TIDES: Oligonucleotide & Peptide Therapeutics EVENT GUIDEdownload.knect365lifesciences.com/2019/B19180Guide.pdf · Strategies Innovations in Peptide Synthesis and Manufacturing CRISPR
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TABLE OF CONTENTSGeneral Information . . . . . . . . . . . . . . .4Agenda at a Glance . . . . . . . . . . . . . . .6Sponsors . . . . . . . . . . . . . . . . . . . . . . . .8Venue Floor Plan . . . . . . . . . . . . . . . . 10TIDES Advisory Board . . . . . . . . . . . 38
Exhibition InformationPassport Contest . . . . . . . . . . . . . . . 13Poster Presentations . . . . . . . . . .24-29Exhibitor Spotlight . . . . . . . . . . . . . . 34Exhibitor List and Floor Plan . . 32, 33
Conference AgendaPre-Conference Workshops . . . 14, 15Tuesday, May 21 . . . . . . . . . . . . . 16, 18Wednesday, May 22 . . . . . . . . . . 20, 21Thursday, May 23 . . . . . . . . . . . . 22, 23
EVENT GUIDE
TIDES: Oligonucleotide &Peptide Therapeutics
4 www.TIDESEvent.com
Admission Admission is limited to persons actively engaged in oligonucleotide and peptide R&D and manufacturing . KNect365 has taken every effort to prohibit admissions to persons not engaged in this area . Children under 18 are not permitted in the Exhibit Hall under any circumstances . Badges and badge holders must be worn at all times while attending the event . Conference badges are non-transferable and lost badges will not be replaced without payment of the full conference registration fee . No exceptions .
Registration Desk Open Monday, May 20 7:00 am - 5:00 pm Tuesday, May 21 7:30 am - 7:00 pmWednesday, May 22 7:00 am - 7:00 pmThursday, May 23 7:30 am - 3:30 pm
Exhibit Hall & Poster Viewing Hours Tuesday, May 21 3:00 pm - 6:45 pm
Wednesday, May 22 10:00 am - 6:45 pm
Thursday, May 23 10:00 am - 2:00 pm
Video/Photo Consent PolicyThis conference is being filmed. When you enter this event, you may be in areas that are being filmed by video or photography.
By entering the event premises, you consent to the filming, display, release, publication, exhibition or reproduction of your image and anything spoken by you to be used for news, Web casts, promotional purposes, telecasts, advertising, inclusion on Web sites, or any other purposes by KNect365 Life Sciences. You release KNect365 Life Sciences and its respective affiliates, employees and representatives, and each and all persons involved from any liability connected with such filming. You have been fully informed of your consent and release .
Program Changes KNect365 does everything in its power to ensure there are no changes to the published program but sometimes circumstances that are beyond our control (i .e . speaker cancellations, speaker changes, etc .) do arise . In the event this does occur, every effort is made to find a suitable replacement. Please Note: The listings and contents of this book are proprietary and cannot be reproduced in part or in whole without permission . Every effort has been made to ensure the accuracy of this Guide . However, KNect365 Life Sciences cannot be held responsible for errors or omissions . Product names may be trademarks or registered trademarks of their companies .
TIDES Networking App
Sponsored by:
All registered attendees receive access to the TIDES app, which allows you to view the full attendee list, schedule meetings, win prizes in the passport contest and more . Download the app on your iOs/Android mobile device by searching for ‘KNect365’ in the app store . All attendees were emailed their log in details before the event . If you need assistance with the app, please visit the registration desk or contact Chisom .Fadeyi@KNect365 .com
Passport ContestDownload and use the TIDES Mobile App to scan all participating companies (listed on page 12) by 1:30 on Thursday . Companies will be labeled with floor decals in the exhibit hall as well . Win prizes like Gift Cards, Airpods, and more! Winners will be announced at booth 119 (the Sales Office) Thursday afternoon at 1:45 . You must be present to win . .
Assistance and Special NeedsOrganizers of the TIDES Conference fully support the Americans with Disabilities Act . If you require assistance of any kind, please inquire at Attendee Registration .
Lost and FoundItems found can be dropped off at Attendee Registration . Items not claimed by the conclusion of the conference will be turned over to building security .
TIDES TVIf you have an interview with TIDES TV find it located at 32nd floor Skyline Room in the exhibit hall
WiFi Sponsored by:
WiFi Network: AmbioTides2019 Password: Ambiopharm1
Follow us on Twitter @TIDES365 and tweet using hash tag #TIDES365
Join KNect365 Life Sciences’ LinkedIn group and becoming a member of our LinkedIn groups: Oligonucleotide and Peptide Development Professionals
Health and Safety Guidelines
The fire alarm sound in this building is a siren
If you discover a fire raise the main alarm at the security desk or at any pull station located through out the venue .
Do not stop to collect your belongings or use elevators
Do not obstruct any exits or gangways
There is a no smoking policy at this event
The assembly point for this event is located at the Marriott Marquis San Diego Marina 333 West Harbor Drive, San Diego, California .
Should you require special assistance please tell a member of KNect365 staff
Please be responsible when plugging laptop and mobile chargers into sockets
General Information
6 www.TIDESEvent.com
Agenda At-A-Glance
MONDAY, MAY 20, 2019 • Pre-Conference Workshops
8:00 am - 12:00 pm
Workshop #1: The State of the Art in mRNA Delivery
(Room: Solana Beach)
Workshop #2: Oligonucleotide Drug Development at Warp Speed: Managing CMC Operations to Support Accelerated
Clinical Development (Room: Misson Beach)
Workshop #3: Potential Green Chemistry Solutions for Peptide Manufacturing
(Room: Ocean Beach)
Workshop #4: Accelerating Peptides to IND: Moving to the Clinic, CMC and
Beyond (Room: Promenade)
1:00 pm - 5:00 pm
Workshop #5: Peptide Aggregation – Challenges, Effects, and Solutions
(Room: Ocean Beach)
Workshop #6: The Path to A Successful Oligonucleotide IND/IMPD Submission:
Regulatory, Nonclinical and CMC Perspectives (Room: Mission Beach)
Workshop #7: Evolving Regulatory CMC Requirements for Peptides
(Room: Promenade)
Workshop #8: Analytical and Bioanalytical Strategies for
Oligonucleotide Therapeutics (Room: Solana Beach)
ThermoFisher Off-Site Reception at Mission Brewery, Monday May 20, Buses depart at 5:30
TUESDAY, MAY 21, 2019 • Main Conference Exhibit Hall & Poster Viewing Hours: 3:00 pm-6:45 pm
8:20 am - 12:15 pm
KEYNOTE SESSION (Room: Seaport ABC): Stanley Crooke, M.D., Ph.D., Chairman of the Board and Chief Executive Officer, Ionis Pharmaceuticals
Kevin Fitzgerald, Ph.D., Senior Vice President and Head of Research, Alnylam Pharmaceuticals Bradley Pentelute, Ph.D., Professor, Chemistry, Massachusetts Institute of Technology
Sarah Boyce, President, Akcea Therapeutics12:15 am -
1:25 Spotlight Luncheon Presentations Sponsored by AJI Bio Pharma Services (Room: Harbor H), Avanti Polar Lipids (Room: Harbor E), TriLink (Room: Harbor G), Ribobio (Room: Harbor F)1:25 pm - 3:00 pm Plenary Session (Room: Seaport ABC)
3:00 pm - 3:45 pm Grand Opening of Poster and Exhibit Hall and Networking Refreshment Break (Grand Ballroom - Lobby Level)
3:45 pm - 5:15 pm Plenary Session (Room: Seaport ABC)
5:15 pm - 6:45 pm Networking Reception in Poster and Exhibit Hall Sponsored by Ribobio
WEDNESDAY, MAY 22, 2019 • Main Conference Exhibit Hall & Poster Viewing Hours: 10:00 am – 6:45 pm7:45 am - 8:15 am Breakfast Spotlight Presentations Sponsored by Polymun (Room: Seaport BC), LGC AxoLabs (Room: Seaport A), Zeochem (Room: Balboa ABC)
Oligonucleotide Discovery, Preclinical and Clinical
Oligonucleotide Chemistry, Manufacturing and Controls
Peptide Discovery, Preclinical and Clinical
Peptide Chemistry Manufacturing and Controls
Room: Seaport A Room: Seaport BC Room: La Jolla AB Room: Balboa ABC
8:25 am - 10:00 am Preclinical Discovery of Oligonucleotides Oligonucleotide CMC Manufacturing Peptide Discovery Strategies Peptide CMC, Quality and Manufacturing
Oligonucleotide Discovery, Preclinical and Clinical
Oligonucleotide Chemistry, Manufacturing and
ControlsPeptide Chemistry
Manufacturing and ControlsPeptide Discovery,
Preclinical and ClinicalmRNA Therapeutics and
CRISPR TherapeuticsRoom: Seaport A Room: Seaport BC Room: La Jolla AB Room: Balboa ABC Room: Gaslamp
10:45 am - 12:15 pm
Preclinical Discovery of Oligonucleotides
Oligonucleotide CMC Manufacturing Peptide Discovery Strategies Peptide CMC, Quality and
Manufacturing CRISPR Therapeutics
12:20 pm - 12:50 pm Spotlight Presentations Sponsored by Nagase (Room: Seaport BC), ST Pharm (Room: Seaport A)
12:50 pm - 1:55 pm Networking Luncheon in Poster and Exhibit Hall
Oligonucleotide Discovery, Preclinical
and Clinical
Oligonucleotide Chemistry,
Manufacturing and Controls
Peptide Discovery, Preclinical and
Clinical
Peptide Chemistry Manufacturing and
Controls
mRNA Therapeutics and CRISPR Therapeutics
Drug Delivery Innovations
and Strategies
Room: Seaport A Room: Seaport BC Room: La Jolla AB Room: Balboa ABC Room: Gaslamp AB Room: Gaslamp CD
1:55 pm - 3:30 pm
Novel Chemistries (1:50-3:35 pm) CMC QC Analytics
for Oligonucleotides
Peptide Discovery Strategies
Innovations in Peptide Synthesis and Manufacturing
CRISPR TherapeuticsNovel Technologies for the Delivery of Macromolecular
Therapeutics4:15 pm - 5:45 pm
Oligonucleotide Discovery and Development
New Frontiers in Peptide Drug Development (Room: Balboa ABC)
5:45 pm - 6:45 pm Networking Reception in Poster and Exhibit Hall Sponsored by Bachem
THURSDAY, MAY 23, 2019 • Main Conference Exhibit Hall & Poster Viewing Hours: 10:00 am-2:00 pm7:45 am - 8:15 am Breakfast Spotlight Presentation Sponsored by Genscript (Room: Seaport BC)
Oligonucleotide Discovery, Preclinical
and Clinical
Drug Delivery Innovations
and Strategies
Oligonucleotide Chemistry,
Manufacturing and Controls
Peptide Discovery, Preclinical and Clinical
Peptide Chemistry Manufacturing and
Controls
mRNA Therapeutics and CRISPR Therapeutics
Room: Seaport A Room: Seaport BC Room: Balboa ABC Room: La Jolla AB
8:25 am - 12:15 pm Extra-Hepatic Delivery of Oligonucleotides
Regulatory PerspectivesInnovations in
Oligonucleotide CMC Individualized Neo-Antigens mRNA Discovery and
Development (8:20am-12:15pm)
12:20 pm - 12:50 pm Spotlight Presentations Sponsored by Intertek (Room: Seaport A), Sumitomo Chemical (Room: Seaport BC)
12:50 pm - 1:55 pm Networking Luncheon in Poster and Exhibit Hall Sponsored by PolyOrg
Oligonucleotide Discovery, Preclinical
and Clinical
Oligonucleotide Chemistry,
Manufacturing and Controls
mRNA Therapeutics and CRISPR Therapeutics
Peptide Chemistry Manufacturing and
Controls
Peptide Discovery, Preclinical and
Clinical
Drug Delivery Innovations
and Strategies
Room: Seaport A Room: Seaport BC Room: Balboa ABC Room: La Jolla AB
1:55 pm - 3:30 pm Oligonucleotides in the Clinic mRNA CMC and Manufacturing Peptide Purification and
Downstream Processing Innovations in Peptide Delivery
8 www.TIDESEvent.com
Thank You to Our Sponsors
Diamond Sponsor Event Partner
Gold Sponsors
Silver Sponsors
Bronze Sponsors
Registration Sponsor Bag Sponsor Lanyard Sponsor
Reception Sponsors Lunch Sponsor Notepad and Pen Sponsor
Spotlight Presentation Sponsors
Associate Sponsors
WiFi Sponsor Exclusive Mobile App Sponsor
10 www.TIDESEvent.com
Venue Floor Plan
GRAND HALL
A
A
B
B
C
C
D
D
GRAND FOYER HALL ATIDES Registration Desk
SEAVIEWPreCon Workshop LunchMonday Only(Registered Workshop Attendees and Workshop Speakers Only)
PARKING
FRONT DESK
MAIN ENTRANCE
SEAPORT TERRACE
SEAPORT BALLROOM
A
BD
C
F
E
ADE
G
H
BALBOA ABCTRACK: Peptide ChemistryManufacturing and ControlsSpotlight Presentation: Zeochem
GASLAMP ABTRACK: mRNA Therapeutics and CRISPR Therapeutics
LA JOLLA ABTRACK: mRNA Therapeutics and CRISPR
Therapeutics (Thursday AM ONLY)TRACK: Peptide Discovery, Preclinical
and Clinical (Wednesday)COMBINED TRACK:
Peptide Discovery, Preclinical and Clinical/Drug Delivery Innovations and Strategies
(Thursday 1:55 PM ONLY
PALMFOYER
HARBOR TERRACE
G
H
I
D
E
F C
B
A
G D A
D
AB
C
AB
C
BA
B
COR
RID
OR
I
COR
RID
OR
II
HARBOR FOYER
SEAPORT FOYERF1
F2
GH
CORR
IDOR
II
CORR
IDOR
I
SECOND LEVEL
C
ICONIC POOL
MISSION BEACHPre-Conference Workshops 2 & 6
PROMENADE APre-Conference Workshops 4 & 7
SOLANA BEACHPre-Conference Workshops 1& 8
OCEAN BEACHPre-Conference Workshops 3 & 5
C B A B AC B A B A
PIER
COVE
ICONIC,A MARILYN
MONROE SPA
SHOW OFFICE 8
OCEAN BEACHFOYER
BANKERS HILLCORTEZ HILLA
B
D
AB
CHILLCRESTNitto Denko Avecia Meeting Room (Wednesday Only)
GOLDENHILL
TORREYHILLS A
BAB
THIRD LEVEL
PROMENADEFOYER
LOBBY LEVEL
SEAPORT ABCKeynote SessionsPlenary Sessions
SEAPORT ATRACK: Oligonucleotide Discovery, Preclinical and Clinical
Spotlight Presentations: LGC Axolabs, ST Pharm SEAPORT BCTRACK: Oligonucleotide Chemistry, Manufacturing and ControlsSpotlight Presentations: Polymun, Nagase, GenScript, Sumitomo Chemical
HARBOR E-F-G-HSpotlight Luncheon Presentations: AJI Bio Pharma Services (Harbor D), Avanti Polar Lipids (Room: Harbor E), TriLink (Room: Harbor G), Ribobio (Room: Harbor F)
POSTER AND EXHIBIT HALL
GASLAMP CDTRACK: Drug Delivery Innovations and Strategies
MEETING ROOMSRoom in Seaport Tower Sponsor
Room #: 967 Agilent Room #: 977 AICRoom #: 477 ChemGenesRoom #: 667 HongeneRoom #: 677 Ionos PharmaceuticalsRoom #: 474 MilliporeSigmaRoom #: 466 Nitto Denko Avecia #1Room #: 877 Nitto Denko Avecia #2Room #: 560 ST Pharm Room #: 777 Thermo Fisher ScientificRoom #: 577 TriLink BioTechnologiesRoom #: 670 Wuxi Apptec
Please note: Sponsored meeting rooms are by invitation only . Please see pages 32-33 for a list of exhibitors and booth #’s if you would like to connect with an exhibitor . You can also reach our exhibitors through the TIDES APP .
12 www.TIDESEvent.com *Schedule subject to change
TIDES PASSPORT CONTEST – PARTICIPATE AND WIN PRIZES!1 . Visit each booth in the Exhibit Hall listed in your passport .
Each booth will be labeled as a “Passport Stop” .2 Download the ‘KNect365’ app on your smartphone and log in using your TIDES
networking app login . Go to the ‘Passport Prize Program’ tab and use your phone’s QR scanner and scan each participating exhibitor . Please visit the registration desk if you need your app log in details .
3 . Attendees are to have scanned ALL participating exhibitors by 1:30 pm on Thursday . The winners will be announced at 1:45 at Booth 119 at the back of the Exhibit Hall . You MUST be present to win .
Check the App for an updated list
Thanks to our exhibitors for donating the following prizes:
Don't miss out on this fun and interactive tour through the Exhibit Hall . Stop by booths marked with a Passport stop around the Exhibit Hall and use the App to scan their QR code . Visit all participating booths up until 1:30 pm on Thursday, to not only walk away with innovative ideas but to have a chance of winning some fabulous prizes . Prizes will be drawn at 1:45 pm on Thursday
Prize Donated by Booth
$150 American Express AIC 502
Fitbit Charge 3 Almac Group 408
Gold Treasure Chest Bachem Americas, Inc. 503
$150 Amazon Gift Card Biotage 404
FitBit BioTechLogic 407
Go Pro Camera - Hero 7 ChemGenes 313
Bose Headphones Corden Pharma Intl 403
Flashdrives Guangzhou RiboBio 606
TBD Intertek 202
TBD Nagase & Co. , Ltd. 818
Gift Card PolyPeptide Group 613
iPad Pyramid Laboratories 402
Amazon Alexa Show QPS 304
Samsung Galaxy Watch ST Pharm 419
Beats headphones Thermo Fisher Scientific 409
$150 Amazon Gift Card Tosoh Bioscience 505
Apple Airpods TriLink BioTechnologies 713
24-26 February 2020 The Westin Miyako KyotoKyoto, Japan
MONDAY, MAY 20, 2019 • CONCURRENT MORNING HALF-DAY WORKSHOPS
Workshop #1: The State of the Art in mRNA Delivery
Morning Half-Day Workshop • 8:00am-12:00pm
(Room: Solana Beach AB) 8:00 Workshop Moderator’s Opening Remarks Örn Almarsson, Ph.D., Head of Formulations, Moderna Therapeutics
8:15 LUNAR®: Enabling mRNA Therapeutics and Vaccines Pad Chivukula, Ph.D., CSO and COO, Arcturus Therapeutics
8:45 Safe Delivery of Nucleic Acid Cargoes Using Anionic Carriers Steffen Panzner, Ph.D., CEO, Germany
9:15 Chemical Design of Synthetic Carriers for CRISPR/Cas Gene Editing and mRNA-mediated Protein Replacement Therapy
Daniel Siegwart, Ph.D., Associate Professor, Department of Biochemistry, UT Southwestern Medical Center
9:45 Networking Refreshment Break 10:15 Advancing the Delivery of LNP-encapsulated mRNA Therapeutics Frank DeRosa, Ph.D., Senior Vice President, R&D, Translate Bio
10:45 Design Aspects of Lipid Nanoparticles for mRNA Deliveryh James Heyes, Ph.D., SVP, Technology Development, Genevant Sciences, Canada
11:15 Delivering mRNA Products from Discovery through Development - Opportunities and Challenges
Hari Pujar, Head of Technical Development, Moderna Therapeutics
11:45 Concluding Remarks and Discussion 12:00 Close of Workshop
(Room: Mission Beach) 8:00 Workshop Co-Moderators’ Opening Remarks G. Susan Srivatsa, Ph.D., President, ElixinPharma Fran Wincott, Ph.D., Wincott & Associates, LLC
8:20 Points to Consider with US and EU Expedited Regulatory Pathways Paul Manley, President and Principal Consultant, Orvieto Consulting
8:50 From Target to Patient; Options for Oligonucleotides as Personalized Medicines Chantal Reed, Ph.D., Vice President, Brain Hz Consulting, Inc.
