Phacilitate Miami: Show Guide

Page 1

Show Your Badge & Save!

January 25-28 2022

From Fun Run to Beach Networking Page 19

Helping advance the next pillar of medicine

Diamond sponsors:



Show guide sponsor:



Contents Meet the Team

04 Phacilitate Membership



05 Upcoming Events


General Information

06 CellGenix



09 Event Partners & Collaborators


Pre-event Day

10 Show Your Badge and Save


Agenda Day 1

12 Sponsors & Exhibitors


Agenda Day 2

16 Life Science Gets its Capital Booster Jab


Agenda Day 3

18 Venue Map and Expo Floorplan


Phacilitate Match

20 Exhibitor Listings


Women in Advanced Therapies



Meet the Phacilitate Team

Anna Osborne Editorial Assistant

Ashley Alderson Marketing Executive

Becky Johnson Vice President, Europe

Tamryn Bowman Operations Assistant

Peter Harkness Commercial Director

Amanda Kendall Head of Membership

Will Gilbert Commercial Director

Richard Logan Covid Security Officer

Fraz Ahmad Community Manager


Georgi Makin Editor

Lauren Howlett Head of Marketing

Emma Winstanley Operations Manager

Jeremy Roden Vice President of Strategic Alliances

Charlotte Wood-Dow Senior Operations Manager

Elizabeth Turner Marketing Executive

Wesley Johnson Vice President, Investor Relations

David Green Vice President, Commercial Operations

Ryan Leahy Vice President of Research

Welcome to Advanced Therapies Week 2022! I am delighted to welcome you back to Miami and look forward to seeing you all in-person again. It has been far too long!

To get the most out of the week and make connections, here are a few things to look out for: The Phacilitate Match Zone - Matching biotech with tools/tech providers and investors to help you build your commercialisation strategy; we can’t wait to have face-to-face meetings once again!

Over the past two years, the advanced therapies field has seen a lot of success. Since January 2020, there has been a 58% increase in clinical trial activity and a 43% increase in Phase III trials. Although the pandemic brought with it tremendous pressure and unique challenges, it did not stop the field innovating and progressing forward with clinical pipelines.

Germfree Mobile Cleanroom Experience - Check out this mobile cleanroom for a flexible, adaptable and quick solution to meet your manufacturing needs.

Mergers, acquisitions and capital raisings have been at an all-time high with 847 deals announced since January 2020, with an average deal value of £143m.

Members Lounge - Where Phacilitate Network Members can take some time-out from the show and enjoy a massage or healthy smoothie.

Five therapies were approved in 2021, including Bristol-Myers Squibb’s Breyanzi, bluebird bio and BMS’ Abecma, Mallinckrodt’s Stratagraft, all approved by the FDA and bluebird’s Skysona and BMS’ Abecma approved in Europe.

5k Fun Run along the shores of Miami Beach What better way to kick-start your morning?

It really has been an exciting few years for our field and we have so much to celebrate here in Miami.

Exhibition Opening Drinks - Meet both new and old industry friends face-to-face with cocktails and icebreakers; something we’ve missed after two years apart!

When putting this event together, we knew we had to celebrate being back and together in-person. We believe that the right audience mix, an agenda full of educational content, and ample opportunities for partnering inperson is key to a successful, productive event. We hope the connections you make in Miami this year will help you build your commercialisation strategy, and ultimately get your therapies to patients.

Nikki Beach Networking - Experience the true Miami lifestyle as we takeover Nikki Beach for an evening of Caribbean food and networking.

5 tracks of educational content - Focused on helping biotech on their commercialisation journey. I look forward to meeting you all this week. Please do follow the Covid guidelines to keep yourself as well as your peers safe, and please do let myself or any member of the Phacilitate team know if there is anything we can do to make your onsite experience the best it can be. Kim Barnes Executive Vice President

* Data taken from Global Data, 1st December 2021


General Information

Opening times: Tuesday Registration 3pm-5:30pm

Super Plenary 4pm-5:30pm

Exhibition Opening drinks 5:30pm-7pm

Stay Safe:

Covid 19

The team from StemExpress is available in reception for COVID testing at any point during the event if you begin to feel unwell or need testing for your return journey. Please ask at the registration desk for more information.

All attendees are asked to declare proof of natural immunity or provide proof of a negative PCR test taken within the last 72 hours on arrival.

Wednesday Fun Run



Conference 8am-6pm

Nikki Beach Networking Dinner at Nikki Beach 7pm-11pm

Thursday Registration & Exhibition 8am-6pm

Conference 8:30am-6pm

Friday Registration & Exhibition 8am-2pm

Conference 8am-12:30pm


The event has been specially designed to allow for social distancing. This includes 13’ aisles and larger feature areas. Deep cleaning will be undertaken by the venue prior to commencing build up and every evening. Regular cleaning throughout the day will also be undertaken in high touch point areas.

Registration & Exhibition

Tickets can be purchased for this at the information desk.

Code of Conduct

Security Please do not leave valuable items unattended at any time during the event. Kindly wear your badge at all times whilst circulating the venue.

All attendees must abide by our Code of Conduct. This is available online at: www. terms-of-use/

Connect to the Wi-Fi: Wi-Fi is complimentary throughout the venue. Please use the following log-in details: Username: Phacilitate Password: ATW22

Hand sanitizers will be provided throughout the show curtsey of Asimov.

Food & Drinks: Face coverings are compulsory unless the individual is medically exempt. These are available within the sanitiser packs kindly sponsored by Wuxi App Tec.

Coffee, tea and water will be available in the catering areas around the exhibition throughout the day. Lunch and snacks will also be served in the exhibition hall.

Helping advance the next pillar of medicine Don’t forget to download the event app to make the most of your time throughout the event!

By downloading the dedicated event app, you will have access to: • AI-powered matchmaking, aligned with your professional goals • Access the event agenda and personalise your daily schedule • Ability to collect e-business cards and form instant connections with attendees at the event.

Scan the QR code with the camera on your phone to download the app!

If you have any questions or need help getting started, our dedicated team can be found at the Information Point by registration.

Accessing your account is easy. Simply enter the email address you used when registering for the event and follow the steps!

*Or search Advanced Therapies Week in the Google or Apple App Stores.


