TIDES: Oligonucleotide & May 7-10, 2018 Peptide ... · Accelerate your pipeline of oligonucleotide...

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TIDES: Oligonucleotide &Peptide Therapeutics

May 7-10, 2018Hynes Convention CenterBoston, MA

THE LARGEST MEETING TO ACCELERATE OLIGONUCLEOTIDE AND PEPTIDE PRODUCTS FROM EARLY DISCOVERY TO LATE-STAGE DEVELOPMENT & COMMERCIALIZATION

Featuring Industry Experts to Help You Fast-Track Product Development

RNAI THERAPEUTICS: PATISIRAN

John Maraganore, Ph.D.Chief Executive Officer Alnylam Pharmaceuticals

DISCOVERY OF SEMAGLUTIDE

Jesper Lau, Ph.D.Vice President Protein & Peptide Chemistry Novo Nordisk A/S, Denmark

mRNA THERAPEUTICS

Stéphane BancelChief Executive Officer Moderna Therapeutics

ADVANCES IN DRUG CARRIERS

Robert S. Langer, Sc.D.Koch Institute Professor MIT

www.TIDESevent.com

For up-to-date program information and new abstracts, visit: www.TIDESevent.com 2

TIDES:Oligonucleotide &Peptide Therapeutics

THE INDUSTRY’S FLAGSHIP MEETING FOR OLIGONUCLEOTIDE AND PEPTIDE SCIENCE, TECHNOLOGY AND NETWORKING

NETWORKING

SCIENCE

TECHNOLOGY

Accelerate your pipeline of oligonucleotide and peptide therapeutics to market by applying best practices and lessons learned from 125+ case studies and new data presentations from global industry leaders working across the entire spectrum of development and production.

Bring your product to market by meeting 90+ leading product and service providers showcasing live technology demonstrations in our exhibit hall.

Connect with 1000+ scientists and executives from 30 countries focused in oligonucleotide and peptide development and production during luncheons, cocktail receptions and networking breaks. Networking has never been easier with the included TIDES app that allows you to view the attendee list and schedule meetings before, during and after the event.

“TIDES is the premier venue to actually network with the peptide community. It attracts the research community up to the clinical community – it covers the entire spectrum of peptide science.”- Dr. Alex Fässler, COO, Bachem AG

“TIDES is a ‘must-go’ conference for scientists working in the peptide/oligonucleotide area”– George Wang, Analytical Chemist,

Bristol-Myers Squibb

”Definitely the best meeting in the US for companies developing peptide therapeutics“

– Rodney Lax, Ph.D., Senior Director, PolyPeptide Group

3Register Early for Best Savings • www.TIDESevent.com • 888-670-8200

AGENDA AT-A-GLANCEMONDAY, MAY 7, 2018 • Pre-Conference Workshops 8:00 am - 12:00 pm

Workshop #1: Mass Spectrometry for Peptides and Oligonucleotides

Workshop #2: An Introduction to messenger RNA (mRNA) Therapeutics

Workshop #3: Risk-Based Approaches to CMC Development of Therapeutic Oligonucleotides

Workshop #4: Novel Technologies for Manufacturing Peptides

1:00 pm - 5:00 pm

Workshop #5: Peptide Aggregation Challenges from API to Drug Product

Workshop #6: An Introduction to CRISPR and Genome Editing Applications

Workshop #7: Lessons from The Peptide Field that Can Be Applied to Oligonucleotides

Workshop #8: The Path to a Successful Oligonucleotide IND/IMPD Submission: Regulatory,

Nonclinical and CMC Perspectives5:30 pm-8:30 pm TIDES Brewery Event Co-Sponsored by Thermo Fisher Scientific and KNect365

TUESDAY, MAY 8, 2018 • Main Conference Exhibit Hall & Poster Viewing Hours: 2:45 pm-7:00 pm8:00 am - 11:45 am

KEYNOTE SESSION: Dr. Robert Langer, Massachusetts Institute of Technology John Maraganore, Ph.D., Alnylam Pharmaceuticals Jesper Lau, Ph.D., Novo Nordisk A/S, Denmark Stéphane Bancel, Moderna Therapeutics

11:45 pm - 12:55 pm Spotlight Luncheon Presentations Sponsored by GAP Peptides, Nagase, TriLink12:55 pm -2:45 pm Plenary Session2:45 pm - 3:25 pm Grand Opening of Poster and Exhibit Hall and Networking Refreshment Break

3:25 pm - 5:30 pm PLENARY SESSION

5:30 pm - 7:00 pm Networking Reception in Poster and Exhibit Hall Sponsored by Ajinomoto and Ribobio

WEDNESDAY, MAY 9, 2018 • Main Conference Exhibit Hall & Poster Viewing Hours: 10:00 am – 6:45 pm7:45 am - 8:15 am Breakfast Spotlight Presentation Sponsored by ST Pharm

Oligonucleotide Discovery, Preclinical and Clinical

Oligonucleotide Chemistry, Manufacturing and Controls

Peptide Discovery, Preclinical and Clinical

Peptide Chemistry Manufacturing and Controls

8:25 am - 12:20 pm RNA Therapeutics: from Bench-to-Bedside Oligonucleotide Manufacturing Technologies for Peptide Lead Discovery CMC, Quality and Regulatory Aspects of Peptide API’s

12:20 pm - 12:50 pm Spotlight Presentations Sponsored by BioSpring GmbH, Ajinomoto Co. Inc., Polymun Scientific GmbH, USP

12:50 pm - 1:55 pm Networking Luncheon in Poster and Exhibit Hall





Delivery of Macromolecular Therapeutics

mRNA, CRISPR and Hot Topics in Oligonucleotides

1:55 pm - 5:45 pm Nonclinical Development of Oligonucleotides Peptide Preclinical and Clinical

Delivery: Cross-Fertilizing Ideas from Oligonucleotides, Peptides,

mRNA and CRISPRmRNA Discovery and Development

mRNA CMC and Manufacturing5:45 pm - 6:45 pm Networking Reception in Poster and Exhibit Hall Sponsored by Bachem

