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Applied Clinical Trials
Rethinking the current pharmaceutical model
You've heard it before. We all have. Pharmaceutical industry productivity is down, while costs are up.
We hear it from our mothers, grandmothers, and friends at social occasions: "Why can't drugs be cheaper," or "Why can't we cure diseases faster?" We all know the issues. The only key question is, what are you going to do about it? Yes, you.
Whatever your role in clinical development, step back for a moment and ask yourself if it can be done better. The pressures that we face in the pharmaceutical industry are not that different than the pressures faced by the chemical, aerospace, and automotive industries over the last two decades. What can we learn from their experiences? And what can you do to make a difference?
If you read the first chapter of Thomas L. Friedman's The World is Flat, you will recognize that anything that can be digitized or routinized can be outsourced. So, we need to rethink what the core competencies of pharmaceutical development are and how to radically improve them.
That is what we are about at Wyeth, and why we have re-engineered Clinical R&D through our clinical breakthrough and Springboard initiatives, formed a joint venture with Accenture called the Alliance for Clinical Data Excellence (ACE), and launched an alliance with ReSearch Pharmaceutical Services (RPS) called MMAX (Maximizing Monitoring Availability and excellence). These changes are just the starting point.
But Wyeth is not alone. Pfizer has launched an alliance with KForce for field monitoring. Quintiles has teamed up with Solvay and a number of biotech firms for joint development and risk-sharing in bringing new compounds to market.
Nowadays, existing models are undergoing major scrutiny. For example, "Because that's the way we've always done it" is no longer an acceptable answer to process questions. And regulatory agencies have been embracing new ideas for conducting studies. In an industry that has largely focused on conformance to standards, we need new ways of thinking.
Good Clinical Practice (GCP) does not mean that there is only one way to conduct a clinical study or enroll patients. GCP is a set of guidelines aimed at ensuring a level of quality consistent with existing regulatory guidelines.
But are there better ways to perform our basic tasks? Are there new approaches to processes that we take for granted as the accepted way of doing things?
What about at your firm? What about your role? Begin to ask yourself how you can make a difference, and embrace change. We all need to contribute to the future success of our industry and the time to begin is now.
Ira Spector, vice president, clinical development operations, Wyeth Research, Collegeville, PA