ROAD TO THE CURE UPDATE MAY 2015 · Parkinson's Resource Organization

ROAD TO THE CURE UPDATE MAY 2015

Category: Road to the Cure

THE SAN DIEGO BIOTECH COMPANY (SDBC) 

“…the failure of the global scientific community to halt and cure neurodegenerative diseases ….the BLOOD-BRAIN BARRIER.”

Non-human Primate Study The San Diego Biotech company revealed last April as ICBI has been working with the Rush University Medical Center (RUMC) to conduct blood-brain barrier (BBB) permeability and therapeutic efficacy study in non-human primates. The Principle Investigator, Dr. Jeffrey Kordower of RUSMC, has begun the process of producing Parkinson’s monkeys and ICBI scientists have begun to generate SMART Molecule in quantities large enough to administer into 8-10 monkeys. Since monkey’s brain resembles to human brain, the success of penetrating the BBB in monkeys would be an unprecedented achievement in the history of science. Each monkey will cost $50,000. The Company is trying to raise funds for the execution of this historic experiment.

ICBI Technology and Chances of Success – It should be noted that the failure of the global scientific community to halt and cure neurodegenerative diseases has been due to one primary factor: The BLOOD-BRAIN BARRIER. Most drugs are denied access to the brain by the blood-brain barrier. Since ICBI now has the technology to deliver drugs into the brain, the risk of drug failure due to poor or no access of drugs to the brain has been removed from the equation. However, it is possible that the first drug for Parkinson’s disease developed by ICBI may not be an ideal drug. Nonetheless, the technology is versatile enough for rapid turnaround of new and improved versions of drugs to find the one that gives maximum benefits to the patients. Our Angel Investors should delight in knowing that what ICBI has accomplished with about $1.8M of their investment funds has not been accomplished by the big pharmaceutical companies, even after spending billions.

Large Pharmaceutical Companies Require Human Proof-of-Concept before Partnering – A question often asked is that if ICBI technology is so good, why a big pharmaceutical company has not funded ICBI? The answer can be found on the web sites of big pharmaceutical companies under the “Partnership” tab. Big pharmaceutical companies want to see proof-of-concept in humans but ICBI is 1–2 years away from human studies. The Company needs a minimum of $3.5M to take one drug through Phase-1 human clinical trials. Compared to what the big pharmaceutical companies are spending on developing drugs, ICBI’s cost would be only a fraction of what is reported in the following article published on the Internet.

Google “Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B” and you will find many sources reiterating the same. That’s 25 Billion with a “B”.

A benchmark report estimates that the cost of bringing a drug to market has more than doubled in the past 10 years. (November 24, 2014 by Rick Mullin and Chemical & Engineering News).

The steep rise in costs comes despite an intense effort in recent years to bring efficiency to pharmaceutical R&D. Credit: Rennett Stowe via flicker.

A new report published by the Tufts Center for the Study of Drug Development (CSDD) pegs the cost of developing a prescription drug that gains market approval at $2.6 billion, a 145% increase, correcting for inflation, over the estimate the center made in 2003.

CSDD’s finding, a bellwether figure in the drug industry, is based on an average out-of-pocket cost of $1.4 billion and an estimate of $1.2 billion in returns that investors forego on that money during the 10-plus years a drug candidate spends in development. The center’s analysis drew from information provided by 10 pharmaceutical companies on 106 randomly selected drugs first tested in humans between 1995 and 2007.

The study concludes that another $312 million is spent on post-approval development—studies to test new indications, formulations, and dosage strengths—for a life-cycle cost of $2.9 billion.

The steep rise in costs comes despite an intense effort in recent years to bring efficiency to pharmaceutical R&D. Offsetting any such savings, according to CSDD, are higher costs due to the increased complexity of clinical trials, a greater focus on chronic and degenerative diseases, and tests for insurers seeking comparative drug effectiveness data.

Noting the high cost of failure in drug development, Joseph A. DiMasi, director of economic analysis at CSDD and principal investigator for the study, says the cost of unsuccessful projects is figured into his group’s analysis.

John LaMattina, senior partner at the venture capital firm PureTech and former head of R&D at Pfizer, says he saw battle lines forming within hours of the report’s publication. “People are automatically saying that pharma, and the Pharmaceutical Research & Manufacturers of America in particular, is really going to use this to justify the high cost of drugs.”

LaMattina counters that pricing should be based not on R&D costs but on the value a drug delivers to patients. Meeting new insurance company requirements to determine that value, he adds, has raised the cost of development at a rate that far outpaces efficiency efforts, which tend to address early-stage research.

LaMattina says, “The value of the Tufts study is that it helps the public understand that this is a high-risk, expensive, and long-term endeavor

Since April 2014 on the PARKINSON’S ROAD TO THE CURE, PRO proudly continues reporting advancements in ICBI and their scientist’s historic work to the Parkinson’s world. This remarkable science continues as they help you understand the never before possible, “real time”, reporting of creating the “Road to the Cure,” including imaging the proteins causing Parkinson’s in the brain of live mice and now primates.

We invite you to contact us if you want information about supporting or investing in The Parkinson’s Road to the Cure. We would be proud to make this important introduction and we continue to salute these scientists as they forge ahead!

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Updated: August 16, 2017