THURSDAY, MAY 10, 2018 • Main Conference Exhibit Hall & Poster Viewing Hours: 10:00 am-2:00 pmOligonucleotide Discovery,

Preclinical and ClinicalOligonucleotide Chemistry, Manufacturing and Controls




8:25 am - 12:15 pm

Oligonucleotide Preclinical and Clinical Development

Starting Materials Improving Peptide Synthesis and Peptide Properties CRISPR Therapeutics

Analytics for Oligonucleotides New Generic Peptide Regulatory Challenges Hot Topics in Oligonucleotides12:20 pm - 12:50 pm Spotlight Presentations Sponsored by CordenPharma, Intertek, Sumitomo Chemical

12:50 pm - 1:55 pm Networking Luncheon in Poster and Exhibit Hall






1:55 pm - 3:30 pm

Oligonucleotide Preclinical and Clinical Development Oligonucleotide and Peptide Drug Product Strategies Peptide Delivery mRNA Delivery


MONDAY, MAY 7, 2018 • PRE-CONFERENCE WORKSHOPS • CHOOSE TWO HALF-DAY WORKSHOPS

Workshop #1: MASS SPECTROMETRY FOR PEPTIDES AND OLIGONUCLEOTIDES

Morning Half-Day Workshop • 8:00am-12:00pm

8:00 Workshop Leader’s Welcome and Opening Remarks Fanyu Meng, Ph.D., Principal Scientist, Analytical Research and Development, Merck Research Labs, Merck & Co., Inc.

8:15 Contribution of High Resolution Mass Spectrometry in Synthetic Peptides: Importance of Detailed Impurity Characterization for Better Manufacturing

David Cosquer, Mass Spectrometry Specialist, Analytical Development, Polypeptide, Belgium

8:45 LC/MS Oligonucleotide Mass Fingerprinting Enables Rapid Characterization of Critical Quality Attributes in Therapeutic mRNA

Serenus Hua, Ph.D., Senior Scientist, Moderna Therapeutics

9:15 Assessment of Peptide Metabolism at the Subcutaneous Injection Site by Liquid Chromatography-high Resolution Mass Spectrometry

Simone Esposito, Ph.D., DMPK Research Scientist, Chemistry - Preclinical Research Unit, IRBM Science Park, Italy

9:45 Networking Refreshment Break 10:15 Oligonucleotide Characterization: Applications and Uses of Mass Spectrometry Gangani Silva, Ph.D., Senior Scientist, Analytical Development, Nitto Avecia

10:45 LC Peak Purity Assessment Using a Novel LC-MS Data Processing Approach Patrik Plattner, Ph.D., Group Leader Mass Spectrometry Service, Bachem AG, Switzerland

11:15 Mass Spectrometry Methodologies for Analytical Control of Synthetic Oligonucleotides Fanyu Meng, Ph.D., Principal Scientist, Analytical Research and Development, Merck Research Labs, Merck & Co., Inc.

11:45 Concluding Remarks and Discussion 12:00 Close of Workshop

8:00 Workshop Leader’s Welcome and Opening Remarks Jim Thompson, Ph.D., Head CMC Project Management, Moderna Therapeutics

8:15 Introduction to mRNA Therapeutics Jim Thompson, Ph.D., Head CMC Project Management, Moderna Therapeutics

9:00 Design and Manufacturing of Chemically Modified Messenger RNA Therapeutics Anton McCaffrey, Ph.D., Senior Director of Research and Development, Biology, TriLink BioTechnologies, Inc.

10:00 Networking Refreshment Break 10:30 Delivery Strategies for mRNAs Luis Brito, Ph.D., Director, Formulation Design, Moderna Therapeutics

11:00 Applications of mRNA Therapeutics Patrick Baumhof, Ph.D., Vice President, Formulation and Delivery, Curevac, Germany

11:30 Panel Discussion and Q&A

12:00 Close of Workshop

7:15 Workshop Registration

Workshop #2: AN INTRODUCTION TO messenger RNA (mRNA) THERAPEUTICS


Workshop #3: RISK-BASED APPROACHES TO CMC DEVELOPMENT OF

THERAPEUTIC OLIGONUCLEOTIDESMorning Half-Day Workshop • 8:00am-12:00pm

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. 8:00 Workshop Co-Leaders’ Welcome and Opening Remarks G. Susan Srivatsa, Ph.D., President, ElixinPharma Fran Wincott, Ph.D., Wincott & Associates, LLC

8:20 Selection and Justification of Regulatory Starting Materials PaulMcCormac,Ph.D.,ExecutiveDirector,PfizerBio-therapeuticPharmaceuticalSciences

9:00 Impurities in Oligonucleotide Drug Substances and Drug Products: Safety Considerations Tom Zanardi, Ph.D., Director, Toxicology, Ionis Pharmaceuticals

9:40 Networking Refreshment Break 10:10 Planning for Oligonucleotide Supply: Personalized Medicine to Large Scale Markets Hans Kistemaker, Ph.D., Senior Scientist, Chemistry & Manufacturing, ProQR Therapeutics, The Netherlands

10:50 Case Study: Evolution of the Rent, Buy or DIY Strategy Lubomir Nechev, Ph.D., Vice President, Process Sciences, Alnylam Pharmaceuticals 11:30 Panel Discussion 12:00 Close of Workshop and Lunch

8:00 Workshop Leader’s Welcome and Opening Remarks Trishul Shah, Director, Business Development, North America, PolyPeptide

8:15 Chemo-enzymatic Synthesis (CEPS) of Exenatide: Laboratory Scale Development Timo Nuijens, Ph.D., Lead Scientist, EnzyPep BV, The Netherlands

8:45 Cost Efficient Peptide Purification via ZEOsphere DRP Mixed-Mode Chromatography Jürgen Machielse, Business Development Director Spherical Gels, Zeochem, Switzerland

9:00 Towards Commercial Manufacturing of Therapeutic Peptides Using Chemo-enzymatic Peptide Synthesis (CEPS)

Jan Pawlas, Ph.D., Scientist, PolyPeptide Group, Sweden

9:30 Bringing Continuous Manufacturing into Peptide Manufacturing Andreas Segerros, CEO, Swedish Biomimetics 3000® Ltd.

