smi group's 2nd annual lyophilization usa 2016 conference

Sponsored by

Highlights for 2016:• J&J presents why lyophilization is no longer just a

downstream process• Understand protein stability and its changes during

freeze drying• Novo Nordisk assess aseptic spray drying as an

alternative to lyophilization• Genzyme share their thoughts on commercial

competitiveness of lyophilized products• Allergan discuss the optimal approach of lyophilization

scale-up

SMi Presents the 2nd Annual Conference and Exhibition on...

27 - 28

APRIL2016Renaissance Woodbridge Hotel,

Iselin, New Jersey, USA

Lyophilization USA

PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSFriday April 29th 2016, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

www.lyophilization-usa.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

Driving Lyo-Productivity through PracticalQbD and Advanced Technologies

@SMIPHARM

Workshop ALyophilization – Development Through Tech Transfer

Workshop Leader: Ralph Tarantino, PhD, Pharmaceutical Consultant & Principal, Steritech Solutions, LLC

08.30 - 12.30

Workshop BAn Empirical Approach to Formulation and Lyophilization

Cycle Development of Parenteral and Diagnostic ProductsWorkshop Leader: J. Jeff Schwegman, CEO, AB BioTechnologies, Inc.

13.30 - 17.30

Chairs for 2016:• Jim Searles, Ph.D., Technical Fellow, Pfizer• Sune Klint Andersen, Principal Scientist, Novo Nordisk

Expert Speaker Panel Includes:

• Dr. Mark Yang, Director of Fill/Finish Development, LateStage Process Development, Genzyme Corp

• Dr Evgenyi Shalaev, Research Investigator, Allergan• Prakash Sundaramurthi, Senior Scientist, Teva Biologics• Dr. Vineet Kumar, Senior Scientist, J&J

BOOK BY JANUARY 29TH 2016 TO SAVE $400BOOK BY FEBRUARY 29TH 2016 TO SAVE $300BOOK BY MARCH 30TH 2016 TO SAVE $200

Lyophilization USA Day One | Wednesday 27th April 2016

08.30 Registration & Coffee

09.00 Chair’s Opening RemarksJim Searles, Ph.D., Technical Fellow, Pfizer

REGULATORY COMPLIANCE – AGENCIES’ EXPECTATIONS FOR LYOPHILIZED PRODUCTS

09.10 OPENING ADDRESS: Effect of Pressure and Dryer Load uponSecondary Drying Rates•Fundamentals of the secondary drying phase•Effects of process parameters such as temperature and

pressure•In-depth focus upon dryer load and pitfalls of scale-upJim Searles, Ph.D., Technical Fellow, Pfizer

09.50 Regulatory Uncertainty vs. Product Development•US-FDA specific requirements vs. critical issues for regulatory

approval in the EU •What is required by the regulators for quality control and

CMC?•How to accelerate approvals working simultaneously for

both markets?David Awotwe-Otoo, Division of Product Quality Research,FDA (Invited)

10.30 Morning Coffee & Networking Break

FROM FORMULATION TO BIO-PROCESSING

11.00 When Lyophilization is No Longer Just a Downstream Process•Dealing with more complex biologics from early stages •Predictive modelling and high throughput screening –

ensuring stability of compound during freeze drying•Latest simulation technologies to decrypt molecular

structure Dr. Vineet Kumar, Senior Scientist, J&J

11.40 Residual Water Content in a Lyophilized Drug Product –Optimizing Secondary Drying•How dry should it be? Determining ideal water content for

drug products•How to customize your drying process•Analytical methods to best analyze effect of residual water

on stabilityLisa Hardwick, Research Scientist, Baxter Healthcare Corporation

12.20 Protein Stability: Change in the Apparent Acidity DuringFreezing and Drying •Stability concerns over lyophilized-products•Excipients to enhance stability and shelf-life•Interaction with APIs•Search for the optimal pH for lyophilizationDr. Evgenyi Shalaev, Research Investigator, Allergan

13.00 Networking Lunch

14.00 QbD – How, What and When?

•Quality by design (QbD) – what exactly is QbD?

•Defining critical attributes and incorporating into drug

development plan

•How will this improve lyophilization process and what are

the challenges?

•From concept to implementation

Speaker to be announced shortly

14.40 Aseptic Spray Drying as an Alternative to Lyophilization?

•Recent breakthroughs in aseptic spray drying technologies

for commercial production

•Approaches for aseptic powder filling

•Comparison of aseptic drying processes

Sune Klint Andersen, Principal Scientist, Novo Nordisk

15.20 Afternoon Tea & Networking Break

TECHNOLOGICAL ADVANCEMENTS IN LYOPHILIZATION

15.50 Process Analytical Technology (PAT) to Develop a Rational

Lyophilization Cycle

•A key attribute not to be neglected – proving PAT to

regulatory agencies

•Update on PAT guidelines and what should be classed as

critical process parameters?

