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For Creating Opportunities for Sites
Title: VP, Site Engagement
Company: Continuum Clinical
Education: BS Microbiology, Arizona State University
Hobbies: Swimming, biking, snowboarding, and anything outdoors that provides an adrenaline rush
Associations: SoCRA, DIA, ACRP
Personal Brand: No retreat, no reserves, no regrets
The way to truly and tangibly solve the industry’s larger problems is by connecting all stakeholders. That’s the view and leadership approach of Nariman Nasser, Continuum Clinical’s VP for site engagement.
At Continuum, she oversees a team of former study coordinators and monitors who provide support to study sites to maximize recruitment and retention. Also, she has built a team of former pharmaceutical sales representatives to leverage big data and physician relationships to deliver highly qualified patient referrals to sites for their clinical studies.
As the driving force behind Continuum’s integrated service offerings, Nariman has worked diligently to connect people and ideas together by proactively engaging cross-functional teams, breaking down silos, and communicating the value of integrated service offerings to clients.
Nariman has had a huge impact on site optimization, as well as the organization, its mission, its sites, and patients globally.
For example, when working on a trial for a chronic pain condition, the client asked for field insights to be gathered. Nariman’s site engagement team worked directly with healthcare providers, while the advocacy relations team worked with patients. Nariman’s team shared key insights from healthcare providers, which when combined with key insights from patients demonstrated gaps in service provision. By providing the client with these insights, the pharma sponsor was able to position itself as a leader within the space by developing educational and awareness materials that would empower both HCPs and patients to have more robust conversations about the condition.
To achieve success, she ensures that everyone is aligned on both positive and negative expectations and applies KPIs and metrics to the desired outcomes. Nariman stays abreast of trends in the industry and strives to understand what patients and pharma companies will be relying on next by focusing on problems that still need solutions.
Nariman also innovates to identify new services that could be beneficial to patients who face barriers in clinical trial participation. For example, she has been one of the strongest proponents for Continuum’s partnership with Lyft. She understands that getting to and from a site can be the biggest challenge for a patient, despite being willing to participate in a research study. By working together with Lyft, Continuum has been able to offer an effective solution to this huge problem. Nariman has gained national attention for the Continuum/Lyft partnership.
Colleagues admire Nariman for her professionalism, her passion, and her compassion. She inspires her teams by her dedication to moving science forward via clinical research. And Nariman’s ability to ensure that lofty ideas can be operationalized is a clear illustration that she knows the clinical environment and the challenges researchers face.
A long-time trailblazer in the industry — whether building or re-imagining functional groups or using technology in new ways to support clinical operations — Nariman is always innovating.
She has more than 15 years of experience in clinical operations, patient recruitment, and portfolio management in academic, pharma, and consortia settings.
She generously gives her time to areas in clinical research that have gaps. For example, Nariman was a member of the Immune Tolerance LEAP Study team that recently showed that regular peanut consumption begun in infancy and continued until 5 years of age led to an 81% reduction in development of peanut allergy in infants deemed at high risk.
Nariman is completely and unconditionally supportive to all of those in her circle of family, friends, and colleagues. She has an open-door policy and is always looking out for the best interests of the department. Nariman looks for and finds inspiration in those around her by identifying each person’s unique qualities and contributions. And when challenges arise, she helps colleagues identify the root of the challenge and shows them how to break it down into smaller, more manageable pieces until the puzzle has been solved.
Colleagues say Nariman is a wonderful peer and mentor to junior staff. She listens to her team’s needs, empathizes with the situation at hand, and rolls up her sleeves to help address any issues.
“I want to help people to achieve their professional goals,” Nariman says. “This requires active listening to help people find their own answers rather than just giving them the answers. It is a wonderful feeling to know that those who have worked with you respect your professional opinion, and this is a responsibility that I do not take lightly.”
