Critical Elements of Conducting Early Phase Clinical Trials in the US for APAC Sponsors

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical, Emerging Market,
  • Thursday, May 12, 2022

There is increasing interest in the Asia-Pacific (APAC) biotech industry in initiating early phase clinical trials in the US. This webinar will address critical areas to consider when planning for the successful development and initiation of an early phase study in the US: regulatory, medical, operational and cultural.

In terms of the regulatory piece, the featured speakers will discuss the Investigational New Drug (IND) Application process, including requirements and timelines. In addition, incorporation of non-US data as well as the potential to bridge studies and arms will be explored. Other key considerations include Investigational Product (IP) export/import, shipping and customs, differences between medical and standard of care practices, study operations and site differences, and overall regulatory timeline differences.

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It will be helpful for the audience to recognize pricing and negotiation differences between their local market and the US and the global markets. There are many reasons behind this, from the very tight labor market in the US in clinical development, to the costs associated with developing a new drug versus a commoditized generic. This webinar will examine the factors that drive negotiations: novelty, quality, timelines and price.

In addition to the differences between APAC and US markets, the speakers will look at the differences between Contract Research Organization (CRO) partners. Webinar attendees will learn about vendors and service providers, including specialized CROs that provide unique capabilities, including flexibility, proactivity and attention to studies. The emerging sponsor may also need help with protocol development and trial design. Therefore, it is important to find the appropriate service providers with capability and expertise.

Differences also abound in operational execution. For example, large academic institutions often have multiple committees that review new studies and provide guidance, approval and/or oversight, which ultimately could affect start-up timelines (versus Asia). In addition, the contracting process at institutional settings is more protracted compared with smaller research settings. The speakers will address the importance of knowing how each individual clinical research site navigates the study start-up process.

From a cultural standpoint, the speakers will discuss the landscape of clinical trial markets in APAC versus the US. It is important to note there is considerable interest in both oncology and non-oncology clinical development. Navigating the diversity of service providers (size, focus, technology) in the US will be extensively covered.

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Because of the various differences in initiating and conducting early phase clinical trials between the APAC and US, it is important for the APAC sponsor to find the best CRO partner ­­­­­­­­­­­— one that is experienced in navigating the US clinical trials landscape, has proven expertise to support regulatory activities and understands cultural differences.

Join this webinar to gain insight into the key elements for APAC sponsors to consider when conducting early phase clinical trials in the US.

Speakers

http://Victoria%20Allgood,%20Atlantic%20Research%20Group

Victoria Allgood, PhD, Vice-President, Scientific Affairs, Oncology, Atlantic Research Group

Dr. Victoria Allgood, with experience in the US, UK and EU across all oncology indications, is adept in design, development, implementation and completion of early phase first-in-man studies through pivotal trials. Dr. Allgood’s specific expertise ranges from small molecules and pathway-targeted agents to complex and personalized cell-based therapeutics and novel recombinant molecules, as well as diagnostic and prognostic molecules and assays.

Dr. Allgood was trained as a laboratory scientist focused on identifying new ways to diagnose, target and treat diseases, but discovered her real passion is moving laboratory discoveries into clinical trials. Previously, she has worked in the biotech and pharmaceutical industry, in academia at The University of Texas MD Anderson Cancer Center, and has held leadership roles in mid-size and large multinational Contract Research Organizations (CROs). Dr. Allgood holds both a BS in Chemistry and a PhD in Physiology from the University of North Carolina at Chapel Hill.

Message Presenter
http://Jane%20Fang,%20Polaris%20Strategic%20Partners,%20Inc.

Jane Fang, MD, MS, CEO & Founder of Polaris Strategic Partners, Inc.