9:20 Use of Prior Knowledge to Establish Enhanced Flexible Platform-based Control Strategies
Zhijie Sui, Ph.D., Senior Scientist, Technical Development, Biogen
9:50 Networking Refreshment Break 10:20 Process Validation Approaches for Accelerated Programs Lisa deCardenas, Regulatory Program Manager, Genentech
10:50 Supporting Accelerated Development - Stability ApproachesEric McKinney, Director, Stability and Specifications, Alnylam Pharmaceuticals
11:20 Panel Discussion with Workshop Speakers
12:00 Close of Workshop
7:15 Workshop Registration (Grand Hall Foyer) and Breakfast (7:00am-8:00am) (Mission Beach Foyer)
Workshop #2: Oligonucleotide Drug Development at Warp Speed: Managing CMC Operations to Support Accelerated
Clinical DevelopmentMorning Half-Day Workshop • 8:00am-12:00pm
Workshop #3: Potential Green Chemistry Solutions for
Peptide ManufacturingMorning Half-Day Workshop • 8:00am-12:00pm
(Room: Ocean Beach) 8:00 Workshop Moderator’s Opening Remarks Trishul Shah, Director, Business Development, North America, PolyPeptide
8:15 Solid-Phase Peptide Synthesis: Being Greener, Being Better Fernando Albericio, Ph.D., Professor, Organic Chemistry, University of Barcelona
9:00 Evolved Enzymes for Commercial Chemical Synthesis Pathways Christina Boville, Ph.D., Resnick Prize Postdoctoral Scholar, Frnces Arnold Lab,
California Institute of Technology
9:45 Networking Refreshment Break 10:15 Convergent Peptide Synthesis in Flow: Preferred Regulatory Strategies for
Commercial Peptide Manufacture Michael Kopach, Ph.D., Senior Research Advisor, Eli Lilly and Company
11:00 Perspectives on Green Chemistry Jon Holbech Rasmussen, Ph.D., Director, Global Development, PolyPeptide Group, Sweden
11:45 Concluding Remarks and Discussion 12:00 Close of Workshop
(Room: Promenade) 8:00 Workshop Moderator’s Opening Remarks Bruce Morimoto, Ph.D., Vice President, Drug Development-Operations, Alkahest
8:15 Analytical Methods, Pre-formulation, and Formulation for Early Phase Development
Christopher Rhodes, Ph.D., President and CEO, Drug Delivery Experts
9:00 IND-enabling, Nonclinical Safety Studies for Peptides: Pharmacokinetics, Bioanalysis and Toxicology
Bruce Morimoto, Ph.D., Vice President, Drug Development-Operations, Alkahest
9:45 Networking Refreshment Break 10:15 Peptide CMC Approaches for a Fast and Successful IND Filing Mimoun Ayoub, Ph.D., Director and Head of North American and Emerging Markets,
CordenPharma International, Switzerland
11:00 Regulatory Perspectives on Peptide Drug Development Mark Longer, Ph.D., Vice President, Regulatory Affairs and Quality, Arena Pharmaceuticals
11:45 Concluding Remarks and Discussion 12:00 Close of Workshop
Workshop #4: Accelerating Peptides to IND: Moving to the
Clinic, CMC and BeyondMorning Half-Day Workshop • 8:00am-12:00pm
12:00-1:00 Networking Luncheon for Workshop Attendees and Workshop Speakers (Room: Seaview)
14 www.TIDESEvent.com
Follow us on Twitter @TIDES365 and tweet using hash tag #TIDES365 15
MONDAY, MAY 20, 2019 • CONCURRENT AFTERNOON HALF-DAY WORKSHOPS
(Room: Ocean Beach) 1:00 Workshop Moderator’s Opening Remarks Christopher Rhodes, Ph.D., President and CEO, Drug Delivery Experts
1:15 Introduction to Peptide Aggregation, Gelation, and Injection Site Precipitation, and the Consequences
Christopher Rhodes, Ph.D., President and CEO, Drug Delivery Experts
1:45 Non-aqueous Approaches to Peptide Aggregation Steven Prestrelski, Ph.D., Chief Scientific Officer, Xeris Pharmaceuticals, Inc.
2:15 In Vitro and in Vivo Models for Injection Site Precipitation and Formulation Solutions
Laxma G. Reddy, Ph.D., Fellow, Formulation and Product Development, Drug Delivery Experts
2:45 Networking Refreshment Break 3:15 Charge Variant Analysis of Therapeutic Peptides
Anuja Rane, Ph.D., Associate Scientist, Teva Pharmaceuticals
3:45 Shining Light on Therapeutic Peptide Aggregation Kinetics in the Presence of ExcipientsKatelyn Smith, Ph.D., Senior Scientist, Merck & Co., Inc.
4:15 Precious Peptides: Phase-appropriate Aggregation Risk Assessment Across Pharmaceutical Development
Suzanne D’Addio, Ph.D., Associate Principal Scientist, Discovery Pharmaceutical Sciences, Merck & Co.
4:45 Concluding Remarks and Discussion
5:00 Close of Workshop
Workshop #5: Peptide Aggregation – Challenges, Effects, and Solutions
Afternoon Half-Day Workshop • 1:00pm-5:00pm
(Room: Mission Beach) 1:00 Workshop Moderator’s 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 OligonucleotidesDoug Brooks, Ph.D., Consultant, Matapalo Pharma Consulting Services
2:45 Networking Refreshment Break 3:15 Getting Your ASO in Top Shape for IND/IMPD Submission: How to Successfully
and Efficiently Identify A Solid Development Candidate Sebastien Burel, Ph.D., Executive Director, Nonclinical Development, Ionis
Pharmaceuticals
4:00 Case Study: DCR-PHXC, An siRNA Therapeutic Being Developed for the Treatment of Primary Hyperoxaluria
Jeffrey Foy, Ph.D., Senior Director, Toxicology, Dicerna Pharmaceuticals
4:45 Concluding Remarks and Discussion
5:00 Close of Workshop
Workshop #6: The Path to A Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and
CMC PerspectivesAfternoon Half-Day Workshop • 1:00pm-5:00pm
Workshop #8: Analytical and Bioanalytical Strategies and Techniques for the Discovery and Development of
Oligonucleotide TherapeuticsAfternoon Half-Day Workshop • 1:00pm-5:00pm
Workshop #7: Evolving Regulatory CMC Requirements
for PeptidesAfternoon Half-Day Workshop • 1:00pm-5:00pm
(Room: Promenade) 1:00 Workshop Moderator’s Opening Remarks Gary Musso, Ph.D., President, Musso and Associates LLC
1:15 Locking the Process- Is It Moving Earlier in Development? Gary Musso, Ph.D., President, Musso and Associates LLC
2:00 European Regulatory Update on CMC Requirements for Synthetic Peptides René Thürmer, Ph.D., Deputy Head, Unit Pharmaceutical Biotechnology, BfArM Federal
Institute for Drugs and Medical Devices, Germany
2:30 Networking Refreshment Break 3:00 Of Peptides and PANDAS: Innovative Preclinical Assessment Tools for Safety
and Efficacy of Protein and Peptide Therapeutics Annie De Groot, M.D., Professor (Research) and Director, Institute for Immunology and
Informatics, University of Rhode Island and Founder, CEO and CSO, EpiVax, Inc., USA
3:45 Quantification of Impurities in Synthetic Peptides Using Proteolytic Sample Preparation and RP ChromatographyMichael Berger, Director, Quality Control, Bachem AG, Switzerland
4:30 Genotoxicity Assessment of Impurities in Peptide/Protein-containing BiotherapeuticsZhanna Sobol, Ph.D., Genetic Toxicology Head, Drug Safety Research and Development, Pfizer, Inc.
5:00 Close of Workshop
(Room: Solana Beach) 1:00 Workshop Moderator’s Opening Remarks Klaus Charisse, Ph.D., Director, Analytical R&D, Alnylam Pharmaceuticals
1:15 Characterization Methods for Physical Properties of Lipid Nano Particles (LNPs) Matthias Kretschmer, Ph.D., Senior Director Analytical Sciences, Alnylam
Pharmaceuticals
1:45 Analytical and Bioanalytical Characterization of Antisense Oligonucleotides Hans Gaus, Ph.D., Director of Structural Biology, Ionis Pharmaceuticals, Inc.
2:15 Bioanalytical Strategies for the Development of Stereo Pure Oligonucleotide Therapeutics
Pallavi Lonkar, Ph.D., Principal Scientist, WAVE Life Sciences
2:45 Networking Refreshment Break 3:15 Analytical Approaches for Determination of Therapeutic Oligonucleotides from
Biological Samples Ingo Roehl, Ph.D., Director, Analytical Chemistry, LGC Axolabs, Germany
3:45 mRNA Analytics Julie Powers, Ph.D., Associate Director, Production, TriLink BioTechnologies
4:15 Panel Discussion with Workshop Speakers
5:00 Close of Workshop
MISSION BREWERY EVENTBuses will depart at 5:30pm from the Hyatt for our adventure to Mission Brewery - one of the top craft breweries in San Diego . The Mission Brewery is located in the amazing historic Wonder Bread Building in East Village – with a 2500 sq .ft tasting room and original brick and bow truss ceilings the space is beautiful and the fresh craft beers paired with a full buffet of neighbor Mexican food will be the best way to kick off you TIDES experience .
Sponsored by
16 www.TIDESEvent.com
Contact us for details: Partners@KNect365Lifesciences.com or call +1.857.504.6684
TIDES: Oligonucleotide &Peptide Therapeutics Digital Week
Tuesday, May 21, 2019 • KEYNOTE SESSION (Room: Seaport ABC)
7:30 Registration (Grand Foyer) and Breakfast (Seaport Foyer)
8:20 Chairperson’s Remarks Firoz D. Antia, Ph.D., Director, Antisense Oligonucleotide Process Development and Manufacturing, Biogen
8:30 Antisense Technology: Today and Tomorrow
Stanley Crooke, M.D., Ph.D. Chairman of the Board and Chief
Executive Officer, Ionis Pharmaceuticals
9:30 RNAi Therapeutics: Onpattro and Beyond
Kevin Fitzgerald, Ph.D. Senior Vice President and Head of
Research, Alnylam Pharmaceuticals
10:15 Networking Refreshment Break
10:45 A Platform for In-solution Enrichment from Large Libraries to Identify Peptide Inhibitors of Protein-Protein Interactions
Bradley Pentelute, Ph.D. Professor, Chemistry, Massachusetts
Institute of Technology
11:30 Quality of Life – It’s Not Just a Numbers Game!
Sarah Boyce President, Akcea Therapeutics
12:15-1:25
SPOTLIGHT PRESENTATION LUNCHEONS
(Room: Harbor H)Track Record of Oligonucleotide and Peptide Manufacturing in Large Scale by Solution Phase Approach AJIPHASE®.Daisuke Takahashi, Ph.D., Senior Principal Researcher, Research Institute for Bioscience Products & Fine Chemicals, AJI Bio Pharma Services, Japan
(Room: Harbor E)Lipid Nanoparticles – From Benchtop to Clinic: A CDMO PerspectiveDi L. Bush, Ph.D., Formulations Director, Avanti Polar Lipids
(Room: Harbor F)Selecting an Asian CMO Partner for Therapeutic Oligonucleotide ManufacturingJ.O. Adams, Head of Research, Ribo Biologics Co. Ltd., China
(Room: Harbor G)Development of Synthetic Self-Replicating RNA Platforms for Oncology Vaccines and TherapeuticsAnton McCaffrey, Ph.D., Senior Director of Emerging Science and Innovation, TriLink BioTechnologiesNathaniel Wang, Ph.D., Head of R&D, RNA Medicines, Synthetic Genomics, Inc.
4-DAY WEBCAST SERIES September 16-19, 2019
18 www.TIDESEvent.com *Schedule subject to change
Tuesday, May 21, 2019 • PLENARY SESSION (Room: Seaport ABC)
1:25 Chairperson’s Remarks Trishul Shah, Director, Business Development, North
America, PolyPeptide
1:30 Using Artificial Intelligence to Accelerate Drug Development and Precision Medicine
Daniele Merico, Ph.D., Director of Molecular Genetics, Deep Genomics
2:00 Parameters for Accelerated Development of Antisense Oligonucleotides as Personalized Medicine
Timothy Yu, M.D., Ph.D., Attending Physician, Division of Genetics and Genomics, Boston Children’s Hospital and Assistant Professor in Pediatrics, Harvard Medical School
2:30 Development of Neoantigen-Based Personalized Cancer Vaccine, NEO-PV-01
Jesse Z. Dong, Ph.D., Vice President, Peptide Chemistry, Neon Therapeutics
3:00 Grand Opening of Poster and Exhibit Hall and Networking Refreshment Break
3:45 mRNA as a Platform Technology Ideally Suited for Individualized Therapeutics
Andreas Kuhn, Ph.D., Vice President RNA Biochemistry & Manufacturing, BioNTech RNA Pharmaceuticals GmbH, Germany
4:15 Manufacturing NeoAntigen Peptides: Requirements and Pragmatism
Trishul Shah, Director, Business Development, North America, PolyPeptide
4:45 PANEL DISCUSSION WITH SESSION SPEAKERS: Personalized Medicine and Individualized Therapies Moderator: Trishul Shah, Director, Business Development, North America, PolyPeptide
The Road to Personalized Medicines and Individualized Therapies
5:15-6:45Networking Reception in the Poster and Exhibit Hall
Sponsored by:
TIDES Europe:Oligonucleotide &Peptide Therapeutics
12-15 November 2019RAI Amsterdam
www.TIDESEuropeEvent.com
EUROPE’S #1 FORUM FOR OLIGONUCLEOTIDE AND PEPTIDE LEADERS TO BUILD SUCCESSFUL PARTNERSHIPS AND ACCELERATE NEW PRODUCTS TO MARKET
Join us for a Japanese inspired evening in the TIDES Exhibit Hall Our food selections include a Ramen Noodle Bar, fortune cookies and origami decor!
