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Your Space - Special Response Team
Have you ever seen a police department’s Special Response Team in action? These are the guys dressed in black with helmets, face shields and very large weapons. I have seen them up close and they are very intimidating, not good if you
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
are a criminal.
Have I been a hostage? In a manner of speaking. I belong to a volunteer group that works with my local police department. One of our “perks” is to take part in scenarios, an exercise that simulates a real-life situat
Have I been a hostage? In a manner of speaking. I belong to a volunteer group that works with my local police department. One of our “perks” is to take part in scenarios, an exercise that simulates a real-life situat
; 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
on. In this case, yes, I’ve been a hostage.
So what exactly does a Special Response team do? They are a very specialized and important branch of the police department. They are called out on hostage situations, armed barricade incide
So what exactly does a Special Response team do? They are a very specialized and important branch of the police department. They are called out on hostage situations, armed barricade incide
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ts, high risk search or arrest warrants and any crisis situation deemed necessary for use of a specialized unit. They can also be utilized in the event of a suicidal individual, civil disorder, natural disasters, riot control, bomb th
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
eats and surveillance. Essentially, they respond to any incident that requires extra resources, equipment and training that cannot be handled by traditional police response.
Tactical teams require members to go through intense and sp
Tactical teams require members to go through intense and sp
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
cialized training. It is a voluntary position, but officers that are interested must pass a rigorous assessment to be considered. Often this includes, but may not be limited to, an oral review board, obstacle course, firearm proficien
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
y and working various scenarios.
Teams will conduct biweekly or monthly training exercises in hostage rescue, dynamic forced entry, covert or stealth clearing of a building, weapons training and, of course, the scenarios.
Teams also
Teams will conduct biweekly or monthly training exercises in hostage rescue, dynamic forced entry, covert or stealth clearing of a building, weapons training and, of course, the scenarios.
Teams also
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
attend outside training course offered throughout the country. They learn and update their training in areas such as shoot/no shoot decisions, securing a perimeter, threat recognition, officer down situations, building searches and th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
use of less lethal weapons.
To keep their training fresh, they will hold one or more scenarios per year. I’ll walk you through the first one I was involved with. The scenario was a hostage situation at an office building. One person
To keep their training fresh, they will hold one or more scenarios per year. I’ll walk you through the first one I was involved with. The scenario was a hostage situation at an office building. One person
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
was down, the number of hostages and suspects was unknown. This is all the information the team is given. The team was comprised of officers that were trying to become members. In this case, we had two suspects and four hostages. Our
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
suspects were police officers on the actual team. I was the last hostage remaining, so I had a complete and inside view of how a tactical team works. My captors found a room with a view of the front door so we could watch the progress
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
of the team. It is a very slow, arduous process. The officers have no idea what they will find or where, so they move at a snail’s pace. In this case it took them forty five minutes just to enter the building!
Once inside, the slow
Once inside, the slow
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
ask continues. We had two hostages hiding in different rooms. When a team finds a hostage or a hostage is released, they must treat them as suspects until they are positive they are not. Once they discovered both of the hidden hostage
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
, they moved on. Next up was to release a hostage. She ran screaming down the hall, only to be ordered to stop, turn around, put her hands on her head and then walk backwards toward the team. Then they gather what information they can
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
as to what yet awaits them. Now we were down to me as the remaining hostage. My captors decided they would “put” me around a corner, threatening to harm me. This was my first close up view of the team. To say the sight before me was i
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
timidating is an understatement! The team was dressed head to toe in black, their body armor making them look bigger and even more imposing. They were armed with high power weapons and were in very close proximity to one another. I wa
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
ted to turn around and tell my captors, “Boys, you need to just give it up now.”
This tactic didn’t work, so my captors and I retired to a room and waited. And waited. Suddenly, the door burst open with men yelling, “get down!” and “
This tactic didn’t work, so my captors and I retired to a room and waited. And waited. Suddenly, the door burst open with men yelling, “get down!” and “
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ang!”, this last because they weren’t even allowed paint bullets. I was tackled by one team member in order to get me out of the line of fire. And, just like that, it was over. It happened so fast, I didn’t have time to think. That is
.
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
exactly what they were meaning to do. The element of surprise. Congrats all around, the remaining hostage is safe!
Following such a drill, the team assembles and discusses what went wrong, what they did right and how anything could h
Following such a drill, the team assembles and discusses what went wrong, what they did right and how anything could h
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
ve been done differently. After experiencing this drill and the others I have been in, I know that all of the team’s hard work has paid off. I feel so much safer knowing there are men such as this in the event of a true life situation
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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