In the longterm, how much industry progresses will depend on how well academia, pharmaceutical companies, and the government work together on some basic principles. This collaboration boils down to a recent talk by Biotechnology Industry Organization CEO Jim Greenwood at the BioNJ 2009 Annual Meeting. The 7-step process he described is outlined below.
1) Provide progressive funding , starting with the National Institutes of Health to carry out stem cell research. This research can open up new opportunities for cures.2) Protect patents. Innovation spurs breakthroughs and saves lives, especially in the biotechnology industry where patent protection is critical to attracting private funding.
3) Support start-ups. Grants and funding for venture-backed biotechnology companies allow these drugmakers to use accounting rules for small companies and keep innovation alive during expensive research phases.
4) Encourage investment. Tax policy that favors investment allows companies to accelerate new treatments.
5) Maintain belief in the US Food and Drug Administration. We need to provide FDA with the resources it needs to review, assess, and approve effective drugs in a timely manner.
6) Increase access. By creating sound reimbursement policies, individuals can better benefit from breakthrough therapies.
7) Ensure safety. Understanding the risks and benefits of drug products, and sharing that information, allows patients to make the best decisions about their treatment.
These long-term steps can help to eliminate pressures faced today by pharmaceutical and biopharmaceutical companies. Challenges such as expiring patents, profit decline, global economic meltdown, and trends toward personalized medicine are changing the ways drugs are produced. Take, for example, process analytical technology, quality by design, and the Product Quality Life Cycle Implementation initiative that the International Society for Pharmacetuical Engineering is driving. With basic principles in tact and supported, drug products will be able to be manufactured more cost effectively without sacrificing quality.
At the same time, different parts of the industry need to collaborate more. Current outsourcing trends already point to increased relationships among equipment suppliers, information technology companies, contract research and manufacturing organizations, engineers, architects, validators, and consulting firms. An integrated approach is vital to producing the most effective and safe drugs.
For our industry, everything is moving at a much faster pace despite the economic downturn.
RJ Palermo is industry vice-president for INTERPHEX 2009, tel. 203.850.5924, [email protected]