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Showing of Streams
12:00pm - 1:00pm

Close of Morning Workshops and Lunch

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Showing of Streams
5:00pm - 5:30pm

Close of Afternoon Workshops

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5:30pm - 8:30pm
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TIDES Brewery Event, Co-Sponsored by Thermo Fisher Scientific and KNect365

See what’s brewing at Harpoon! Join us at this exclusive TIDES event at the Harpoon Brewery & Beer Hall, located in Boston's Seaport District. Harpoon offers a full selection of Harpoon beers straight from the source along with delicious pretzels to pair with your pint. Cap off your evening by taking a guided tour of the brewery or challenge a coworker to a game of giant Jenga! This is the perfect place to enjoy beer with TIDES attendees and our sponsor Thermo Fisher Scientific.

All registered TIDES attendees are welcome to RSVP, but space is limited! Registered attendees may RSVP here: https://www.surveymonkey.com/r/TIDES2018breweryRSVP

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7:00am - 8:00am 60 mins
Workshop Registration
8:00am - 8:15am 15 mins
Half-Day AM Workshop 1: Mass Spectrometry for Peptides and Oligonucleotides
Workshop Leader's Welcome and Opening Remarks
  • Workshop Leader Fanyu Meng, PhD - Principal Scientist, Analytical Research and Development, Merck Research Labs
8:00am - 8:15am 15 mins
Half-Day AM Workshop 2: An Introduction to messenger RNA (mRNA) Therapeutics
Workshop Leader's Welcome and Opening Remarks
  • Workshop Leader James Thompson, PhD - Head of CMC Project Management, Moderna Therapeutics, Inc.
8:00am - 8:20am 20 mins
Info
Half-Day AM Workshop 3: Risk-based Approaches to CMC Development of Therapeutic Oligonucleotides
Workshop Co-Leaders' Welcome and Opening Remarks
  • Workshop Co-Leader G. Susan Srivatsa, PhD - President, ElixinPharma
  • Workshop Co-Leader Fran Wincott, PhD - President, Wincott & Associates, LLC

There is a growing trend in the pharmaceutical industry towards accelerated development of therapeutics to address unmet medical needs. The shorter timelines coupled with increasing complexity of the development candidates and/or delivery systems presents extraordinary challenges for managing the chemistry, manufacturing and controls activities. Key to regulatory and operational success is a risk based approach to management of manufacturing, product quality and supply chain. This workshop will address important concepts for balancing and mitigating a variety of risks (safety, economic or regulatory, etc.) towards successful clinical development, regulatory approval and commercialization of therapeutic oligonucleotides.

8:00am - 8:15am 15 mins
Half-Day AM Workshop 4: Novel Technologies for Manufacturing Peptides
Workshop Leader's Welcome and Opening Remarks
  • Workshop Leader Trishul Shah, MS - Director Business Development, PolyPeptide Laboratories Inc.
8:15am - 8:45am 30 mins
Info
Half-Day AM Workshop 1: Mass Spectrometry for Peptides and Oligonucleotides
Contribution of High Resolution Mass Spectrometry in Synthetic Peptides: Importance of Detailed Impurity Characterization for Better Manufacturing
  • David Cosquer - Mass Spectrometry Specialist, Polypeptide

Characterizing large peptide impurities with confidence is a challenge. Affordable High Resolution Mass Spectrometry (HRMS) systems, coupled to UHPLC open new opportunities. This presentation will show through real case studies, how in-house HRMS technology allows fast identification and enables chemists to build up knowledge for better manufacturing processes.

8:15am - 9:00am 45 mins
Half-Day AM Workshop 2: An Introduction to messenger RNA (mRNA) Therapeutics
Introduction to mRNA Therapeutics
  • James Thompson, PhD - Head of CMC Project Management, Moderna Therapeutics, Inc.
8:15am - 8:45am 30 mins
Info
Half-Day AM Workshop 4: Novel Technologies for Manufacturing Peptides
Chemo-enzymatic Synthesis (CEPS) of Exenatide: Laboratory Scale Development
  • Timo Nuijens, PhD - Lead Scientist, EnzyPep B.V.

