Viewpoints

On April 26 the National Academies of Sciences and the Institute of Medicine released guidelines for human embryonic stem (hES) cell research, the result of eight months of deliberations by a human research ethics committee I co-chaired with MIT's Richard O. Hynes. Composed of scientists, physicians, lawyers, ethicists, a social scientist, and a private citizen, the committee held a two-day public workshop and numerous meetings. We also reviewed international guidelines, policies, and procedures in this field.

Biotechnology and life sciences companies come in all shapes and sizes. Some are multinational companies with vast resources and others are small companies working with a few new compounds. Regardless of size or market position, these companies should all have one common question of those that handle their insurance: Will their current insurance program protect their assets and investments in the event of a significant loss? Understanding the nature of risks, acquiring suitable insurance, and comprehending policy issues when claims arise are essential to protecting assets and obtaining reimbursement when losses occur.

In this century, we are unlikely to face biomedical issues more complex and controversial than that of human cloning coupled with embryonic stem cell research. With the stakes so high — promises of cures and therapies for a host of devastating diseases and medical conditions set against impassioned disputes about when life begins — the cloning debate has evolved beyond the realm of scientific discourse and into the spotlight of public opinion. Unfortunately, this intense scrutiny, largely fueled by the media, has resulted in the misrepresentation of facts, and the twisting of scientific opinions as statements about cloning are often taken out of their appropriate context. In an attempt to counteract this damaging trend, The Science Advisory Board decided to poll its members about some of the most controversial aspects of the cloning debate.

Disposable products and systems have come a long way since they first entered the small-lab market in the 1970s. Today they are available for practically every aspect of biopharmaceutical manufacturing. Disposable systems are used for filtration, clarification, purification, and separation applications used in the production of vaccines, monoclonal antibodies, and other therapies. As the use of disposable systems grows, the concept of a completely disposable manufacturing process is becoming a reality.

In today's competitive and fast-paced environment, owner companies must get products to market quickly and efficiently. By redefining how they provide services and products, suppliers can enhance their value and help owner companies reap the greatest financial returns.

Biopharmaceutical companies are developing clever technologies for plant made pharmaceuticals (PMPs). When will the promise for the future turn into reality?

Cancer treatment has grown into a multibillion-dollar business responsible for saving and improving the lives of countless patients each year. One of the approaches generating a flurry of interest is monoclonal antibodies.

In general, people in other countries pay less for brand-name prescription drugs than people in the US. As a result, some Americans travel to Canada or Mexico to get their prescriptions, and an increasing number are using the Internet to buy drugs from other countries.

The US will, beyond doubt, remain the world leader in life sciences for the foreseeable future. However, as with other sectors, bioscience - both R&D and business - is increasingly global. For US researchers and business leaders alike, it makes increasing sense to look beyond the shores of America for both expertise and profit-making opportunities. For many, the principal partner of choice has been - and will remain - the United Kingdom. There are sound reasons for this.

There is no current capacity crunch due to increased investments in new facilities.

Commercial embodiments of genetically modified inventions are protected in Canada.

As the various industry sectors expand drug discovery and development activities, there will be more direct competition as well as opportunities for collaboration.