SMi Group's Lyophilization USA 2018 conference returns for its 4th year this November in Iselin, New Jersey

1. INVITED CHAIR FOR 2018:
Timothy McCoy, Associate Director, Pharmaceutical
Development, Biologics Research and Development,
Sanofi
KEY SPEAKERS INCLUDE:
Alex Langford, Senior Associate Scientist,
Pfizer
Fabrice Schlegel, Senior Engineer,
Amgen
Rui Fang, Senior Scientist,
Merck
Sushma Kommareddy, Associate Director,
Formulation Development, Takeda
Alina Alexeenko, Professor,
Purdue University
HIGHLIGHTS IN 2018:
• Discover novel techniques and advances within
lyophilization
• Gain insight into the regulatory challenges in
lyophilization; and how to overcome these challenges
• Discuss the current unmet needs within lyophilization;
and action points needed to address these needs
• Explore the most recent analytical and other
technologies in lyophilization
• Hear from experts on alternative freeze-drying methods
beyond vial lyophilization
CONFERENCE: 15TH-16TH
NOV
2018RENAISSANCE WOODBRIDGE HOTEL, ISELIN, NJ, USA
Technological advancements within
lyophilization
SMi presents the 4th Annual Conference on…
Lyophilization
USA
SPONSORED BY
www.lyophilization-usa.com
Register online or fax your registration to +44 (0) 870 9090 712
or call +44 (0) 870 9090 711
SMi Pharma
@SMiPharm
#lyousa
REGISTER BY 29TH JUNE AND SAVE $300
REGISTER BY 28TH SEPTEMBER AND SAVE $100

2. Lyophilization USA
Day One | Thursday 15th November 2018 www.lyophilization-usa.com
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Timothy McCoy, Associate Director, Global Pharmaceutical
Development, Biologics Research and Development, Sanofi
NOVEL TECHNIQUES AND ADVANCES WITHIN LYOPHILIZATION
OPENING ADDRESS
9.10 Comparing and contrasting two methods of controlled
nucleation for use in lyophilization: A live viral vaccine (LVV)
perspective
• Evaluation of two methods of controlled nucleation:
ressurization/ depressurization technology and “ice fog”
technology
• Can controlled nucleation impart consistency whilst maintaining
vaccine potency?
• Impact on cycle time, consistency and moisture levels
Morrisa Jones, Senior Scientist, Vaccine Drug Product
Development, Merck & Co., Inc.
9.50 Continuous monitoring of sublimation rate for individual containers
in freeze drying processes
• Negating the need for conventional gravimetric measurements
• Providing more accurate measurements than TDLAS
• Introducing minimal disturbance to the freeze drying process
• Facilitating data acquisition for recipe design
Pouya Tavousi, Post-Doctoral Fellow, Biomedical Engineering,
University of Connecticut
10.30 Morning Coffee
11.00 Development of Lyophilized Anthim® for Injection
• Liquid Drug product developed into Lyophilized Drug Product
• Process Development, Transfer, Scale Up and Validation
• Working with several CMOs
• Working within US Government funding and regulatory
restrictions
Colin Campbell, Director, Process Development, Elusys
Therapeutics
REGULATORY CHALLENGES IN LYOPHILIZATION
11.40 Tech Transfer and scale up challenges and considerations for
lyophilized products
• Practical approaches to tech transfer and scale up of the
lyophilization process
• Avoiding pitfalls and overcoming challenges
• Collaborating with vendors of lyophilization equipment and
consumables
• Case study
Session Reserved for Allergan
12.20 Networking Lunch
NOVEL ANALYTICAL & OTHER TECHNOLOGIES IN LYOPHILIZATION
13.30 Novel technologies to enhance the freeze drying process
• Freeze-drying process optimization
• Understanding the effect of each step of the cycle on the drug
product
• Clinical parameters in primary drying
• How to ensure the right process conditions
Session Reserved for Sponsor
KEYNOTE ADDRESS
14.10 Freeze dryer characterization and application to drug
product development and scale up
• Characterization of bench, pilot and industrial scale freeze
dryers
• Product characterization & measurement of Rp
• Application of models to the development of a lyophilization
cycle
• Scale up
• PAT applications to development and scale up
Timothy McCoy, Associate Director, Pharmaceutical
Development, Biologics Research and Development, Sanofi
14.50 Afternoon Tea
15.20 Embedding predictive in-silico models into Amgen’s lyophilization
processes
• Operationalizing in-silico models through the deployment of
web-based applications for:
- Lyo process development
- Tech transfer and scale up
- Recovery from process deviation at the manufacturing scale
(models as soft-sensors)
• Beyond the vial model:
- Roadmap for more complex first principle models
Fabrice Schlegel, Senior Engineer, Amgen
KEYNOTE ADDRESS
16.00 Formulation and excipient selection for lyo product
development of vaccines
• Challenges in handling labile vaccine antigen
• Approaches for excipient selection and formulation
• Long term product stability and potency assays
Sushma Kommareddy, Associate Director, Formulation
Development, Takeda
16.40 Chairman’s Closing Remarks and Close of Day One
Register online at www.lyophilization-usa.com
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime
networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your
industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call:
Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
SUPPORTED BYOFFICIAL ASSOCIATION

