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Monday, Jul 14th
8:00 AM – 12:00 PM EDT
Workshop: Liquid Chromatography to Characterize and Purify your LNP Drug Product
Speaker: Tristan Kovačič, n/a – Sartorius BIA Separations
Speaker: Nejc Pavlin
Speaker: Mojca Tajnik Sbaizero, n/a – Sartorius BIA Separations
Industry Session
Sponsored By
Monday, Jul 14th
8:00 AM – 4:30 PM EDT
Workshop: Recent Advances in Oral Peptide Delivery – From Molecule to Market
Chair: Andy Lewis, BPharm (Hons) PhD (he/him/his) – Quotient Sciences
Chair: Stephen T. Buckley, PhD – Novo Nordisk
Chair: David J. Brayden, PhD (he/him/his) – University College Dublin
Industry Session
Sponsored By Quotient Sciences, Frontiers Media S.A., Genentech, Inc., Janssen Phamaceutica NV, a Johnson & Johnson Company, Protagonist Theraputics, Bristol Myers Squibb Co., Novo Nordisk
Monday, Jul 14th
8:00 AM – 8:30 AM EDT
1 - Welcome & Introductions
Industry Session
Monday, Jul 14th
8:30 AM – 9:00 AM EDT
2 - An assessment of the trends in oral peptide administration
Chair and Speaker: David J. Brayden, PhD (he/him/his) – University College Dublin
Industry Session
Monday, Jul 14th
9:00 AM – 9:30 AM EDT
3 - Characterization of macrocyclic peptide drug interactions with bile salts and biorelevant colloids in the context of oral delivery
Speaker: Tahnee Denning – Genentech
Industry Session
Monday, Jul 14th
9:30 AM – 10:00 AM EDT
4 - Overcoming barriers to oral macromolecule delivery: What is coming next
Chair and Speaker: Stephen T. Buckley, PhD – Novo Nordisk
Industry Session
Monday, Jul 14th
10:00 AM – 10:30 AM EDT
5 - Coffee Break
Industry Session
Monday, Jul 14th
10:30 AM – 11:00 AM EDT
6 - Applications of PBPK Modelling in Oral Peptide Delivery
Speaker: Ricardo Diaz de Leon Ortega – Quotient Sciences
Industry Session
Monday, Jul 14th
11:00 AM – 11:30 AM EDT
7 - Pre-clinical screening of permeation enhancers for oral peptide administration in oral dosage forms: update on GI-ORIS
Speaker: Tom Vonderlach – Vivtex Corporation
Industry Session
Monday, Jul 14th
11:30 AM – 12:00 PM EDT
8 - Employing Endogenous Pathways for Efficient Paracellular Uptake of Peptide and Vesicular Transcytosis of Protein Therapeutics
Speaker: Randall Mrsny – University of Bath
Industry Session
Monday, Jul 14th
12:00 PM – 12:30 PM EDT
9 - Roundtable 1
Speaker: David J. Brayden, PhD (he/him/his) – University College Dublin
Speaker: Randall Mrsny – University of Bath
Speaker: Neil Mathias – Bristol Myers Squibb
Industry Session
Monday, Jul 14th
12:30 PM – 1:30 PM EDT
10 - Lunch Break
Industry Session
Monday, Jul 14th
1:30 PM – 2:00 PM EDT
11 - The development of the oral macrocycle, MK-0616, for treating hypercholesterolemia
Speaker: Douglas Johns – Merck Research Laboratories
Industry Session
Monday, Jul 14th
2:00 PM – 2:30 PM EDT
12 - Enabling Oral Delivery of Peptides through Molecular and Formulation Design: A J & J Perspective
Speaker: Sumit Arora, PhD – Johnson and Johnson Innovative Medicine
Industry Session
Monday, Jul 14th
2:30 PM – 3:00 PM EDT
