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Most Financial analysts (Buy and Sell Side) are likely aware of the inquiry from the SEC into y

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

our company. Your Investor Relations organization has to be:

a) Proactive about communicating<

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

Examples of combination products may in

r> b) Forthright with what they know and dont know
c) Resist speculating the outcomes and

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

possible causality
d) Be clear about timelines and milestones
e) Be honest about imp

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

ct to employee morale, customer momentum and partner/supplier concerns.

Address these question

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

Combination pro

below in a clear, concise manner and you will have a better crisis handling experience:

1. Wi

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

ll the restatement have a material impact on your previous years earnings, revenues and cash fl

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

w, balance sheet, etc.?

2. What is the extent of the options backdating? How many instances a

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

d how long was this going on?

3. Have you formed a special committee to look into the matter?

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

Who in the Board of Directors is heading up the audit committee? What experience do they have

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

n dealing with crisis of this magnitude before?

4. What has your reaction from empoyees been?

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

Following aspects would a

hat actions are you taking to prevent mass exodus?

5. Are you going to lower earnings estimate

dd to the challenges in developing combination products:

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

s and revenue targets since management will be distracted to solve this issue?

6. What are imp

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

ications from a legal standpoint? How exposed are your Directors? What is the level of your DOE

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

insurance?

7. What about customers? Are they concerned and what is their level of concern?

8.

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

When do you expect to complete this process of investigation? What are the key milestones we s

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

Professional from academic institutions, pharmaceutical industries, health care indust

ould track?

9. Who all are going to be fired / let go because of this issue?

10. What is your

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

process to continue ongoing communication with us on this issue?

Your IR and Finance team will

.

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

not have all the answers, but these questions need to be brainstormed before you have the call

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

Companies that provide selfless information through particip

with the analysts.

http://blog.vangal.com

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

Plastic fundraising cards are proving to be very effective with many different types of businesses and organizations. These wallet-sized wonders are being created as a tool to raise money for charitable organizations, in addition to the flexibility of producing cards for gift, loyalty and membership marketing purposes. Plastic fundraising cards usually include a variety of discounts that are accepted through the participation of local, regional and national merchants in your target marketing area.

Several success stories have emanated from the lean manufacturing initiatives. Although some organizations were not able to sustain the success after a few years, many others kept building on the initial success through continual improvements in processes. Discussed below are the keys to lean manufacturing success that were common for most of the success stories:

While installing your new accounting software you have most likely been asked whether you would like to use one of the default charts of accounts included with the program or develop your own. But you may ask what if I don’t need all these accounts and how do I know which accounts I should keep. And should I use a numbering system or not? Let me help.

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