Reader Disputes Merck-Serono/Quintiles Collaboration As Being Game Changing

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

In the April 2014 issue of Life Science Leader magazine, I wrote A Game-Changing Approach To CRO Collaboration. It was based on an in-person interview conducted with Annalisa Jenkins, former EVP and global head of R&D at Merck-Serono, while attending the BIO CEO & Investor conference this past February in New York City. In May I received feedback from a reader of the article disputing the collaboration as being game changing. With their permission, I have reproduced their comments below.

Exclusive Relationships Are Devoid Of Innovation

“I would like to comment on the recent edition of the Life Science Leader publication for April 2014, specifically regarding the article, “A Game Changing Approach to CRO Collaboration.” I have worked my entire professional career in the CRO industry, mixed between operational roles and business development for the past 17 years. I have worked with several of the large Pharma companies as well as the small emerging biotechs and have seen highly efficient, flexible organizations cultivating cultures of accountability and teamwork. In turn, I have also worked with teams that are myopic, inflexible and disorganized to a degree where there is either no accountability and/or massive leadership voids. First, I would like to challenge the notion that what Merck Serono has done in regards to their partnership is in any way “innovative.” How does this model deviate from ones currently in place, specifically when compared to an organization with 1 or 2 assets outsourcing all of their clinical development to one CRO? I would argue that the relationship between a CRO and a small or virtual company creates a more fruitful partnership due to the innovator’s “need” of the CRO to support or provide the development resources and input on their plan. Too often these exclusive partnerships between large pharma and big box CROs are devoid of innovation entirely and fail to use the experience and collective knowledge of both organizations to optimize the clinical development plan. They are entirely service model partnerships.  As evidence, when defining the measurements of success for Merck Serono, they are focused on elements used to evaluate the success of a service partnership, i.e. operational (reduction of cycle times), people (engagement in the work via survey), financial (cost reduction). I have been listening to this mantra since my start in the industry. These are the foundations of what transactional models are based upon and hardly innovative. The only thing “innovative” about the Merck Serono partnership is the reduction of providers and the elimination of CRO competition, the lack of an alternate voice to provide innovative or fresh perspectives on the strategy or design of the study and the deleveraging of Merck Serono’s purchasing power. Indeed, Ken Getz from Tufts recently published his findings that alliance partnerships have slightly more change orders than transactional ones, so even this is debatable.”

Idealism — The Foundation Of Successful Sponsor/CRO Partnerships

“Our goal as an industry is to develop new products to improve and/or save lives. This [is] what all keeps us employed. As naïve or idealistic as this sounds, shouldn’t an innovative partnership pull more from a CRO partnership than just resources and measure more than reductions in time and cost? When an alliance is created that truly breaks down the idea of a partnership, where the innovator doesn’t refer to the CRO as a partner but truly thinks, believes, operates and integrates them into a “one” team concept, then a fertile environment is created where innovation can occur. Indeed, when an innovator can bring 2 partners to the table to discuss the development strategy and plan for a product and integrate the knowledge, technology and resources from both, then we have taken an even larger step in our progress towards a more effective and innovative partnership. When the innovator discards the notion that they solely own the asset and instead the team owns the asset, then I believe a more inclusive approach that utilizes the grey matter of the CRO will prove to be truly innovative. Therefore, measuring the performance and effectiveness of the partnership should be: how many new products are brought to market? Do the products possess greater data regarding safety and efficacy? How has the experience of the CRO lead to the best or most appropriate label or supported the development to create a successful launch via a data driven approach. What is the utility of saving time and cost if the product is not approved, there are data quality issues or there is incomplete data to support re-imbursement launching a fast follower to formulary?  The philosophy and objectives of the partnership must change to truly be innovative.  This in turn will change behaviors, process and outcomes.  And that is the most critical variable that should be sought after in the partnership, the outcome.  The partnership must not be measured entirely on time and cost, this perpetuates the notion that these variables derive success and that accountability ends and is transferred to someone else once the study ends.  Indeed, these partnerships are often touted as successful despite a non-approval or other undesirable outcome, because cycle times were reduced.  Is that truly success? For too long we have been constrained by the shackles of a siloed approach that neither applies [n]or integrates the philosophy of an innovative partnership.”

Your Feedback Make Us Better

Many love to hear the good, while shunning the bad and the ugly. Such is not the case for us at Life Science Leader magazine. Feedback on what we are doing well is always appreciated. However, those willing to challenge us will most certainly make us better in the long run. Not long ago, I had the opportunity to sit in on an interview being conducted by Wayne Koberstein with Eli Lilly & Company’s CEO, John Lechleiter. During the discussion, Lechleiter made a poignant quote. I am pleased Wayne was able to capture Lechleiter’s sentiments with regard to being the recipient of bad news in the article’s sidebar entitled – On The Chairman’s Watch p. 28, second paragraph. “People are predisposed, I think, to telling you good news, but I’d rather hear the bad news — and I’d rather hear it quickly.” I would say that pretty much sums up how we feel with regard to being the recipient of reader feedback. Thanks for making the time to share your comments, suggestions, and yes, even contradictory opinions. Sometimes, Bad is Stronger Than Good [pdf] when it comes to having a deeper impact.