On our most recent Coffee & Conversations podcast episode, podcast hosts Brigid and Shelby joined CSOFT’s President and CEO Shunee Yee and Professor Victoria Elegant, who serves as Vice-President of JAPAC Regional Medical Head of Amgen to discuss The Next Generation of Global Medical Affairs. With CSOFT’s month-long theme of Collaboration Across Borders in focus, the episode explored the evolution of global medical affairs and the innovative technology shaping the future of drug development and patient care.

So what are medical affairs? Global medical affairs teams help to disseminate information from pharmaceutical companies to healthcare providers and drive the adoption of new technologies and treatments across the globe. Thus, enhancing overall global health through collaborative cross-cultural innovation is a key objective for medical affairs teams.

A central part of advancing this process is new technology. Innovative technologies have enabled medical affairs teams to connect with healthcare providers and receive instant feedback to tailor their offerings. Additionally, digital outreach and virtual technologies like AI and machine learning, Hololens and hologram technologies, and telehealth and teletrials have increased educational and training opportunities for medical affairs teams and helped optimize patient care across borders. Patient-centric care also is vital for improving global healthcare, and as one aspect of delivering it, medical affairs teams increasingly collaborate with patient associations to strengthen and amplify the patient voice. In essence, as Professor Elegant summarized, the future of global medical affairs needs to ensure, “we have the right drugs, to meet the right needs and that they get to the right patients, in the right way.”

Inspired by the podcast discussions, CSOFT sat down again with Professor Elegant for an exclusive follow up interview to elaborate on important themes including drug development, education, patient voice, and clinical trials.

CSOFT: In the podcast, you spoke of how pharmaceutical companies and regulatory authorities have had to adapt quickly to fast-track the drug development processes, particularly in the development and distribution of vaccinations worldwide, as these processes would usually take at least 10+ years to oversee. As a result, there is now more of a demand and increased expectations to sustain these faster development times for drugs. What sort of challenges will this mean for the future of drug development, particularly from a global medical affairs’ perspective?

Professor Elegant: The primary challenges will be talent who are able to adapt to the changing mindset, re-engineering processes for speed, engaging closely with external stakeholders, particularly regulatory authorities, to ensure the expectations are met. In addition, increasingly, patient needs and perspectives will need to be taken into account to ensure that a drug is available to patients [and that] it meets their needs and is accessible. Medical affairs engages externally along the entire development process, so is critical in making sure that the insights form external engagements are brought back to the teams and incorporated into the fast moving process.

CSOFT: In the podcast, you emphasized how global medical affairs teams should collaborate more with patient associations and patient advocacy groups to enhance the patient voice. Can you elaborate on this and give examples of where coordinating with patient associations would enhance patient engagement in global clinical trials and clinical studies?

Professor Elegant: In therapeutic areas, such as for example, psoriasis, or asthma, there are objective measures but also patient reported outcomes are increasingly being used. Often the correlation between physicians’ perceptions of their patient needs, and the patient and caregiver needs, are different. When patients/patient groups are brought in at an early stage of designing a clinical trial, it has been found that the trial recruits faster and thus finishes earlier, has fewer amendments and has improved patient retention. After HIV/AIDS trials were shown to have better outcomes following engagement with patients, the FDA (Food & Drug Administration) now requires patient input before, during, and after the clinical trial. Increasingly, as trials become more complex, the patient voice needs to be incorporated.

CSOFT: In the episode, you stated that overall, the mission of the next generation of global medical affairs should be about partnering with our external stakeholders to improve patient outcomes and improve standards of care. Additionally, in your paper, Reimagining Scientific Engagement During COVID-19 published on the Medical Affairs Professional Society, it stresses the need for pharmaceutical companies and healthcare professionals to come together to extend their focus on patient education. We know education is a topic that is dear to your heart; but from your experience, what role do you think education has the potential to play in the future of drug development and improving patient outcomes?

Professor Elegant: Education is critical in order to ensure that those involved in the development process – internally and externally – have full knowledge and understand the objectives therapeutic area, process etc in order to facilitate enhancement and speed of the trial, to bring a medicine to patients with unmet medical needs.

CSOFT: Expanding on the podcast, we know that the pandemic in a sense accelerated the adoption of technology within the industry and when conducting global clinical trials and studies. Can you provide some examples of how AI and virtual technologies as well as machine learning are supporting decentralized clinical trials and studies?

Professor Elegant: Australia has sponsored a tele trials program, in order to execute remote trials efficiently. Wearables such as patient monitoring for migraine, atrial fibrillation among others are allowing large amounts of data collection which is then analyzed rapidly. CT scans, X-rays increasingly are using AI in certain areas to diagnose conditions, such as breast cancer, osteoporosis.

CSOFT: In the podcast, you spoke of how the cost of clinical trials in Asia is not really an underlining factor for why an increasing number of clinical trials are being conducted in Asia. If it is not the case, then what are the main driving factors behind this phenomenon? Is this trend driven by regulatory authorities or a demand for meeting the need to include diverse patient groups in trials?

Professor Elegant: This trend is driven by regulatory authorities given that in China, Japan Korea and India, there is a legal requirement for local trials to collect local data, given that drugs in Asian populations are not necessarily the same as in Caucasian populations in efficacy and safety, so in order to get drugs registered in those jurisdictions, trials are mandated. In order to be present in the world’s second and third pharmaceutical markets, the trials have to be executed.  There is also a demand to increase diversity on clinical trials, particularly to ensure a significant Asian dataset. Finally, Asia has 50% of the world’s population and thus there are large groups of patients potentially available to participate in trials.

CSOFT: We are seeing an increase in clinical trials also in Latin America and in other regions across the globe, can you elaborate on the changing market of global clinical trials?

Professor Elegant: Clinical trials were traditionally performed in US Europe Canada and Australia – investigators are experienced, have the necessary infra structure, are known to the authorities and are often global thought leaders. As more and more trials are being performed, centers may become saturated and so increasingly global organizations are turning to other parts of the globe to execute the trials and recruit the number of patients needed.

 

Thank you Professor Victoria Elegant for your informative responses – CSOFT is very excited for the next generation of medical affairs! To listen to this episode, click here. Coffee & Conversations is taking a small hiatus and will be back for more fascinating episodes in August.