried about their pro

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

spects of ever getting married. Some of these women have completely given up on their marriage ideals and opted to have children outside of marriage. The prevailing message suggests that it is more likely for

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

Combination pro

Black women to become mothers than wives.

The roundtable discussions I facilitate provide safe environments for men and women to honesty discuss the issues that affect how we relate to one another. The men h

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

ave reported to me that the events leave them truly affected by how their non-committal behavior affects women. And some of the women have come back to me and confessed that they did not realize how much they

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

truly needed their men until we all came together and truthfully communicated.

I would like to share some of the events that take place during these roundtable discussions in hopes of inspiring others to take

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

up the cause. These are not dating events but rather bonding events that bring Black men and women together as friends first. The focus is never on 'hooking up' but rather on how we can build stronger, trusti

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

ng, lasting relationships.

Ice Breaker The event begins with a series of icebreakers. One of my favorite icebreakers is when everyone has to exchange a friendly hug after introducing themsel

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

es. The participants are also asked to state what they hope to take away from the discussions.

Ground Rules We go over brief rules of conduct prior to the discussions. There are also handou

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

Following aspects would a

ts provided, that remind the participants to be respectful in their comments and responses.

Openers In the beginning, some folks may be on edge, not really knowing what to expect, so I try to

dd to the challenges in developing combination products:

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

make the discussion fun and interactive. A fun opener is when the men are asked to place questions in a container addressed to the women and the women place their questions in a separate container addressed t

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

o the men. The questions are passed around the table, which affords everyone the opportunity to participate in the conversation and it serves as a good way to get everyone warmed up.

Exercises
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ng>I plan several exercises during the roundtable discussions but a favorite is what I call "Love Affirmations". I ask the men and women to pick names from separate containers. The women will choose men and th
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
e men will choose women. The men are asked to get down on bended knee and profess their love for Black women and the women in exchange profess their love for Black men. They must each begin their statement wi
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
th "I love you Black Man because…" and they are left to fill in the blank. This has nothing to do with romance. I designed this exercise to encourage an atmosphere of unity and to drive home the message that
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
this is not a women vs. men forum. "Love Affirmations" is always a hit and never fails to draw a few tears. But, they are good tears. Healing tears that bring us closer to understanding how Black men and wome
.

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
n can improve their relationships.

So, that's a quick run through of some of the techniques I use to encourage the dialogue. If you are interested in beginning your own roundtable discussions, these are great
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ways to get the talks underway. Complaining will get us nowhere but positive communication can lead to stronger friendships, relationships and marriages. It all has to start somewhere and we all have our part

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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Summary - Black Men and Women Coming to the Table

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