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As show organisers, we are committed to create a safe environment to protect exhibitors, delegates, contractors and our staff to ensure we can run an enjoyable and successful event for all in 2022. In line with government and local authority guidance, as well as using our own professional judgment as event organizers, we are implementing extensive measures in response to COVID-19. Some of these are outlined below: Physical Distancing • T he Floor plan has been specially designed to allow for social distancing. 13’ aisles and larger feature areas have been put in place to maximize space and enhance delegate experience.

Onsite Covid Protocols

• C lear signage will be provided to encourage all to keep a safe distance and respect others. • S ocial distance marshals will assist with the management of delegate flow. • D elegate numbers on the show floor will remain well below the venue safety capacity. Conference • S eating will be spread out allowing for space between chairs and leaving wide aisles in the conference rooms. • Q uestions will be able to be submitted via an app, instead of hand held microphones. Speaker microphones will be disinfected between use. Cleaning and Hygiene • T he Miami Beach Convention Center has successfully achieved GBAC STAR status, which means it has been certified by the Global Biorisk Advisory Council for its “superior ability to prepare for, respond to, and recover from biorisk and infectious disease situations.” • D eep Clean by the venue prior to commencing build up and every evening. • A n enhanced cleaning regime during show open periods, with extra attention given to high frequency touch points such as toilets, door handles and handrails. • V enue air filtration system will allow fresh air to be filtered onto show floor to increase ventilation. Personal Hygiene • H and sanitisers will be provided throughout the Show. • H ygiene reminders to regularly wash hands, not exchange business cards and refrain from personal greetings (a handshake or a hug) will be in place throughout the venue.

• S temExpress will provide a testing facility at the event venue. Test results would be available within 30-45 minutes of performing the swab. Tests cost $89. • A ll attendees will be required to wear a face-covering that securely covers their mouth and nose at all times inside the venue unless eating, drinking, or presenting on stage. Face coverings should be a minimum of surgical grade quality. Homemade or makeshift coverings (e.g. scarfs) will not be permitted. Those with a medical exception from wearing face coverings will need to provide proof of exception to staff as they arrive at the venue. • I f you develop new symptoms, you are required to take a PCR test and self-isolate until you receive a negative result. If you receive a positive result, you will need to notify the Phacilitate team as soon as possible by emailing charlotte. After the Event Travelling Internationally StemExpress will have a testing facility onsite where you can purchase a PCR COVID test for your return journey. Results will be guaranteed within 24 hours. COVID Travel Requirements per Country Travelling Domestically Attendees have the option to purchase a PCR self-testing kit to take home with them to test upon their return from the event. Results provided within 72 hours of shipping back to StemExpress Labs. Visit the StemExpress desk in the lobby on arrival at the event venue.


Super Plenary

25th January 2022 15:00

Registration Open 16:00 - 17:30

Superplenary: Perspectives on the Future of the Cell and Gene Therapy Field Chairperson’s Remarks: Anthony Davies, Dark Horse Consulting 16:10 F ireside Chat: The Patient Perspective Lisa Ward, Patient Advocate Tom Whitehead, Emily Whitehead Foundation 16:30 Fireside Chat: The Pharma Perspective Shepherd Mpofu, Novartis Gene Therapies 16:50 Fireside Chat: The Investor Perspective Craig Shepherd, Blackstone Life Sciences 17:10 Wrap up 17:30

Exhibition Opening Drinks


Exhibition Opening Drinks 17:30 On Tuesday, January 25th we will be opening the exhibition with networking drinks, celebrating the tools and tech helping us get one step closer to commercialising advanced therapies. Join us at 17:30 for themed zones, cocktails and ice-breakers to enhance your networking experience. Sponsored by


Day 1 26th January 2022 06:30 - 07:00

Fun Run


Registration Open

09:00 - 10:30

Opening Plenary: Where Are We Now and Where Are We Headed? Ballroom A-D Where Are We Now and Where Are We Headed?

09:00 Chairperson’s Remarks Emma Cheesman, Biopharma Excellence 09:10 Presentation Janet Lambert, Alliance for Regenerative Medicine 09:25 Presentation

Susan Nichols, Propel Biosciences

09:40 Presentation

Peter Marks, FDA

09:55 Topical Speaker Q&A Panel: The Next Five Years: Speakers in Session Joined By:

Shephard Mpofu, Novartis Gene Therapies Bruce Levine, University of Pennsylvania

10:30 - 11:00 11:00 - 12:30

Morning Refreshment Break Pipeline & Therapeutic area Updates Ballroom E What Are the Cell and Gene Therapies of the Future?

Breakout Tracks

11:00 Chairperson’s Remarks Lavakumar Karyampudi, Moffitt Center 11:05 P resentation Kent Christopherson, Orchard Therapeutics 11:25 Presentation Ryan Cawood, WuXi Advanced, Therapeutics/ OXGENE 11:45 Presentation Jason C. Foster, Ori Biotech 12:05 Topical Speaker Speakers from the Session

12:30 - 13:30

Commercialising the Therapies of the Future Ballroom H Overcoming Challenges and Setting Up for Success on the Path to Commercialisation 11:00 Chairperson’s Remarks Anthony Davies, Dark Horse Consulting 11:05 Presentation Barbara Biznak Blumenfeld, Buchanan & Rooney PC 11:20 Presentation Donna Rill, Triumvira Immunologics 11:35 Presentation Joseph Garrity, Lonza 11:50 Topical Speaker Q&A Panel: Speakers from the Session

New and Enabling Technologies

From Collection to Delivery

Manufacturing Advanced Therapies

Ballroom G Viral Vector Development: Safe & Effective Viral Vectors for Therapeutic Success

Ballroom F

Ballroom A-D Achieving Operational Excellence in Cell & Gene Therapy Manufacturing

11:00 Chairperson’s Remarks Nathalie Celement, Stealth Biotech 11:05 Presentation James Miskin, Oxford Biomedica 11:25 Presentation Patrick Westmoreland, Bristol Myers Squibb 11:45 Presentation Chris Reardon, Dyno Therapeutics 12:05 T opical Speaker Q&A Panel: Speakers from the Session

Lunch Briefings

12:30 ScaleReady Briefing Future-Proofing Cell Therapy Production 12:30 Terumo Blood and Cell Technologies Briefing Unlocking the Potential of Advanced Therapies Through Collaborations


