Mary Costello

Mary Costello

Mary Costello has spent over thirty years in the healthcare and clinical research fields, working in commercial leadership roles with large organizations like Covance and Thermo Fisher and more recently supporting the growth and expansion of eClinical Solutions and Elligo Health Research. She has served on several industry advisory groups and is a Founder and Board Member of BioAustin. At Medable she serves as Head of the Site and Investigator Network and is passionate about ensuring the site voice and experience helps shape improvements to the clinical research industry.

Recent posts by Mary Costello

2 min read

Decentralized Shouldn't Mean Disorganized

By Mary Costello on Jan 15, 2021 9:30:06 AM

Decentralized clinical studies are referred to by a variety of names - virtual, digital,  - the list goes on. Yet, whatever you may call it matters not; instead it’s the core tenets of this idea that matter most. Here, the inherent patient-centricity of decentralized studies is both the goal and the reward.

For those who may not know, decentralized trials are executed through a combination of TeleHealth and traditoinal in-office settings. Instead of office visits, DCTs often include visits that may be conducted remotely, with patients at home for some or all of the trial. 

However, simply arming potential participants with access to or actual apps and devices is not a recipe for success. A clinical trial is, at minimum, an exercise in detailed planning and should always be subjected to a “what if” modeling to plan and to identify  what can be prevented or mitigated.

Thus, it comes as no surprise to veterans of clinical trial logistics that the unprecedented challenge of vaccinating waves of Americans with an ultra-cold product was going to be difficult. The decision on how to deploy was left up to states, with seemingly little planning for a central repository to pre-register or track patients nationally.

The goal was to have 20 million vaccinated by December 31st, 2020. The end result, according to Reuters? A much lower 2.8 million. 

The reason? According to multiple reports across Reuters, Newsweek, CNBC and others was simple - a failure in planning and communication.

While the Federal government was responsible for, and relatively successful in providing the allocated number of doses to States, progress halted there. A number of key oversights, such as leaving States to plan their own distribution to residents, as well as developing last minute contracts with retail vendors like Walgreens to administer vaccinations have slowed the pace.

As such, Americans have found themselves left in the dark, with little to no information on how to register for the vaccine, where to go, and most importantly, the timeline to vaccination?

 So, what’s the lesson to be learned here? That decentralized does not have to mean disorganized. 

Clinical trial leaders need to employ the same planning principles that have underwritten successful trial conduct for decades. Proper planning, communication, and room for flexibility are key for all trials - decentralized or traditionally managed. Thankfully, there are several examples in the clinical trial world that sponsors and CROs can look to in order to plan a proper decentralized trial.

New tools in the industry afford us new hope and new access for communities that have historically been denied a chance to participate in research. However, the imperative should be in making all aspects of the study as accessible as possible including thinking through how to communicate, register and prepare participants. 

Here in Texas, we are struggling to move into 1B. Houston, one of the largest and hardest hit areas of the US, has been overwhelmed with too few locations offering the vaccine. In fact, many rural Texas counties have not even received a shipment of product. Imagine if we had used the time we had from February until now to create an online registry for people to register, learn about the vaccines, identify accessible locations, and share confidential health information that would help pre-qualify and stratify vaccine recipients. We would be in a much better position today.

Never shortchange up front planning or underestimate the value of communication. It will be the foundation for success.

 

3 min read

Why I Joined Medable: a New Generation of Leaders

By Mary Costello on Oct 15, 2020 11:54:08 AM

Like many of you, I was saddened to learn of Ruth Bader Ginsberg’s passing a couple weeks ago. She served as an icon and inspiration to many. I think women who benefited from her work and her decisions, the loss felt almost personal. For me, spending most of my career as a single mother working in a very fast paced industry, I often felt as though in order to succeed professionally, I needed to minimize the impact of balancing motherhood with the demands of work.   

Times are changing and traditional roles are evolving. Now many fathers are sharing the responsibilities of children. But when I was coming up through the ranks of the workforce, that evolution had not yet taken place.

In my 30 plus years of working, every single leader of every single company for which I worked were men. I’ve had the good fortune to work with inspirational company heads and to learn from their styles and their leadership and vision.  

Today I find myself at Medable, and it’s the first time I have worked for a female CEO. So, is there a difference?  

My experience has been similar to those of many others. A recent article in Newsweek, focusing on the difference in responses between female led countries versus male led countries amidst COVID noted that "world leaders who are women have been more likely to use language focusing on compassion and social cohesion”. Forbes published an article last year examining the different ways genders are socialized and found that “women excel in leadership positions because they have developed soft skills necessary for effective leadership...traits like empathy, communication and listening". In 2019, HBR  evaluated 360 degree reviews and found that "women in leadership positions" were perceived just as - if not more - competent as their male counterparts". Yet the percentage of female CEOs of public companies still does not reflect the population.  

There is some evidence of progress. A woman just assumed the CEO position for the BNSF - the first female to hold the leadership position for a railroad. GlaxoSmithKline, one of the largest pharmaceutical companies in the world, is led by a woman.  

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So what's been the difference for me, a woman in her late 50s, arguably closer to the final years of my career than I am to its beginning? Medable's culture is shaped by our leader, Michelle Longmire, a physician and founder who believes in the power of passion and drive.  But she also believes strongly in the power of people and connection and works to connect with her teams and collaborators in a very personal way.  

When I was contemplating leaving my former position to join Medable, I asked one of my colleagues for her thoughts on the best thing about Medable and her instant reply was "Michelle. She's inspirational". Despite the stereotype, women want to see one another succeed and it is inspiring to see how our CEO has taken an industry problem as a challenge and an opportunity and built a company around solving those problems. Her skills as a listener mean that the team is drawn to her and willing to share ideas; her openness to multiple perspectives feels different than what I've experienced at other organizations.

We mourn the passing of Justice Ginsberg – a petite, soft voiced judge who will be remembered partly for her belief that "you can disagree without being disagreeable."  Justice Ginsberg showed us that leaning into our traditionally female qualities wasn't limiting and may in fact be liberating.  I appreciate all she did for our country and, in particular, the women in this country.  Equally today I appreciate the opportunity to experience a new generation of female leadership.  

Thanks Michelle and the Medable team – it’s been a great journey so far!

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