Times...They Are A-Changin'

March 6, 2009
Marissa Shapiro

Applied Clinical Trials

Industry professionals address the changes taking place in pharma and propose an upheaval of current business models to welcome new ones that are adapted for the ever-evolving clinical trials climate.

Change was a heavily focused upon topic at IIR’s Clinical Trials Congress this year, held in Philadelphia on February 10-11 at the Loews Hotel. Whether it was lent to the booming technological field, the vast amount of mergers and collaborations or even if it all came down to the feeble economy, the message was still clear-as industry changes, so too should your business model.
           
Outsourcing to partnering
It’s no doubt that business ventures have become grander. And with that growth pharma has inevitably become even more dependent on working with companies outside of its own.

“We get an early platform and realize we can’t do everything ourselves,” Eric Terhaerdt, head of clinical development, global drug development, for AstraZeneca described of his experience. “There’s an emerging market out there to help us, and many pharmas are going that way.”

These business relationships have experienced change, however, in that they are moving from a client relationship to more of a business partnership. “We went through a time when outsourcing really worked and now we’re looking at working more collaboratively,” Joel Scherer, managing director of Chorus R&D Initiative for Eli Lilly, noted. “It makes more economic sense to do both.” 

Internal barriers
“I think we are our own worst enemy,” William Matthews, vice president of BIO research & development management operations for Centocor, observed. “We have to start to think differently about the way we design clinical trials.” He also went on to acknowledge that pharma has developed too many me-too products.

And despite the economic downturn, companies are continuing to spread their business into foreign borders. While this is a clear indicator of business growth, it also breeds new challenges. “How do we maintain a small company R&D culture with the global mass industry required?” Matthews asked.

Product offering is what Scherer perceives as a pressing issue. “We need to think about productivity across the entire value chain,” he said. For example, he pointed out that late stage development is a large enterprise, requiring a lot of firepower, which is why it is best handled by large companies.

Value vs revenue
“It is the best of times for science and the worst of times for cost and reimbursement,” Matthews said as he reflected on the current state of the clinical trials industry. He continued, “Science drives pipelines. We need to capitalize on the best of times on the science side by understanding disease areas in depth, optimizing knowledge, and targeting our discovery.” He also suggested a heavy investment in translational medicine.

“Financially our old business model is not sustainable. We estimate time and cost and quality of targets, yet we’re still in the situation we are today,” Matthews added.

While financial return is a top, if not the top, priority in any business, Terhaerdt maintained, we need “not focus on price, but value. And price is a part of that.” He pointed out that focusing solely on price is a losing strategy because people will pay for better-valued products.

Bucket list
Terhaerdt noted what he believes are three vital areas in need of being addressed: access to leading science internally and externally; exploitation of information; and operational excellence. “We need to find out internally how to optimize these three buckets,” he said.

In addressing the first challenge, Terhaerdt acknowledged it revolves primarily around the task of accessing the research being conducted around the world. Or, from his personal perspective, “accessing the other 97% of research outside of AstraZeneca.” 

With the following challenge, he questions, “How do company’s get information in real-time to increase the value of medicine?” The exploitation of information, as Terhaerdt suggested, would allow company’s access to it instantaneously through its own records.

In the case of operational excellence, Terhaerdt raised the issue of pharma needing to find what’s core, and the need to use technology to do so.

Early bird savings
While all presenters highlighted their own challenges and potential solutions, each met in the middle with the concept of “picking winners early and losing losers early,” as Terhaerdt stated when discussing early investment.
           
“Early development is becoming incredibly complex,” Matthews observed. “We minimize investment until we have a proven proof of concept.”

Similarly, Scherer mentioned, “One of the focuses of the group I run is on early portfolio development...this makes up 25% to 30% of Lilly’s early development.” Like Matthews, he also added that Lilly limits early investment until they have validated data.

“We don’t have a playbook anymore,” observed Scherer. “Industry is trying new ideas-some will work, some won’t work.” And whether companies turn to collaborations, emerging technology or the dissolution of self-inflicted issues, there is no avoiding that changing times call for changing measures.