Often, collaborating documents in a team or in a business can feel like a complex sports play gone wrong. The ball gets passed off to the wrong person, dropped, or even lost. In addition, most docum
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
ent collaboration happens electronically. We are always told to save and resave these electronic documents, but it gets to the point that we can’t even keep track of which draft we’re on. Not to ment
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
ion our hard drive gets overloaded with so many similar document names that it blows the whistle on us until there are no longer “too many men on the field.” Huddle up! Let’s talk about 3 keys to mak
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ing sure that every document we collaborate on is sure to score with our bosses, our clients, and each other.
Create Compatibility
Collaboration requires compatibility. In order to create cohere is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
mpatibility, we need technology on our side. If you have ever tried to open a document from a member of your team that was in a format that was not compatible with the applications on your computer,
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
you are not alone.
Whether you are making a presentation, a budget, a report, a notice, a memo, or anything else that will be written in collaboration with another person or other people, all involve
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
d need to be able to read documents written in various applications. You will send it to a team member or a boss or a client via email, and you will want them to be able to open it, add their changes
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
in collaboration, and send it back without any problems.
Too often in trying to collaborate, we have to keep emailing other members of our team, asking them to switch the document from one format to
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
another, prolonging the can’t-be-prolonged projects. This way of working does not fit into a fast-paced business culture.
Leave No Player Behind
All too often, drafts come back without you 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
knowing it, and inevitably, some changes are not included—you left a player behind. Applications that send notifications about changes save time and increase collaboration effectiveness.
Think about
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
the people to whom you send collaborative documents. Usually that group of people includes someone from your upline and probably even a client. Those are key players whose changes and suggestions mus
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
t never be lost in the collaboration process. The side effects may be severe.
The most important thing is that nobody knows everything, but everybody knows something. And, when making collaborative c
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
hanges in a document nobody will catch every mistake or add a helpful insight, but everybody will catch some mistake or add a helpful insight. If players get left out, that important document, whatev
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
er purpose it may serve, glides further away from perfection. Just imagine the CFO of a company being left out of an important financial presentation or document. What if one number is off?
Don’t
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
Drop the Ball
The last point is that organization is key to collaboration, and that despite our best efforts there are times when we forget something; we drop the ball. In document collaboratio
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
n, you’ve got to hold on to the ball, because it may roll out of sight if you drop it. That means that you might have to start from scratch, lose vital information, get in trouble with the boss, and
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
get in trouble with the client.
Automatic notification, which tracks any work or changes on a MS document, acts a sticky note that will post itself immediately when a new draft of a document arrives
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
in the MS email or other applications. Now-a-days, you can even receive notification immediately upon arrival of the document.
The trick is to avoid any guess work, to maintain detailed records, and
.
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
to keep everyone in the loop. Collaboration will take place on every level business and most often cross managerial and company borders. Clients will be involved. Bosses will be involved.
Remember th
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
ese three keys of collaboration. Document collaboration in your company needs to be compatible with your software, it needs to keep everyone informed, and it needs to help keep the business organized
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products