Collection Centers of the Future: Standardisation and Optimising Apheresis for Quality Control 11:00 Chairperson’s Remarks Aaron Solis, AGC Biologics 11:05 Presentation John Manis, Harvard Medical School 11:25 Presentation Lizette Caballero, Janssen 11:45 Presentation Ludwig Camusot, Cell Matters 12:05 T opical Speaker Q&A Panel: Speakers from the Session Joined by: Joseph Schwartz, Mt. Sinai

11:00 Chairperson’s Remarks Sharon Brownlow, Cell and Gene Therapy Catapult 11:05 Presentation Tara Crnkovich, AstraZeneca 11:20 Presentation Fabian Gerlinghaus, Cellares 11:35 Presentation Tod Sulchek, CellFE 11:50 Presentation Anthony Renodon, Treefrog Therapeutics 12:05 Topical Speaker Q&A Panel: Speakers from the Session

13:30 - 15:00

Commercialising the Therapies of the Future Workforce of the Future: Talent, Change Mangement and Enabling Future Development Ballroom H

Breakout Tracks

13:30 Chairperson’s Remarks Jeff Boyd, Heidrick & Struggles 13:35 Presentation Angela Justice, TCR2 Therapeutics 13:50 Presentation Stephen Ward, Cell and Gene Therapy Catapult 14:05 Presentation Jill Elliot, Novo Nordisk 14:20 Presentation Lynn Fischer, Title21 14:35 Topical Speaker Q&A Panel: Speakers from the Session

15:00 - 15:30 15:30 - 17:00

From Collection to Delivery

Ballroom G

Ballroom F

13:30 Chairperson’s Remarks Tom Bollenbach, Advanced Regenerative Manufacturing Institute 13:35 Presentation Ohad Karnieli, Adva Biotechnology

Patient-Centric Development: Supporting Improved Patient Outcomes 13:30 Chairperson’s Remarks Blair Clark-Schoeb, Aruvant 13:35 Presentation David Pearce, Sanford Health & TrueTrials 13:55 Presentation James Wang, Juventas Cell Therapy

13:55 Presentation Nathan Moore, Takeda

14:15 Presentation Julia Tarasenko, Marken

14:15 Presentation Dale Hanna, AmerisourceBergen 14:35 Topical Speaker Q&A Panel: Speakers from the Session joined by: Jon Ellis, Invetech

14:35 Topical Speaker Q&A Panel: Joined by: Tom Whitehead, Emily Whitehead Foundation

Afternoon Refreshment Break Pipeline & Therapeutic Commercialising area Updates the Therapies of the Future Ballroom E Ballroom H Area Advancement Development in Neurology and Ophthalmology

Breakout Tracks

New and Enabling Technologies Implementing New and Enabling Technologies into Existing Processes

15:30 Chairperson’s Remarks Daniel Gincel, Longeveron 15:35 Presentation Anthony Oliva, Longeveron 15:55 Presentation Rachel Legmann, Repligen 16:05 Presentation Magali Taiel, GenSight Biologics 16:35 Topical Speaker Q&A Panel: Speakers from the Session

Delivering Projects and Managing Timelines in the Variable, Continuously Changing Environment of Cell and Gene Therapy 15:30 Chairperson’s Remarks Kim Raineri, AVROBIO 15:35 Presentation Melissa Sebok, American Red Cross Biomedical Services 15:55 Presentation Holly May, AVROBIO 16:15 Presentation Peter Walters, CRB Group 16:35 T opical Speaker Q&A Panel: Speakers from the Session

New and Enabling Technologies

From Collection to Delivery

Manufacturing Advanced Therapies

Ballroom G Accelerating the Digitalisation Revolution in CGT Development

Ballroom F Building an Effective Supply Chain/ Temperature-Controlled Therapeutics

Ballroom A-D Key Considerations in Cell and Gene Therapy Manufacturing - CMC, Process and Regulatory

15:30 Chairperson’s Remarks Maria Croyle, University of Texas at Austin

15:30 C hairperson’s Remarks Barbara Biznak Blumenfeld, Buchanan Ingersoll & Rooney PC

15:30 Chairperson’s Remarks Fabio Fachin, Takeda 15:35 Presentation Anirban Ghosh, Genentech 15:50 Presentation Matthew Lakelin, TrakCel 16:05 Presentation Fabio Fachin, Takeda 16:20 Presentation Robert Lechich, Global OT/ IT Quality Services 16:35 Topical Speaker Q&A Panel: Speakers from the session joined by:

15:35 Presentation Maria Croyle, University of Texas at Austin

15:35 P resentation Carmen Brenner, Novadip

15:50 Presentation Mark Sawicki, Cryoport

15:50 P resentation Emily Gateau, Exothera

16:05 Presentation Robert Newman, Fujifilm Irvine Scientific

16:05 Presentation Pinar Cicalese, Immatics

16:20 Presentation Ivan Wall, 16:20 Presentation FourPlus Sadaf Naz Khan, Immersive Janssen 16:35 Topical Speaker

16:35 Topical Speaker Jacob Becraft, Q&A Panel: Strand Therapeutics Speakers from Dragan Djorjevic, the session Takeda

Q&A Panel: Speakers from the Session

Evening Briefing 17:00 - 18:00

Cytiva Briefing: Add it up: 3 things to consider for capacity expansion

19:00 - Late

Networking Beach Dinner

For more details on the agenda please see the event app


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Nikki Beach What better way to experience the true Miami lifestyle than with dinner on the beach? This year we are taking over the original Miami beach club, Nikki Beach, from 7–11pm on Wednesday January 26th. Enjoy a mix of Caribbean food, networking and a fire show. It’s time to celebrate being back together again!