3. Lyophilization USA
www.lyophilization-usa.com Day Two | Friday 16th November 2018
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Timothy McCoy, Associate Director, Global Pharmaceutical
Development, Biologics Research and Development, Sanofi
CHALLENGES IN FREEZE DRYING
OPENING ADDRESS
9.10 Challenges of lyophilized product development
• Formulation challenges
- Excipients selection
- Dosage forms: solution, suspension, & oral melt
- Route of administration: iv, im and oral
- Solvents: aqueous and non-aqueous
- API: biologics & small molecules
• Process challenges
• Device selections
Yanming Zu, Director, Research and Development,
Abon Pharmaceuticals
9.50 Freezing of biologics formulations - impact of formulation
composition and sugar types on stability
• Biologics formulations liquid or lyophilized often require a
freezing step once the drug substance is manufactured, before
converting it to a drug product
• Case study highlighting the importance of protein: sugar ratios in
biologics formulations that require freezing
• Importance of drug substance storage container, protein
concentration, sugar type
Hiten Gutka, Associate Director, Formulation Development,
Oncobiologics
10.30 Morning Coffee
11.00 ssHDX/MS for solid protein formulations
• Current methods used for the characterization of protein stability
in lyophilized formulations
• Solid state hydrogen deuterium exchange coupled with mass
spectrometry (ssHDX/MS)
• ssHDX/MS provide better correlation with accelerated stability
results compared to other techniques
• Current understanding of ssHDX/MS and its limitations
Mohamed AbouGhaly, Postdoctoral Research Associate,
Purdue University
11.40 End user challenges, perspectives and advantages of freeze
drying technology
• Freeze dryer market trends
• Cross contamination handling and process challenges
• Considerations for lyophilization
Dena Flamm, Business Development Manager, Optima
12.20 Networking Lunch
PANEL SESSION
13.30 Process modelling and simulation
• Need for modelling and simulation tools to support the design of
lyophilized products
• Developing models and simulations to characterize the impact
of process variations on product quality using physics based and
statistical approaches
• Need for user friendly models
• Simulations needed for accelerated lyophilization process
development and closed-loop control
Timothy McCoy, Associate Director, Global Pharmaceutical
Development, Biologics Research and Development, Sanofi
Fabrice Schlegel, Senior Engineer, Amgen
Pouya Tavousi, Post-Doctoral Fellow, Biomedical Engineering,
University of Connecticut
KEYNOTE ADDRESS
14.10 How the freezing protocol can influence protein stability
during lyophilization
• Understanding freezing-induced stresses to proteins
• Impact of controlled ice nucleation on protein stability and
batch uniformity
• The role of residence time in the freeze-concentrate on protein
stability
Rui Fang, Senior Scientist, University of Connecticut, Merck
14.50 Afternoon Tea
BEYOND VIAL LYOPHILIZATION: ALTERNATIVES TO CONVENTIONAL METHODS
KEYNOTE ADDRESS
15.20 Vacuum-foam drying of biotherapeutics: Process
considerations and stabilization of human T cells
• Development of vacuum-foam drying technology
• Comparison of foam drying and freeze-drying
• Future direction
Alex Langford, Senior Associate Scientist, Biotherapeutics
Pharmaceutical Research and Development, Pfizer
16.00 The future of lyophilization through participation in LyoHub
• Overview of unmet needs in lyophilization
• Strategies to address these unmet needs
• Future direction of lyophilization
• LyoHub key action points
Alina Alexeenko, Professor, Purdue University
16.40 Chairman’s Closing Remarks and Close of Day Two
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Lyudmyla Durneva, SMi Marketing on +44 (0) 20 7827 6088 or
email: ldurneva@smi-online.co.uk
SUPPORTED BY

