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Preclinical Form and Formulation for Drug Discovery
Gordon Research Conference

Frontiers of Materials Science in Early Drug Development

Dates

June 4-9, 2017

Location

Stoweflake Conference Center
Stowe, VT

Organizers

Chairs:
Narayan Variankaval & Eric Munson

Vice Chairs:
Karthik Nagapudi & Elizabeth M. Topp

Meeting Description

The 2017 Preclinical Form and Formulation for Drug Discovery Gordon Research Conference will present cutting-edge research on evaluation of appropriate form and enabling formulations for drug candidates to facilitate the mechanistic understanding and development of drug delivery from drug discovery. New topics for this installment of the conference series will focus on cutting-edge characterization tools, emerging modes of production and delivery of pharmaceuticals including 3D printing and devices, advanced biophysical characterization tools and the materials science and engineering aspects of API-excipient interactions. The emerging area of mechano-chemistry as an enabling tool in early drug development will also be highlighted in a session.

The conference will bring together academic and industry leaders in pharmaceutical materials science, preclinical formulation science and bio-pharmaceutics in both the small molecule and biologics areas. Experts will share methodologies that enable the deep mechanistic insights into how different delivery systems work. Additionally, discussions will focus on ways that science and technology could transform the current state in this area and identify further knowledge gaps in scientific understanding and technological capabilities that can be explored and discussed at future conferences.

The conference will highlight topics on amorphous materials - with an emphasis on the science behind understanding the long-term stability and fundamental factors affecting the bio-performance of such enabling platforms. Methods that can improve physical properties of materials, novel formulations that can modulate delivery in a temporal manner, computational methodologies that can aid in predictions, and instrumentation technologies that can be leveraged to understand product performance, will also be explored.

Related Meeting

This GRC was held in conjunction with the "Preclinical Form and Formulation for Drug Discovery" Gordon Research Seminar (GRS). Refer to the associated GRS program page for more information.

Contributors

Meeting Program

Sunday
2:00 pm - 9:00 pmArrival and Check-in
6:00 pmDinner
7:30 pm - 7:40 pmWelcome / Introductory Comments by GRC Site Staff
7:40 pm - 9:30 pmKeynote Session: Drugs as Materials
Discussion Leader: Karthik Nagapudi (Genentech, USA)
7:40 pm - 8:20 pmRonald Smith (Merck Research Laboratories, USA)
"The Formulator's Fab Five: Form, Function, Formulation, Fit and Foresight"
8:20 pm - 8:35 pmDiscussion
8:35 pm - 9:15 pmDaniel Anderson (Massachusetts Institute of Technology, USA)
"Nano Particulate RNA Delivery and In Vivo Genome Editing"
9:15 pm - 9:30 pmDiscussion
Monday
7:30 am - 8:30 amBreakfast
8:30 amGroup Photo
9:00 am - 12:30 pmAdvanced Characterization Techniques for Small Molecules
Discussion Leader: Joseph Lubach (Genentech, USA)
9:00 am - 9:40 amDan Fu (University of Washington, USA)
"Imaging Drug Formulation with Stimulated Raman Scattering Microscopy"
9:40 am - 10:00 amDiscussion
10:00 am - 10:30 amCoffee Break
10:30 am - 11:10 amAaron Rossini (Iowa State University, USA)
"Sensitizing Solid-State NMR Spectroscopy for the Characterization of Pure and Formulated APIs"
11:10 am - 11:30 amDiscussion
11:30 am - 12:10 pmAxel Zeitler (University of Cambridge, United Kingdom)
"Applications of Terahertz Spectroscopy in Pharmaceutical Development"
12:10 pm - 12:30 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
3:00 pm - 4:00 pmPower Hour
The GRC Power Hour is an optional informal gathering open to all meeting participants. It is designed to help address the challenges women face in science and support the professional growth of women in our communities by providing an open forum for discussion and mentoring.
Organizers: Julie Champion (Georgia Institute of Technology, USA) and Annette Bak (AstraZeneca, Sweden)
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:30 pm - 9:30 pmAmorphous Pharmaceuticals: New Insights into Predicting Stability and Designing Formulations
Discussion Leader: Mike Morgen (Capsugel, USA)
7:30 pm - 8:00 pmMarian Paluch (University of Silesia in Katowice, Poland)
"The Molecular Factors Relevant for the Physical Stability of Amorphous Drugs"
8:00 pm - 8:10 pmDiscussion
8:10 pm - 8:40 pmMichael Pikal (University of Connecticut, USA)
"The Impact of Specific Surface Area (SSA) on Stability of Amorphous Pharmaceuticals"
8:40 pm - 8:50 pmDiscussion
8:50 pm - 9:20 pmGeoff Zhang (AbbVie Inc., USA)
"Amorphous Solid Dispersion of Poorly Soluble Drugs: Understanding the Enhanced Dissolution and Absorption"
9:20 pm - 9:30 pmDiscussion
Tuesday
7:30 am - 8:30 amBreakfast
9:00 am - 12:30 pmNovel Manufacturing Methods
Discussion Leader: Adam Procopio (Merck Research Laboratories, USA)
9:00 am - 9:40 amMatthew Becker (University of Akron, USA)
"Protein and Small Molecule Delivery from Poly(ester Urea)s"
9:40 am - 10:00 amDiscussion
10:00 am - 10:30 amCoffee Break
10:30 am - 11:10 amLee Cronin (University of Glasgow, United Kingdom)
"Digitising Matter: From 3D Printed Reactionware to Robotics"
11:10 am - 11:30 amDiscussion
11:30 am - 12:10 pmJennifer Lewis (Harvard University, USA)
"Printing Soft Matter in Three Dimensions"
12:10 pm - 12:30 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:30 pm - 9:30 pmAdvances in the Delivery of Bio-Therapeutics
Discussion Leader: Elizabeth Topp (Purdue University, USA)
7:30 pm - 8:00 pmJulie Champion (Georgia Institute of Technology, USA)
"Assembly of Therapeutic Proteins into Structures that Enable Their Delivery"
8:00 pm - 8:10 pmDiscussion
8:10 pm - 8:40 pmDavid Mooney (John A. Paulson School of Engineering and Applied Sciences, Harvard University, USA)
"Hydrogel-Based Drug Delivery: Preprogrammed to On-Demand"
8:40 pm - 8:50 pmDiscussion
8:50 pm - 9:20 pmEugene Cheung (Moderna Therapeutics, USA)
"Dissecting Lipid Nanoparticle-Based mRNA Delivery"
9:20 pm - 9:30 pmDiscussion
Wednesday
7:30 am - 8:30 amBreakfast
9:00 am - 12:30 pm

