Outsourcing to Biotechs Is the Answer for Many Pharma Companies' Development

Small, mid-sized and large pharmaceutical companies are turning to outsourcing to free up cash for more early-stage marketing endeavors, according to a new study from Cutting Edge Information.

Early-stage development and commercialization resources can be hard to come by, as most pharmaceutical executives can attest to. Cutting Edge Information's study found that companies that focus their limited early-stage resources on commercialization have a distinct advantage once their products reach the market.

"Uniting R&D and Marketing for Integrated Early-Stage Market Preparation" is Cutting Edge Information's latest study. The report reveals that pharmaceutical companies are looking towards the biotech sector to outsource development of new drugs. In doing so, the company can free up resources to market drugs currently in their pipelines.

"It is no secret that the top pharmaceutical products each year are backed by hundreds of millions in marketing dollars," says Elio Evangelista, research team leader at Cutting Edge Information."Pharma-biotech partnerships have become a more popular method for pharmaceutical companies to outsource drug development and fill pipeline gaps."

One profiled company is in favor of shrinking business unit departments and creating small internal teams to handle deals with small biotechs to outsource most of the early-stage pre-clinical work. The idea is based on the biotech industry's capability to develop innovative products morequickly than slow-moving, large pharmaceutical companies. The company invests almost as much in early-stage research as it would for an in-house compound, but it outsources the work to smaller, faster-moving biotechs, which assume some of the risk that the company would otherwise retain.

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Researchers Find Deadly Prescription Drug Effects Six Years Before FDA

Northwestern University's Charles Bennett, M.D., is a super sleuth of potentially deadly prescription drug reactions. He leads a national SWAT team of doctors called RADAR (Research on Adverse Drug Events and Reports) based out of Northwestern's Feinberg School of Medicine.

They swoop in to investigate early signs of trouble years before the Food and Drug Administration (FDA) takes notice.

A new study by Bennett, the A.C. Buehler professor in Economics and Aging at Northwestern's Feinberg School of Medicine, and a hematologist and oncologist at Northwestern Memorial Hospital, found RADAR identified serious drug reactions six years earlier than the FDA and drug companies.

RADAR's proactive safety efforts and reports also were much more comprehensive than those from the FDA or drug companies, according to the study. RADAR's reports provided doctors with important medical insights as well as guidance for prevention, diagnosis and treatment.
The study will be published in Archives of Internal Medicine.

Since Bennett launched RADAR in 1998, his research has resulted in black box warnings on billion dollar drugs like Plavix that may have saved thousands of lives. He has also provided guidance to help physicians more safely administer drugs. More than 100,000 people die each year from reactions to medications. The FDA is under attack for its passive and inefficient methods of learning about these problems.

Why is RADAR so nimble" Bennett's network includes hematologists and oncologists around the country and the world. His phone rings weekly with calls from concerned doctors alerting him to possible new trouble. After such a call, Bennett probes for clues that led to a life-threatening reaction to a drug. ‘What's the age and weight of the patient, x-rays, details of the physical exam and blood tests"' he'll ask. He'll canvas doctors to see if they've seen similar cases. If a vital piece of evidence is missing, Bennett even will track down a doctor at home on a Sunday and ask her to drive back to her office to check a chart. Then Bennett and his team fit all the puzzle pieces together to figure out what happened and how to prevent it in the future.

The new study also shows, however, that the FDA and drug companies were faster than RADAR to spread the word about serious adverse drug reactions. RADAR relies on publishing its studies in peer-reviewed medical journals, a process that takes longer than the FDA's warning letters to doctors and the drug companies' package inserts.

Thus, it's time for a formal collaboration between RADAR and the FDA to wed their strengths, said Bennett, who also is co-director for cancer control of the Robert H. Lurie Comprehensive Cancer Center.

"We need to work together as partners," Bennett says of the FDA. "Pharmaceutical side effects are one of the top five causes of death in this country. We want to move it out of the top five. This is the way to start that process and save thousands of lives."

Bennett envisions a formal partnership with the FDA in which he would share RADAR's investigations on safety issues, arrive at a joint insight on drug problems and have the FDA distribute the information to doctors.


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Tiny Sensors Could Aid Environmental Protection, Pharmaceuticals

By Emil Venere

Researchers at Purdue University have shown how to create a new class of tiny sensors for applications ranging from environmental protection to pharmaceutical preservation.

Although similar "gas-flow sensors" are currently being used for a variety of industries, the new sensor is the first that works on the scale of micrometers and nanometers, or millionths and billionths of a meter, respectively, said Steven Wereley, an associate professor of mechanical engineering.

Gas-flow sensors currently used, including those in residential gas meters to determine how much to charge customers, operate on a principle known for at least 100 years. According to that principle, as gas flows over a surface, such as the wall of a pipe or an object flying through the air, molecules of gas nearest the surface remain stationary. The molecules farther away from the surface move progressively faster.

"That model works really well in many situations, including aerodynamics and applications where the scale of the flow is large compared to the size of the molecules," Wereley says.

This principle, however, does not apply to gas flowing through channels on the scale of micrometers or nanometers, meaning ordinary designs will not work for sensors needed for applications on those scales. In such applications, gas molecules immediately adjacent to the wall of a tube do flow and are said to "slip."

"This exception to the model carries important design implications," Wereley said.

Findings will be detailed in a research paper to be published in the February issue of the Journal of Micromechanics and Microengineering. The paper describes how the sensor is designed.

Gas-flow sensors that operate on the scale of micrometers and nanometers could have applications in environmental protection, particularly to measure the leakage of hydrocarbon fumes from fuel tanks in new cars on the manufacturing line. Federal environmental guidelines specify how much leakage is allowable.

Automakers currently test empty fuel tanks by pressurizing them with a gas, such as helium, and then measuring whether the pressure drops, indicating leakage. The test is limited because, while it can determine whether a tank is leaking, it cannot reveal how severe the leak is. Using a sensor capable of measuring gas flow on small scales would make it possible to yield more accurate data.

An accurate test also could be applied to the pharmaceutical industry, which preserves drugs in packages filled with a gas free of the molds and impurities of ambient air. Pharmaceuticals are shipped and stored in the packaging, and the industry tests packages for leakage, but gas-flow sensors could be used to test them more accurately.

The Purdue researchers worked with industry to develop the sensors, which currently are too costly to be manufactured profitably. The research is associated with the Microfluidics Laboratory at the Birck Nanotechnology Center in Purdue's Discovery Park.


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