Drug Name Development: The Regulatory Changes to Know About & How to Prepare for a Successful 2018

Did you know every 6-month delay to launch can mean an average loss of $100 million[i]? Depending on the market you’re looking to launch a product in, or what phase your drug sits in development, there are different regulatory factors and milestones you need to be aware of. When it comes to naming your asset, you need a partner to guide you through these milestones to develop the best regulatory submission strategy.

In 2017, the FDA introduced new guidance for naming biosimilars and biologics, and the EMA made changes to their name review schedule that will impact submission deadlines and planning. This year, the industry began to understand the impact Health Canada’s 2015 naming guidance is having on drug name approvals.

But how do these changes affect your trade name development and regulatory name submission strategies?

During this webinar you will learn about securing drug name approvals from three major regulatory bodies:

• FDA
  • Overview of the 2017 guidance for non-proprietary naming of biological products
  • Prospective Naming vs. Retrospective Naming of Biologicals
  • Helps ensure your tradename will pass guidance
• EMA
  • Recent changes to the EMA NRG review schedule and how this impacts your asset’s timeline
  • Recommendations for successful name submissions with the EMA NRG
• Health Canada
  • Two years have passed since Health Canada released the agency’s updated naming guidance
  • Hear what we have learned and our recommendations moving forward
• Looking forward to 2018 and best practices to set up your name submissions for success

[1] Invention Reinvented, McKinsey Perspectives on Pharmaceutical R&D, 2010

Speakers

Brittany Scott, Creative Director

As creative director, Brittany oversees a variety of creative verbal and visual solutions for clients across all industries. Her broad knowledge and experience in branding provide her with the ability to think outside of the box when developing client deliverables.

Prior to joining the Addison Whitney team, Brittany worked for Wells Fargo and Continental Tire North America in marketing roles. She has experience in web development, interactive marketing and design, rebranding initiatives, and both online and print design. Brittany holds a bachelor of arts in journalism and mass communications from the University of North Carolina at Chapel Hill.

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Betsy Lard, VP, Managing Director

As Vice President, Managing Director, Betsy provides leadership to client teams and ensures strategic alignment across project deliverables. She leverages past successes and ongoing regulatory feedback to guide client teams through the brand development and regulatory review process. Betsy formerly served as the Director of Brand Strategy, where she was responsible for developing brand equity assessments, competitive brand positioning and architecture/ nomenclature strategies. Her background in strategy continues to provide a valuable backdrop for successful and strategic brand development.

Prior to joining the Addison Whitney team, Betsy worked in marketing and public relations. She earned her Bachelor of Science degree in journalism from the University of Kansas. Betsy has been working with Addison Whitney for 11 years.

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Barbara Gerber, VP Managing Director – London

As managing director for Addison Whitney Europe, Barbara oversees business development and client relationships for the region.

Her background included roles as Senior Director Client Services Europe at InterbrandHealth, SVP Business Unit Director Europe at ghg and co-founder and managing director with Grey Healthcare Italia srl. Barbara is also a founding member of, and served as president for the Healthcare Businesswomen’s Association (HBA) Europe. Barbara studied at Università  degli Studi di Milano (University of Milan) where she received her doctorate in immunology. She has 20 years of experience, and her key clients include: Bayer, Chiesi Farmaceutici, MundiPharma, NeuroVive, Sanofi, and Zambon.

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Nancy Kirschbaum, Senior Director, Regulatory Strategy and Consulting

Nancy Kirschbaum has served as an FDA product reviewer, review committee chair and scientific lead, partnering with regulated industry to develop and approve safe and effective biological medicines. She has over 20 years of experience in the field of thrombosis and hemostasis, including peer reviewed publications in discovery science, development of clinical diagnostic assays and over 10 years as a principal regulator of coagulation factors. She played a leading role in the development and approval of both plasma derived and recombinant Factor VIII products and was a key contact for policy development and determination regarding potency assays for recombinant Factor VIII products.

As part of the inVentiv Health Regulatory and Consulting Strategy team, she has successfully partnered with clients to develop biosimilar products in the US.

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