Fast-track your journey from R&D to commercialization
In a complex, competitive, and fast-paced market, startups in biotechnology and biopharma, and early-stage medical device companies face many challenges on their journey from R&D to commercialization. Hosted by USDM Life Sciences in collaboration with Box, this on-demand virtual event provides valuable guidance and best practices to drive your compliance and technology strategy and roadmap.
What you’ll learn
- How emerging industry trends in quality and technology shape early-stage IT strategy and roadmap decisions.
- The regulatory implications of the FDA’s Computer Software Assurance (CSA) guidance for emerging companies.
- A framework for managing GxP cloud workloads to enable automation and create more efficient, continuously compliant business processes.
- How to manage and share content and documents securely while meeting GxP and CSA expectations, with attention to data integrity.
- Practical ways the right technology supports virtual audit success.
About the event
Session 1 | IT & Quality Strategy & Roadmap
A discussion on trends in emerging life sciences technology and compliance.
- Emerging industry trends in quality and technology
- IT strategy and roadmap guidance
- Quality considerations in early-stage planning
- Regulatory implication of the FDA’s CSA guidance
- Live Q&A
Panelists:
- Roger Davy, Director Customer Engagement, USDM
- Paula Dawson, Senior Program Manager, USDM
- Dom Glavach, Chief Security Officer and Chief Security Strategist, CyberSN
- Matt Webb, Interim CIO, Elevar Therapeutics
Watch a highlight clip from Session 1 below:
Session 2 | Maintaining Cloud Compliance & Enabling Automation
How to manage your GxP cloud workloads to enable automation and create more efficient GxP business processes.
- An integrated approach to Quality & IT
- USDM framework for compliance to enable a continuously compliant tech stack
- Quality orchestration through automation
- Live Q&A
Panelists:
- Beth Clarke, VP and CIO, IT and Site Operations, Halozyme Therapeutics
- Nathan Cracraft, VP IT & Facilities, Vaxcyte
- Hovsep Kirikian, Director of Product Management, USDM
- Don Zinn, Director of Emerging Compliance, USDM
Session 3 | Compliant Cloud Content Management
Businesses run on content. Learn how content and documents can be managed and shared while staying secure.
- GxP and CSA compliance for content management
- How customers are using cloud content management to achieve efficiency and security
- What the right technology can do to help achieve virtual audit success
- Live Q&A
Panelists:
- Manu Vohra, Managing Director, Global Life Sciences, Box
- Ganesh Visvanathan, Cloud Product Manager, USDM
- Erin Christy, Vice President of Emerging Life Sciences & Clinical Solutions
Why this matters: Emerging life sciences companies have to build compliance into their technology stack from day one — without the headcount or legacy systems of larger organizations. USDM helps these teams adopt a modern, risk-based approach: applying CSA thinking to validation, keeping GxP cloud workloads continuously compliant, and managing regulated content securely so that quality and IT move at the speed of the business. The goal is a compliant foundation that scales from R&D through commercialization, not one that has to be rebuilt at every milestone.
Frequently asked questions
Who is this virtual event for?
It is designed for startups in biotechnology and biopharma, and early-stage medical device companies navigating the journey from R&D to commercialization — particularly the IT, quality, and security leaders responsible for building a compliant technology strategy and roadmap.
What does the FDA’s CSA guidance mean for emerging companies?
The event discusses the regulatory implications of the FDA’s Computer Software Assurance guidance for early-stage planning and validation. You can read more in our overview of Computer Software Assurance (CSA).
How can emerging companies keep GxP cloud workloads compliant?
Session 2 covers an integrated approach to quality and IT and USDM’s framework for a continuously compliant tech stack. Our USDM Cloud Assurance approach keeps validated cloud systems compliant as they change.
How is content managed compliantly in the cloud?
Session 3 explores how content and documents can be managed and shared securely while meeting GxP and CSA expectations and supporting virtual audit success, including maintaining data integrity for the records those systems hold.
Can I watch this event on demand?
Yes. This is a recorded virtual event. Watch the Session 1 highlight clip above, and contact USDM to access the full sessions or to discuss your emerging life sciences compliance and technology roadmap.
Watch on demand: Press play on the highlight clip above to preview Session 1. To access the full virtual event or talk through your IT, quality, and compliance roadmap with our team, contact USDM Life Sciences.
Please email usdm@usdm.com with any questions.