Despite recession risk, global biopharmaceutical markets continue to grow and remain a desirable option for APAC-based companies. However, recent examples of Chinese asset rejections by the US Food & Drug Administration — largely due to insufficient patients in the US as well as lack of diversity of patients — underscores the need for companies to plan for global multiregional clinical trials. Meanwhile, increasing use of health technology assessments (HTA) across key markets including Europe and Japan suggests that proving a significant level of efficacy against existing comparators, rather than placebo, is becoming more important. Furthermore, as therapy areas become increasingly more crowded and commoditized, having a broad clinical and commercial strategy is unlikely to pay off.
Thus, companies increasingly face difficulties designing their global multiregional clinical trials in a way that corresponds to the needs of global regulators and optimizes the overall commercial success of products in global biopharmaceutical markets — all while minimizing costs associated with their clinical trial programs. There is therefore a growing need to re-evaluate trial design strategies to not only meet approval requirements, but also drive product market uptake and overall commercial success. This requires early engagement with regulatory bodies addressing important topics such as endpoints and standard of care for control arms, as well as making accommodations for payer preferences through levers like more precise exclusion and inclusion criteria.
This webinar will cover key considerations for developing strategic and optimized global multiregional clinical trials. Register to learn how addressing regulatory, pricing, market access and commercial strategy considerations early in the clinical development planning and design process can help support future commercial success for APAC-developed assets on the global stage.
Joy Chen, PhD, EMBA, APAC Regulatory Lead & Head of China, Global Regulatory Affairs Solutions, Syneos Health
Joy holds a PhD in pharmacology from the US and has 20 years’ experience in regulatory affairs. Joy leads regulatory strategy and implementation for the APAC region and engages in product lifecycle management. Her extensive therapeutic area background includes oncology, CNS, respiratory, infectious disease, immunology, CV and diabetics/metabolism as well as medical devices/diagnostics, advanced therapies and rare disease.
Anthony Messina, PhD(c), MSc, CCRP, Director, Assessment & Insights Learning Solutions, Syneos Health
Anthony Messina is an experienced clinical research scientist and professional within the pharmaceutical research industry. In his current role at Syneos Health, Anthony provides medical affairs support, auditing, training and oversight for industry, academic, and government-sponsored clinical trials phase I, II, and III.
Khalil Ahmed, VP Medical Affairs, Europe, Syneos Health
Khalil is responsible for Syneos Health Deployment Solutions Medical Affairs strategy and operations with a particular focus on driving quality and excellence among Field Medical Teams for its clients in all stage of product life cycle.
Khalil possess extensive experience in supporting clinical development, new product launch excellence, patient journey, product and brand Management, integrated commercial model design, operational excellence, who has been working with products in different stages of their life cycle in broad range of therapeutic areas including Immunology, Oncology, CNS, Rare Diseases, Renal, Cardiovascular, Infectious Diseases, Urology, Diabetes, Vaccines among others
Stacey Fergusson, Senior Director, Corporate Development, Illingworth Research Group – a Syneos Health Company
Stacey has over 13 years’ experience in a variety of roles encompassing global Project Management, Outsourcing, Contracting, Vendor Management and Corporate Development. She has led the set-up, implementation and oversight of clinical programs, operational teams and strategic partnerships across APAC. In her current role, Stacey is responsible for leading Illingworth’s global business expansion and Vendor Management functions. Stacey holds a BSc and PhD in microbial genetics from the University of York, UK, and has a passion for travel, particularly within the APAC region.
Chris Wells, Senior Director, Patient Concierge, Illingworth Research Group – a Syneos Health Company
Chris Wells leads Illingworth Research’s patient concierge division, PatientGO, supporting sites and patients with travel, accommodation and expense reimbursement services.
Rosanne Campbell, Senior Project Leader, Value, Access & HEOR, Syneos Health Consulting
Rosanne Campbell is senior project leader for value, access and HEOR at Syneos Health Consulting, based in London. Rosanne brings more than eight years of experience in HEOR and PMA consulting to Syneos Health’s Pricing and Market Access practice in Europe. She has worked on a wide range of projects including economic models, literature reviews, reimbursement dossiers and market access strategy across Europe, Asia and the US. Rosanne studied in Ireland and London with degrees in Business, Economics and Health Economics.
Who Should Attend?
This session would be of interest to biopharma executives in APAC involved in:
- Commercial Ops
- Clinical Development
- Clinical Ops
- Vendor Management
- Pricing and Market Access
- Medical Affairs
Syneos Health® (Nasdaq: SYNH) is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs, and commercial capabilities to address modern market realities.
Together we share insights, use the latest technologies, and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.