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As a professional speaker, one of my biggest challenges is to grab the attention of my audience within the first few minutes of the presentation- grab them by the throat if you will. I do this by coming out in a suite and tie, following an introduction in which I have been described as a recent college g

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

raduate who earned both of his degrees with a 4.0 GPA and placement on the Deans and Presidents List. I am portrayed as someone who was once an honors roll student, star athlete, father and family man. Upon entering the stage I ask the audience to take a close look at my face.

“This is the face, as you

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

Examples of combination products may in

r were just told, of a recent college graduate, a recent college graduate who earned both his degrees with the highest academic honors available. This is the face of a kind man, an honest man, a trustworthy man, and a man of his word. Please take a close look at this face.” Now the hook- I then turn ar

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

ound, pull a pantyhose mask over my face and turn back around brandishing a toy pistol. I now ask them to take a look at this face. “This is the face of a man who on March 20th, 1992 walked in to the First Tier National Bank, pointed a semi-automatic pistol at the tellers face and demanded all of the tw

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

enties, fifties and hundreds. This would be the first of five armed bank robberies that I would commit over a six month crime spree when I was twenty-eight years old.” I then pull the mask off and explain to them that both these faces are mine. “The transformation between the two, the transformation fr

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

Combination pro

m a suicidal, drug induced bank robber to what you see standing before you today took place gradually, over 7.5 years within the confines of a federal prison.”

PRISON DOES NOT ALWAYS MEAN STEEL BARS AND RAZOR WIRE

What does me earning two college degrees while incarcerated have to do with HR Management?

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

It is my belief that we all have internal prisons, “prisons within ourselves” that are just as confining as those walls that held me for 7.5 years. I am talking about being a prisoner to things like fears, addictions, depression, overeating, overworking, bad relationships- the list could go on and on

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

. Only when we ourselves, and those we bring into our companies are “whole” personally can we then become better professionally.

It is also my belief that these “internal prisons” is the number one cause in lost productivity and the largest contributor to declining quality. If your people are worried a

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

bout their relationships, their fears or their addictions, are they giving you the best eight hours they possibly can? No, they’re going to be on the phone mending relationships, feeding addictions and being preoccupied with their fears. If your employees bring to the job with them the burdens of their

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

personal life, you are getting at the very best someone who is distracted and at the very worst someone who is contributing nothing to your bottom-line.

WHETHER A PRISONER OR ON THE PAYROLL

Prison is an institution and an organization. Your company is an institution and an organization. When you stop

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

o think about their structures, they are not that different. Warden/CEO, Caseworker/Manager, Inmate/Employee. The only difference is whether you come to it voluntarily, which for many employees is in question as they feel as though they are prisoners to their profession. How did I metaphorically esca

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

Following aspects would a

pe my prison? By being proactive in my work, not reactive. This is what I suggest to HR Managers.

Reactive people let the environment dictate what they do, and to some extent protect them. Proactive people shake things up and experiment with new ideas and procedures. When speaking to HR groups I am o

dd to the challenges in developing combination products:

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

ften asked what steps can be taken to help employees escape their internal prisons, after all they many times say, “We are not psychologists or psychiatrists.” I explain that you do not have to be, but what you do have to do is let your employees know that you care about their personal lives and that the

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

company is committed to their overall well-being.

This can be done in the form of personal days, having counselors available, strict confidentiality policies, and classes that can teach managers what to look for in employees who may be struggling with personal issues. If these things are in place, and

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

if we truly create an environment in which we make our employees feel like family both during work hours and after, can you imagine the effect on tardiness, absenteeism, productivity, turnover and quality?

RECIDIVISM

Turnover. In prison you want them leaving early and never coming back. Within your co

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

pany you want them staying forever. How can both be accomplished? Prisons need to stop being all about incarceration, and nothing about rehabilitation. Companies need start caring about the personal lives of their people. Since diversity in the workforce is an HR issue, I will conclude with something

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

Professional from academic institutions, pharmaceutical industries, health care indust

that is very close to my heart. An ex-con can be your most dedicated, grateful and hardworking employee. If you have one within your company you know what I’m talking about, if you don’t, it’s time you discovered this truth.

But before this can happen on a large scale, our prison systems across the cou

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

ntry need to give offenders a chance to succeed. Because of budget cuts most institutions are forced to spend their precious funds on security related issues, and that leaves almost nothing for vocational and educational programs. Let’s do some simple math. It cost $35,000 per year to house one inmate

.

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

(and this is a conservative figure). It would cost a fraction of that to educate that same inmate. I have seen studies, which show that the re-arrest rate of those who come out of prison with at least two years of prison, an Associates Degree, is 10%. Those who come out with no schooling at all have a

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

Companies that provide selfless information through particip

re-arrest rate of nearly 60%.

The numbers speak for themselves. Hire an ex-offender and contribute to a human being once again becoming a productive member of our society- you may just find that they prove to be your best employee(s)- especially if you let them know you care about their internal prisons

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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European store fixtures are sought by most store owners. It is found to be more advanced technologically than American fixtures. This is because Europeans combine innovative designs with the latest manufacturing techniques to create new products. Customers are therefore able to get store displays and fixtures in attractive and stylish designs.

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