Maximizing the Value of Real-World Data and Real-World Evidence to Accelerate Healthcare Transformation in China: Summary of External Advisory Committee Meetings.

Use of real-world data (RWD) is gaining wide attention. To bridge the gap between diverse healthcare stakeholders and to leverage the impact of Chinese real-world evidence (RWE) globally, a multi-stakeholder External Advisory Committee (EAC) and EAC meetings were initiated, aiming to elucidate the current and evolving RWD landscape in China, articulate the values of RWE in ensuring Chinese patients' equitable access to affordable medicines and solutions, and identify strategic opportunities and partnerships for expansion of RWE generation in China. Chinese and international experts who are clinicians and academic researchers were selected as EAC members based on their professional background and familiarity with RWD/RWE. Three EAC meetings were held quarterly in 2023. Various topics were presented and discussed for insights and suggestions. Nine experts from China, one from South Korea, and two from Europe were selected as EAC members and attended these meetings. Experts' presentations were summarized by theme, including the RWD landscape and RWE enablement in China, as well as global development of a patient-centric ecosystem. Experts' insights and suggestions on maximizing the RWD/RWE value to accelerate healthcare transformation in China were collected. We concluded that though data access, sharing, and quality are still challenging, RWD is developing to support evidence generation in the medicinal product lifecycle, inform clinical practice, and empower patient management in China. RWD/RWE creates value, accelerates healthcare transformation, and improves patient outcomes. Fostering a patient-centric ecosystem across healthcare stakeholders and maintaining global partnerships and collaboration are essential for unlocking the power of RWD/RWE.

A blueprint for success in real-world evidence: "glocal" approach to building capabilities and generating impactful evidence.

The past decade has seen the increasing influence and relevance of real-world data (RWD) and real-world evidence (RWE) in healthcare decision making. The value added by RWD/RWE has prompted the pharmaceutical industry to develop high performing systems and practices to harness the power of evidence generated at the global level. However, this worldwide transformation provides outstanding opportunities to support capability building within local affiliates and to impact key country-level stakeholders through resulting evidence. Therefore, we present an Evidence Blueprint Initiative, which links the global and local ("glocal") skills, and furthermore addresses the opportunities and gaps in evidence generation capabilities at the local level. Cross-functional experts were recruited at the local, regional, and global level to define best practices. A framework was developed to characterize the foundational expertise needed and to assess markets' existing capabilities. Subsequently, targeted roadmaps were developed and implemented to build capabilities in specific areas within each affiliate. The impact from the Blueprint is encouraging, resulting in improved local evidence plans, established evidence teams, enhanced RWD use and strategic implementation of patient centric science in local affiliates. The success of the Blueprint resides in empowering affiliates to realise their local evidence generation ambitions and to match them to their local context. It strengthens and expands the ties between various parts of the organisation and the external environment while building fit-for-future evidence capabilities from local affiliates.

The 7+ Habits of Highly Effective Medical Directors.

Medical Directors in the pharmaceutical industry are responsible for fulfilling multiple roles, including scientific expert, conscience keeper and people leader, as well as being the external face of the organisation. The capabilities described in the book The 7 Habits of Highly Effective People® are not just the integral qualities of a successful leader, they are important capabilities that are critical to becoming an impactful medical leader too. As scientific, functional and enterprise leaders, country and cluster Medical Directors must possess these seven qualities. Each of the seven habits can be adapted and utilised to shape the specific areas that Medical Directors are responsible for: intuitive creativity, patient centricity, prioritisation, enterprise leadership, communication and behavioural change, building a team, partnering and scientific and technological leadership. To excel in their function, current and future Medical Directors need to sharpen their existing skills and build specific capabilities. Energy management in physical, mental, emotional and spiritual domains is the way forward.

Customer Centricity in Medical Affairs Needs Human-centric Artificial Intelligence.

The evolution of healthcare, together with the changing behaviour of healthcare professionals, means that medical affairs functions of pharmaceutical organisations are constantly reinventing themselves. The emergence of digital ways of working, expedited by the COVID-19 pandemic, means that pharmaceutical-healthcare relationships are evolving to operate in an increasingly virtual world. The value of the pharmaceutical medical affairs function is dependent on understanding customers' needs and providing the right knowledge at the right time to physicians. This requires a human-centric artificial intelligence (AI) approach for medical affairs, which allows the function to query internal and external data sets in a conversational format and receive timely, accurate and concise intelligence on their customers.

Developing Medical Affairs Leaders Who Create the Future.

Medical affairs has evolved over recent years from a support, to a partner, to a strategic leadership function. In the future, there will be significant changes in healthcare and pharmaceutical industries, and many of these will be due to technological advances and digitalisation. Medical affairs will be largely influenced by these developments in terms of partnerships with key stakeholders, embracing innovation and patient-centric healthcare, and demonstrating value for novel treatment options. In order to secure future success within their roles, medical affairs professionals will have to demonstrate specific capabilities founded on communications and behavioural change, business leadership acumen, knowledge acquisition and self-development, and the ability to generate real-world evidence from insights and expertise within data science and analytics. It will be our responsibility as medical affairs leaders to create this foundation for the leaders of tomorrow.

Consolidating Russia and Eurasia Antibiotic Resistance Data for 1992-2014 Using Search Engine.

BACKGROUND: The World Health Organization recognizes the antibiotic resistance problem as a major health threat in the twenty first century. The paper describes an effort to fight it undertaken at the verge of two industries-healthcare and Data Science. One of the major difficulties in monitoring antibiotic resistance is low availability of comprehensive research data. Our aim is to develop a nation-wide antibiotic resistance database using Internet search and data processing algorithms using Russian language publications. MATERIALS AND METHODS: An interdisciplinary team built an intelligent Internet search filter to locate all publicly available research data on antibiotic resistance in Russia and Eurasia countries, extracted it, and collated it for analysis. A database was constructed using data from 850 original studies conducted at 153 locations in 12 countries between 1992 and 2014. The studies contained susceptibility and resistance rates of 156 microorganisms to 157 antibiotic drugs. RESULTS: The applied search methodology was highly robust in that it yielded search precision of 58 vs. 20% in a typical Internet search. It allowed finding and collating within the database the following data items (among many others): publication details including title, source, date, authors, etc.; study details: time period, locations, research organization, therapy area, etc.; microorganisms and antibiotic drugs included in the study along with prevalence values of resistant and susceptible strains, and numbers of isolates. The next stage in project development will try to validate the data by matching it to major benchmark studies; in addition, a panel of experts will be convened to evaluate the outcomes. CONCLUSIONS: The work provides a supplementary tool to national surveillance systems in antibiotic resistance, and consolidates fragmented research data available for 12 countries for a period of more than 20 years.