Musical entertainment featuring Japanese American koto performer Reiko Obata . Ms . Obata is based in San Diego, California and will perform traditional and contemporary Japanese koto music .
20 www.TIDESEvent.com
WEDNESDAY, MAY 22, 20197:30 Registration (Room: Grand Foyer)
Breakfast Spotlight Presentations7:45-8:15
Cost Efficient Peptide Purification via ZEOsphere DRP Mixed-Mode Chromatography (Room: Balboa ABC)Timothy O’Mara, Sales Manager, Itochu Chemicals America
Lessons Learned from Liposomal Products and Processes – Chemistry, Manufacturing and Controls (Room: Seaport BC)Andreas Wagner, Ph.D., Head of Liposome Technology, Polymun Scientific GmbH, Austria
Preclinical and Clinical Development of Oligonucleotide Therapeutics: Covering the Value Chain from Lead ID to Phase 1 Supply (Room: Seaport A)Hans-Peter Vornlocher, Ph.D., Managing Director Research, LGC AxolabsJuergen Mueller, Ph.D., Commercial and Strategic Development Director, LGC Axolabs
Oligonucleotide Discovery, Preclinical and Clinical
Oligonucleotide Chemistry, Manufacturing and Controls
Peptide Discovery, Preclinical and Clinical
Peptide Chemistry Manufacturing and Controls
Preclinical Discovery of Oligonucleotides
Oligonucleotide CMC Manufacturing Peptide Discovery Strategies Peptide CMC, Quality and
ManufacturingRoom: Seaport A Room: Seaport BC Room: La Jolla AB Room: Balboa ABC
8:25 Chairwoman’s RemarksShuling Guo, Ph.D., Vice President, Antisense Drug Discovery, Ionis Pharmaceuticals
Chairman’s RemarksDoug Brooks, Ph.D., Consultant, Matapalo Pharma Consulting Services
Chairman’s RemarksWaleed Danho, Ph.D., Consultant, Danho & Associates
Chairman’s RemarksAlex Fässler, Ph.D., Bachem Holding AG, Switzerland
8:30 Human Genetics Moves from Clinic to Bench and Back: Develop Antisense Therapies for Inherited DiseasesShuling Guo, Ph.D., Vice President, Antisense Drug Discovery, Ionis Pharmaceuticals
Industrial Scale Manufacture of 2-cyanoethyl-N,N,N′,N′-tetraisopropylphosphorodiamidite (Phos reagent)Peter Thornton, Ph.D., Scientist, Solvay Solutions, United Kingdom
Genetically Encoded Selection of Novel Cyclic and Bicyclic Architectures Ratmir Derda, Ph.D., Associate Professor, Department of Chemistry, University of Alberta, Canada
CMC Development Concept for Synthetic Peptides Tanja Huth, Ph.D., Group Leader QA/RA Project Management, Bachem AG, Switzerland
9:00 Targeted Delivery of Oligonucleotides to Muscle with Antibody Oligo Conjugates. Arthur A. Levin, EVP, Research and Development, Avidity Biosciences
Increasing Yields and Reducing Waste in Oligonucleotide ManufactureAnna Watson, Senior Scientist (Process Engineer), Pharmaceutical Technology and Development, AstraZeneca, United Kingdom
Chemoenzymatic Synthesis of MacrocyclesDavid Craik, Ph.D., Professor of Biomolecular Structure, Institute for Molecular Bioscience, University of Queensland, Australia
Supply Chain and CMC Considerations during Development of Lumicell’s Cleavable PEGylated Peptide-dyeConjugate for Fluorescence Guided Surgery Daniel Harris, Ph.D., Director of Drug Manufacturing, Lumicell
9:30 Development of microRNA TherapeuticsAimee L. Jackson, Ph.D., Vice President of Research, miRagen Therapeutics
Development of A Novel Method for Manufacturing A Single-stranded Long-chain RNA Oligomer, Which Is An Active Pharmaceutical Ingredient of TRK-250Hideaki Inada, Senior Research Associate, Pharmaceutical Research Laboratories, Toray Industries, Inc., Japan
The Power of Isoacyl Chemistry: Its Application to Insulin and GlucagonFa Liu, Ph.D., Director of Discovery Chemistry, Novo Nordisk Research Center Seattle
APL-2 Drug Substance: Strategic Dual-sourcing of a PEG-ylated Peptide during Late Stage Clinical DevelopmentNajib Maslouh, Vice President of Manufacturing and Technical Operations, Apellis Pharmaceuticals
10:00 Networking Refreshment Break in Poster and Exhibit Hall
Oligonucleotide Discovery, Preclinical
and Clinical
Oligonucleotide Chemistry, Manufacturing
and ControlsPeptide Discovery,
Preclinical and ClinicalPeptide Chemistry Manufacturing and
ControlsmRNA Therapeutics and
CRISPR Therapeutics
Room: Seaport A Room: Seaport BC Room: La Jolla AB Room: Balboa ABC Room: Gaslamp AB10:45 Overcoming the Hurdle of
Subcutaneous Delivery of mRNA in LNP to Enable Treatment of Chronic DiseasesShalini Andersson, Ph.D., Senior Director and Head of New Therapeutic Modalities, AstraZeneca, Sweden
Enzyme Catalysed Assembly of OligonucleotidesDavid Tew, Project Leader and GSK Senior Fellow, Advanced Manufacturing Technology, GlaxoSmithKline, United Kingdom
An Appropriate Screening Funnel at An Early Stage of Peptide Discovery is Key to Success: An OverviewStefania Colarusso, Senior Research Scientist, Peptide Chemistry, IRBM Science Park SPA, Italy
Introducing Green and Sustainable Chemistry in Liquid Phase Peptide Manufacturing Processes El Djouhar Rekaï, Ph.D., Head of Development & Manufacturing Process, PolyPeptide Group, Belgium
CRISPR TherapeuticsCo-Chairwomens’ Remarks Cecilia Fernández, Ph.D., Senior Director, Platform Strategy and Operations, Editas MedicineRubina Parmar, Ph.D., Director, Chemistry, Intellia Therapeutics(10:50) CRISPR/Cas Lipid Nanoparticle Formulations Optimized for Delivery and In Vivo Gene EditingChristopher Cheng, Ph.D., Associate Director Formulation Technology Development, Casebia Therapeutics
11:15 Small Activating RNAs – An Innovative Platform for Gene Activation David Blakey, Ph.D., Chief Scientific Officer, MiNA Therapeutics, United Kingdom
Applications of Hydrophilic Interaction Chromatography (HILIC) to OligonucleotidesZachary Parsons, Ph.D., Research Scientist II, Avecia
Epitope Targeted Protein Catalyzed Capture AgentsHeather Agnew, Ph.D., Vice President R&D Operations, Indi Molecular
Building Enzymatically Degradable Tissue Scaffolds with Thiol-ene Photo-click Polymer Chemistry: Development of Peptide Linkers for Biological Functionality, Chemical Reactivity, and Manufacturing Stability Peter Mariner, Ph.D., Director of Wound Healing, Mosaic Biosciences
PANEL DISCUSSION: Optimizing Lipid Nanoparticles (LNPs) for Liver Delivery of CRISPR/Cas9Panel Discussion Moderator: Manmohan Singh, Ph.D., Vice President, Pharmaceutical Sciences and Delivery Technologies, Beam TherapeuticsPanelists:Rubina Parmar, Ph.D., Director, Chemistry, Intellia TherapeuticsAndy Geall, Ph.D., Vice President of Formulations, Analytics and Chemistry, Avidity BiosciencesSamuel Clarke, Ph.D., Director, Research and Development, Precision NanoSystems, Canada
11:45 Intrathecal Delivery of siRNA Conjugates Leads to Robust and Durable Silencing in the Central Nervous SystemStuart Milstein, Ph.D., Associate Director, Alnylam Pharmaceuticals
Purge-based Risk Assessment for Solvent and Small Molecule Impurities Generated during Oligonucleotide SynthesisRobert Gronke, Ph.D., Senior Principal Scientist, Technical Development, BiogenBen Andrews, Ph.D., Scientific Investigator, API Chemistry, GlaxoSmithKline, United Kingdom
Challenges and Emerging Approaches in Peptide Phage Display and Its Application in Targeting Stem Cell Receptors Rami Hannoush, Ph.D., Principal Scientist & Group Leader, Early Discovery Biochemistry, Genentech
Drug Substance Dual Sourcing: a CMC Opportunity during Manufacturing Process ValidationMarc C. Constant, PharmD, Senior Director, CMC, NoNO Inc., Canada
12:15 Transition to Spotlight Presentation Rooms
Concurrent Spotlight Presentations12:20 Manufacturing of Oligonucleotide API Using
Nucleotide Blockmers (Room: Seaport BC) Masanori Kataoka, Ph.D., Chief Technical Officer, Shikoku Nucleic Acid Chemistry (S-NAC), Japan
Comparison of Purification Strategy in Oligonucleotide API Manufacture: Chromatography and Desalting Processes (Room: Seaport A)Kyeong Eun Jung, Ph.D., Senior Vice President, Head of Oligo and R&D Division, ST Pharm. Co. Ltd., South Korea
12:50 Networking Luncheon in Poster and Exhibit Hall
Follow us on Twitter @TIDES365 and tweet using hash tag #TIDES365 21
WEDNESDAY, MAY 22, 2019
Oligonucleotide Discovery, Preclinical
and Clinical
Oligonucleotide Chemistry,
Manufacturing and Controls
Peptide Discovery, Preclinical and
Clinical
Peptide Chemistry Manufacturing and
Controls
mRNA Therapeutics and CRISPR Therapeutics
Drug Delivery Innovations and
Strategies
Novel Chemistries CMC QC Analytics for Oligonucleotides
Peptide Discovery Strategies
Innovations in Peptide Synthesis and Manufacturing
CRISPR TherapeuticsNovel Technologies for the Delivery of Macromolecular
TherapeuticsRoom: Seaport A Room: Seaport BC Room: La Jolla AB Room: Balboa ABC Room: Gaslamp AB Room: Gaslamp CD
1:55 (1:50) Chairman’s RemarksDmitry Samarsky, Ph.D., Chief Technology Officer, Sirnaomics
Chairman’s RemarksClaus Rentel, Ph.D., Executive Director, Analytical Development/QC, Ionis Pharmaceuticals
Chairman’s RemarksRami Hannoush, Ph.D., Principal Scientist & Group Leader, Early Discovery Biochemistry, Genentech
Chairman’s RemarksMark Smythe, Ph.D., Founder and Vice President, Protagonist Therapeutics, Australia
Chairman’s RemarksEugenio Marco, Ph.D., Senior Scientist, Computational Biology, Editas Medicine
Chairman’s RemarksAndrew Latham, Ph.D., Director, Enabling Technologies, Merck(1:55) Reinventing
Oligonucleotide Synthesis Phil Baran, Ph.D., Professor, Department of Chemistry, The Scripps Research Institute2:00 High Resolution Mass
Spectrometry Enabled Sensitive Impurity Profiling and Structural Characterization of OligonucleotidesKui Yang, Ph.D., Chemist, Division of Pharmaceutical Analysis, CDER, US FDA
Peptide Drug Products: Formulation Development and Process Characterization to Inform Control StrategiesSuzanne D’Addio, Ph.D., Associate Principal Scientist, Discovery Pharmaceutical Sciences, Merck & Co.
