Emanate Blogs

The Detectives of the Pharma World: A Conversation with Bethany Van Veen

Different pills scattered, with side effects written on strips of paper among them

“The only reason pharmacovigilance exists is to protect patients.”

In this series, we talk with people in the life sciences that you don't hear much about. These are people whose work is integral to the success of clinical trials and thus to the development and approval of new drugs, therapies, medical devices, and to the progress of digital health.

Sleep walking.

Sleep driving.

Hallucinations. Strange half-sleeping activities that are not remembered later.

Recently Ambien, Lunesta, and Sonata, prescription sleep aids, had their FDA warnings changed to include a "boxed warning" on the package, the FDA's highest drug warning level. (https://www.nytimes.com/2019/04/30/health/sleep-drugs-ambien-side-effects.html)

These changes to the warnings on Ambien and the other sleeping drugs are a result of pharmacovigilance. Pharmacovigilance (or PV) is a critical but somewhat mysterious niche within the greater pharma industry. According to Bethany Van Veen, the field has evolved so much over the last 10-15 years that even many people in related functions don't necessarily have a good handle on what it is that a pharmacovigilance department does.

But it all boils down to protecting patients, even prior to dosing patients for the first time in clinical trials.

From Med School to Drug Safety...

Meet Bethany Van Veen. Current PV ninja and founder of Perspective Pharmacovigilance, and former physician candidate.

Bethany had wanted to be a physician from childhood, and pursued that goal single-mindedly until the year after college graduation. It was the first time she’d had a break in her schooling, as she went through the lengthy process of applying and waiting to be accepted to medical school.

"I had wanted to visit San Francisco for a long time. I also needed to pay the bills, so I signed up with a staffing firm, and they placed me in a data entry position for a pharmacovigilance team, in San Francisco." This was different than Bethany's pre-med experiences to this point, and just the kind of change she wanted.

"I had no idea what the team did; I knew nothing about drug development or the pharmaceutical industry, so this was a crash course in everything pharma."

“There really has been this paradigm shift to recognizing how important pharmacovigilance is at the beginning of the process.”

She enjoyed her work there while she continued to navigate the medical school application process. And then the unthinkable happened.

"I didn't get in!" She laughs now, but she was devastated.

It had never occurred to her that she might not be accepted to medical school.

"It turns out to have been a blessing in disguise, because my career in pharmacovigilance has been such an extraordinary one. It's been so challenging and so fulfilling. In hindsight I'm thrilled that circumstances forced me down this path early on, and if I had had any exposure, any idea, I would have chosen this from the start."

...And from Drug Safety to Founder

Bethany worked at multiple pharma companies in leadership roles, and ended up at Intermune as Senior Director of Pharmacovigilance Operations. This company was a small, US-only pharma outfit getting ready to market their new drug in other countries. In order to prep the company for overseas regulatory submissions and sales Bethany ended up doing two years of nearly non-stop travel setting up the PV function in affiliate offices around the globe.

"It was an extraordinary experience, one that I wouldn't trade for anything." But when she discovered she was pregnant with her second child, she realized that international travel combined with the sheer volume of regulations across the globe, weren't going to allow time to parent an infant.

She contacted people in the industry to let them know that she was thinking about working on a consulting basis, and asked if they needed any help. She had a contract within a week, and Perspective Pharmacovigilance, LLC was born. Perspective PV is a boutique consulting firm offering specialized services for pharmacovigilance activities including risk management and safety sciences, operations, quality management and safety systems during clinical development through and beyond product launch.

“Patient safety is paramount. The ONLY reason pharmacovigilance exists is to protect patients.”

Bethany had expected consulting to be a stopgap measure to improve her work/life balance and let her raise her kids, but it turned into a whole new chapter in her career.

"I had no idea how much fun it was going to be to deal with those super interesting challenges more frequently than I had in a full-time position with one company."

The Allure of PV and its Ever-Changing Challenges

"What's most exciting? All the different components of pharma that combine into one specialty!” Bethany enthuses. She points out that PV incorporates elements of data management, operations, quality assurance, clinical science, regulatory, legal and technology in order to meet the pharmacovigilance requirements.

"I love that there are so many challenges associated with PV! There are so many different hats you can wear during a day, and I love that things are changing constantly."

There is also high demand for PV specialists. People who combine a curiosity about the world, a desire to learn, are logical and detail-oriented and have good critical thinking skills are likely to succeed in PV.

Bethany says, “You learn 'Safety 101' and the fundamentals of pharmacovigilance activities when you start, but then you have to be able to apply that to an extraordinary number of scenarios that there is no book for. There is a lot of gray area.”

The Future is Bright

While Bethany sees pharma as behind other industries in applying machine learning or AI, she says it has already started. “Especially in terms of speeding up case processing efforts, by replacing human data entry with AI, that’s the logical first step.” Several big pharma companies have successfully utilized AI for pulling data into the safety database. With the sources of safety data expanding and the regulator expectations increasing, companies are forced to identify more efficient way of gathering and analyzing safety data.

“It (PV) didn't exist many years ago, and nasty side effects would go more or less undocumented, until truly horrific side effects finally raised the need for regulation.”

As far as AI replacing humans in PV, it's not likely to happen soon. Data evaluation is incredibly complicated and requires human input. Additionally, the regulators are very clear that the pharma company ultimately holds the accountability for data integrity and the risk of missing a potential safety signal is too high.

But when it comes to data, one of the things that she hopes is on the horizon is a solution that meets the needs of both a safety database and a clinical database. There are some tools out there currently, but they do not meet all of the requirements for the safety database. She recognizes that there are challenges, but says, “In this technologically advanced age, with all the resources and skilled problem-solvers out there, I imagine we are not far away from such a solution!”

Another area of opportunity is the expansion of the skilled PV workforce. “There currently is a shortage of highly-trained and effective PV staff”. There are a few post grad educational options specializing in PV, but not many. Many of the other pharma functions have developed certification programs (project management, clinical operations, regulatory affairs). “The entire industry could benefit from the development of a PV certification program in the US.”

“We really have come a long way!” Bethany points out that 20 years ago, as the "safety" people, pharmacovigilance wasn't even part of the conversation in early development until there was a serious adverse event. "There really has been this paradigm shift to recognizing how important pharmacovigilance is at the beginning of the process."

 
Bethany Van Veen

Founder and Strategic Advisor at Perspective Pharmacovigilance, LLC, Bethany Van Veen is a pharmacovigilance evangelist. She also teaches a class in PV for SF State’s Clinical Trial Design & Management certificate program.

Find her on LinkedIn

   
 

Leave a Reply

Your email address will not be published. Required fields are marked *