•Developing a PAT toolbox – from single vial to batch

monitoring

•Assurance of product quality and regulatory compliance

Session reserved for sponsor

16.30 Panel Discussion: Is Lyophilization the

Way to Go Forward?

•Exploring current market trends for

pharmaceutical products and needs for lyophilization

•Marrying sciences with commerciality – scalability and

product quality

•Exploring the alternatives to lyophilization

Moderators:

Dr. Salman Mazummil, Drug Product Development, Janssen

Dr. Padam N. Sharma, Ph.D., Injectables, Sterile

Manufacturing and Development Global Pharmaceutical

Technology, Allergan

17.10 Chairman's Closing Remarks and Close of Day One

Register online at: www.lyophilization-usa.com • Alternatively fax

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement yourcompany’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand yourclient base within the context of an independent discussion specific to your industry. Should you wish to jointhe increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on+44 (0) 20 7827 6168 or email: [email protected]

Sponsored by Official Media Partners

One 2 One™ is a global leader in sterile injectables contractmanufacturing. We carefully guide your medicine fromdevelopment through launch, harnessing 25+ years of expertise inbiopharmaceutical fill and finish. Organizational strengths includein-depth experience with complex biologics and a lyophilizationcenter of excellence. www.one2onecmo.com

Lyophilization USADay Two | Thursday 28th April 2016


09.00 Chairman's Opening RemarksSune Klint Andersen, Principal Scientist, Novo Nordisk

QUALITY CONTROL AND COMPLIANCE FOR LYOPHILIZATION

09.10 OPENING ADDRESS: Commercial Competitiveness ofLyophilized Products •Lyophilization is often unavoidable for biologics and is a

growing market•Strategies to reduce lyophilization cycle and cost for

commercial manufacturing•New technologies that can shorten lyophilization

development time and improve its efficiency•Dried but not lyophilized? Technologies beyond

lyophilizationDr. Mark Yang, Director of Fill/Finish Development, Late Stage Process Development, Genzyme Corp

09.50 Controlled Nucleation – Reliability and Consistency? •Project updates on controlled nucleation•How to ensure process consistency and homogeneity of

products – physio-chemical characterization?•Overcoming regulatory uncertainty•Scaling up – the need for a robust monitoring and

surveillance systemSpeaker to be announced shortly

10.30 Morning Coffee & Networking Break

11.00 Excipient Behaviour in Frozen and Freeze-Dried Systems – Potential Impact on Product Performance•Buffers, bulking agents and lyoprotectant•Characterization techniques•Implications on processing and final product performance Dr. Raj Sury, Professor, University of Minnesota

11.40 Solute Behavior in Sub-Zero Temperatures – Impact onFreeze-Dried Products – Case Studies•Lyophilization from two immiscible liquids at sub-zero

temperature•Condenser temperature as CPP•Scale-up issues with vial fogging

Prakash Sundaramurthi, Senior Scientist, Teva Biologics

12.20 Networking Lunch

MAXIMIZING PRODUCTIVITY AND EFFICIENCY

13.20 Quality Assessment for Lyophilization and Lyophilized

Products

•From sterilization to an accurate fill/finish dosage

•The evolving and emergence of complex and combination

products – requirements for PFS

•GMP and define standard operating procedures (SOPs) for

your CMOs


14.00 Freeze Thaw for Protein Stabilization

•How to store and what temperature range is optimal?

•Freeze thaw process – will this impact on drug quality and

efficacy?

•Product stability during storage – eliminating crystallization

and extending shelf-life

Jamie Tsung, Principal Scientist, Drug Product Development,

Momenta Pharmaceuticals


15.10 Comparability Studies for Tech Transfer in Lyophilization

•Designing tech transfer program of lyophilization cycle to

improve success rate

•How to minimize workload and overcome key challenges of

ice nucleation and bulk formulation

•Enhancing performance of drying

•Site and plant selection


15.50 Panel Discussion: Looking Beyond

– Is Drying the Only Way to Go?

•How dry should it be? Determining water

content for drug products

•How to customize your drying process?