New Engineering Tools for Peptide Synthesis: Prediction, Control and Automation to Boost Process PerformancesOlivier Ludemann-Hombourger, Ph.D., Global Director Innovation and Strategy, PolyPeptide Group, France
Successful Millimole gRNA Production & Highly Resolving Purity Test MethodsJoe Guiles, Ph.D., Head of Development, Nucleic Acid Solutions Division, Agilent Technologies, Inc.
Polymeric Architecture Affects Cellular and in vivo Delivery of Nucleic Acids and Genome EditingTheresa M. Reineke, Department of Chemistry, University of Minnesota
(2:20) Biomimetic Chemistry of RNAi TherapeuticsMuthiah (Mano) Manoharan, Ph.D., Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals
2:30 An Ion-Pair HPLC-UV-MS Methodology for Quality Control Analysis of Oligonucleotide TherapeuticsCarolyn Mazzitelli, Ph.D., Associate Director, Ionis Pharmaceuticals
Beyond Biologics: Targeting VEGF-A and PD-1 with Synthetic D-proteins Dana Ault-Riche, Ph.D., CEO, Reflexion Pharmaceuticals
Commercial Manufacturing of Disulfide-Rich PeptidesMichael Pennington, Ph.D., Chief Scientific Officer, AmbioPharm, Inc.
Characterizing Lipid Nanoparticle Function to Inform on mRNA Vaccine DesignMarian Gindy, Ph.D., Executive Director, Pharmaceutical Sciences, Merck Research Laboratories
(2:45) Enhancing Therapeutic Profile of ASOs Using Gap-modificationsPunit Seth, Ph.D., Vice President, Medicinal Chemistry, Ionis Pharmaceuticals
(2:45) Evaluating Genome Editing Specificity with CRIPSR/CAS9 and CPF1Eugenio Marco, Ph.D., Senior Scientist, Computational Biology, Editas Medicine
3:00 Selectivity in Ion-pairing Reversed Phase Liquid Chromatography of OligonucleotidesBrian Trammell, Ph.D., Principal Scientist, Analytical Development, Avecia
Long-Acting Human Growth Hormone Analogue Somapacitan by non-Covalent Albumin BindingHenrik Sune Ramírez-Andersen, Scientific Director, Novo Nordisk A/S, Denmark
Peptide Manufacturing Scale-up ConsiderationsRobert Topping, Ph.D., Distinguished Scientist, Development Synthetic Chemistry, CordenPharma Colorado
Optimization of Novel Polymeric Delivery Vehicles by Chemical EvolutionErnst Wagner, Ph.D., Chair, Professor and Chair, Pharmaceutical Biotechnology, Department of Pharmacy, Ludwig Maximilians University, Germany
(3:10-3:35) From Stereopurity to Precision Medicine: Optimizing the Properties of Antisense Nucleic Acid TherapeuticsChandra Vargeese, Ph.D., Senior Vice President, Head of Drug Discovery, WAVE Life Sciences
3:30 Networking Refreshment Break in Poster and Exhibit Hall
Oligonucleotide Discovery and Development
CMC QC Analytics for Oligonucleotides New Frontiers in Peptide Drug Development CRISPR Therapeutics
Novel Technologies for the Delivery of Macromolecular
TherapeuticsRoom: Seaport A Room: Seaport BC Room: Balboa ABC Room: Gaslamp AB Room: Gaslamp CD
4:15 From Rectal Solution to Oral Capsule: Life Cycle Management of Cobitolimod, a Novel Immunomodulatory Oligonucleotide for Local Treatment of Active Ulcerative ColitisChristine Dieterich Johansson, Ph.D., Senior Project Manager CMC and Pre-clinical, InDex Pharmaceuticals, Sweden
Control of Impurities for siRNA TherapeuticsMatthias Kretschmer, Ph.D., Senior Director Analytical Sciences, Alnylam Pharmaceuticals
Reimagining Drug Discovery: How Artificial Intelligence Can Balance the Return on Research Investment and Fuel New Peptide DiscoveriesNora Khaldi, Ph.D., Founder and Chief Scientific Officer, Nuritas Ltd., Ireland
Novel Cas12a Mutants with Improved Activity and Expanded PAM Recognition DomainsMark Behlke M.D., Ph.D., Chief Scientific Officer, Integrated DNA Technologies
mRNA Vaccination with Charge-altering Releasable Transporters Elicits Human T cell Responses and Cures Established Tumors in MiceRobert Waymouth, Ph.D., Robert Eckles Swain Professor of Chemistry, Stanford University
4:45 Preclinical and Clinical Development of AST-008, A Toll-like Receptor Agonist 9 Spherical Nucleic Acid for Immuno-oncology ApplicationsWeston Daniel, Ph.D., Senior Director of Program Management, Exicure, Inc.
Experiences as Commercial Release Lab for OligonucleotidesSusann Rosmus, Ph.D., Head of Quality Management, BioSpring GmbH, Germany
The Orally Available Clinical Stage All-D-enantiomeric Peptide PRI-002 Reverses Cognition Deficits and Decelerates the Neurodegeneration Phenotype in Transgenic Alzheimer’s Disease Mouse ModelsDieter Willbold, Ph.D., Director, ICS-6 Structural Biochemistry, Forschungszentrum Jülich, Germany
sgRNA Plate-Based Synthesis For In Vitro CRISPR ScreeningMichelle Young, Principal Scientist, Intellia Therapeutics
Rapidly Identifying Nanoparticles for Non-hepatocyte RNA Delivery by Testing Thousands in vivo Using DNA BarcodesJames Dahlman, Ph.D., Assistant Professor, Biomedical Engineering, Georgia Institute of Technology
5:15 DTx Pharma: Leveraging Fatty Acids as Targeting Ligands to Enable Delivery of RNA Medicines Beyond the LiverArthur Suckow, Ph.D., CEO and CSO, DTx Pharma
A Look into the Future of Analytical Method Development and ValidationNina Cauchon, Ph.D., Director, Regulatory Affairs CMC, Amgen
Progress in the Development of Peptide Therapeutics for Unmet Medical NeedsMark Smythe, Ph.D., Founder and Vice President, Protagonist Therapeutics, Australia
Synthesis and Characterization of High Purity gRNAs for CRISPR-based TherapeuticsStacy Capehart, Ph.D., Scientist II, Editas Medicine
Characterizing the Therapeutic Application of messenger RNA-lipid Nanoparticles Ying Tam, Ph.D., Chief Scientific Officer, Acuitas Therapeutics
5:45-6:45 Networking Reception in Poster and Exhibit Hall Sponsored by:
22 www.TIDESEvent.com
THURSDAY, MAY 23, 2019
7:30 Registration (Room: Grand Foyer)
Breakfast Spotlight Presentation (Room: Seaport BC)
7:45-8:15
Application of Semiconductor Based Oligo Pool in Precision Diagnostics Jianpeng Wang, Senior Scientist, Genscript
Oligonucleotide Discovery,
Preclinical and Clinical
Drug Delivery Innovations and
StrategiesOligonucleotide Chemistry, Manufacturing and Controls
Peptide Discovery,
Preclinical and Clinical
Peptide Chemistry
Manufacturing and Controls
mRNA Therapeutics and CRISPR Therapeutics
mRNA Discovery and Development
Seaport A Seaport BC Balboa ABC La Jolla AB
Extra-Hepatic Delivery of Oligonucleotides Regulatory Perspectives Individualized Neo-Antigens
(8:20) Chairman’s RemarksAnthony Partridge, Ph.D., Senior Principal Scientist, Early Discovery Pharmacology, Translational Medicine Research Centre, Merck Sharp & Dohme, Singapore
(8:25) Inhibition and Degradation of Drug Targets Using bioPROTAC mRNAs – A Novel Approach with Broad Therapeutic PotentialAnthony Partridge, Ph.D., Senior Principal Scientist, Early Discovery Pharmacology, Translational Medicine Research Centre, Merck Sharp & Dohme, Singapore
8:25 Chairman’s RemarksMuthiah (Mano) Manoharan, Ph.D., Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals
Chairman’s RemarksG. Susan Srivatsa, Ph.D., President, ElixinPharma
Chairman’s RemarksTrishul Shah, Director, Business Development, North America, PolyPeptide
8:30 RNAi Delivery: Overcoming a Billion Years of Evolutionary Defenses Steven Dowdy, Ph.D., Professor, Cellular and Molecular Medicine, UCSD School of Medicine
Regulatory Agency Questions and Learnings from Recent Commercial SubmissionsJennifer Franklin, Director, CMC Regulatory Affairs, Ionis Pharmaceuticals
A New Source of Frameshift Neoantigens for Vaccines and DiagnosticsStephen Albert Johnston, Ph.D., Chief Executive Officer, Calviri, Inc.
