Bio Economy Forum

Drug Development & Approval I:

Biologics and Biosimilar Development and Approval in the US

1:20 – 3:20 PM on Thursday (August 10, 2017)

Therapeutic biologics often represent cutting-edge research in which the latest scientific discoveries are translated into novel therapies that provide new treatment options for patients. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available. Biologic development and approval have been very active, and more than one third of new drugs approved by US FDA’s Center for Drug Evaluation and Research (CDER) are biologics in recent years. The Biologics Price Competition and Innovation Act (BPCI Act) created an abbreviated licensure pathway for biological products shown to be biosimilar to an FDA-licensed reference product. Unlike with generic drugs of the traditional small molecule type, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. This session will focus on the current status in novel biologic developments and the trends in biologics and biosimilar developments and its methodologies.

Topics include industry perspectives and regulatory perspectives of biologics and biosimilar developments and approvals.

Chair:
Hae-Young Ahn, Ph.D., RAC
Food and Drug Administration
Haeyoung.ahn@fda.hhs.gov
Co-Chair:
Myeong-Hee Yu, Ph.D, MBA, LL.M
Biomedical Research Institute
Korea Institute of Science and Technology
mhyu@kist.re.kr
Co-Chair:
SooYoung Lee, Ph.D
Celltrion Biotechnology
Research Institute 1
SooYoung.Lee@celltrion.com

Agenda

  • 1:20 pm            Global View of Biosimilar and Remsima® Success Story, SooYoung Lee (Celltrion)
  • 1:50 pm            Recent CMC Trends in Biotechnology Products Development: Regulatory Perspective, Jun Park (FDA)
  • 2:20 pm            Totality of the Evidence for Biosimilarity: Clinical Considerations, Nikolay Nikolov (FDA)
  • 2:50 pm            Patent Strategies in the Biosimilar Space: Strategic Considerations in obtaining, asserting or challenging patents,
    Joo Mee Kim (Rothwell, Figg, Ernst & Manbeck, pc)

 

 


Drug Development & Approval II:

How to maximize return of time and effort investment in drug development and approval

3:40-5:40 PM on Thursday (August 10, 2017)

Drug development & approval is known to have time and energy consuming processes with relatively slow and low return of investment while they require timely execution of multi-disciplinary decisions.  Meanwhile, nature of drug development & approval becomes increasing competitive as indicated by a few statistical information related to the novel drug approved in 2016*; 95% (19 drugs) was approved in the first review cycle, 36% (8 drugs) were the first-in-class, and 73% (16 drugs) was designated in expedited development and review methods. The situation is more challenging for emerging sponsors due to limited resources and lack of experiences. The session is to share and discuss cases to facilitate drug development & approval across diverse stages in the processes for maximizing the return of time and effort investment focusing on situations with emerging sponsors.

* 2016 NOVEL DRUGS summary, US FDA, January 2017, https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM536693.pdf

Co-Chair:
Sang Mok Chung, Ph.D
Food and Drug Administration
sangmok.chung@fda.hh.gov
Co-Chair:
Jin Sun Kim, MD, Ph.D
Hanmi Pharm Co

 

Agenda 

  • 3:40 pm           Critical Role of Translational Sciences for the Development of Anticancer Agents, Jin Sun Kim (Hanmi)
  • 4:10 pm            Clinical Drug Development Based on Modeling & Simulations: A Tool to Increase Return of Investment, Holly Kimko (Janssen R&D of Johnson & Johnson)
  • 4:40 pm           Clinical Trials R Us: Cases of Good, Bad and Ugly, Sang Mok Chung (FDA)
  • 5:10 pm            Panel Discussions, combined Session I & II
    Panelists: Hae Young Ahn(FDA), Myeong-Hee Yu (KIST), SooYoung Lee (Celltrion), Jun Park (FDA), Nikolay Nikolov (FDA), Joo Mee Kim (Rothwell, Figg, Ernst & Manbeck, pc), Sang Mok Chung (FDA), Holly Kimko (Jassen R&D), Jin Sun Kim (Hanmi)