From healthcare to religious discussions, everyone is bringing forth their personal opinions about biotech and big pharma. Trouble is, what most of these pontificators know about restriction enzymes, microarrays, pharmacogenomics, or plasmids is minimal.
While such ignorance may be unfortunate in cocktail conversation, it can prove downright disastrous if you are dealing, even tangentially, with the biotech or pharmaceutical industries. To help investors, sales personnel, lobbyists, university administrators, and all connected folks comprehend exactly where the front lines of the biosciences are heading, BioNJ is offering a two-day seminar titled “Industry Knowledge for the Non-scientist,” on Thursday and Friday, March 17 and 18, at 9 a.m. at Princeton University’s Bowen Hall. Cost: $945. Visit www.bionj.org.
The course is designed by #b#Stacy Franklin#/b#, founder of Maryland-based Biotech Primer Inc., which provides biotech training. Franklin has gathered a corps of industry veterans, all Ph.D.s, who take time from their professions to instruct. What began as a one-woman seminar has now grown to an international school with classes given in house or at major associations throughout North America, the Pacific rim, and Europe. (visit www.biotechprimerinc.com.)
Daughter of a high school athletic coach father and homemaker mother, Franklin grew up in Annandale and fell in love with scientific research at her regional high school. “They had a planetarium, electron microscopes, and it opened a vast, exciting realm for me,” she says.
After graduating from Towson University in 1990 with a bachelor’s in chemistry and biology Franklin remained in academe, teaching high school science in Maryland and abroad. She returned home to take her biotech master’s from John Hopkins University, then went to work for the Maryland State Bioscience Alliance. “It was there I saw the need for basic bioscience education” says Franklin. “People cannot buy, sell, vote for, negotiate for, or invest in an industry they don’t understand. And if you don’t know the field, everybody sees right through you.” In 2001 she launched Bioscience Primer Inc. and has filled her classes ever since.
For the past two decades bioscience has been viewed akin to renaissance alchemy — striving to move through the experimental stages and into the realm of fixed, proven principles. Consequently, the public has mantled both the science and the scientists with a cloak of dubious mysticism. Terms like “genetic engineering,” “stem cells,” and “clones” still send Frankensteinian shivers through many. But for Franklin, bioscience is merely a matter of new tools for old tasks.
#b#Bioscience basics#/b#. Bioscience, at this stage, is the method of using living cells to develop medicinal products. “We really are not smart enough yet to compete synthetically with the natural cell,” says Franklin. The cells are just so good at producing the desired proteins — mostly enzymes and antibodies — that they must be our factories for awhile.
A century and a half ago, pharmaceutical science stood at an analogous stage. With drug synthesis at a primitive infancy, developers concentrated on creating remedies from the earth’s smorgasbord of natural offerings — like making aspirin from willow bark.
“The great leap forward,” Franklin says, “came when Genentech realized you could slice and dice DNA into the various genes that could foster specific amino acids into specific proteins.” Today such engineered monochronal antibodies have extended the lives of thousands of cancer patients. The benefits have proved solid and the proteins’ use increasingly gains dependability. In the past year the FDA approved 25 new drugs. Seven of them were biologics.
Today the FDA is urging all pharmaceutical firms to employ bioscience in the development of companion diagnostics. This personalized testing involves a sampling of the patient’s DNA to determine how swiftly his system metabolizes the potential treatment. If acceptable, the medicine’s dose is exactly adjusted. “It’s not only a great benefit for the patient,” says Franklin, “but it saves a great amount of time and expense, allowing doctors to nail the diagnosis the very first time.”
#b#Healthcare costs#/b#. As revenue-squeezed governments slash funding and healthcare costs come under ceaseless scrutiny, bioscience research is often viewed as woefully unaffordable. Countering this, Franklin is quick to point out simple supply and demand data.
Prior to genetic engineering, all insulin for diabetes treatment came from the spleens of slaughtered cows and pigs. Now that diabetes has reached epidemic proportions, there simply is not enough from that source. “Today with insulin genetically engineered more cleanly and inexpensively grown in bacteria, the low-income population are not denied this medicine,” she says.
On a longer-term basis, the development of stem cell treatments offers such a wide range of potential cures to a significant percentage of the population that the savings proves the investment. The latest emerging Alzheimer therapies can potentially prevent tens of thousands of dollars in patient warehousing per individual.
The highly charged placenta-harvesting question for stem cells may soon become moot. Currently researchers can induce adult stem cells within, say, bone marrow to create more healthy red blood cells. Yet evolving experimentation is leading to certain growth hormones that may encourage these adult stem cells to revert to an earlier stage of development and create other kinds of bodily tissue. The prospects are exciting and limitless.
#b#Micro investing#/b#. The old joke used to say that biotech was the only industry in which you never had to produce a product to attract capital. Just display your plans for this or that molecule; the government would fund you; and venture investors would back you for a piece of the grant monies. But Franklin notes that those days are long gone. Government funds have dried up.
Bioscience investors today are much more savvy, Franklin says. They want a product, a delivery date, and a sales analysis (not just patient statistics). Early-stage companies are being pushed aside as those further along the trial process gain favor.
Oncology treatments are still the top investor favorite. Behind them come treatable diseases with high percentages of victims globally: depression, mental illness, autism, and food allergies. Certain venture capital firms have recently taken to specializing in orphan diseases — those lesser-known illnesses claiming fewer than 200,000 people worldwide. Their appeal lies in the FDA’s more rapid clinical testing regimen.
At some point, individuals and the state must ask some prickly health questions — what is a human life worth? How much can I afford to spend in order to prevent the vagaries of aging, dementia, and loss of mobility? How many people can a nation afford to treat — and how thoroughly — without bankrupting its resources?
To make these determinations it will be necessary to have the science backing them up. As Franklin says, “if we choose to remain uninformed about the possibilities, we are limiting, and condemning ourselves.” —