From The Editor | September 22, 2015

WIB Profile: Embrace Change Management Or Expect To Fail

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

WIB Profile: Embrace Change Management Or Expect To Fail

One of the things I most enjoy about writing these Women in Bio (WIB) articles is seeing the impressive education and experience of the female executives I profile. Angie Maurer is no exception. She obtained a BSN degree in Nursing from Saint Mary's College of California and Samuel Merritt College intercollegiate nursing program. Six years later she opted to add business expertise to her repertoire, and obtained an MBA in general business administration from the University of Phoenix and a Six Sigma Green Belt Certificate from Villanova University.

Angie took her education and put it to use in the clinical field, starting off as a Clinical Research Associate at Clinimetrics, before moving on to Timi3 Systems, Scios, Medifacts International and MAP Pharmaceuticals, attaining greater responsibility along the way and eventually attaining the position of Clinical Research Manager.

From there she transitioned to consulting, and has spent the last nine years working with various medical device, pharma and biotech companies such as Theravance, PDL BioPharma, Neodyne Bioscience, Resverlogix, XOMA, and Maquet. In 2006 she started her own consulting firm, and continues to provide consulting support to Gilead Sciences and ReVENT Medical. She also has a CCRA certification from the Association of Clinical Research Professionals and is a member of the San Francisco chapter of Women in Bio.

In this WIB profile article, Angie discusses her greatest passion:  educating life science executives on how to deal with change management within their companies.   

Ed Miseta: Tell us about the consulting work you do.

Angie Maurer: Currently, my main focus is on risk management. I believe this is a hot topic and will continue to be for many years. The main reason is that it seems to take executives and personnel in the pharma industry a long time to accept, adapt, and deal with change within their organizations. Everyone knows the pharma industry tends to be rather conservative, and that is as true today as it has always been.

Miseta: So I'm guessing risk-based monitoring is a growing opportunity for you right now?

Maurer: Yes, it definitely is. My clients range from small to large pharma companies. The biggest challenge many of them are facing right now is how to implement risk management programs into every level of the organization. Risk-based monitoring is obviously a large part of that. In fact, I will be doing a presentation on Leveraging Technology with Risk Based Monitoring at the SCOPE conference in February 2016 in Miami. RBM is a very hot topic and I think the entire industry, big and small companies alike are recognizing that this has the potential to completely change how we perform clinical trials. 

Miseta: Can you give us an example of a challenge that companies are facing?

Maurer: Sure. For example, a sponsor company that is about to start a trial using risk-based monitoring will have a vendor company come to them and claim "We can do it all." If you are that sponsor company, how do you assess that statement? What is the best way for you to assess the capabilities of that vendor? How do you know if what they have to offer is right for you? Answering those questions requires an understanding of the company needs, their trials, their technological capabilities, and of course the qualifications of the vendor.  That guidance is what I provide to them. In that regard, my Six Sigma training comes in handy a lot.

I also enjoy talking to vendors and travelling to shows and conferences to learn about new products and systems. It is that knowledge that will allow me to make the right recommendations. I also help many sponsors to develop their own tools and programs internally, if they prefer to do that rather than turn to an outside vendor.

Miseta: You mentioned the challenge of getting companies to embrace change. Why is that a struggle for sponsors?

Maurer: In order to get any kind of risk management effort off the ground there is a good amount of change management that must take place. Employees inherently do not like change, so getting them to adopt, understand, and accept the changes you are proposing will always be difficult.

Change management has to involve and focus on the people who will be doing the work and using the tools. Getting employees to the point where they adopt, understand, and accept change will involve moving them out of their comfort zone. That is never easy. If they do not understand what you are trying to implement, you will not get the right amount of buy in from them. If that happens, the effort will not succeed. So while change management does not sound like a critical issue, it is by far the one thing that will cause most of these efforts to fail.

Miseta: Any recommendations on how companies can ensure their efforts are successful?

Maurer: I'll mention two. First, it must start at the executive level. If you do not have buy in at that level, you will not have it at any level. The effort must be driven from the top down. Executives that give lip service to the effort but do not embrace it are wasting their time and money.

Second, vendor selection and management is absolutely critical. There are a lot of product vendors out there and all of them will tell you they have the right solution for you. But a vendor that has the right solution for one company may not have the best solution for another. Sponsors need to have the ability to look at a vendor and assess their offering based on the internal needs of their company. There are a lot of potential partners out there, so this is not an easy task. This will always be a challenge for the small and midsized companies that may not have the staff in-house to perform a proper analysis. I find it is not as big a problem for the Big Pharma companies that have strategic partnerships and preferred provider relationships in place.

Miseta: Are there different challenges those companies might face?

Maurer: Actually there are. And that just reminded me of another trend I have been seeing. Large pharma companies seem to appreciate the benefits of working with strategic partners and preferred providers. But there will be times when that partner company is not performing well or not meeting your needs. When those situations arise, you often still have to work with them. This can be a problem for many companies who then have to figure out what is the best way to make the relationship work.  More importantly, they may have to decide when it is time to sever the relationship, and, if that is the only option, what is the best way to go about doing it.   

Miseta: Aside from RBM, are you seeing anything else that has the potential to transform clinical trials?

Maurer: There are a number of new technologies currently hitting the market. It's hard to predict at this point how big an impact they will have, but I expect it will be great. I also expect they will impact all stages of the trial, not just clinical operations. Let's consider just one of these: wearable devices. For years companies have been asking what they can do to increase patient recruitment and retention. There are products in the development pipeline that will forever change site interactions with patients. The challenge will be figuring out how to maximize the potential of these technologies to improve trial efficiencies and outcomes. One of the best examples of this is the Apple watch.

I think Apple will play a large role in this industry because they see the potential their technology holds to improve clinical trials and the lives of patients. The excitement over these technologies will not go away anytime soon. Technology is moving very fast and the industry is conservative and slow to adopt them. As a result, this will be a hot topic for years to come.