For many years, Contract Research Organizations (CROs) have sought to move beyond their role as fee-for-service providers and branch out into strategic alliances with pharmaceutical companies. These emerging services alliances pattern to some degree the partnerships that pharmaceutical companies form with biotech firms and with each other—but there are differences too. This CRO/Sponsor evolution became a talking point on Thursday, Sept. 10 at the 2015 ASAP BioPharma Conference in the session “Enabling Innovation and Value Creation in Sponsor/CRO Collaborations.” Moderated by Doug Williams, business development consultant at BioDigital, the discussion addressed the benefits in two partnering mini-presentations: Covance/Eli Lilly and Company and EMD Serono/Quintiles.
In 2008, Lilly and Covance created a groundbreaking 10-year strategic agreement that spans the drug development process, explained Andrew Eibling, CSAP, global vice president and alliance manager at Covance, about the history of the partnership. “It involved working across the spectrum and various silos of drug development.”
Today, Covance has a highly successful cardio vascular partnership with Lilly. At the beginning, it required lots of fine-tuning, because in the rush to get started, they missed out on some crucial steps, recalls Jay Turpen, senior director of clinical laboratory operations at Lilly.
“First, we got the right people together to frame out how we were going to work together. It’s so crucial to invest in defining the process: how to communicate, what hand-offs look like, handling escalation. There were skeptics from both companies, so we took time and invested in kaizan events to determine the likely areas where there was the most friction in the program, and invested proactively in those areas,” he added. “Creating a culture of one team with one approach and applying alliance management was successful, and we were able to enroll the study in less than … the scheduled 24 months, and it was 98-99 percent clean through the process.”
Then there was a second added value—partnering on laboratory research. “What’s in the best interest of both Lilly and Covance as we build this new lab system? What information is in our mutual interest?” they asked. “We got literally thousands of people working on these alliances. There needed to be common linkages across those silos,” Turpen added. The central labs group started a unique rewards recognition program. And they reached the point where they now pass patient information back and forth.
The final results? “Lilly’s CEO said that it was the best study the company has ever done. It was a high five, a best practice, a solid metric for what a great job that team did,” said Eibling.
In the case of EMD Serono/Quintiles, Quintiles’ clinical development division wanted a CRO who got involved early in clinical stages sitting at the development table. The companies also were looking for processing standards, high benchmarks, and most of all, innovative minds at the boardroom table. They signed a partnership with EMD Serono in 2013, and the CRO became a partner in drug/biosimilar development.
“Clinical development is challenging because how do you persuade patients and physicians to join a trial? Or are you going to fall back on biosimilar drug development?” Those were some of the key questions raised by Raymond Huml, DVM, executive director of strategic drug development and head of global biosimilars strategic planning at Quintiles Biosimilars Center of Excellence, and Louk Pechtold, CA-AM, director—alliance management biosimilars, in the biosimilars unit at Merck Serono SA.
Biosimilars are follow-on copies of originator medicines made from living tissues (e.g., monoclonal antibodies). The question of biosimilar drug development is increasingly important because by 2020, some $100 billion of original biological medicines will lose intellectual property protection.
They also addressed the question of how alliance managers factor into drug/biosimilar development. “We have upper management, middle level, and closer-to-the-ground alliance management. There are alliance managers that look over entire portfolios, but at the end of the day, you need someone who understands the differences or subtleties. And there are differences with biosimilars,” explained Pechtold.
“The main value in collaboration is leveraging innovation from one partner to another,” Huml added. Regulatory experience is a plus, and having a global reach can be an advantage. “Those with experience working with multiple companies also have an advantage over one-on-one,” he concluded.