10:00 Networking Refreshment Break 10:30 Group-Assisted Purification (GAP) Technology and Its Future Potential for Peptide Synthesis

ColeSeifert,Ph.D.,ChiefScientificOfficer,GAPPeptides,LLC

11:00 Unlocking the Potential for the Future of SPPSJon Holbech Rasmussen, Ph.D., Director, Global Development, PolyPeptide Group, Sweden

11:30 Panel Discussion 12:00 Close of Workshop and Lunch

Workshop #4: NOVEL TECHNOLOGIES FOR MANUFACTURING PEPTIDES



MONDAY, MAY 7, 2018 • PRE-CONFERENCE WORKSHOPS • CHOOSE TWO HALF-DAY WORKSHOPS

1:00 Workshop Leader’s Welcome and Opening Remarks Trishul Shah, Director, Business Development, North America, PolyPeptide

1:15 Peptide Aggregation JuergTschopp,Ph.D.,ChiefExecutiveOfficer&President,StratumMedicalCorporation

2:00 Assessment of Deamidation and Aggregation of Peptide VariantsMohammad Al-Sayah, Ph.D., Senior Scientist, Genentech, Inc.

2:45 Networking Refreshment Break 3:15 The Effect of Peptide Aggregation on Downstream Purification: A DISASTER Imre Sallay, Ph.D., Manager, Technical Sales, DAISOGEL Group, Osaka Soda, Co., Ltd., Japan

4:00 Solid-State NMR Investigation of Insoluble Aggregation of Peptide Drugs Yongchao Su, Ph.D., Associate Principal Scientist, Merck & Co.

4:30 Panel Discussion


Workshop #5:

PEPTIDE AGGREGATION CHALLENGES FROM API TO DRUG PRODUCTAfternoon Half-Day Workshop • 1:00pm-5:00pm

1:00 Workshop Leader’s Welcome and Opening Remarks Cecilia Fernández, Ph.D., Senior Director, Platform Strategy and Operations, Editas Medicine

1:15 CRISPR’s Road to the Clinic TJ Cradick, Ph.D., Head of Genome Editing, CRISPR Therapeutics

1:45 Development of High Quality CRISPR/CAS9 Agents Terence Ta, Ph.D., Scientist II, Editas Medicine

2:15 Genome instability and Cas9 specificity Tom Barnes, Ph.D., Senior Vice President, Innovative Sciences, Intellia Therapeutics

2:45 Networking Refreshment Break 3:15 Peptide Technology to Deliver CRISPR Ribonucleoprotein in Cells David Guay, Ph.D., Research Director, Feldan Therapeutics, Canada

3:45 Delivery of CRISPR/Cas RNP Using Polymer Nanoparticle System KunwooLee,Ph.D.,ChiefExecutiveOfficer,GenEdit

4:15 Panel Discussion 5:00 Close of Workshop

Workshop #6:

AN INTRODUCTION TO CRISPR AND GENOME EDITING APPLICATIONSAfternoon Half-Day Workshop • 1:00pm-5:00pm

1:00 Workshop Leader’s Welcome and Opening Remarks Jennifer Lockridge, Ph.D., SVP, Program Development, Dicerna Pharmaceuticals, Inc.

1:15 Regulatory Perspectives and Points to Consider in Making Successful Oligonucleotide IND/CTA Submissions

Paul Manley, President and Principal Consultant, Orvieto Consulting

2:00 CMC Perspectives on Oligonucleotides Vidhya Gopalakrishnan, Ph.D., Senior Vice President, Pharmaceutical Development, Quark Pharmaceuticals, Inc.

2:45 Networking Refreshment Break

3:15 Considerations for the Early Preclinical Development of Oligonucleotide-based Therapeutics Sarah Voytek, Ph.D., Associate Director, Preclinical Development, Bluebird Bio

4:00 Case Study: Lessons Learned from IND/IMPD Submissions for DCR-PH1, A Synthetic siRNA in a Lipid Nanoparticle FormulationJennifer Lockridge, SVP, Program Development, Dicerna Pharmaceuticals, Inc.

4:30 Panel Discussion


Workshop #8:

THE PATH TO A SUCCESSFUL OLIGONUCLEOTIDE IND/IMPD SUBMISSION: REGULATORY, NONCLINICAL AND CMC PERSPECTIVES

Afternoon Half-Day Workshop • 1:00pm-5:00pm

1:00 Workshop Leader’s Welcome and Opening Remarks Gary Musso, Ph.D., President, Musso and Associates LLC 1:10 Introductory Presentation on Peptide Chemistry Michael Verlander, President, Proactive Quality Compliance, Inc. 1:35 Synergy between Synthesis of Oligonucleotide and Peptide: From Concepts to Practical Applications Yogesh S. Sanghvi, Ph.D., President, Rasayan, Inc.

