Just Other Articles

After happening across an article on Asperger Syndrome, Jack wrote me about his new employee with whom he was quite pleased and also quite baffled. Jack talked about the similarities he saw between Al, his new employee, and the characteristics of a person with Asperger syndro

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

me. Al was hired because he excels in understanding and managing the software systems this business uses. The problem arose with the more routine skills that did not come naturally to Al, but are crucial to work place survival.

Jack was not sure how or whether to suggest to A

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

Examples of combination products may in

l that he explore a possible Asperger diagnosis, but what Jack was sure of, was that some steps had to be taken in order to keep Al on as his employee. We decided not to worry about what the diagnosis might be, if indeed there was one, and concentrate on helping Al with behav

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

ior change and independence.

Following are four specific and concise action steps Jack and I designed in a series of email exchanges:

Goal #1 Getting Comfortable with the Plan

Jack: “I don’t know how to talk to Al about doing this work with you, without riski

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

ng that he will feel ‘singled out'."

Ellen: I think you will find Al won't be surprised and will be relieved that his weak spots are out in the open. Let’s do everything in consultation with Al one-step at a time.

The Plan: In a short conversation, Jack simp

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

Combination pro

ly said to Al, "We both have a lot to remember and we need systems to help us get our work done.” Jack also explained he was working with me. Al was receptive, saying more structure would be good. Jack added a little extra assurance for Al, saying to him “If you have any quest

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

ions about anything, I will try to be available immediately, please come see me.”

Goal #2 Remembering End of Day Routines

Jack: “Al stays late to finish projects several nights a week. I really like this! But he does not ever remember that the last person to l

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

ave puts the phone on night call forwarding to voice mail."

The Plan: We established the Office Manual. Al set himself up with a small divided binder, with ‘To remember’ sections for End of Day and Beginning of Day. In his End of Day section he has a page for ‘Before

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

I walk out’ where he enters the details he needs to remember about turning on the call forwarding. The first two times Al was last to leave, Jack had to mention the next morning that he had forgotten to look at his Office Manual the night before. Within two weeks, just the ha

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

bit of opening his manual cued Al remember to forward the phones. By the third week, call forwarding became a habit for Al when he was last out.

Goal #3 Password Change Follow Through

Jack: “Al has the job of creating and routinely changing passwords used by

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

others on the office. The procedure is that Al has the responsibility of recording them in the computer directory where everyone goes to access the updates. The problem is that Al forgets and people are getting frustrated and their work flow is interrupted when they can’t get

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

Following aspects would a

into files.”

The Plan: Al's manual has a section for ‘Procedures’. Jack teaches Al the procedure and Al take over with the responsibility of referring to his book regularly. If a password is not updated, Jack simply says “Al please refer to the procedure I taught you

dd to the challenges in developing combination products:

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

for passwords.” Jack does NOT tell Al the action he needs to take. It is in the book and exploring for the answer will help Al establish the new habit sooner.

Goal #4 Involving Al in Creating his Strategies

Jack: There are so many details and procedures to kee

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

p an office running. As soon as I put one strategy in place there’s more to deal with.

The Plan: Encourage Al to look for ways to keep adding to and evolving the manual. Coach him to come up with more strategies that help him move toward independence.

Al’s Plan:

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

/b>

1. As part of his end of the day routine, Al placed his manual on top of his computer so he would come in and see it in an obvious place each morning. He reminded himself right in his manual to leave the manual on the computer, last thing!

2. On the front of the binder,

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

Al printed in big letters Look here first. This cued him that he had resource on hand before getting overwhelmed.

3. Al reviewed his manual throughout the day at times he designated to spend working on absorbing the information.

Feedback

Al: It is g

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

Professional from academic institutions, pharmaceutical industries, health care indust

reat that I don’t have to wonder how to do something or worry that I am doing things wrong. There is less and less for me to remember as I review the manual. I liked being able to use my own ideas and strategies to further personalize this for me.

Jack: The time I w

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

as taking to explain and correct has dramatically reduced. I am getting my own schedule back on track! The best strategy is that once Al has the system recorded in his work manual, I can now just choose from one of two short comments. “Al did you look at your list today?” or

.

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

“Al you have a list that tells you this procedure.” It’s working great!

Very important tip: Keep your plan firmly in place until you have given it a generous amount of time to settle into place. Then evaluate. When you think your strategies aren't working, giving u

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

Companies that provide selfless information through particip

p is usually the reason why!

See companion articles by Ellen Mossman-Glazer~

Communication Tips to Help Your Employee with Asperger Syndrome Thrive in Your Work Place

Practical Tips to Help Your Employee with Asperger Syndrome Get Established in Your Office

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

Just Other Articles - Help Your Employee With Asperger Syndrome Get into the Flow of Your Office Routines

Related Articles: