Bora Erdemli

The debate over who will drive healthcare’s transformation—incumbents or outsiders—is far from settled. Both have critical roles to play. Outsiders bring the fresh, consumer-centric perspectives that can ignite innovation, while incumbents offer the deep understanding and infrastructure necessary to navigate healthcare’s unique challenges. Whether through collaboration, competition, or a combination of both, the future of healthcare will depend on how these forces interact and evolve.

Medical affairs is at another crossroads. For most of its history, medical affairs’ mission has been straightforward: ensuring that healthcare professionals (HCPs) treat patients in the safest, most efficacious and most appropriate way. It accomplished this mission through trickle-down education, meeting with key opinion leaders (KOLs) and other top HCPs to make sure they understood the latest scientific data, and then relying on those leaders to cascade scientific opinion across the… Mehr anzeigen

Medical affairs is at another crossroads. For most of its history, medical affairs’ mission has been straightforward: ensuring that healthcare professionals (HCPs) treat patients in the safest, most efficacious and most appropriate way. It accomplished this mission through trickle-down education, meeting with key opinion leaders (KOLs) and other top HCPs to make sure they understood the latest scientific data, and then relying on those leaders to cascade scientific opinion across the practitioner universe. We might refer to this as the “first era of medical affairs,” a time where medical affairs presented itself as the field’s scientific expert.

In more recent history, medical affairs has been asked to become a strategic “third pillar” of the pharmaceutical industry. Medical affairs accepted the invitation to join the table with other functional strategic decision-makers, including commercial and R&D. ZS estimates that between 2019 and 2023, the percentage of medical affairs leaders who report directly to their company’s CEO doubled, from approximately 30% to near 60%. And while that still leaves many medical affairs leaders without a comparable seat at the table, the rise of medical affairs’ critical contributions to the pharmaceutical industry and to healthcare more generally is undeniable. As others have noted already, the “second era of medical affairs”—as the strategic partner—has begun.

This paper explores two primary questions:
What does the coming third era of medical affairs mean? What is driving it, when will it be here and what changes can we expect to see?
What are the talent and culture needs that medical affairs will require to meet the new challenge of medical impact @ scale? Weniger anzeigen

In the complex tapestry of healthcare, the domain of rare diseases represents a frontier laden with both grave challenges and profound opportunities. Within this domain, medical affairs stands as a pivotal force, equipped to forge a path through the labyrinth of scientific, regulatory and market access challenges. The role medical affairs plays is multifaceted in leading the charge against rare diseases—underpinning the strategies that leverage unique opportunities, overcoming prevailing… Mehr anzeigen

In the complex tapestry of healthcare, the domain of rare diseases represents a frontier laden with both grave challenges and profound opportunities. Within this domain, medical affairs stands as a pivotal force, equipped to forge a path through the labyrinth of scientific, regulatory and market access challenges. The role medical affairs plays is multifaceted in leading the charge against rare diseases—underpinning the strategies that leverage unique opportunities, overcoming prevailing barriers and articulating a clear call to action for global leadership. Weniger anzeigen

Medical affairs professionals often discuss how the function can join R&D and the commercial team as a pillar of the pharmaceutical organization—but what if it can be even more? ZS’s head of medical excellence, Andy Higgins, recently spoke with Ashton Harper, head of medical affairs for Roche Diagnostics U.K. and Ireland, and Bora Erdemli, head of ZS’s medical affairs practice in Europe, to hear how medical affairs teams are fulfilling their roles as connectors to their pharmaceutical… Mehr anzeigen

Medical affairs professionals often discuss how the function can join R&D and the commercial team as a pillar of the pharmaceutical organization—but what if it can be even more? ZS’s head of medical excellence, Andy Higgins, recently spoke with Ashton Harper, head of medical affairs for Roche Diagnostics U.K. and Ireland, and Bora Erdemli, head of ZS’s medical affairs practice in Europe, to hear how medical affairs teams are fulfilling their roles as connectors to their pharmaceutical organizations, other organizations and the healthcare ecosystem and society at large. Weniger anzeigen

This month, TJ and Aubrey sit down with a couple of leaders from PIE's client, ZS. During their conversation with and , they ask questions such as: What does it mean to be your authentic self? How can leaders cultivate a culture in which employees feel safe to show up as themselves? And much more.

