7:15 AM - 8:15 AM
Registration & Refreshments
8:15 AM - 8:20 AM
Chair’s Opening Remarks
Rosario LoBrutto, Head of Pharmaceutical Sciences and Global Expansion, Radius Health
8:20 AM - 9:05 AM - Keynote
Technology & Innovation
Model for Long-Acting Injectables
Jaymin Shah, Senior Research Fellow, Pfizer
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
A Biopharmaceutics Perspective on Oral Delivery of Peptides, Proteins and Oligonucleotides
Manuel Sanchez-Felix, Associate Director, Novartis Institute for BioMedical Research
Device Development
Digital Transformation: Impact on Healthcare Industry & Quality Engineering
Alie Jahangir, Director, SaMD and Medical Devices, 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
Finding Signal in the Noise: Visualizing Big Data to Design Better Drugs
Dennis Leung, Director and Manager of the Discovery Pharmaceutics and Preformulation , Genentech
Technology & Innovation
Leveraging Melt-Spray-Congeal Microspheres as a Versatile, Patient-Centric Oral Multiparticulate Platform
Brett Kopina, Principal Scientist, Pfizer
10:20 AM - 10:50 AM - Solution Spotlights
Small Molecules
Leveraging Rapid Clinical Assessments to Accelerate Pediatric Formulation Development
Biologics
Innovative Gastro-Retentive Drug Delivery Technologies for Improving Therapeutic Outcomes of Challenging Compounds
Pavan Handa, Senior Vice President, Specialty Portfolio Management , Amneal Pharmaceuticals
Siva Vaka, Director, Formulation R&D, Amneal Pharmaceuticals
Device Development
Direct-to-Organ Drug Delivery – Opportunities, Challenges, and Ideas
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
Drug Product Design and Biopharmaceutics Considerations for Long-Acting Injectables
Simone Alidori, Scientific Leader, Associate Fellow, GSK
Device Development
Building an Autoinjector Development and Supply Ecosystem
Mark Howansky, Vice-President, Device Development and Commercialization, Viridian Therapeutics
12:15 PM - 12:45 PM - Solution Spotlights
Small Molecules
Role of PLGA Variability in Controlled Drug Release from Dexamethasone Intravitreal Implants
Biologics
Empowering Biologics Delivery: Croda Pharma’s Comprehensive Portfolio of Biopharma Solutions
Sreejit Menon, Research and Technology Manager, Croda Pharma
Katherine McQuillan, Research Scientist, Nautilus Biosciences, a division of Croda Canada
Technology & Innovation
Driving Towards Patient-Centricity with Drug-Eluting Implants
Tom Quinci, External Partnerships Leader, 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, Associate Research Fellow, Drug Product Design, 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 (Cheuk-Yui) Leung, Ph.D, Associate Director, CMC Formulations, Agios Pharmaceuticals Inc.
Biologics
Characterization of the Hydrolytic Activity of Polysorbate Degrading Host Cell Proteins
Anthony Tomlinson, Technical Development Principal Scientist , Genentech
Device Development
Addressing Challenges in Combination Product Development for SC Delivery
2:50 PM - 3:40 PM
Networking & 1-2-1 Meetings
3:40 PM - 4:10 PM - Solution Spotlights
Small Molecules
Overcoming Challenges in Complying with a New Monograph During a Pandemic – Captisol® Success Story
Ryan Memmer, Manager, Quality Control and Development , Singota Solutions
Biologics
Scaling Up RNA LNP’s for Commercial Success
Jignesh Patel, Field Application Scientist, Precision NanoSystems
Technology & Innovation
Silicone-Free Option for Delivery of Sensitive Biologics and Conjugate Vaccines in Glass Pre-Filled Syringes
4:15 PM - 4:45 PM - Case Studies
Biologics
Overcoming Formulation Challenges for Complex Bispecific Antibody Drug Product Development
Xiaofeng Lu, Principal Research Scientist, AbbVie
Device Development
Formulation & Device Considerations for Subcutaneous (SC) Delivery of Biotherapeutics
4:50 PM - 5:20 PM - Case Studies
Small Molecules
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
Biologics
Preformulation Assessment for Large Biotherapeutics Enabling Early Understanding of the Clinical Service Formulation
Shwetha Iyer, Principal Scientist, Novartis
Device Development
Context is Key: Understanding Human Factors Validation Study Results
Alexandra Benbadis, Usability Leader, Sanofi
5:20 PM - 5:50 PM - Case Studies
Technology & Innovation
Tuning LNP Formulation to Enable Extrahepatic Delivery
Nathan Westcott, Director, Delivery Platform, Beam Therapeutics
Biologics
The Challenges and Opportunities for Subcutaneous Delivery of High Dose/Volume Biologics
Deep Bhattacharya Ph.D, Senior Scientist, Drug Product Design and Development, Pfizer
Device Development
