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Tuesday, May 12
 

8:00am EDT

Registration Opens & Continental Breakfast for Attendees
Tuesday May 12, 2026 8:00am - 9:00am EDT
Tuesday May 12, 2026 8:00am - 9:00am EDT
  Morning Networking Break

8:55am EDT

Welcome and Chairperson’s Introduction & Opening Remarks
Tuesday May 12, 2026 8:55am - 9:00am EDT
Speakers
avatar for Firouz Asgarzadeh, PhD

Firouz Asgarzadeh, PhD

President of Consulting Services, OSD Pharmaceutical Solutions
Firouz Asgarzadeh, Ph.D. is founder of OSD Pharmaceutical Solutions LLC (an independent consulting firm) which provides formulation and process development services to pharmaceutical companies. Dr. Asgarzadeh has over 29+ years of global R&D and commercial experience in leadership... Read More →
Tuesday May 12, 2026 8:55am - 9:00am EDT

9:00am EDT

From Formulation to Function: Engineering Drug Product Quality to Maximize Therapeutic Performance
Tuesday May 12, 2026 9:00am - 9:40am EDT
Crowne Plaza Princeton - Conference Center by IHG
For drug product scientists and formulators, the ultimate measure of success lies not just in developing a stable formulation, but in ensuring that a drug product consistently delivers its intended therapeutic effect. In this keynote, Mansoor Khan will explore how a deeper scientific understanding of drug product quality—through critical quality attributes (CQAs), advanced analytical characterization, and mechanistic insights into formulation–process–performance relationships—can be leveraged to engineer medicines that perform reliably in patients. The session will highlight emerging strategies that integrate formulation science, materials characterization, and predictive modeling to strengthen product robustness, enhance bioavailability, and reduce variability. By connecting drug product design with real-world therapeutic performance, this keynote will provide a forward-looking perspective on how product quality research can drive the next generation of high-performing pharmaceutical products.
Speakers
avatar for Mansoor Khan, PhD

Mansoor Khan, PhD

Dean & Distinguished Professor of Pharmaceutical Sciences & Ex CDER FDA, Texas A&M University
Tuesday May 12, 2026 9:00am - 9:40am EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  Keynote

9:40am EDT

Amorphous Solid Dispersions and Crystallinity
Tuesday May 12, 2026 9:40am - 10:10am EDT
Crowne Plaza Princeton - Conference Center by IHG
The presentation will cover the industrial perspectivefor managing risk of crystallinity in amorphous soliddispersions, covering three key areas:
• Manufacturability
• Stability
• Bioavailability

Learning Objectives
• Norm on basics of solid dispersions
• Establish understanding of failure modes for soliddispersion based on manufacturing technology
• Develop appreciation for environmental controlswith respect to crystallinity
• Grow understanding of crystallinity impact on PKperformance
Speakers
avatar for Jim Di Nunzio, PhD

Jim Di Nunzio, PhD

Distinguished 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 →
Tuesday May 12, 2026 9:40am - 10:10am EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

10:10am EDT

Innovating Oral Drug Delivery: Enabling Small and Macromolecule Therapies
Tuesday May 12, 2026 10:10am - 10:40am EDT
Crowne Plaza Princeton - Conference Center by IHG
The oral administration of macromolecules such as peptides and proteins continues to be limited by harsh gastrointestinal conditions, rapid enzymatic degradation, and poor membrane permeability. Novel delivery technologies—such as sophisticated lipid-based systems, delayed-release softgel platforms, and buccal or sublingual approaches—are emerging to overcome these barriers. By protecting sensitive compounds, directing site-specific release in the intestine, and leveraging lymphatic transport pathways, these solutions aim to enhance systemic exposure. This presentation will highlight the scientific rationale and data demonstrating how these innovations are advancing the clinical feasibility of oral macromolecule delivery. The current state of macromolecule delivery and recent advances in this space will be discussed.
Speakers
avatar for Karunakar (Karu) Sukuru, PhD

Karunakar (Karu) Sukuru, PhD

Global Vice President, Pharma Product Development & Head of Scientific Advisory, Catalent
Karunakar Sukuru is a distinguished leader in the pharmaceutical industry, with over three decades of expertise in Drug Product and Technology Development. At Catalent, he oversees the development of small molecule Rx products, guiding a team of over 800 scientists across 14 sites... Read More →
Tuesday May 12, 2026 10:10am - 10:40am EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

