Mastering Immunogenicity Conference - … · 2nd Mastering Immunogenicity September 17-18, 2012 ... · The Magdalen Centre · Oxford Science Park · Oxford OX4 4GA · UK · T. +44

ProImmune Ltd. · The Magdalen Centre · Oxford Science Park · Oxford OX4 4GA · UK · T. +44 870 042 7279

ProImmune Inc. 4281 Express Lane Suite L2378 Sarasota, FL 34238 USA· T. +1 888 505 7765

Email: [email protected] · Web: www.proimmune.com Page 1 of 18

2nd Mastering Immunogenicity September 17-18, 2012

British Consulate-General, Boston MA, USA

Our 2nd Mastering Immunogenicity Conference will focus on the wide range of

technologies available for immunogenicity risk management of biologics and

consumer products, and how these can be incorporated into your program strategy

to improve your chances of successful product development.

Learn about the latest strategies and technologies

Discuss challenges and exchange ideas

Improve the outcome of your R&D programs

Join leaders in the immunogenicity field for a two day conference to learn what constitutes a

successful strategy for managing immunogenicity risk at the preclinical stage, and explore

the business case for introducing immunogenicity assessment into your program.

The aim of the summit is to share expert knowledge and to discuss the improvements

needed in design and implementation of research and development, and highlight how

making these changes will directly benefit you. The knowledge gained will help you to set

the direction of your future research and give you practical ideas on how to improve

outcomes.

Presentations by experts will provide an overview of the wide range of technologies

currently used for immunogenicity risk management and how they can be incorporated for a

‘quality by design’ approach.

The event’s interactive format allows you to suggest topics for the parallel breakout sessions

within the themes of the program, thus your participation can have a direct impact on

shaping advances in this fast moving field.

This event offers a great opportunity to meet and share information with like-minded

scientists from other organizations, and to help shape the future of your R&D programs.




Current Speaker List Manoj Rajadhyaksha Director, Bioanalytical Sciences, Regeneron, Tarrytown, NY

Bonnie Rup Pharmacokinetics, Dynamics and Metabolism, Pfizer, Andover MA

Fiona Harding Senior Principal Research Scientist, Biologics Technology, Abbott Biotherapeutics Corp, Redwood City, CA

Alexandra Joseph Associate Scientific Director, Genzyme, Framingham, MA

Nik Schwabe CEO, ProImmune Ltd

Bob Dubridge Chief Scientific Officer, Full Spectrum Genetics, Inc., South San Francisco, CA

Valerie Quarmby Principal Scientist and Director of the Department of BioAnalytical Sciences, Genentech, San Francisco CA, USA

Sebastian Spindeldreher Head of PK/PD Bioanalytics II, Novartis Pharma AG, Basel, Swizterland

Eric Furfine

President of Research & Development Eleven Biotherapeutics, MA, USA

Jeremy Fry Director of Sales, ProImmune Ltd, Oxford, UK

Conference Inquiries Email: [email protected] Telephone (toll free): USA & Canada - +1 888 505 7765; All other countries - +44 (0) 870 042 7279

Comments from delegates at ProImmune’s Mastering Immunogenicity Conference, September 2011 Lauren Nardini, Merck, NJ ‘Good diversity of presentations, Good discussion and topics’ Scott McClain, Syngenta, NC ‘Appreciated the mix of expertise from different fields’ Anja Langenkamp, F. Hoffmann-La Roche Ltd, Switzerland ‘It was very good; focussed and the right duration’ Martin Pearse, CSL, Australia ‘Interesting, Informative, Interactive and intellectually stimulating’

http://www.gene.com/gene/research/researchvision.html

mailto:[email protected]




Program

Day 1: Monday 17th September, 2012

08:30-09:00 Arrival, registration, breakfast (coffee, tea, pastries)

09:00-09:15 Welcome and conference overview

09:15-10:15 Keynote Address

Manoj Rajadhyaksha

Director, Bioanalytical Sciences, Regeneron, Tarrytown, NY

Working towards building a “Value Added Proposition” for Immunogenicity Prediction and Risk Management

10.15-11.00 Coffee and networking

11.00-11.35 Alexandra Joseph

Associate Scientific Director, Biologics at Genzyme Corp, Framingham, MA, USA

A Case Study of Immune Tolerance Induction: Controlling Anti-Drug Antibody (ADA) Responses

11.35-12.05 Bonnie Rup

Immunogenicity Sciences, Pharmacokinetics Dynamic and Metabolism at Pfizer, Andover, MA, USA

Unwanted immunogenicity risk in biotherapeutic discovery and development: advances, gaps, opportunities.

