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Workshop
[Free Online Workshop] New Product Launch: What Does it Take to Bring a New Product to Market?
Speakers:
Angie Lewis-White, Myovant Sciences; Eileen Ring, Alladapt Immunotherapeutics Inc.; Renard Jackson, Frontida BioPharm, Inc.; Lewis Stuart, CymaBay Therapeutics, Inc.; Kurt Mayrand, ChemoCentrys; John Farris, Graphite Bio
Organizers:
Minli Xie, Erasca Inc.; Angie Lewis-White, Myovant Sciences
Date:
2023-02-08- 02/09/2023
Time:
8:30-12:30 Pacific Time
Registration fee:
Free
Location:
Online via zoom
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2023-02-04
(it will close sooner if the seating cap is reached)
About the Topic
After years of hard work in research and development of a new drug, what does it take for a small entrepreneur company to successfully launch a new product in this highly competitive and highly regulated environment. Drug launch requires a cross-functional planning, coordination and implementation, and this workshop will describe the key areas and activities go into preparation and execute a launch including some case studies. Often, decisions made early during development would impact launch preparations. The goal of this workshop is to provide some fundamentals on:
1) an overview to key elements for a new product launch including considerations during early research & development 2) creating a commercial plan through market research, brand establishment and building a sales force 3) important role of market access and process of establishing market access 4) meeting the compliance requirements in both quality and regulatory aspects 5) understanding on importance of a robust commercial supply chain in today’s world 6) what is involved with serialization and third-party logistics
Note: This is an online meeting, The Zoom link will be sent to the registrants 1+ days before the event. About the SpeakersThe speakers are experienced leaders in the Pharma/Biotech industry who have taken multiple products to market successfully. They will share their experiences and bring these fundamentals to life through examples.
Session 1 (Feb. 8, 2023)
PST
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EST
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Topic
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Presenter
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8:30-8:35 am
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11:30-11:35 am
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Welcome Remarks
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Minli Xie, Erasca Inc.
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8:35-9:30 am
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11:45am-12:30 pm
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Commercial Supply Chain
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Angie Lewis-White, MyovantSciences Inc.
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9:30-10:15 am
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12:30-1:15 pm
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Packaging & Serialization
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Eileen Ring, AlladaptImmunotherapeutics Inc.
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10:15-10:30 am
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1:15-1:30 pm
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Break
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break
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10:30-11:15 am
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1:30-2:15 pm
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3PL & Inventory Management
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Angie Lewis-White, MyovantSciences Inc.
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11:15am -12:00 pm
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2:15-3:00 pm
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Supplier Contributions/Perspectives
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Renard Jackson, Adare Pharma Solutions
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12:00-12:30 pm
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3:00-3:30 pm
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Session 1 Q&A
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-
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Session 2 (Feb. 9, 2023)
PST
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EST
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Topic
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Presenter
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8:30-8:35 am
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11:30-11:35am
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Welcome Remarks
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Minli Xie, Erasca Inc.
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8:35-9:30 am
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11:35am-12:30pm
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Marketing Research & Commercialization Strategy
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Lewis Stuart, CymaBayTherapeutics, Inc.
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9:30-10:30 am
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12:30-1:30pm
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Market Access (Pricing and Reimbursement)
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Kurt Mayrand, ChemoCentryx Inc. (Amgen)
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10:30-10:45 am
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1:30-1:45pm
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Break
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-
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10:45-11:45 am
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1:45-2:45pm
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Quality and Regulatory Considerations
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John Farris, Graphite Bio Inc.
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11:45am-12:30 pm
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2:45-3:30 pm
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Session 2 Q&A
Panel Discussion
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Panel
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2024-10-10, [In-Person] Regulatory Global Submission: Strategies and Best Practices for FDA, EMA and PMDA
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