Indeed, what she’s most proud of is the fact that most of her former staff going back more than 10 years still go to her regularly for mentorship and career advice.(PV)
For Breaking New Ground
Title: Senior Director, Clinical Operations
Company: Astellas Institute for Regenerative Medicine
Education: BA, Bucknell University
Family: Her parents, Richard and Susan Baker, her mom instilled a strong sense of right and wrong and her dad has helped her develop an ability to navigate through the inevitable grey areas
Hobbies: Cooking, entertaining family and friends, serious Boston Celtics and college basketball fan
When Astellas acquired what was Ocata Therapeutics in 2016, and renamed it Astellas Institute for Regenerative Medicine (AIRM), one of the first hires was Kate Giovino.
To those who know and have worked with her, this decision was no surprise. Colleagues describe her determination, hard work, and effectiveness in the clinical research arena as inspiring and aspiring.
She has played a vital role in leading the integration of AIRM into the broader Astellas Pharma clinical development organization. She executed a delicate balancing act to leverage processes and standard operating procedures necessary for high performance in a fully compliant manner, while maintaining the spirit of a small company.
Kate was able to innovate and move away from traditionally structured processes that are needed as organizations grow but that can also be an inadvertent side effect of stifling innovative thinking and the mentality of “it can’t be done that way” can become entrenched.
Perhaps best described as an instigator, Kate likes to ask how existing clinical research processes can be adapted to encompass regenerative medicine products. She is motivated by a challenge and never hesitates to take on demanding or difficult tasks. Equally important, she ensures that projects are completed with an exemplary level of quality.
“I have been fortunate throughout my career to work at the intersection of novel products and high unmet medical need,” she says. “The combination of breaking new ground and working on products with the potential to change medicine is very motivating.”
Given the nature of regenerative medicine, Kate understands the importance of persistence.
“The development of novel products rarely takes a well-defined path, so it’s important to be prepared to work through challenges and set-backs,” she says.
Before joining AIRM, Kate served as VP of clinical operations at Organogenesis. During her time at the company, the team she worked with obtained FDA approval of Apligraf, a living cell-based product to treat chronic venous leg ulcers — an experience she considers a career highlight.
Kate would like to see the industry to collaborate more effectively on the nonproprietary aspects of clinical development, for example the development and validation of novel endpoints and sharing access to specialized and expensive equipment.
At a clinical trial level, Kate says success is measured by the ability of the clinical trial to definitively enable scientifically sound decision-making. This is accomplished by ensuring the study is well-designed, planned, executed, and reported. “Success is also seeing team members gain new skills and apply those skills to achieve their personal development goals,” she says.
Colleagues credit Kate with having a high level of emotional intelligence, integrity, humility, personal accountability, open-mindedness, tireless pursuit of excellence, and genuine concern for her colleagues, which contribute to her success as a leader.
Always supportive, Kate enhances the performance of her team members by providing excellent coaching and promoting a supportive environment to enable each team member to be successful.
Leadership, she says, is about getting the right people to do the right thing in the right way at the right time.
“I like to focus on assembling and developing the right team; I truly believe that a high performing team can overcome almost any challenge,” she says. (PV)
Dr. Clare Grace
For Building the Connections for Site Innovation
Title: VP, Site and Patient Access
Company: Syneos Health
Education: Ph.D., Molecular Oncology, University of Manchester Institute of Science and Technology (UMIST)
Family: Her husband Nick for the meals and cups of tea passed into her home office most nights while she is on teleconferences and supporting her travel commitments
Hobbies: Golf, gardening, cooking, and walking
Personal Brand: Be the change
For Clare Grace, Ph.D., there is nothing more motivating than contributing to reducing the burden of disease in the world. It’s what led her to a career in clinical research and to her current role as VP, site and patient access for Syneos Health. And after meeting her for two minutes, you are inspired by her passion and dedication to making a difference.