12.05-1.20 Lunch

1.20-1.55 Jeremy Fry

Director of Sales at ProImmune Ltd

Tools and technologies for comprehensive immunogenicity risk management

1.55-2.30 Bob DuBridge

Chief Scientific Officer at Full Spectrum Genetics, Inc., San Francisco, CA, USA

MapEng™ A Powerful, New Tool in the Engineering of Biobetter Therapeutics

2.30-3.00 Coffee

3.00-4.50 Breakout session: Presenting the Business Case for Immunogenicity Risk Management




Moderator: Manoj Rajadhyaksha

4.50-5.00 Summary of the day

Monday evening - informal networking reception for all attendees, with drinks and canapés at Meadhall

Day 2: Tuesday 18th September, 2012

09:00-09:35 Valerie Quarmby

Principal Scientist and Director of the Department of BioAnalytical Sciences at Genentech, San Francisco, CA, USA

9.35-10.10 Fiona Harding

Senior Principal Research Scientist, Biologics Technology at Abbott Biotherapeutics Corp, Redwood City, CA, USA

Characterizing Immune Responses to Therapeutic Antibodies.

10.10-10.50 Coffee

10.50-11.25 Sebastian Spindeldreher

Head of PK/PD Bioanalytics II, NIBR-TS-PCS, Biologics Safety & Disposition (BxSD) at Novartis Pharma AG, Basel, Switzerland

Assessing the Immunogenicity Risk for Biotherapeutics – our experience with the available tools

11.25-12.00 Eric Furfine

President of Research & Development Eleven Biotherapeutics, Cambridge, MA, USA

Preclinical Assessment of the Immunogenic Potential of EBI-005, a Novel Protein IL-1 Inhibitor for the Topical Treatment of Dry Eye Syndrome

12.00-1.20 Lunch

1.20-2.00 Nik Schwabe

CEO, ProImmune Ltd

2.00-4.00 Breakout session: Tools and Technologies Forum

(with coffee incorporated)

Moderator: Bonnie Rup

4.00-4.15 Summary and Conclusions

4.30-6.00 Drinks, nibbles and networking




Presentations, Abstracts & Introduction to the Speakers

Manoj Rajadhyaksha

Director, Bioanalytical Sciences, Regeneron, Tarrytown, NY

Keynote Address: Working towards building a “Value Added Proposition” for Immunogenicity Prediction and Risk Management The immunogenicity profile of a biotherapeutic is determined by a multiplicity of factors ranging from

product related, patient (host) related, bioanalytical to process or manufacturing related factors. This

creates a complex situation that does not allow direct correlation of such risk factors to the observed

incidence of immunogenicity. Therefore, a mechanistic understanding of how these risk factors

individually or in concert influence the overall incidence and risk of immunogenicity is crucial to

design the best benefit/risk profile for a given biotherapeutic in a given indication.

In light of the observations that this field of Predictive Immunogenicity has not progressed sufficiently

in the past few years, several forums have focused on investigating the impediments and the reasons

behind these impediments that contributed to the lack of progress. The Predictive immunogenicity

survey and the Open Forum that was conducted under the AAPS NBC banner provided insights into

some of the gaps that exist in this regard. One of the key observations was that almost all biotech

pharma scientists were familiar with the predictive tools but very few of them were actually using it.

This in fact results in very little data coming in the public domain. That cascades into an impression of

poor reliability of these tools in predicting clinical relevance of immunogenicity, culminating into very

few companies using these tools. This chain must be broken if this field has to progress.

At present prediction of immunogenicity is not requested by the regulatory agencies. The lack of such

information does not preclude a sponsor from filing and getting approvals of biotherapeutics. Most

sponsors are effectively managing the associated immunogenicity risks in clinic for their drugs, with a

variety of strategies from medications to monitoring. So then why would a sponsor spend time and

money to gather such data? We believe this disconnect is primarily due to the lack of an established

“Value Added Proposition” for the employment of predictive immunogenicity exercises in drug

development. Investments will flow in this area if the science, the collaborations and the data clearly

demonstrate how these predictive immunogenicity studies can directly influence the commercial

success or failure of a drug.

Therefore we have made an attempt to illustrate through examples the value added proposition by

collecting information from literature and various sources in the industry to highlight how predictive

immunogenicity efforts can impact the bottom line in due course of time. It is this sort of information

that needs to be disseminated to Sr. Management in the Pharma and the Biotech industry who can

provide for the funding and influence the course of this discipline leading to more case studies and

consolidation of the knowledgebase to further the science of making safe and effective drugs.




