2025 Summit on Innovations in Controlled Release, Bioavailability Enhanceme: Full Schedule

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8:00am EDT

Registration Opens & Continental Breakfast for Attendees

Wednesday May 7, 2025 8:00am - 9:00am EDT

Brunswick Prefunction

Wednesday May 7, 2025 8:00am - 9:00am EDT
Brunswick Prefunction

Morning Networking Break

9:00am EDT

Welcome and Chairperson’s Introduction & Opening Remarks

Wednesday May 7, 2025 9:00am - 9:10am EDT

Brunswick Ballroom

Wednesday May 7, 2025 9:00am - 9:10am EDT
Brunswick Ballroom

9:10am EDT

From Intermittent to Flow: SMART Data Integrity Lessons and Commonsense Driving Pharma’s Manufacturing Evolution

Wednesday May 7, 2025 9:10am - 9:50am EDT

Brunswick Ballroom

The pharmaceutical industry is undergoing a profound transformation, shifting from traditional batch processes to continuous manufacturing. This evolution is partly propelled by advances in Process Analytical Technology (PAT) and the foundational principles of Quality by Design (QbD). Transitioning to a SMART factory mode of operation, however, requires technological innovation, significant professional development, and the maturity of regulatory and management systems. The issue of data integrity breaches (BAD-I), with its historical implications and current prevalence, serves as a critical backdrop for understanding how to balance technological progress with the necessary professional and systemic maturity. This balance is essential to ensure the successful guidance of pharmaceutical manufacturing through this revolutionary phase. In this presentation, we will introduce a SMART framework designed to provide a common-sense foundation for navigating the complexities of pharmaceutical manufacturing’s evolution. This framework will offer ways to ensure that data integrity, technological advancements, and professional maturity move in concert toward a more efficient and compliant future.

Speakers

Ajaz Hussein, PhD

Consultant & Fmr Deputy Director Office of Pharmaceutical Science, FDA

Dr. Ajaz S. Hussain is a highly accomplished pharmaceutical scientist with adistinguished career spanning academia, industry, and regulatory affairs. Currently serving as anadvisor to technology companies, he brings expertise from extensive leadership roles. Dr.Hussain was the President... Read More →

Wednesday May 7, 2025 9:10am - 9:50am EDT
Brunswick Ballroom

Keynote

9:50am EDT

Spray Drying Digital Twin for Rapid and Efficient Process Development, Scale-up, and Tech-Transfer

Wednesday May 7, 2025 9:50am - 10:30am EDT

Brunswick Ballroom

Speakers

Nima Yazdanpanah, PhD

Fmr FDA ETT & Principal, Procegence

Nima is a consultant on advanced manufacturing and modeling and simulation in pharmaceutical and fine chemical industries. His area of expertise covers modeling and simulation and digitalization, process design and scale-up, and advanced manufacturing.With more than 20 years of diverse... Read More →

Wednesday May 7, 2025 9:50am - 10:30am EDT
Brunswick Ballroom

General Session

10:30am EDT

Morning Networking Break in Exhibit Hall

Wednesday May 7, 2025 10:30am - 11:00am EDT

Brunswick Prefunction

Wednesday May 7, 2025 10:30am - 11:00am EDT
Brunswick Prefunction

Morning Networking Break

11:00am EDT

Long-Acting Injectable Products – Design and Biopharmaceutics Opportunities

Wednesday May 7, 2025 11:00am - 11:45am EDT

Brunswick Ballroom

Wednesday May 7, 2025 11:00am - 11:45am EDT
Brunswick Ballroom

General Session

11:45am EDT

The Development of scLNP for Extrahepatic RNA Delivery

Wednesday May 7, 2025 11:45am - 12:25pm EDT

Brunswick Ballroom

Speakers

Qi-Ying Hu

Chief Executive Officer, Corti Therapeutics

Qi-Ying is drug discovery leader with 20+ years’ experience in large pharma and biotech. Extensive experience in leading discovery and platform team, and advancing candidates into clinical studies.Co-inventor of one FDA approved drug: Isturisa® [LCI699, FDA & EMA approval in 2020]Over... Read More →

Wednesday May 7, 2025 11:45am - 12:25pm EDT
Brunswick Ballroom

General Session

12:25pm EDT

Networking Lunch

Wednesday May 7, 2025 12:25pm - 1:30pm EDT

Brunswick Prefunction

Wednesday May 7, 2025 12:25pm - 1:30pm EDT
Brunswick Prefunction

Morning Networking Break

1:30pm EDT

Implications of Solution Phase Phenomena and Nanodroplet Formation upon Dissolution of Amorphous Dispersions in Simulated and Aspirated Intestinal Media

Wednesday May 7, 2025 1:30pm - 2:05pm EDT

Brunswick Ballroom

Speakers

Ahmed Elkhabaz, PhD

Senior Scientist, Analytical Research and Development, Merck & Co.

