Clinical Experts

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PharmaVOICE Staff

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These clinical development experts are redefining clinical operations to increase efficiencies, reduce costs and timelines, and improve the safety profiles of bringing new medicines to patients.

Unwavering determination to further clinical research

Igniting change by…
ensuring cross-functional and geographical connectivity among team members

Jessica Vermeulen, M.D., Ph.D.
Title: VP, Clinical Development
Company: Janssen Pharmaceutical Companies of Johnson & Johnson
Education: M.D., Ph.D., University of Amsterdam, Netherlands
Company Awards: Johnson & Johnson leadership medal for developing siltuximab
Associations: ASH, ASCO

Jessica Vermeulen, M.D., Ph.D., is not only passionate about developing new treatment options for rare disease patients, she is also extremely successful at it. She is responsible for developing siltuximab, which is marketed under the brand name Sylvant, the first approved treatment for multicentric Castleman’s disease. For her leadership and scientific contributions to the siltuximab program, Dr. Vermeulen was awarded the Johnson Medal. At the beginning of 2021, Dr. Vermeulen did it again. She and her team achieved the world’s first and only FDA approval — Darzalex Faspro (daratumumab) — for the treatment of newly diagnosed AL amyloidosis patients, an area of great unmet medical need.

Since 2019, Dr. Vermeulen has been the global clinical head of the daratumumab program focusing on the development of the subcutaneous formulation as initial treatment for transplant eligible multiple myeloma and AL amyloidosis. She has delivered numerous high-quality, practice-changing studies for daratumumab study teams, leading to several global regulatory submissions and approvals. Today, more than 200,000 patients around the world have been treated with daratumumab. Many lives were saved or improved due to her work and leadership, colleagues say.

Developing siltuximab and daratumumab have been her most challenging feats so far, but also her most fulfilling. “One of the biggest challenges in the development of new treatment regimens in rare diseases is to align on clinically meaningful endpoints,” she says. “When there’s no precedent, you have to take a deep dive in what the unmet medical need defines and how to assess a benefit that is both clinically meaningful for patients and objective to allow regulators to assess the benefit-risk profile accurately. Getting alignment on such endpoints that are critical for success has been challenging but extremely exciting.”

Her more than 20 years of industry experience includes substantial expertise across multiple oncology indications and products, including acting as the 2013 lead of the clinical team overseeing the ibrutinib (Imbruvica) development program for non-Hodgkin’s lymphoma.

On top of her important role in clinical development, Dr. Vermeulen is a true people leader, prioritizing connecting and developing other team members around her as well. According to colleagues, she is a truly inspiring leader, scientist, physician, and mentor who personifies the drive to improve the lives of patients worldwide. She was instrumental in creating a diverse, oncology clinical R&D team in Leiden, Netherlands. While expanding the Leiden team, she stimulated cross-connections with the oncology clinical R&D teams elsewhere in Europe, and ensured quarterly meetings were held to build on the expertise and leadership of oncology clinical R&D as a whole.

During the current pandemic, with everyone being home-based, she has created cross-functional and geographical connectivity among team members to ensure a strong and connected culture.

Dr. Vermeulen’s singular focus is to inspire and coach her team to bring novel treatment options to patients in need. She hopes that, one step at a time, this process will lead to the ultimate goal of eliminating cancer.

Her service-focused leadership style has energized large multidisciplinary teams to successfully develop multiple novel medicines for many of the world’s most fatal diseases. As a leader, Dr. Vermeulen employs a hands-on and logical approach that encourages, recognizes, and rewards teamwork and innovation. Her rapport with her colleagues and mentees is renowned and has inspired countless junior staff members who attribute their learnings to her guidance and mentorship.

She is attuned to the personal well-being of her colleagues and quickly recognizes challenges and stress factors. She invests in the development of her direct reports, helping them seek opportunities for growth and leadership.

“I am passionate about my drive to develop new treatment options for patients, we should give all that we have to do that,” Dr. Vermeulen says. “Also, I care deeply about my team, realizing the potential is as big as my team. Creativity is another attribute I think defines how I approach problems, see opportunities, and see life in general.”