Chemo-enzymatic peptide synthesis (CEPS) technologies present the opportunity to manufacture long peptides with very significantly increased yields. This has been demonstrated at benchtop scale for the 39-mer peptide exenatide using a 21-mer peptide ester and an 18-mer peptide, where the "peptiligase" coupling efficiency exceeded 97% and the final overall yield exceeded 50%. In particular, the fragment strategy, choise or C-terminal ester, enzyme development and reaction design at gram scale will be elaborated.

8:20am - 9:00am 40 mins
Half-Day AM Workshop 3: Risk-based Approaches to CMC Development of Therapeutic Oligonucleotides
Selection and Justification of Regulatory Starting Materials
  • Paul McCormac, PhD - Executive Director, Pfizer Bio-therapeutic Pharmaceutical Sciences
8:45am - 9:15am 30 mins
Info
Half-Day AM Workshop 1: Mass Spectrometry for Peptides and Oligonucleotides
LC/MS Oligonucleotide Mass Fingerprinting Enables Rapid Characterization of Critical Quality Attributes in Therapeutic mRNA
  • Serenus Hua, PhD - Senior Scientist, Moderna Therapeutics

Recent advances towards mRNA therapeutics prompt a need for robust analytical methods capable of characterizing this new class of drugs. We demonstrate the use of specific enzymatic digestions followed by LC/MS mass fingerprinting to evaluate the critical quality attributes (CQAs) of mRNA therapeutics.

8:45am - 9:00am 15 mins
Half-Day AM Workshop 4: Novel Technologies for Manufacturing Peptides
Cost Efficient Peptide Purification via ZEOsphere DRP Mixed-Mode Chromatography
  • Jurgen Machielse - Business Development Director Spherical Gels, Zeochem AG
9:00am - 10:00am 60 mins
Info
Half-Day AM Workshop 2: An Introduction to messenger RNA (mRNA) Therapeutics
Design and Manufacturing of Chemically Modified Messenger RNA Therapeutics
  • Anton McCaffrey, PhD - Senior Director of Research and Development, Biology, TriLink BioTechnologies, Inc.

Messenger RNA (mRNA) therapeutics are an exciting new modality for genome editing, gene replacement, antibody expression and vaccines. A broad overview of mRNA applications, design, manufacturing, quality control and GMP production will be provided.

9:00am - 9:40am 40 mins
Half-Day AM Workshop 3: Risk-based Approaches to CMC Development of Therapeutic Oligonucleotides
Impurities in Oligonucleotide Drug Substances and Drug Products: Safety Considerations
  • Tom Zanardi, PhD - Director, Toxicology, Ionis Pharmaceuticals
9:00am - 9:30am 30 mins
Info
Half-Day AM Workshop 4: Novel Technologies for Manufacturing Peptides
Towards Commercial Manufacturing of Therapeutic Peptides Using Chemo-enzymatic Peptide Synthesis (CEPS)
  • Jan Pawlas, PhD - Scientist, PolyPeptide Group

Chemo-enzymatic peptide synthesis (CEPS) has recently emerged as a powerful tool for the synthesis of a wide range of peptides and proteins.1 Using Exenatide as a model substrate we report an industrial assessment of various aspects of the CEPS technology from the standpoint of large scale cGMP production of peptide based drugs.

9:15am - 9:45am 30 mins
Info
Half-Day AM Workshop 1: Mass Spectrometry for Peptides and Oligonucleotides
Assessment of Peptide Metabolism at the Subcutaneous Injection Site by Liquid Chromatography-high Resolution Mass Spectrometry
  • Simone Esposito, PhD - DMPK Research Scientist, IRBM Science Park

