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Understanding New FDA's Guidance on Biosimilar Product Development
   LIVE Webcast  

 


Event Details:                                                                                                                                                          

The Food and Drug Administration released the first draft guidance on Biosimilar Products early February. The draft specifically contains 3 guidance documents on (1) Scientific Considerations; (2) Quality Considerations; and (3) Biosimilars: Questions and Answers Guidance. The issued guidance aims to help pharmaceutical industry comply with the requirements under the BPCI Act and to successfully prove that their product is biosimilar to a biologic product approved by the FDA. But the guidance raises many questions in the industry that has to be answered, including the cost of complying.

To explore and understand the new draft guidance, the Knowledge Group is putting together a panel of experts to help pharmaceutical industry and their advisers understand its implication. The speakers will share their expert opinions and best practices in a two-hour LIVE Webcast. A live interaction with the audience in a question and answer format is also included in this event.

Course Level: Intermediate
Prerequisite: None
Method Of Presentation: Group-Based-Internet
Developer: The Knowledge Group, LLC
Recommended CLE/CPE Hours: 1.75 - 2.0
Advance Preparation: Print and review course materials
Course Code: 124304
Recording Fee: $299 (Please click here for details)

 

Featured Speakers for Understanding New FDA's Guidance on Biosimilar Product Development LIVE Webcast :


Agenda  (click here to view more)


SEGMENT 1:
Fiona Greer, PhD, Global Director of BioPharma Services Development,
SGS M-Scan

Challenges for Characterization and Comparabilty testing of Biosimilars.
  • • Why is analytical characterisation essential throughout all stages of biosimilar development?
  • • What are the regulatory issues associated with characterization and comparability testing of Biosimilars to demonstarte Biosimilarity?
    • - Characterisation of the Innovator
    • - Side by Side Comparison of Innovator and Biosimilar
  • • What are the issues regarding the choice of Reference Product?
  • • How can we characterize complex protein/glycoprotein products? Which techniques, old & new, are suitable for comparability testing ? FDA have stated they will review applications based on "the totality of the evidence".


SEGMENT 2:
Joseph A. Mahoney, Partner,
Mayer Brown

  • • “Biosimilar” vs. “Interchangeable” Statutory Definitions
    • o Marketing and Data Exclusivities Innovator receives
    • o Marketing and Data Exclusivities Biosimilar “interchangeability” exclusivity
  • • FDA Draft Guidance Documents
  • • Patent Protection Clues Provided by Guidances
  • • Patent Searching and Monitoring
  • • FTO Analysis
    • o FTO Analysis to Later Patent Exchange
    • o FTO Analysis: American Invents Act Issues, Caselaw
    • o FTO Analysis: Interpreting the Caselaw
    • o FTO Analysis: Preserving the Privilege


SEGMENT 3:
Sanya Sukduang, Partner,
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

  • • The BPCIA patent information exchange process
  • • The potential for stealth biosimilar applications who fail to disclose application to reference product sponsor and what Reference Product Sponsors can do about it


SEGMENT 4:
John J. Molenda, PhD, Counsel,
Mayer Brown

  • •Implications of Lovenox® and Abbott’s Citizen Petition on Biosimilars Development




SGS M-Scan
Fiona Greer, PhD
Global Director of BioPharma Services Development
speaker bio »»

Mayer Brown
Joseph A. Mahoney
Partner
speaker bio »»

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Sanya Sukduang
Partner
speaker bio »»

Mayer Brown
John J. Molenda, PhD
Counsel
speaker bio »»



Who Should Attend?

- Biotech/Pharma Attorneys
- General Counsel
- Senior Executives
- Consultants & Clients in the Biotech and Pharmaceutical Industries
- Biotech/Pharma Industry Lawyers
- Life Sciences and Health Care Practice Consultants/Advisors
- Senior Management
- Accountants
- Professionals coming from Biotech and Pharmaceutical Firms

Why Attend?

This is a must attend event for anyone interested in understanding the New Biosimilar Guidance and its impact to the industry.

