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Just Other Articles - New Leader - Figuring Out What to Do
When John was promoted to his first management job, his boss gave him a book about twelve traits a leader must have. His father gave him a different book about the characteristics of great leaders. His sister sent him an article about the new leadership. And his bro
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
ther-in-law sent him a different article on the same subject, but with different advice.
When John's wife, Susan, walked into the den that night, she found him grimly staring into space. The books and articles were scattered around him.
"I can't make sense of this,"
When John's wife, Susan, walked into the den that night, she found him grimly staring into space. The books and articles were scattered around him.
"I can't make sense of this,"
; 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
e groused, "One book is telling me that good bosses have integrity and values. The other one says that great leaders have vision. One article says that command and control is dead and I should let people control things but the other one talks about using technology to
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
monitor behavior. I liked it better before I was promoted. Then, I knew what to do."
"Maybe that's the answer," offered Susan, "You've said you want to be a boss like Karen, the woman you worked for in your first job in marketing. What did she do?"
"Gosh," John pa
"Maybe that's the answer," offered Susan, "You've said you want to be a boss like Karen, the woman you worked for in your first job in marketing. What did she do?"
"Gosh," John pa
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
sed and thought. "To start with, she was always touching base with us. Even when I was on the road, she was checking in to see how I was doing and if I needed anything and if I understood what she wanted. What are you doing?"
Susan looked up innocently. "I'm taking
Susan looked up innocently. "I'm taking
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
notes, darling. When this is over you won't remember a thing you said and you'll ask me and I won't remember either. Remember what the Chinese say, 'the palest ink is stronger than the strongest memory.'"
"So what did you write down?"
"Touch base a lot. Why do yo
"So what did you write down?"
"Touch base a lot. Why do yo
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
think that worked?"
John leaned back and stared at the ceiling. "Well, every time we connected I think we learned about each other. I could make sure I understood what she wanted. She asked about a lot of things. As I think about it, though, the conversations wer
John leaned back and stared at the ceiling. "Well, every time we connected I think we learned about each other. I could make sure I understood what she wanted. She asked about a lot of things. As I think about it, though, the conversations wer
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
different in the beginning."
"How so?"
"When I was new, there was a lot more instruction. She told me what to do and how to do it. Later we discussed things. And during the end of the time I worked for her, she'd just assign things to me. I never thought about th
"How so?"
"When I was new, there was a lot more instruction. She told me what to do and how to do it. Later we discussed things. And during the end of the time I worked for her, she'd just assign things to me. I never thought about th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
t till just now. It was a gradual thing."
"What else?"
"You always knew what Karen wanted."
Susan broke in, "That's nothing special. I know what my boss wants, even though he never tells us."
"I think that's different." John was leaning forward now, gesturing wit
"What else?"
"You always knew what Karen wanted."
Susan broke in, "That's nothing special. I know what my boss wants, even though he never tells us."
"I think that's different." John was leaning forward now, gesturing wit
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
h his hands. "Karen made a point of telling us, as a group and one at a time. We didn't have to guess. It was all out in the open."
"When I started working for her she sat me down laid out her expectations. There were her 'Three Rules' that we were never supposed to
"When I started working for her she sat me down laid out her expectations. There were her 'Three Rules' that we were never supposed to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
break. We joked a lot about them, but we all knew the rules and we followed them. She also told me how she liked to be briefed and how often. She gave me guidelines about how to know when I could make a decision on my own and when I should check in with her."
"Then,
"Then,
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
very week we sat down and discussed what had to be accomplished. And she was always checking to make sure we understood. And …"
Susan held up her hand. "Whoa. I get it. I wrote down: 'Lay out clear expectations over and over. Check for understanding.' Is that about
Susan held up her hand. "Whoa. I get it. I wrote down: 'Lay out clear expectations over and over. Check for understanding.' Is that about
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
it?"
"Yeah. But there's one more thing about that. She treated everyone a little differently. New people got more instruction. Some of us, like me got lots of contact, I think because we like it, but other people, like Arnie, got left alone except for Karen's ubiq
"Yeah. But there's one more thing about that. She treated everyone a little differently. New people got more instruction. Some of us, like me got lots of contact, I think because we like it, but other people, like Arnie, got left alone except for Karen's ubiq
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
uitous check-ins."
"Arnie was the guy you called 'The Hermit?'"
"That's him. He did great work, but he didn't like people checking on his progress all the time. Karen used to joke that she just slipped assignments under his door and waited to get his excellent repor
"Arnie was the guy you called 'The Hermit?'"
"That's him. He did great work, but he didn't like people checking on his progress all the time. Karen used to joke that she just slipped assignments under his door and waited to get his excellent repor
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
s back."
"So she treated everyone a little different, depending on their experience and on the way they liked to be dealt with. Is that right?"
"Yep. It was different strokes for different folks and different strokes for the same folks at different times."
Susan sm
"So she treated everyone a little different, depending on their experience and on the way they liked to be dealt with. Is that right?"
"Yep. It was different strokes for different folks and different strokes for the same folks at different times."
Susan sm
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
led and wrote that down. "Anything else that she did that you think is worth doing?"
John thought again. "There is, and it's got a kind of funny name."
"And that would be?"
"She called it the 'Dinosaur Principle.' I guess she learned it at a seminar someplace. Any
John thought again. "There is, and it's got a kind of funny name."
"And that would be?"
"She called it the 'Dinosaur Principle.' I guess she learned it at a seminar someplace. Any
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
ay it was that problems are like dinosaurs. If you get them small, they're easy to deal with. But if you let them grow big, they can eat you."
"You're right, it's kind of funny, but it makes sense. So does everything else. Want to hear my list?"
"Absolutely."
Sus
"You're right, it's kind of funny, but it makes sense. So does everything else. Want to hear my list?"
"Absolutely."
Sus
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
an smiled. "Here's how I got it down."
"Touch base a lot. Set clear expectations. Check for understanding. Treat people differently based on their performance and preference. The Dinosaur Principle."
"That's it. You're right. I do know what to do. All I really
"Touch base a lot. Set clear expectations. Check for understanding. Treat people differently based on their performance and preference. The Dinosaur Principle."
"That's it. You're right. I do know what to do. All I really
.
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
eed to do is think about Karen and how she did things and then adapt a bit for my own style and situation."
"Good plan, John. In fact, what I think you've done is identify what we call a 'role model.'" They both laughed.
John stood up. "I think I'll save these boo
"Good plan, John. In fact, what I think you've done is identify what we call a 'role model.'" They both laughed.
John stood up. "I think I'll save these boo
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
s and articles for inspiration and ideas." He leaned down to pick up the books.
"I'll take care of those. You need to go write a think you note to Karen."
"I sure do. And, maybe, if I'm lucky she'll be willing to be a mentor for me and I can keep learning from her.
"I'll take care of those. You need to go write a think you note to Karen."
"I sure do. And, maybe, if I'm lucky she'll be willing to be a mentor for me and I can keep learning from her.
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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