Subcutaneous injection is the most common administration route for peptide therapeutics. Catabolism at the injection site can be a major degradation pathway for many peptides, and in some cases it can significantly affect pharmacokinetics, particularly bioavailability. The presentation will describe the development and the application of a liquid chromatography-high resolution mass spectrometry-based in vitro assay to study the metabolic stability in the subcutaneous tissue of peptides in human and preclinical species (rat and minipig). The assay allows for the simultaneous determination of degradation rate (half-life) of the parent peptide and identification of metabolites generated from enzymatic proteolysis. Validation was first performed using known therapeutic peptides such as human insulin, GLP-1 and LHRH analogs. Finally, the method was successfully applied in a real peptide drug discovery scenario, showing a good correlation between in vitro metabolic stability and in vivo bioavailability after SC administration in rats, but also between in vitro and in vivo metabolism. The implementation of this assay in the screening cascade can be beneficial in many ways, including the possibility to drive the synthesis of peptides with higher bioavailability and prioritize compounds for in vivo studies, thus reducing the number of in vivo procedures.

9:30am - 10:00am 30 mins
Info
Half-Day AM Workshop 4: Novel Technologies for Manufacturing Peptides
Bringing Continuous Manufacturing into Peptide Manufacturing
  • Andreas Segerros - CEO, Swedish Biomimetics 3000® Ltd

SB3000 are working with a disruptive technology for continuous manufacturing of peptides. The benefits are many; notably no need for scale up processes, a very predictable and transparent manufacturing process leading to pristine data on both purity and yield. This address both the FDA’s push for more predictable manufacturing processes, and environmental and cost issues facing the manufacturing society.

9:40am - 10:10am 30 mins
Half-Day AM Workshop 3: Risk-based Approaches to CMC Development of Therapeutic Oligonucleotides
Networking Refreshment Break
9:45am - 10:15am 30 mins
Half-Day AM Workshop 1: Mass Spectrometry for Peptides and Oligonucleotides
Networking Refreshment Break
10:00am - 10:30am 30 mins
Half-Day AM Workshop 2: An Introduction to messenger RNA (mRNA) Therapeutics
Networking Refreshment Break
10:00am - 10:30am 30 mins
Half-Day AM Workshop 4: Novel Technologies for Manufacturing Peptides
Networking Refreshment Break
10:10am - 10:50am 40 mins
Info
Half-Day AM Workshop 3: Risk-based Approaches to CMC Development of Therapeutic Oligonucleotides
Planning for Oligonucleotide Supply: Personalized Medicine to Large Scale Markets
  • Hans Kistemaker, PhD - Senior Scientist, Chemistry & Manufacturing, ProQR Therapeutics

During this workshop we will present the broad and diverse pipeline of ProQR Therapeutics and the focus will be on the planning and manufacturing of drug substance supply for the different (pre-)clinical programs within ProQR. Moreover, we will discuss the challenges associated with having very different DS supply needs in combination with very short and strict timelines.

10:15am - 10:45am 30 mins
Info
Half-Day AM Workshop 1: Mass Spectrometry for Peptides and Oligonucleotides
Oligonucleotide Characterization: Applications and Uses of Mass Spectrometry
  • Gangani Silva, PhD - Senior Scientist, Analytical Development, Nitto Avecia

At Avecia, mass spectrometers of varying capabilities are used in variety of oligonucleotide characterization studies. These include molecular weight determinations, sequence confirmations, and impurities characterization. Different approaches along with appropriate examples will be presented; suitability of different mass spectrometers for each characterization will also be discussed.

10:30am - 11:00am 30 mins
Half-Day AM Workshop 2: An Introduction to messenger RNA (mRNA) Therapeutics
Delivery Strategies for mRNAs
  • Luis Brito, PhD - Director, Formulation Design, Moderna Therapeutics
10:30am - 11:00am 30 mins
Half-Day AM Workshop 4: Novel Technologies for Manufacturing Peptides
Group-Assisted Purification (GAP) Technology and Its Future Potential for Peptide Synthesis
  • Cole Seifert, PhD - Chief Scientific Officer, GAP Peptides, LLC
10:45am - 11:15am 30 mins
Info
Half-Day AM Workshop 1: Mass Spectrometry for Peptides and Oligonucleotides
LC Peak Purity Assessment Using a Novel LC-MS Data Processing Approach
  • Patrik Plattner, PhD - Group Leader Mass Spectrometry Service, Bachem AG

MS coupled to the HPLC-purity-method is used within a comprehensive control strategy to ensure product quality. Therefore, MS is rapidly developing into a routine QC technology. With our approach we address this challenge by an efficient LC-UV-MS peak purity workflow allowing to fully exploit the capabilities of state-of-the-art MS analysis.