13 - An Oral Macrocycle to Access Intracellular RAS Targets in Cancer: The Road to Formulation Design of LUNA18 for Phase I Trials
Speaker: Takamitsu Ueto – Chugai Pharma
Industry Session
Monday, Jul 14th
3:00 PM – 3:30 PM EDT
14 - Coffee Break
Industry Session
Monday, Jul 14th
3:30 PM – 4:00 PM EDT
15 - BIONND™, a device technology for the administration of peptides across the stomach
Speaker: Karsten Lindhart – Biograil Ltd
Industry Session
Monday, Jul 14th
4:00 PM – 4:30 PM EDT
16 - Roundtable 2
Speaker: Andy Lewis, BPharm (Hons) PhD (he/him/his) – Quotient Sciences
Speaker: Manuel Sanchez-Felix, PhD (he/him/his) – Halozyme
Speaker: Stephen T. Buckley, PhD – Novo Nordisk
Speaker: Mo Masjedizadeh – Protagonist Therapeutics
Industry Session
Monday, Jul 14th
8:30 AM – 1:00 PM EDT
Biologics Summit Part II: Next Generation Drug Delivery Devices: Facilitating Decentralized Care and Global Access to Biotherapeutics
Industry Session
Monday, Jul 14th
8:30 AM – 8:35 AM EDT
Words of Welcome & Opening
Chair: Beate Bittner, PhD – F. Hoffmann - La Roche
Chair: Simon Matoori, n/a – Université de Montréal
Industry Session
Monday, Jul 14th
8:35 AM – 8:45 AM EDT
Introduction to Nucleic Acid Delivery
Chair and Speaker: Simon Matoori, n/a – Université de Montréal
Industry Session
Monday, Jul 14th
8:45 AM – 9:15 AM EDT
Optimizing Non-Viral Delivery to Enable Gene Editing Therapies
Speaker: Luis Brito, PhD (he/him/his) – Beam Therapeutics
Industry Session
Monday, Jul 14th
9:15 AM – 9:45 AM EDT
Understanding Hypoxia's Impact on mRNA Lipid Nanoparticle Therapies
Speaker: Owen S. Fenton, PhD – University of North Carolina at Chapel Hill
Industry Session
Monday, Jul 14th
9:45 AM – 10:15 AM EDT
Redefining Lung Therapy Through Inhalable RNA Dry Powder Formulations
Speaker: Benjamin Winkeljann, PhD (he/him/his) – Ludwig-Maximilians-University Munich
Industry Session
Monday, Jul 14th
10:30 AM – 11:00 AM EDT
Advancing Glioblastoma Treatment with RNA Vaccines: When Immunotherapy Meets Nanomedicine
Speaker: Flavia Sousa, PhD – University of Groningen
Industry Session
Monday, Jul 14th
11:00 AM – 12:00 PM EDT
Keynote Address
Speaker: Daniel G. Anderson, PhD – Massachusetts Institute of Technology
Industry Session
Monday, Jul 14th
12:00 PM – 12:30 PM EDT
AI-Driven Design of Lipid Nanoparticles for mRNA Delivery
Speaker: Bowen Li, PhD (he/him/his) – University of Toronto
Industry Session
Monday, Jul 14th
12:30 PM – 1:00 PM EDT
Conclusion & Closing Remarks
Chair and Speaker: Beate Bittner, PhD – F. Hoffmann - La Roche
Chair and Speaker: Simon Matoori, n/a – Université de Montréal
Industry Session
Monday, Jul 14th
9:00 AM – 4:30 PM EDT
Workshop: Oral Drug Delivery From Today to Tomorrow: Latest Innovations Best Practices
Industry Session
Sponsored By
Monday, Jul 14th
1:00 PM – 5:00 PM EDT
Workshop: 3D Printing for Precision Drug Release
Industry Session
Sponsored By
Monday, Jul 14th
1:00 PM – 5:00 PM EDT
Workshop: Diagnostics with Phospholipids - Phospholipids for Pharmaceutical Applications
Speaker: Simon Drescher, PD Dr (he/him/his) – Phospholipid Research Center
Speaker: Michael Kahn, PhD – Lipoid, Inc.
