Cases - Business

Rather than sending out RFPs (Request For Proposals) and seeking out another transfer agent, it is a much better idea to try and work things out with your

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

current agent. This is the preferable route to take for most businesses, as it is much easier than the alternatives and should be chosen if at all possib

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

Examples of combination products may in

e. Seeking out another transfer agent and trying to make the switch might not be worth your while if you can remedy the situation with your current transf

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

r agent.

To fix the situation, you will need to open discussions with your transfer agent. Before beginning the process, make a list of items that you wo

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

ld like your transfer agent to improve upon and specify what level of service you expect them to provide. Place these points in order of importance - what

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

Combination pro

improvements are most important to you, your company and top management?

Schedule a meeting with the account manager (and his or her manager if applicabl

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

) to discuss in a clear and coherent manner what you expect of a transfer agent. Make sure he/she fully understands the implications of your expectations

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

nd can promise to firmly adhere to them.

Inform the transfer agent of your intention to tour their shop as a prospective client would. This ensures that

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

ou are serious about working well with the transfer agent and want to be treated as an important customer. Also, be sure to get all your expectations, agr

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

ements and the promises of the transfer agent in writing as soon as possible. You can’t leave any room for future misunderstandings.

After the tour decid

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

whether or not the account manager or any of the staff you observed are adequately qualified or equipped with the resources to carry out your specific ex

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

Following aspects would a

pectations. All too often an account manager is the root cause of the problem, due to lack of experience, skill or training. Hiring a new account manager

dd to the challenges in developing combination products:

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

ay be the solution you were looking for.

At this point in the game, if you are satisfied with the progress you’ve made with the issue and feel that the t

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

ansfer agent both understands your needs and can deliver on its new promises, there is no need to set a tight deadline for full compliance. On the other h

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

nd, if you’ve reached the point at which you don’t yet feel confident that the transfer agent will change its ways without further prodding, it might be a

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

good idea to consider making a change.

Before sending out the usual RFP, however, make sure ahead of time that your potential new transfer agent truly un

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

Professional from academic institutions, pharmaceutical industries, health care indust

erstands what you’re looking for - in plain English.

Most importantly, when researching a new transfer agent, pay little heed to the often erroneous clai

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

s many agents make as to their abilities and successes. Stay focused on the needs specific to your company and stick to these expectations, making sure th

.

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

transfer agent possesses the requisite resources and track record in the areas that are important to you. The transfer agent should outline these points

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

Companies that provide selfless information through particip

n its RFP response and on the tour, but you should also look for feedback from other clients who are similar in size, complexity and goals to your company

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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I'm always amazed at how disorganised most businesses are. The huge amount of opportunities that fall by the wayside due to poor management. Let me tell you what happened to me recently. The Car...

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Cases - Not Satisfied With Your Transfer Agent? What to Do

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