10:50am - 11:30am 40 mins
Half-Day AM Workshop 3: Risk-based Approaches to CMC Development of Therapeutic Oligonucleotides
Case Study: Evolution of the Rent, Buy or DIY Strategy
  • Lubomir Nechev, PhD - Vice President, Process Sciences, Alnylam Pharmaceuticals, Inc.
11:00am - 11:30am 30 mins
Half-Day AM Workshop 2: An Introduction to messenger RNA (mRNA) Therapeutics
Applications of mRNA Therapeutics
  • Patrick Baumhof, PhD - Vice President, Formulation & Delivery, CureVac AG
11:00am - 11:30am 30 mins
Info
Half-Day AM Workshop 4: Novel Technologies for Manufacturing Peptides
Unlocking the Potential for the Future of SPPS
  • Jon Holbech Rasmussen, Ph.D. - Director Global Development, PolyPeptide Group, Belgium

The SPPS technology is now more than 50 years old, and it is acknowledged as the most versatile standard approach for making peptides. Still, the biphasic system, where the product-being-made is attached to the solid phase, presents a number of challenges for developing and executing highly efficient processes in a complex environment. To overcome these challenges, there is a need for an increased level of process and chemistry understanding and control of the actual systems. By taking a look at the processes with a renewed combination of theoretical and practical tools, the first steps in generating further understanding are taken. In this presentation concepts and data are shared.

11:15am - 11:45am 30 mins
Info
Half-Day AM Workshop 1: Mass Spectrometry for Peptides and Oligonucleotides
Mass Spectrometry Methodologies for Analytical Control of Synthetic Oligonucleotides
  • Fanyu Meng, PhD - Principal Scientist, Analytical Research and Development, Merck Research Labs

Synthetic oligonucleotides hold great potential to serve as therapeutics for the treatment of human diseases. In this presentation, we illustrate how different mass spectrometry methodologies can be used to characterize these complex molecules.

11:30am - 12:00pm 30 mins
Half-Day AM Workshop 2: An Introduction to messenger RNA (mRNA) Therapeutics
Panel Discussion and Q&A
11:30am - 12:00pm 30 mins
Half-Day AM Workshop 3: Risk-based Approaches to CMC Development of Therapeutic Oligonucleotides
Panel Discussion
11:30am - 12:00pm 30 mins
Half-Day AM Workshop 4: Novel Technologies for Manufacturing Peptides
Panel Discussion
11:45am - 12:00pm 15 mins
Half-Day AM Workshop 1: Mass Spectrometry for Peptides and Oligonucleotides
Concluding Remarks and Discussion
12:00pm - 1:00pm 60 mins
Close of Morning Workshops and Lunch
1:00pm - 1:15pm 15 mins
Half-Day PM Workshop 5: Peptide Aggregation Challenges from API to Drug Product
Workshop Leader's Welcome and Opening Remarks
  • Workshop Leader Trishul Shah, MS - Director Business Development, PolyPeptide Laboratories Inc.
1:00pm - 1:15pm 15 mins
Half-Day PM Workshop 6: An Introduction to CRISPR and Genome Editing Applications
Workshop Leader's Welcome and Opening Remarks
  • Workshop Leader Cecilia Fernández, PhD - Director, Platform Development, Editas Medicine
1:00pm - 1:10pm 10 mins
Half-Day PM Workshop 7: Lessons from the Peptide Field that Can be Applied to Oligonucleotides
Workshop Leader's Welcome and Opening Remarks
  • Workshop Leader Gary Musso, PhD - President, Musso and Associates LLC
1:00pm - 1:15pm 15 mins
Half-Day PM Workshop 8: The Path to a Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Workshop Leader's Welcome and Opening Remarks
  • Workshop Leader Jennifer Lockridge, PhD - Senior Vice President, Program Development, Dicerna Pharmaceuticals, Inc.
1:10pm - 1:35pm 25 mins
Half-Day PM Workshop 7: Lessons from the Peptide Field that Can be Applied to Oligonucleotides
Introductory Presentation on Peptide Chemistry
  • Michael Verlander, D.Phil. - President, Proactive Quality Compliance, Inc.
1:15pm - 2:00pm 45 mins
Half-Day PM Workshop 5: Peptide Aggregation Challenges from API to Drug Product
Peptide Aggregation
  • Juerg Tschopp, PhD - Chief Executive Officer & President, Stratum Medical Corporation
1:15pm - 1:45pm 30 mins
Info
Half-Day PM Workshop 6: An Introduction to CRISPR and Genome Editing Applications
CRISPR's Road to the Clinic
  • TJ Cradick, PhD - Head of Genome Editing, CRISPR Therapeutics