- Detailed guidance given by the most qualified key leaders & experts
- Hear directly from key regulators & thought leaders
- Interact directly with panel during Q&A

Advanced registration is recommended as space is limited. Click the registration button below to sign up for this course today. Significant discount applies for early registration.

Registration Information:                                                                                                                                    


Disclaimer:
Please note, the event date is firm although it may be subject to change. Please click here for details.
The Knowledge Group, LLC is producing this event for information purposes only. We do not intend to provide or offer business advice. The contents of this event are based upon the opinions of our speakers. The Knowledge Congress does not warrant their accuracy and completeness. The statements made by them are based on their independent opinions and does not necessarily reflect that of The Knowledge Congress' views. In no event shall The Knowledge Congress be liable to any person or business entity for any special, direct, indirect, punitive, incidental or consequential damages as a result of any information gathered from this webcast.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Understanding New FDA's Guidance on Biosimilar Product Development
LIVE Webcast
Event Sponsors




SGS Life Science Services is a leading contract service organization providing clinical research, analytical development, biologics characterization, biosafety, and quality control testing. Delivering solutions for pharmaceutical, biologics, and medical-device manufacturers, SGS provides clinical trial management (Phase I to IV) and services encompassing bioanalytical testing, data management, biostatistics, and regulatory consultancy. SGS also offers GMP/GLP contract laboratory services that include analytical chemistry, microbiology, stability studies, bioanalysis, extractables and leachables, virology, and protein analysis. With the recent acquisition of Vitrology, SGS expands its service offering for biologics in the areas of cell bank and virus seeds characterization, raw material and bulk harvest testing (sterility, mycoplasma, viruses), final product testing for residual DNA, and safety consultancy services. Operating 27 facilities in 14 countries, SGS Life Science Services represents the broadest global network of contract analytical laboratories.




Mayer Brown LLP is a global law firm advising clients across the Americas, Asia and Europe. The firm’s multi-disciplinary Intellectual Property practice is uniquely positioned to provide a full range of services to its clients, including litigation and enforcement, counseling and prosecution, proceedings before the ITC and transactions. As many of the firm’s lawyers have earned technical degrees in such fields as biochemistry, chemistry, pharmacy, microbiology and chemical, mechanical and electrical engineering, they not only have a full understanding of IP law but also its practical application. Mayer Brown has extensive experience in handling issues related to the life sciences industry, including proven success in Hatch-Waxman litigation, representation of institutions in negotiating patent licenses, and successful patent, trademark and copyright litigation.




With more than 375 intellectual property lawyers, Finnegan is one of the largest IP law firms in the world practicing all aspects of patent, trademark, copyright, and trade secret law, including counseling, prosecution, licensing, and litigation. Finnegan represents key innovators, including established multinational leaders as well as small, start-up companies, with IP assets that promise advancements in the life sciences field. Finnegan has delivered successful, sophisticated legal strategies to help pharmaceutical and biotech clients protect, advocate, and leverage their valuable IP assets. ]

Our clients are involved in a diverse area of biological products, such as antibodies, blood products, therapeutic proteins, and personalized medicines. From claim drafting and prosecution to developing winning litigation strategies, we provide a full range of services to our pharmaceutical and biotech clients. For more information, please visit www.finnegan.com.



Speaker Firms:




 

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Attention New York Attorneys:

This program is approved for CLE credit under New York’s Approved Jurisdiction policy. The Knowledge Group, LLC is an approved sponsor in the state of California, a New York Approved Jurisdiction. This program fulfills the non-traditional format requirement of exceeding 60 minutes in length. Please note only experienced attorneys (more than 2 years) are eligible to receive CLE credit via non-traditional format learning platforms. The Knowledge Group will verify attendance during the webcast via secret words (3 per credit hour) and by auditing attendees log in and log out records. All verification instructions will be provided during the webcast. Once attendance verification requirements have been completed, the attendee will be issued a certificate of attendance be The Knowledge Group for the course with the recommended number of credit hours. The Certificate of Attendance is normally sent via email in 24 hours or less.

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