Since starting at Johnson & Johnson in 2005 in the clinical R&D program, she has brought tremendous energy and commitment to every role she has had with increasing responsibilities in each, most recently resulting in a promotion to VP. Her ability to motivate all team members simultaneously and with sincerity, solidifies the team around a sense of purpose and the need to do things differently. She has a true gift that motivates others to want to be on her team that is focused on improving the lives of those suffering from any disease, no matter how rare or underrecognized. (PV)

What is best for our people?

Igniting change by…
setting a vision and leading people to it

Diana Cucos
Title: Executive VP, Global Clinical Operations and Biometrics
Company: Syneos Health
Personal Awards: Healthcare Businesswomen’s Association Luminary, 2017

Diana Cucos, executive VP, global clinical operations and biometrics at Syneos Health, joined the CRO business 20 years ago. Today, she leads a team of 5,500 global employees, consisting of 453 managers, directors, and VPs.

She possesses all of the traits of a successful leader, but the one that puts her above the rest is her ability to consistently apply her core set of beliefs in every situation she faces. Plus, she stands by those principles no matter how difficult. She goes to work every day to make everyone successful, not just herself.

As a leader, Diana sets a vision and brings people to it, using her skills of collaboration, communications, and observation. Her team members say she gives everyone a voice and encourages them to continue growing and learning about clinical research; she does this by embracing everyone’s passion at work, integrating the team, scheduling valuable meetings, and generating happiness in the workplace. She knows how to empower staff members to capitalize on their own talents and work toward success.

Adding to Diana’s extensive list of talents as a leader, colleagues also call her “wicked smart.” Routinely, she will step into completely unfamiliar territory and quickly discover solutions that others didn’t see. She breaks down complex situations into simpler components, allowing everyone else to handle those complexities. It’s a style that elevates those around her to succeed by supporting them in a subtle way.

For her, success is all about people. She believes if talented people are given the tools, the knowledge, and support to succeed, they will achieve great things. Diana is the springboard to helping people achieve their success, and it’s all in a day’s work to her.

Colleagues know that working with Diana on a business challenge will elicit one particular question from her. She will undoubtedly ask, “What is best for our people?” No matter what the solution or initiative is, it needs to represent how it will benefit others. It is crucial to have leaders like Diana who put people first and are guided by simple questions like “is it the right thing to do?”

Diana says one of the most challenging and, ultimately, most rewarding achievements in her career was leading her team through the pandemic. She evolved her leadership style to fit the needs of her associates, made swift changes to support the business delivery, and partnered with customers on a deeper level than ever before.

Her team bonded in new ways as they moved to strictly virtual interactions, sharing Zoom cameras, and more pieces of their personal lives. In March 2020 Diana began sending a daily thought to reflect on, share nuggets of wisdom, and provide a connection to the leaders in her organization.

These nuggets inspired team members and helped them to lead their teams through the challenges of 2020. In April, the practice spread to all team leaders who each took a day of the week to share their daily thoughts with one another. This simple act of sharing a daily thought as a leadership team created bonds that will last a lifetime. Diana’s initiatives have had a cascading effect to develop not only leaders at the top, but at all levels within Syneos Health.

To help others during the pandemic, Diana initiated “Support Our Communities,” which is an opportunity for all individuals within the organization to collectively impact their communities. During four-week periods, the company tracked its impact on food security and supporting children. The efforts resulted in 3,720 donated meals across 29 countries over four weeks, and in another four weeks brought joy to 3,685 children in 27 countries.

Another career challenge she reveled in was having the opportunity to lead in a new functional area she knew little about. “Starting from a point of limited knowledge of the functional delivery ended up being a significant growth opportunity personally and professionally,” she says. “Taking on something new challenges what you know, how you interact with others, how you listen, and how you ideate. As challenging as it can be to move from solid, confident ground and take a leap of faith into a new area, it really stretches you in a positive way.”

Diana strives to be an authentic leader and interacts with customers, peers, and her team with the same sense of service, empathy, and integrity. She hopes she is known for mentoring leaders to be passionate about providing solutions to the constantly evolving industry, and to be equally passionate about their teams and building future generations of leaders who prioritize leading with empathy, courage, and integrity. (PV)

Creating value for patients

Igniting change by…
innovating and transforming

Stacy Wu, M.D.
Title: VP, Head of Global Clinical Research, CNS
Company: Sunovion Pharmaceuticals
Education: Bachelor’s degree, Brown University; M.D., New York University School of Medicine
Company Awards: President’s Excellence Award (Avanir Pharmaceuticals), 2019; Agitation in Alzheimer’s Disease Team Award (Avanir Pharmaceuticals), 2018, 2019
Associations: American Academy of Neurology; American Course on Drug Development and Regulatory Sciences Alumni; Babson Executive Education Women’s Leadership Program Alumni; Brown University Alumni Association
Giving Back: Sunovion Hands On community service program
Twitter handle: @sunovion

Stacy Wu, M.D., VP, head of global clinical research, CNS, at Sunovion Pharmaceuticals, began her career as a physician before hearing the siren call of pharma research.