4. Lyophilization USA
Sponsored by
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising
and branding packages, uniquely tailored to
complement your company’s marketing strategy.
Prime networking opportunities exist to entertain,
enhance and expand your client base within the
context of an independent discussion specific to
your industry. Should you wish to join the increasing
number of companies benefiting from sponsoring
our conferences please call:
Alia Malick on +44 (0) 20 7827 6168 or email:
amalick@smi-online.co.uk
www.ellab.com
Optima Pharma develops and manufactures
packaging technologies for pharmaceutical
products. Systems from Optima Pharma are
used to process blood plasma products,
vaccines, oncology and biotech products.
Our extensive technology portfolio includes
washing machines, sterilization tunnels, filling
and sealing, robotic product handling, freeze
drying systems, isolator technology and other
functions.
www.optima-packaging.com/en-us

5. SMi PHARMACEUTICAL
EVENT PLANNER 2018-19
SEPTEMBER 2018
Biosimilars & Biobetters
26 - 27 September, London, UK
Immuno-Oncology
26 - 27 September, London, UK
OCTOBER 2018
Cell & Gene Therapy
10 - 11 October , London, UK
Orphan Drugs & Rare Diseases
17 - 18 October, London, UK
NOVEMBER 2018
USA WEEK
Superbugs & Superdrugs USA
12 - 13 November, New Jersey, USA
Biosimilars North America
14 - 15 November, New Jersey, USA
Lyophilization USA
15 - 16 November, New Jersey, USA
Ophthalmic Drugs
26 - 27 November , London, UK
DECEMBER 2018
Cold Chain Distribution
10 - 11 December, London, UK
JANUARY 2019
Pre-Filled Syringes & Injectable Drug Devices
16 -17 January, London, UK
Pharmaceutical Microbiology
21 - 22 January, London, UK
Social Media in the Pharmaceutical Industry
21 - 22 January, London, UK
FEBRUARY 2019
Parallel Trade
5 - 6 February, London, UK
3D Cell Culture
20 - 21 February, London, UK
RNA Therapeutics
20 - 21 February, London, UK
SMi Pharma
@SMiPharm
#lyousa

6. LYOPHILIZATION USA
Conference: 15th -16th November 2018, Renaissance Woodbridge Hotel, Iselin, NJ, USA
4 WAYS TO REGISTER
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
ONLINE at www.lyophilization-usa.com
POST your booking form to: Events Team, SMi Group Ltd,
1 Westminster Bridge Road, London, SE1 7XW
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk
Unique Reference Number
Our Reference P-269
Payment must be made to SMi Group Ltd, and received before the event,
by one of the following methods quoting reference P-269 and the delegate’s
name. Bookings made within 7 days of the event require payment on booking,
methods of payment are below. Please indicate method of payment:
□ UK BACS Sort Code 300009, Account 11775391
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Swift (BIC): LOYDGB21013, Account 11775391
IBAN GB75 LOYD 3000 0911 7753 91
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DOCUMENTATION
I cannot attend but would like to Purchase access to the following Document Portal/
Paper Copy documentation. Price Total
□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80
□ The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
PAYMENT
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VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged
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conference.
□ Book by 29th June to receive $300 off the conference price
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Terms and Conditions of Booking
DELEGATE DETAILS
VENUE Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: events@smi-online.co.uk or fax +44 (0) 870 9090 712