Wednesday May 7, 2025 1:30pm - 2:05pm EDT
Brunswick Ballroom

Bioavailability Stream

1:30pm EDT

Long-Acting Intravitreal Dexamethasone Implant: Process, Drug Release Mechanism and Bio-Predictive In Vitro Drug Release Testing

Wednesday May 7, 2025 1:30pm - 2:05pm EDT

Brunswick Ballroom

Speakers

Feng Zhang, PhD

Assistant Professor, Pharmaceutics & Drug Delivery, University of Texas at Austin

Feng Zhang is an associate professor at the Division of Molecular Pharmaceutics and DrugDelivery at College of Pharmacy at The University of Texas at Austin. He received his Ph.D. in pharmaceuticsfrom the University of Texas at Austin. He worked in the industry for 14 years prior... Read More →

Wednesday May 7, 2025 1:30pm - 2:05pm EDT
Brunswick Ballroom

Continuous Manufacturing Stream

2:05pm EDT

Dissolution of Copovidone-Based Amorphous solid Dispersions: Influence of Atomic Layer Coating, Hydration Kinetics, and Formulation

Wednesday May 7, 2025 2:05pm - 2:40pm EDT

Brunswick Ballroom

Speakers

Dana Moseson

Senior Principal Scientist, Small Molecule Drug Product Design, Pfizer (Awaiting final confirmation)

Dana E. Moseson, PhD., is a Senior Principal Scientist working in the Formulation and Process Design group of the Drug Product Design department at Pfizer in Groton, CT, where she specializes in the formulation design, characterization, and manufacturing of early-stage clinical drug... Read More →

Wednesday May 7, 2025 2:05pm - 2:40pm EDT
Brunswick Ballroom

Bioavailability Stream

2:05pm EDT

Potential of Multi-particulate Techniques in Solidifying Self-Emulsifying Drug Delivery System

Wednesday May 7, 2025 2:05pm - 2:40pm EDT

Brunswick Ballroom

Speakers

Tasneem Gandhi, PhD

Formulation and Process Scientist, Glatt

Wednesday May 7, 2025 2:05pm - 2:40pm EDT
Brunswick Ballroom

Continuous Manufacturing Stream

2:40pm EDT

Melt Extrusion Deposition: 3D Printing for Modified Release Products

Wednesday May 7, 2025 2:40pm - 3:10pm EDT

Brunswick Ballroom

Wednesday May 7, 2025 2:40pm - 3:10pm EDT
Brunswick Ballroom

Continuous Manufacturing Stream

2:40pm EDT

Bioavailability Insights Case Study: Non-Standard Approaches to Improve Bioavailability

Wednesday May 7, 2025 2:40pm - 3:15pm EDT

Brunswick Ballroom

Speakers

Ruchit Trivedi, PhD

Director, CMC Pharmaceutics, Eli Lilly

Ruchit Trivedi is a Director, CMC Pharmaceutics at Eli Lilly based in Indianapolis, Indiana. Previously, Ruchit was a Director of Formulation at BioDuro-Sundia and also held positions at Pfizer, Banner Life Sciences, CU Denver, Northeastern University.

Wednesday May 7, 2025 2:40pm - 3:15pm EDT
Brunswick Ballroom

Bioavailability Stream

2:40pm EDT

Advancing Oral Modified Delivery for Rare Diseases via Lipid Based formulations

Wednesday May 7, 2025 2:40pm - 3:15pm EDT

Brunswick Ballroom

Speakers

Eduardo Jule, PhD,

Business and Technical Consultant, Evolve Consulting

Eduardo Jule earned his PhD in Materials Engineering from the University of Tokyo, where he specialized in designing polymer-based nanoparticles as cytotoxic payload carriers. He later transitioned to a Business Development role at NanoCarrier. Following that, he joined Capsugel and... Read More →

