TIDES: Oligonucleotide & Peptide Therapeutics EVENT GUIDEdownload.knect365lifesciences.com/2019/B19180Guide.pdf · Strategies Innovations in Peptide Synthesis and Manufacturing CRISPR

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


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 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)


and Clinical


and Strategies





Controls


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


and Clinical





Controls


Clinical


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


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


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


(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


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)


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


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


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.


(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


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


Contact us for details: [email protected] 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 .


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 Chemistry, Manufacturing and Controls


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


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


WEDNESDAY, MAY 22, 2019


and Clinical




Clinical


Controls


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


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:


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,


Peptide Chemistry



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


10:45 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:


THURSDAY, MAY 23, 2019





Peptide Discovery,



and StrategiesPeptide Chemistry


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


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 .


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



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 | [email protected]



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



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.



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


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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


Exhibitor Spotlight

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Booth 704

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Booth 522

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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

TIDES: Oligonucleotide & Peptide Therapeutics EVENT GUIDEdownload.knect365lifesciences.com/2019/B19180Guide.pdf · Strategies Innovations in Peptide Synthesis and Manufacturing CRISPR

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