If you haven’t already bought your ticket, you can purchase one at the information desk by registration

Sponsored by


Day 2 27th January 2022 Registration Open

07:30 08:30 - 09:30

Morning Briefings Invetech Morning Briefing: Why So Shy? Implementing Disruptive Technologies With Confidence in Cell Therapy

09:30 - 10:30

Roundtable Discussions

Phacilitate Restaurant Roundtable #1: Battling Bottlenecks, the Capacity Question: Navigating the Shifting Demand and Supply Needs of Advanced Therapy Manufacturing Dan Stanton, Bioprocess Insider Roundtable #2: Understanding the Principles of Cryopreservation and How They Impact Cell & Gene Therapy Develoment and Subsequent Manufacturability Dominic Clarke, Discovery Life Sciences Roundtable #3: Treatment Development Paradigm for Quality of Life Conditions: Regulatory Considerations & Collaboratice Ecosytem Jenna Dale, Cook Myosite Roundtable #4: Navigating the Unknown: Unique Challenges of Manufacturing Uncharted Technologies Jo Anne Valentino, Minaris Regenerative Medicine Roundtable #5: Choosing Between Templated and Bespoke Processes for Scalable Viral Vector Manufacturing Jerry Keybl, MilliporeSigma Roundtable #6: Successfully Connecting Patients With Their Personalized Therapies Through Resilient and Scalable End-to-End Supply Chains Radila Feldmann, Time:Matters Roundtable #7: Exploring Bedside Autologous CGT Manufacturing Chris Wegener, Fresenius Kabi Roundtable #8: Digitalization; Implementing a Unified Platform to Enable Transformative Progress for Cell and Gene Therapy Timelines Vasu Rangadass, L7 Informatics

Breakout Tracks

11:00 - 12:30

12:30 - 13:30

Pipeline & Therapeutic area Updates Ballroom E Development in Allogeneic Cellular Therapies

Commercialising the Therapies of the Future Ballroom H Working With A CDMO is Not Just an Outsourcing a 11:00 Chairperson’s Partnership: Learnings Remarks Dominic Clarke, From Successful Biotech/CDMO Discovery Life Partnerships Sciences 11:05 Presentation 11:00 Chairperson’s Sven Kili, Remarks Antion Tim Schroeder, Biosciences CTI 11:20 Presentation 11:05 Presentation Kimberly Tim Schroeder, Negrin, CTI Charles River 11:20 Presentation Laboratories Alex Klarer, 11:35 Presentation Biocentriq Jeff Liter, 11:35 Presentation Luminary Becky Cap, Therapeutics BioBridge & 11:50 Presentation GENCURE David Sheehan, 11:50 Presentation Nucleus Qian Hao, Therapeutics Porton Bio 12:05 Topical Speaker 12:05 Topical Q&A Panel: Speaker Speakers from Q&A Panel: the Session Speakers from the Session

New and Enabling Technologies Ballroom G Industry 4.0 Approaches Transforming Cell and Gene Therapy 11:00 Chairperson’s Remarks Dragan Djorjevic, Takeda 11:05 Presentation Bruce Levine, University of Pennsylvania 11:20 Presentation Ryan Cawood, WuXi Advanced Therapeutics and OXGENE 11:35 Presentation Sean Werner, Sexton Biotechnologies 11:50 Presentation Kwok Pang, Autolomous 12:05 Topical Speaker Q&A Panel: Speakers from the Session

From Collection to Delivery CRL/HemaCare Ballroom F Arriving at your Cell & Gene Therapy Destination: Navigating the Many Journeys Within the Journey

Manufacturing Advanced Therapies Ballroom A-D Reducing Timelines with Innovative Scale Up and Scale Out Technologies 11:00 Chairperson’s Remarks 11:00 Chairperson’s Joseph Mickso, Remarks CAI Matthew M. 11:05 Presentation Hewitt, Arnaud Charles River Deladeriere, Laboratories Triumvira 11:05 Presentation Immunologics Michael 11:25 Presentation Lehmicke, George Alliance for Buchman, Regenerative Catalent Medicine Cell & Gene 11:20 Presentation Therapy Farzin Farzaneh, Presentation ViroCell-Biologics 11:45 Tania Pereira, 11:35 Presentation Univercells Peter Walters, Technologies CRB 12:05 Topical Speaker 11:50 Presentation Q&A Panel: Donna Rill, Speakers from Triumvira the Session Immunologics 12:05 Topical Speaker Q&A Panel: Speakers from the Session

Lunch Briefings Resiliance Briefing Technology, Disruptive Innovation and Partnerships That Are Revolutionizing How Medicines Are Made



Chairperson’s Remarks, Matthew M. Hewitt, Charles River Laboratories

13:30 - 15:00

Pipeline & Therapeutic area Updates Ballroom E Development in Future Therapies for Non-Oncology Indications

Breakout Tracks

13:35 Presentation Will Chou, Aruvant 13:50 Presentation Allen Feng, HebeCell Corp 14:05 Presentation Abdulkader Rahmo, SMS Biotech 14:20 Presentation Dhavnit Shah, Garuda Therapeutics 14:35 Topical Speaker Q&A Panel: Speakers from the Session

15:00 - 15:30 15:30 - 17:00

Breakout Tracks

13:30 Chairperson’s Remarks Ian Goodwin, FUJIFILM Diosynth Biotechnologies 13:35 Presentation Stefanos Theoharis, Bone, Therapeutics 13:55 Presentation Gabriella Perell, Bio-Techne 14:15 Presentation Greg Roumeliotis, Orgenesis 14:35 Topical Speaker Q&A Panel: Speakers from the Session

New and Enabling Technologies: Ballroom G Delivery Solutions and Alternatives for Gene and Cell Therapy

Manufacturing Advanced Therapies: Ballroom A-D Upstream Bioprocessing Optimisation and Support for Early Development

13:30 Chairperson’s Remarks Kevin N. Ramdas, Longeveron

13:30 Chairperson’s Remarks Mamta Kalra, Immatics

13:35 P resentation Kei Kishimoto, Selecta Biosciences

13:35 Presentation Lisa McClain Moss, Longeveron

13:50 Presentation Leisha Kopp, Mirus Bio

13:55 Presentation Cedric Ait Mansour, Sony Biotechnology

14:05 Presentation Metin Kurtoglu, Cartesian Therapeutics

14:15 Presentation Garrie Richardson, Biolife Solutions

14:20 Presentation Kurt Swogger, BioPact 14:35 Topical Speaker Q&A Panel: Speakers from the Session