Dr. Manoj Rajadhyaksha obtained his basic training in Molecular Immunology at Roswell Park Cancer

Institute at SUNY Buffalo, NY. After his PhD graduation, he joined IMMCO Diagnostics Inc, where he

held positions of increasing responsibility. In his diagnostic career, Dr. Rajadhyaksha identified the

autoantigen for Celiac disease and established a 510K approved diagnostic test to diagnose celiac

disease. He now holds a US patent for this discovery and the diagnostic test. Dr. Rajadhyaksha later

moved to Centocor (now Janssen) where he led the effort of establishing cell based Neutralizing

antibody assay unit and also directed bioanalysis for preclinical immunogenicity and biomarkers. Dr.

Rajadhyaksha then moved to Pfizer where as an Associate Research fellow he was leading the PDM

efforts in Pfizer Neuroscience Therapeutic Area on multiple projects. He also led a group that was

responsible for the development of preclinical & discovery phase bioanalytical assays for PK,

biomarker and Immunogencity for all biologic products in the Neuroscience, Oncology, and

Cardiovascular Therapeutic areas product pipeline. At present, Dr. Manoj Rajadhyaksha directs the

Bioanalytical Science Department at Regeneron Pharmaceuticals Inc, overseeing various aspects of

preclinical, clinical, PK, biomarker, and immunogenicity assays. Overall Dr. Rajadhyaksha has total of

three patents, two SBIR grants, more than thirty 510K approved commercial diagnostic tests for

various autoimmune diagnostics disorders and several publications to his credit in various areas he

has worked in.

Bonnie Rup

Immunogenicity Sciences, Pharmacokinetics Dynamic and Metabolism at Pfizer, Andover, MA, USA

Unwanted immunogenicity risk in biotherapeutic discovery and development: advances, gaps, opportunities The biotherapeutics field continues to expand and introduce both new innovative therapies, as well

as biosimilar and improved versions of marketed biotherapeutics into the clinic. In this environment,

risk of inducing unwanted anti-therapeutic immune responses (immunogenicity) remains a concern

due to the potential to affect safe or efficacious use, or affect development costs, regulatory

pathways, or competitive position in the market. Because of the potential risks to product safety and

survivability, there is increasing pressure to develop improved methods to assess risk of unwanted

immunogenicity and its consequences in order to inform risk mitigation strategies and business

decisions. Well known factors contributing to risk for development of immunogenicity include

product-, patient or disease-, and treatment regimen-related attributes. Most likely, multiple factors

contribute simultaneously to overall risk. This presentation will overview the sources of risk and how

incorporation of new risk assessment tools could provide more accurate assessment to improve risk

mitigation.

Bonnie Rup works in the Pharmacokinetics, Dynamics and Metabolism-New Biological Entity (PDM-

NBE) organization at the Pfizer Andover Massachusetts site where she leads the PDM-NBE

Immunogenicity Discipline, which supports immunogenicity risk assessment for the R&D

portfolio. She is co-chair of the Pfizer Immunogenicity Expert Working Group and serves on Pfizer’s

Biotherapeutics Advisory Council.




Bonnie was previously Assistant Vice President of Protein Bioanalytics in Wyeth, responsible for

developing and applying immunoassays and other ligand binding methods to characterize PK and ADA

response from discovery through post-marketing and Drug Safety and Metabolism Therapeutic Area

Head for Wyeth’s Hemophilia Products. Previously she held various positions in Wyeth, Genetics

Institute and Monsanto/Searle. She received a B.S. in microbiology from the University of

Massachusetts, Amherst and a Ph.D. in the area of viral immunology from the Microbiology Dept,

University of Texas, Austin, after which she held postdoctoral positions at Duke University and the

University of Rochester, NY, studying viral and cellular immunology.

Bonnie is an active member of the American Association of Pharmaceutical Sciences (AAPS)

Immunogenicity of Therapeutic Proteins Focus Group (Co-founder, Past Chair, current Steering

Committee Member) and is a past chair of the AAPS Ligand Binding Assay Bioanalytical Focus Group,

and a member of BioSafe and European Immunogenicity Platform. With several of these

organizations, she has been a co-author for publications related to for monitoring the immunogenicity

of therapeutic proteins.