•Stability prediction and modelling

Panellists:

Sune Klint Andersen, Principal Scientist, Novo Nordisk

Prakash Sundaramurthi, Senior Scientist, Teva Biologics

Dr. Raj Sury, Professor, University of Minnesota

16.30 Chairman’s Closing Remarks and Close of Day Two

Supported by

x 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 Teri Arri, SMi Marketing on +44 (0) 207 827 6162 or email: [email protected]

Official Publications

Overview of the Workshop: This half-day workshop will aim to provide practical experience fordelegates on meeting QbD requirements and other CMCchallenges encountered in the development of lyophilizeddosage forms. The impact of lyophilization as a pharmaceuticalunit operation is expected to grow as the biopharmaceuticalmarket continues to expand. Hence, a well-defineddevelopment and tech transfer plan based on QbD principles willmitigate downstream risks and ensure smooth scale-up, approvaland launch of lyophilized products.

Key Benefits of Attending: Through interactive discussions and case reviews, this workshopwill help you to address all the above challenges relating toparallel trade. You will be able to re-assess the best strategy andoption suitable to your business including pricing and supplymanagement.

08.30 Registration & Coffee09.00 Workshop Leader's Opening Remarks09.10 Developing a Thorough Development Plan to Meet

CMC Requirements• Which regulatory technical requirements impact

most for complex biologics and combinationproducts?

• Incorporating QbD into product development• Examples and challenges

09.40 Roundtable Discussion - Criticality Analysis forLyophilization• CQAs and CPPs• Documentation• Examples/challenges

10.10 Roundtable DiscussionWorkshop attendees will be encouraged to sharetheir challenges and experiences, and togetherseek best solution to assist with a successful drugdevelopment and lyophilization program

10.30 Morning Coffee11.00 Lyophilization: Tech Transfer and Scale-Up

• Check off list for scale-up• Process equipment considerations• Validation issues• Examples/challenges

11.40 Roundtable Discussion12.00 Q&A12.30 Closing Remarks from Workshop Leader and

End of Workshop

About the Workshop Host:Ralph Tarantino, PhD, Pharmaceutical Consultant &Principal, Steritech Solutions, LLCDr. Tarantino is a Subject Matter Expert in theformulation of injectable dosage forms, with over 25years’ experience in the pharmaceutical industry. He

was instrumental in the development of numerous marketeddrug products. His experience ranges from bench level scientist tosenior manager at Hoffmann-La Roche Inc. where he was theDirector of Sterile Product Formulation and Clinical Manufacturingfor 17 years. Dr. Tarantino specializes in peptide/proteinformulations, drug delivery systems and the solubilization of newmolecular entities. He has trained FDA reviewers on the topic of peptide/protein formulation and mentored numerousundergraduate and graduate scientists in the development andmanufacture of sterile products.

Currently he serves as consultant to pharmaceutical, investmentand legal firms. His projects have included evaluation of drugdelivery technologies, expert testimony in formulation relatedcases and criticality analyses of drug product formulation andmanufacture.

Highlights of Dr. Tarantino's Career:Leadership role in development of 9 marketed products and SterileProduct Subject Matter Expert for Sterile products at Roche NutleyGlobal Peptide Delivery Champion. Head of Sterile ClinicalManufacturing with 7 successful Pre-Approval Inspections ExtensiveFDA interactions and FDA trainer for Biopharmaceutical Formulationand Stability Leader in international harmonization and ChairInternational Formulation technology Working Group for SterileProducts Invited Lecturer, American Association of PharmaceuticalScientists Eastern Regional Meeting, “Technology Transfer for SterileDosage Forms” Adjunct Assistant Professor in PharmaceuticalSciences, Long Island University Elected Chair, Basic PharmaceuticalSciences, Academy of Research and Science, BasicPharmaceutical Sciences Representative, Education StandingCommittee, American Pharmaceutical Association.

HALF-DAY POST-CONFERENCE WORKSHOP AFriday 29th April 2016

08.30 - 12.30Renaissance Woodbridge Hotel, Iselin,

New Jersey, USA

Lyophilization – DevelopmentThrough Tech Transfer

Workshop Leader:Ralph Tarantino, PhD, Pharmaceutical Consultant &

Principal, Steritech Solutions, LLC

Overview of the Workshop: This seminar will cover the benefits of developing anoptimized formulation for freeze-dried products to improvethe quality and consistency, while also reducing the cycletime and costs. This session will include all of the aspects ofunderstanding the justification for freeze-drying, the thermalproperties of the formulation (crystalline, amorphous,mixed), the analytical techniques employed tocharacterized these systems, and how all of this informationis used to develop a stable, optimized, cGMP compliantproduct.


14.00 Workshop Leader's Opening Introduction

14.10 From Proof of Concept to Design of Experience (DoE)• Why early stage formulation is important to

lyophilization?• What are the critical attributes and factors to

consider?• How can we improve the stability and formula

to suit lyophilization?