2:00 A Triple Contemplation - Regulatory Considerations on Recombinant Proteins, Synthetic Peptides and OligonucleotidesRené Thürmer, Ph.D., Deputy Head, Unit Pharmaceutical Biotechnology, BfArM Federal Institute for Drugs and Medical Devices, Germany

2:45 Networking Refreshment Break 3:15 An Engineer’s Perspective on Oligonucleotide Manufacturing and Applications from the Peptide Field Christina Nacos, Associate Director, Oligonucleotides, Corden Pharma Colorado 3:40 Peptide and Oligonucleotide Therapeutics: Bioanalytical Challenges and Lessons Learned

RafiqIslam,SeniorDirectorBioanalyticalServices,Celerion 4:05 Alternative Manufacturing Strategies and Concepts Used on Peptides; Considerations for Use in

OligonucleotidesGary Musso, Ph.D., President, Musso and Associates LLC

4:30 Panel Discussion 5:00 Close of Workshop

Workshop #7:

LESSONS FROM THE PEPTIDE FIELD THAT CAN BE APPLIED TO OLIGONUCLEOTIDES

Afternoon Half-Day Workshop • 1:00pm-5:00pm

TIDES BREWERY EVENT May 7 from 5:30pm-8:30pm

Co-Sponsored by and

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


TUESDAY, MAY 8, 2018 • KEYNOTE SESSION

7:00 Registration and Coffee 8:00 Chairperson’s Remarks Muthiah (Mano) Manoharan, Ph.D., Senior Vice President of Drug Discovery,

Alnylam Pharmaceuticals

8:10 Advances in Drug Carriers of Medicine Dr. Robert Langer David H. Koch Institute Professor,

Koch Institute of Integrative Cancer Research, Massachusetts Institute of Technology

8:55 Keynote Q&A

9:00 RNAi Therapeutics Delivered: Patisiran and Beyond John Maraganore, Ph.D. ChiefExecutiveOfficer,AlnylamPharmaceuticals

9:40 Keynote Q&A

9:45 Networking Refreshment Break

10:15 The Discovery of Semaglutide – A Journey from Ala Scan to Structural Design of GLP-1 Analogues

Jesper Lau, Ph.D. Vice President, Protein & Peptide Chemistry, Novo Nordisk A/S,

Denmark

10:55 Keynote Q&A

11:00 Thoughts on Building a Biotech Company Enabled by New Science

Stéphane Bancel ChiefExecutiveOfficer,ModernaTherapeutics

11:40 Keynote Q&A

11:45-12:55

SPOTLIGHT PRESENTATION LUNCHEONS

11:45 A New Method of Peptide Synthesis via Group-Assisted Purification (GAP) TechnologyColeSeifert,Ph.D.,ChiefScientificOfficer,GAPPeptides, LLC

11:45 Solution-phase Synthesis of Oligonucleotides via Segmental ApproachMamoru Hyodo, Ph.D., Chief Researcher, R&D Unit, Shikoku- Nucleic Acid Chemistry (S-NAC), Japan

11:45 Advantages of in vivo DNA Barcoding in Nanoparticle Selection and Therapeutic Gene Editing at the Target Site with CRISPR/CAS9 for β-thalassemiaJames Dahlman, Ph.D., Assistant Professor, Biomedical Engineering, Georgia Institute of Technology and Emory Medical School MikeHouston,Ph.D.,ChiefScientificOfficer,TriLink BioTechnologiesTJ Cradick, Ph.D., Head of Genome Editing, CRISPR Therapeutics


12:55 Chairperson’s RemarksCecilia Fernández, Ph.D., Senior Director, Platform Strategy and Operations, Editas Medicine

1:00 Fireside Chat: The Emergence of CRISPR Therapeutics BillLundberg,M.D.,ChiefScientificOfficer,CRISPRTherapeutics VicMyer,Ph.D.,ChiefTechnologyOfficer,EditasMedicine Tom Barnes, Ph.D., Senior Vice President, Innovative Sciences,

Intellia Therapeutics

1:45 MC4R Pathway Defects: Treatment of Rare Monogenic Forms of Obesity

LexVanderPloeg,Ph.D.,ChiefScientificOfficer,RhythmPharmaceuticals

2:15 Launching Clinical Antisense Oligonucleotide Manufacturing Capability in a Biologics Company

Sheron Branham, Associate Director, ASO Process Engineering and Manufacturing, Drug Product Facility, Biogen

2:45 Grand Opening of Poster and Exhibit Hall and Networking Refreshment Break

CMC for Oligonucleotides and Peptides: Current Regulatory Trends

3:25 Chairperson’s Remarks G. Susan Srivatsa, Ph.D., President, ElixinPharma

3:30 CMC Regulatory Considerations for Oligonucleotides and Peptides: What Are the Common Questions and Challenges Faced by Both Oligo and Peptide Developers

René Thürmer, Ph.D., Deputy Head, Unit Pharmaceutical Biotechnology, BfArM Federal Institute for Drugs and Medical Devices, Germany

4:00 CMC Regulatory Perspectives and Strategies: Integrating Experiences from Different Product Modalities to Accelerate Development of New Molecules

Allison Wolf, Principal Research Scientist, Global Regulatory Affairs CMC, Eli Lilly

4:30 SPINRAZA® (nusinersen) Approval: CMC Strategies and Lessons Learned

Firoz D. Antia, Ph.D., Director, Antisense Oligonucleotide Process Development and Manufacturing, Biogen

5:00 CMC Regulatory Panel DiscussionModerator: G. Susan Srivatsa, Ph.D., President, ElixinPharmaPanelists:René Thürmer, Ph.D., Deputy Head, Unit Pharmaceutical Biotechnology, BfArM Federal Institute for Drugs and Medical Devices, Germany Allison Wolf, Principal Research Scientist, Global Regulatory Affairs CMC, Eli LillyFiroz D. Antia, Ph.D., Director, Antisense Oligonucleotide Process Development and Manufacturing, Biogen

5:30pm-7:00pm

Networking Reception in Poster and Exhibit HallJoin fellow attendees and speakers for the TIDES opening night networking reception. Enjoy drinks and appetizers with colleagues while viewing the exhibits and scientificpostersessions.Sponsored by

and

TUESDAY, MAY 8, 2018 • PLENARY SESSION


WEDNESDAY, MAY 9, 2018Oligonucleotide Discovery,

Preclinical and ClinicalOligonucleotide Chemistry, Manufacturing and Controls



7:30 Registration and Coffee

Breakfast Spotlight Presentation7:45-8:15

Readiness to One-stop Manufacturing Service for Oligonucleotides and Phosphoramidites for Commercial Scale Kyeong Eun Jung, Ph.D., Senior Vice President, Head of Oligo and R&D Division, ST Pharm, South Korea