14:50 Topical Speaker Q&A Panel: Speakers from the session

Afternoon Refreshment Break Pipeline & Therapeutic area Updates Ballroom E Development in Cell Therapies for Solid Tumors 15:30 Chairperson’s Remarks Chris Ballas, Innovative Cellular Therapeutics 15:35 Presentation Christopher Ballas, Innovative Cellular Therapeutics 15:50 Presentation Mark Throsby, Gadeta 16:05 Presentation Jak Knowles, Affini-T Therapeutics 16:20 Presentation Nina Bauer, Millipore Sigma 16:35 Topical Speaker Q&A Panel: Speakers from the Session

17:00 - 18:00

Commercialising the Therapies of the Future: Ballroom H Tech Review: New Platforms and ClosedSystems to Enable Commercial Success

Commercialising the Therapies of the Future Ballroom H Moving the Industry Towards Automated Systems for Scale Up Success 15:30 Chairperson’s Remarks J. Kelly Ganjei, AmplifyBio 15:35 Presentation Kim Raineri, AVROBIO 15:55 Presentation Edita BotonjicSehic, Pall Corporation 16:15 Presentation Dan Strange, TTP

New and Enabling Technologies Ballroom G Analytics, Data and IT Tech Solutions - an Overview of Best Practices and Technology 15:30 Chairperson’s Remarks Cenk Sumen, Stemson Therapeutics

From Collection to Delivery Ballroom F Standardising Raw Materials to Reduce Outcome Variability

anufacturing M Advanced Therapies Ballroom A-D End-to-End and Downstream Bioprocessing 15:30 C hairperson’s Remarks Robert Speziale, Speziale Consulting Services

15:35 Presentation George Smith, Turnstone Bio

15:30 Chairperson’s Remarks Dawn Henke, Standards Coordinating Body for Regenerative Medicine 15:35 Presentation Joseph Schwartz, Mount Sinai

15:50 Presentation Christa Feasley, Cytovance

16:05 Presentation Pierre-Axel Vinot, 16:35 Topical Speaker Sparing Vision Q&A Panel: 16:20 Presentation Speakers from Judith Koliwer, the Session Koerber Joined by Pharma Mike Oricco, Standards Coordinating Body for Regenerative Medicine

15:50 Presentation Cate Dyer, StemExpress 16:05 Presentation Joy Aho, Be The Match BioTherapies

15:35 Presentation Michael Mercaldi, Homology Medicines 15:50 Presentation Peter Danforth, Wacker Biotech GmbH 16:05 Presentation Eduard Ayuso, Dinaqor

16:20 Presentation 16:20 Presentation Dawn Henke, Ken Rando, Standards Comecer Coordinating Body 16:35 Topical Speaker 16:35 Topical Speaker for Regenerative Q&A Panel: Q&A Panel: Medicine Speakers from Speakers from 16:35 Topical Speaker the Session the Session Q&A Panel: Speakers from the Session

Evening Briefings

PBS Biotech Briefing Overcoming Scale Up Process Development Challenges for Pluripotent Stem Cell Derived Therapies For more details on the agenda please see the event app


Day 3 28th January 2022 07:30

Registration Open

09:00 - 10:30

Pipeline & Therapeutic area Updates Ballroom E Development in Cell and Gene Therapy to Treat Rare and Difficult Indications

Breakout Tracks

09:00 Chairperson’s Remarks Holly May, AVROBIO

Commercialising the Therapies of the Future Ballroom H How to Market my Company to Investors: Lessons Learned from Successful Investment and Funding Rounds

09:05 Presentation John Maslowski, Forge Biologics

09:00 Chairperson’s Remarks Bryan Potilove, Broadoak Capital Partners

09:20 Presentation Dan Smith, Charles River Laboratories

09:05 Presentation Amritha Jaishankar, Maryland Stem Cell Research Fund

09:35 Presentation Samik Basu, Cabaletta Bio 09:50 Presentation Michael Leek, TC Biopharm 10:05 Topical Speaker Q&A Panel: Speakers from the Session

09:20 Presentation Lou Walcer, The Kevin M. McGovern Family Center for Venture Development in the Life Sciences, Cornell University 09:35 Presentation Brian Feth, Xcellbio 09:50 Presentation Mathias Svahn, NextCell Pharma

New and Enabling Technologies Ballroom G Changing the Cell Therapy Landscape With in vivo Therapies: is This a Viable Alternative for Point-of-Care Therapeutics? 09:00 Chairperson’s Remarks David Perritt, Lupagen 09:05 Presentation David Fontana, Umoja Pharma 09:20 Presentation Alan P. Kypson, RES Hospital/UNC 09:35 Presentation Dan Shelly, Prescient Therapeutics 09:50 Presentation Tamer Mohamed, Aspect Biosystems 10:05 Topical Speaker Q&A Panel: Speakers from the Session

10:05 Topical Speaker Q&A Panel: Speakers from the Session Joined by Jak Knowles, Affini-T Therapeutics

10:30 - 11:00 11:00 - 12:30

Morning Refreshment Break Pipeline & Therapeutic area Updates Ballroom E Development in Stem Cells and Regenerative Medicine

Breakout Tracks

11:00 Chairperson’s Remarks Paul Kosnik, Orgenesis 11:05 Presentation Ian McNiece, BioCardia 11:20 Presentation Phil Morton, Albumedix 11:35 Presentation Anthony Ting, Bone Therapeutics 11:50 Presentation Mari Mitrani, Organicell Regenerative Medicine 12:05 Topical Speaker Q&A Panel: Speakers from the Session

Commercialising the Therapies of the Future Ballroom H Patient and Payer Challenges: Enabling Access to Patients Through Market Access, Pricing and Patient-Led Discussion 11:00 Chairperson’s Remarks Lucas De Breed, August Care 11:05 Presentation Lucas De Breed, August Care 11:20 Presentation John Schick, Instil Bio 11:35 Presentation Clark Paramore, bluebird bio 11:50 Presentation Tom Whitehead, Emily Whitehead Foundation

12:05 Topical Speaker Q&A Panel: Speakers from the session


New and Enabling Technologies Ballroom G Achieving Best Practice in Quality Control and Assurance 11:00 Chairperson’s Remarks Richard McFarland, Advanced Regenerative Manufacturing Institute 11:05 Presentation Emily English, Cartesian Therapeutics 11:20 Presentation Rhessa Diaz, Bristol Myer Squibb 11:35 Presentation Félix Montero-Julian, bioMérieux 11:50 Presentation Sarah Thomas, REGENXBIO 12:05 Topical Speaker Q&A Panel: Speakers from the Session

For more details on the agenda please see the event app

Join Team Phacilitate for a 5k run along the shores of Miami beach – what better way to kick start your morning? The run will start at 7am on Wednesday January 26th and can be completed in your own time. T-shirts and water bottles will be supplied, just bring yourselves and your running gear! Sponsored by:

Phacilitate Members Lounge The member lounge is an area to recharge throughout the day. Enjoy healthy smoothies, take a break on a reset pod or have a massage to get yourself ready for more networking.

Germfree Mobile Cleanroom Experience Visit the Cleanroom check it out on the floorplan!


Phacilitate Match Lunch 27th January 12:30pm Sponsored by:


MATCH Pairing therapeutic developers with the specialists they need to advance healthcare

To find out more about our Match program, get in touch with Amanda. You will find her in the Match Zone on the exhibition floor. Sponsored by:


The Women in Advanced Therapies mentorship programme through Phacilitate enabled us to get connected and start this new enterprise.


platform that enables us to bring the most innovative products and services from the current market to our business stakeholders. Stella Ho Senior Global Category Manager Biologics & CGT Technical Development Novartis

Mentorship and networking for women working in advanced therapies

I mentored Megan Livingston. Through the mentor-mentee relationship I identified her as a very capable individual. I started a new company focused on thin film technology for the storage of vaccines, mRNA drugs, and gene therapy treatments at room temperature. Megan became employee number one at Jurata Thin Film Inc.

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Phacilitate Match was developed as a bespoke matchmaking service geared towards therapeutic developers who are looking to meet with potential partners. Our goal is to help you create connections and potential partnerships that generate real value and outcomes, helping you to build your commercialisation strategy.

The cell and gene therapy community has a skills gap across all levels right up to board positions. Companies struggle to recruit, retain, develop and promote employees for our rapidly growing and maturing industry. Diversity and inclusion at all career levels is necessary if companies want to access untapped market space and retain their top talent and competitive advantage. Women in Advanced Therapies is a specialist group for members of the Phacilitate network. It provides mentorship and networking for women working in advanced therapies. The goal is to build the foundations for a community to help recruit, retain, develop and promote women, creating leaders of tomorrow and encouraging new women to join the sector. To find out how you can get involved in the class of 2022, please visit women-in-advanced-therapies-apply-for-2022 or speak to Kim Barnes here at the show.

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CellGenix GMP DC – Optimized Medium for the Generation of Human DCs ®

Dendritic cells (DCs) are a diverse group of specialized antigenpresenting cells with key roles in the initiation of the primary immune response, and clinical studies have demonstrated their ability to induce efficient antitumor immunity1. CellGenix® GMP Dendritic cells medium (DCM) is xeno-free, and serumfree medium used for the generation of human dendritic cells (DCs). It has been developed and optimized for the easy and efficient generation of immature as well as fully mature myeloid Dendritic Cells from peripheral blood monocytes. Previously our DCM contained pharmaceutical grade lipid mix which consisted of chicken egg-derived lecithin. The new xeno-free medium does not contain any non-human-derived components. Removing animal components increases safety and makes it easier to overcome regulatory hurdles.

Omitting Lecithin from the Formulation does not Alter the Functionality of DC We conducted a set of comparative studies which include, DC yield, phenotype assay, migration capacity towards CCL21 gradient, antigen uptake, T cell activation assay, and all of the comprehensive studies verified that the performance of lecithin -deficient media is equivalent to the performance of Lipofundin-containing media. For example, To assess the capacity of mDC to induce T cell proliferation in a mixed lymphocyte reaction, isolated allogeneic naïve CD4+ T cells were labeled with CellTrace Violet, which will stain the plasma membrane. After coculturing the labeled CD4+ T cells with mDC for 5 days. CellTrace Violet staining was analyzed by flow cytometry (Figure 1) . As with each division the dye gets more diluted in the plasma membrane of the T cells, a decrease in CellTrace Violet staining indicates the proliferation of T cells. More than 70% of all labeled T cells divided at least once after coculture irrespective of the medium the DC were generated indicating that both media are equally competent to prime allogeneic naïve CD4+ T cells. iDC were generated from CD14+ monocytes using GM-CSF (800 IU/mL) and IL-4 (1000IU/mL) over 5 days. iDC were matured to mDC using TNF- (800 IU/mL), IL-6 (1600 IU/mL), IL-1 (1300 IU/mL) and PGE2 (1µg/mL) over 48 hours. Naive CD4+T cells were labeled with CelltraceViolet. CellTrace Violet staining of CD3+ T cells was analyzed by flow cytometry.

Feature provided by:

Figure 1: Induction of T cell proliferation by mDC.

(A) Unlabeled CD4+ T cells (B) Negative control: CD4+ T cells + IL-2 only. (C) Positive control: CD4+ T cells activated with antiCD3/antiCD28 beads + IL-2. (D) CD4+ T cells + DC generated in medium containing Lipofundin. (E-G) CD4+ T cells + DC generated in three different lots of media without Lipofundin.

Conclusion CellGenix® GMP DC serum-free and xeno-free medium combine both quality and safety with excellent performance due to state-of-the-art production, stringent quality control, and expert regulatory support. CellGenix® GMP DCM is optimized for the generation of human DCs and offers robust and superior performance without the use of serum. Comprehensive studies verified that the performance of the new DC medium XF equivalent to the performance of the current DC medium with regard to a variety of tested parameters e.g. DC recovery, phenotype, migration, antigen up-take und T cell priming capability. This ensures reliable and consistent results which is crucial for the standardization of your ATMP manufacturing process. CellGenix® GMP DCM is the best media available on the market and all materials used in production are procured from reliable manufacturers and suppliers; and their origin and impurity profile are assessed before use. 1. S adeghzadeh M, Bornehdeli S, Mohahammadrezakhani H, Abolghasemi M, Poursaei E, Asadi M, Zafari V, Aghebati-Maleki L, Shanehbandi D. Dendritic cell therapy in cancer treatment; the state-of-the-art. Life Sci. 2020 Aug 1;254:117580. doi: 10.1016/j.lfs.2020.117580. Epub 2020 Mar 20. PMID: 32205087.