10:40am EDT

Morning Networking Break in Exhibit Hall
Tuesday May 12, 2026 10:40am - 11:10am EDT
Tuesday May 12, 2026 10:40am - 11:10am EDT
  Morning Networking Break

11:10am EDT

Breaking the Dose Barrier for Subcutaneous Drug Delivery: Advancing High-Concentration Biologics Through Smart Device Design and Patient-Centered Innovation
Tuesday May 12, 2026 11:10am - 11:40am EDT
Crowne Plaza Princeton - Conference Center by IHG
Amorphous solid dispersions (ASDs) are supersaturating formulations that enhance both the
High-dose biologic drug products have become increasingly prevalent for treating chronic diseases across diverse therapeutic areas, with subcutaneous (SC) self-administration emerging as the preferred delivery route driven by patient and healthcare provider demand. However, developing these products presents unique complexities requiring careful strategic planning and robust development strategies. This presentation provides a comprehensive analysis of SC combination drug product development, focusing on the critical interplay between high-concentration formulation design, delivery device selection, and biopharmaceutical attributes that collectively minimize clinical risk factors. Key developmental challenges addressed include formulation strategies for achieving therapeutic doses, large-volume delivery through optimized drug-device combinations, pharmacokinetic (PK) bridging risk assessment, and patient tolerability considerations. By integrating formulation science, device engineering, and clinical bridging strategies, this presentation offers guidance for successfully navigating the complex development pathway of high-dose SC biologics from concept to commercialization.
Speakers
avatar for Indrajit Ghosh, PhD

Indrajit Ghosh, PhD

Scientific Director, Biologics Product Development, Bristol Myers Squibb
Pharmaceutical Sciences, CMC, and Innovation Leader with 23 years of end-to-end drug product development across biologics and small molecules from preclinical research through commercial launch. Currently leading device-enabled subcutaneous delivery programs for high-dose biologics... Read More →
Tuesday May 12, 2026 11:10am - 11:40am EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

11:40am EDT

Beyond Solubility - A New Pharmaceutical Classification Guiding Enabled Formulations in the Modern Molecular Landscape
Tuesday May 12, 2026 11:40am - 12:10pm EDT
Crowne Plaza Princeton - Conference Center by IHG
Modern drug development faces a significant challenge as over 70% of new pharmaceutical compounds struggle with low solubility. A novel classification framework is introduced to improve the design of enabled formulations, specifically focusing on amorphous solid dispersions. This system moves past basic solubility issues to evaluate how and when to consider the impact of dissolution and diffusion as rate limiting steps to absorption. By categorizing these complex molecular properties, the framework helps researchers determine how to optimize their amorphous formulation for optimal performance. Ultimately, this approach provides a sophisticated strategy for optimizing bioavailability in an increasingly complex chemical landscape.
 
  • With over 70% of new drugs being solubility-limited, rising molecular complexity requires advanced bioavailability enhancement strategies.
  • Amorphous solid dispersions (ASDs) remain a leading solution, yet their application must evolve alongside modern chemical properties.
  • A new classification system guides formulation design by identifying when to optimize beyond basic solubility to consider dissolution rate, the formation of solubilized species, or to consider the addition of permeation enhancers.
Speakers
avatar for Erica Schlesinger, PhD

Erica Schlesinger, PhD

Vice President of Technical Development, Seran Biosciences
Sponsors
avatar for Seran Bioscience

Seran Bioscience

At Serán, Our mission is to provide optimized drug development and manufacturing services for our clients, from discovery to the clinic. Our science-driven approach utilizes predictive design tools, novel chemistry, analytical tools, enabling delivery technologies, and a thorough... Read More →
Tuesday May 12, 2026 11:40am - 12:10pm EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

12:10pm EDT

Lifecycle Management and Reformulation Opportunities for Peptides and Challenging Small Molecules
Tuesday May 12, 2026 12:10pm - 12:40pm EDT
Crowne Plaza Princeton - Conference Center by IHG
As pharmaceutical pipelines increasingly yield complex APIs—including poorly permeable small molecules and peptides—first-generation drug products often fall short of the ideal Target Product Profile. Sub-optimal bioavailability, positive food effects, and reliance on parenteral administration present significant hurdles to patient compliance and market success.
This presentation explores how lipid-based formulations provide a proven, low-risk toolkit for strategic lifecycle management and 505(b)(2) reformulations. By leveraging IID-listed lipid excipients, formulators can mitigate absorption challenges for small molecules, develop specialized dosage forms, and even achieve the “holy grail” of patient-centricity—oral peptide delivery.
Highlighting real-world case studies and future-facing formulation approaches, this session will demonstrate how lipid excipients enable value-added reformulations that bring new life to existing assets.
Speakers
avatar for Nicholas DiFranco, MEM