GMP Liposome Production from Microfluidics to Large-scaleCharalamposKoutsoulas,Ph.D.,HeadofLiposomeR&D,PolymunScientificGmbH,Austria

8:25 (8:00) Chairperson’s Welcome and Opening RemarksShuling Guo, Ph.D., Executive Director, Exploratory and Genetic Diseases Drug Discovery, Ionis Pharmaceuticals

Chairperson’s RemarksDoug Brooks, Ph.D., Consultant, Matapalo Pharma Consulting Services

Chairperson’s RemarksRami Hannoush, Principal Scientist & Group Leader, Genentech

Chairperson’s RemarksAlex Fässler, Ph.D., COO, Bachem Holding AG, Switzerland

(8:05) FEATURED PRESENTATION: Rational Vaccinology: Structure-Function Relationships in the Development of Immunotherapeutic AgentsChad Mirkin, Ph.D., Professor of Chemistry, Institute for Nanotechnology, Northwestern University

RNA Therapeutics: from Bench-to-Bedside Oligonucleotide Manufacturing Technologies for Peptide Lead Discovery CMC, Quality and Regulatory Aspects of Peptide API’s

8:30 (8:35) Develop Antisense Therapies for Genetic DiseasesShuling Guo, Ph.D., Executive Director, Exploratory and Genetic Diseases Drug Discovery, Ionis Pharmaceuticals

Oligo Market Expansion and Responding to the Capacity and Technological Challenges Joe Guiles, Ph.D., Head of Development, Agilent Technologies, Inc.

Plants as Sources for Peptide Lead DiscoveryDavid Craik, Ph.D., Professor of Biomolecular Structure, Institute for Molecular Bioscience, University of Queensland, Australia

Higher Molecular Weight (HMW) Peptide Impurities – Control Strategies and Acceptance CriteriaRalph Schönleber, Ph.D., Vice President Research & Development, Bachem AG, Switzerland

9:00 From Discovery to the Clinic: Translational Strategies for OligonucleotidesPatrick Haslett, M.D., Executive Director of Clinical Research, Alnylam Pharmaceuticals

White Paper on Oligonucleotide ImpuritiesNadim Akhtar, Ph.D., Principal Scientist, AstraZeneca, United Kingdom

Massively Parallel Synthesis and Screening of Linear Peptides and Macrocycles using Peptide MicroarraysLauren Goodrich, Ph.D., Scientist, Technology Innovation, Roche

Producing the Highly Potent PeptideRick Dauer, Ph.D., Distinguished Engineer, Program Management Organization, Corden Pharma Colorado

9:30 mRNA Therapies for Acute Regenerative and Chronic ApproachesNils Bergenhem, Ph.D., Director, Strategy and External Innovation, CVMD IMED Biotech Unit, AstraZeneca Pharmaceuticals

Assessing the Fate and Purge of Product Related Impurities in the Manufacture of siRNAsPaul Peng, Ph.D., Principal Scientist, Process Sciences, Alnylam Pharmaceuticals

Carbon-Carbon Bond Formation on PeptidesJanos T. Kodra, Principal Scientist, Protein & Peptide Chemistry, Novo Nordisk A/S, Denmark

Control of Non-peptide Related Impurities in APIs Originated from Materials/Consumables/Equipment Contact through Process Manufacturing and StorageEl Djouhar Rekai, Ph.D., Head of Operation Products, PolyPeptide Group, Belgium

10:00 Networking Refreshment Break in Poster and Exhibit Hall

10:45 Development of RNAi-based Modulation of sFLT1 As a Novel Approach for Treatment of PreeclampsiaAnastasia Khvorova, Ph.D., Professor, RNA Therapeutics Institute, University of Massachusetts Medical School

Manufacturing Process Development for PMOBao Cai, Ph.D., Director, Process Development, Sarepta Therapeutics

Engineering Potent NaV1.7 Inhibitory Peptide−Antibody ConjugatesJustin Murray, Ph.D., Principal Scientist, Hybrid Modality Engineering, Therapeutic Discovery, Amgen

Highly Pure Octreotide - Development and Scale-Up of a State-of-the-art SPPS Process Stefan Eissler, Ph.D., Director API Manufacturing, Bachem AG, Switzerland

11:15 Stereochemical Control of Antisense Oligonucleotides Enhances Target EfficacyZhong Zhong, Ph.D., Vice President and Head of Biology, Wave Life Sciences

Antisense Oligonucleotide Purification Process: Successes and Challenges During Scale-upRobert Gronke, Ph.D., Senior Principal Scientist, Technical Development, Biogen

Emerging Approaches for Peptide Drug DiscoveryRami Hannoush, Principal Scientist & Group Leader, Genentech

Purification of Peptides by Twin-column Countercurrent ChromatographyThomas Müller-Späth, Ph.D., Senior Scientist, Institute for Chemical and Bioengineering, ETH Zurich, Switzerland

11:45 Sustained Suppression of Huntingtin mRNA and Protein throughout the Central Nervous System after Intrathecal Administration of Antisense OligonucleotidesHolly Kordasiewicz, Ph.D., Executive Director, Neuroscience Drug Discovery Department, Ionis Pharmaceuticals

Scale Matters – The Importance of Designing Scalable Processes and EquipmentJohn Batal, Director of Engineering, Nitto Avecia

Small Scaffold Proteins for Drug Discovery John Dwyer, Ph.D., Director, Protein Engineering, Ferring Research Institute

Transitioning Manufacturing Development from Clinical Supply to Registration and Pre-Commercial Process from the Small Company PerspectiveDaveGarmanPh.D.,ChiefTechnologyOfficer,NoNO

12:15 Transition to Spotlight Presentation Rooms

Concurrent Spotlight Presentations12:20 nsights into the

Sequence Fidelity of Chemically Synthesized OligonucleotidesHüseyin Aygün, Ph.D., Managing Director (CSO), BioSpring GmbH, Germany

Comparison between AJIPHASE® and Solid-phase Synthesis for Large Scale Oligonucleotide ManufacturingDaisuke Takahashi, Ph.D., Senior Principal Researcher, Ajinomoto Co. Inc., Japan

