Fourteen years ago, Betsy Patterson was a 34-year-old single mom with three kids ages 5 to 10. She was a registered
nurse in oncology working on the bone marrow transplant unit, where cancer patients go to replace the marrow cells
destroyed by cancer treatments. She was reminded daily just how terrible cancer could be. And then she found her
own lump.
Betsy was diagnosed with non-Hodgkin's lymphoma (NHL), a malignant growth of immune system cells that begin to
form tumors in lymph nodes and throughout the body. NHL, a deadly cancer that affects an estimated 250,000 Americans,
is growing at a rate second only to lung cancer. About 55,500 new patients will be diagnosed in this country this
year, and 25,000 will die of the disease. There is no cure for most patients, and only 60% of patients treated
with the conventional treatments-toxic radiation and chemotherapy-are still alive 5 years after diagnosis.
Because there were no other symptoms, she and her doctor adopted a "wait and see" approach. Betsy did
very well for 9 years. Her lymph nodes would periodically balloon up but then disappear before she even had time
to see the doctor. She remarried, and life went on.
But in 1995 things changed. Betsy enrolled in graduate nursing school-the stress level went up. Within weeks, tumor-filled
lymph nodes were popping out all over her body. A biopsy showed that her lymphoma had kicked into overdrive. Her
doctor suggested immediate chemotherapy, and she entered a 9-month Phase II clinical trial protocol with two drugs-fludarabine
and mitoxantrone.
Chemotherapy works by killing off rapidly dividing cells, such as tumors. Unfortunately,there are lots of healthy
cells in our bodies that also divide rapidly-hair follicles, the cells lining the digestive tract, the bone marrow
cells that produce red blood cells to carry oxygen, and the immune system's white blood cells. During chemotherapy,
your hair falls out, your mouth develops ulcers, your gut loses the ability to absorb food properly, your red cell
count gets so low that there is not enough oxygen getting to your organs, and your immune system loses the ability
to protect you from infection. Some drugs damage the kidneys and the heart. Most lymphoma patients die not of the
direct effects of their disease, but of complications of the treatment. Chemotherapy is essentially a race to kill
the tumor before the treatment kills the patient.
Betsy's doctor told her that fludarabine was not associated with extreme toxicity-he expected her to keep her hair,
and her job, throughout the 9-month protocol. But to Betsy, it felt as though the treatment was killing her pretty
quickly. "The chemo was very tough on my veins and I felt pain with each infusion burning up my arms. Within
days of the first treatment, I was sick as a dog, with uncontrolled nausea and vomiting."
Within 3 weeks of the first treatment, Betsy got another unpleasant surprise. "The drugs were so toxic to
my ovaries that they just stopped producing hormones. I went into abrupt menopause and all the wonderful things
that means-constant hot flashes; loss of sexual libido; major physical changes; serious night sweats that would
soak the bed, my nightgown, and my poor husband; and my periods ended. Sleep was totally disrupted for both of
us. Nobody had warned me about this effect. These were major quality-of-life problems for me and for my family."
At the end of the 9-month protocol, she began replacement hormone therapy. At that point, her body felt and looked
like that of a much older woman. The hormone therapy, which she will need to take for the rest of her life, helped
return some of her body to normal. But some of the induced changes are permanent...
Summary
Written by a well-known industry insider, From Alchemy to IPO addresses the coming-of-age of biotech products
and companies and traces the history of biotechnology from its early inception in the seventies to today's heyday
of new solutions and breakthrough treatments. It describes the amazing entrepreneurial trail of product development,
novel business models, and critical trials that eventually pave the way to market. This is the first book to accurately
record the inner workings of an industry-biotechnology-that's on the verge of living up to its monumental promise
to change the world as we know it.
Table of Contents
Preface ix
Acknowledgments xiii
Part 1 The Roots of Biotechnology
1 Biotech in the Beginning 3
2 Genentech : The Leader of the Pack 13
3 The Amgen Story 31
4 An Exception to Every Rule : Genzyme 43
5 The Other Biotech : Monoclonal Antibodies 48
Part 2 Biotech's Building Blocks
6 Biotech Star Wars 59
7 The Human Genome Project 67
8 Tools for Genome Studies : BioChips and Microarrays 73
9 Treating Disease at the Gene : Antisense Drugs 82
10 Gene Therapy 85
11 Following the Path of Communication: Signal Transduction 89
12 Brand-New Knees : Tissue Engineering and Cell Replacement 92
13 Building New Drugs : Combinatorial Chemistry 97
14 Agricultural Biotechnology 105
Part 3 The Business of Biotech: Product Development and Financing
15 The Drug Development Process : From Test Tubes to Patients 111
16 Speed Bumps and Brick Walls : Clinical Trial Design 124
17 Biotech Bankers 131
18 Initial Public Offerings 146
19 Creative Financing 155
20 Corporate Partners and the Urge to Merge 161
Part 4 Biotech Stocks
21 The Biotech Stock Landscape 183
22 Picking the Right Stocks 198
Appendix A Biotech Timeline 219
Appendix B Biotechnology-Derived Products on the Market 224
Appendix C Biotech Web Sites and Resources 230
Appendix D BioVenture Consultants' Biotech Stock Report 235
