Main Subject - Business

Tomorrow’s the day and you’re dreading it. You’re scheduled to give a presentation to the senior management team about the new program you’re proposing. You’re excited and enthusiastic about the program but nervous and anxious about the presentation. You don’t know how you’ll manage to sleep tonight. These thoughts keep running through your mind; What

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

if I stumble? What if I talk too fast? What if they get bored? What if they ask questions and my mind goes blank?

Do any of these sound familiar? If you answered yes, don’t worry! Try some of these simple strategies for your next presentation to help you build confidence and credibility with your audiences.

Developing your presentation

Change the

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

Examples of combination products may in

aradigm: Think from your listeners’ perspective.

If you can change your focus from, "What do I want to communicate?" to, "What does the audience need to hear and understand?" you can be a more relevant and engaging presenter. By focusing on your listeners’ needs, rather than on yourself, you can relax and let that focus guide you through the developm

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

ent and delivery of your presentation.

Here are the essential questions that will help you stay on track:

Who is your audience?
What is most important to them?
What is their current level of knowledge on your topic?
What do they want or need to know about this topic?

If you can’t answer the above questions, it’s impo

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

tant that you do some research to find the answers. If your presentation is an educational or training session, you might want to send out a pre-class questionnaire or survey to learn the current knowledge level of your audience. This can be a simple 5 to 10-question, one-page document that you email or fax. If your presentation is more informational

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

Combination pro

r persuasive, you might want to make some phone calls to learn what you can about your audience.

What’s your objective?

Every presentation you give should have an objective or purpose. Why? Because your objective will help ensure that you stay focused on the topic. And, by defining your objective in the beginning of the development process, you’ll s

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

ave time.

Structure

Utilize a presentation structure that consists of a beginning, middle and end. In presentation language these components are called the opening, body and close. The purpose of the opening is to introduce yourself and your topic. The opening gives a short preview of the information you plan to cover. You may also want to include s

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

me startling data or a quotation. The main purpose of the opening is to get your audiences’ attention. The body of the presentation contains the main ideas and details you want to convey, while the close is the ending. During the close, you may wish to provide a summary of your main points to help the audience remember them. Also, any action items of

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

follow-up information should be in the close.

Delivering your presentation

About nervousness

Most people feel nervous and anxious before giving a presentation. This fear and anxiety can start the minute they’ve been given the assignment and can last until the presentation is over. It’s important that we accept the fact that we’re going to be nervou

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

and learn how to work with it. Try this three-step process developed by Lee Glickstein of Speaking Circles International to ease your nerves:

1. Feel your feet on the ground.

This will help to set a firm foundation for you and has a calming effect.

2. Breathe. And, most importantly, notice that you are breathing.

Most of us when we are nervous or

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

anxious tend to hold our breath and that only makes us feel worse.

3. Speak every word to the eyes and heart of another human being.

Every time you stand in front of any audience, you are building a relationship. If you want people to listen and pay attention to you, you have to listen and pay attention to them. By having a more personal connection

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

Following aspects would a

with your audience you will develop rapport faster. By looking at people individually, not seeing a group, you can be more relaxed and at ease. Try to have a one-on-one conversation with everyone in the room.

Five strategies to project confidence

1. Reduce your usage of filler words.

Filler words are words that we say unconsciously that add no mean

dd to the challenges in developing combination products:

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

ng to our communications. Examples of filler words are um, uh, ah, okay, so, you know, well, but, like, etc. The big problem with filler words is that if you use them frequently, they tend to chip away at your credibility and can make you sound unsure and unprepared. To start reducing usage, you first have to become aware of when and how frequently yo

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

u use them. The best way to do this is to either audiotape or videotape yourself giving a presentation. Then listen, or better yet, have someone else listen to the tape for filler words. Provide a checklist of filler words and ask the reviewer them count how many you use. It’s fine to use one here and there—using them repeatedly is the problem. Once y

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

u have an awareness of which filler words you use, you can start trying to reduce them. Substitute a pause where the filler words would normally occur and your listeners will thank you.

2. Be aware of body language and posture.

Just as mother used to say, stand up straight. Posture is important. Walk with erect posture and confident strides. Also ha

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

e an awareness of your body language. Show confidence with an open body position. This means hands at your sides not crossed in front of you or hidden in pockets. Keep your hands where the audience can see them and use gestures for emphasis.

3. Remember that you are the expert.

You probably know more than your audience does about your topic. That pu

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

Professional from academic institutions, pharmaceutical industries, health care indust

ts you at an advantage and should instill confidence. Remember, though, to be relevant. You need to know your audience’s level of knowledge on your topic so you can start where they are.

4. Keep your cool when things get hot.

No matter what happens, keep your composure. If you are using technology, be warned: It is bound to malfunction just when you

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

need it most. For peace of mind, have a Plan B ready just in case. If you can think in advance about what might go wrong, and have a contingency plan ready, you can continue and keep your cool. Every presenter has a personal horror story of how the laptop or projector crashed in the middle of their presentation. Be prepared.

5. Have a good time.

If

.

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

you are having a good time, chances are, so is your audience. Put a smile on your face and be excited and enthusiastic in your delivery. You will breathe life even into dull subjects and help your listeners be engaged in your talk.

The close

I hope you’ll practice some of the strategies listed here. Don’t feel that you have to do all of them during

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

Companies that provide selfless information through particip

our next presentation. You might want to think about what your biggest presentation challenge is and pick one improvement that you’d like to make. I can guarantee that you’ll feel more confident as you incorporate and practice these suggestions. And remember: Do what you can to enjoy your time at the front of the room and your audiences will enjoy you

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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