Update on USP Standards for Therapeutic Peptides and Impurity Measurements Michael Huang, Ph.D., U.S. Pharmacopeia, Senior Science & Standards Liaison

12:50 Networking Luncheon in Poster and Exhibit Hall


WEDNESDAY, MAY 9, 2018 (continued)

Oligonucleotide Discovery,

Preclinical and Clinical

Oligonucleotide Chemistry,

Manufacturing and Controls

Peptide Discovery, Preclinical and

Clinical

Peptide Chemistry Manufacturing and

Controls

Delivery of Macromolecular

Therapeutics mRNA, CRISPR and Hot

Topics in Oligonucleotides

1:55 Chairperson’s RemarksCindy Berman, Ph.D., Toxicology Consultant

Chairperson’s RemarksVed Srivastava, Ph.D., Vice President, Chemistry, Intarcia Therapeutics

Chairperson’s RemarksMarian Gindy, Ph.D., Executive Director, Pharmaceutical Sciences, Merck Research Laboratories

Chairperson’s RemarksAndreas Kuhn, Ph.D., Vice President RNA Biochemistry & Manufacturing, BioNTech RNA, Germany Pharmaceuticals GmbH

Nonclinical Development of Oligonucleotides Peptide Preclinical and ClinicalDelivery: Cross-Fertilizing Ideas from Oligonucleotides, Peptides,

mRNA and CRISPRmRNA Discovery and Development

2:00 Introduction of the Oligonucleotide Safety Working Group (OSWG)Jeffrey Foy, Ph.D., Director, Nonclinical Writing & Documentation, Celgene

Engineering “Smartness” into Insulin: Glycosylated Insulins with Responsivity to Physiological Levels of GlucoseSongnian Lin, Ph.D., Director, Chemistry Modalities, Merck Research Laboratories

Overcoming Endosomal Entrapment in Drug Delivery with Cyclic Cell-Penetrating PeptidesDehua Pei, Ph.D., Professor, Department of Chemistry and Biochemistry, Ohio State University

mRNA Therapeutics: Ex-vivo and In-vivo Modification of Antigen Presenting CellsKris Thielemans, M.D., Ph.D., Professor, Vrije UniversiteitBrusselandChiefScientificOfficer,eTheRNA immunotherapies NV, Belgium (2:20) Short Updates from OSWG Subcommittees

2:30 From Excitement to Despair to Exhilaration in 13 Months – The Story of Arrowhead’s Move from DPCs to the TRiM™ PlatformThomas Schluep, Vice President, Program Management, Arrowhead Pharmaceuticals

Clinical Development of Oral Calcitonin for OsteoporosisNozer Mehta, Ph.D., Principal, Peptide Technologies LLC

Targeted Delivery of Antisense Oligonucleotides to Pancreatic β-cellsShalini Andersson, Ph.D., Senior Director Drug Metabolism & Pharmacokinetics, CVMD Innovative Medicines, AstraZeneca, Sweden

mRNA-based Cancer ImmunotherapeuticsRobert Jabulowsky, Ph.D., Deputy Head of Project Management, BioNTech AG, Germany

3:00 Improved Specificity of Conjugate siRNAs through Chemical ModificationsMark K. Schlegel, Ph.D., Senior Scientist, RNAi Discovery, Alnylam Pharmaceuticals

Designing Peptides for the Medici Drug Delivery System™AndrewA.Young,M.D.,Ph.D.,ChiefScientificOfficer, Intarcia Therapeutics, Inc.

Design and Development of Lipid Nanoparticles for mRNA VaccinesMarian Gindy, Ph.D., Executive Director, Pharmaceutical Sciences, Merck Research Laboratories

VEGF mRNA in Cardiovascular DiseaseAnna Collén, Ph.D., Project Leader VEGF Project, AstraZeneca, Sweden


Nonclinical Development of Oligonucleotides (continued) Peptide Preclinical and Clinical (continued)Delivery: Cross-Fertilizing Ideas from Oligonucleotides, Peptides,

mRNA and CRISPR (continued)mRNA CMC and Manufacturing

4:15 Translational Insights of Oligonucleotide ADME and Toxicology: From Bench to Bedside with a GalNAc-conjugated Anti-miRSteven Neben, Ph.D., Senior Director, Research and Development, Regulus Therapeutics

Oral Delivery of Constrained Peptides to Treat Gastrointestinal DisordersMark Smythe, Ph.D., Founder and Vice President, Protagonist Therapeutic, Australia

Robust In Vivo Gene Editing with Systemic Lipid Nanoparticle Delivery of CRISPR/Cas9 RNA ComponentsAmy Rhoden Smith, Ph.D., Principal Scientist, Intellia Therapeutics

Essential Quality Attributes of mRNA-containing Lipid NanoparticlesPeter Lutwyche, Ph.D., Chief Technical OperationsOfficer,ArbutusBiopharma,Canada

4:45 DCR-PHXC vs. DCR-PH1: A Comparison of Nonclinical Development Programs for siRNA Delivered Using GalNAc Conjugates or Lipid NanoparticlesJennifer Lockridge, Ph.D., SVP, Program Development, Dicerna Pharmaceuticals, Inc.

Development of Neoantigen-Based Personalized Cancer Vaccine NEO-PV-01 Jesse Z. Dong, Ph.D., Vice President, Peptide Chemistry, Neon Therapeutics

Centyrin Designer Proteins for Targeted DeliveryKarynO’Neil,Ph.D.,ChiefScientificOfficer, ArōBiotherapeutics

Quality Control of mRNA for Preclinical and Clinical StudiesAndreas Kuhn, Ph.D., Vice President RNA Biochemistry & Manufacturing, BioNTech RNA Pharmaceuticals GmbH, Germany

5:15 Panel Discussion Heat Shock Protein Chaperoned Long Synthetic Peptide Cancer VaccinesMark Findeis, Ph.D., Senior Director, Research Biochemistry, Agenus, Inc.

