Medical Affairs Drives and Is Driven By Innovation

Proceedings: DIA China 2019

Medical Affairs Drives and Is Driven By Innovation

Yi Liu
Medical Director
dMed Biopharmaceutical

edical Affairs covers a wide range of responsibilities in the pharmaceutical industry, but none is more important than its bridging of patients, policy makers, pharmacists, and physicians. The medical affairs agenda at the DIA China Annual Meeting 2019 shared forward-looking insights on medical ethics, real world evidence, and medical affairs’ evolving role in local biotechnology projects and organizations launching new drugs in China.

Key Takeaways

The crux of the ethical issue in interactions between the pharmaceutical industry and healthcare professionals is the complex relationship among scientific innovation, patient care, and commercial benefit.
The difference in the effect estimate between observational studies of real world data and data generated by randomized clinical trials is often not due to the difference in their study methodologies per se, but to the level of heterogeneity of the studies.
A patient-centric and innovative new product launch plan is based on a medical strategy built upon three key pillars: the patient’s medical story or journey, evidence generation, and innovative medical education.

Medical Ethics

It is critical for pharmaceutical industry professionals to adopt and apply a “medical ethics” mindset. Ethics in science tend to follow innovation in science. But policy makers can help research and other professionals avoid ethical malpractice by developing clear guidance and instructions after announcing new regulations relating to these innovations.

Liming Wang, a renowned popular science writer and professor in biology, cited gene edited babies and related experimental scandals as case studies for the need to raise awareness of medical ethics management and for constructing a proper ethics oversight system, as are cases of “ethics dumping,” when developed-world scientists conduct unethical or questionable research in low-income countries.

The crux of the ethical issues in interactions between the pharmaceutical industry and healthcare professionals is the complex relationship among scientific innovation, patient care, and commercial benefit.

Utilization and Challenges of Real World Data

China’s broad and vast electronic healthcare databases are a real world data advantage. But their variability in data quality, incomplete data, biases, and other limitations remain true disadvantages. Real world evidence is currently supporting drug development for rare diseases, expanded indications, the development of Traditional Chinese Medicine prescriptions, and hospital preparations in China. Single-arm, pragmatic, and prospective cohort are trial study designs commonly used in real world studies.

The EMPRISE (Empagliflozin Comparative Effectiveness and Safety) Study was presented as a Real World Evidence Case Study. Designed to generate generalizable information on the effectiveness and safety of empagliflozin from a broader patient population when treated in routine clinical care, EMPRISE also answered questions, such as the drug’s impact on healthcare resource utilization and the cost of a real world study, that the original pivotal clinical trials were not designed to address. Results from real world studies with study designs that minimize confounding factors and potential biases, while taking precautions with the interpretation of results, could complement randomized clinical trials; perhaps these findings can be translated into routine clinical practice.

Real world data analyses of patients receiving routine care have provided findings similar to those found in randomized clinical trials, which may support the effectiveness of supplemental indications for approved medications. The difference in the effect estimate between observational studies of real world data and data generated by randomized clinical trials is often not due to the difference in their study methodologies per se, but in the level of heterogeneity of the studies.

Medical Affairs in Domestic Pharmaceutical Companies

China joining the ICH has spurred reforms in regulations that have significantly expedited new drug approvals during the last three years. Medical Affairs teams face new challenges and great opportunities in delivering new products to patients in China efficiently.

The goal of product lifecycle management—to maximize the value of an individual product—requires cross-functional collaboration. Medical Affairs plays a critical role in such tasks as new formulations, new administration routes, revised dosages, new indications, and patient population expansion. This applies to new product development to developing the robust clinical evidence package to product launch to maintaining a mature product portfolio.

Medical Affairs is also important in developing a robust product launch plan, including engagement with key opinion leaders in the relevant therapeutic area or patient community, internal and external communication, and post-approval evidence generation and analysis. A patient-centric and innovative product launch plan will be based upon the three key pillars of a medical strategy: medical story, evidence generation, and innovative medical education. Medical Affairs may also consider developing and leading early internal training and preparation as a company adds new therapeutic areas to its product portfolio.

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