Wednesday May 7, 2025 2:40pm - 3:15pm EDT
Brunswick Ballroom

Continuous Manufacturing Stream

3:15pm EDT

Enabling Nanoparticle Technologies Making the Insoluble Soluble

Wednesday May 7, 2025 3:15pm - 3:30pm EDT

Brunswick Ballroom

Speakers

Jason Riggs, PhD

Principal Scientist Principal Scientist, Microsize

Wednesday May 7, 2025 3:15pm - 3:30pm EDT
Brunswick Ballroom

Bioavailability Stream

3:15pm EDT

CDMO Case Studies For Delayed Release and Solubility Enhancement

Wednesday May 7, 2025 3:15pm - 3:30pm EDT

Brunswick Ballroom

Wednesday May 7, 2025 3:15pm - 3:30pm EDT
Brunswick Ballroom

Continuous Manufacturing Stream

3:30pm EDT

Afternoon Networking Break in Exhibit Hall

Wednesday May 7, 2025 3:30pm - 4:00pm EDT

Brunswick Prefunction

Wednesday May 7, 2025 3:30pm - 4:00pm EDT
Brunswick Prefunction

Morning Networking Break

4:00pm EDT

Calculating pH-Solubility Profile and pHmax for Monoprotic Salts of Poorly Water-Soluble Weak Bases

Wednesday May 7, 2025 4:00pm - 4:35pm EDT

Brunswick Ballroom

Speakers

Fan Meng, PhD

Senior Scientist, Formulation & Drug Delivery, Sanofi

Wednesday May 7, 2025 4:00pm - 4:35pm EDT
Brunswick Ballroom

Bioavailability Stream

4:00pm EDT

Beyond the Capsule: Unlocking the Full Potential of Lipid Excipients in Oral Solid Dosage Forms

Wednesday May 7, 2025 4:00pm - 4:35pm EDT

Brunswick Ballroom

Lipid excipients offer tremendous in vivo performance benefits for oral drug delivery by improving solubility/bioavailability, enhancing absorption, and mitigating food effect. While lipids are typically employed in capsule formulations such as soft gels and liquid-filled hard capsules, there is growing interest in incorporating the benefits of lipid excipients into oral solid dosage forms, such as tablets.

In this presentation, we will provide an overview of how lipid excipients enhance bioavailability and discuss unique approaches to formulating oral solid dosage forms using well-known lipid chemistries.

Speakers

Nicholas DiFranco, MEM

Senior Global Marketing Manager - Pharmaceuticals, Gattefossé

Nick DiFranco, MEM, is the Senior Marketing Manager at Gattefossé Pharmaceuticals USA. In this role, he isresponsible for developing and executing a strategy to grow our North American market presence.Most recently, Nick was the Global Market Segment Manager for Oral Treatments at Lubrizol Life Science Health (LLS Health). In his role, Nick coordinates a multi... Read More →

Wednesday May 7, 2025 4:00pm - 4:35pm EDT
Brunswick Ballroom

Continuous Manufacturing Stream

4:35pm EDT

Synchrotron Computed Tomography Combined with AI-Based Image Analysis for the Characterization of Spray Dried Amorphous Solid Dispersion Particles

Wednesday May 7, 2025 4:35pm - 5:10pm EDT

Brunswick Ballroom

Speakers

Tatiana Marcozzi, PhD

Senior Scientist, Oral Solid Dosage, Janssen

Tatiana is a principal scientist in the oral solid development team of Johnson and Johnson Innovative Medicine. Tatiana holds a master of science in Pharmaceutical chemistry and technology from the University of Bologna (Italy) and she is an industrial PhD candidate at Gent University... Read More →

Wednesday May 7, 2025 4:35pm - 5:10pm EDT
Brunswick Ballroom

Bioavailability Stream

4:35pm EDT

Design Considerations of Osmotic Tablets

Wednesday May 7, 2025 4:35pm - 5:10pm EDT

Brunswick Ballroom

Speakers

Jim Di Nunzio, PhD

Associate Principal Scientist, Oral Solid Dosage Drug Product Development, Merck & Co.

Dr. James DiNunzio has over 12 years of oral solid dosage drug product development experience and currently serves as an Associate Principal Scientist at Merck & Co. Dr. DiNunzio received his Ph.D. in Pharmacy (Pharmaceutics track) from The University of Texas at Austin, and holds... Read More →

Wednesday May 7, 2025 4:35pm - 5:10pm EDT
Brunswick Ballroom

Continuous Manufacturing Stream

5:10pm EDT

Chair’s Closing Remarks, Drinks Reception in Exhibit Hall and End of Day One

Wednesday May 7, 2025 5:10pm - 6:30pm EDT

Brunswick Prefunction

Wednesday May 7, 2025 5:10pm - 6:30pm EDT
Brunswick Prefunction

Morning Networking Break