Development of mRNA Nanomedicines for DeliveryHeinrich Haas, Ph.D., Vice President, RNA Formulation & Drug Delivery, BioNTech AG, Germany

mRNA Vaccines and Therapeutics: CMC PerspectivesKristian Link, Ph.D., Associate Director, Analytical Development, Moderna Therapeutics

5:45Networking Reception in Poster and Exhibit Hall Sponsored by


THURSDAY, MAY 10, 2018






7:30 Registration and Coffee

8:25 Chairperson’s RemarksPaul Metz, Principal Consultant, Metz Biotechnology Consulting, LLC

Chairperson’s RemarksClaus Rentel, Ph.D., Executive Director Analytical Development/QC, Ionis Pharmaceuticals

Chairperson’s RemarksTrishul Shah, Director, Business Development, North America, PolyPeptide

Chairperson’s RemarksArthur A. Levin, EVP Research and Development, Avidity Biosciences

Oligonucleotide Preclinical and Clinical Development Starting Materials New Generic Peptide Regulatory Challenges CRISPR Therapeutics

8:30 HEPLISAV-B Path to ApprovalRandall Hyer, M.D., Ph.D., Vice President, Clinical Development and Medical Affairs, Head, Drug Safety and Pharmacovigilance, Dynavax Technologies Corporation

Transfer of Analytical Methods for DNA and MOE Phosphoramidites from LC-Ion Trap to LC-QTOF Mass SpectrometryKyeong Eun Jung, Ph.D., Senior VP, Head of Oligo and R&D Division, ST Pharm. Co. Ltd., South Korea

Registration of Generic Peptide Drug Substances, Where Are the Challenges and How Should These Be Approached?Peter Larsson, Global Director Regulatory Affairs, PolyPeptide Group, Sweden

Development of Cellular Therapies Using CRISPRVicMyer,Ph.D.,ChiefTechnologyOfficer,Editas Medicine

(8:50) Opportunities and Challenges of the FDA Draft Guidance ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Gerhard Haas, Ph.D., Vice President, Quality Assurance and Regulatory Affairs, Bachem AG, Switzerland

9:00 Temporary Inhibition of P53 for Tissue Protection: From Therapeutic Concept to Prevention of Acute Kidney Injury in Humans following Kidney Transplantation and Cardiac SurgeryElenaFeinstein,M.D.,Ph.D.,ChiefScientificOfficer,QuarkPharmaceuticals,Israel

Analytics for Oligonucleotides Presentation Title TBABenjamin Kleinstiver, Ph.D., Pathology Instructor, Massachusetts General Hospital

Development of a Platform Impurity Characterization Method for RNAi TherapeuticsBo Pang, Ph.D., Associate Director, Analytical Development, Alnylam Pharmaceuticals

(9:10) Assays for Evaluating RLD and Generic Peptide Drugs In Silico and In Vitro in Preparation for ANDAAnnie De Groot, M.D., Founder, CEO and CSO, Epivax, Inc.

9:30 Novel Chemical Modifications for Improving Pharmacological Function of siRNAsMuthiah (Mano) Manoharan, Ph.D., Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals

Assay Determination by Mass Spectrometry for Oligonucleotide TherapeuticsMark Madsen, Ph.D., Associate Director, Analytical Development & Quality Control, Ionis Pharmaceuticals

Panel Discussion Heavily Modified Guides for SpyCas9-mediated Genome EditingJonathan K. Watts, Ph.D., Associate Professor, RNA Therapeutics Institute, University of Massachusetts Medical School



(continued)

Analytics for Oligonucleotides (continued)

Improving Peptide Synthesis and Peptide Properties Hot Topics in Oligonucleotides

10:45 Advanced GalNAc-siRNA Platform and Its Therapeutic ApplicationsTorstenHoffmann,Ph.D.,ChiefScientificOfficer,SilenceTherapeutics,Germany

Improving Specificity of Reverse-Phase Analytical Purity Methods for OligonucleotidesJonathan Neidigh, Ph.D., Analytical Development Group Leader, Nitto Avecia

Bachem’s Experience with the Registration of Peptide APIs in JapanValeska Kreibich, Ph.D., Specialist Regulatory Affairs, Bachem AG, Switzerland

RNA Activation in NASH, Liver Failure and Hepatocellular CarcinomaNagy Habib, M.D., Head of R&D, MiNA Therapeutics Ltd., United Kingdom

11:15 New Drug Discovery Concepts for LNA Therapeutics Troels Koch, Ph.D., VP & Head of Research, RNA Therapeutics, Roche pRED, Roche Innovation Center Copenhagen, Denmark

Separation of Composite Impurities of OligonucleotidesClaus Rentel, Ph.D., Executive Director Analytical Development/QC, Ionis Pharmaceuticals

Automated Flow Peptide Synthesis: Toward Amide Bonds at Nature’s PaceBradley L. Pentelute, Ph.D., Professor, Chemistry, Massachusetts Institute of Technology

Antisense Control of RNA Splicing to Treat Genetic DiseasesHuw M. Nash, Ph.D., COO and CBO, Stoke Therapeutics

11:45 Inhibition of Difficult to Drug Tumor Cell and Immuno-Oncology Targets with Next Generation Antisense A. Robert MacLeod, Ph.D., Vice President, Oncology and Exploratory Discovery, Ionis Pharmaceuticals

Development of a Robust Analytical Control Strategy for the Manufacture of Liquid Oligonucleotide ProductsJessica Stolee, Ph.D., Senior Scientist, Biogen

Considerations in the Development and Implementation of Analytical Methods for Understanding and Controlling the Chemical and Physical Stability of Formulated Synthetic Peptides and OligonucleotidesPaul L. Walsh, Ph.D., Principal Scientist, Merck Research Labs

Axiomer® Technology: Therapeutic Oligonucleotides for Directing Site-specific A-to-I Editing by Endogenous ADAR EnzymesAntti Aalto, Ph.D., Senior Scientist, ProQR Therapeutics NV, The Netherlands

