Goodwin’s Late Stage Drug Development practice has published a roadmap to commercial launch. The roadmap identifies key action items – beyond completing Phase 3 clinical development – that are integral to successful commercial launch of a new therapeutic product. To view this roadmap, click here.
To accompany the roadmap, Goodwin’s Late Stage Drug Development team has created a series of webinars discussing commercialization. In these webinars, the speakers have addressed:
- How to maximize the value of available regulatory and patent exclusivities
- Strategies for commercialization and leveraging global and regional partnerships in order to expand commercial reach
- How the Inflation Reduction Act of 2022 has caused sweeping changes to how the government intends to pay for pharmaceuticals and biologics
Tune in below!
Please note that our webinar and event recordings are for informational purposes only; CLE credit is only available for our guests attending live webinars and other events.
FDA Approval is Coming: Part 1 – Securing Exclusivities and Maximizing Patent Term
November 17, 2022
For Part 1 of our Late Stage Drug Development Commercialization Roadmap webinar series, we addressed strategies for companies to consider following FDA approval of a new drug product in order to maximize the value of available regulatory and patent exclusivities. Brian Burgess and Alex Varond, co-chairs of Goodwin’s FDA Litigation practice, addressed how and when to pursue regulatory exclusivities, as well as how to defend their scope before the FDA. Olivia Uitto, a partner in Goodwin's Life Sciences practice, discussed key steps to take to protect and maximize a company’s patent estate, including applying for patent-term extensions and patent-term adjustments, and solidifying issues related to patent ownership in preparation for possible infringement litigation.
Speakers
Brian Burgess
Olivia Uitto
Alexander Varond
FDA Approval is Coming: Part 2 – Partnering for Successful Commercialization
January 19, 2023
For Part 2 of our Late Stage Drug Development Commercialization Roadmap webinar series, Noelle Dubiansky and Sarah Stoiber from Goodwin's Licensing and Commercial Contracting Life Sciences practice addressed strategies for commercialization and leveraging global and regional partnerships in order to expand commercial reach, including co-development, co-commercialization and co-promotion agreements, as well as profit-sharing mechanisms that reduce capital spend and promote value. They discussed other key commercial agreements along the pathway to approval, from securing commercial suppliers, distributors and third-party contractors for sales and market access to securing advisory board members and key opinion leaders.
Speakers
Noelle Dubiansky
Sarah Stoiber
The Inflation Reduction Act & Medicare Pricing for Drugs and Biologics: Part 1
January 26, 2023
In this webinar, Matt Wetzel, a partner in Goodwin’s Life Sciences Regulatory team, gave an overview of recent sweeping changes to how the government intends to pay for pharmaceuticals and biologics under the Inflation Reduction Act of 2022. The new Medicare price negotiation program, inflation-based rebates, and other changes to how Medicare covers and pays for drugs will have an impact for many years to come. Matt provided an analysis of the Inflation Reduction Act’s requirements as well as discussed how drug companies are currently reacting, and what they can do to prepare for the Inflation Reduction Act’s full implementation.
Speakers
Matt Wetzel
The Inflation Reduction Act & Medicare Pricing for Drugs and Biologics: Part 2
April 27, 2023
Matt Wetzel, Life Sciences Partner at Goodwin, conducted a webinar covering the latest updates on the Inflation Reduction Act and the law’s sweeping changes to how the government intends to pay for pharmaceuticals and biologics. The new Medicare price negotiation program, inflation-based rebates, and other changes to how Medicare covers and pays for drugs – including changes to prescription drug benefits for America’s seniors - will have an impact for many years to come. Matt provided an analysis of the Inflation Reduction Act’s requirements, the federal government’s ongoing implementation of the law, how drug companies are currently reacting, and what they can do to prepare for the Inflation Reduction Act’s full impact.
Speakers
Matt Wetzel
Contacts
- /en/people/b/burgess-brian
Brian Burgess
Partner - /en/people/d/dubiansky-noelle
Noelle C. Dubiansky
Partner - /en/people/u/uitto-olivia
Olivia D. Uitto
Partner - /en/people/w/wetzel-matt
Matt Wetzel
PartnerLife Sciences Regulatory & Compliance - /en/people/s/stoiber-sarah
Sarah Stoiber
Partner
