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AH Biotech 8 1 Dr. Abraham Hassan knew that he couldn't put off the decision any longer. AH Biotech die Bound Brook, New Jersey-based company started by this psychiatrist-turned- entrepreneur, had developed a novel drug that seemed to promise long-term relief from panic attacks. If it gained approval from the Food and Drug Administration (FDA), it would he the company’s first product. Tr was now time for large-scale clinical trials. Bur where should AH Biotech conduct those tests? David Berger, who headed up research and development, was certain he already knew the answer to that question: Albania. “Look, doing these trials in Albania will be quicker, easier, and a lot cheaper than doing them in the States,” he pointed out. “What's not to like?" Dr. Hassan had to concede that Berger’s arguments were sound. If it did trials in the United States, AH Biotech would spend considerable time and money advertising lot patients and then finding physicians who'd be willing to serve as clinical trial investigators. Rounding up U.S. doctors prepared to take on that job was getting increasingly difficult. They just didn’t want to rake rime out ol their busy practices to do the testing, not to mention all the recordkeeping that such a study entailed. In Albania, it was an entirely different story. There were few legal or political barriers to testing drugs. And it was one of the poorest Eastern European countries—if not the poorest—with a just barely functioning health care system. Albanian physicians and patients would practically line up at AH Biotech's doorstep begging to take part. Physicians there could earn much better money as clinical investigators for a U.S. company than they could actually practicing medicine, and patients saw signing up as test subjects as their best chance for receiving any treatment at all, let alone cutting-edge Western medicine. All these factors meant that the company could count on realizing at least a 25 percent savings (maybe even more) by running the rests overseas. So, what’s not to like? As the Egyptian-born CEO of a start-up biotech company with investors and employees hoping for its first marketable drug, there was absolutely nothing not to like. It was when he thought like a U.S.- trained physician that Dr. Hassan felt qualms. If he used U.S. test subjects, he knew they’d likely continue to receive the drug until it was approved. At that point, most would have insurance that covered most of the cost of their prescriptions. But he already knew that it wasn’t going to make any sense to market the drug in a poor country like Albania, so when the study was over, he’d have to cut off treatment. Sure, he conceded, panic attacks weren't usually fatal. Rut he knew how debilitating these sudden bouts of feeling completely terrified were—the pounding heart, chest pain, choking sensation, and nausea. The severity and unpredictability of these attacks often made a normal life all but impossible. How could he offer people dramatic relief and then snatch it away? 1. Do the clinical trials in Albania. You'll be able to bring the drug to market faster and cheaper, which will be good for AH Biotech's employees and investors and good for the millions of people who suffer from anxiety attacks.

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Management, Loose-Leaf Version

13th Edition
Richard L. Daft
Publisher: South-Western College Pub
ISBN: 9781305969308

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Section
BuyFindarrow_forward

Management, Loose-Leaf Version

13th Edition
Richard L. Daft
Publisher: South-Western College Pub
ISBN: 9781305969308
Chapter 4, Problem 1ED
Textbook Problem
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AH Biotech81

Dr. Abraham Hassan knew that he couldn't put off the decision any longer. AH Biotech die Bound Brook, New Jersey-based company started by this psychiatrist-turned- entrepreneur, had developed a novel drug that seemed to promise long-term relief from panic attacks. If it gained approval from the Food and Drug Administration (FDA), it would he the company’s first product. Tr was now time for large-scale clinical trials. Bur where should AH Biotech conduct those tests?

David Berger, who headed up research and development, was certain he already knew the answer to that question: Albania. “Look, doing these trials in Albania will be quicker, easier, and a lot cheaper than doing them in the States,” he pointed out. “What's not to like?"

Dr. Hassan had to concede that Berger’s arguments were sound. If it did trials in the United States, AH Biotech would spend considerable time and money advertising lot patients and then finding physicians who'd be willing to serve as clinical trial investigators. Rounding

up U.S. doctors prepared to take on that job was getting increasingly difficult. They just didn’t want to rake rime out ol their busy practices to do the testing, not to mention all the recordkeeping that such a study entailed.

In Albania, it was an entirely different story. There were few legal or political barriers to testing drugs. And it was one of the poorest Eastern European countries—if not the poorest—with a just barely functioning health care system. Albanian physicians and patients would practically line up at AH Biotech's doorstep begging to take part. Physicians there could earn much better money as clinical investigators for a U.S. company than they could actually practicing medicine, and patients saw signing up as test subjects as their best chance for receiving any treatment at all, let alone cutting-edge Western medicine. All these factors meant that the company could count on realizing at least a 25 percent savings (maybe even more) by running the rests overseas.

So, what’s not to like? As the Egyptian-born CEO of a

start-up biotech company with investors and employees hoping for its first marketable drug, there was absolutely nothing not to like. It was when he thought like a U.S.- trained physician that Dr. Hassan felt qualms. If he used U.S. test subjects, he knew they’d likely continue to receive the drug until it was approved. At that point, most would have insurance that covered most of the cost of their prescriptions. But he already knew that it wasn’t going to make any sense to market the drug in a poor country like Albania, so when the study was over, he’d have to cut off

treatment. Sure, he conceded, panic attacks weren't usually fatal. Rut he knew how debilitating these sudden bouts of feeling completely terrified were—the pounding heart, chest pain, choking sensation, and nausea. The severity and unpredictability of these attacks often made a normal life all but impossible. How could he offer people dramatic relief and then snatch it away?

1. Do the clinical trials in Albania. You'll be able to bring the drug to market faster and cheaper, which will be good for AH Biotech's employees and investors and good for the millions of people who suffer from anxiety attacks.

Summary Introduction

To Explain:

Do the clinical trials in Albania. You'll be able to bring the drug to market faster and cheaper, which will be good for AH Biotech's employees and investors and good for the millions of people who suffer from anxiety attacks.

Introduction:

Any pharmaceutical company can launch its product only If it gained approval from the Food and Drug Administration (FDA). But before applying for approval from FDA, you need to do a lots of clinical trials. Doing clinical trials is really a tough job because you need to find the country where its allowed thereafter you will have to do marketing by visiting the doctors, chemist shops etc.

Explanation of Solution

David Berger, who headed up research and development, was sure he already knew the answer to that question: Albania. Because doing these test in Albania will be faster, easier, and a lot cheaper than doing them in the states. In Albania, it was an entirely contrasting story. There were few legal or political obstruction to testing drugs. And it was one of the poorest Eastern European Countries-if not the poorest-with a just barely working health care system. Albanian physicians and patients would practically line up at AH Biotech's doorstep begging to take part. Physicians there could earn much better money as clinical scientist for a U.S. company than they could actually exercise medicine, and patients saw signing up at test subjects as their best opportunity for get any treatment at all, let alone cutting edge western medicine...

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