BioBusiness

The current focus on cost-of-goods (COGS) models is underplaying the benefits of disposables technology in biopharmaceutical manufacturing. The best method for accounting for the benefits of reduced and delayed capital expenditures is through the use of NPV analysis.

It is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced.

The comparative research approach may be preferable to price controls in the guise of government negotiations for the Medicare drug benefit, coverage denials, and limits on access to new technologies.

Following the market crisis of the first quarter of 2008, biotech IPOs and financing are down, but partnering continues, and mergers and acquisitions (M&As) remain hot.

Most local and global clinical research organizations (CROs) consider an operational presence in India as key to their overall business plans. India is clearly on course to become the next hub for clinical trials.

The current overcapacity situation in the bio/pharmaceutical industry is a reminder that CMOs need to come up with business models and value propositions that are based on more than just selling capacity.

Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.

A decision-criteria matrix and cost models helped pinpoint the best distribution approach for the short- and long-term.

The outsourced service provider should be considered an extension of your own laboratory.

After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider and preparing quality agreements.

When a biopharmaceutical company pursues an outsourcing strategy, the choice of a contractor is a critical and strategic decision.

The book is a useful, comprehensive, and truly an excellent reference source of biopharmaceutical information.

There are several steps that you can take to ensure that you get the greatest benefit from consultants.

The new patent regime is challenging the Indian biopharm industry to transition from generics to novel products.

Engaging executive leadership in the quality process is the key to compliance success.

As more biotechs turn to convertible note financing instead of traditional venture capital, they need to be aware of investors' demands.

Did the 2005 Patents Act engender a Western intellectual property rights culture in the country?

The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight.

Now is a good time for companies to know their suppliers well.

The supply base for preclinical and clinical development services continues to expand in China.

Two business models that companies can follow to map their strategy from concept to implementation.

India is restructuring its regulation of biopharmaceuticals to help the country's industry compete internationally.

Despite the rising fears about a slowing economy, the biotech industry will continue to maintain its momentum this year.

How an electronics engineer led the first Indian company to carry out indigenous development of a recombinant vaccine.

The cause of the heparin crisis is still unknown. We do know, however, that the FDA is severely underfunded.

Indian biogenerics could form a major piece of the global biotherapeutics market in the future.

Putting business principles to work in biotechs requires careful implementation of nine critical business systems.

Biotechs can avoid becoming a zombie by having a thorough business plan and a clear focus.

Our second annual salary survey assesses not only how much people earn, but also how they feel about it.

Strategic alliances and partnering deals were a big biotech news story during 2006-with deal values setting an all time record of over $23 billion for the year. The strategic partnering trend continues during 2007 and in this column we present some frequently asked questions and answers about the merger and acquisition (M&A) activity in the life sciences sector.