Advanced Methods in the Biophysical Characterization of Large Molecules

Discussion Leader: Kunal Bakshi (GlaxoSmithKline, USA)
9:00 am - 9:40 amJason Cheung (Merck, USA)
"The Use of Biophysical Characterization During Product Development"
9:40 am - 10:00 amDiscussion
10:00 am - 10:30 amCoffee Break
10:30 am - 11:10 amWei Qiang (Binghamton University, State University of New York, USA)
"Mechanisms of the Membrane Insertion of pHLIP Induced by Residue-Specific Protonation and Its Applications in Drug Delivery"
11:10 am - 11:30 amDiscussion
11:30 am - 12:10 pmCindy Ren (Amgen, USA)
"Emerging Automated Technologies for Miniaturized Formulation Development"
12:10 pm - 12:30 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:00 pm - 7:30 pmBusiness Meeting
Nominations for the Next Vice Chair; Fill in Conference Evaluation Forms; Discuss Future Site and Scheduling Preferences; Election of the Next Vice Chair
7:30 pm - 9:30 pmPredictive Sciences in Form and Formulation Development
Discussion Leader: Jonathan Miller (Vertex Pharmaceuticals, Inc., USA)
7:30 pm - 8:00 pmYuriy Abramov (Pfizer R&D, USA)
"In Silico Solid-State Chemistry Applications in Pharmaceutical Industry"
8:00 pm - 8:10 pmDiscussion
8:10 pm - 8:40 pmFilippos Kesisoglou (Merck & Co., Inc., USA)
"Quantitative Biopharmaceutics: Use of Modeling and Simulation to Inform API and Formulation Decisions"
8:40 pm - 8:50 pmDiscussion
8:50 pm - 9:20 pmAlexandre Tkachenko (University of Luxembourg, Luxembourg)
"Accurate and Affordable Calculation of Polymorphic Lattice (Free) Energies: Are We There Yet?"
9:20 pm - 9:30 pmDiscussion
Thursday
7:30 am - 8:30 amBreakfast
9:00 am - 12:30 pmAdvances in the Delivery of Small Molecules
Discussion Leader: Annette Bak (AstraZeneca, Sweden)
9:00 am - 9:40 amAnette Mullertz (University of Copenhagen, Denmark)
"Tuning Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) Towards the Desired Drug Absorption Profile"
9:40 am - 10:00 amDiscussion
10:00 am - 10:30 amCoffee Break
10:30 am - 11:10 amKarthik Rajagopal (Genentech, USA)
"Development of Polymer-Based Sustained Release Formulations for Protein and Peptide Delivery"
11:10 am - 11:30 amDiscussion
11:30 am - 12:10 pmYoon Yeo (Purdue University, USA)
"Carrier-Free Delivery of Anti-Cancer Drugs"
12:10 pm - 12:30 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:30 pm - 9:30 pmMechanochemistry: From Co-Crystals to Peptides
Discussion Leader: Tomislav Friscic (McGill University, Canada)
7:30 pm - 8:00 pmDuncan Browne (Cardiff University, United Kingdom)
"Mechanochemistry for Organic Synthesis: Expect the Unexpected"
8:00 pm - 8:10 pmDiscussion
8:10 pm - 8:40 pmWilliam Jones (University of Cambridge, United Kingdom)
"Mechanochemistry as a Solid Form Screening Approach in Drug Development"
8:40 pm - 8:50 pmDiscussion
8:50 pm - 9:20 pmFrederic Lamaty (CNRS, France)
"May the Mechanical Force Be with You: The Case of Peptides and Organometallics"
9:20 pm - 9:30 pmDiscussion
Friday
7:30 am - 8:30 amBreakfast
9:00 amDeparture

Research reported in this publication was supported by the National Center For Advancing Translational Sciences of the National Institutes of Health under Award Number 1R13TR001914-01A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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