The biotech industry, which in years past has emphasized molecular biology and biochemistry in its research and development, has more recently placed increased focus on cell, developmental, and system biology techniques. This shift in research has led to greater interest in stem cell research and cell-based therapies.

Major breakthroughs in stem cell research could dominate the biotech revolution. The convergence of the knowledge developed from geonomics and proteonomics of the last decade and the ability to use stem cells as a research platform, could result in new biological pathways, ultimately leading to better understanding of the aging process as well as discovering novel biological targets to cure diseases.

The 2008 US Presidential Republican and Democratic candidates, Senators McCain and Obama, have provided responses on this issue to the non-profit, non-partisan education organization Scientits and Engineers for America (SEA). Here are their respective responses to the following question:

Stem cell research advocates say it may successfully lead to treatments for many chronic diseases and injuries, saving lives, but opponents argue that using embryos as a source for stem cells destroys human life. What is your position on government regulation and funding of stem cell research?

Senator John McCain: "While I support federal funding for embryonic stem cell research, I believe clear lines should be drawn that reflect a refusal to sacrifice moral values and ethical principles for the sake of scientific progress. Moreover, I believe that recent scientific breakthroughs raise the hope that one day this debate will be rendered academic. I also support funding for other research programs, including amniotic fluid and adult stem cell research which hold much scientific promise and do not involve the use of embryos. I oppose the intentional creation of human embryos for research purposes and I voted to ban the practice of “fetal farming,” making it a federal crime for researchers to use cells or fetal tissue from an embryo created for research purposes.

Senator Barack Obama: "Stem cell research holds the promise of improving our lives in at least three ways—by substituting normal cells for damaged cells to treat diabetes, Parkinson’s disease, spinal cord injury, heart failure and other disorders; by providing scientists with safe and convenient models of disease for drug development; and by helping to understand fundamental aspects of normal development and cell dysfunction.

For these reasons, I strongly support expanding research on stem cells. I believe that the restrictions that President Bush has placed on funding of human embryonic stem cell research have handcuffed our scientists and hindered our ability to compete with other nations. As president, I will lift the current administration’s ban on federal funding of research on embryonic stem cell lines created after August 9, 2001 through executive order, and I will ensure that all research on stem cells is conducted ethically and with rigorous oversight.

Expanded Polystyrene (EPS); the plastic we love to hate. It’s been around for so long it’s hard to imagine what life would be like without it. Let’s face it, as plastics go, EPS is very conspicuous — large white pieces limitless in shape and size, not to mention the loose fill “peanuts” that seem to migrate everywhere. It’s obnoxiously voluminous. At the same time it troubles us to know that the containers we use to ship our temperature-sensitive healthcare products (as well as use to protect many of the consumer goods we purchase — everything from televisions to double lattes), is ultimately destined to lie in a landfill somewhere for centuries to come. It’s another inconvenient truth of 21st century life; one of those things we know we should do without but which we will never be prepared to relinquish. But in many respects, EPS has been unfairly vilified...

You can read the entire Contract Pharma article here.

The 6th Annual IQPC Cold Chain Distribution for Pharmaceuticals Conference was held

September 22-25, 2008, at the Philadelphia Convention Center, Philadelphia, PA. More than 300 delegates and 34 exhibitors participated.

Presentation topics were focused on logistics with an emphasis on international transport, clinical trials and the "last mile" of distribution. It was slightly more technical with less overt selling than in years past and there was no shortage of panel discussions and roundtables in addition to only a few case history presentations.  The event reflected the maturing of this segment of distribution as both presenters and audience were far more knowledgeable than in the past.  

The conference began with regulatory speakers from the UK and Canada providing updates to activities in their respective agencies. They concur that temperature monitoring will be viewed as a must-have, or a “critical component” to good distribution practices for time and temperature sensitive healthcare freight. Harold Rode of Health Canada was completely non-committal when pressed about when the agency is going to publish the revised edition of guide 0069 (currently under review).

Mary Foster of Catalent, and the person responsible for the re-write of USP General Chapter <1079> Good Storage and Shipping Practices, and stated that the new document draft ( 49 pages and more than 3X longer than the current edition) was submitted to the USP Expert Committee on Packaging. It came as a surprise to many in attendance that references to Mean Kinetic Temperature as it relates to transportation were removed by the USP 1079 revision committee and that they strongly recommended to the EC that it remain out of the document.

Other presentations of note: the new TSA 100% cargo screening regulations drew many questions for the presenter, Brad Elrod, Manager Global Logistics & Security, Pfizer, and  Jean-Pierre Emond from the University of Florida made a well documented presentation on testing he has done on the new generation of insulated sea containers and whetted the appetite of those considering the possibility of using them as an alternative to air freight. These containers are so well insulated that they hold only 40% of the payload of existing insulated reefers. He cited a reduction in freight costs by 40%. Their use is not without significant risk however, especially during loading and unloading at the port when there is no means to control the logistics or ability to provide AC power to run the refrigeration units. Emond objectively stated that the greatest drawback to this technology is that there are only 30 containers worldwide and the developer is not expected to play “build it and they will come.”

The “sponsors,” or service and supply partners to the industry appeared well organized. There were neary twice as many than at last year's conference (19). There is a definite shift in representation of those exhibiting, with 12 3PL and specialty logistics and transport providers, 10 data management companies and 12 packaging / platform providers.