12:15 Transition to Spotlight Presentation Rooms


THURSDAY, MAY 10, 2018Concurrent Spotlight Presentations

12:20 Oligonucleotide Downstream Optimization for Large Scale Manufacturing Amanda Lewis, Senior Chemist, Oligonucleotide Division, Corden Pharma

Sumitomo’s Approach for Large-Scale Synthesis of Long RNA Oligos Akihiro Sakata, Senior Research Scientist, Sumitomo Chemical Co., Ltd., Japan

Analytical Challenges in the Characterisation of Therapeutic Oligonucleotides Jordi Trafach, Characterisation Manager, Intertek Pharmaceutical Services

12:50 Networking Luncheon in Poster and Exhibit Hall


Oligonucleotide Chemistry,

Manufacturing and Controls

Peptide Chemistry Manufacturing and

ControlsPeptide Discovery,

Preclinical and ClinicalmRNA, CRISPR and Hot Topics in

Oligonucleotides

1:55 Chairperson’s RemarksPaul Metz, Principal Consultant, Metz Biotechnology Consulting, LLC

Chairperson’s RemarksMimoun Ayoub, Ph.D., Director and Head of North American and Emerging Markets, CordenPharma International, Switzerland

Chairperson’s RemarksBruceMorimoto,Ph.D.,VicePresident,ScientificAffairs,Celerion, Inc.

Chairperson’s RemarksStephen Spagnol, Ph.D., Senior Scientist, Sterile Formulation Sciences, Merck Research Laboratories


Oligonucleotide and Peptide Drug Product Strategies Peptide Delivery mRNA Delivery

2:00 Effects on Lp(a), Oxidized Phospholipids and Monocyte Inflammation by Antisense Oligonucleotides Targeting Apolipoprotein(a)Nicholas Viney, Executive Director, Clinical Development, Ionis Pharmaceuticals

Microbial Aspects of Oligonucleotide SolutionsJulie Ma, Ph.D., Associate Director, Pharmaceutical Development, Ionis Pharmaceuticals

Design and Development of a Novel Peptide-centric Drug Delivery SystemSheauyu Teddy Hsu, Ph.D., Managing Director, Adepthera

Development of New Lipid Nanoparticles for mRNA-based TherapeuticsKerry Benenato, Ph.D., Director, Chemistry, Moderna Therapeutics

2:30 Antibody-Olignonucleotide Conjugates (AOC): Exploiting Cell Surface Receptors for Directed Delivery and Uptake of siRNA Arthur A. Levin, EVP Research and Development, Avidity Biosciences

Combining Peptides and Oligonucleotides in a Nanoparticle Drug ProductMarc Lemaitre, Ph.D., Principal, ML Consult and Chief OperatingOfficer,Sirnaomics,Inc.

PASylation: the Biological Alternative to PEGylationLars Friedrich, Scientist, XL-protein GmbH, Germany

Progress in the Delivery of mRNA TherapeuticsKim Askew, Ph.D., Director, Pharmacology, Translate Bio

3:00 Some Chemical Insights of Delivery Utilizing GalNAc-siRNA ConjugatesKallanthottathil G. Rajeev, Ph.D., Senior Director, Chemistry, Alnylam Pharmaceuticals

Statistical Models for Predicting the Long-Term Storage of Peptide Drug Products Using Accelerated Stability Jameson Bothe, Ph.D., Associate Principal Scientist, Analytical Sciences – MRL, Merck & Co.

Design and Development of a Glucose-Responsive Insulin FormulationChristopherA.Rhodes,Ph.D.,ChiefTechnologyOfficer,Sensulin LLC and President & CEO, Drug Delivery Experts

Optimizing mRNA TherapeuticsPatrick Baumhof, Ph.D., Vice President Formulation & Delivery, CureVac AG, Germany

3:30 Close of Conference


MEET THE PEOPLE BEHIND THE PRODUCTS & GET THE ANSWERS YOU NEED

For more information on how you can connect with key buyers at TIDES 2018, contact: Patrick Shaughnessy (Companies A-N) at [email protected] or call 857-262-5325

Aimee Croke (Companies O-Z): +1.857.504.6697 [email protected]

EXHIBITORS as ofJanuary 23

aapptecAdvanced AnalyticalAdvanced ChemTech (A Division of CreoSalus)Agilent Technologies.AICAjinomoto Althea, IncAkzoNobelAlmac GroupAM ChemicalsAmbioPharmAsahi Kasei Bioprocess America Inc.Avanti Polar LipidsBACHEMBCN PeptidesBerry & Associates BioAutomationBioSpringBioSynthesisBiotageBioTechLogicBio-Works SwedenC.A.T GmbH& Co KG CarbosynthCEMChemical Computing GroupChemGenesCMIC, Inc.CordenPharmaCPCScientificGAP PeptidesGE HealthcareGlen ResearchGranlenGuangzhou Ribobio Co., LtdGyros Protein TechnologiesHerbert Brown PharmaceuticalHongene Biotechnology Ltd.Horizon Discovery

Hybio Pharma CoInterchem/AnyGen Co., Ltd.InterchimIntertekJenKem Technology Kinovate Life Sciences, IncLGCLI-COR Biosciences MilliporeSigmaNagase & Co. LtdNeuland LaboratoriesNitto Denko AveciaNOF CorporationPace Analytical Life Sciences, LLCPhenomenexPolymunScientificPolyPeptide LaboratoriesPPDPurolite Life SciencesPyramid LaboratoriesQPSQuality Assistance Quanta BioDesignSenn Chemicals Shen Zhen JYMedSolvay ST PharmSunresin New MaterialsSussex ResearchSyngene International Ltd.ThermoFisherScientificTosoh Bioscience LLCTriLink BiotechnologiesUnited States Pharmacopeia (USP)USV Private LTDWaters CorporationW.R. Grace & Company Zeochem AG

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TIDES: Oligonucleotide & May 7-10, 2018 Peptide ... · Accelerate your pipeline of oligonucleotide...

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