A guy goes into a doctor’s office and gets diagnosed with epilepsy.
“Here, take these pills,” says the doctor.
Two weeks later the patient returns, complaining he still suffers from seizures.
“That’s impossible,” says the doctor. “The lab tests prove you have epilepsy and these pills cure epilepsy.”
Actually, notes #b#Salvatore Salamone#/b#, founder of Saladax Biomedical Inc. in Bethlehem, Pennsylvania, both of this physician’s assumptions may be correct. He is merely limiting himself to old, outdated diagnostic tools. The patient has received no further diagnostic testing to see precisely how much of this wonder drug his body can tolerate, and how much remains in his blood for how long.
Salamone joins an expert panel discussing how new diagnostics and personalized medicine will transform drug development and improve patient care at the “BioNJ Diagnostics Breakfast Briefing” on Thursday, September 16, at 7:30 a.m. at the Bridgewater Marriott. Cost: $65. Visit www.bionj.org.
Though just recently gaining medical acceptance, the new personalized diagnostics revolution has been 30 years in coming, and Salamone has been a major mover in the cause for most of that time. Son of Manhattan fish store owners, Salamone grew up in Edison. He attended Villanova University, earning bachelor’s degrees in bioscience and chemistry in 1976, followed by a chemistry master’s and Ph.D. from Rutgers.
During his postdoctoral research at Oxford, pharma giant Hoffmann-La Roche recruited Salamone into its diagnostics division. During his 17-year tenure, he helped grow the company from $60 million to $2.4 billion in sales, and brought in seven product lines and more than 70 new drugs to market. Eventually becoming vice-president of research and development at Roche Diagnostics, Salamone began developing his advanced diagnostic techniques to accompany each new drug.
Bent on carrying on this personalized diagnostic into the field of oncology, Salvatore teamed up with fellow Roche veteran Adrienne Choma and in 2004 founded Saladax, which offers the MyCare system for monitoring cancer therapy effectiveness and dose tolerance.
“Instead of having the standard blood tests show the glucose or enzyme levels,” says Salamone, “we now bring diagnostics up to the next level. We can individually check for a patient’s predisposition to a disease and treatment reaction. And we can track how the disease is progressing under treatment.” Such expanded, personalized service, while an obvious enhancement of patient care, is not always greeted gratefully by the medical community.
#b#Drug dosing of old#/b#. Traditionally, doctors prescribe drug dosages based on the patient’s BSA — body surface area. Basically, it involves a height-weight-age formula. Developed in 1916 and standardized throughout the 1950s, most drug therapies are still doled out this way. The problem is, surface is not the sole factor. Other variables such as body metabolism and psychological and genetic predisposition can easily sway dosage requirements by as much as 35 percent. Additionally, BSA is associated with one’s drug plasma level which may vary 30-fold.
The nice thing about BSA is that it may be determined swiftly by a physician with a handheld calculator. The unfortunate thing, Salamone has found, is that more than half the people receiving cancer drugs were under-medicated. “You’re playing with people’s lives here,” he says. “It a disaster to over medicate and cause toxicity, but it’s even worse to under-medicate and allow the disease to run rampant.”
#b#Individualizing care#/b#. By determining one person’s genetic predisposition to appropriate therapies, physicians may eliminate potentially toxic or ineffective treatments. Salamone is calling for such formulized, globally accepted predisposition standards. To achieve this, vast numbers of patients would have to be tested and stratified according to responses.
“This will entail a major change in the entire pharmaceutical industry,” he says. “Hopefully within 10 years you will see patients diagnostically placed into the right groups to receive the right drugs.”
Once this right drug is administered, a regimen of periodic tests form a tracking system to monitor the blood level of the therapy and the progress of the disease. It is this repeated testing to which a great number of physicians seem to have developed surprising resistance.
The three parts of such drug management include developing a test that will accurately indicate the drug’s levels, determining the proper nontoxic, yet effective dose scales, and selling the practice to the medical community. “Typically this last part is the hardest,” laughs Salamone.
Pharma partnering. Despite some resistance, the one-dose-fits-all days are dwindling. Leaders like Genentech already develop a diagnostic process with each new drug they bring to market. The FDA is mandating personalized drug monitoring for many new therapies. It requires a whole new branch of research and development, which the giant pharmaceutical manufacturers are gladly turning over to qualified smaller partners.
These small, specialized firms, such as Saladax, that concentrate on primarily one field of disease and the appropriate therapies offer great in-depth knowledge. And like most small, niche teams, they can get the job done faster and for far less cost than establishing a new, separate division in-house to attack the personalized drug management challenge.
Currently, Saladax is finalizing a partnership with Bristol-Myers Squibb to handle that firm’s oncological diagnostic needs. It seems a natural match. But being on the side of the angels and new potential revenue streams does not always usher one through the large corporation’s double doors. Salamone lists several attributes the small firm had better have on ready display when trying to partner with a major pharmaceutical company.
“Probably the greatest asset is having someone on your team who speaks corporate language,” says Salamone. “Both Adrienne and I had spent years in Roche, so we knew what they were looking for and how they operated.”
Smaller companies not so fortunate should seek out a business development expert who has the time and savvy to knock on all the right doors and make the right pitch once he’s inside.
Salamone’s other recommendation is that you bring in an impressive team with a track record. Most large companies realize that the small firm sitting across the table is probably more flexible and cost effective. “So the big thing you must prove to your potential partner is that you can deliver a quality product in a timely manner. And do it over and over again,” says Salamone.
Everybody in the health care profession is looking for better patient care. It is not only humanitarian, it is the best source of new revenue. So when our patient now comes into his physician complaining of seizures, with the new evolved method of diagnostics and monitoring, the doctor can take the time, take the tests, and make sure that this patient is getting what he requires today, and continually down the line. And that’s a win-win for all.