“After completing my neurology residency, I completed a fellowship in Parkinson’s disease and other movement disorders, then completed a clinical research fellowship in multiple sclerosis,” she recalls. “In this capacity, I was able to train clinical trial investigators and developed lasting relationships with industry partners. I decided to transition into the pharmaceutical industry, where I was able to significantly contribute to clinical programs for neurological disorders.”

Making the transition from practicing physician to working within the biopharmaceutical industry was a challenge for Dr. Wu. “However, I welcomed the ability to expand my impact from treating one patient at a time to having a broader and different reach on patients and clinical research,” she says.

Dr. Wu is proud to support Sunovion’s continuing work and investment in the discovery and development of central nervous system (CNS) treatments. “I am rewarded each day working in CNS clinical research where there is a need for new treatment paradigms that can positively impact patients,” she says. “And I’m honored to inspire my team every day to make a difference for patients and their families and leverage cross-functional collaboration to accelerate drug development timelines as a key to success.”

Her focus on influencing the future of CNS development includes management of a global Phase III program for Ulotaront (SEP-363856), which has a novel mechanism of action to treat schizophrenia and has received breakthrough therapy designation from the FDA.

Dr. Wu says one of her most recent accomplishments, contributing to the approval of Kynmobi to address Parkinson’s disease, is a career highlight.

Colleagues say Dr. Wu is committed to excellence, collaboration, and care, and elicits that same dedication in those around her. She is recognized as a leader of leaders, serving as a mentor for colleagues and encouraging people to work in adjacent disciplines to round out their industry experience and position themselves for leadership positions in the future.

Dr. Wu considers herself open, honest, and transparent and strives to lead by example. “I really try to understand what teams and individuals may be encountering in terms of difficulties or roadblocks and focus on finding ways to provide needed resources or tools, while providing strategic guidance,” she says. “I make myself available to brainstorm and be a sounding board for their ideas.”

In making the transition from an individual contributor, with a depth of knowledge, to a leader overseeing highly skilled professionals with a diverse range of expertise, she says it is important to understand their roles and disciplines. “My focus is to ensure that everyone’s expertise contributes to a bigger goal,” Dr. Wu says. “And as a leader, I need to enable these synergies help everyone elevate their contributions to a higher, more innovative level by working together.”

As a mentor, Dr Wu is focused on helping junior members of the Sunovion team understand more about clinical research and CNS in depth. “I strive to figure out what they are most stimulated by and interested in and help develop those skill sets and find activities and responsibilities that match this career development path,” she says.

Her mentoring bent is reflected in her support of Sunovion Hands On. “The Sunovion Hands On community service program, now in its 10th year, supports many community, youth and education, and humanitarian relief causes,” Dr. Wu says. “I am particularly proud of our STEM work to advance the next generation of innovators through skills-based volunteering and education for students in neuroscience.”

When the pandemic forced Sunovion to switch to virtual work, Dr. Wu held regular check-ins with individuals and planned virtual gatherings to discuss various topics so that people felt connected and informed.

“During COVID-19, as we worked remotely, it was imperative for me to really learn more about each of the people in my department, who may be at different stages of their careers and have different working styles,” she says. “I was then able to tailor my leadership style and approach to each individual member of my team to ensure that we stayed connected, especially in a virtual environment.”

Even in her downtime, she finds herself focusing on her CNS mission. She recently completed “Hidden Valley Road,” a nonfiction book about the journey a 20th century American family undertook when six of their 12 children were diagnosed with schizophrenia.

“The book Hidden Valley Road has been inspiring to me, since this illuminates our mission to serve and create value for patients,” she says. “I have shared this book with colleagues since it addresses how CNS disorders can really impact everyone in a family. This story reinforces the importance of the work that our team does to help patients and bring forward new treatment options for these debilitating conditions.” (PV)

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