Advice Pool - Self Improvement

A GIFT OF A LIFETIME

LINCOLN NE-Mark Blazek is a small town guy. He never wanted to leave small town Nebraska and there was only one college he ever wanted to attend. He had the big dream of so many young boys and the courage of

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

just those few who have made the Nebraska walk-on program legendary in college football.

"I had a chance to go to college on a full ride scholarship playing basketball," the thirty-five year old Valparaiso lawyer turned banker recalled. "I had just enough money to go to Nebraska for one year. T

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

Examples of combination products may in

here was no other financial help around for me so I had a year to get it done. I could have gone to one of the acadimies but I didn't want to leave Nebraska for that long."

Get it done was exactly what this defensive safety prospect from Raymond Central High School did. He enrolled at Nebraska,

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

walked-on and in no time at all, he made the 4th. string. "You have to have a little luck to succeed," he said and luck came from a most unlikely source. It would be the year of the ticket scandal at Nebraska resulting in NCAA sanctions. Players who didn't follow the rules about handing out stud

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

ent athlete tickets to the satisfaction of the NCAA had to step aside. Blazek went from 4th string to 2nd string in the blink of a questioning NCAA eye.

His first year money was also running out so he needed to make some decisions. "I heard about the Nebraska National Guard program and how they

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

Combination pro

ould pay for college if you signed up." The recruiter came out to visit Mark and his parents and signed him up. "My dad was out of work at the time so he signed him up, too. We took the test together and were sworn in together."

Blazek's National Guard detour found him roaming around a Ft. Knox

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

training battlefield in a tank. That's not bad training when you consider the size of oncoming offensive college linemen. The following fall, he traded his Nebraska National Guard tank helmet for a white one with a red stripe and a red N on the sides. His first game was against the pesky South Ca

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

rolina team who brought the fight to Nebraska in a home and away series.

"Early on, the coaches were looking at me as a corner but I knew I wasn't fast enough," he noted. Blazek was one of the last guys with average speed and a big heart to play in the secondary. To win the big ones, the Nebrask

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

a coaches knew they would need more speed at those positions. But for now, the coaches picked a competitive small town kid with lots of personal drive.

"We went out to play UCLA for my senior season opener," he recounted, "and by the end of the first quarter, they were up something like 28 to 0."

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

That game was not one of the best memories in Husker Football history. But, there was a bright spot.

"Troy Aikman was UCLA's quarterback," Blazek said. "I picked off one of his passes and got hit by one of our guys, Charles Fryer. I was just worried about hanging onto the ball until Fryer start

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

d pulling me up. 'Get up and run, get up!' Fryer hollered at me." Blazek did just that and returned the interception for a seventy-five yard touchdown. It may still be Aikman's longest interception for a touchdown.

Aikman's revenge came a little later in the game. UCLA had Nebraska backed up to

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

Following aspects would a

the three-yard line and ran an option Blazek's way. All that stood between Aikman and the goal line was a pulling 300 lb. guard who set his sights on Balzek. The result was much worse than another UCLA touchdown. Blazek suffered a torn hamstring muscle.

"No one knew how to treat that injury,"

dd to the challenges in developing combination products:

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

Blazek said. "I could jump OK but I had lots of pain on any forward motion." Blazek spent the remainder of his football career doing what many of the players really wanted to do all of the time. "I couldn't practice. The trainers had me rest all week and just play on Saturday. That's what a lo

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

t of the guys wanted to do anyway. They would come out in sweats and I was dressed. Coach Osborne sent those guys back to put on pads and told me to put on sweats and take it easy. It really was funny."

Blazek went on to some post season honors including Academic All-American and Honorable Ment

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

ion Big 8 and was also selected to play in the Japan Bowl. "We were at a press event and were all wearing our school jerseys. Aikman was there and I went up to introduce myself," Blazek explained. "He knew who I was when he saw my jersey."

At another academic event, Blazek sat next to the Corne

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

l Head Football Coach. Mark was toying with the idea of becoming a graduate assistant at Nebraska while going to law school. "The Cornell Coach said his fishing buddy was the Dean of the Cornell Law School and he made me the same offer on the spot but I wanted to stay in Nebraska."

Blazek did ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve some thoughts about playing pro football. His wife Kim is related to former Husker Brett Clark who went on to play for the Washington Redskins. "Brett told me I could play pro but I was ready to move on," Blazek said.

Blazek graduated from Nebraska Law School, worked for a Lincoln firm and we

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

nt back home to Valparaiso and took a position as a Senior Vice President of a local bank. He still serves in the Nebraska National Guard and works closely developing leadership qualities for the Nebraska Bankers Association.

Does he have any words of wisdom for young want-to-be Huskers? "You m

.

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

ust develop discipline and a good work ethic," he said. "The most athletic players don't always play. You have to be there at the right time and work hard. If you do, you will get your chance at Nebraska."

The young boys of Valparaiso don't have to look far to find a real Nebraska hero. They h

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

Companies that provide selfless information through particip

ave a former Nebraska Safety who now stands guard with the Nebraska National Guard. Major Mark Blazek has given all he can to play and stay in Nebraska. Not only does he love Nebraska; he honors Nebraska with his dedication. Perhaps that's what folks mean when they say, "it's a gift of a lifetime.

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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