7:30 AM - 8:25 AM
Registration & Refreshments
8:25 AM - 8:35 AM
Chair’s Opening Remarks
8:35 AM - 9:05 AM - Keynote
Technology & Innovation
Mesoporous Silicon and Silica Nanomaterials for Drug Delivery Applications
9:10 AM - 9:40 AM - Case Studies
Small Molecules
Biopharmaceutical Performance Enhancement via Nano Sized Crystalline and Amorphous Solid Dispersed Materials
Shawn Yin, Scientific Director, Bristol-Myers Squibb
Biologics
Peptide Nanoparticles as an Approach for Stable High Concentration Formulations
Dennis Leung, Director and Manager of the Discovery Pharmaceutics and Preformulation , Genentech
Technology & Innovation
Melt Spray Congeal Microspheres: A Flexible Oral Multiparticulate Platform for Patients
Sheri Shamblin, Director, Pfizer
9:45 AM - 10:15 AM - Case Studies
Small Molecules
Physiologically-Based Biopharmaceutics Modelling to Inform Drug Product Quality and Clinical Decisions
Filippos Kesisoglou, Distinguished Scientist, Pharmaceutical Sciences and Clinical Supply, Merck
Biologics
A Biopharmaceutics Perspective on Oral Delivery of Peptides, Proteins and Oligonucleotides
Manuel Sanchez-Felix, Associate Director, Novartis Institute for BioMedical Research
Device Development
Current application of computational modelling and simulation in designing and validating specific drug delivery devices
Alie Jahangir, Associate Director, Combination Products & Digital Health , Janssen
10:20 AM - 10:50 AM - Solution Spotlights
Small Molecules
Solution Spotlight by Quotient Sciences
Biologics
Solution Spotlight by Amneal Pharmaceuticals
Device Development
Direct-to-Organ Drug Delivery – Opportunities, Challenges, and Ideas
Harshal Shah, BioPharma Sector Head, Cambridge Consultants
Tim Phillips, Principal Human Factors Engineer, Cambridge Consultants
10:50 AM - 11:40 AM
Networking & 1-2-1 Meetings
11:40 AM - 12:10 PM - Case Studies
Small Molecules
Predicting Powder Flow Obstruction in Solid Dosage Form Manufacture
Chen Mao, Distinguished Scientist, Small Molecule Pharmaceutical Sciences, Genentech
Biologics
Long-Acting Injectables – Biopharmaceutics and Drug Product Design
Simone Alidori, Scientific Leader & Associate Fellow, GSK
Device Development
Device Development Strategies for Long Acting Injectables
Scott Nunn, Director, Device Development , Gilead
12:15 PM - 12:45 PM - Solution Spotlights
Small Molecules
Solution Spotlight by Sever Pharma Solutions
Biologics
Solution Spotlight by Croda Pharma
Technology & Innovation
Solution Spotlight by Celanese
12:45 PM - 1:45 PM
Networking Lunch
1:45 PM - 2:15 PM - Case Studies
Small Molecules
End to End Digital Design for ER Tablet Drug Delivery Systems with Functional Coating
Alfred Berchielli, Formulation and Process Scientist , Pfizer
Biologics
Accelerating Discovery to FIH through Early Formulation Risk Assessments of Novel Biologics
Suman Luthra, Director Discovery Pharmaceutical Sciences, Merck
Device Development
Development of Drug Delivery and Photoactivation Devices for the Treatment of Bladder Cancer
Keith Faucher, Senior Director Device Development and Innovation, Aura Biosciences
2:20 PM - 2:50 PM - Case Studies
Small Molecules
Pediatric Formulation Design – From Adult to Children
Curtis Leung, Senior Scientist, Agios
Biologics
Characterization of the Hydrolytic Activity of Polysorbate Degrading Host Cell Proteins
Anthony Tomlinson, Technical Development Principal Scientist
Device Development
Applying Design Control & Control Strategy to Support the Development of Combination Drug Products
2:50 PM - 3:40 PM
Networking & 1-2-1 Meetings
3:40 PM - 4:10 PM - Solution Spotlights
Small Molecules
Solution Spotlight by Ligand Pharmaceuticals
Biologics
Solution Spotlight by Precision NanoSystems
Device Development
Solution Spotlight by EdgeOne Medical
4:15 PM - 4:45 PM - Case Studies
Small Molecules
The Future of Assessing Oral Absorption Potential and Developability Risk in Drug Discovery
Maya Lipert, Principal Scientist
Biologics
Small Molecule Crystallographic and Modeling Strategies to Improve Solubility
Xiaofeng Lu, Principal Research Scientist, AbbVie
Device Development
Formulation and Device Considerations for Subcutaneous Delivery