Alexandra Joseph

Associate Scientific Director, Biologics at Genzyme Corp, Framingham, MA, USA

A Case Study of Immune Tolerance Induction: Controlling Anti-Drug Antibody (ADA) Responses Many protein and peptide therapeutics have been approved for clinical use. Depending upon the

physical and biochemical properties of the therapeutic as well as administration procedures, anti-drug

antibodies (ADA) can be generated against the therapy. In many patients, ADA

has shown little apparent impact on patient outcome. There are instances, however, where the

immunogenicity of therapeutic proteins can affect drug efficacy and patient safety. At times it is

difficult to predict which protein therapies and patient populations are likely to develop significant

levels of ADA. In an effort to control immune responses to protein therapeutics in relevant patient

populations, we have focused on identifying regimens of immune tolerance induction that may be

applicable for clinical use. We have demonstrated in nonclinical studies that a low dose induction

regimen of methotrexate can induce immune tolerance to a number of therapeutics in both normal

and disease settings. We will present current data relating to our ADA-reducing regimen of

methotrexate.

Dr. Alexandra Joseph is Associate Scientific Director of Investigative Clinical Immunology within

Clinical Laboratory Sciences at Genzyme, a Sanofi company. Her current focus is in inducing immune

tolerance to therapeutic proteins. In addition, Alexandra leads the preclinical immunogenicity

mitigation group for the Therapeutic Immunogenicity Focus Group of AAPS. Prior to joining Genzyme

in 2003, she was a Cancer Research Institute Fellow in Klaus Rajewsky’s laboratory at the Immune

Mediated Disease Institute and Harvard Medical School. She received her PhD at Tufts University

Sackler School of Biomedical Sciences.




Sebastian Spindeldreher

Head of PK/PD Bioanalytics II, NIBR-TS-PCS, Biologics Safety & Disposition (BxSD) at Novartis Pharma AG, Basel, Switzerland

Assessing the Immunogenicity Risk for Biotherapeutics – our experience with the available

tools

Multiple in silico tools as well as in vitro and in vivo assays have been utilized during the past few

years to predict the immunogenicity to biotherapeutics in patients. Still, the predictive value of these

tools is debatable and more data is required in the public domain to better correlate the results from

in silico, in vitro and in vivo methods with the clinical outcome. Finally, improvement and

standardization of the already available methods as well as development of additional tools may be

required to achieve improved and consistent predictivity. This presentation will focus on some of the

available tools, how we use them during drug development and the experiences we made with them

so far. Further, a short insight into the activities focusing on the evaluation of available and

development of news prediction tools of the European Innovative Medicines Initiative project ABIRISK

(Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the

risk) will be provided.

Sebastian Spindeldreher has a Diploma / Master in Biology from the University of Heidelberg,

Germany, and a PhD in Immunology, specializing in antigen presentation, from the Basel Institute for

Immunology and the Roche Center for Medical Genomics, Switzerland. In 2005, Sebastian started at F.

Hofmann-La Roche as a postdoctoral fellow and latterly worked as a lab head in the field of

immunosafety. Sebastian joined Novartis Pharma in 2008 as Fellow in Translational Sciences and

Safety and was responsible for elaborating a strategy and setting up the relevant technologies to

assess and minimize the risk for immunogenicity of biotherapeutics. Since beginning of 2010,

Sebastian took over additional responsibility as a Head of PK/PD Bioanalytics, being responsible for a

group of lab heads and scientists working on bioanalysis of biotherapeutics. This involves

development and validation of assays for pharmacokinetic, pharmacodynamic and immunogenicity as

well as analysis of pre-clinical and clinical samples in a GLP environment.




Jeremy Fry

Director of Sales, ProImmune Ltd

Tools and technologies for comprehensive immunogenicity risk management

Developers of biologics recognize the need to understand the potential implications of

immunogenicity of their drug candidates. Of all the bioanalytical challenges faced in drug design and

development, immunogenicity is probably the most important, but also one of the most complex and

difficult issues to address. There are many tools and technologies available to manage

immunogenicity risk at a preclinical stage - but which should you choose? This talk will cover a range

of tools and technologies for immunogenicity risk management including antigen presentation assays

to directly measure in vivo peptide antigen characterization using Mass Spectrometry, Dendritic cell -

T cell assays to measure responses to fully formulated biologics, physical HLA-peptide Binding Assays,

naive T cell Proliferation Assays to measure responses to individual epitopes

Jeremy's DPhil. was carried out at the University of Oxford, developing gene therapy strategies to

induce immunological tolerance in transplant recipients. Jeremy joined ProImmune to generate a new

class of MHC multimer staining reagents. For the past 10 years as ProImmune's Director of Sales, he

has led the sales team in a growing business, focusing on technologies that radically improve our

understanding of immune responses.