15.45 Scaling Up - Considerations and Preparation• Tech transfer considerations and challenges• PAT and freeze drying• How to select the optimal temperature range

for your products• QA and manufacturability in a commercial

scale

16.30 Q&A

17.30 Workshop Leader's Closing Remarks and End of Workshop

About the Workshop Host:J. Jeff Schwegman, CEO, AB BioTechnologies, Inc.J. Jeff Schwegman, Ph.D. is the Founder and CEO of where he develops formulations,lyophilization cycles, determines residual moisture by

Karl Fischer, and provides thermal characterization studiesincluding freeze-drying microscopy and DSC.

He holds patents and develops new technologies within thelyophilization field. Dr. Schwegman received his Ph.D. fromPurdue University in 2003, and in 2008 he founded ABBioTechnologies which is a contract laboratory offering fullscale formulation, analytical and lyophilization developmentof both small and large molecules. He routinely lecturesaround the world and teaches courses on formulation,stabilization and process development of lyophilized products.

About the Organization:AB BioTechnologies, Inc. is a small, privately held companylocated in Bloomington, Indiana, that is dedicated toproviding the highest quality service in formulationdevelopment, lyophilization cycle development/ optimization,analytical development, thermal characterization, andeducation and training in the development of injectable drugproducts and diagnostics.

Since we are a small, privately held company with minimaloverhead, we can complete your project in record time at thelowest possible cost.

HALF-DAY POST-CONFERENCE WORKSHOP BFriday 29th April 2016

13.30 - 17.30Renaissance Woodbridge Hotel, Iselin,

New Jersey, USA

An Empirical Approach to Formulationand Lyophilization Cycle Development of

Parenteral and Diagnostic Products

Workshop Leader:J. Jeff Schwegman, CEO, AB BioTechnologies, Inc.

FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711

POST your booking form to: Events Team, SMi Group Ltd, 2nd FloorSouth, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

LYOPHILIZATION USA Conference: Wednesday 27th April & Thursday 28th April 2016, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Workshops: Friday 29th April 2016, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

4 WAYS TO REGISTERwww.lyophilization-usa.com

If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email [email protected]

Payment: If payment is not made at the time of booking, then an invoice will be issued and must bepaid immediately and prior to the start of the event. If payment has not been received then creditcard details will be requested and payment taken before entry to the event. Bookings within 7 daysof event require payment on booking. Access to the Document Portal will not be given until paymenthas been received.Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, anotherdelegate to take your place at any time prior to the start of the event. Two or more delegates maynot ‘share’ a place at an event. Please make separate bookings for each delegate.Cancellation: If you wish to cancel your attendance at an event and you are unable to send asubstitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providingthat cancellation is made in writing and received at least 28 days prior to the start of the event.Regretfully cancellation after this time cannot be accepted. We will however provide theconferences documentation via the Document Portal to any delegate who has paid but is unableto attend for any reason. Due to the interactive nature of the Briefings we are not normally able toprovide documentation in these circumstances. We cannot accept cancellations of orders placedfor Documentation or the Document Portal as these are reproduced specifically to order. If we haveto cancel the event for any reason, then we will make a full refund immediately, but disclaim anyfurther liability.Alterations: It may become necessary for us to make alterations to the content, speakers, timing,venue or date of the event compared to the advertised programme.Data Protection: The SMi Group gathers personal data in accordance with the UK Data ProtectionAct 1998 and we may use this to contact you by telephone, fax, post or email to tell you about otherproducts and services. Unless you tick here □ we may also share your data with third parties offeringcomplementary products or services. If you have any queries or want to update any of the data thatwe hold then please contact our Database Manager [email protected] or visitour website www.smi-online.co.uk/updates quoting the URN as detailed above your address on theattached letter.

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A/C Name SMI GROUP LTD Sort Code 300009,Account Number 11775391 CCY USD□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AUIBAN GB75LOYD30000911775391BIC LOYDGB21013□ Cheque We can only accept cheques in US Dollars.□ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges.

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DOCUMENTATIONI cannot attend but would like to purchase access to the following DocumentPortal/paper copy documentation Price Total□ Access to the conference documentation

on the Document Portal $799.00 + VAT $958.80□ The Conference Presentations – paper copy $799.00 - $799.00

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□ Conference & 2 Workshops $2997.00□ Conference & 1 Workshop AM □ PM □ $2398.00□ Conference only $1799.00□ 2 Workshops only $1198.00□ 1 Workshop only AM □ PM □ $599.00

PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees $1598 + VAT $1917.60The conference fee includes refreshments, lunch, conference papers, and access to theDocument Portal. Presentations that are available for download will be subject todistribution rights by speakers. Please note that some presentations may not be availablefor download. Access information for the document portal will be sent to the e-mailaddress provided during registration. Details are sent within 24 hours post conference.