Outsourcing-Pharma (OSP) recently spoke with Amy Cramer (AC), Global Product Development Strategic Partnerships with Pfizer, about close collaboration with other stakeholders in the clinical care process—including patients—can increase chances of success in drug development.
OSP: Could you please tell me a little bit about your background—how you got into the industry, history with Pfizer, and what you enjoy most about your job.
AC: I am a registered nurse; previously, I was a clinical research coordinator, trainer for a large electronic healthcare record company and I worked for a world class academic medical institution in clinical research informatics. I have my Certification in Healthcare Quality and a Master’s in the Management of Clinical Informatics (MMCi) from Duke University School of Medicine.
My area of research includes the secondary use of electronic health care record data for clinical research. Streamlining clinical research to gain efficiencies is my passion and my current work at Pfizer.
I joined Pfizer after collaborating with the pharmaceutical industry on eSource, the technology platform for collecting and managing clinical data. Pfizer was leading the conversation, and I saw a great opportunity to positively disrupt the future of research, so I joined them. The people at Pfizer have the courage, vision and dedication to be bold with the clear goal of making research more efficient, accessible and patient-centric.
OSP: Could you please share Pfizer’s perspective/philosophy about clinical research as a care option?
AC: Pfizer is committed to bringing medicines and vaccines to the world faster. Quality and patient safety are the foundation of all healthcare; research is a part of the healthcare ecosystem, and therefore has the same foundation.
There are a multitude of opportunities for improvement when clinical research aligns in more ways with clinical care. Bridging clinical research and clinical care is important to provide the best clinically relevant care to patients.
For example, clinical care data supports the development of clinical research, and clinical research learnings can ultimately inform clinical care. As opportunities for efficiencies and patient centricity are demonstrated from bridging the two, research stakeholders will embrace the concepts.
OSP: Why is collaboration important, and what are some ways Pfizer seeks out and forges such connections?
AC: Patients are at the center of healthcare, and we need a holistic view of the healthcare ecosystem, which includes clinical research. Pfizer participates in many public and private partnerships. Pfizer is a key stakeholder in the creation of many of these opportunities and encourages the research community to collaborate with all stakeholders, including those practicing clinical care.
OSP: What lessons has Pfizer learned from your collaborations with academics, the patient community, health systems and other stakeholders?
AC: The drive to reduce burden in one stage can often create a bottleneck in another. The best way to prevent this is to review the process end-to-end with all stakeholder perspectives represented. This has been the secret to success in our collaborations: working with and listening to others.
Lessons learned are best tackled by failing fast and moving on. It takes courage to be bold and know when to let go of an idea because it doesn’t meet requirements or expectations.
OSP: Could you please tell me a bit about your partnership with the Ochsner Health system, including recent developments?
AC: Co-developing innovation projects with Ochsner Health has been a great experience. Each team has pushed the boundaries, while maintaining safety and quality, to deliver research in a more efficient way. The eSource work is near and dear to my heart because of the time I have dedicated to making it a reality.
Going live, migrating clinical research from an electronic health record (EHR) to our Pfizer systems using the HL7 FHIR standard, is a huge step in moving the industry forward. It is an accomplishment that I am very proud to have been part of. Does eSource work? Yes, it does. We are doing it!