Bob DuBridge

Chief Scientific Officer at Full Spectrum Genetics, Inc., San Francisco, CA, USA

MapEng™ A Powerful, New Tool in the Engineering of Biobetter Therapeutics Genetic analysis of point mutations is a valuable tool in elucidating protein structure/function

relationships. We have designed and implemented a new analytical platform based on efficient gene

synthesis and high throughput DNA sequencing to generate and analyze in parallel the effects of

many hundreds of point mutations on protein binding. Our MapEng™ protein analysis platform

guides the design of biobetter molecules with a variety of improvements, including enhanced affinity,

reduced immunogenicity, modified cross reactivity and pH sensitivity. We have used this system to

assess the effects on affinity of all possible point mutations in and around heavy chain CDR3 of

Avastin. Up, down and neutral mutations with respect to binding were discovered or confirmed




published results. These results demonstrate the utility of MapEng™ for creating biobetter

therapeutics.

Dr. DuBridge received his B.A. in Biology from the University of California at San Diego in 1981 and his

Ph.D. in Genetics from Stanford University in 1987. After completing his postdoctoral studies at

Genentech in 1989, Dr. DuBridge was one of the founding scientists of Cell Genesys, Inc. where he

was responsible for setting up systems to create genetic knockouts in primary human cells. He later

became the Director of the Massively Parallel Signature Sequencing (MPSS) project at Lynx

Therapeutics and his group was responsible for setting up the first next generation sequencing

platform. From 1999 to 2010 Dr. DuBridge led the New Technologies and Antibody Engineering

groups at Eos and then PDL Biopharma. During this time his group humanized numerous therapeutic

antibodies and developed a new antibody engineering platform called PxP.

In 2010 Dr. DuBridge founded Full Spectrum Genetics to develop a novel, high throughput mutation

profiling system to create detailed structural maps of protein binding sites. These maps can be used

to rationally design biobetter therapeutics through the optimization of a variety of biophysical

characteristics including: increased affinity, decreased immunogenicity, improved stability and

solubility and optimized cross-reactivity.

Valerie Quarmby Principal Scientist and Director at Genentech, San Francisco, CA, USA

While at Genentech, Dr Quarmby has provided bioanalytical methods and strategies to enable IND,

BLA, sBLA, NDA and CTD filings for: Nutropin AQ, Nutropin Depot, Xolair, Raptiva, Rituxan, Avastin,

and Lucentis. She has also played a key role in developing many of the bioanalytical methods and

strategies for therapeutic proteins that are currently in the Genentech/gRED drug development

pipeline.

Dr Quarmby currently chairs an internal group that establishes bioanalytical strategies for all protein

therapeutics in the gRED drug development pipeline, and also consults with project teams within

gRED and across the Roche group as a subject matter expert. She is an active member of AAPS, and

she is currently Chair-Elect of the AAPS Therapeutic Protein Immunogenicity Focus Group. She is also

the co-author of several AAPS sponsored industry guidance documents along with numerous

technical publications in peer-reviewed journals.

Dr Quarmby holds a B.Sc. from the University of London, England and a Ph.D. in Hormone Physiology

from the Imperial Cancer Research Fund and the University of London. Dr Quarmby was an NIH

Visiting Postdoctoral Fellow, then joined the Laboratories for Reproductive Biology and the

Department of Pediatric Endocrinology at the University of North Carolina in Chapel Hill. Prior to

joining Genentech, Dr Quarmby worked in the field of clinical diagnostics at Bio-Rad Laboratories and

at Endocrine Sciences/Esoterix.




Fiona Harding

Senior Principal Research Scientist, Biologics Technology at Abbott Biotherapeutics Corp, Redwood City, CA, USA

Characterizing Immune Responses to Therapeutic Antibodies. Humanized and fully human antibodies are largely non-immunogenic when administered to patients.

However, in some cases the development of neutralizing anti-drug antibodies can occur. The

presence of anti-drug antibodies can impact safety and efficacy. I will discuss the development of

immunological responses to what should be very tolerogenic proteins, and will provide insights into

engineering immunologically risk-reduced antibody therapeutics.

