A successful technocrat of global standing, Shari Medendorp oversees Premier Consulting, a business unit of Premier Research, where she leads the team that provides developing biotech and specialty pharma companies with strategic product development and global regulatory consulting. There, Ms. Medendorp is a global strategic and operational leader of multiple technical divisions, successfully delivering solutions and results for its biotech customers and value for the company.
After graduating with a master’s degree in biostatistics from the University of Michigan, Ms. Medendorp began her career as a biostatistician at the Cleveland Clinic Foundation, where she collaborated with the medical team on the planning and evaluation of clinical research. Her career led her to the clinical research service industry, where she’s held roles leading biometrics teams at a number of clinical research organizations, including SCIREX Corporation, Reliance Clinical Research Services, CliniRX, and Premier Research. Achieving 20 years of experience in the field, Ms. Medendorp joined the executive leadership team at Premier Research in spring of 2022 as President of Premier Consulting.
In a thorough interview with Insights Care, Mrs. Medendorp shares how is she is successfully delivering clinical research for her biotech clients and value for the company:
Kindly brief us about yourself and your professional journey so far.
Early in my career, I worked as a biostatistician in a large research hospital, helping physicians and scientists with their research while surrounded by patients and their families who needed top-of-the-line therapies to treat their diseases. This connected the data I worked with to real people and brought home the perspective that clinical research, at its core, is about bringing hope to patients who need it. Ever since, this has been my driving force.
I subsequently broadened my clinical development experience through a series of positions at several clinical research organizations, building global teams to deliver conclusive results for clients and, ultimately, patients. Today I have the privilege of leading Premier Consulting, a business unit of Premier Research, which affords me the broadest reach yet—helping customers navigate the complex pathway from the very early stages of development all the way through the product life cycle.
Please tell us about Premier Research and how your role is shaping the organization.
Premier Research is a strategic product development SM company that is Built for Biotech. We help the most innovative companies transform life-changing ideas and breakthrough science into new medical treatments and solutions. Premier Research has a vision of being the end-to-end product development partner for biotech and MedTech.
Many of our customers are pioneers working in spaces that have yet to be defined. This creates a need for highly tailored strategic and regulatory support early in the development process. The Premier Consulting team provides that early support and has the flexibility to engage at any point in the development life cycle. We guide our customers in developing and executing strategic roadmaps that support fundraising, regulatory strategy, drug development and commercialization. We support them from the start of the development journey to the end of the process.
What are the key products and services of Premier Research and how is it impacting the demographic concerned?
Our work spans disease areas that are life-altering and, in many cases, underserved—rare diseases, overlooked women’s health conditions, cancer. Patients and their families desperately seek new solutions to address their health challenges. We shape the research that delivers amazing science to patients in need, working quickly to deliver end-to-end strategy, regulatory, nonclinical, clinical pharmacology, CMC, submission, quality, and commercial solutions that are best in class.
Drug and device development is complex and highly regulated. Our goal is to simplify the process with a customer-centric culture that pairs efficiency with quality to guide sponsors every step of the way. We tailor development plans to meet the most rigorous global regulatory requirements, address the diversity of each patient population, and deliver results for sponsors— with a dedication to understanding and addressing the challenges of the patient journey.
What are the core values of the organization? How are you leading it to achieve its vision and mission statement?
We are driven by the knowledge that what we do every day has a profound effect on the well-being of the patients we support and the sponsors we work with. It’s this impact that inspires us. We are invested in offering seamless solutions that sponsors can grow with, progressing from an idea all the way to market entry and beyond. Doing so requires a collaborative team with distinct skill sets and diverse perspectives. As a global business, we bring together people from a variety of backgrounds, cultures and educational focus areas to form the strongest team. Together we can do more than any one of us can alone.
We have also made ownership and empowerment mainstays of our culture, and we are deeply engaged in the development and growth of our team. Continuous learning is essential to address the constantly evolving needs of the research industry and the sponsors we support. By creating a positive work environment where staff are inspired to grow, we can have an extraordinary impact.
How has your expertise on biostatistics helped you ensure an upward sloping growth curve for the company? How is it revolutionizing the current industry?
At a high level, biostatistics focuses on understanding the question(s) at hand, defining objectives, designing and implementing methods to best address those objectives, and interpreting results to gain understanding. It is analytical at its core, enabling data to eventually lead to insights and discoveries. It’s collaborative by nature, requiring the ability to build strong relationships across key stakeholders to work as a team. In clinical development, data drives what we do. The core skill sets for biostatistics translate well to the broader clinical development environment, where clean, conclusive data and insights are our key deliverables.
Clinical development and research continue to grow more complex as new study designs, computational methods, and study strategies are developed and implemented. In addition, the industry is increasingly focusing on the patient journey and incorporating real-world data into the research process. Biostatistics is critical in designing solutions to simplify how we approach more complex problems and study designs to optimize insights.
As an experienced leader, what advice would you like to give to aspiring entrepreneurs and enthusiasts who wish to venture into the competitive industry that you are serving?
The clinical development and healthcare space is continuously changing, even more so given the lessons we have learned from COVID. To make the most of this, my advice is to never stop learning and exploring. Understand your unique gifts and continuously explore how best to use them to make an impact. Seek out trusted advisors along the way. Care about and respect those around you and help them find their gifts and put them to use. Find others from diverse backgrounds who share your vision and motivation, build trust and seek ways to help each other become better.
What are the future goals of the company? How does it envision scaling its operations in 2022 and beyond?
We will continue to evolve as biotech, specialty pharma, and MedTech companies change their approach to product development, expanding how they use technology to simplify processes and deliver insights quickly. With our ability to engage clients early in development and support them throughout the product life cycle, we believe we can eliminate roadblocks, improving how clinical research is delivered to patients and the speed at which new health solutions become available in the marketplace.
“I recently commented to our Premier Consulting lead that all virtual biopharma companies should engage Premier as a strategic partner. It is not only the depth of regulatory experience — meeting with the FDA five to six times a month — and the breadth of functional expertise, but also their responsiveness. Premier Consulting is a key strategic partner that will help us succeed and bring our life-saving products to market.”
– Biotech President and CEO, Opioid Abuse Deterrent Technology