Steven C. Persak, Director, Device Development/MRL , Merck
Will Forrest, Principal Scientist, Sterile & Specialty Products, Merck
4:50 PM - 5:20 PM - Case Studies
Small Molecules
Integrated Pre-Formulation and Drug Product Characterization Efforts Leading to Nimble Advancement of Drug Candidates to Human Clinical Trials
Gaauri Naik, Director, Pharmaceutics, Relay Therapeutics
Biologics
Liquid pre-formulation assessment for monoclonal antibodies and new modalities
Shwetha Iyer, Principal Scientist, Novartis
Technology & Innovation
Beginning with the End in Mind: Risk Based Approach for Oral First in Human Formulation Development
Varsha Dhamankar, Director, Head of Formulation Development, Ribon Therapeutics
5:20 PM - 6:00 PM - Panel Discussion
Technology & Innovation
Preparing for Patient-Centric Drug Development Regulations
6:00 PM - 6:10 PM
American DDF Poster Presentation Award & Chair's Closing Remarks
6:10 PM - 7:10 PM
Drinks Reception
8:00 AM - 8:15 AM
Registration & Refreshments
8:15 AM - 8:20 AM
Chair’s Opening Remarks
8:20 AM - 9:05 AM - Keynote
Technology & Innovation
9:10 AM - 9:40 AM - Case Studies
Small Molecules
Impact of Crystallinity on Performance of Amorphous Solid Dispersions
James DiNunzio, Director, Merck
Biologics
Formulation & Process Development Considerations for Non-Viral Gene Delivery
Amey Bandekar, Associate Director - Biologics Drug Product Development & Manufacturing , Sanofi
Technology & Innovation
Inflammation-Responsive Supramolecular Gels for Controlled Drug Delivery
Nitin Joshi, Assistant Professor , Harvard Medical School
9:45 AM - 10:15 AM - Solution Spotlights
Small Molecules
Solution Spotlight by Nanoform
Biologics
Solution Spotlight by TBC
Technology & Innovation
Solution Spotlight by Ardena
10:20 AM - 10:50 AM - Case Studies
Small Molecules
Enabling or Not? – A Journey of FIH Formulation Development for a Poorly Water-Soluble Deuterated Weak Basic Development Candidate
Yan He, Head of Early Formulation Development, Sanofi
Biologics
Fixed-Dose Combination Drug Production Development
Zhi Chen, Associate Scientific Director, Bristol Myers Squibb
Device Development
10:50 AM - 11:40 AM
Networking & 1-2-1 Meetings
11:40 AM - 12:10 PM - Case Studies
Small Molecules
Biologics
Biopharmaceutics Aspects on Long-Acting Injectables Drug Products
Jun Zhang, Director, Drug Product Formulation and Process Development, Affinivax
Technology & Innovation
Development of ASD Formulation for Clinical Studies – From Amorphous Theoretical Solubility Calculation to ASD Tablet Development
Wei Zhang, Principal Scientist, Small Molecule Pharmaceutics , Genentech
12:15 PM - 12:45 PM - Solution Spotlights
Small Molecules
Solution Spotlight by WuXi STA
Biologics
Solution Spotlight by Hovione
Device Development
Solution Spotlight by Gerresheimer
12:45 PM - 1:45 PM
Networking Lunch
1:45 PM - 2:15 PM - Case Studies
Biologics
HPBCD as an Excipient in Low Dose Protein Formulations
Shreya Kulkarni, Senior Scientist II, AbbVie Biotherapeutics
Technology & Innovation
Formation and Inhibition of Nitrosamines in Drug Product
Kausik Nanda, Principal Scientist , Merck
Device Development
2:20 PM - 2:50 PM - Solution Spotlights
Small Molecules
Solution Spotlight by Lubrizol
Biologics
Solution Spotlight by TBC
Device Development
Solution Spotlight by TBC
2:50 PM - 3:30 PM
Networking & 1-2-1 Meetings
3:30 PM - 4:00 PM - Case Studies
Small Molecules
Small Molecule Crystallographic and Modeling Strategies to Improve Solubility
Tina Xiong, Associate Principal Scientist, Merck
Biologics
Current Challenges During CMC Development and Delivery of Novel Modalities
Cesar Calero, Senior Scientist Biologics Drug Product Development & Manufacturing, Sanofi
Technology & Innovation
Release Mechanisms of Amorphous Solid Dispersions: Role of Drug-Polymer Phase Separation and Morphology
Hitesh S. Purohit, Senior Scientist II, Formulation Sciences, AbbVie
4:00 PM - 4:30 PM - Keynote
Technology & Innovation
Global Alliance Management and Partnership Success
Rosario LoBrutto, Head of Pharmaceutical Sciences and Global Expansion, Radius Pharma
4:45 PM - 4:50 PM
Chair’s Closing Remarks