Her goal at Syneos Health is to work more directly with sites to improve communications and connections among key industry players to streamline therapies to patients. She and her team have created a platform to drive change in working with clinical research sites to drive more efficient research, establishing Syneos Health as a leader in site relationships. The company has been recognized as the leading large global CRO by investigator sites in the last two global CenterWatch surveys.
Dr. Grace believes that at the heart of any challenge is communication, whether it is with sites or patients. To address this situation, she and her team went out and asked the sites about their needs and based on the feedback they have been able to create meaningful and valuable programs.
Innovative initiatives led by Dr. Grace include the Catalyst program, designed to strengthen collaborations with research sites worldwide with the aim of increasing predictability and harnessing input and insights to develop best practices. Another initiative was the investigator payments program to streamline and improve the payment process for clinical trial sites.
Dr. Grace and her team have partnered with the Center for Information and Study on Clinical Research Participation (CISCRP) to develop an educational campaign to stress the importance of the clinical trial participation in advancing public health. One event, called Inspiring Hope, was designed to build a community of problem-solving advocates to present creative ideas that are feasible, sustainable, and create long-term impact on the broader clinical research community.
She is focused on innovation, saying the anticipated changes in healthcare delivery and new technology will revolutionize the way healthcare is delivered and the way clinical trials are conducted. “Innovations are already impacting sites — new technologies and methodologies — such as eSource, clinical grade sensors, and telehealth,” she says. “These new methodologies, combined with unprecedented access to data and information and new technologies such as machine learning, will transform our industry.”
One of the biggest challenges, Dr. Grace believes, is the effective use and interpretation of data, given that there is so much clinical information being generated from both internal and external sources. In this environment, the use and interpretation of the correct data sources to develop the right plan is becoming more and more of an art form, she maintains.
The decision to join the clinical research industry came after she completed her Ph.D., when she quickly discovered that academic research was not for her. “I felt the work I was doing was too distant from a clinical endpoint, which is a huge motivator for me,” she says
While completing her Ph.D., the signaling mechanisms she was investigating became the basis for a huge number of new drug targets and mechanisms of action of oncology drugs, and helped her enormously in the next steps of her career. “I can say since then I have never looked back or been happier in my choice of clinical research,” she says.
Dr. Grace follows her father’s advice, that you can achieve anything in life if you are prepared to work hard enough. “The first step to success is to believe you can do it; the second is to instill that belief in your team,” she says.
She inspires her colleagues by ensuring people are linked to the larger goal, which is to address the impact of disease and understand the burden it carries. “For every person who suffers from a life-impacting disease, there are multiple family and supporters who are also severely impacted,” she says. “It is important to be happy in your work; we spend so many hours away from our families that it is important to ensure that those hours are challenging, stimulating, and most of all enjoyable.”
Dr. Grace believes that the most challenging times are usually an opportunity to learn about oneself and one’s team. “It’s important to keep focused on the end goal and take the time to reflect on what you are learning and feed that back into the team to make stronger more connected teams,” she says.
Having experienced incredible personal growth from the support of many different mentors, including Dr. Susan Atkinson (PharmaVOICE 100 — 2017), Jean Chitwood (PharmaVOICE 100 — 2016), Tara Fitzgerald (PharmaVOICE 100 — 2014), and Jeff Kueffer (PharmaVOICE 100 — 2013), she says it is important to pay it forward.