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Life Science Gets its Capital Booster Jab PHACILITATE’S WESLEY JOHNSON EXPLORES MORE TOP DEALS FROM THE PAST MONTH OR SO IN THE LATEST INSTALMENT OF HIS INVESTMENT BLOG SERIES. The life science industry continues its red hot form into November with a plethora of M&A transactions and funding rounds being wrapped up and placed under the proverbial Christmas tree. One deal in particular that stood out from the crowd in November was Blackstone stamping their authority in the UK with one of the largest private financings of a UK biotech company, and the largest from a single source. Blackstone’s capital injection in Autolus seems to be following a trend of an increasing amount of ‘take-private” transactions being launched across the sector, especially in the United Kingdom. According to a recent article by Lexology, since the start of 2021, market experts have seen nearly £35bn of bids launched in the United Kingdom alone. Research suggests that this trend to take private is arguably because public markets are not pricing assets correctly… However, returning to the round-up, below I have highlighted a few of the industry’s top transactions concluded for the month of November.

Europe Blackstone Life Sciences invested up to $250 million in Autolus Therapeutics. Autolus Therapeutics plc, a clinical-stage biopharmaceutical company, and Blackstone Life Sciences, have completed strategic collaboration and financing agreement under which funds managed by Blackstone will provide up to $250 million in equity and product financing. The funds will support Autolus with the advancement of its CD19 CAR-T cell investigational therapy product candidate, obecabtagene autoleucel, as well as next generation product therapies of obe-cel in B-cell malignancies. | Read more >> Freeline Therapeutics to raise up to $75 million in Public Offering of American Depositary Shares. Freeline Therapeutics, a clinical-stage biotechnology company developing transformative gene therapies for patients suffering from inherited systemic debilitating diseases, has entered into and open market sale agreement to offer and sell American Depositary Shares, each ADS representing one ordinary share in a public offering, for gross proceeds of up to $75 million. The company attends to use the proceeds from the offering to fund activities relating to the continued development of product candidates and gene therapy platform and for other general corporate purposes, including but not limited to, working capital, capital expenditures, investments, acquisitions. Source: Global Data on 16 December 2021


Neuroplast secures $11.5 million in Series B funding. Dutch stem cell biotech Neuroplast, a developer of autologous stem cell therapies has raised a total of $11.5 million in funding from investors Lumana Invest, Brightlands Venture Partners, LIOF, and from the Innovation Credit from the Netherlands Enterprise Agency, to further advanced the clinical development of a transformative treatment for traumatic spinal cord injury, and to obtain conditional EMA market approval for its Neuro-Cells® stem cell therapy. | Read more >> Oncternal Therapeutics enters into a codevelopment agreement with Karolinska Institute. Oncternal Therapeutics, a clinical– stage biopharmaceutical company focused on the development of novel oncology therapies, has entered into agreement with Karolinksa Institutet’s NextGenNK Competence Center for the development of next generation NK cell-based cancer immunotherapies as a collaborative partner. | Read more >> EverImmune has raised $5.7 million in a Series A funding. EverImmune, a biotechnology company specialising in the development of live biotherapeutic products in the field of microbiota oncology has raised $5.7 million in a Series A funding from undisclosed private investors. The funds raised in the Series A round will support the clinical development of Oncobax AK, the company’s Live Biotherapeutic Product, which is used as an oral adjuvant to anticancer immunotherapies. | Read more >> Chroma Medicine acquires Epsilen Bio. Chroma, a new genomic medicine company pioneering epigenetic editing, has acquired Esilen Bio Srl, a biotechnology company developing transformative therapies for patients affected by underserved medical conditions, to develop the develop the technology pioneered at Epsilen and the San Raffaele Telethon Institute. Source: Global Data on 16 December 2021

Achilles Therapeutics enters into licensing agreement with Secarna Pharma. Achilles Therapeutics UK Ltd, a clinical-stage biopharmaceutical company developing precision T cell therapies targeting clonal neoantigens, has entered into a research, option and license agreement with Secarna Pharmaceuticals GmbH & Co. KG, a biopharmaceutical company focusing on the discovery and development of next-generation antisense oligonucleotide(ASO) therapies to address challenging or previously undruggable targets. | Read more >>

Organon to acquire Forendo Pharma for $945 million. In an effort to expand its pipeline of candidates targeting novel treatments in women’s health, Organon has signed a definitive agreement to acquire Forendo Pharma for approximately $954 million. | Read more >>

North America Arbor Biotechnologies raises $215 million in Series B financing. Arbor Biotechnologies, a biotechnology company discovering and developing the next generation of genetic medicines has raised $215 million in Series B financing. Including this round, the company has raised over $400 million to date. Arbor plans to use the proceeds to advance its lead programs in liver and CNS diseases into the clinic and progress a pipeline of precision editing therapeutics, while also continuing to invest in its novel discovery engine to develop the next generation of gene editing technology. | Read more >> Chroma Medicine raises $125 million in Series A financing. Chroma Medicine, a new genomic medicine company pioneering epigenetic editing has raised $125 million in financing to support continued development of the company’s epigenetic editing platform and advancement of its pipeline of targeted therapeutics. Atlas Venture and Newpath Partners seeded the company with participation from Sofinnova Partners. Source: Global Data on 16 December 2021

Merck acquires Acceleron Pharma for $11.5bn. Merck has completed its acquisition of Acceleron Pharma for $11.5bn in a move to augment its cardiovascular portfolio through lead candidate sotatercept, a potentially first in class therapy for pulmonary arterial hypertension in phase 3 trials, as well as with marketed anaemia drug Reblozyl(luspatercept-aamt). | Read more >> MANA Therapeutics raises $7.5 million in final closing of Series A financing. MANA Therapeutics, a clinical-stage company creating non-engineered, off the shelf allogeneic cell therapies that target multiple cancer antigens has completed the final closing of its Series A financing, bringing the total raised to $42 million. The additional funding will allow MANA to accelerate the start of clinical studies for its approach to off-the-shelf allogeneic cell therapy for patients with transplant-ineligible AML and select solid tumours. | Read more >> Treadwell Therapeutics raises $91 million in Series B financing. Treadwell, a clinical-stage biotechnology company developing novel, crossmodality medicines for unmet needs in cancer, has raised $91 million in oversubscribed series B financing. The proceeds from the financing will allow Treadwell to continue the clinical and preclinical development of its broad, multi-modality pipeline. | Read more >>