Fiona A. Harding received her Ph.D. in Microbiology and Immunology from the University of

Rochester, Rochester, New York. Her thesis detailed the immunoglobulin genomic organization in the

little skate, Raja erinacea, and T cell responses in the frog Xenopus laevis. She characterized CD28

signaling in mouse CD4+ and CD8

+ T cells as a postdoctoral fellow with Dr. James P. Allison at the

University of California, Berkeley. Fiona was supported in her postdoctoral research by an Irvington

Institute Fellowship grant. Since completing her postdoctoral studies, Fiona has worked at numerous

biotechnology companies in the San Francisco Bay Area. These include GenPharm International (now

Medarex), Genencor International (DuPont) and Protein Design Labs (now Abbott Biotherapeutics).

She is currently a Senior Principal Research Scientist at Abbott Biotherapeutics, where she has been

able to combine her two favorite scientific topics: immunoglobulin structure and function, and

cellular immunology.

Eric Furfine

President of Research & Development at Eleven Biotherapeutics,

MA, USA

Preclinical Assessment of the Immunogenic Potential of EBI-005, a Novel Protein IL-1

Inhibitor for the Topical Treatment of Dry Eye Syndrome

With more than 20 years of experience in drug research and development, Eric Furfine has been

involved in advancing numerous products into clinical development across multiple therapeutic areas.

Prior to joining Eleven Biotherapeutics, Dr. Furfine was Senior Vice President of Research and

Preclinical Development at Adnexus, a Bristol-Myers Squibb R&D Company. In this role, he directed

and led all activities in the discovery, preclinical development and much of clinical pharmacology of

Adnectins, which are novel targeted protein therapeutic agents. Previously, he was Vice President of




Preclinical Development at Regeneron Pharmaceuticals, responsible for all aspects of preclinical

development and a significant portion of clinical pharmacology. Dr. Furfine also spent more than a

decade in senior level research positions at GlaxoSmithKline, where he was program leader and co-

inventor of LEXIVA® (fosamprenavir calcium). Dr. Furfine conducted his postdoctoral research at

University of California, San Francisco and holds a Ph.D. in Biochemistry from Brandeis University.

Nikolai Schwabe

CEO, ProImmune Ltd

Nik Schwabe founded ProImmune Ltd in 2000 with Dr Linda Tan. Prior to founding ProImmune, Nik

was responsible for Business Development and Intellectual Property at Bookham Technology plc, a

fibre-optic components maker based in Abingdon, Oxon. Before joining Bookham he worked as a

financial analyst at Salomon Brothers International in London, advising clients on financial portfolio

strategies. Nik holds a D.Phil. in Theoretical Physics from Oxford University

Continuing the discussion Following our 2011 Mastering Immunogenicity meeting, we set up a LinkedIn group, to share information and foster debate on immunogenicity risk management. We hope it provides a useful forum for continuing the discussions initiated at this meeting.

http://www.linkedin.com/groups/Mastering-Immunogenicity-4197467/about






The British Consulate-General, Boston, Massachusetts British Consulate-General, One Broadway, Cambridge, Massachusetts 02142, USA Telephone: +1 (617) 245 4500 http://ukinusa.fco.gov.uk/en/about-us/other-locations/boston/ The city of Boston is an international center of higher education and a center for medicine and biotechnology, and consequently is a fitting location for ProImmune's first 'Mastering Immunogenicity' conference.

As you join the lively and productive discussions during the two days of our event, we trust you will also find time to enjoy the sights and atmosphere of one of the oldest cities in the United States. Boston is as close to the Old World as the New World gets, an American city that proudly trades on its colonial past, having served a crucial role in the country's development from a few wayward pilgrims right through to the Revolutionary War. No other city in America gives a better feel for the events and people behind the nation's birth, all played out in Boston's wealth of emblematic and evocative colonial-era sights. Equally alluring are the city's attractive public spaces, and the diversity of its neighborhoods – student hives, ethnic enclaves, and stately districts of preserved townhouses.

Biotechnology/Life Sciences Discoveries are made every day in the labs of Cambridge's biotechnology corporations, which make up nearly one-third of Massachusetts's biomedical companies. Cambridge has established itself as the epicentre of the world's biotechnology industry, currently hosting over seventy biotech companies which employ more than 10,000 people, including leading-edge companies such as Amgen, Biogen IDEC, Vertex, Genzyme, Shire, Pfizer, Momenta Pharmaceuticals and the prestigious Whitehead Institute. The cluster of biotechnology companies in Cambridge, specifically in the Kendall Square area, has earned it the nickname "Genetown."