This week, it's fantastic to welcome one of our regular contributors, Bora Erdemli, Associate Principal and Leader of Medical Affairs Practice, Europe, ZS, to The GOLD Podcast studio to discuss all things medical affairs.


In his own words, “pharmaceutical organisations have a Ferrari in their multi-car garage and they are driving it to do the grocery shopping”, and Isabel was intrigued to find out more about the value of medical affairs and why Bora believes it isn’t being utilised… Mehr anzeigen

This week, it's fantastic to welcome one of our regular contributors, Bora Erdemli, Associate Principal and Leader of Medical Affairs Practice, Europe, ZS, to The GOLD Podcast studio to discuss all things medical affairs.


In his own words, “pharmaceutical organisations have a Ferrari in their multi-car garage and they are driving it to do the grocery shopping”, and Isabel was intrigued to find out more about the value of medical affairs and why Bora believes it isn’t being utilised effectively.


But that’s not all. Tune in to listen to Bora's thoughts on how the function can better meet the needs of healthcare professionals and what skills the future MA workforce will need to succeed. Weniger anzeigen

This article by the MAPS Digital and Medical Strategy Focus Area Working Groups (FAWGs) provides top-level framework and broad conceptual categories for understanding digital structures within Medical Affairs and biopharmaceutical/MedTech organizations, helping leaders to make organizational decisions to drive their digital strategy with intention and purpose

Historically, the purpose and value of medical affairs has been poorly understood and inadequately measured by wider pharma organisations. As its responsibilities grow, how can companies ensure appreciation and tracking of its value coincide with this progress?

For decades, medical information teams have played an important role across the healthcare ecosystem by serving patients, caregivers, physicians and other healthcare stakeholders—and yet their resourceful work is often overlooked and undervalued. This is especially confusing considering medical information professionals are among the few teams who are proactively contacted by customers and not the other way around. With more than 3.5 billion people worldwide currently using smartphones to… Mehr anzeigen

For decades, medical information teams have played an important role across the healthcare ecosystem by serving patients, caregivers, physicians and other healthcare stakeholders—and yet their resourceful work is often overlooked and undervalued. This is especially confusing considering medical information professionals are among the few teams who are proactively contacted by customers and not the other way around. With more than 3.5 billion people worldwide currently using smartphones to access and request information promptly, medical information teams know they will play an increasingly important role as custodians of large volumes of vital information. As a key reference source, the medical information function within medical affairs will continue to support pharma companies in planning and strategizing for the future. Weniger anzeigen

We identified important regional differences in difficult-to-treat asthma prevalence, including uncontrolled disease and OCS use in Australia. These findings provide an understanding for healthcare providers, patient advocates, and policymakers of the regions where patients are in the greatest need of improved asthma care and are exposed to high levels of OCS as a consequence of poor asthma control. The reasons for these findings will need to be examined in each area and are likely to reveal… Mehr anzeigen

We identified important regional differences in difficult-to-treat asthma prevalence, including uncontrolled disease and OCS use in Australia. These findings provide an understanding for healthcare providers, patient advocates, and policymakers of the regions where patients are in the greatest need of improved asthma care and are exposed to high levels of OCS as a consequence of poor asthma control. The reasons for these findings will need to be examined in each area and are likely to reveal contributing sociodemographic or environmental factors. Clinical implications may also be identified, such as a need for targeted patient and practitioner education, access to primary care medical services, and better access to asthma specialist referral. Weniger anzeigen

OCSs are often prescribed to patients with asthma that remains uncontrolled with maintenance therapy. We performed a real-world analysis to describe the geographic distributions of patients with asthma and OCS dispensed in Nordic countries. This observational, retrospective study examined patient-level data from nationally prescribed drug registries from January to December 2018 for individuals aged ≥12 years in Denmark, Finland, and Sweden. Using an algorithm based on asthma treatment… Mehr anzeigen