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-disciplinary team offering excipients and services for controlled release and solubility enhancement in oral solids and... Read More →
Sponsors
avatar for Gattefossé USA

Gattefossé USA

Since 1880, Gattefossé has developed and manufactured high-quality lipid excipients for human and animal health. Our oral excipients offer solubility/bioavailability enhancement, sustained release, lubrication, and taste-masking. We also provide solubilizers, penetration enhancers... Read More →
Tuesday May 12, 2026 12:10pm - 12:40pm EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

12:40pm EDT

Networking Lunch
Tuesday May 12, 2026 12:40pm - 1:40pm EDT
Tuesday May 12, 2026 12:40pm - 1:40pm EDT
  Morning Networking Break

1:40pm EDT

Combining Extended Release with Bioavailability Enhancement
Tuesday May 12, 2026 1:40pm - 2:10pm EDT
Crowne Plaza Princeton - Conference Center by IHG
A growing proportion of modern small-molecule drug candidates are challenged by oral absorption limitations arising from poor solubility, poor permeability, or both. For compounds that also require prolonged exposure, formulation strategy becomes more complex, particularly when once-daily dosing is desirable for chronic therapy, patient convenience, adherence, or competitive product positioning. In these cases, conventional immediate-release or standard modified-release approaches may be insufficient to achieve the desired pharmacokinetic and therapeutic profile.

This presentation will discuss emerging oral formulation strategies that combine amorphous solid dispersions with extended-release design to address both bioavailability and duration of exposure in a single dosage form. By pairing supersaturation-enabling systems with controlled-release architectures, these hybrid approaches offer a path to improve absorption while maintaining targeted release kinetics. Using a series of case studies, we will show how such strategies can be used to better match in vivo pharmacokinetic performance to therapeutic goals and program requirements. The discussion will focus on practical formulation considerations and lessons learned in applying these integrated platforms to next-generation oral medicines.
Speakers
avatar for Michael Grass, PhD

Michael Grass, PhD

Head of Innovation, Bend BioScience
Tuesday May 12, 2026 1:40pm - 2:10pm EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

2:10pm EDT

Engineering Solubility: Modern Approaches in OSD Formulation
Tuesday May 12, 2026 2:10pm - 2:40pm EDT
Crowne Plaza Princeton - Conference Center by IHG
Poor solubility continues to limit the performance of many oral drug candidates. This session explores how strategic formulation design in oral solid dosage (OSD) development can enhance solubility and drive better bioavailability outcomes. From enabling technologies to rational design principles, attendees will gain practical insights into approaches that improve drug performance while supporting efficient and scalable development.
Speakers
avatar for Kush Patel, PhD

Kush Patel, PhD

Research Fellow, Oral Product Development, Pfizer, Inc.

Tuesday May 12, 2026 2:10pm - 2:40pm EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

2:35pm EDT

Safe by Design: Benefit-Risk Assessment Based Pediatric Excipient Selection
Tuesday May 12, 2026 2:35pm - 2:50pm EDT
Crowne Plaza Princeton - Conference Center by IHG
The dilemma to select appropriate excipients for paediatric products can be resolved by applying systematic benefit-risk assessment process, by using the newly developed “Paediatric Excipient Risk Assessment (PERA)” framework and tool which will be presented and demonstrated by case studies in this session. Attendees will gain insights into how to balance functionality with safety to support the development of effective pediatric patient centric medicines.
Speakers
avatar for Anjali Agrawal, PhD

Anjali Agrawal, PhD

Executive Director, Marketing Product Development Portfolio, Novo Nordisk
Tuesday May 12, 2026 2:35pm - 2:50pm EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

3:00pm EDT

Afternoon Networking Break in Exhibit Hall
Tuesday May 12, 2026 3:00pm - 3:30pm EDT
Tuesday May 12, 2026 3:00pm - 3:30pm EDT
  Morning Networking Break