(8:50) Evaluation of Modified Interferon alpha mRNA Constructs for the Treatment of Non-melanoma Skin CancerMarkus Mandler, Ph.D., Chief Scientist Officer, Accanis, Austria
9:00 Moving Antibody-Oligonucleotide Conjugates (AOCs) into DevelopmentAndy Geall, Ph.D., Vice President of Formulations, Analytics and Chemistry, Avidity Biosciences
Quality Development in European Early Access Approaches (PRIME) René Thürmer, Ph.D., Deputy Head, Unit Pharmaceutical Biotechnology, BfArM Federal Institute for Drugs and Medical Devices, Germany
Improving Formulation Consistency of Individualized, Peptide-based Therapies Using Self-assembling NanoparticlesGeoffrey Lynn, M.D., Ph.D., CEO, Avidea Technologies
(9:15) Messenger RNA Therapeutics for Bone Regeneration and for Pulmonary DiseasesChristian Plank, Ph.D., Chief Technology Officer, Ethris GmbH, Germany
9:30 Ocular Delivery of siRNA Conjugates: Efficient and Durable Gene Silencing of TTR after Single Intravitreal Administration of siRNA ConjugatesJayaprakash Nair, Ph.D., Associate Director, Research, Alnylam Pharmaceuticals
Spinraza Regulatory CMC ExperiencesMia Kiistala, Associate Director Regulatory Affairs, Biogen
Pioneering NeoAntigen Immunotherapies: via ATLAS & Rethinking Peptide NeoAntigensDaniel DeOliveira, Ph.D., Director of Pharmaceutical Sciences & Manufacturing, Genocea Biosciences
(9:40-10:05) Novel mRNA ImmunotherapiesRobert Jabulowsky, Ph.D., Deputy Head of Project Management, BioNTech AG, Germany
10:00 Networking Refreshment Break in Poster and Exhibit Hall
10:45 Targeting RNA with Antisense Oligonucleotides to Treat Diseases of the CNSPaymaan Jafar-nejad, M.D., Associate Director, Ionis Pharmaceuticals
Innovations in Oligonucleotide CMC
FlowVax: A Synthetic, Adjuvanted Microsphere Peptide Vaccine PlatformScott Burkholz, Bioinformatics Data Scientist, Flow Pharma
Nucleoside-modified mRNA Immunization against Infectious DiseasesNorbert Pardi, Ph.D., Research Assistant Professor of Medicine, University of Pennsylvania
Saving GalNAc: Improvements on Solution-Phase Conjugation of OligonucleotidesSimon Breitler, Ph.D., Process Chemist, Roche, Switzerland
11:15 Extrahepatic Targeting and the Future of Oligonucleotide TherapeuticsDavid Rozema, Ph.D., Head of Therapeutic Chemistry, Empirico Therapeutics
Control of Oligonucleotide Drugs: Product Quality Attribute Assessment to Ascertain CriticalityRobert Duff, Ph.D., Principal Scientist, Attribute Sciences, Amgen
FDA Regulatory View on Personalized Medicine Concepts for Therapeutic PeptidesSyed Rafat Husain, Ph.D., Research Chemist, Division of Cellular and Gene Therapies, Office of Tissues and Advanced Therapies, CBER, FDA
mRNA Based Vaccines Expressing RSV are Immunogenic and Protective in Preclinical Models of Respiratory Syncytial Virus InfectionPedro Cejas, Ph.D., Associate Principle Scientist, Merck
11:45 Inhibition of Glutathione S-Transferase P (GSTP) for the Treatment of KRAS-Driven NSCLC using a Novel siRNA Lipid NanoparticleRoger Adami, Ph.D., Senior Director Pharmaceutical Sciences, Nitto BioPharma, Inc.
Delivering Answers Through InnovationBrian Carothers, Vice President and General Manager, Nucleic Acid Solutions Division, Agilent Technologies, Inc.
Panel Discussion with Sessions SpeakersModerator: Trishul Shah, Director, Business Development, North America, PolyPeptide
Program on Self-amplifying RNAs for Prophylactic VaccinationNicolas Delahaye, Ph.D., Technology Project Leader, GSK
12:15 Transition to Spotlight Presentation Rooms
Concurrent Spotlight Presentations12:20-12:50
(Room: Seaport BC)Sumitomo’s Approach: Development of Manufacturing and Analytical Methods for Manufacturing High Quality Long RNA OligosTakashi Miki, Senior Research Scientist, Health & Crop Sciences Research Laboratory, Sumitomo Chemical Co Ltd., Japan
(Room: Seaport A)Approaches to Data Analysis for CMC Testing of Oligonucleotide TherapeuticsJo-Anne Riley, Senior Scientist, Oligonucleotide Services, Intertek Pharmaceutical Services
12:50 Networking Luncheon in Poster and Exhibit Hall
Sponsored by:
Follow us on Twitter @TIDES365 and tweet using hash tag #TIDES365 23
THURSDAY, MAY 23, 2019
Oligonucleotide Discovery, Preclinical and Clinical
Oligonucleotide Chemistry,
Manufacturing and Controls
mRNA Therapeutics and CRISPR Therapeutics
Peptide Discovery,
Preclinical and Clinical
Drug Delivery Innovations
and StrategiesPeptide Chemistry
Manufacturing and Controls
Oligonucleotides in the Clinic mRNA CMC and Manufacturing Innovations in Peptide Delivery Peptide Purification and Downstream Processing
Seaport A Seaport BC La Jolla AB Balboa ABC1:55 Chairman’s Remarks
Annekathrin Haberland, Ph .D ., Director Regulatory Affairs, Berlin Cures GmbH, Germany
Chairman’s RemarksHeinrich Haas, Ph .D ., Vice President, RNA Formulation & Drug Delivery, BioNTech AG, Germany
Chairman’s Remarks Christopher Rhodes, Ph.D., President and CEO, Drug Delivery Experts
Chairman’s Remarks Marc Jacob, Ph.D., Business Development Manager, Purification Technologies - North America, Phenomenex
2:00 Update on the DCR-PHXC and DCR-HBV Clinical Programs and Other Pipeline ProgressBob Brown, Ph.D., CSO and SVP, Research, Dicerna Pharmaceuticals
Characterization of Critical Quality Attributes of mRNAPenggao Duan, Ph.D., Principal Scientist, Moderna Therapeutics
Adhesive Dermally Applied Microarray (ADAM): Experience in Osteoporosis, Diabetes and MigraineMahmoud Ameri, Ph.D., Vice President, Research and Development, Zosano Pharma
Industrial Peptide Purification – Challenges and ConceptsRalf Eisenhuth, Ph.D., Process Manager Technology Transfer and Chromatography, Bachem AG, Switzerland
2:30 The Oligonucleotide Agent BC 007 Neutralizes Agonistic Autoantibodies Directed Against β1-Adrenoceptors - Data of Clinical Phase 1 TrialAnnekathrin Haberland, Ph.D., Director Regulatory Affairs, Berlin Cures GmbH, Germany
Defining Critical Quality Attributes for RNA Nanoparticle Manufacturing from Extended CharacterizationHeinrich Haas, Ph.D., Vice President, RNA Formulation & Drug Delivery, BioNTech AG, Germany
Engineered Amphiphilic Peptides Enable Delivery of Protein and CRISPR Cargoes to Cells David Guay, Ph.D., Research Director, Feldan Therapeutics, Canada
Aggregation of Peptides in Preparative ChromatographyAnthony Zidell, Analytical Chemist, Corden Pharma Colorado
3:00 Anti-FGF2 Aptamer RBM-007 in Phase I/IIa Trials for Wet AMDYusuf Ali, Ph.D., CEO, RIBOMIC USA
Manufacturing and Characterization of mRNA ConstructsUlrich Blaschke, Ph.D., Vice President for Technical Development, CureVac AG, Germany
Exploiting a Novel Cell Death Mechanism for Selective Killing of Cancer Cells Upregulating Homologous Recombination Maria Soloveychik, Ph.D., CEO, SyntheX, Inc.
High-Throughput Approaches to Column Screening for the Preparative Purification of PeptidesSteven McIntyre, Peptide Process Development Department Manager, Almac Group, United Kingdom
3:30 Close of Conference
TIDES: Oligonucleotide &Peptide TherapeuticsMay 11-14, 2020Hynes Convention CenterBoston, MA
SEE YOU NEXT YEAR
24 www.TIDESEvent.com
Poster Presentations (continued)Poster Presentations
BIOANALYTICAL STRATEGIES AND TECHNOLOGIESA1 Polymeric Adsorbents for Reverse Phase Chromatography Daryl Gisch DowDupont
DRUG DELIVERY INNOVATIONS AND STRATEGIESC0 Liquid Phase Synthesis of Oligonucleotides by Nanostar Sieving Andrew Livingston Imperial College London
C1 Liquid Phase Synthesis of Mono-disperse PEGs by Nanostar Sieving Piers Gaffney Imperial College London
C2 Defined Multimeric Oligonucleotides for Enhanced Therapeutic Effect Jonathan Miles Brown MPEG LA LLC
C3 Development of an Advanced DNA Barcoded Lipid Nanoparticle (LNP) Platform That Can Quantify the Biodistribution of Functional LNPs with RNA Payloads in vivo
Cory Sago Guide Therapeutics
C4 Potential Mechanism of Anticancer Nano-Therapy Jingyuan Yu UGANT LLC
C5 Biodegradable Lipids for Delivery of Nucleic Acid Vaccines Jessica Cohen GSK Vaccines
C6 Tunable BAIT-based Nanoparticle Technology for Sustained Biologics Delivery
Michael Sekar Amma Therapeutics
C7 The impact of lipid to RNA ratio on RNA packing in Lipid Nanoparticles and their In Vitro Potency
Andrzej Pitek GSK Vaccines
C8 Development of Self-Degradable Lipid-Like Material for RNA delivery Hiroki Yoshioka NOF Corporation
C9 Estimating Patent Office Allowance Rates for Therapeutic Payload Delivery Inventions
Joseph Mallon Knobbe Martens
C10 High-density Lipoprotein Particle Delivery of siRNA Robert Sons Fannin Innovation Studio
C11 Enhanced Antisense Oligonucleotide Delivery via AGTR1 Targeting Carol Kuo Ionis Pharmaceuticals, Inc.
C12 Centyrin Targeted Delivery of siRNA to Non-Hepatic Cells Robert Kolakowski Aro Biotherapeutics
mRNA THERAPEUTICS AND CRISPR THERAPEUTICSD1 Purification of mRNA with reverse-phase chromatography Alex Levine Nacalai USA
D2 Scalable Manufacture of mRNA Lipid Nanoparticles using a Novel Microfluidic Mixing Architecture
Viet Nguyen Precision NanoSystems
D3 Identification of Novel RNA Binding Proteins (RBPs) and Their Putative Functions in Neurogenesis
Sung-Oh Huh Hallym University College of Medicine
D4 CodeSphere - Molecular Encoding of Nanoparticles for Targeted Cargo Delivery
Keith Moss Technical University of Denmark (DTU)
D5 Identification of miR-210 Target Genes Yan Zeng Nanjing Agricultural University
D6 Knowledge and Perceptions of Adverse Events Folowing Immunization Among Healthcare Professionals in Africa: A Case Study from Ghana
Peter Yamoah College of Health Sciences (Pharmacy)
D7 CDMO Outsourcing: Considerations for the Development, Scale-up and Manufacturing of mRNA Therapeutics
Jessica Madigan TriLink Biotechnologies
Dedicated Poster Viewing HoursEven- Numbered Posters (ending in 2,4,6)Tuesday, May 21: 5:30-6:30 pm
Odd-Numbered Posters (ending in 1,3,5)Wednesday, May 22: 5:45-6:45 pm
Exhibit Hall & Poster Viewing Hours
Tuesday, May 21, 3:00 pm - 6:45 pmPM Refreshment Break – 3:00 pm-3:45 pm Reception – 5:15 pm-6:45 pm
Wednesday, May 22, 10:00 am – 6:45 pmAM Refreshment Break – 10:00 am-10:45 amLunch— 12:50 pm-1:55 pm PM Refreshment break – 3:30 pm-4:15 pm Reception – 5:45 pm-6:45 pm
Thursday, May 23, 10:00 am – 2:00 pmAM Refreshment Break – 10:00 am-10:45 am Lunch—12:50 pm-1:55 pm
Poster presentations will be on display at all times during Exhibit Hall viewing hours . Poster presenters may stand by their posters at any time, but to ensure that attendees are able to meet poster presenters at specific times during the conference, we have designated the listed days/times as “Dedicated Poster Viewing” Hours . We ask poster presenters to stand by their posters during the dedicated hours listed to make it easy for attendees to “find” you . We will be promoting these dedicated poster viewing hours during the conference to facilitate better attendee and poster presenter interactions and discussions .
