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The best joint ventures are with people in your own network – those that already know, like and trust you. However, there’s nothing to stop you from partnering with “cold”

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

contacts – those you’ve never associated with before, and you would therefore need to build a relationship with. This simply means it will take a bit more time to execute t

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

Examples of combination products may in

he joint venture because any “cold” contact would need time to evaluate your character and your business before committing to a partnership with you.

One of the skills you

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

need to acquire if you choose to joint venture with a “cold” contact is this... getting past the gatekeeper!

Your potential joint venture partners may not pick up the phone

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

themselves. They may have a secretary, or an assistant, or a receptionist that screens calls before putting the calls through to them, or someone that screens letters befo

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

Combination pro

re putting the letters in front of them. These people are known as gatekeepers. Your potential partners may even have a permanent voicemail kind of set up. In this case,

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

the voicemail is the gatekeeper.

Here are some tips for getting past the gatekeeper:

• When you call the office, treat the gatekeeper with the same respect that you would

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

treat the potential partner. This will make them warm up to you. Sound important, but courteous e.g. “Hello there, please put me through to Joe Smith.”

• Develop a relati

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

onship with a source that knows your potential partner, and then receive an introduction from that source so that you go in with the introduction from the source. So, when

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

you call the potential partner’s office and the gatekeeper asks what your call is regarding, you can say “His good friend, Jim Benson asked me to call him.”

• Adopt the gat

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

ekeeper i.e. develop a relationship with them. Do this by engaging in a conversation with them whenever you call. Developing a relationship with the gatekeeper comes in ha

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

Following aspects would a

ndy when you’ve been unable to reach your potential partner because they’re often out of the office.

• If you’re calling from an international destination, say “Hello there

dd to the challenges in developing combination products:

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

, please put me through to Joe Smith, and let him know it’s Tom from Italy.” As a result of the time zone difference and the cost of the call, an international phone call i

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

mmediately gives the impression that the call is very important. The gatekeeper is likely to put you through without asking why you’re calling.

• Send a letter first. In

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

the letter, ask the potential partner to expect your call on a certain date. This way you can say “He’s expecting my call,” when the gatekeeper asks what your call is regar

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

ding.

• Another approach is to email your potential partner to check if they’ve received your letter, and then ask for the best time to call them. In this instance, it’s l

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

Professional from academic institutions, pharmaceutical industries, health care indust

ikely that your potential partner will let their gatekeeper know that your phone call is expected.

• If a voicemail is the gatekeeper, it’s best to send in a letter first,

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

and then follow up by leaving a voicemail message. However, if you choose not to send a letter first, then simply introduce yourself and let your potential partner know why

.

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

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

Companies that provide selfless information through particip

by Habiba Abubakar and Emprez. All rights reserved.

Note: You are welcome to republish this article as long as the resource box at the end is included fully and unaltered

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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