Dr. Jane Fang has 25 years of unique multidisciplinary experience in medical practice, life science research and global biopharmaceutical R&D across US and China. Her broad global expertise in clinical development strategy, clinical trial conduct and digital innovation has helped emerging and growing biotechs develop their plans to go global in seamless and culturally sensible ways. Trained as a research physician with deep knowledge of both China and US healthcare systems and clinical trial environment, Dr. Fang has extensive global study experience in oncology, autoimmune and respiratory diseases, metabolic and cardiovascular diseases, infectious diseases and vaccine development.

Dr. Fang has contributed to AstraZeneca/MedImmune’s Durvalumab, Benralizumab and FluMist development. She is also a pioneer of digital innovation for clinical trials in the areas from RWD (real world data) to virtual trials. Prior to founding Polaris Strategic Partners, Dr. Fang had worked at leading global biopharmaceutical companies such as AstraZeneca/MedImmune, Schering-Plough/Merck, the consulting company MSA and top academic medical centers and teaching hospitals in the US and China.

Message Presenter
http://Frank%20Li,%20BLA%20Regulatory,%20LLC

Frank Li, MD, PhD, RAC, Founder of BLA Regulatory, LLC

Dr. Frank Li is the Founder of BLA Regulatory based in Maryland, USA. He is an expert in clinical and regulatory affairs. Dr. Li has been working in the biopharmaceutical industry for more than 16 years, with AstraZeneca, MedImmune, AZ BioVenture, Ascentage, and SNBL. Dr. Li contributed significantly as the Regulatory Project Lead to the development of FASENRA (Benralizumab, an anti-IL5R antibody for asthma) from Ph-2 to Worldwide Marketing applications and approvals including US, EU, Switzerland, Canada, Australia, Japan, and Brazil. Dr. Li also was the US and Canadian Regulatory Lead for a biosimilar Biologics License Application (BLA) filed with the US Food and Drug Administration (FDA) and New Drug Submission (NDS) with Health Canada, and got review approval. Dr. Li has had many successful Investigational New Drug (IND) and Clinical Trial Application (CTA) preparation and approvals worldwide for clients including Asian and Pacific regions as a regulatory professional.

Dr. Li obtained his PhD degree in molecular medicine from Kyoto University, School of Medicine, Japan. Dr. Li did a medical residency in surgical departments followed by clinical research training for his master’s degree in China-Japan Friendship Hospital and Peking Union Medical College in Beijing, China. Dr. Li studied and contributed to clinical studies of adoptive immunotherapy using T lymphocytes and dendritic cells for the treatment of breast cancer and melanoma patients. Dr. Li also conducted cytokine signal transduction research as a postdoctoral fellow in the US. Dr. Li obtained his Regulatory Affairs Certificate (RAC) from the Regulatory Affairs Professionals Society (RAPS) in 2005.

Message Presenter

Who Should Attend?

  • Chief Executive Officers
  • Compound Lead Portfolio Managers
  • Venture Capitalists
  • Chief Medical/Scientific Officers
  • Regulatory Leads
  • Pharmacovigilance/Safety Teams
  • Investigators
  • Biomarkers Scientists
  • Clinical Development Teams
  • Clinical Operations Teams
  • Project Management Teams
  • Procurement Managers
  • Clinical Supply Management Teams

What You Will Learn

Attendees will learn:

  • Clinical trial start-up and execution in the US is complex and may differ from the APAC experience
  • Timelines for new drug development are longer and riskier, so early planning is better
  • The differences between service providers are vast in the US compared with APAC
  • The diversity of sites and processes in the US demand different site selection strategies

Xtalks Partner

ARG

ARG is a contract research organization focused on oncology, immunology, and neurology, providing comprehensive clinical program development services ranging from pre-launch consulting to commercialization, achieving over 50 market authorizations to date. Founded in 2004 with the vision that every project should be highly individualized, ARG has experienced consistent growth across the globe, expanding our reach to include drug and device strategic consulting, clinical trial management services, and clinical data and analytic solutions. ARG uses first-in-class technology platforms along with relationship-driven flexibility to optimize clinical studies because we believe everyone deserves to be well.

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