Preclinical Outsourcing

Final Thoughts

By Steve Snyder, Contributing Editor | April 4, 2012

Time to say “goodbye”

This will be the last article that I write for Contract Pharma. After over seven years of sharing my views on preclinical outsourcing with you on a regular basis, I have decided that it’s time to bring this wonderful journey to an end. We will now pause a moment to allow the cheering to subside from the CRO management teams that endured my rants and unsolicited advice over the years. [Pause] Now, to my existing and potential consulting clients, I hasten to add that although I will no longer be writing for Contract Pharma this does not mean that I am quitting my consulting business. I mention this because along the way, my writing and consulting identities seemed to become intertwined; just because I’m stopping one, it doesn’t mean I’m stopping the other. You may recall that in some of my past articles, I advised about the importance of understanding the difference between perception and fact. Well, let’s call this first paragraph an example of my own perception management.

So why stop now? I feel that, especially recently, I have been repeating the same themes over and over again. I mean you can only talk about layoffs, quality, and perceived management miscues so much, right? When I first started writing these articles seven years ago, the preclinical outsourcing industry was a topic-rich environment. I would tell colleagues at the time that it felt like the articles almost wrote themselves. I couldn’t make this stuff up! All I had to do was capture my observations in words, but over the years this became an increasingly more time-consuming task.

So, for this final article, I would like to share some final thoughts that I hope will stay with you going forward.

When I received feedback from readers over the years, a common comment was that in some articles, I “said what needed to be said.” It’s probably fair to say that the articles that prompted this feedback were those where I offered unsolicited advice to CRO management teams. Because I am an independent consultant, I have the opportunity to observe sponsor and CRO interactions from an external perspective. I have always acknowledged that it is easy to tell someone how to run their business when you don’t own those day-to-day responsibilities. Where financial professionals advise clients not to invest in opportunities that they don’t understand, I tried to advise preclinical CRO senior management teams about the danger of not understanding their own business operations.

Recently, it occurred to me that the real issue might not be about understanding but the way that senior management teams either don’t get or don’t listen to information they need to make sound business decisions. Business leaders don’t need to be operational experts as long as someone is feeding them essential organizational information. Herein is the problem. It is important to consider the role that fear plays in day-to-day and strategic business decisions.
Let’s face it: since I am not employed by a sponsor company or a CRO, it has been “safe” for me to comment through these articles. If I “said what needed to be said,” why didn’t management teams hear or understand this same feedback from their own employees? Fear. The recent tough economic times have made employees more concerned about their job security. Just as the years where a business “took care of” its employees have passed, it is fair to say that we have seen the end of employee organizational loyalty. Today, employees will do what they can to protect their jobs; in many cases this means they will say nothing to challenge the status quo. This is not just a CRO issue, but a societal one.

We have slipped into an environment where sharing bad news or speaking up is perceived as not being conducive to long-term job security. Why would an employee take on that personal risk when saying nothing may allow bad news to reach management via other sources? Perhaps the technical staffs fear they will lose their jobs if they share operational concerns, or perhaps their supervisors will fear that they will look bad to their managers if they bring these concerns forward. Are senior mangers afraid to admit that they made the wrong staffing decisions or don’t they realize it because others fear discussing performance issues? It can go on and on.

If you are a part of a management team in a preclinical CRO, I am willing to bet that somewhere in your organization there is information that is not getting to you because of fear. Do you really want to manage by a lack of information? In my opinion, our business society somewhere along the way lost the openness necessary to manage effectively. It is time for organizational straight talk and for a safe business environment to make it happen. If you are in a leadership role, are those around you telling you what you want to hear? Have you created an environment where it is safe to challenge the status quo?

The hot word these days in preclinical CRO marketing literature is “innovation.” It seems like every organization claims to be a leader in innovation. If you are in a leadership role in a CRO, is your business environment one of innovation or suffocation? Do you really reward employee performance or do you reward conformance? Are you sure that the fear of looking is not really the driving force in your organization? Are you sure that your own fear of looking bad is not behind your own decision making? If you accept that the relationship dynamics between a business and its employees have changed over the years, then leadership styles that were born in the past are unlikely to be effective today. It’s not too late to change.

Animal Welfare
Several years ago, I wrote a column in response to the well-publicized, accidental death of a non-human primate at a preclinical CRO. It is said that journalists should strive to leave their emotions out of their reporting. While I don’t know that I would consider myself as a journalist, I do know that I did not leave my emotions aside when I wrote that column. My goal in writing it was to motivate those organizations that conduct animal research to enact tougher procedures and better training so that we would never have to hear of an accidental death again. If the tone of the article was such that research operations were motivated to act to avoid being singled out in subsequent articles then so be it. I make no apologies for trying to improve animal welfare. My only regret is that I did not write that article when the first well-publicized event happened a year earlier at another preclinical CRO. Perhaps if I had acted then, the subsequent accidents would not have occurred.

That being said, I urge the research community to continue to strive for excellence in the care of laboratory animals. I may be retiring from writing this column, but I will unretire in a heartbeat to voice my displeasure should I learn of another senseless accident in a research facility. Like many other operational issues, the best animal welfare procedures in the world mean nothing if they are not followed. Mistakes are not acceptable when it comes to animal welfare. Ongoing staff awareness, training and vigilance need to be the way of life for animal welfare programs in all research organizations. Especially after all the economic challenges the industry has endured, I encourage all research employees to redouble their efforts in this area.

The Impact of the Investment Community
I have come to appreciate that in the preclinical CRO industry, the expectations of the investment community are not always in the best interest of operational excellence. Beyond the formulas that determine how much revenue can be generated from a study room at a preclinical CRO, we shouldn’t lose sight of the fact that people conduct drug development activities. It is reasonable to assume that the probability of higher quality research is often times directly proportional to the experience level of the staff. When management teams cut their research staff to appease investors, the subsequent loss of expertise and the additional workload that must be shouldered by the remaining staff only increases the potential for operational errors. Obviously, preclinical CROs need investors to stay in business. Management teams are therefore challenged to manage investor expectations while maintaining acceptable operational standards. This seems to be especially challenging for those in publically traded companies. I hope investors will realize that, with strong leadership, the path to success is measured by operational effectiveness and not square footage.

Global Awareness
One of the benefits of writing for Contract Pharma has been the opportunity to connect with individuals from around the world. Over the years, I’ve communicated with readers from Europe, Asia, Australia, South America, and North America. I appreciate your questions and your feedback. I tried to think globally when I constructed my articles, but many times I know that the subject matter was more “America-centric” and I am truly sorry about that.

In closing, I would like to acknowledge several groups who made these articles possible. First, I’d like to thank Gil Roth, the editor of Contract Pharma, and his team for their editorial assistance. It is important for you to know that their contributions were purely to improve readability. Gil was very supportive in allowing me to share my views even when they weren’t popular with some industry organizations.

I also want to thank you, my readers. It was your feedback, your acknowledgements, and your ideas that helped keep me going over the years. One thing that pleases me the most is that I eventually realized that I had developed a following of loyal readers and I do appreciate all of you so much. One day I received feedback from a reader who told me how much she appreciated my articles. She told me that she liked my writing style because “it feels like you are speaking to us.” I was.

Steve Snyder is a consultant with more than 25 years of experience in preclinical toxicology as an outsourcing customer and provider. He can be contacted at