“I have a responsibility to contribute to others’ personal growth and journey, and in doing so, I often learn as much as the mentee,” she says. “It is important that I am always learning, always contributing to the organization’s goals, and, most importantly making a difference in patients’ lives.” (PV)
For Moving Risk-Based Monitoring Forward
Title: Senior VP, Clinical & Medical Operations
Company: Advanced Clinical
Education: RN, St. Anne’s School of Nursing/University of Illinois, Chicago
Family: Husband, Larry and daughter Lizzie, who have supported her throughout her career; as well as parents Calvin and Chari Nantz
Hobbies: Entertaining and traveling, spending free time with friends and family; dog lover with two Shelties — Sunny and Scout
Awards/Honors: inVentiv, 2011 President’s Club Winner; Advanced Clinical, 2015 President’s Club Winner; Innovator of the Year
Associations: DIA, RAPS, Illinois Nurses Association, ACRP, 100 Women Who Care — Northshore, Ill. chapter
Personal Brand: Be Kind
Cheryle Evans, senior VP, clinical and medical operations, at Advanced Clinical is a trail-blazing, innovation-driving, industry-collaborating, authentic-leading supporter of clinical research. Cheryle inspires her teams as well as audiences far and wide with her extensive knowledge on topics ranging from risk-based monitoring (RBM) implementation to rare disease research challenges.
Within the past year alone she has been a contributing thought leader on several clinical operationally related webinars, lent her voice to roundtable discussions, and was a session presenter at the 2017 and 2018 Drug Information Association (DIA) global annual meeting, the 8th Annual Clinical Quality Oversight Forum (CQOF), and the 9th Annual Summit for Clinical Operations Executives (SCOPE).
Relying on more than 30 years of clinical research operations experience, complemented by her expertise as a critical care nurse, Cheryle brings complex clinical programs to life with an electric energy. She has guided large-scale, global clinical teams to success with her refined management and leadership approach that centers on solving problems at the root cause, maximizes efficiencies, and exceeds goals and expectations. Cheryle finds ways to tap into on-the-cusp technological solutions for application to today’s challenges.
After joining Advanced Clinical in 2013, a time when RBM was still emerging, she created a path for the company to lead the contract research industry in how RBM is applied to clinical trials. While work in this area is still ongoing with varying degrees of adoption across the industry, after about two years and 1,038 man-hours, she emerged on the other side. Cheryle established the framework needed to identify the right data visualization partners, and in collaboration with an industry sponsor, she guided both organizations through the start-up of the RBM pilot program. She leveraged the knowledge and resources gained from that experience to develop an in-depth training course for pharma and biotech companies that included a mock risk assessment.
Today, she consults with other sponsor organizations on how to establish the necessary framework. “I want to be a driver of innovation, bringing data-driven monitoring to mid-size pharma, biotech, and device companies,” she says. “I also want to build trusted relationships that result in improving the process of conducting clinical research.”
Cheryle also has a creative side that she uses to maintain a positive and strong workplace culture. One example of her intuitive approach to problem solving involved team meetings. At a time when project workloads were increasing, she noticed teams across the organization were overloaded and overbooked by meetings. After doing some research, she found that too many meetings can negatively impact productivity — it takes 20 to 30 minutes before and after a meeting for people to fully regain focus. Her solution: a “no-meeting Thursday” policy, which means one day a week is reserved for team members to truly focus on productivity, free of distractions. The policy increased productivity throughout the organization and was eventually instituted at three of Advanced Clinical’s sister companies.
Colleagues admire her for going above and beyond to leverage teaching moments that enlighten and motivate those around her to be the best they can be. They also count Cheryle as a trusted mentor; she has influenced significant career growth of many current and former team members. “I believe in empowerment, teaching the principles, and giving folks the tools but not the answers,” she says. “What we do makes a difference in the lives of others.”
With the current shortage of clinical research expertise in the marketplace, she is committed to helping equip the next generation of leaders with meaningful skills and experiences that will drive quality clinical research results. For her, this means training CRAs and project managers to become more analytical in their operational approach to meet growing industry demands for remote and RBM models. Advanced Clinical’s university program, which was developed in partnership with organizations such as the Association for Clinical Research Professionals (ACRP), helps life-sciences professionals gain clinical research-specific skills and experience.
