2025’s Summit Program Agenda is currently being developed
Controlled and Modified Release
- Oral Drug Delivery Systems
- Long Acting Injectable Drug Delivery Systems
- Transdermal Drug Delivery Systems
- Modified release coating systems
- Biodegradable and Biocompatible Polymers
- Nanotechnology in Controlled Release
- Pulmonary Drug Delivery Systems
- The Role of Controlled Release in Optimizing Therapeutic Outcomes
- Patient Centric / Pediatric Dose Development
- 3D Printing in Controlled and Modified Release
- Regulatory considerations
- Continuous manufacturing of Controlled and Modified Release products
- Continuous modified release coating systems
- Continuous long-acting microsphere manufacturing
Bioavailability Enhancement
- Formulation strategies for improved absorption of poorly soluble and/or poorly permeable drugs
Solubility and dissolution enhancement techniques:
– Lipid-Based formulations
– Micronization
– Nanomedicine
– Nanocarriers
– Spray Dried Dispersions (SDD)
– Hot Melt Extrusion (HME)
– Kinetisol - Biopharmaceutics classification system (BCS) and its implications
- In vitro-in vivo correlations (IVIVCs)
- Continuous manufacturing technologies for Bioavailability Enhancement
Continuous Manufacturing
- Continuous biopharmaceutical manufacturing
- Continuous manufacturing of oral solids
- Spray Drying and Continuous Manufacturing of Pharmaceutical Materials
- Melt Extrusion and Continuous Manufacturing of Pharmaceutical Materials
- Continuous reactors for pharmaceutical manufacturing
- Recent regulatory status in continuous manufacturing
- Continuous Manufacturing equipment change over time
- Capacity planning for continuous pharmaceutical manufacturing facilities
- Continuous modified release coating equipment
- Continuous fluid-bed coating
- Continuous tablet-coating
- Continuous lyophilization
Main Conference Day One – Tuesday June 25, 2024
7:45am
9:00am
Collaboration is King! Ice Breaker
9:10am
9:10am
Selection of Modified Drug Release Technologies Based on API Preferences
Joseph Della Rocca, PhD
Associate Principal Scientist
Merck & Co.
9:45am
How To Accelerate Drug Product Optimization: Integrated Program Delivery Using Translational Pharmaceutics
Aruna Railkar, PhD
Senior Research Fellow
Quotient Sciences
10:20am
Percolation Behavior in an Immediate Release Tablet Dosage Form
Prajwal Thool
Scientist III, Synthetic Molecule Pharmaceutics
Genentech
10:50am
11:20am
Long-Acting Injectables Product Development: Opportunities and Challenges
Seth Forster, PhD
Senior Scientist, Pharmaceutical Commercialization Technology
Merck & Co.
11:55am
The competences and Intricacies of Fluid Bed Technologies
Zafar Iqbal, PhD
Vice President & Head of Pharmaceutical Development
Glatt
12:30pm
1:45pm
Impact of Physical Attributes on Long Acting Formulation Injectability
Kelly Zhang, PhD
Senior Scientist, Analytical Enabling Capabilities – MBC | Analytical Research & Development
Merck
2:20pm
Deconstructing Annealing Phenomena in MR Lipid Multiparticulates
Kellyn Zagaja, PhD
Principal Scientist, Drug Product Design
Pfizer
2:55pm
Co-Excipient Strategies for Controlled Release Formulations
As chronic diseases become more prevalent in an aging global population, the need for controlled- and extended-release formulations is growing. These dosage forms offer an appealing way to minimize pill burden for patients and improve adherence to medications. While many extended-release formulations rely on cellulosic polymers, such as HPMC, combinations of excipients may offer key technical and patient benefits to a formulation, such as smaller tablet size and better control over drug release. In this presentation, we will explore the potential of Lubrizol’s Carbopol® polymers to enhance extended-release performance and overcome shortcomings of single-polymer solutions. Join us to learn more about:
- The current formulation and manufacturing landscape for extended-release tablets
- Key technical and patient-centric challenges in extended-release
- Benefits of Carbopol® polymers for matrix tablets, including precedence of use
- Case studies demonstrating robust extended-release performance from Carbopol-HPMC matrices
- Strategies for enhanced formulations via granulation and direct compression
Jim Baxter, MS
North American Technical Business Development Manager, Pharmaceutical Excipients
Lubrizol
3:10pm
Afternoon Networking & Refreshment Break in Exhibit Hall
3:40pm
CDMO Case Studies For Delayed Release and Solubility Enhancement
Robert Wenslow, PhD
Vice President of Business Development
Crystal Pharmatech
4:00pm
Scaling Up Oral Modified Release Drug Delivery Process for Maximum Impact
Firouz Asgarzadeh, PhD
President of Consulting Services
OSD Pharmaceutical Solutions
4:35pm
Cellular Model of the Oral Lymphatic Absorption Pathway
Ryan Pelis, PhD
Senior Principal Scientist, Pharmacokinetic Sciences
Novartis
5:10pm-
6:15pm
Main Conference Day Two – Wednesday, June 26, 2024
8:00am
9:00am
9:10am
Predictive Potential and Operational use of SCISSOR to Streamline SC Biologics Drug Development
Mikhail Murashov, PhD
Senior Scientist, Sterile and Specialty Products
Merck & Co.
9:45am
Liquid Crystal Mediated Release of Water-Soluble Peptides from Polymeric Nanoparticles
Sophia R Dasaro
Graduate Student
Purdue University
10:20am
Efficient New Tools for Solubility Enhancement and Lifecycle Management: Apisolex™ and Apinovex™ Polymers
Innovations in drug discovery and repurposing have generated renewed interest in small molecule development. While these efforts have grown the global project pipeline, many candidates suffer from solubility and bioavailability challenges. In order to formulate these complex molecules, new technologies and formulation approaches are needed to meet technical requirements while ensuring patient safety/compliance. Lubrizol Life Science’s injectable-grade Apisolex™ and oral-grade Apinovex™ polymers were designed to overcome poor solubility and unlock the future of small molecule drug delivery. Join us to learn about:
- Key considerations for novel solubility enhancement technologies
- New tools for solubility enhancement: Apinovex™ and Apisolex™ polymer technologies
- Case study data demonstrating solubility enhancement and high stable drug loading
- Safety/toxicity updates and future plans
- The importance of manufacturing and quality support for novel technologies
Liliana Miinea, PhD
Global Technology Manager, Pharmaceutical Excipients
Lubrizol Life Science
10:35am
Morning Networking & Refreshment Break
11:00am
Roadmap for Development of Subcutaneous Dosage Form of High Dose Antibody Products
Indrajit Ghosh, PhD MBA
Associate Scientific Director, Biologics Product Development
Bristol Myers Squibb
11:30am
Translational Formulation Approaches for the Oral Delivery of eRo5/bRo5 Molecules
Ketan Patel, PhD
Associate Professor of Pharmaceutics
St. John’s University
11:55am
Strategies for ASD Formulation Development
Erica Schlesinger, PhD
Vice President of Technical Development
Seran Biosciences
12:30pm
Networking Lunch
1:45pm
Melt-Spray-Congeal Microspheres as a Versatile, Oral Multiparticulate Platform for Colon Delivery
Dipy Vasa, PhD
Principal Scientist, Drug Product Dev
Pfizer
2:20pm
Topical Ophthalmic Drug Delivery: Insights from Marketed Products
Anand Uhbe, PhD
Senior Scientist, Sterile Liquids Product Development
Abbvie
2:55pm
Using PBPK Modeling for Risk Assessment in Drug Product Development
Siddharth S. Kesharwani, PhD
Biopharmaceutics Scientist
Sanofi
3:30pm
Chair’s Closing & 2024 Summit Concludes
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