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Carla has run her start-up company single-handed for three years and she is doing well. In coaching her, w

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

e have started to work on her time management only to realise that she has worked every weekend for

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

Examples of combination products may in

two years, has not taken a holiday for 18 months, and now finds it hard to dedicate time in the evening to

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

her family or friends. She felt the best option was to recruit her first employee.

Be clear wha

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

t you expect

We created a job description of what the employee’s duties would be, how they wo

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

Combination pro

ld support Carla and what skills and experience are required.

Find the right attitude th

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

n train the skills

Recognising we are unlikely to find a clone of Carla, we decided to find someone w

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

ho matches her general attitude and approach to work, customers, and business. After all, with the

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

ight attitude, we train up any skills gaps as we find them.

List the interview questions

T

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

ensure a fair selection process, Carla wrote down the interview questions to ask each job a

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

plicant. As she interviewed them, she wrote their answers against the list to help her remember who

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

Following aspects would a

was interviewed and what they said.

This interview record is proof (suitable for a tribunal) that

dd to the challenges in developing combination products:

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

everyone answered the same questions and the process was fair – meeting the needs of our employment laws t

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

at proscribe discrimination against gender, age, race, religion or anything else ‘personal’.

On

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

ly recruit the best

Carla interviewed four people but was not happy with any of them. After discussi

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

g her feelings and conclusions, she decided to re-advertise the job and do another round of interviews. Al

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

Professional from academic institutions, pharmaceutical industries, health care indust

hough this delay was frustrating, the second bunch turned up two good applicants and she offered the job t

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

o one of them.

Now that she and her new employee are working as a team, Carla is back to working a 35 hou

.

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

week. I expect that next month, we will refocus the business coaching on reviewing the skills that nee

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

Companies that provide selfless information through particip

training and looking at how the business processes need to change to fit the new business team

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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In Most organizations, travel and entertainment (T&E) expenses are often overlooked as insignificant or inevitable. Because of that, they do not immediately come to mind in the context of traditional supply chains.

Placing a good PR story in your chosen media is a very cost-effective means of burnishing your business image. By getting your company talked about by the newspapers, radio stations and TV channels, your prospects, customers, suppliers and employees will all gain an interest in your products and services.

I've read often that long sales letters on the Internet or in email sales media get better results than short sales letters. My use of the Internet and that of my colleagues indicates this might not be correct. This article considers whether long sales letters are still as effective and in fact whether they ever were effective.

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