New England Weather http://weather.weatherbug.com/MA/Cambridge-weather.html?zcode=z6286&zip=02142 For further information about visiting Boston and the surrounding area browse the official tourism website for Boston. www.cityofboston.gov

http://ukinusa.fco.gov.uk/en/about-us/other-locations/boston/

http://weather.weatherbug.com/MA/Cambridge-weather.html?zcode=z6286&zip=02142

http://www.cityofboston.gov/




Accommodation

Delegates are responsible for arranging their own accommodation. The following are suggested options for accommodation in the vicinity of the British Consulate-General, One Broadway, Cambridge Massachusetts 02142, USA Royal Sonesta Hotel (within easy walking distance of the venue), 4 Stars http://sonesta.com/corporate 40 Edwin H. Land Blvd. Cambridge MA 02141 617-806-4200 $236.00 plus tax/Night, $27.00 for parking w/ in and out access Marlowe, a Kimpton Hotel, 4 Stars www.hotelmarlowe.com 25 Edwin H Land Blvd Cambridge MA 02141 617-868-8000 $319.00 plus tax/Night, $20.00 for parking w/ in and out access Best Western Hotel Tria, 4 Stars http://hoteltria.com 220 Alewife Brook Pkwy Cambridge MA 02138 617-491-8000 $162.00 plus tax/Night, $12.00 for parking a night w/in and out access Hyatt Regency Cambridge (near to the venue), 3.5 Stars http://cambridge.hyatt.com/hyatt/hotels 575 Memorial Dr. Cambridge MA 02139 617-492-1234 $254.00 plus tax/Night, $35.00 for parking a night w/in and out access Courtyard by Marriot Boston-Cambridge (near to the venue), 3 Stars www.marriott.com/hotels/travel/boscy-courtyard-boston-cambridge/ 777 Memorial Dr. Cambridge MA 02139 617-492-7777 $249.00 plus tax/Night, $28.00 for parking a night w/in and out access Holiday Inn, Boston-Somerville http://www.holidayinn.com/hotels/us/en/somerville/bossv/hoteldetail 30 Washington Street Somerville MA 02143 617-628-1000 From $181.99 plus tax/Night

http://sonesta.com/corporate

http://www.hotelmarlowe.com/

http://hoteltria.com/

http://cambridge.hyatt.com/hyatt/hotels

http://www.marriott.com/hotels/travel/boscy-courtyard-boston-cambridge/

http://www.holidayinn.com/hotels/us/en/somerville/bossv/hoteldetail




Travel to the British Consulate-General, Boston British Consulate-General, One Broadway, Cambridge, Massachusetts 02142, USA Full details of how to get to the venue, and a map, are at the following link: http://ukinusa.fco.gov.uk/en/about-us/other-locations/boston/contact-details/directions-parking Directions by Road From the West: • Take Mass. Pike East • Exit 18 to Cambridge (the exit is on the left) • After paying the $1.00 toll, the road splits, bear right off the ramp • Turn right at Massachusetts Avenue • Turn left onto Vassar Street, road becomes Galileo Galilei Way • Turn right at Broadway, then make a left at 3rd Street to access the building’s parking garage

From the South: • Take 93 North. • Take the Storrow Drive exit • **Follow ramp, it will split, stay to the right, and you will go under a short tunnel • Get into the left lane and go UP the first ramp on the left • At the end of the ramp, turn right and go over the Longfellow Bridge • Continue on Main Street • Bear right to stay on Broadway, make an immediate right turn on 3rd street to access the building’s parking garage

From the North: • Take 93 South • Take the Storrow Drive exit • **Follow directions as coming from South

From Logan Airport: • Follow signs to Summer Tunnel • Go through tunnel and stay to the left • Take the Storrow Drive exit **Follow directions as coming from the South

Daytime parking Parking is available for visitors at the following rates. The garage is accessible via the 3rd Street side of the building. Monday through Friday Enter 6:00am – 4:00pm 0-15 minutes Free 1 hour or less $5 2 hours or less $10 3 hours or less $13 Over 3-10 hours $15 Over 10-24 hours $18 Evening parking Enter after 4:00pm to close $5* (any exit after 10:00pm incurs a fee of $18)

http://ukinusa.fco.gov.uk/en/about-us/other-locations/boston/contact-details/directions-parking

http://ukinusa.fco.gov.uk/en/about-us/other-locations/boston/contact-details/directions-parking