Patient-Centric Product Design & Digital Technology as Successful Inhalation Therapy Enablers
5:55 PM - 6:25 PM - Keynote
Biologics
Selecting and Developing High Quality Antibody Theranostics
Sathya Venkataramani, Director Biological Research, AbbVie
6:25 PM - 6:35 PM
American DDF Poster Presentation Award & Chair's Closing Remarks
Rosario LoBrutto, Head of Pharmaceutical Sciences and Global Expansion, Radius Health
6:35 PM - 7:20 PM
Drinks Reception
8:00 AM - 8:30 AM
Registration & Refreshments
8:30 AM - 8:35 AM
Chair’s Opening Remarks
Rosario LoBrutto, Head of Pharmaceutical Sciences and Global Expansion, Radius Health
8:35 AM - 9:05 AM - Case Studies
Technology & Innovation
Mesoporous Silicon and Silica Nanomaterials for Drug Delivery Applications
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
Dimitrios Pelekoudas, Scientist , Sanofi
Device Development
Developing Wearable Injection Devices for Large Volume Drug Delivery
Anthony F. Coston, Technical Lead Device Design and Process Development, Biogen
9:45 AM - 10:15 AM - Solution Spotlights
Small Molecules
A Patient and Planet Centric Approach to Enabling Bioavalability
Sergie Letser, Deputy CCO, Senior VP Business Development, Nanoform
Technology & Innovation
Rapid and Material-Sparing Feasibility Screening for Hot Melt Extrusion
Amanda Pluntze, Scientist III, Research & Development, Lonza
Technology & Innovation
Formulation Strategies to Improve the Bioavailability of APIs with BCS Classification II and IV
Dave Seghers, Head of Sales , Ardena
10:20 AM - 10:50 AM - Case Studies
Small Molecules
Enabling or Not? A FIH Oral Solid Dosage Form Development Journey for a Poorly Water-Soluble Deuterated Weakly Basic Candidate
Yan He, Head of Early Formulation Development, Sanofi
Biologics
Formulation and Analytical Challenges in Development of Fixed-Dose Combination Products for Biologics
Zhi Chen, Associate Scientific Director, Bristol Myers Squibb
Technology & Innovation
Simplifying Design: Empowering Future Drug Delivery Innovations
Nitin Joshi, Assistant Professor , Harvard Medical School
10:50 AM - 11:40 AM
Networking & 1-2-1 Meetings
11:40 AM - 12:10 PM - Case Studies
Small Molecules
Patient Centric Drug Development
Twinkle Christian, Principal Scientist, Amgen
Small Molecules
Insights on Developing Amorphous Solid Dispersion Formulations for Early Clinical Studies
Wei Zhang, Principal Scientist, Small Molecule Pharmaceutics , Genentech
Technology & Innovation
Development and Clinical Translation of Neuroinflammation-Targeted Systemic Dendrimer Nanomedicines
12:15 PM - 12:45 PM - Solution Spotlights
Small Molecules
Accelerate First-in-Human Studies by Leveraging Integrated CMC Platform and Solid State Development
Sheng Hu, Director, CMC Project Management, WuXi STA
Technology & Innovation
Controlled and Sustained Drug Delivery - How Epidel™ is Changing Long-Acting Drug Development
Márcio Temtem, Senior Director, Strategic Business Management Products, Hovione
Ian Parrag, Vice President of R&D, Ripple Therapeutics
Device Development
Facilitating Subcutaneous Self-Administration of Biopharmaceuticals for Enhanced Patient Experience
Dr. Reza Abedian, Senior Medical Affairs Manager, Gerresheimer
12:45 PM - 1:45 PM
Networking Lunch
1:45 PM - 2:15 PM - Case Studies
Technology & Innovation
Formation and Inhibition of Nitrosamines in Drug Product
Kausik Nanda, Principal Scientist , Merck
Biologics
Strategy for Intestinal Delivery of a GIP/GLP1 Co-Agonist Peptide
Huyen Tran, Ph.D., Director in Formulation and Delivery, Eli Lilly and Company
Technology & Innovation
3D Tablet Design Software as Patient Centric Approach to Promote Swallowability of Solid Oral Dosage Forms
2:20 PM - 2:50 PM - Solution Spotlights
Small Molecules
Apisolex™ and Apinovex™ Polymers: Efficient New Tools for Solubility Enhancement and Lifecycle Management
Nick DiFranco, Global Market Manager, Oral Drug Delivery , Lubrizol Life Science – Health
Biologics
Trehalose, Sucrose and Amino Acids: Essential Components of Platform Biopharma Formulations
Sudhakar Voruganti, Director, Business Development, Pfanstiehl
Technology & Innovation
Lipid Manufacturing via CTDMO Services – A Process Chemistry Perspective
Christian Kuzniewski, Senior Manager Process Development, MilliporeSigma
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, Principal Research Scientist, AbbVie
4:00 PM - 4:30 PM - Case Studies
Technology & Innovation
Global Alliance Management and Partnership Success
Rosario LoBrutto, Head of Pharmaceutical Sciences and Global Expansion, Radius Health
4:30 PM - 4:35 PM
Chair’s Closing Remarks
Rosario LoBrutto, Head of Pharmaceutical Sciences and Global Expansion, Radius Health