With Cheryle’s encouragement, many team members have completed the program and experienced career growth as a direct result. Cheryle is quick to credit an important mentor in her life, Julie Ross, president of Advanced Clinical. “I have worked with Julie for 21 years; she has been a guiding light and trusted mentor. I think sometimes she saw more in me than I saw in myself. She has an amazing way of bringing out the best in everyone.” (PV)
For Impacting Many Lives
Title: Project Director
Education: BS, Computer Engineering, Syracuse University
Family: Her mother Jocelyne Jerome, who left everything she knew and owned in Haiti and came to the United States; her husband Benjy Desir, and her three amazing daughters — Hailey, Carrie, and Zoe
Hobbies: Reading, running, volunteering at kids schools/field trips/church, traveling
Awards/Honors: 2018 CEO Award, Synteract; Several Work Worth Doing Awards, Quintiles
Personal Brand: Purpose in this world spreads far beyond yourself
Making a difference in the lives of patients is what motivates Francoise Desir each day. As senior project manager at Synteract she is responsible for the overall coordination and management of clinical trials from start-up through close-out activities and she draws on more than a decade of extensive experience in project management, clinical study start-up, regulatory document review and maintenance, contract negotiation, clinical supplies, and customer service to best serve her teams and clients.
Colleagues admire Francoise’s unflappability and poise when dealing with potentially difficult topics with clients and her optimism, leadership, and her ability to creatively problem-solve inspires her teams and peers.
What drives Francoise is the joy she derives from what she does and knowing that she has an opportunity to make a difference in the lives of patients. “I have deep concern and sympathy for all human beings, from my family, to my colleagues, to the cashier at the local grocery store, to those who are battling hunger in third-world countries,” she says.
Francoise generously helps onboard new coworkers and she serves as a mentor to junior project managers and project associates; she teaches them how to be an effective clinical research associate, guides their projects and plans to ensure they are following SOPs, answers questions, and offers to assist with client interactions. She is always available to answer questions or provide guidance even if it’s not for a study or program for which she is responsible.
She would like to be remembered for her dedication, efforts, and energy that she has given to the industry, which she loves. “I truly believe in the important impact that clinical research has on my life, the life of my family and friends, and on society. My career in this industry is not coincidental; it began as an accident, but developed into a passion. I quickly realized the impact that one person can truly have in the life of many people through this industry,” she says.
Francoise says the key to moving along this life journey and adapting to the never-ending changes is to remember that these changes will stretch and bend you, forming you into the very person you need to become in order to claim your space in the world.
“My greatest rewards are hearing patients and caregivers say because of this product, my mother, my father, or myself will see my children/grandchildren get married; hearing sponsors speak about the wonderful partnerships we have to bring new products to the market; and hearing my children talk about how mommy is in the business of changing lives and helping people,” she says.
Francoise is a citizen of the world and encourages her children to be socially conscious and active. Recently, she made a two-week journey with her husband and 13 of their family members to Ghana, West Africa, to bring medical supplies to a local clinic serving mothers and children that was having a hard time meeting the needs of its community.
“I was born and raised in Haiti,” she says. “I experienced first-hand the struggles and poverty of living in a third-world country, including having very limited access to basic healthcare. My husband, also of Haitian descent, and I believe that our purpose on this earth is to positively impact as many lives as possible. Therefore, we are always looking for opportunities to give back.”
She is overwhelmed by the idea that there are so many people across the globe who do not have access to healthcare — education, supplies, and treatments. “My interest in this area is formed by my personal experiences and the experiences of my love ones up to present day; therefore my passion runs deep and has been the very instrument that led me toward the field of clinical research,” Francoise says. “We have all heard the phrase ‘Knowledge is the key.’ This is true when you have access to such knowledge — whether it is from school, a mentor, books, etc. The problem is that there are so many people who are unable to possess such knowledge and education.”
She is undeterred in her pursuit of changing the status quo, and she has a long-term professional goal to complete her Ph.D. in public health leadership and use her voice, skills, and leadership to promote and support the effort toward improving public health initiatives across the world. (PV)