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

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

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

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

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

9:00am EDT

Chairperson’s Welcome & Opening Remarks

Thursday May 8, 2025 9:00am - 9:05am EDT

Brunswick Ballroom

Thursday May 8, 2025 9:00am - 9:05am EDT
Brunswick Ballroom

9:05am EDT

Excipient Reactivity and Drug Stability in Formulations

Thursday May 8, 2025 9:05am - 9:45am EDT

Brunswick Ballroom

Speakers

Masih Jaigirdar, PhD

Former Senior Product Quality Reviewer, FDA

Mashuddin Jaigirdar is a retired pharmaceutical scientist with over 35 years of global experience in formulation development, process technology transfer, and manufacturing for brand and generic pharmaceuticals. He served as a Senior Quality Reviewer at the U.S. FDA, contributing... Read More →

Thursday May 8, 2025 9:05am - 9:45am EDT
Brunswick Ballroom

General Session

9:45am EDT

Lipid-based formulations: Maximizing the delivery of the poorly soluble drugs

Thursday May 8, 2025 9:45am - 10:15am EDT

Brunswick Ballroom

Speakers

Yogesh Bachhav, PhD

Associate Director, AiCuris

Yogeshwar Bachhav is a pharmacist by training and has PhD in advanced drug-delivery systems from ICT, Mumbai (India). He has around 16 years of post-PhD experience in Europe in the field of pharmaceutical development of investigational drugs. He has contributed to the success of the... Read More →

Thursday May 8, 2025 9:45am - 10:15am EDT
Brunswick Ballroom

General Session

9:45am EDT

Osmotic-Controlled Release Oral Tablets: Technology and Functional Insights

Thursday May 8, 2025 9:45am - 10:15am EDT

Brunswick Ballroom

Speakers

Kenneth Ogueri, PhD

Senior Researcher, Drug Product Design and Process Manufacturing, Pfizer

Dr. Kenneth S. Ogueri is currently a researcher in drug product design (DPD), Pfizer worldwide R&D. Kenneth does research in materials engineering, polymer science, formulations and their applications in oral therapeutic drug delivery, regenerative engineering, and other biomedical... Read More →

Thursday May 8, 2025 9:45am - 10:15am EDT
Brunswick Ballroom

General Session

10:15am EDT

Strategies for ASD Formulation Development

Thursday May 8, 2025 10:15am - 10:50am EDT

Brunswick Ballroom

Speakers

Erica Schlesinger, PhD

Vice President of Technical Development, Seran Biosciences

Erica Schlesinger has over 12 years of professional experience in technical development, research and development, formulation development, drug delivery, process chemistry, education, engineering, and teaching. In 2018, they served as VP Technical Development and Director, R&D for... Read More →

Thursday May 8, 2025 10:15am - 10:50am EDT
Brunswick Ballroom

General Session

11:20am EDT

Enhanced Bioavailability of Small Molecules, Peptides and Proteins by Nanoparticle Formation using Scalable Flash NanoPrecipitation

Thursday May 8, 2025 11:20am - 11:50am EDT

Brunswick Ballroom

Thursday May 8, 2025 11:20am - 11:50am EDT
Brunswick Ballroom

General Session

11:50am EDT

Using PBPK Modeling for Risk Assessment in Drug Product Development

Thursday May 8, 2025 11:50am - 12:20pm EDT

Brunswick Ballroom

Speakers

Siddharth Kesharwani

Director, Small Molecule CMC Development, AbbVie

Ph.D. (Pharmaceutical Sciences) with 5+ years of experience in fast-paced pharmaceutical industry, management consulting, and higher education with 25+ publications, 15 awards, 5 grants, and >50 invited seminars and presentations at national/international meetings.Certificate in Healthcare... Read More →

Thursday May 8, 2025 11:50am - 12:20pm EDT
Brunswick Ballroom

General Session

1:30pm EDT

Consumer-Centric Nasal Bioavailability Enhancement Formulation Development

Thursday May 8, 2025 1:30pm - 2:00pm EDT

Brunswick Ballroom

Speakers

Shabbir Lobo, PhD

Staff Scientist, Global Innovations and Product Development, Bayer

Shabbir is a skilled formulator in Transdermals, Modified Release oral Dosages and Topicals for Abbreviated New Drug Application (ANDA) and 505 b2 submissions. Attuned to current FDA regulations for a QbD based product development. dFMEA through the development of dosage form and... Read More →

Deb Das, PhD

Senior Associate Director & Science Fellow, Research and Development, Bayer

Debanjan (Deb), is a drug delivery scientist and an innovation-driven technical manager with over 19 years of product development experience in driving projects from concept to commercialization. He has marketed more than 40 commercial products in US (small molecules & biologics... Read More →

Thursday May 8, 2025 1:30pm - 2:00pm EDT
Brunswick Ballroom

1:30pm EDT

Exploring Diverse Routes for Parenteral Delivery via PK profile; Subcutaneous Oil Formulations

Thursday May 8, 2025 1:30pm - 2:05pm EDT

Brunswick Ballroom

Thursday May 8, 2025 1:30pm - 2:05pm EDT
Brunswick Ballroom

2:00pm EDT

The Rise of Continuous Manufacturing: Melt Granulation and Melt Extrusion in Pharma

Thursday May 8, 2025 2:00pm - 2:30pm EDT

Brunswick Ballroom

Speakers

Richard Steiner, PhD

Head of Sales & PCM Practice Lead, Pharmatech Associates

Richard Steiner, a seasoned professional with over 30 years of experience in sales, currently leads the sales efforts at Pharmatech Associates as the Head of Sales and Practice Lead for Pharmaceutical Continuous Manufacturing. Richard's extensive career includes notable leadership... Read More →

Thursday May 8, 2025 2:00pm - 2:30pm EDT
Brunswick Ballroom

2:35pm EDT

Overcoming Bioavailability Barrier to Deliver Protein Degraders

Thursday May 8, 2025 2:35pm - 3:10pm EDT

Brunswick Ballroom

Speakers

Chong-Hui Gu, PhD

SVP Head of CMC, LifeMine Therapeutics

Chong-Hui Gu, currently working at LifeMine Therapeutics as the Head of CMC and QA, has an extensive background in the pharmaceutical industry. Prior to joining LifeMine Therapeutics, Chong-Hui held roles at Foghorn Therapeutics, Agios Pharmaceuticals as the Head of CMC and DHODH... Read More →

Thursday May 8, 2025 2:35pm - 3:10pm EDT
Brunswick Ballroom

3:10pm EDT

Long-Acting Injectables Product Development: Opportunities and Challenges

Thursday May 8, 2025 3:10pm - 3:35pm EDT

Brunswick Ballroom

Speakers

Pratik Saha

Director, Biopharmaceutics, Drug Product Development, GlaxoSmithKline

Thursday May 8, 2025 3:10pm - 3:35pm EDT
Brunswick Ballroom

3:35pm EDT

Chair’s Closing Remarks and End of Summit

Thursday May 8, 2025 3:35pm - 3:40pm EDT

Brunswick Ballroom

Thursday May 8, 2025 3:35pm - 3:40pm EDT
Brunswick Ballroom

Morning Networking Break