Meet Beth Tulip, Senior Executive Director, Clinical Trial Management, Medpace
Medpace is pleased to announce the addition of a new clinical operations expert, Beth Tulip, to its infectious diseases & vaccines and women’s health leadership team.
Beth Tulip is a Senior Executive Director of Clinical Trial Management with over 25 years of clinical research experience in the industry. She has an established record for generating and implementing innovative, strategic solutions that consistently result in optimal performance throughout Phase I-IV of the drug development life cycle. She is a recognized leader in the industry with expertise in the areas of infectious diseases, vaccines, women’s health, and pediatrics.
In this interview, we learn more about Beth’s background and the expertise that she brings to Medpace.
Tell us about your background in clinical research.
I started my career in clinical research as a clinical research associate (CRA), where I was immediately drawn to infectious diseases trials, which included vaccines. I have spent most of my career working at large clinical research organizations (CROs) and have garnered extensive experience in operationalizing, leading, and providing strategic guidance to sponsors and cross-functional teams, specifically in infectious diseases, vaccines, women’s health, and pediatric drug development. I have led or contributed to the development of 23 antibacterial, antiviral, and vaccine assets that resulted in FDA and EMA approvals in my career thus far.
I’ve always had a desire to help others, whether by saving lives or enriching them in some way. After working directly with hospitalized patients for seven years, I had an opportunity to become a CRA at a CRO. As I thought about where I could make a greater impact in helping others, the answer was clinical research; this realization drove me to make a career transition into this industry.
What drew you to Medpace?
I was drawn to Medpace as the company’s focus is on the scientific and medical integrity of clinical trials, primarily for small to mid-size biotech companies. I really enjoy working with smaller biotech companies as it feels like a true partnership versus a transactional relationship to help bring their drug to market. Therapeutic alignment is incredible as it does not stop with medical and operations; it extends to other functional areas such as data management and biostatistics. I’m thrilled to be here and to collaborate with the experts at Medpace, including the medical, clinical operations, and functional teams to expand the already existing expertise in infectious diseases, vaccines, and women’s health.
What are some operational challenges and considerations in vaccine clinical development?
There are many challenges and considerations when it comes to vaccine clinical development. Even with vaccinations that successfully mitigate or eliminate diseases caused by different pathogens, there are still emerging pathogens and those that continue to evolve. Vaccines must be constantly updated to keep up. It is challenging to stay ahead of that, and developing different technologies to pivot quickly is important.
Additionally, vaccine trials can be very fast-paced and large, especially vaccine trials for seasonal diseases such as flu and RSV. They require significant operational collaboration amongst sponsors and every functional service within a CRO. It is essential to have seamless systems integration for vaccine drug development, everything from the labs to safety to EDC, and having it all in a one-stop shop so that clients and sites can see data in real time and respond in real time if trends are seen. When recruiting healthy normal volunteers so quickly, waiting to do data analysis until the end, as is typically done in traditional trials, would result in missing potentially significant safety and immunogenicity endpoints.
The Medpace ClinTrak® system is a perfect solution for vaccine drug development. Integrating data from several different sources into a database to see a full picture of a patient takes time, which is time that these vaccine trials sometimes don’t have. ClinTrak provides real time access to all patient and study data, which is a perfect fit for rapidly enrolling vaccine trials.
Collaboration and concise communication, both internally and with our sponsors, are critical for the successful operationalization of vaccine studies. Not only is there a need to manage these trials rapidly from a patient safety and efficacy perspective, but the sponsors may also be trying to beat a competitor to the market with the same type of vaccine.
From a clinical development standpoint, what new vaccine developments are you most excited about?
One good thing that came out of COVID-19 was the expedited acceptance and utilization of mRNA vaccines as they can be developed and adapted quickly versus other types of vaccine platforms, including live attenuated or viral vector vaccines, for example. Ever since the introduction and acceptance of mRNA vaccines, we are starting to see the trend of vaccines cross over into other therapeutic areas more than just infectious diseases, such as cancer and substance abuse.
Maternal-fetal vaccines, especially vaccines for respiratory syncytial virus (RSV), cytomegalovirus (CMV), and hepatitis B virus (HBV), are an incredibly exciting area of development. With the technology available to immunize both the mother and the fetus, the door is open for the development of other maternal-fetal vaccines.
In addition, the latest developments in the delivery methods are exciting. As vaccines are typically administered via an injection, there are now some unique ways of vaccine delivery, making it easier for some people to get the vaccines, such as nasal delivery and microneedle array patches. A benefit of these patches is that they can be stored at room temperature. This is quite different from mRNA vaccines that must be stored in a -60- or -70-degree freezer on site, which can be challenging for facilities based on the volume of vaccines needed to be kept at that temperature.
Tell us about your interests in women’s health.
Several of the Infectious Diseases and Vaccines trials I’ve led in the past crossed into the women’s health arena, such as the human papillomavirus (HPV) vaccine development and women’s urogynecologic indications such as urinary tract infections, vaginal candidiasis, and bacterial vaginosis to name a few.
There are now several biotech and pharma companies dedicated exclusively to women’s health drug development, some specific to menopause related concerns. It is exciting that women’s health drug development is on the rise, and I am looking forward to contributing to the continued growth of this niche therapeutic area at Medpace.
From a clinical development standpoint, what innovations in women’s health are you most excited about?
It is important to understand diverse populations of women from various racial, ethnic, and socioeconomic backgrounds in clinical trials, especially with the FDA’s guidance on diversity in January 2023. Women’s health trials can be challenging due to their age range, spanning from adolescence to geriatrics, and the inclusion of women with different medical conditions. This FDA guidance is exciting because it promotes inclusion in clinical trials, which includes women’s studies.
Femtech is another area of excitement. This is the utilization of software, diagnostics, and services that use technologies to focus specifically on Women’s Health. Femtech includes fertility solutions, menses/ovulation tracking apps, pregnancy/nursing care, and sexual and reproductive wellness. Femtech is really about empowering women to take control of their own health care through technology.
Learn more about Medpace’s experience in: