COVER STORY
Ensuring Equity in Clinical Research: Insights from Pfizer’s Dr. Aida Habtezion
By: Vera Kovacevic, PhD
Interviewee: Aida Habtezion, MD, MSc, FRCPC, AGAF, Chief Medical Officer and Head of Worldwide Medical & Safety, Pfizer
COVER STORY
Ensuring Equity in Clinical Research: Insights from Pfizer’s Dr. Aida Habtezion
By: Vera Kovacevic, PhD
Interviewee: Aida Habtezion, MD, MSc, FRCPC, AGAF, Chief Medical Officer and Head of Worldwide Medical & Safety, Pfizer
Diversity in clinical trials remains a significant challenge in the pharma industry. Hispanics/Latinos make up 18 percent of the population but only 13 percent of clinical trial participants. Similarly, Black/African Americans represent 13 percent of the US population but only seven percent of clinical trial participants. And Asian Americans make up six percent of the US population but only around two percent of participants. This lack of diversity can result in treatments that are less effective or have unforeseen side effects in underrepresented populations.
According to the US Food and Drug Administration (FDA), Diversity Action Plans must be implemented for applicable studies.
Pfizer has been proactive in addressing these disparities. The company’s efforts include intentional recruitment strategies to ensure that clinical trials reflect the diverse populations who will ultimately use the medications and vaccines developed. This approach not only aims to improve health outcomes but also builds greater trust in medical research within these communities. The company has been a leader among its peers in setting enrollment goals for diversity and published a framework that has become the standard.
Another critical area of focus in clinical research is the return of clinical data to participants. This practice, often overlooked in the past, is crucial as it makes participants feel valued and integral to research studies. Historically, participants in clinical trials seldom received their individual data.
Pfizer’s Clinical Trial Participant Data Return Initiative is a groundbreaking effort to bridge this gap. This initiative provides participants with their individual data, enhancing their engagement and fostering a sense of ownership and transparency in the research process. By ensuring that participants have access to their own health information, Pfizer is empowering individuals to make informed health decisions and building greater trust in the clinical research enterprise.
In a recent interview with Xtalks, Aida Habtezion, MD, MSc, FRCPC, AGAF, Chief Medical Officer and Head of Worldwide Medical & Safety at Pfizer, shared her unique journey and insights into her patient-first approach to medical safety and care, including her thoughts on clinical trial diversity and the return of data to participants. Her leadership has been pivotal in driving Pfizer’s efforts to foster a more inclusive and transparent clinical research environment.
Transitioning from Academia to Industry Leadership
Prior to joining Pfizer, Dr. Habtezion was an endowed and tenured Professor of Medicine, a practicing physician and scientist at Stanford University’s School of Medicine, Division of Gastroenterology and Hepatology. Dr. Habtezion describes her move from Stanford to Pfizer as a once-in-a-lifetime opportunity, coinciding with an unprecedented global health crisis — the COVID-19 pandemic.
“To transition from the world I grew up in – academic medicine...to come to a large company like Pfizer, I saw it as the chance of a lifetime to step out of my comfort zone,” she stated. This shift allowed her to witness and contribute to the rapid development and deployment of Pfizer’s COVID-19 vaccine and treatment.
She highlighted the privilege of being at the forefront of a global effort to combat a pandemic, which she describes as impacting “millions and billions of lives.” This transition not only expanded her horizons but also allowed her to see the direct translation of scientific discoveries into impactful medical solutions on a global scale.
Influencing Medical Safety and Patient Care
With over three decades of clinical and research expertise, Dr. Habtezion brings a deep understanding of balancing efficacy and safety in drug development. Having transitioned from Stanford to Pfizer, she leverages her experience to keep patient welfare at the forefront.
“Through my experience as a physician scientist and clinician, I was able to bring a unique understanding of the patient journey, in terms of addressing and treating diseases, to Pfizer,” she said.
The many years she spent in the clinic reinforced the necessity of comprehending patient experiences, which is crucial for developing therapies that improve health outcomes. At Pfizer, she oversees the organization responsible for monitoring the benefit-risk profile and safety of Pfizer’s portfolio of products from the first person that receives an investigational medicine or vaccine to the millions of patients that rely on these marketed therapies every day.
“When you are treating patients, you are always thinking about the medicines and vaccines that you’ll use, the benefit-risk.”
Dr. Habtezion’s dual experience as a physician and scientist allows her to integrate clinical insights with scientific research, ensuring therapies are both innovative and safe. She emphasizes the importance of continuous evaluation of new data to maintain high safety standards.
Dr. Habtezion’s efforts reflect her dedication to integrating patient care with medical safety, ensuring Pfizer’s products meet the highest standards and address diverse patient needs.
“At Pfizer, you can really see how we are prioritizing the patient voice beginning at the earliest stages of research, all the way to the development of a therapeutic or a vaccine that can be used in clinical practice.”
— Aida Habtezion, MD, MSc, FRCPC, AGAF, Chief Medical Officer and Head of Worldwide Medical & Safety, Pfizer
“At Pfizer, you can really see how we are prioritizing the patient voice beginning at the earliest stages of research, all the way to the development of a therapeutic or a vaccine that can be used in clinical practice.”
— Aida Habtezion, MD, MSc, FRCPC, AGAF, Chief Medical Officer and Head of Worldwide Medical & Safety, Pfizer
Integrating Patient Voices in Clinical Research
Dr. Habtezion emphasizes the essential role of patient perspectives in clinical research. Understanding and integrating patient voices from the earliest stages of research is crucial for developing effective medicines and vaccines.
“We have to be very intentional in terms of being active listeners and partnering with patients to ensure their voice is reflected in all aspects of research and development.”
At Pfizer, patient feedback is gathered early in the clinical trial process to ensure trials are patient-friendly and inclusive. “It’s really important to tie those two together because at the end, that’s what we are. We are focused on bringing breakthroughs that can have significant impact in patient health and human health,” she said.
Pfizer has made significant strides in ensuring that their clinical trials are patient-centric. Dr. Habtezion highlighted initiatives such as decentralized clinical trials and the creation of accessible platforms like PfizerClinicalTrials.com, designed to make clinical trial information more accessible and helping individuals learn about and prepare for participation.
“We want to make sure that from start to finish and beyond, participants have the best clinical trial experience possible.”
These efforts aim to make clinical trials more accessible and ensure diverse representation, which is critical for developing medicines and vaccines that are effective across different populations.
Embedding Equity in Research and Drug Development
Dr. Habtezion is a strong advocate for embedding equity throughout Pfizer’s R&D process. Recognizing the profound impact of social determinants on health outcomes, she emphasizes the importance of inclusivity and diversity from the outset of any research initiative.
Equity at Pfizer means ensuring that all populations, regardless of race, ethnicity, age or sex, are represented in their research. This inclusive approach ensures that the medicines and vaccines developed are effective across diverse groups.
To advance this commitment, Pfizer launched the Institute of Translational Equitable Medicine (ITEM) in 2021. This initiative aims to embed equity into all aspects of the R&D pipeline, address health disparities, and promote inclusivity in clinical trials. Leading ITEM, Dr. Habtezion works to close gaps in health disparities, ensuring all communities benefit from medical advancements.
“The main goal [of ITEM] is to really strive towards advancing health equity using a multi-level and end-to-end approach, whether it’s in our early research, our clinical trials or our medical practices.”
ITEM’s work includes ensuring that clinical trials reflect the diverse populations who will ultimately use Pfizer’s products. This means intentionally recruiting participants from varied backgrounds to ensure comprehensive data on how different populations respond to new treatments.
“At Pfizer we take a patient-centric approach to how we develop medicines and vaccines so that equity and inclusivity are embedded in everything that we do.”
In addition, PfizerLink.com, an industry-sponsored registry, connects potential participants with future clinical trials, promoting diversity. “We are ensuring that we are intentional and we think about the diverse population that our medicines and vaccines are going to be used so that our clinical trials can reflect those populations as well.”
Pfizer is also focused on understanding how different populations are affected by diseases and how they respond to treatments. This involves considering factors such as environment and other social determinants of health in their R&D processes.
Dr. Habtezion’s leadership in this area ensures that Pfizer’s approach to equity is comprehensive and actionable, promoting health equity and improving health outcomes for all communities. Her efforts reflect a deep commitment to addressing and reducing health disparities through thoughtful, inclusive research practices.
“Ensuring diversity in research and development, from the beginning, is very important from an end-to-end perspective.”
— Aida Habtezion, MD, MSc, FRCPC, AGAF, Chief Medical Officer and Head of Worldwide Medical & Safety, Pfizer
“Ensuring diversity in research and development, from the beginning, is very important from an end-to-end perspective.”
— Aida Habtezion, MD, MSc, FRCPC, AGAF, Chief Medical Officer and Head of Worldwide Medical & Safety, Pfizer
Returning Clinical Data to Participants
A significant innovation at Pfizer is the Participant Data Return Initiative, whereby Pfizer is the first among its industry peers to provide clinical trial participants with their individual data. Historically, participants rarely received their own data, but Pfizer recognized the importance of addressing this gap based on participant feedback.
“It empowers the participants to have information about their own health, reaffirming their decision to participate in clinical trials,” said Dr. Habtezion.
This initiative reflects Pfizer’s commitment to transparency and trust in science. By returning data to participants, Pfizer not only honors their contribution but also enhances their engagement and trust in the research process.
The Participant Data Return Initiative allows individuals to benefit from their participation even after the trial ends. Participants can use their data to make informed health decisions and share it with their healthcare providers for better ongoing care. “This is while simultaneously respecting the scientific integrity of that clinical trial as well as ensuring that we are protecting individual’s confidentiality as well as privacy at all times,” she said.
Dr. Habtezion highlighted that this initiative has been built over almost a decade, incorporating feedback from participants to ensure it meets their needs effectively. The initiative now scales to individuals in the US for every trial, a testament to Pfizer’s dedication to patient-centric research.
Furthermore, Pfizer goes beyond merely returning data. They provide plain language study results summaries to make the information accessible and understandable to participants, regardless of their medical or scientific background.
This approach ensures that participants are kept informed of the outcomes of the trials they were a part of, fostering a sense of involvement and appreciation for their contributions.
By treating participants as partners in the research process, Pfizer ensures that their experiences and contributions are valued and respected.
The Future of Pharmaceutical Research: AI, Machine Learning and Precision Medicine
Looking ahead, Dr. Habtezion is excited about the potential of emerging technologies such as AI and machine learning in pharmaceutical research. These tools are changing the way data is analyzed and used to develop new therapies.
“AI and machine learning enable us to build more efficiencies, develop predictive models and gain medical insights that can bring new hypotheses and new ways to design clinical trials,” she said.
“It’s an exciting time to be in medicine and research and development, with new technologies helping to enable more precise and effective treatments for patients.”
Dr. Habtezion’s journey from academia to Pfizer highlights the importance of integrating scientific research with practical medical applications. Her focus on patient-centric research and equity positions Pfizer at the forefront of pharmaceutical innovation.
As she continues to lead Pfizer’s Worldwide Medical & Safety organization, her vision and dedication promise to bring advancements in global health.
ABOUT Aida Habtezion
As Chief Medical Officer of Pfizer, Aida Habtezion leads Pfizer’s Worldwide Medical & Safety organization responsible for ensuring that patients, physicians and regulatory agencies are provided with information on the safe and appropriate use of Pfizer medications. Her organization is responsible for monitoring the benefit-risk profile and safety of Pfizer’s portfolio of products from the first person that receives an investigational medicine or vaccine to the millions of patients that rely on these marketed therapies every day. Her team leads Pfizer’s Institute of Translational Equitable Medicine (ITEM), an initiative spanning research, development and medical activities to close gaps in health disparities. The Institute leverages science, data and translational expertise to integrate equity across Pfizer’s end-to-end development pipeline.
Prior to joining Pfizer, Dr. Habtezion was an endowed and tenured Professor of Medicine, a practicing physician and scientist at Stanford University’s School of Medicine, Division of Gastroenterology and Hepatology. She is board certified in Gastroenterology in both Canada and the United States. She led a large translation research lab funded by multiple NIH, DOD and foundation grants focused on understanding disease mechanisms and identifying potential immune-based therapeutic targets for pancreatic and intestinal inflammatory diseases and authored over 100 high-impact publications in top peer-reviewed journals. She also served as an Associate Dean for Academic Affairs, a faculty member in Stanford’s Immunology PhD program, Neuroscience Institute, Cancer Institute, Maternal & Child Health Research Institute, interdisciplinary biosciences institute Bio-X and a faculty fellow at Stanford’s ChEM-H (Chemistry, Engineering & Medicine for Human Health).
Dr. Habtezion served in several national and international study sections, including six years in NIH study section, the American Gastroenterological Association (AGA) Institute Research Awards and the AGA Research Policy Committee.
Dr. Habtezion is the recipient of the Robert Wood Johnson Harold Amos Medical Faculty Development Award, Gastroenterology & Hepatology Teaching Award, the Immunology Faculty Mentor of the Year and the Kenneth Rainin Foundation Synergy Award.
She is a Fellow of the American Gastroenterological Association, an Allen Distinguished Investigator, an elected member of the American Society for Clinical Investigation (ASCI) and the Association of American Physicians (AAP). She currently serves on the New York Academy of Sciences Board of Governors, the Executive Board for the International Science Reserve, the Connecticut Business & Industry Association Board of Directors, the Pfizer Foundation Board, the PhRMA Foundation Board of Directors and is the past president of the American Pancreas Association.