Antios Therapeutics raises $75 million in a Series B-1 funding. Antios Therapeutics, a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus(HBV), has raised $75 million series B-1 financing. The proceeds from this financing will be used to advance the clinical development of ATI-2173, Antios lead Phase 2b clinical candidate. | Read more >> Krystal Biotech prices in public offering shares for $250 million. Krystal Biotech, a gene therapy company leveraging its novel, redosable gene therapy platform and in-house manufacturing capabilities to develop therapies to treat serious rare diseases, has priced the underwritten public offering of 2,666,667 shares of its common stock, at a price of $75 per share, to raise gross process of $200 million. | Read more >> Turnstone Biologics enters into Research Collaboration with Moffitt Cancer Center. Turnstone Biologics Corp, a clinical-stage biotechnology company pioneering the development of cancer immunotherapies, has entered into a multi-year research collaboration with Moffitt Cancer Center, for pre-clinical development of investigational tumourinfiltrating lymphocyte therapies. | Read more >> Atara Biotherapeutics to raise up to $100 million in Public offering shares. Atara Biotherapeutics, an allogeneic T-Cell Immunotherapy company pioneering the development of transformative therapies for patients with serious diseases including tumors, hematologic cancers and autoimmune diseases, has entered into a sales agreement to offer and sell shares of its common stock in public offering, for gross proceeds of up to $100 million. Source: Global Data on 16 December 2021

Arbor Biotechnologies raises $215 million in Series B financing. Arbor, a biotechnology company discovering and developing the next generation of genetic medicines has completed an oversubscribed and up-sized $215 million Series B financing. This round was led by Temasek, Ally Bridge Group, and TCG Crossover. Arbor plans to use the proceeds to advance its lead programs in liver and CNS disease into the clinic and progress a pipeline of precision editing therapeutics, whilst also continuing to invest in its novel discovery engine to develop the next generation of gene editing. | Read more >> SQZ Biotechnologies to raise up to $75 million in public offering of shares. SDZ Biotechnologies company, a clinical stage cell therapy company developing treatments for multiple therapeutic areas, has announced underwritten public offering of shares, to raise proceeds of up to $75 million. The company intends to use the proceeds to advance the clinical development of product candidates and for working capital and general corporate purposes. Source: Global Data on 16 December 2021

INOVIO Pharma to raise up to $300 million in public offering of shares. Inovio, a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases associated with HPV, has announced underwritten public offering of shares, to raise gross proceeds of up to $300 million. The company intends to use the proceeds for general corporate purposes, including clinical trial expenses, research and development expenses, working capital, general and administrative expenses, manufacturing expense and potential acquisitions of companies and technologies.


Source: Global Data on 16 December 2021


Chinook Therapeutics completes full exercise of underwriters over–allotment option in public offering of shares for $183.5 million. Chinook, a clinicalstage biotechnology company developing precision medicines for kidney diseases, has completed the upsized underwritten public offering of 9,538,572 shares of its common stock at a price to public of $14 per share, which includes the exercise in full of the underwriter’s option to purchase an additional 1,710,000 shares of its common stock. Chinook intends to use the proceeds from this offering to advance the phase 3 ALIGN trial of atrasentan in patients with IgA nephropathy and the phase 2 AFFINITY basket trial of atrasentan in patients with proteinuric glomerular diseases, initiate laterstage-clinical development of BION-1301 for IgAN, mover forward the development of CHK-336 for hperoxalurias and continue progress on research and discovery programs. | Read more >> ANI Pharma raises $75 million in public offering of shares. ANI Pharmaceuticals, a pharmaceutical company, has completed the underwritten public offering of 1,500,000 of its common stock of price of $50 per share, for proceeds of $75 million, before deducting the underwriting discounts and commissions and other offering expenses. ANI intends to use the net proceeds from the offering to fund its Cortrophin commercialisation efforts, including but not limited to, sales and marketing and consulting expenses related thereto, and for general corporate purposes. Furthermore, ANI may also use a portion of the proceeds to inlicense, acquire or invest in additional businesses, technologies, products or assets. | Read more >>

Imugene and Eureka Therapeutics into collaboration. Imugene, a clinical stage immuneoncology company, and Euraka Therapeutics, a clinical-stage biotechnology company developing novel T-cell therapies a treat solid tumors, announced a collaboration to evaluate Imugene’s CD19 oncolytic virus on CARlytics technology in combination with Eureka’s anti-CD19 ARTEMIS T- cell therapy for the treatment of solid tumors. | Read more >>

With increasing competition across the life science industry being fuelled by new entrants and investors looking for the next big growth opportunity, transactions continue to flourish. In a recent article by McKinsey, they noted that large pharmaceutical companies still very much rely on biotechs as a source of innovation. With the top dozen pharma companies having more than $170 billion in excess reserves that could be available for spending on M&A, the prospect for further financing and deal-making look very promising going forward.

About ATIN Success is not just what you know, but who you know. The Advanced Therapies Investment Network (ATIN) which is powered by Phacilitate, helps advance the next pillar of medicine by hosting the world’s leading marketplace that connects executives and investors. ATIN helps support your deal flow, by facilitating curated meeting introductions mixed with high-quality algorithmic matchmaking for biotechnology, specialty pharma and medtech companies working in advanced therapies. For more information about how to join this specialist group, please contact me directly via: wesley.johnson@


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CellGenix® GMP TCM CellGenix® GMP TCM

Serum- and xeno-free medium Serum- and xeno-free medium High lot-to-lot consistency High lot-to-lot consistency Sustained viability Sustained viability Optimized for and verified CellGenix Advert with CAR-T cells

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Safe | GMP Compliant | Reliable Contact us: CellGenix – - 38 CellGenix Contact us: GmbH | Am Flughafen 16 | 79108 Freiburg | Germany HQ: Sartorius US: CellGenix Inc.–| One New Hamsphire Avenue,-Suite 125 | Portsmouth, NH 03801 | USA CellGenix