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CBA 2017-2018 Workshop Series 1

CBA 2017-2018 Workshop Series 1

2017-2018 Workshop series-1

Trends in Biopharmaceutical Industry
Opportunities and Challenges in the Development of Biosimilar Products

生物类似药开发中的机遇与挑战

 生物类似药近年来已经成为国内外制药界的热点领域,面对专利保护已经或即将到期的许多生物药以及庞大的市场,大家对许多问题,例如Biosimilar 生物类似药是否与原研药等效?为何便宜很多?是否涉及侵权?如何解决?" 等等都很好奇。为了回答这些问题, 由美国华人生物医药科技协会(Chinese Biopharmaceutical Association-USA, CBA-USA)主办、美京华人活动中心(Chinese Culture and Community Service Center,CCACC),美国质量协会509(American Society for Quality Section 509)和美国国立卫生研究院中国学生学者联谊会(Chinese Students and Scholars Association at the National Institute of Health, NIH-CSSA)协办的CBA 2017-2018年第一次职业发展研讨会将于8月26日9点半至1点半在CCACC举办. 不管你是在校学生,博士后研究员,临床研究员(医生)或者是考虑转换职业的在职人员,美国华人生物医药科技协会2017- 2018职业发展研讨会都不容错过。我们邀请到3位嘉宾分别从专利,FDA评审和跨国制药公司的经历和心得来谈谈“生物制药行业趋势:生物类似药开发中的机遇与挑战——Trend in Biosimilar : opportunities and challenges?"

注: CBA研讨会全程英文。

Click here to register on Eventbrite

Download the flyer (PDF)

Time: 9:30 am-1:30 pm, August 26, 2017 (Saturday)

Location: Chinese Culture and Community Service Center (CCACC), 9318 Gaither Road, Suite 215, Gaithersburg, MD 20877

Cost: FREE for active members of CBA, CCACC, NIH-CSSA or ASQ509; $5 for public

 

Agenda

  • 9:30-9:40 am Introduction and Announcements
  • 9:40-10:00 am Self Introduction for All Attendees
  • 10:30-11:00 am Dance, Dance, Dance: Intricacy in Biosimilar Patent Challenge by Peng Sun, Ph.D, JD, Associate and Intellectual property lawyer with Foley & Lardner LLP
  • 11:00-11:30 am Development of Biosimilars: a small yet reliable step towards affordable healthcare by Juhong Liu, Ph.D. Review Chief, Division III, Office of Biotechnology Product, CDER, FDA
  • 11:30-11:40 am Break
  • 11:40-12:10 am Demonstration Biosimilarity - Challenges and Opportunities by Patrick Liu, M.D., Ph.D., Vice President of Global Biologics R&D and Head of Global Bioassays and Technology at Teva Pharmaceuticals
  • 12:10-12:40 pm Panel discussion: Opportunities and Challenges
  • 12:40-1:30 pm   Pizza Lunch and Network

 

Speaker Biosketches

Peng Sun, PH.D., JD., Associate and Intellectual property lawyer with Foley & Lardner LLP

Dr. Sun is an intellectual property lawyer with Foley & Lardner LLP. He focuses his practice on patent counseling, portfolio strategy, and intellectual property due diligence for investment companies, public and private companies in life industry, and academic institutions.  Dr. Sun has served clients in various technical fields including small molecules, peptides, antibodies, genomic, gene therapy, precision medicine, viruses, drug delivery, diagnostics, and medical devices. He is a member of the firm’s Chemical, Biotechnology & Pharmaceutical Practice.

Prior to joining Foley, Dr. Sun was an associate attorney with a law firm in the D.C. metropolitan area, where he counseled domestic and international clients on patent, trademark, and comprehensive FDA regulatory matters. He also was a postdoctoral fellow at Johns Hopkins University School of Medicine.

During law school, Dr. Sun was a summer associate with Foley & Lardner LLP, as well as a judicial intern to the Honorable Susan Braden and the Honorable Dania Zane, both of the U.S. Court of Federal Claims. His experiences also include working as a patent agent at a reputable IP law firm and a law clerk for Maryland Office of the Public Defender.

 

 

Juhong Liu, PH.D. Review Chief, Division III, Office of BiotechnologyProduct, CDER, FDA

Dr. Juhong Liu received his Ph.D. in Biochemistry and Molecular Biology in Peking Union Medical College. He obtained research training as a postdoctoral and staff scientist in Laboratory of Pathology of the National Cancer Institute where he worked on purification and characterization of transcription factors. He joined the Division of Therapeutic Proteins, Office of Biotechnology Products (OBP) in 2008 and is now the Review Chief of Division of Biotechnology Review and Research II of OBP. He involved in reviews of regulatory submissions of a variety of protein products, including monoclonal antibodies, enzyme replacement therapy products, cytokines, and hormones.  Over the past few years, he has also heavily involved in the regulatory review of biosimilar IND and BLA submissions of several product classes.

 

 

Patrick Liu, M.D., Ph.D., Vice President of Global Biologics R&D and Head of Global Bioassays and Technology at Teva Pharmaceuticals

Patrick Liu, M.D., Ph.D., is Vice President and Head of Biologics, Assays and Technology at Teva Pharmaceuticals. He leads a global team with responsibilities from late stage research, through IND, clinical trials and marketing registration, with focus on product biological characterization, nonclinical and clinical PK/PD, biomarker evaluation and immunogenicity assessment for both innovative biologics and biosimilars development.

Prior to joining Teva, Dr. Liu held positions as a Director at Tanox and then Genentech with increased responsibilities in the leadership role for the development and commercialization of a variety of new biologics across the therapeutic areas of oncology, hematology, immunology, allergy, respiratory and infectious diseases. He has contributed to the success of developing many blockbuster medicines including Avastin, Herceptin, Perjeta, Lucentis, Xolair and Copaxone, and many other biologics such as Lonquex, Granix, Ovaleap and most recently Cinqair. Dr Liu had practiced medicine, specializing in Endocrinology and also holds a Ph.D. in Molecular Biology and Biochemistry from Peking Union Medical College and Chinese Academy of Medical Sciences.
 

 

 

Organizer
CBA workshop organizing committee c/o Kevin Li
Chinese Biopharmaceutical Association (CBA-USA)
PO Box 61362, Potomac, MD 20859-1362
Email: li.cishan@gmail.com Website: www.cba-usa.org

Co-sponsors
CCACC (Chinese Culture and Community Service Center)
American Society for Quality Section 509 ( www.asq509.org ) – Washington DC and Maryland Metro - Biomed/Biotech Special-Interest-Group (http://www.asq509.org/ht/d/sp/i/31557/pid/31557)
NIH-CSSA (Chinese Students and Scholars Association of the National Institutes of Health)

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