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Sharon Ayd, MBA, PhD

VP & Principal, Regulatory CoE, Advarra

Sharon Ayd is a veteran in leading scientific teams at multiple organizations. With extensive experience in translational science, clinical development, regulatory affairs, go-to-market strategy, and operations, as well as product lifecycle management, Ayd has assisted in developing successful commercialization of biopharmaceuticals and combination products. Ayd shares her passion and experience in life sciences as an adjunct professor at Northwestern University and at the University of Wisconsin as well as a published author. She has a bachelor’s degree from Northeastern Illinois University, an MBA from Lewis University, and a Ph.D. from the University of Illinois.

Sharon Ayd

Latest Posts by Sharon

 
Webinar

A Guide for Successful Cell and Gene Therapy Research

Upcoming: September 27

Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.

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White Paper

Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success

Explore the regulatory challenges and pathway guidance for sponsors bringing innovative rare and orphan therapies to market.

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Blog

An Evolving Regulatory Environment for Rare and Orphan Diseases

By 1983, only 38 orphan drugs received FDA approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases.

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4 min. read
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Blog

Regulatory Considerations for Pharmaceutical Product Lifecycle Management

New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.

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4 min. read
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Webinar

Regulatory Pathways: When to Follow a 505(b)(2) or an ANDA

Critical insights and key considerations for selecting the best regulatory pathway to ensure success for new drug application submissions.

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Blog

Common Pitfalls in Preparing an IND Application

While the IND application process may be straightforward to some, we explore the most common pitfalls as sponsors prepare for submission.

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6 min. read
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Blog

Beginner’s Guide to Pre-IND Meetings

This blog provides a beginner’s overview of what the pre-IND meeting is and how to prepare for one.

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4 min. read
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Webinar

The IND Journey Phase I – Navigating Success

Explore strategies for advancing investigational new drug (IND) submissions and a comprehensive guide through Phase I of the IND journey.

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Webinar

The NDA 505(b)(1) Pathway to Regulatory Approval

Dive into current regulatory challenges your teams face and recommends strategies to expedite go-to-market plans across multiple activities

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