Product Support
From Idea Through Commercialization
Guidance on complex legal and regulatory issues at every stage of your journey from R&D through commercialization.
I help you navigate and manage a variety of issues that can arise during your product’s life cycle.
Strategic product management requires experienced legal and regulatory analysis of complex issues. Having led product support for two different oncology franchises, and worked with a variety of other brands, I’ve handled the broad range of matters that touch a product including R&D, safety, manufacturing, commercial, marketing and licensing support.
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Clinical Development
I bring health law expertise to R&D, providing anti-kickback and FDA regulatory advice on matters including investigator interactions, patient recruitment and third-party oversight.
Managing these early details can help support the data integrity a company needs to rely on in subsequent filings.
2
Late-Stage Development
I help clients navigate the line between scientific exchange and pre-approval promotion as they form their medical affairs functions and begin interacting with KOLs.
3
Launch
I help brand lawyers support the myriad issues that arise during launch and commercialization by analyzing programs, developing staff guidance and training for thorny issues, and advising on strategies for a variety of matters including brand planning, meeting competition, external funding and patient support programs.
Key issues I can help you address
General & Contract
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​​I’d like to conduct a privileged audit; can you help me with the review and analysis?
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We just got a congressional inquiry. Can you help us respond?
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Can you create useful guidance to enable our sales staff to communicate thorny reimbursement issues?
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I’ve just negotiated a government contract with myriad “standard” commitments. Can you help me work with Compliance to ensure we can execute on these?
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How can I establish better collaboration with Compliance so our organization can pull through execution on key advice?​
Brand & Marketing
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Can my brand team offer a free wellness app to patients?
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How can we work with influencers and endorsers?
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How can my brand teams interact with patient organizations?
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Can my R&D organization put up a website to communicate scientific information?
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Can you help us establish a patient hub?