Advice You - Business

At some point in your presentation you will be expected to answer questions from your audience. They might have some burning questions that need to

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

be answered before they buy into your message. Handling their questions with authority can make the difference for you between a successful presen

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

Examples of combination products may in

ation and a waste of time. This is the opportunity for the audience to test your knowledge on the topic and commitment to your message.

1. Explain

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

at which points during the presentation you will take questions and how individuals will be recognized to speak. Point out the microphones they sh

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

uld use. State the rules that must be followed to ask questions.

2. Prepare how you will answer questions - especially the worst questions. Imagin

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

Combination pro

e how confident you will look when they hit you with the killer question - the question that is intended to skewer you to the wall. Instead you smi

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

e and calmly respond with a positive answer. Craft and rehearse the answers to these difficult questions before the presentation.

3. Maintain cont

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

rol of the questioning. Formally recognize the questioner before they speak and limit the number of questions. Allow only one person to speak at a

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

ime.

4. When listening to the question look at the questioner while moving away to include the whole group. Paraphrase the question for the group.

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

State your answer to the group. Beware of answering only to the questioner.

5. Kick start the question period with, "A question I am often asked

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

s, …".Then answer your 'question'. This helps to prime the pump and encourages others to ask questions.

6. If you don't know the answer offer, "I

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

Following aspects would a

don't know the answer to that question but give me your card and I will get back to you." Beware! You can only do this once or twice. Anymore and y

dd to the challenges in developing combination products:

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

u will look dumb.

7. If you can't answer a question but know that someone in the audience may know ask, "I know there are experts in the audience,

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

how would they answer this question?" Only do this if you know there are experts in your audience.

8. When you get the person who strongly disagr

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

es with you and refuses to shut up, respond, "Thank you for your opinion, I know there are different schools of thought on this issue - I am tellin

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 you what has worked for me."

9. Avoid repeating, "Thank you that's a good question." after every question - the questions might not be good, and

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

Professional from academic institutions, pharmaceutical industries, health care indust

the audience will see through your insincerity.

10. Never end your presentation with a question period and closing with 'no more questions? Well t

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

hat's all'. That is a weak close. Instead always finish with a closing statement that will resonate with the audience and reinforce your message.

.

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

onus tip: Plant the question you most want to hear. Before the program begins, ask someone sitting near the back to 'pose' the question on your sig

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

Companies that provide selfless information through particip

nal.

Any questions? Contact George Torok, "The Speech Coach for Executives", to deliver powerful presentations and handle questions with authority

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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