The Next Wave of Commercial Development
View the webinar playback below featuring Alison Finger of bluebird bio, Eric Mosbrooker of Audentes Therapeutics and Christopher Vann of Autlos. The webinar includes discussion around the next wave of cell and gene therapies is poised to enter the market. Hear how these developers are shaping their commercial plans. Panelists will address how the landscape has changed since the first products were introduced, what lessons they took away from the first wave of products, how payors and regulators are evolving in their approach to new therapies, and how COVID-19 is affecting commercial strategies, among other topics.
Potential COVID-19 Treatments Using Cell Therapies
View the webinar playback below bringing together science, clinical information, and business ethics surrounding the use of mesenchymal stem cells (MSCs) to treat COVID-19. This 75-minute webinar covers the science and potential therapeutic benefit of MSCs to treat COVID-19; what patients and patient groups should understand about these therapies; and finally, the ethical and safety concerns for companies and clinics promoting therapies outside of a recognized regulatory process or prior to the conclusion of a clinical trial.
Cell and Gene Therapy Market Access in a COVID-19 World: Challenges and Opportunities
View the webinar playback below featuring Eric Faulkner of NAMCP and Evidera; Michael Ackerman of Anthem Blue Cross/Blue Shield of Virginia; Jim Cross, a former National Medical Director of a top commercial plan; and Richard Powell of MedPOINT Management. The webinar includes discussion around how COVID-19 changes the way we think about healthcare decision making and places intense pressure on financial management at all levels of the health system. Topics include what are the implications for curative cell and gene therapies? In the near- to mid-term, how might patient access to cell and gene therapies be impacted? How do we navigate the balance between transformative effect and cost in relation to other therapies? Are there benefits of single-administration therapies beyond what US managed care typically considers? What is needed to chart the way forward? View the dialogue with national and regional commercial organizations to debate what cell and gene therapy access looks like in the wake of COVID-19.
Cell Therapy Treatments for COVID-19
View the webinar playback below featuring Dr. Racheli Ofir of Pluristem and Dr. Eric Jenkins of Athersys as they discuss potential treatments for Acute Respiratory Distress syndrome (ARDS) in COVID-19 patients.
What Biotechs Need to Know About Fundraising in the Midst of COVID-19
View the webinar playback below featuring Gbola Amusa of Chardan, John Maslowski of Castle Creek Biosciences and Jason Pitts of Sofinnova Investments as they discuss the immense economic challenges brought on by COVID-19 and the impact on investment in the cell and gene therapy space. Topics include the current funding landscape, what investors are looking for when evaluating new and follow-on opportunities, and how companies can best prepare to fundraise in the midst of the pandemic.
FDA Clinical Trial Guidance During COVID-19
View the webinar playback below featuring ARM and FDA representatives Tejashri Purohit-Sheth and Ilan Irony from the Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, as they discuss the effect of COVID-19 (coronavirus) on cell and gene therapy clinical trials. Discussion topics include assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.
Understanding the Coronavirus Emergency Loan Program for Small Businesses
View the webinar playback below featuring speakers Mary Beth Bosco, Nicole Elliott and Joel Roberson, Partners at Holland & Knight LLP, as they discuss the emergency loan program for small businesses established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. This fiscal stimulus program went live Friday, April 3 and loans will only be available until funds are exhausted, so the government is advising borrowers to apply as soon as possible. More information on the emergency loan program is available here.
The Alliance for Regenerative Medicine would be happy to provide slides from any of its webinars to our members. Please contact Jeanette Lazusky for more information.
About the Webinar Series
The Alliance for Regenerative Medicine will be hosting a webinar series that will cover key issues in the gene, cell, and tissue-based therapeutic sector, including challenges presented by the ongoing COVID-19 pandemic. Check back for updates on upcoming webinars.