Follow us on Twitter @TIDES365 and tweet using hash tag #TIDES365 25
Poster Presentations (continued)
D8 An In Depth Structural and Functional Correlation Study of UX053 mRNA Drug Substance, a Developmental Therapeutic for Glycogen Storage Disease III (GSD III)
Zheng Meng Ultragenyx Pharmaceutical
D9 Simultaneous Quantification of Nucleic Acid Delivery Mediated by >100 Nanoparticles with 10-21 g Sensitivity
Melissa Lokugamage Georgia Institute of Technology
OLIGONUCLEOTIDE CHEMISTRY, MANUFACTURING AND CONTROLSE1 Analysis of Long RNA Oligonucleotides Masataka Shibata Sumitomo Chemical Co
Ltd
E2 Variability in the UV/VIS Spectroscopy Based Concentration Determination of Oligonucleotides
Daniel Fletcher Roche Molecular Systems
E3 Small Scale Automated Crossflow Platform for High Throughput Downstream Process Screening”
Craig Christofidis Sartorius Stedim
E4 GalNAc Clusters as Regulatory Starting Material Martin Olbrich F Hoffmann La Roche Ltd
E5 Purification of Oligonucleotides by Agarose-Based Anion Exchange Chromatography
Cecilia Unoson Bio-Works
E6 Solid-Phase Synthesis of Phosphorothioate Oligonucleotides Using Sulfurization Byproducts for in situ Capping
Li Xiao Biogen
E7 Breaking the Yield-Purity Trade-Off in Chromatography Purification of Peptides and Oligonucleotides
Thomas Muller-Spath ETH Zurich
E8 Formulation and Process Parameter Development for the Terminal Sterilization of Antisense Oligonucleotide Drug Products
Daniel DeCollibus Biogen
mRNA THERAPEUTICS AND CRISPR THERAPEUTICS
26 www.TIDESEvent.com
Poster Presentations (continued)
E9 Strategies for Efficient, High Throughput Optimization of the Synthesis of Biopolymers
Cyf Ramos-Colon Gyros Protein Technologies
E10 Method optimization and Evaluation for RNA Purity Analysis using CE-LIF Technology
Matt Salem SCIEX
E11 Considerations for Terminally Sterilized Oligonucleotide Drug Products
Julia Ma Ionis Pharmaceuticals
OLIGONUCLEOTIDE DISCOVERY, PRECLINICAL AND CLINICALE12 Antisense Oligonucleotide-Mediated Knockdown of Mitochondrial
Fusion and Fission Factors Modulates Mitochondrial Morphology and Basal Mitophagy
Daniel Garcia Ionis Pharmaceuticals
E13 Neuroprotective Effects of NXP031 in the MPTP-induced Mouse Model of Parkinson’s Disease
Soonhye Hwang Nexmos
E14 Solution-phase Optimization Studies and Soild-phase Synthesis of Morpholinophosphoramidate Oligonucleotides
Heera Krishna, Katarzyna Jastrzebska
University of Colorado
E15 A Specific Anti-Drug Antibody Assay for an Oligonucleotide Therapeutic
Valerie Leesch Charles River
E16 Metabolite Profiling of Oligonucleotides using Liquid Chromatography Coupled with High Resolution/Accurate Mass (HR/AM) Mass Spectrometry
Juan Rogness Covance
E17 Taking advantage of Architectural Diversity when Developing Locked Nucleic Acid (LNA) Antisense Oligonucleotides as RNA-Targeting Therapeutics
Natalia Paprgyri Technical University of Denmark
E18 Asymmetric siRNA Therapeutics for Fibrotic Disease Treatment June Park OliX Pharmaceuticals
E19 Determination of Ricin Exposures in Blood Samples by Detecting the Presence of Either Active Ricin or Ricin-Induced Depurinated 28S rRNA Isolated from Cell-free RNA
Reut Falach IIBR
E20 Bi-functional and Cell-Selective CpG-STAT3 Antisense Oligonucleotides for Solid Tumor Immunotherapy
Marcin Kortylewski City of Hope
E21 Extending the Lower Limits of Quantification of a Therapeutic Oligonucleotide Through Microflow LC-MS/MS
Yi Zhang SCIEX
E22 Modelling PNPLA3 Induced Non-Alcoholic Fatty Liver Disease using iPS-derived Hepatocytes
Kalpesh Jhaveri Definigen Limited
E23 Quantitative Whole Body Autoradiography in rats using Intrathecal Administration of a Tritium Labeled LNA-modified Oligonucleotide
Erich Koller Roche Innovation Center Basel
E24 Purification of Oligonucleotides using Capto Q ImpRes Per Denker Custom Design Media
E25 Characterization of Synthetic Oligonucleotides using LC-MS and LC MS/MS
Sean McCarthy SCIEX
E26 Next Generation miR-29 Mimics as Hepatic and Pulmonary Fibrosis Therapeutics
Benjamin Werner miRagen Therapeutics
E27 Exploring the Mechanisms of Kidney Uptake of Oligonucleotides Yongfeng Jiang Alnylam Pharmaceuticals
E28 Nanoparticle-mediated Delivery of a Modified Transfer RNA restores Function in Primary hBE Cells Derived from Cystic Fibrosis Patients With Nonsense Mutations
Michael Torres ReCode Therapeutics, Inc.
OLIGONUCLEOTIDE CHEMISTRY, MANUFACTURING AND CONTROLS
THE POWER TO MAKE
OLIGO & PEPTIDE CDMO SERVICES WITH SOLID PHASE & AJIPHASE®
SEEMLESS SUPPLY FROM RESEARCH TO COMMERCIAL QUANTITIES
New GMP facility launched
in April 2019
1st OligoProcess in Japan
GeneDesign.jp | AjiBio-Pharma.comInfo-e@genedesign.co.jp
28 www.TIDESEvent.com
Poster Presentations (continued)
PEPTIDE CHEMISTRY MANUFACTURING AND CONTROLSF1 Effect of fatty Acid Length on Autophagy Activation and
Anti-Inflammation of Human Keratinocytes.Jongphil Kong Incospharm Corporation
F2 A Brief Evaluation of the Impact of Thermal, Shear and Light Stress on Adalimumab
John Rockwell Catalent Pharma Solutions
F3 A New Scalable Economical Synthesis of Fmoc-D-Ile Utilizing a Renewable Ni(II) Complex Giving Extremely High Chiral Purity
Todd Romoff Hamari Chemicals USA Inc
F4 Ion-Pairing Effect on the Retention Behavior of Synthetic Peptides in Reversed-phase Liquid Chromatography
George Wang Bristol-Myers Squibb
F5 Development of a Multi-step Purification for Liraglutide Marc Jacob Phenomenex
F6 Overcoming Challenges when Implementing an LC-MS Approach for Synthetic Peptide Impurity Profile Monitoring
Joe Fredette Waters Corporation
F7 Robust Silica Gel-based Stationary Phase Tetsuyuki Saika DAISO Fine Chem USA
F8 New Concept of Peptide Chemical Synthesizer Taiki Shamoto Innovation center
F9 The ACS Green Chemistry Institute Pharmaceutical Roundtable: Accelerating the Development of Greener Peptide and Oligonucleotides Syntheses
Isamir Martinez, Michael Kopach, Ben Andrews and Albert Isidro-Llobet
ACS Green Chemistry Institute (GCI)
F10 Triptorelin Acetate: A Therapeutic Peptide Case Study Elena Curti USP
Follow us on Twitter @TIDES365 and tweet using hash tag #TIDES365 29
Poster Presentations (continued)
PEPTIDE DISCOVERY, PRECLINICAL AND CLINICALG1 NanoClick Assay: A High-Throughput, Target Agnostic Permeability
Assay Combining NanoBRET Technology and Intracellular Cycloaddition Chemistry
Jeffrey Schubert Merck
G2 Improving Optical and MS Performance in Peptide LC-US/MS Using IonHance Difluoroacetic Acid
Paula Orens Waters Corporation
G3 Predicting Immunogenicity of Peptide Drugs and their Impurities using in Silico tools: Taspoglutide Case Study
Aimee Mattei EpiVax, Inc.
G4 Innovative Preclinical Assessment Tools for Safety and Efficacy of Protein and Peptide Therapeutics … of Peptides and P-ANDAS
Brian Roberts EpiVax, Inc.
G5 PT320, a long-acting Exenatide, as the First-in-class Drug for the Treatment of Parkinson's disease
Jin Jung Peptron Inc.
