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When Joy Westrum looks into the faces of men who have hit rock bottom, she doesn't see despair; she sees potential. As President of the Second Chance Program (www.secondchancecenters.com), Westrum

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

has often witnessed the disintegrating lives of men who have committed violent crimes because of their addiction to drugs. Yet she has also been a part of their transformation into citizens who 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

ve kicked their drug habits, gained self-respect, and created productive lives. "With the right tools, criminal addicts can turn their lives around," says Westrum. "My passion to help them is fuel

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

d by the results we're seeing. It really restores your hope in mankind."

Westrum's work in prisoner rehabilitation began over a decade ago. "I looked at the recidivism issue and saw how it was ba

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

krupting our communities," she says. "The majority of violent crimes are drug- and alcohol-related, so I knew that the prisoners needed tools and a vital education on life issues that would help t

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

Combination pro

em rebuild themselves from the bottom up."

Westrum's husband, Rick Pendery, founded the Second Chance Program in Mexico, and the couple worked in prisons in Ensenada and Tijuana. "We worked with

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

early six thousand prisoners, and really succeeded in turning a large part of the prisons into functioning rehabilitation centers," says Westrum. "There would be 600 to 800 hardened inmates studyi

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

g in one large room, with only our staff members to monitor them. The prisoners would study together six days a week, eight hours a day, and we never had a serious incident." The Second Chance Pro

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

ram reduced recidivism by 90 percent, as documented by three university studies.

What's the secret? The cornerstone of the Second Chance Center is four modules designed to restore personal integr

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

ty and self-esteem: drug withdrawal and rehabilitation; education; self-respect; and life skills. The drug withdrawal and rehabilitation modules involve drug-free withdrawal using vitamins and a s

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

una-based detox, then working with the inmate to increase communication skills, gain emotional control, and accept responsibility for his actions. The education module is designed to achieve inmat

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

Following aspects would a

e literacy and increase proficiency, while the self-respect component consists of shifting the inmate's moral compass and increasing personal responsibility. The life skills module involves teachi

dd to the challenges in developing combination products:

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

g the inmate to critically evaluate those who have a positive or negative influence on his life and learn tools to help him succeed. The protocol utilized in the Second Chance Program is based on

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

iscoveries by L. Ron Hubbard in the fields of drug and criminal rehabilitation.

Westrum's experience led her and Pendery to open up the Second Chance Center in Albuquerque, N.M., last fall. The s

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

cure lock-down facility currently houses 55 men who have been given alternative sentencing, and has a waiting list of over 200. The facility has 600 beds with the capacity to treat over 1,000 resi

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

ents a year. Renovation is underway to bring more of the facility's beds online.

"For the first time, we're actually diverting serious substance abusers from jails and prisons into a facility tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

gives them what they need to turn their lives around," says Westrum. "Since the cost is equal to or less than what the state would spend to house the inmates, everyone wins. With the low recidivi

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

m rate, taxpayers don't have to foot the bill for future incarcerations, and the prisoners have been trained and empowered to lead successful and rewarding lives."

The success of the Second Chanc

.

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

Center has led to plans to expand the Albuquerque facility, and Westrum is fielding calls from other states that would like to bring Second Chance to their jurisdictions. "Ninety-eight percent of

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

Companies that provide selfless information through particip

the population we serve doesn't want to be stuck in the trap of drugs and crime. They want a way out. I'm thankful that we can give them the education and tools they need to lead successful lives.

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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