This talk will include an introduction to using CRISPR, starting with the repurposing of the bacterial adaptive immune system, CRISPR's use as a research tool, and therapeutic uses. This overview will include different Cas9 system, choice of target sites, high-throughput testing, preclinical assays, an overview of bioinformatics and the path to therapeutic use.

1:15pm - 2:00pm 45 mins
Info
Half-Day PM Workshop 8: The Path to a Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Regulatory Perspectives and Points to Consider in Making Successful Oligonucleotide IND/CTA Submissions
  • Paul Manley - President and Principal Consultant, Orvieto Consulting

FDA and EU National Authorities have similar approaches to review and approval of clinical trials, however key areas of difference need to be understood to achieve successful applications. This presentation provides advice for oligonucleotide companies covering: 1) Pre-submission dialogue 2) Differences in application content and Regulatory Agency review approaches and 3) Commitments during and after trial completion.

1:35pm - 2:00pm 25 mins
Half-Day PM Workshop 7: Lessons from the Peptide Field that Can be Applied to Oligonucleotides
Synergy between Synthesis of Oligonucleotide and Peptide: From Concepts to Practical Applications
  • Yogesh Sanghvi, PhD - President, Rasayan Inc.
1:45pm - 2:15pm 30 mins
Info
Half-Day PM Workshop 6: An Introduction to CRISPR and Genome Editing Applications
Development of High Quality CRISPR/CAS9 Agents
  • Terence Ta, PhD - Scientist II, Editas Medicine

We will discuss recent advancements at Editas, developing technologies that drive reagent quality and enable evaluation of safe and effective CRISPR-based medicines. These include aspects of our methods and quality control processes for guide RNA and ribonucleoprotein complexation, as well as novel guide RNA chemistries.

2:00pm - 2:45pm 45 mins
Info
Half-Day PM Workshop 5: Peptide Aggregation Challenges from API to Drug Product
Assessment of Deamidation and Aggregation of Peptide Variants
  • Mohammad Al-Sayah, PhD - Senior Scientist and Group Leader, Small Molecule Analytical Chemistry, Genentech, Inc.

Deamidation and aggregation were observed during the chemical synthesis and during the release of a peptide from the formulated product. This presentation will focus on the assessment of different peptide variants designed to mitigate these risks and allow the nomination of a more stable peptide for clinical development.