OCSs are often prescribed to patients with asthma that remains uncontrolled with maintenance therapy. We performed a real-world analysis to describe the geographic distributions of patients with asthma and OCS dispensed in Nordic countries. This observational, retrospective study examined patient-level data from nationally prescribed drug registries from January to December 2018 for individuals aged ≥12 years in Denmark, Finland, and Sweden. Using an algorithm based on asthma treatment combinations defined by the Global Initiative for Asthma (GINA), we identified patients with asthma, those on GINA Step 4–5 treatments, and those being dispensed ≥2 courses of OCS and determined volumes of OCS dispensed to these patients over the 1-year analysis period. Data were plotted geographically within each country using colour-coded heat maps. The overall asthma prevalence rates were 7.4% in Denmark, 11.6% in Finland, and 8.1% in Sweden. In Denmark, Finland, and Sweden, respectively, the frequencies of patients on GINA Step 4–5 treatments were 19%, 15%, and 16%; among whom 10%, 23%, and 5% received ≥2 courses of OCS. The rates of patients on GINA Step 4–5 treatments who were dispensed OCS in each country were 23%, 30%, and 46%, of which 22%, 17%, and 10% were dispensed doses averaging ≥5 mg/day over the year. Heat maps revealed considerable heterogeneity in geographic densities of patients with asthma and OCS claims within each country. Taken together, these results demonstrate regional variations in estimated asthma severity, control, and OCS dispensed within and between countries. Patterns of medication use suggest that a high proportion of patients in Denmark, Finland, and Sweden are on GINA Step 4–5 treatments, many of whom are dispensed OCS; this poses a considerable corticosteroid burden to these patients. Geographic differences in medication use within and between Nordic countries may reflect variations in population characteristics and/or treatment approaches. Weniger anzeigen

The FDA has released new guidance on the use of real-world data and real-world evidence in drug development. Why was greater clarification needed, and how can medical affairs drive adoption with this innovative form of evidence generation?

From the ubiquitous use of online and video calls to the emergence of telehealth, the pandemic accelerated
digitalization across industries. In healthcare, digital technologies are improving prevention, screening and
diagnosis, while enabling more precise monitoring of patients’ diseases progression and adherence to care
plans. From the perspective of Medical Affairs teams in pharmaceutical, biotechnology and medical
technology organizations, digitalization allows new ways of… Mehr anzeigen

From the ubiquitous use of online and video calls to the emergence of telehealth, the pandemic accelerated
digitalization across industries. In healthcare, digital technologies are improving prevention, screening and
diagnosis, while enabling more precise monitoring of patients’ diseases progression and adherence to care
plans. From the perspective of Medical Affairs teams in pharmaceutical, biotechnology and medical
technology organizations, digitalization allows new ways of generating, analyzing, and interpreting data, as
well as emerging mechanisms for scientific exchange, insight generation/management and forward-looking
strategies to communicate findings with internal and external stakeholders. In short, digitalization offers
Medical Affairs teams working within the healthcare ecosystem the opportunity to rethink strategy and
actions across the lifecycle of traditional and nontraditional products, elevating Medical Affairs as a strategic
partner within and beyond the organization.1
This article is the first in a three-part collaboration between the MAPS Digital and Medical Strategy Focus Area
Working Groups (FAWGs) describing the role of Digital in guiding and enabling Medical Affairs strategy. Here
we seek to define Digital, identify its value to internal and external stakeholders, and provide a recipe for
embedding digital into Medical Affairs strategy. Weniger anzeigen

There’s no doubt that technology will continually support our society in the future; however, if pharma companies don’t evolve their Medical Information capabilities and teams from being operational to strategic, they will miss the vital insights needed to truly change the game.

“Alexa, how will we access Medical Information in the next few years?"

how #medicalaffairs organizations have an opportunity to re-design their Medical Information capabilities to enhance patients’, physicians’ and healthcare professionals’ experiences while providing accurate and personalized information.

