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Pliant Therapeutics
This highly visible leadership role thrives through fierce collaboration with multidisciplinary teams, embracing broad experience in modern DMPK science to optimize and advance both small and large molecule candidates.
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FibroGen
Senior Director Clinical Pharmacology
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Xencor
Scientist, Immuno-Oncology
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Xencor
Research Associate 3, Immuno-Oncology
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Genentech
Senior Scientist, Small Molecule Analytical Chemistry
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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
|
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
|
EST
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Topic
|
Presenter
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8:30-8:35 am
|
11:30-11:35am
|
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
|
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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2023-04-03, [Free Online Symposium] Pediatric Drug Development: Regulatory and Clinical Considerations and Clinical Pharmacology Approaches
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2023-04-24, [In-Person] Preclinical Development & IND Filing for Small Molecules: Nuts, Bolts and Best Practices
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2023-05-24, [In-Person] Preclinical Development and IND Filing for Antibody-Based Therapeutics: Nuts, Bolts and Best Practices
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2023-05-26, [Free Online Workshop] Nonclinical Carcinogenicity Studies: Fundamentals, Case Studies and Regulatory Trends
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2023-06-20, [Free Online Symposium] Highlights of 2022 FDA Approvals
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Ads (in random order)
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