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Preclinical Form & 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 Site Information

Organizers

Chairs:
Narayan Variankaval & Eric Munson

Vice Chairs:
Karthik Nagapudi & Elizabeth M. Topp

Application Deadline

Applications for this meeting must be submitted by May 7, 2017. Please apply early, as some meetings become oversubscribed (full) before this deadline. If the meeting is oversubscribed, it will be stated here. Note: Applications for oversubscribed meetings will only be considered by the Conference Chair if more seats become available due to cancellations.

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 will be held in conjunction with the "Preclinical Form & Formulation for Drug Discovery" Gordon Research Seminar (GRS). Those interested in attending both meetings must submit an application for the GRS in addition to an application for the GRC. 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
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: David Vodak (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 (Abbott Laboratories, 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 pmAdvances in the Delivery of Small Molecules
Discussion Leader: Annette Bak (AstraZeneca, Sweden)
7:30 pm - 8:00 pmAnette Mullertz (University of Copenhagen, Denmark)
"Tuning Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) Towards the Desired Drug Absorption Profile"
8:00 pm - 8:10 pmDiscussion
8:10 pm - 8:40 pmKarthik Rajagopal (Genentech, USA)
"Development of Polymer-Based Sustained Release Formulations for Protein and Peptide Delivery"
8:40 pm - 8:50 pmDiscussion
8:50 pm - 9:20 pmYoon Yeo (Purdue University, USA)
"Carrier-Free Delivery of Anti-Cancer Drugs"
9:20 pm - 9:30 pmDiscussion
Thursday
7:30 am - 8:30 amBreakfast
9:00 am - 12:30 pm

Predictive Sciences in Form and Formulation Development

Discussion Leader: Jonathan Miller (Vertex Pharmaceuticals, Inc., USA)
9:00 am - 9:40 amYuriy Abramov (Pfizer R&D, USA)
"In Silico Solid-State Chemistry Applications in Pharmaceutical Industry"
9:40 am - 10:00 amDiscussion
10:00 am - 10:30 amCoffee Break
10:30 am - 11:10 amFilippos Kesisoglou (Merck & Co., Inc., USA)
"Quantitative Biopharmaceutics: Use of Modeling and Simulation to Inform API and Formulation Decisions"
11:10 am - 11:30 amDiscussion
11:30 am - 12:10 pmAlexandre Tkachenko (University of Luxembourg, Luxembourg)
"Accurate and Affordable Calculation of Polymorphic Lattice (Free) Energies: Are We There Yet?"
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
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