At the MAPS EMEA 2020 Annual Meeting, 150+ delegates attended a special session that
discussed how Field Medical engagement has evolved as a result of COVID-19. The group from
a number of different Medical Affairs organizations also analyzed what the future of talent
acquisition and retention is likely to look like moving forward. This report shares the key insights
from the special session and provides further context from Medical Affairs colleagues who have
first-hand knowledge… Mehr anzeigen

At the MAPS EMEA 2020 Annual Meeting, 150+ delegates attended a special session that
discussed how Field Medical engagement has evolved as a result of COVID-19. The group from
a number of different Medical Affairs organizations also analyzed what the future of talent
acquisition and retention is likely to look like moving forward. This report shares the key insights
from the special session and provides further context from Medical Affairs colleagues who have
first-hand knowledge of the ever-changing Field Medical role. Weniger anzeigen

Precision medicine could transform the standard of care from a one-size-fits-all approach into more precise and targeted disease treatment, but there is ground still to be covered when it comes to engaging payers and physicians with this practice. What are the obstacles in the way of rolling out precision medicine and how can medical affairs professionals overcome them to fast-track adoption for patients?

We finally know how to get online for virtual meetings, but do we actually know how to connect during those meetings?



The originally planned multi-year roadmaps built by many companies to ramp up virtual engagement, ended up turning into short sprints. We now realize getting online is only the start of the journey. Even with rapid adjustments to the guidance and engagement plans, physicians’ availability and willingness to engage virtually varies globally. ZS believes virtual… Mehr anzeigen

We finally know how to get online for virtual meetings, but do we actually know how to connect during those meetings?



The originally planned multi-year roadmaps built by many companies to ramp up virtual engagement, ended up turning into short sprints. We now realize getting online is only the start of the journey. Even with rapid adjustments to the guidance and engagement plans, physicians’ availability and willingness to engage virtually varies globally. ZS believes virtual field medical engagement will continue to increase and will perhaps grow even more in the coming months and years, which introduces another layer of uncertainty around how to effectively connect virtually. Weniger anzeigen

In this environment of rapid and constant change, our customers’ core need remains the same: access to unbiased, credible and timely scientific and clinical information. Medical affairs organizations have a unique opportunity to quickly adopt and execute across virtual channels. This will enable medical teams to drive value for their customers right now and, in the long term, it will be the foundation of a truly customer-centric digital strategy.

From April 15-17, ZS attended the World Vaccine Congress in Washington, D.C. for the first time, where more than 1,500 leading vaccines professionals from the pharma industry, academia, government and NGOs gathered to discuss the global future of vaccines. Topics ranged from critical success factors of creating effective private-public partnerships, to deep dives on the clinical challenges behind developing a universal flu vaccine, to the innovation of using microgravity in space to support… Mehr anzeigen

From April 15-17, ZS attended the World Vaccine Congress in Washington, D.C. for the first time, where more than 1,500 leading vaccines professionals from the pharma industry, academia, government and NGOs gathered to discuss the global future of vaccines. Topics ranged from critical success factors of creating effective private-public partnerships, to deep dives on the clinical challenges behind developing a universal flu vaccine, to the innovation of using microgravity in space to support vaccine development. Weniger anzeigen

The study was designed to determine how physicians prefer to access information from pharmaceutical companies today, what kind of interactions they have with pharma reps and how their relationships are evolving. The study also aims to understand how pharmaceutical companies can be more effective in leveraging their sales force and marketing strategy through different channels.

With multidrug-resistant cases of tuberculosis increasing globally, better antibiotic drugs and novel drug targets are becoming an urgent need. Traditional β-lactam antibiotics that inhibit D,D-transpeptidases are not effective against mycobacteria, in part because mycobacteria rely mostly on L,D-transpeptidases for biosynthesis and maintenance of their peptidoglycan layer. This reliance plays a major role in drug resistance and persistence of Mycobacterium tuberculosis (Mtb) infections. The… Mehr anzeigen

