Bikash Chatterjee
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The old saying, "May you live in interesting times," takes on new meaning in our industry today. It has been nearly three
years since the FDA issued the final report for its landmark initiative, cGMPs for the 21st Century: A Risk Based Approach. This single publication has challenged us to rethink every aspect of the drug development lifecycle. And it assumes new,
greater meaning as we attempt to assess the emerging capabilities of the global marketplace.
Outsourcing, of course, has been a cornerstone of our industry for decades. Historically, the industry has sought contract
organizations for early-and late-stage services. In the past, preclinical programs relied on specialty service sectors to
provide protocol development, execution and analysis services for toxicology, and preclinical modeling support. Mature programs
looked to contract organizations specializing in clinical support and commercial packaging support. In the good old days,
a supplier quality audit and forecast commitment within a contract formed the foundation of an outsourcing quality plan.
Today things are very different. The stagnating IPO market makes it increasingly difficult for emerging companies to bring
their products to market. Without the cash to fund late-stage clinical trials or build commercial facilities, these firms
have no choice but to license their products and outsource the manufacturing. But as the sophistication of products and the
spotlight on product development continue to grow, so do the risks associated with choosing the right outsourcing partners.
Scale up and technology transfer have always been complex undertakings. In the 1980s and 1990s, when contract packaging was
the lion's share of the outsourcing activity, labeling errors were the primary reasons for regulatory citations and recalls.
Nowadays, we in the industry typically outsource product manufacturing as well as packaging and distribution. Think of the
potential for quality issues before us. Complicating the challenge is the lure of emerging contract manufacturing organizations
(CMOs) and clinical research organizations (CROs) overseas which promise a highly educated workforce with well-funded facilities
and operations at highly attractive prices.
The reality is that the tasks ahead of us are complex. In the US we have struggled to meet the compliance expectations of
the FDA. Now we have the opportunity to apply a risk-based framework to our development and quality plans. The stakes of the
game are higher; success no longer relies simply on using classical quality metrics to assess a suitable CMO. The CMO's participation
in regulatory claims will soon escalate; to what degree, however, is up to us. We will now have to rely on them for far more
than just execution of processes. These organizations will play a significant role in our technical, regulatory, and market
claims. Knowing this, we must evolve our criteria when evaluating and selecting CMOs and CROs, and address all aspects of
this new relationship. Cost, technical ability, experience, stability, compliance capability, and organizational flexibility
all take on added significance in our decision making. How well US and European CMOs and CROs embrace this truth, along with
how quickly emerging firms from the Far East adapt to this new requirement, will set the outsourcing landscape for the next
decade.
Bikash Chatterjee is President of Pharmatech Associates, Foster City, CA, 650.227.0177, bchatterjee@pharmatechassociates.com
