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Cases - The Fly-In
Early this week, I received a call from someone referred by a friend of mine in Utah. He was being flown in for an interview by
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
a firm with whom he had been in conversations for quite some time and wanted some coaching before his interview. After all, it
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
had been a decade since he interviewed!
In circumstances like this, I try not to overload someone; in his case, he had an adv
In circumstances like this, I try not to overload someone; in his case, he had an adv
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
antage because as a long term consultant, he was used to selling his abilities.
I asked him about a few details.
What time is
I asked him about a few details.
What time is
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
your flight?
Who’s going to pick you up?
What’s your schedule that night?
In his case, he had an afternoon flight. After he
Who’s going to pick you up?
What’s your schedule that night?
In his case, he had an afternoon flight. After he
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
landed, he was going to rent a car and drive to a restaurant to meet the person who is sponsoring his candidacy for dinner; th
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 next day would be when the heavy interviewing would occur.
For one of my clients, they fly people out the day before, have a
For one of my clients, they fly people out the day before, have a
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
driver take them to a hotel to stay overnight, then interviews start in earnest the next morning (they bring people in the day
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
before so that if flights are delayed or even cancelled, the interview schedule isn’t impacted).
Given that he was meeting so
Given that he was meeting so
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
meone from the employer for dinner (I thought of how rumpled I can be after a flight), he planned to change at the airport into
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
appropriate attire for dinner, rather than travel in his suit.
I have had companies treat the driver like a surveillance memb
I have had companies treat the driver like a surveillance memb
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
er and report back any rude or obnoxious behavior. I have had job seekers abuse the ability to charge by expensing expensive li
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
quor to their room.
Be smart about lies ahead of you.
You will be someone else’s control for a day or so. What can you do to
Be smart about lies ahead of you.
You will be someone else’s control for a day or so. What can you do to
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
perform at peak?
Try to get a sense of your schedule. I have a client that will interview for five or 6 hours. Can your blood
Try to get a sense of your schedule. I have a client that will interview for five or 6 hours. Can your blood
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
sugar hold that long?
Traveling across time zones? East coast people have it easier interviewing on the West coast. They may b
Traveling across time zones? East coast people have it easier interviewing on the West coast. They may b
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
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 up early but, a 9AM interview is like interviewing at noon for them. If you reverse it, a West coast person is interviewing a
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
t 6AM and may be up at the equivalent of 4 for breakfast, appearance preparation and to get to the interview (always arrive on
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
time).
I remember Muhammad Ali would always start and finish each round strong to create an impression with the judges. Do the
I remember Muhammad Ali would always start and finish each round strong to create an impression with the judges. Do the
.
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
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
same. Start and finish each meeting at peak.
Read some of earlier writings on interviewing at my blog which you can access at
Read some of earlier writings on interviewing at my blog which you can access at
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
www.jeffaltman.com
And, remember, you are not a rock star who will expense a limo and numerous expensive bottles of champagne
And, remember, you are not a rock star who will expense a limo and numerous expensive bottles of champagne
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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