With multidrug-resistant cases of tuberculosis increasing globally, better antibiotic drugs and novel drug targets are becoming an urgent need. Traditional β-lactam antibiotics that inhibit D,D-transpeptidases are not effective against mycobacteria, in part because mycobacteria rely mostly on L,D-transpeptidases for biosynthesis and maintenance of their peptidoglycan layer. This reliance plays a major role in drug resistance and persistence of Mycobacterium tuberculosis (Mtb) infections. The crystal structure at 1.7 Å resolution of the Mtb L,D-transpeptidase LdtMt2 containing a bound peptidoglycan fragment, reported here, provides information about catalytic site organization as well as substrate recognition by the enzyme. Based on our structural, kinetic, and calorimetric data, we propose a catalytic mechanism for LdtMt2 in which both acyl-acceptor and acyl-donor substrates reach the catalytic site from the same, rather than different, entrances. Together, this information provides vital insights to facilitate development of drugs targeting this validated yet unexploited enzyme. Weniger anzeigen

Quinone reductases type 1 (QR1) are FAD-containing enzymes that catalyze the reduction of many quinones, including menadione (Vit K3), to hydroquinones using reducing equivalents provided by NAD(P)H. The reaction proceeds with a ping-pong mechanism in which the NAD(P)H and the substrate occupy alternatively overlapping regions of the same binding site and participate in a double hydride transfer: one from NAD(P)H to the FAD of the enzyme, and one from the FADH(2) of the enzyme to the quinone… Mehr anzeigen

Quinone reductases type 1 (QR1) are FAD-containing enzymes that catalyze the reduction of many quinones, including menadione (Vit K3), to hydroquinones using reducing equivalents provided by NAD(P)H. The reaction proceeds with a ping-pong mechanism in which the NAD(P)H and the substrate occupy alternatively overlapping regions of the same binding site and participate in a double hydride transfer: one from NAD(P)H to the FAD of the enzyme, and one from the FADH(2) of the enzyme to the quinone substrate. The main function of QR1 is probably the detoxification of dietary quinones but it may also contribute to the reduction of vitamin K for its involvement in blood coagulation. In addition, the same reaction that QR1 uses in the detoxification of quinones, activates some compounds making them cytotoxic. Since QR1 is elevated in many tumors, this property has encouraged the development of chemotherapeutic compounds that become cytotoxic after reduction by QR1. The structures of QR1 alone, and in complexes with substrates, inhibitors, and chemotherapeutic prodrugs, combined with biochemical and mechanistic studies have provided invaluable insight into the mechanism of the enzyme as well as suggestions for the improvements of the chemotherapeutic prodrugs. Similar information is beginning to accumulate about another related enzyme, QR2. Weniger anzeigen

Conserved residues in protein-protein interfaces correlate with residue hot-spots. To obtain insight into their roles, we have studied their mobility. We have performed 39 explicit solvent simulations of 15 complexes and their monomers, with the interfaces varying in size, shape, and function. The dynamic behavior of conserved residues in unbound monomers illustrates significantly lower flexibility as compared to their environment, suggesting that already before binding they are constrained in… Mehr anzeigen

Conserved residues in protein-protein interfaces correlate with residue hot-spots. To obtain insight into their roles, we have studied their mobility. We have performed 39 explicit solvent simulations of 15 complexes and their monomers, with the interfaces varying in size, shape, and function. The dynamic behavior of conserved residues in unbound monomers illustrates significantly lower flexibility as compared to their environment, suggesting that already before binding they are constrained in a boundlike configuration. To understand this behavior, we have analyzed the inter- and intrachain hydrogen-bond residence-time in the interfaces. We find that conserved residues are not involved significantly in hydrogen bonds across the interface as compared to nonconserved. However, the monomer simulations reveal that conserved residues contribute dominantly to hydrogen-bond formation before binding. Packing of conserved residues across the trajectories is significantly higher before and after the binding, rationalizing their lower mobility. Backbone torsional angle distributions show that conserved residues assume restricted regions of space and the most visited conformations in the bound and unbound trajectories are similar, suggesting that conserved residues are preorganized. Combined with previous studies, we conclude that conserved residues, hot spots, anchor, and interface-buried residues may be similar residues, fulfilling similar roles. Weniger anzeigen