30 www.TIDESEvent.com
32 www.TIDESEvent.com
Exhibit Hall Map
Exhibit & Poster Hall Viewing HoursTuesday, May 21 3:00 pm - 6:45 pmWednesday, May 22 10:00 am - 6:45 pm Thursday, May 23 10:00 am - 2:00 pm
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AAPPTEC. . . . . . . . . . . . . . . . . . . . .209
Advanced ChemTech (A Division of CreoSalus) . . . . . . .703
Agilent Technologies . . . . . . . . . . .413
AIC . . . . . . . . . . . . . . . . . . . . . . . . . .502
AJI Bio Pharma Services. . . . . . . .602
Aldevron . . . . . . . . . . . . . . . . . . . . .812
Almac Group. . . . . . . . . . . . . . . . . .408
Alturas Analytics . . . . . . . . . . . . . .207
AM Chemicals . . . . . . . . . . . . . . . .718
AmbioPharm. . . . . . . . . . . . . . . . . .418
Asahi Kasei Bioprocess. . . . . . . . .213
Aspen. . . . . . . . . . . . . . . . . . . . . . . . . . 2
Asymchem Inc . . . . . . . . . . . . . . . .719
Avanti Polar Lipids. . . . . . . . . . . . .203
Bachem Americas, Inc. . . . . . . . . .503
BCN Peptides . . . . . . . . . . . . . . . . .507
Berkshire Sterile Manufacturing .321
BianoGMP GmbH . . . . . . . . . . . . . .721
BioNTech Innovative Manufacturing Services GmbH . .714
BioSpring. . . . . . . . . . . . . . . . . . . . .521
Bio-Synthesis, Inc. . . . . . . . . . . . . .422
Biotage . . . . . . . . . . . . . . . . . . . . . .404
BioTechLogic . . . . . . . . . . . . . . . . .407
Bio-Works Sweden . . . . . . . . . . . . .802
Cambrex . . . . . . . . . . . . . . . . . . . . .109
Carbosynth . . . . . . . . . . . . . . . . . . .618
CEM . . . . . . . . . . . . . . . . . . . . . . . . .518
ChemGenes . . . . . . . . . . . . . . . . . .313
CMIC . . . . . . . . . . . . . . . . . . . . . . . .704
Corden Pharma Intl . . . . . . . . . . . .403
CPC Scientific . . . . . . . . . . . . . . . . .302
CS Bio . . . . . . . . . . . . . . . . . . . . . . .208
Daiso Fine Chem . . . . . . . . . . . . . .307
Definigen . . . . . . . . . . . . . . . . . . . . . . . 3
Drug Delivery Experts . . . . . . . . . .808
EpiVax, Inc. . . . . . . . . . . . . . . . . . . .114
Eurogentec . . . . . . . . . . . . . . . . . . .816
Exelead . . . . . . . . . . . . . . . . . . . . . .110
Fluoroprobes . . . . . . . . . . . . . . . . . . . 1
GE Healthcare BioSciences . . . . .617
GenScript . . . . . . . . . . . . . . . . . . . .102
Granlen . . . . . . . . . . . . . . . . . . . . . .620
Guangzhou RiboBio . . . . . . . . . . . .606
Gyros Protein Technologies . . . . .607
Herbert Brown Pharmaceutical & Research Laboratories. . . . . . . .206
Hongene Biotechnology . . . . . . . .309
Hybio Pharma Co . . . . . . . . . . . . . .305
Innovassynth Technologies . . . . .123
Intavis . . . . . . . . . . . . . . . . . . . . . . .421
Intellia Therapeutics Inc . . . . . . . .104
Follow us on Twitter @TIDES365 and tweet using hash tag #TIDES365 33
Exhibit Hall Map
719 818
816
105 802
105
107
109
804
806
808
713
814
812
617
718
716
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104
106
603 702
607
704
706
503 602
505
507
509
604
606
513
519
521
403 502
407
409
303 402
305
307
309
404
406
408
203 302
207
209
304
306
103 202
321
105
107
109
113
206
208
213
219
221
223
313
318 319
322 323
122
413
418 419
420 421
422 423
125123
613
518
621
522
721
714
820
712
620
618
622
SALES OFFICE
5321
719 818
816
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Granlen . . . . . . . . . . . . . . . . . . . . . .620
Guangzhou RiboBio . . . . . . . . . . . .606
Gyros Protein Technologies . . . . .607
Herbert Brown Pharmaceutical & Research Laboratories. . . . . . . .206
Hongene Biotechnology . . . . . . . .309
Hybio Pharma Co . . . . . . . . . . . . . .305
Innovassynth Technologies . . . . .123
Intavis . . . . . . . . . . . . . . . . . . . . . . .421
Intellia Therapeutics Inc . . . . . . . .104
Interchem . . . . . . . . . . . . . . . . . . . .804
Interchim. . . . . . . . . . . . . . . . . . . . .702
Intertek . . . . . . . . . . . . . . . . . . . . . .202
JenKem Technology . . . . . . . . . . .306
Kinovate Life Sciences . . . . . . . . .621
LEWA Bioprocess Group . . . . . . . .103
LGC Axolabs . . . . . . . . . . . . . . . . . .113
LGC, Biosearch Technologies . . .603
Luxembourg Bio Technologies. . .125
Nagase & Co. , Ltd.. . . . . . . . . . . . .818
Neuland Labs . . . . . . . . . . . . . . . . .105
Nitto Denko Avecia . . . . . . . . . . . .513
NOF . . . . . . . . . . . . . . . . . . . . . . . . .522
Novatia LLC. . . . . . . . . . . . . . . . . . .112
Phenomenex. . . . . . . . . . . . . . . . . .604
Polymun Scientific . . . . . . . . . . . . .219
PolyPeptide Group . . . . . . . . . . . . .613
PPD . . . . . . . . . . . . . . . . . . . . . . . . .707
Precision NanoSystems . . . . . . . .423
Purolite Life Sciences . . . . . . . . . .622
Pyramid Laboratories . . . . . . . . . .402
QPS . . . . . . . . . . . . . . . . . . . . . . . . .304
Quanta Biodesign. . . . . . . . . . . . . .712
Sciex . . . . . . . . . . . . . . . . . . . . . . . .509
Senn Chemicals . . . . . . . . . . . . . . .519
Shenzhen JYMed Technology Co.,Ltd . . . . . . . . . . . .709
Sierra Bio. . . . . . . . . . . . . . . . . . . . .107
Singota Solutions. . . . . . . . . . . . . .118
Solvay . . . . . . . . . . . . . . . . . . . . . . .223
ST Pharm . . . . . . . . . . . . . . . . . . . .419
STA Pharmaceutical, a WuXi AppTec company (WuXi STA). . . .806
Sumitomo Chemical Co Ltd . . . . .705
Sunresin New Materials Co., Xi'an . . . . . . . . . . . . . . . . . . . . . . . . .319
Sussex Research . . . . . . . . . . . . . .318
Symbiosis Pharmaceutical Services Ltd . . . . . . . . . . . . . . . . . .820
Syngene Intl . . . . . . . . . . . . . . . . . .716
Thermo Fisher Scientific . . . . . . . .409
Tianjin Nankai Hecheng S&T Co. Ltd. . . . . . . . . . . . . . . . . . .122
Tosoh Bioscience. . . . . . . . . . . . . .505
TriLink BioTechnologies . . . . . . . .713
United States Pharmacopeia . . . .323
USV Private Ltd. . . . . . . . . . . . . . . .706
Vetter Pharma . . . . . . . . . . . . . . . .106
Waters Corporation . . . . . . . . . . . .406
Wolfe Laboratories, LLC . . . . . . . .322
Wyatt Technology . . . . . . . . . . . . .814
Yield Engineering . . . . . . . . . . . . . . . . 5
YMC . . . . . . . . . . . . . . . . . . . . . . . . .100
Zeochem AG . . . . . . . . . . . . . . . . . .303
Zhang Jiagang Alabiochem Tech. Co. Ltd,. . . . . . . . . . . . . . . . . .221
Zhejiang Peptites Biotech Co. Ltd 420
34 www.TIDESEvent.com
Exhibitor Spotlight
Booth 209
Booth 703
Booth 502
Booth 602
Booth 408
Booth 207
Booth 418
Booth 213
Booth 719
Booth 203
Booth 503
Booth 507
Booth 714
Booth 422
Booth 404
Booth 802
Booth 109
Booth 518
Booth 704
Booth 302
Booth 808
Booth 816
Booth 206
Booth 804
Booth 202
Booth 621
Booth 603
Booth 522
Booth 423
Booth 622
Booth 606
Booth 419
Booth 705
Booth 409
Booth 713
Booth 420
36 www.TIDESEvent.com
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38 www.TIDESEvent.com
Firoz D. Antia, Ph.D., Director, Antisense Oligonucleotide Process Development and Manufacturing, Biogen
Mimoun Ayoub, Ph.D., Director and Head of North American and Emerging Markets, CordenPharma International, Switzerland
Fabrizio Badalassi, Ph.D., Director, Chemical Development, Ferring Pharmaceuticals, Denmark
Cindy Berman, Ph.D., Toxicology Consultant
Doug Brooks, Ph.D., Consultant, Matapalo Pharma Consulting Services
Bob D. Brown, Ph.D., Chief Scientific Officer and Senior Vice President, Research, Dicerna Pharmaceuticals
Waleed Danho, Ph.D., Consultant
Jesse Z. Dong, Ph.D., Vice President, Peptide Chemistry, Neon Therapeutics
Alex Fässler, Ph.D., Bachem Holding AG, Switzerland
Elena Feinstein, M.D., Ph.D., Chief Scientific Officer, Quark Pharmaceuticals, Israel
Cecilia Fernández, Ph.D., Senior Director, Platform Strategy and Operations, Editas Medicine
Rami Hannoush, Principal Scientist & Group Leader, Early Discovery Chemistry, Genentech
Chris Holmes, Ph.D., CMC Consultant
Nigel Horscroft, Area Head, Molecular Therapy, CureVac AG, Germany
Marc Jacob, Ph.D., Business Development Manager, Purification Technologies – North America, Phenomenex
Troels Koch, Ph.D., Industry Expert
Andreas Kuhn, Ph.D., Vice President RNA Biochemistry & Manufacturing, BioNTech RNA Pharmaceuticals GmbH, Germany
Jesper Lau, Vice President, Protein & Peptide Chemistry, Novo Nordisk A/S, Denmark
Arthur A. Levin, EVP Research and Development, Avidity Biosciences
Jennifer Lockridge, Ph.D., SVP, Program Development, Dicerna Pharmaceuticals
Muthiah (Mano) Manoharan, Ph.D., Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals
Bruce Morimoto, Ph.D., Vice President, Drug Development-Operations, Alkahest
Gary F. Musso, Ph.D., President, Musso and Associates LLC
Lubomir V. Nechev, Ph.D., Vice President, Process Sciences, Alnylam Pharmaceuticals
Rubina Parmar, Ph.D., Director, Chemistry, Intellia Therapeutics
El Djouhar Rekai, Ph.D., Head of Operation Products, PolyPeptide Group, Belgium
Claus Rentel, Ph.D., Executive Director, Analytical Development/QC, Ionis Pharmaceuticals
Christopher A. Rhodes, Ph.D., President and CEO, Drug Delivery Experts
Christoph Rosenbohm, Ph.D., VP and Head of Discovery Operations, Roche Innovation Center Copenhagen, Denmark
Dmitry Samarsky, Ph.D., Chief Technology Officer, Sirnaomics
Tomi Sawyer, Ph.D., Distinguished Scientist, Discovery Chemistry Modalities & Peptide Drug Hunter, Merck Research Laboratories
Punit P. Seth, Ph.D., Vice President, Medicinal Chemistry, Ionis Pharmaceuticals
Trishul Shah, Director, Business Development, North America, PolyPeptide Laboratories
Stephen T. Spagnol, Ph.D., Senior Scientist, Large Molecule Drug Product Development, Johnson & Johnson
Ved Srivastava, Ph.D., Vice President of Chemistry, Intarcia Therapeutics
G. Susan Srivatsa, Ph.D., President, ElixinPharma
Jim Thompson, Ph.D., Head CMC Project Management, Moderna Therapeutics
Blake Unterreiner, Business Development Manager, Nucleic Acid Solutions Division, Agilent Technologies
Sridhar Vaddeboina, Ph.D., Vice President, Analytical Development, Nitto Denko Avecia
Fran Wincott, Ph.D., President, Wincott & Associates, LLC
SPECIAL THANKS TO THESE TIDES 2019 GUEST SESSION CHAIRSÖrn Almarsson, Ph.D., Head of Formulations, Moderna Therapeutics
Klaus Charisse, Ph.D., Director, Analytical R&D, Alnylam Pharmaceuticals
Shuling Guo, Ph.D., Vice President, Antisense Drug Discovery, Ionis Pharmaceuticals
TIDES 2019 Advisory Board
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