3:30pm EDT

Right Platform, Right Time: A Decision Framework for Solubility Challenges
Tuesday May 12, 2026 3:30pm - 4:00pm EDT
Crowne Plaza Princeton - Conference Center by IHG

Speakers
avatar for Imre Vitez

Imre Vitez

Pre-formulation Manager, Ardena
Imre is a preformulation scientist with experience in materials characterization and th physical properties evaluation of pharmaceuticals. He is responsible for managing the preformulation function at Ardena Somerset by supporting the hot melt extrusion, oral solids, spray dry, nano-milling... Read More →
Tuesday May 12, 2026 3:30pm - 4:00pm EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

4:00pm EDT

Precision PK by Design: KinetiSol™- Enabled BAE and Controlled Release
Tuesday May 12, 2026 4:00pm - 4:30pm EDT
Crowne Plaza Princeton - Conference Center by IHG
Precisely controlling exposure is critical to maximizing efficacy and minimizing risk. This session explores how KinetiSol™-enabled bioavailability enhancement (BAE) and controlled-release (CR) design enable next-generation PK optimization. Learn how high-energy amorphous processing and formulation tuning can rapidly shape exposure profiles—improving absorption, extending duration, and aligning PK with therapeutic intent for challenging APIs.
Speakers
avatar for Dave Miller, PhD

Dave Miller, PhD

Chief Scientific Officer, AustinPx
Tuesday May 12, 2026 4:00pm - 4:30pm EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

4:30pm EDT

The Hidden Secrets of Designing a Robust Oral Controlled Release Formulation
Tuesday May 12, 2026 4:30pm - 5:00pm EDT
Crowne Plaza Princeton - Conference Center by IHG
Designing robust oral controlled release formulations requires more than extending drug release—it demands a deep understanding of formulation, physiology, and performance variability.
This session uncovers the often-overlooked factors that impact success, from material selection and release mechanisms to in vivo predictability and scalability. Gain practical insights into avoiding common pitfalls and building formulations that deliver consistent, reliable performance from development through commercialization.
Speakers
avatar for Ali Rajabi-Siahboomi, PhD

Ali Rajabi-Siahboomi, PhD

Advisory, Leadership & innovation, ALi Pharma Solutions, LLC
Tuesday May 12, 2026 4:30pm - 5:00pm EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

5:00pm EDT

Developing Drug Products for Oral Delivery of Challenging Molecules: Formulation Design and Biopharmaceutical Considerations
Tuesday May 12, 2026 5:00pm - 5:30pm EDT
Crowne Plaza Princeton - Conference Center by IHG
Small molecules that belong to BCS II and IV classes pose developability challenges and require formulation strategies to enhance oral bioavailability. This talk will discuss various strategies to overcome this problem. 1) Amorphous solid dispersions (ASDs)- This section will focus on dissolution mechanism of ASDs and strategies (surfactants, pH modifiers) to increase drug load in ASD without comprising dissolution performance. 2) Prodrugs- Considerations for developing prodrugs for rapidly crystallizing compound and impact of pro-moeity selection on prodrug performance will be discussed. 3) Permeation enhancers (PEs) for BCS IV- Utilizing PEs for enhancing oral bioavailability of BCS IV compound and impact of solid form and formulation strategy on performance of the PE will be discussed.
Speakers
avatar for Anura Indulkar, PhD

Anura Indulkar, PhD

Principal Scientist, Oral Formulation Sciences, Merck & Co.
Anura Indulkar, PhD is an Associate Principal Scientist in the Oral Formulation Sciences organization at Merck & Co., Inc since Mar 2025. She received her PhD in Industrial and Physical Pharmacy from Purdue University in 2017. She earned her Master’s in Pharmaceutics from National... Read More →
Tuesday May 12, 2026 5:00pm - 5:30pm EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  General Session

5:30pm EDT

Chair’s Closing Remarks, Drinks Reception in Exhibit Hall and End of Day One
Tuesday May 12, 2026 5:30pm - 6:30pm EDT
Crowne Plaza Princeton - Conference Center by IHG

Tuesday May 12, 2026 5:30pm - 6:30pm EDT
Crowne Plaza Princeton - Conference Center by IHG 900 Scudders Mill Rd, Plainsboro Township, NJ 08536, USA
  Morning Networking Break
 

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Crowne Plaza Princeton - Conference Center by IHG
  • General Session
  • Keynote
  • Morning Networking Break