By Rail Red Line: the venue is located conveniently on the Kendall Square Stop. The Red line is the primary subway line serving Cambridge. Stops within the city include, from west to east, Alewife, Davis (in Somerville), Porter, Harvard, Central and Kendall/MIT. Trains run regularly throughout the day, starting at approximately 5:15 a.m. weekdays and Saturdays, 6 a.m. on Sundays, and at intervals of ten to 14 minutes (except during rush hour, when trains run every seven or eight minutes), until approximately 12:15 a.m. the following morning. The current fare on the Red Line is $1.70 with a Charlie Card or $2 with a Charlie Ticket. From the MBTA (Massachusetts Bay Transit Authority) (leaving Park Street): • Take the Red Line heading toward Alewife • Get off at Kendall Square • Walk down Main Street towards the city of Boston • Cross over Broadway; the Consulate is located in the tall beige building with a Dunkin’ Donuts in the lobby




Registration for 2nd Mastering Immunogenicity Fax the two pages of the registration form to: USA & Canada: +1 775 206 4635 All other countries: +44 870 712 0588 COMPLETE IN BLOCK CAPITALS

Salutation (Dr, Prof, Mrs, Mr etc.)

First Name

Last Name

Organization

Department

Address Line 1

Address Line 2

Address Line 3

City

State

Zip

Country

Work Phone

Cell / Mobile Phone

Work Fax

Email

Payment (see terms and conditions of registration):

Payment is by credit card and will be charged within a few working days of receipt of the registration form. Payments from organizations in the UK and from certain states in the USA must supply a tax exemption certificate if available.

Early Bird delegate fee, register by July 31: $475, £285, €320

Full delegate fee, register on or after August 1: $595, £360, €400

Credit card type

(Visa, Master card, AmEx)

Credit card number

Credit card expiry date

Credit card CVC

Name on card

Invoice address,

(if different from above)

Special Requirements

Please indicate any special requirements you need.




Terms and conditions of booking for the ProImmune Mastering Immunogenicity conference, 17-18 September 2012. Registration: Places at the event are limited and will be allocated on a first-come, first-served basis.

Confirmation: Confirmation of receipt of your registration form will be by email to the address given in the form within 5 working days of receipt of your form. The email will confirm if your registration was successful and the amount that will be charged to your credit card. Badges will not be mailed before the event. Bring your confirmation to the registration counter on arrival on day 1.

Fee: The conference fee includes all sessions over the two days, lunch, refreshments, evening drinks reception and any conference documentation. For some organizations in the UK and in some states in the USA, sales tax or UK VAT may be applicable; an exemption certificate must be supplied if relevant. USA states where sales tax is applied: IL, IN, ME, MD, VA.

Early Bird delegate fee, register by July 31: $475, £285, €320

Full delegate fee, register on or after August 1: $595, £360, €400

Payment: Payment for the event is by credit card. Your card will be charged in full within a few working days of receipt of registration form. You will be mailed an invoice to the address you supplied in the registration form.

Cancellation: If you wish to cancel your attendance at the event before August 1st your payment will be refunded, less an administration charge of 25%. If cancellation is after 1st August the payment will not be refunded. Should you be unable to attend, a substitute delegate is welcome to take your place at no extra charge. ProImmune will make available summit documents to a delegate who is unable to attend and has paid.

Cancellation by ProImmune: In the unfortunate event that the event is cancelled, ProImmune will refund your registration fee in full. In the event of cancellation, ProImmune is not liable for any other costs incurred by delegates in connection with their attendance, including, but not limited to transport and accommodation costs.

Changes to the program: It may be necessary for reasons beyond the control of the organizer to alter the content and timing of the program, or the identity of the speakers. ProImmune reserves the right to alter the program without notice including the substitution of speakers and / or topics. ProImmune is not responsible for any loss or damage as a result of such a substitution or alteration to the event. IMPORTANT: ALL DELEGATES ARE REQUIRED TO BRING PHOTO-IDENTIFICATION IN ORDER TO ENTER THE BRITISH CONSULATE-GENERAL. We recommend you bring your photo-drivers licence or your passport.

ProImmune Ltd. Standard terms and conditions of sale apply.

www.proimmune.com/ecommerce/page.php?page=terms

I agree to the terms and conditions of booking for the ProImmune Mastering Immunogenicity conference.

Signature

Date

V1.10 Last revision 5th September 2012

http://www.proimmune.com/ecommerce/page.php?page=terms

Documents

Mastering Immunogenicity Conference - … · 2nd Mastering Immunogenicity September 17-18, 2012 ... · The Magdalen Centre · Oxford Science Park · Oxford OX4 4GA · UK · T. +44