2:00pm - 2:45pm 45 mins
Half-Day PM Workshop 7: Lessons from the Peptide Field that Can be Applied to Oligonucleotides
A Triple Contemplation - Regulatory Considerations on Recombinant Proteins, Synthetic Peptides and Oligonucleotides
  • René Thürmer, PhD - Deputy Head, Unit Pharmaceutical Biotechnology, BfArM Federal Institute for Drugs and Medical Devices
2:00pm - 2:45pm 45 mins
Half-Day PM Workshop 8: The Path to a Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
CMC Perspectives on Oligonucleotides
  • Vidhya Gopalakrishnan, Ph.D. - Senior Vice President, Quark Pharmaceuticals
2:15pm - 2:45pm 30 mins
Info
Half-Day PM Workshop 6: An Introduction to CRISPR and Genome Editing Applications
Genome instability and Cas9 specificity
  • Thomas Barnes, PhD - Senior Vice President, Innovative Sciences, Intellia Therapeutics

Mammalian genomes contain tens of thousands of sites where DNA double-strand breaks (DSBs) occur, many recurrently. We find that a significant number of nominal Cas9 off-target sites are in fact background DSBs, suggesting that background DSBs can inflate measures of Cas9 imprecision. Allowing for this, we find ~45% of guides under our standard conditions have no detected off-target activity.

2:45pm - 3:15pm 30 mins
Half-Day PM Workshop 5: Peptide Aggregation Challenges from API to Drug Product
Networking Refreshment Break
2:45pm - 3:15pm 30 mins
Half-Day PM Workshop 6: An Introduction to CRISPR and Genome Editing Applications
Networking Refreshment Break
2:45pm - 3:15pm 30 mins
Half-Day PM Workshop 7: Lessons from the Peptide Field that Can be Applied to Oligonucleotides
Networking Refreshment Break
2:45pm - 3:15pm 30 mins
Half-Day PM Workshop 8: The Path to a Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Networking Refreshment Break
3:15pm - 4:00pm 45 mins
Info
Half-Day PM Workshop 5: Peptide Aggregation Challenges from API to Drug Product
The Effect of Peptide Aggregation on Downstream Purification: A DISASTER
  • Imre Sallay, PhD - Manager, Technical Sales, DAISOGEL Group, Osaka Soda Co., Ltd

The biggest RP silica based HPLC process is doomed by the strong tendency of insulin and its analogues to aggregate on the column. CIP (Cleaning in Place) by aggressive solvents is necessary to balance process economy. The development process of better separation tools (stationary phases) will be discussed using real industrial examples.

3:15pm - 3:45pm 30 mins
Info
Half-Day PM Workshop 6: An Introduction to CRISPR and Genome Editing Applications
Peptide Technology to Deliver CRISPR Ribonucleoprotein in Cells
  • David Guay, PhD - Research Director, Feldan Therapeutics

To fulfill a need for non-viral delivery methods intended for ex vivo cell therapy and in vivo local administration, we developed a peptide-based technology that enables efficient entry of CRISPR ribonucleoprotein complex in cells. These amphiphilic cationic peptides are optimized to deliver proteins in hard-to-transfect cells, including Natural Killer and airway epithelia cells.


3:15pm - 3:40pm 25 mins
Info
Half-Day PM Workshop 7: Lessons from the Peptide Field that Can be Applied to Oligonucleotides
An Engineer's Perspective on Oligonucleotide Manufacturing and Applications from the Peptide Field
  • Christina Nacos - Associate Director, Oligonucleotides, Corden Pharma Colorado

Corden Pharma Colorado has an impressive track record in peptide manufacturing innovation. Applications and technologies from our peptide learnings are considered for oligonucleotide manufacturing processes. The traditional oligonucleotide production concepts are challenged from an engineer's perspective and new approaches to manufacturing will be presented.

3:15pm - 4:00pm 45 mins
Info
Half-Day PM Workshop 8: The Path to a Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Considerations for the Early Preclinical Development of Oligonucleotide-based Therapeutics
  • Sarah Voytek, PhD - Associate Director, Preclinical Development, Bluebird Bio

Decades after the first clinical testing of oligotherapeutic drugs, there exists a sparsity of specific regulatory guidances to aid in the appropriate design of preclinical programs for this class of molecules. This presentation will summarize key considerations for the successful preclinical development of oligonucleotide drugs, including selection of appropriate animal models, test article controls, dose scaling, pharmacokinetic determinations, and special study design considerations.