Speaker: Alexander Kreft – Lipoid GmbH
Speaker: Christian Nehls
Speaker: Simon Matoori, n/a – Université de Montréal
Virtual Speaker: Klazina Kooiman
Speaker: Samir CHERKAOUI, PhD – BRACCO Suisse
Speaker: Mans Broekgaarden, PhD (he/him/his) – Grenoble-Alpes University, Inserm
Industry Session
Sponsored By
Monday, Jul 14th
1:00 PM – 5:00 PM EDT
Workshop: Clinical Development & Regulatory Pathways of Subcutaneous Formulation for Biologics
Speaker: Beate Bittner, PhD – F. Hoffmann - La Roche
Speaker: Gerard Bruin (he/him/his) – Pharmacokinetic Sciences / Novartis
Industry Session
Sponsored By
Monday, Jul 14th
1:00 PM – 1:10 PM EDT
1 - Welcome & Introductions
Speaker: Yulian Zhang, PhD & MBA – Triastek, Inc.
Industry Session
Monday, Jul 14th
1:10 PM – 1:30 PM EDT
2 - 3D Printing of Pharmaceuticals: From Inception to the Present
Speaker: Xiaoling Li, PhD – Thomas J. Long School of Pharmacy at the University of the Pacific
Industry Session
Monday, Jul 14th
1:30 PM – 2:00 PM EDT
3 - 3D Printing Technologies, Equipment, and Processes for Pharmaceutical Applications
Speaker: Jiancheng Liu – University of the Pacific
Industry Session
Monday, Jul 14th
2:00 PM – 2:45 PM EDT
4 - Accelerating Dosage Form Development through Digital Product Development using 3D printing
Speaker: Xiaoling Li, PhD – Thomas J. Long School of Pharmacy at the University of the Pacific
Industry Session
Monday, Jul 14th
2:45 PM – 3:00 PM EDT
5 - Coffee Break
Industry Session
Monday, Jul 14th
3:00 PM – 3:45 PM EDT
6 - Rapid and Predictable Achievement of Complex PK Profiles In Vivo Via 3D Printing
Speaker: Tim Tracy – Tracy Consultants
Industry Session
Monday, Jul 14th
3:45 PM – 4:30 PM EDT
7 - FDA Perspective on Additive Manufacturing/3D Printing and the Regulatory Approval Process
Speaker: Ahmed Zidan – Center for Drug Evaluation and Research, FDA
Industry Session
Monday, Jul 14th
4:30 PM – 5:00 PM EDT
8 - Panel Q&A
Moderator: Yulian Zhang, PhD & MBA – Triastek, Inc.
Industry Session
Tuesday, Jul 15th
9:00 AM – 10:00 AM EDT
Tech Forum: Innovative excipient technologies for next generation drug delivery systems
Speaker: Elena Draganoiu, PhD – Lubrizol Life Science Health
Speaker: Liliana Miinea, PhD (she/her/hers) – Lubrizol Life Science Health
Industry Session
Sponsored By
Tuesday, Jul 15th
9:00 AM – 10:00 AM EDT
Tech Forum: Molecular modeling and Machine Learning for Drug Formulation
Speaker: John Shelley, PhD – Schrödinger
Speaker: David Nicholson, M.S.CEP, PhD – Schrödinger
Speaker: Benjamin Coscia, PhD – Schrödinger
Industry Session
Sponsored By
Tuesday, Jul 15th
9:00 AM – 10:00 AM EDT
Tech Forum: The Role of a Trusted Partner in Advancing Resorbable Polymers for Controlled Drug Release
Speaker: Nathalie Gonzalez – Corbion
Speaker: Julien Bérard – Corbion
Industry Session
Sponsored By
Tuesday, Jul 15th
9:00 AM – 10:00 AM EDT
Tech Forum: Transforming Nanoparticle Analysis: What Light Scattering Techniques Reveals About LNPs & Liposomes
Speaker: William Penny, Ph.D. – Waters | Wyatt Technology
Industry Session
Sponsored By
Tuesday, Jul 15th
5:30 PM – 6:30 PM EDT
Innovation Showcase
Industry Session
Wednesday, Jul 16th
9:00 AM – 10:00 AM EDT
Tech Forum: Advancing Nucleic Acid Therapeutics: Certest Pharma’s Development of Ionizable Lipids, LNP Platforms,and Targeted Delivery Systems.
