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Speaker/Moderator Bios are available here.

 

RECORDINGS

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To view the recordings from the NIF 2025, click here. 

 

​PRESENTATIONS

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​Day 1 - Thursday, September 18, 2025

• Housekeeping and Rules of Engagement​

Mary Devlin Capizzi, Faegre Drinker, IPAC-RS Secretariat

• Welcome, Workshop Objectives, & Introductions

Carolyn Berg, Catalent

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​Session 1: Scientific Understanding - Moderator:  Laleh Golshahi, Virginia Commonwealth University

• Intranasal Nanovaccines for Tuberculosis Prevention: Novel Strategies in Formulation and Delivery

Sara Maloney Norcross, RTI International

• Brain Bound! Nose-to-Brain Delivery with In-situ Intranasal Gels

Vivek Gupta, St. John’s University

•  Current and Future Nasal Pipeline: Benefits and Challenges in Drug Repurposing

​Irene Rossi, Harro Höfliger

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Session 2: Marrying Formulation and Device & the Role of Preclinical Models - Moderator: Sana Hosseini, Aptar Pharma

• Delivering for Patients: Navigating Nasal Routes for Optimal Impact

Reenal Gandhi, Aptar Pharma

• How to Use Non-clinical Models in Intranasal Drug Development

Philip Kuehl, Lovelace Biomedical

• Strategic Product Design for Liquid Nasal Formulations: A Target Profile Perspective

Lucas Silva, Nanopharm, An Aptar Pharma Company

• A Novel Modified-Release Nasal Self-Nanoemulsifying Drug Delivery System (n-SNEDDS) for Enhanced Solubility, Retention, and Brain Targeting

Deb Das, Bayer Healthcare LLC

• Intranasal Nose-to-Brain Delivery of ST266 Cell Secretome: From Non-Human Primate to Clinical Translation

​Larry Brown, Noveome Biotherapeutics, Inc.

• Developing Nasal Powder Products: Formulation, Delivery and Characterization

​Alan Watts, Catalent Pharma Solutions

• Nano-CNSTM: Patient-centric CNS Medicines

Kay Olmstead, Nano PharmaSolutions, Inc. 

• Development of a Loxapine Nasal Powder: Leveraging a 505(b)(2) Regulatory Pathway and PK Bridging to Enable At-Home Prevention of Acute Agitation

Paul Shields, Aptar Pharma

Panel Discussion:  The Future of Nasal Drug Delivery: Trends and Innovations

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Day 2 - Friday, September 19, 2025

• Welcome & Workshop Objectives - Day 2

Carolyn Berg, Catalent

 

Session 3: Good Practices for Manufacturing and Commercialization - Moderator:  Eric Uffman, Proveris Laboratories

• Sniffing Out the Standards: Making Sense of Evolving Nasal Spray Testing

 Maria Smith, Proveris Laboratories

• ​Commercializing Nasal Sprays: Overcoming Challenges in Manufacturing & Tech Transfer for Sterile and Non-Sterile Products

Mark Ignaczak, Catalent Pharma Solutions

• Development and NDA Approval of STS101 (Dihydroergotamine Nasal Powder)

​Robert Schultz, Satsuma Pharmaceuticals, Inc.

[pdf of presentation is not available, please contact the presenter with any questions rob@satsumarx.com]

 

Session 4: Regulatory Perspective - Moderator:  Julie Suman, Aptar Pharma

 

• Recommendations for Demonstrating Bioequivalence of Complex Nasal Sprays: Scientific Thinking and Regulatory Research  [This presentation was pre-recorded, audio is available on recordings webpage.]

Susan Boc, US Food & Drug Administration

• Navigating Regulatory Bridging Strategies for Nasal Product Development

Rachel Ward, Kymanox

• Post Approval Change Strategy

S. Prasad Peri, Eli Lilly and Company 

Panel Discussion: Regulatory Roundtable