Main Subject - Business

There is a myth that great speakers are born, not made. This is based on the misconception that somehow certain individuals have the innate ability to stand in front of an audience with no anxiety and give a moving, dynamic speech. The truth is, however, that great speakers generally spend years developing and practicing t

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

heir art of communication. All great speakers had to learn the basics of organization, preparation, delivery and dealing with anxiety. In order to do anything well, it takes constant practice and a mastery of the basics. Speaking is no different.

One of the most important techniques you can apply to become a more confide

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

Examples of combination products may in

t and effective speaker is to reduce anxiety. If implemented, the following tips could help reduce your anxiety before your next presentation:

* Organize – Focus on your presentation.
 * Visualize – Mentally rehearse a perfect presentation with questions and answers.
 * Practice – Standing up, out loud, using visual a

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

ds. Obtain feedback from others. * Breathe – Sit up or stand erect, not relaxed. Inhale deeply a number of times. * Focus on Relaxing! * Release Tension – Try isometric exercises. Tighten and release your muscles. Start with toes and end with fists. * Move – Flex your muscles – don’t lock! Use a cordless microphone.

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

* Eye Contact with the Audience – Think one on one. Connect with the audience and make yourself personable. Use the feedback and energy you receive from your audience.

Planning your presentation is another component to becoming an effective speaker and presenter. There are essentially two steps that should be foll

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

Combination pro

wed prior to delivering a presentation: 1) develop your objectives and 2) analyze your audience. In preparation, one must identify the values, needs and constraints of the attendees and the level of knowledge of the audience. For example, do not use slang, jargon, acronyms, or technical terms without explanation. It shou

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

ld also be determined in advance “what will work” and “what won’t work”. In other words, what will gain you the most favorable reaction. In order to ascertain these items in advance, you should put yourself in the shoes of the people who will be listening to your presentation.

The next phase towards improving your effecti

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

e oral presentation skills is organizing your thoughts. There are a number of steps to this process:

Step #1: Brainstorm main ideas.  Use index cards or post it notes and only use one idea per card.
 Step #2: State the sub points.  Ideally there should be between 2-5 sub points in your presentation.  Be specific using

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

explanations, data and evidence to back up your points. Step #3: State the benefits. Specifically state the benefits before and at the end of the body of your presentation. Step #4: Develop handouts. Handouts should reinforce important points, summarize action items and include supporting data. Step #5: Develop visual

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

aids (PowerPoint slides, charts and graphs). Visual aids should be used to focus the attention of your audience, reinforce the verbal message and to stimulate interest. Keep in mind that effective presentations are people-centered, not media-centered. Too many presentations rely on the media to carry the message. While t

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

e media can certainly help, it’s your interaction and rapport with the audience that makes the difference between an effective or ineffective presentation. Step #6: Main idea preview/review sentence (i.e. Tell them what you’re going to tell them, tell them, then tell them what you told them). Step #7: Develop the introduct

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

Following aspects would a

ion. Get the audience to focus their attention on you, provide background information and introduce yourself – who you are and why you’re qualified. Step #8: Develop the conclusion. Your conclusion should be persuasive like a “call to action”. Spell out what specifically they need to do, when and how.

The delivery

dd to the challenges in developing combination products:

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

of your presentation is another key to a successful presentation. An effective presentation should be delivered in the following sequence:
• Introduction
• Preview Sentence
• Main Ideas and Sub Ideas
• Benefits
• Review Sentence
• Conclusion

In order to come across to your audience as confid

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

nt and persuasive, you should consider the way you physically deliver your points to your audience. The following are some helpful tips to help you achieve a level of confidence in delivering your presentation:

* Posture – Stand up straight, but avoid being stiff. Do not shift your weight from side to side.
* Movemen

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

– Keep yourself at least 4-8 feet from the front row – don’t pace!
* Gestures – Your presentation should be a form of animated conversation. Avoid keeping your hands in your pockets or on your hips, crossing your arms or wringing your hands.
* Eye Contact – Do not look at the back of the room or over their heads.

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

Maintain good eye contact to build rapport, trust and confidence.
* Using your Voice – Avoid being monotone which is generally caused by anxiety. Also avoid talking too fast. When people are nervous, they sometimes trip on their words. Be cognizant of your volume. Make sure that everyone can hear you.

At the concl

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

Professional from academic institutions, pharmaceutical industries, health care indust

usion of a presentation, there is generally a question and answer session that should be prepared for in advance. To prepare for this last hurdle, you should anticipate the questions that you could potentially be asked ahead of time. The key is to prepare for the worst and rehearse your responses to such questions. The mo

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

e you prepare your answers the more well versed and confident you will be. One tip you might employ during the question and answer session is to repeat the question being asked. This will give you some additional time to prepare your response. In general, we think five times faster than we speak! Whatever you do, it is i

.

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

portant that you maintain your style. If you don’t know the answer to the question you are being asked, be honest and say that you don’t know but that you will find out. Remember to really listen to the questions, do not interrupt and make sure that you stay focused on the individual asking the question. Finally, don’t fo

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

Companies that provide selfless information through particip

get to thank your audience for all of their excellent questions.

If you employ these techniques, you will be on your way to becoming a more effective speaker and delivering successful presentations. For information on workshops on how you or your team can deliver more effective presentations, please feel free to contact us

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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