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Consultant's Perspective...

The threat of violence whether it emanates from a disgruntled employee or the threat of terrorism require both a concerted and an individual response. Terrorism in any form is terrorism. Having been exposed to the daily taunts, acts of intimidation, verbal threats of bodily harm are as debilitating psychologically as the blunt strike or the piercing bullet. Vigilance and security aware

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

ness makes for a good prescription. In my previous writings on the topic of workplace security, I've attempted to draw a correlation between the disgruntled employee and the terrorist from within by suggesting similar patterns of behavior, traits and characteristics coupled with freedom of access and possession of the company’s secrets. My observations clearly implied a volatile ingredient worthy of skeptical asses

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

Examples of combination products may in

sment.

Following a recent article written by Louis Rovner, Ph.D, entitled “Protecting Your Company from Terrorism Within”, I interviewed him regarding the article. Dr. Rovner is a psychologist in LA who consults to businesses, government agencies and law enforcement agencies, one of a handful of polygraph – psychologist nationwide. He believes that the potential for disaster is at every employer’s doorstep and I a

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

gree with the assessment. He said, “Thousands of Terrorist call the United States home…hundreds of terrorist sleeper cells scattered throughout the U.S. awaiting orders and instructions need to assimilate in order to survive”. What do they do? The thrust of this edition is a testimonial to the existing synergy between Dr. Rovner and I on the topic of workplace security as a legitimate discussion. I believe the so

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

lution to the minimization of any potential exposure is an aggressive but practical security plan which addresses the workplace security issues in greater detail incorporating training and security awareness.

Now I would like to draw that necessary correlation between the seamless similarities existing between the “event driven” explosive conduct of the “disgruntled employee” and “the Terrorist from within”. In a

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

Combination pro

n investigation I conducted several years ago an otherwise hard working employee with a diagnosed personality disorder was reassigned from his regular duties due to a medical determination. It was to have been a temporary change. However, during the ensuing assignment he was exposed to constant abusive taunting and harassment by co-workers. In response he began retaliating in his own way, initially innocuously and

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

eventually more aggressively. The verbal threats directed at co-workers and supervisors escalated to more hostile conduct. It was clear he was sending a message of his displeasure. While left alone at the office computer terminal he began browsing the Internet for bomb making sites. He had been engaged in this clandestine operation for several days before a sharp supervisor noticed his strange behavior at the term

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

nal. In an effort to protect the evidence, he used a ruse to get the employee away from the terminal until my arrival. The subsequent interview of the employee disclosed a pattern of hostile retaliatory conduct in response to a lack of confidence in management and his co-workers to protect him from the abuse. His aggression escalated from the verbal to the near physical as he sought ways to avenge his tormentors.

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

Are You Really Safe…?

Before we get into a technical discussion about the potential Terror from within, we need to answer a few questions and remind you that the problem lies well within your ability to manage. Do you know what to look for? Do you have a mechanism to address breeches of safety or security? Are your employees properly screened during the hiring process? Is there a Workplace Violence Prevention Pol

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

icy and Program and lastly, are employees receiving relevant training? If we acknowledge NO to any of these questions we have the ability to take corrective action NOW. I know how resource intensive the process can be, but you don’t have to go at it alone. Like the disgruntled employee who is “event driven” the Terrorist waits for the event. In both cases, they are the classic “sleepers” willing to hide their inte

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

ntions until they are ready to act out. Linda Lockwood, PhD at the Metropolitan State College, Denver, Colorado reminds us that workplace violence is obviously a serious problem that must be better understood in order to prevent its occurrences. I ask that we consider the threat from within a bit more seriously by developing your security policy and plans to minimize your exposure.

Protecting Your Company From Ter

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

Following aspects would a

rorsim From Within…

In the article by Dr. Rovner, he writes that the Employee-Terrorist is “calculated” and will wait for the opportunity to strike, while using the employer to survive beyond the stipends provided by their terrorist group, the unwitting employer is the potential target depending on the type of business or government agency. But even if the companies are not specifically targeted says, Dr. Rovner,

dd to the challenges in developing combination products:

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

they are indirectly and unknowingly supporting Terrorist by providing a source of income. Like the Terrorist who awaits the call to action, the disgruntled employee is “event driven” by the circumstances. Both the “Terrorist” and the “Disgruntled Employee” share some other common opportunities as “employees”; they have access to the company and are familiar with the company secrets.

The Potential Threat…

Driving

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

home a clear and evident example of the potential terrorist’s ability to penetrate even a secure environment, I am reminded of the British Daily Mirror Reporter, Ryan Parry who compromised the Buckingham Palace’s hiring and recruitment procedures by providing false credentials and gaining precarious access to the President of the United and his wife while staying at the palace. Even though the palace had an elabor

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

te security system and employed the most stringent security measures to guarantee the safety of President Bush, Parry successfully breeched security by falsifying his references. According to security officials they were satisfied that both the security and criminal records check were robust and done correctly. The response may have satisfied some political end but didn’t answer the question of what type of employe

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 background check was done to authenticate and validate the hiring during the screening process. Such access was a breach at the hiring phase when in all likelihood, the responsibility fell on the lonely shoulders of a lowly paid clerk who merely followed the checklist.

5) What To Look For…?

I believe the collaborative process of the Threat Assessment Team concept enhances the essentials and promotes shared awar

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

Professional from academic institutions, pharmaceutical industries, health care indust

eness in the identification of the potential threatening applicant during the hiring process. The same collaborative process can be used to insure the right individual passes the hiring and recruitment process early on before permanent employment. Dr. Rovner says that companies, agencies and organizations can take preventive measures. He suggests that the Human Resource Department be a bit more aggressive during t

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

he hiring phases by instilling the essential skills of the investigator. Verification of all data at the hiring process is critical. He said, “One of the scariest things about the Terrorist is that they look just like you and me”. While psychologist have not developed a foolproof terrorist profile, he suggests that most Terrorists posses a number of the same traits. Tactfully worded questions during the interview

.

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

process will alert the interviewer. Dr. Rovner further suggest that since the Terrorist possess common traits the use of properly designed questions will tell whether the applicant has most or all of the traits.

He suggest they are:

- Loners
- Dissatisfied with their lives
- Have low self-esteem
- Are true believers
- Are antisocial
- Lack pity or remorse
- Have grievances against

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

Companies that provide selfless information through particip

our country and our allies
- Are tremendously loyal to their terrorist group.

Anyone intimately familiar with the Threat Assessment Process would quickly discern that some of the Terrorist’s traits and characteristics are common to the disgruntled employee. If you would like a copy of Dr. Rovner's article, please request if via email and I will send you a copy of along with contact information for Dr. Rovner

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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Examining the positive effects of recruiting skilled and low skilled workers from abroad, for jobs that cannot be filled locally due to the skills gap or lack of local applicants.

Entrepreneurs seem to be so lucky, so often. People see their success and attribute much of their good fortune to luck. What luck that they thought the idea would work. The luck of the Irish for old Doyle, don't you think? It was his great good luck to file that patent when he did.

Improving organizational performance is the job of management within a business and over the years many solutions have been investigated with varying success. However the behaviors of peak performers have been overlooked. This article looks at the behaviours associated with top performers who are 5 times more productive than their average performing colleagues.

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