3:40pm - 4:05pm 25 mins
Info
Half-Day PM Workshop 7: Lessons from the Peptide Field that Can be Applied to Oligonucleotides
Alternative Manufacturing Strategies and Concepts Used on Peptides; Considerations for Use in Oligonucleotides
  • Gary Musso, PhD - President, Musso and Associates LLC

Peptides and Oligonucleotides often use a manufacturing process train of SPPS for synthesis, a deprotection step, purification by chromatography and isolation by lyophilization. Alternative  or telescoped processes that have been successfully used for some peptides.  Examples or case studies for these will be presented.  In addition, some hypothetical concepts will be introduced that could also transform processes for both “Tides”.

3:45pm - 4:15pm 30 mins
Info
Half-Day PM Workshop 6: An Introduction to CRISPR and Genome Editing Applications
Delivery of CRISPR/Cas RNP Using Polymer Nanoparticle System
  • Kunwoo Lee, PhD - Chief Executive Officer, GenEdit

Delivery is a key challenge in developing CRISPR based therapeutics. In this presentation, I will present polymer based delivery systems for CRISPR/Cas ribonucleoprotein. In vivo proof-of-concept data in muscle tissue and other tissues will be presented.


4:00pm - 4:30pm 30 mins
Info
Half-Day PM Workshop 5: Peptide Aggregation Challenges from API to Drug Product
Solid-State NMR Investigation of Insoluble Aggregation of Peptide Drugs
  • Yongchao Su, PhD - Associate Principal Scientist, Merck & Co. Inc.

We present the first study in pharmaceutical sciences that the structure of insoluble aggregate of a representative peptide drug has been determined at a molecular level. This enables us to identify residues that lead to backbone rearrangement, which can facilitate optimization of peptide drugs with lower risks of aggregation.

4:00pm - 4:30pm 30 mins
Half-Day PM Workshop 8: The Path to a Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Case Study: Lessons Learned from IND/IMPD Submissions for DCR-PH1, A Synthetic siRNA in a Lipid Nanoparticle Formulation
  • Jennifer Lockridge, PhD - Senior Vice President, Program Development, Dicerna Pharmaceuticals, Inc.
4:05pm - 4:30pm 25 mins
Half-Day PM Workshop 7: Lessons from the Peptide Field that Can be Applied to Oligonucleotides
Peptide and Oligonucleotide Therapeutics: Bioanalytical Challenges and Lessons Learned
  • Rafiq Islam - Senior Director, Bioanalytical Services, Celerion, Inc.
4:15pm - 5:00pm 45 mins
Half-Day PM Workshop 6: An Introduction to CRISPR and Genome Editing Applications
Panel Discussion
4:30pm - 5:00pm 30 mins
Half-Day PM Workshop 5: Peptide Aggregation Challenges from API to Drug Product
Panel Discussion
4:30pm - 5:00pm 30 mins
Half-Day PM Workshop 7: Lessons from the Peptide Field that Can be Applied to Oligonucleotides
Panel Discussion
  • Moderator Gary Musso, PhD - President, Musso and Associates LLC
4:30pm - 5:00pm 30 mins
Half-Day PM Workshop 8: The Path to a Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Panel Discussion
5:00pm - 5:30pm 30 mins
Close of Afternoon Workshops
5:30pm - 8:30pm 180 mins
Info
TIDES Brewery Event, Co-Sponsored by Thermo Fisher Scientific and KNect365

See what’s brewing at Harpoon! Join us at this exclusive TIDES event at the Harpoon Brewery & Beer Hall, located in Boston's Seaport District. Harpoon offers a full selection of Harpoon beers straight from the source along with delicious pretzels to pair with your pint. Cap off your evening by taking a guided tour of the brewery or challenge a coworker to a game of giant Jenga! This is the perfect place to enjoy beer with TIDES attendees and our sponsor Thermo Fisher Scientific.

All registered TIDES attendees are welcome to RSVP, but space is limited! Registered attendees may RSVP here: https://www.surveymonkey.com/r/TIDES2018breweryRSVP