Speaker: Jesus Aznar Morales, MBA – Certest Biotec
Speaker: Javier Giménez-Warren, n/a – Certest Biotec
Industry Session
Sponsored By
Wednesday, Jul 16th
9:00 AM – 10:00 AM EDT
Tech Forum: Chroniject Technology: A Solution to Long Acting Injectable Formulation and Scale-Up Challenges
Speaker: Rachel Minrovic (she/her/hers) – Oakwood Labs
Industry Session
Sponsored By
Wednesday, Jul 16th
9:00 AM – 10:00 AM EDT
Tech Forum: Non-viral RNA Delivery with Biodegradable Ionizable Lipids
Speaker: Syed Reza, MD, PhD (he/him/his) – NOF AMERICA Corporation
Industry Session
Sponsored By NOF CORPORATION
Wednesday, Jul 16th
9:00 AM – 10:00 AM EDT
The Recent Advancements in the Gene Delivery Toolbox
Speaker: Kenneth R. Sims, Jr., PhD – Battelle Memorial Institute
Speaker: Alexander Wesselhoeft, PhD – Gene and Cell Therapy Institute (GCTI) at Mass General Brigham (MGB)
Speaker: Ashley Craddick, MBA – Forge Biologics
Industry Session
Sponsored By
Wednesday, Jul 16th
1:00 PM – 2:30 PM EDT
Industry Roundtable: Critical considerations, challenges, opportunities and strategies in development of once a day (QD) formulations
Speaker: Firouz Asgarzadeh – Sagimet
Speaker: Sandip Tiwari, PhD (he/him/his) – BASF
Speaker: Anil Kane – Thermo Fisher Scientific
Speaker: Matt Dawes – Thermo Fisher Scientific
Industry Session
Sponsored By
Thursday, Jul 17th
9:00 AM – 10:00 AM EDT
Tech Forum: Functional Ready-to-Fill Capsules: A Targeted GI Delivery Solution from Pre-Clinical to Commercial
Speaker: Mohammed I. Syed, n/a – Evonik Corporation, St. Johns University
Industry Session
Sponsored By
Thursday, Jul 17th
9:00 AM – 10:00 AM EDT
Tech Forum: Innovations in Oral Delivery of New Drug Modalities
Speaker: Vincent Jannin, n/a – Capsugel France SAS / Lonza
Speaker: Anette Müllertz, n/a (she/her/hers) – University of Copenhagen
Speaker: Joseph O’Shea – Cork University
Industry Session
Sponsored By
Thursday, Jul 17th
9:00 AM – 10:00 AM EDT
Tech Forum: Innovative Strategies for Long-Acting Injectables: Exploring PharmaShell Technology
Speaker: Joel Hellrup, PhD (he/him/his) – Nanexa AB
Speaker: Mårten Rooth – Nanexa AB
Industry Session
Sponsored By
Thursday, Jul 17th
1:00 PM – 2:30 PM EDT
Industry Roundtable: Industry Advances in the Advancement of Long-Acting Therapies - Round Table Discussion with Gilead Sciences
Speaker: Tyler Novak, PhD (he/him/his) – Gilead Sciences
Speaker: Marcus Deloney, PhD – Gilead Sciences
Speaker: Robert C.H Gresham, PhD. (he/him/his) – Gilead Sciences
Speaker: Bhanu Singh, BVSc, MS, DACVP, DABT, Fellow IATP – Gilead Sciences
Industry Session
Sponsored By
Thursday, Jul 17th
3:00 PM – 4:00 PM EDT
Member Startups Session
Industry Session