Katja Rudell, PhD, CPsychol is a Senior Director and Global Team lead of the COA Science team at Parexel. Her team is staffed with social science researchers who are positioned all over the world and can provide a culturally diverse opinion on disease management in various regions. They develop and validate new instruments to capture disease progression, evaluate patients’ perceptions of tolerability, satisfaction with treatment and outline innovative treatment effects. The researchers are identifying patient-relevant concepts for use in endpoint models to capture treatment effects of new treatments.
Katja is a senior executive with more than 17 years of experience in the health care and pharmaceutical industries. Katja acquired pharmaco-economics and health outcomes expertise whilst working in clinical settings (NHS -UK), academia, industry and now consultancy. She focussed on patient-based services and patient-focused research, health care consulting, sales strategy, and execution, and in both global and US focused outcomes research. She has held positions with increasing leadership responsibility at several well-regarded universities and companies, including University College London, University of Kent, UK, Pfizer, AstraZeneca, Shire (now Takeda) and Parexel. Her professional accomplishments have been recognized by several professional organizations (British Psychological Society, European Health Psychology Society, ISPOR) and resulted in numerous appointments, including: Industry Chair of the Innovative Medicines Initiative Qualitative Research and Systematic Literature Review team to create an Composite Endpoint for COPD (PROActive Initiative for EMA and EFPIA, Methods group at CPATH PRO Working group for the US, and Inaugural Chair of the COA Special Interest Group at ISPOR and held a fellowship in the department of psychiatry at the Queen Mary College, University of London.
Katja is a chartered psychologist and holds a PhD in ‘Psychology as applied to Medicine’ from the Queen Mary College, University of London. She was instrumental in setting up the COA Special Interest Group at ISPOR, was the elected Inaugural chair of the COA Special interest Group and has attended ISPOR conferences for 16 years as poster, speaker, and guest lecturer on clinical outcomes design (including patient reported outcomes research). Katja is a passionate patient and ex-caregiver who has an active presence on social media to network and advocate for patient relevant outcomes research. Katja has conceptualised and executed on over two hundred projects and trials in her lifetime career in outcomes research and is currently able to influence by guiding, mentoring, and training her own COA Staff at Parexel. Katja takes immense pride in growing organizations and fostering young, progressive, yet patient experience-based research activities. For Katja, there is no greater joy than making a difference to patients’ lives, collaborating with her colleagues and external experts and learning about new research techniques and advocating for better and faster outcomes research.
ISPOR Vision Statement by Katja Rudell
I am running to be an ISPOR Board Member because I am passionate about our field and believe I can serve to realize ISPOR’s Strategic Plan for 2024-7. During my 17 years in the health care, university, and pharmaceutical industries, I have been committed to training, guiding, and mentoring the next generation of outcomes research (OR) scientists. I have acquired a large network from various high class complex organizations, private public partnerships and collaborate effectively across organizations with multiple stakeholders; this, in turn, assists me in understanding multiple perspectives at speed. My hope is to further serve ISPOR with my collective experience and connections to various organizations.
The technological advances in digital health solutions and new COA endpoint developments have been unsurpassed and many different stakeholders appreciate the value that diverse COAs may bring but are also perplexed by it. Having a COA expert at the table for ISPOR decisions would help the organisation to be better prepared. ISPOR is to my mind the hallmark of successfully demonstrating pharmacoeconomic outcomes research as a new scientific field. Academic researchers, consultants, pharmaceutical and medical device industry colleagues, and students have a strong membership presence and affiliation with ISPOR. It is notable that the FDA quotes ISPOR as a body with authority on what is constitutes good research practice for health care economic information as well as more recently attendees from European HTA agencies such as IQWIG and EMA.
My vision is for ISPOR to extend its remit and focus on patient-based experiences for hard to reach and so-called difficult patients who are not able to verbalize their functioning themselves. I believe our efforts should be based on ensuring that those patients too benefit from new health technologies and that may sometimes only be assessed by independent observers and caregivers. HTA bodies should get as comfortable with those based assessments as they have gotten with utility assessments such as EQ-5D and SF-6D when making health care decisions. I would love to bring my individual experiences of talking to hundreds of patients across various conditions for COA design and validation expertise to ISPOR. Understanding measurement science better should help us all develop better healthcare and generate products that resonate rather than sit on a shelf or being discarded after first use.
I am proud to have been able to influence pharmaceutical industry representatives, government agencies and others to pay attention to patient and caregiver perspectives and would be honored to have an opportunity to actively participate in realizing ISPOR’s Strategic Plan for 2024-7.