where thought leaders meet! meet and network with over 40 speakers including · 2012-12-04 ·...

www.proteins-forum.com

Where thought leaders meet!

Strategic direction

More speakers and the full Bioleaders agenda inside!

Meet and network with over 40 speakers including:

Dr Richard Murray, Senior Vice President Biologics & Vaccines Research & Development, Merck Research Laboratories

Dr Neil Weir, Senior Vice President Research, UCB

Dr Herren Wu, Vice President R&D, Head of BioSuperiors & Head of Antibody Discovery & Protein Engineering, MedImmune LLC

Leopold Bertea, PhD, Vice President Governance & Bio-Business, Sanofi Global Biotherapeutics

Reed V. Tuckson, MD, FACP, Executive Vice President & Chief of Medical Affairs, UnitedHealth Group

Dr William Strohl, Vice President, Biologics Research, Janssen Research & Development LLC, Pharmaceutical Companies of Johnson & Johnson

F. Owen Fields, PhD, Vice President, Regulatory Strategy, Worldwide R&D, Pfi zer

Stefan Wildt, Vice President, Head of Integrated Biologics Profi ling, Novartis Institutes for BioMedical Research

Ursula Redeker, PhD, Head Technical Development Biologics Europe, F.Hoffmann La Roche

James W. Bryson, PhD, Executive Director, Protein Science & Structure, Bristol-Myers Squibb

For more information, or to book your place please visit www.proteins-forum.com, call us on: +44 (0)20 7384 8046, or email [email protected]

Platinum Sponsors: Endorsed by: Academic Sponsor:

For more information or to book your place please visit www.proteins-forum.com, call us on: +44 (0)20 7384 8046, or email [email protected]

Dr Richard Murray, Senior Vice President Biologics & Vaccines Research &

Development, Merck Research Laboratories

Dr Neil Weir, Senior Vice President Research, UCB

Leopold Bertea, PhD, Vice President Governance & Bio-Business, Sanofi Global

Biotherapeutics

Dr Herren Wu, Vice President R&D, Head of BioSuperiors & Head of Antibody

Discovery & Protein Engineering, MedImmune LLC

Dr Kathleen Clouse, Director, Division of Monoclonal Antibodies, The Offi ce of

Biotechnology Products, CDER, FDA

Reed V. Tuckson, MD, FACP, Executive Vice President & Chief of Medical Affairs,

UnitedHealth Group

Dr William Strohl, Vice President, Biologics Research, Janssen Research &

Development LLC, Pharmaceutical Companies of Johnson & Johnson

F. Owen Fields, PhD, Vice President, Regulatory Strategy, Worldwide R&D, Pfi zer

Stefan Wildt, Vice President, Head of Integrated Biologics Profi ling, Novartis

Pharma AG / Novartis Institutes for Biomedical Research

Dr Uma Kuchibhotla, Chief Scientifi c Offi cer, Biotherapeutics Lead Optimization,

Eli Lilly

Dr Axel Hoos, Vice President, Oncology R&D, DPU Head, Combination Therapies,

GlaxoSmithKline

Daniel E. Schaufelberger, PhD, Scientifi c Director, CMC Leader, Pharmaceutical

Development & Manufacturing Sciences, Janssen Research & Development

LLC; Member of the J&J Pediatric Center of Excellence

Ursula Redeker, PhD, Head Technical Development Biologics Europe, F.Hoffmann

La Roche

Robert Kastelein, PhD, Associate Vice President, Biologics Strategy, Merck

Research Labs

James W. Bryson, PhD, Executive Director, Protein Science & Structure, Bristol-

Myers Squibb

JoAnn Suzich, PhD, Vice President, Infectious Disease / Vaccines Research,

MedImmune LLC

Dr Arthur Tzianabos, Vice President & Head, Research & Early Development,

Shire HGT

Dr Derek O’Hagan, Vice President & Global Head of Vaccine Delivery &

Formulation Research, Novartis Vaccines & Diagnostics

Dr Barbara Paldus, CEO, Finesse

Ravi A. Madan, MD, Assistant Clinical Investigator, Medical Oncology Branch &

Affi liates, National Cancer Institute

Reiner Laus, MD, President & Chief Executive Offi cer, BN

ImmunoTherapeutics

Carsten Olbrich, PhD, Senior Scientist Formulation Development Liquids, Bayer

Pharma AG

Dr Mark Bagarazzi, Chief Medical Offi cer, Inovio Pharmaceuticals

Dr Fred J. Cassels, Chief, Enteric & Hepatic Diseases Branch (EHDB), DMID, NIAID,

NIH

Klaus Schwamborn, PhD, Chief Development Offi cer, Pepscan Therapeutics

Dr Ronald Ellis, Senior Vice President, Research & Development & CTO, NasVax Ltd

John L. Marquardt, Jr, JD, MBA, PhD, Principal, Marquardt Law

Qin, Wang, PhD, Principal Scientist, Preclinical Pharmacokinetics & in vitro ADME,

Biogen Idec, Inc

Dr Arne Skerra, Professor, TUM & Founder, Pieris AG

Dr Jerald Sadoff, Senior Advisor, Crucell Vaccine Institute

Timothy Cooke, PhD, Chief Executive Offi cer, NovaDigm Therapeutics, Inc

Ali Fattom, PhD, Senior Vice President Vaccine Research &Development, NanoBio

Corporation

Mark Throsby, PhD, COO, Merus

Neal Fowler, CEO, Liquidia Technologies, Inc

Christopher F. Nicodemus, MD, FACP, Chairman, AIT Inc

Carlos V. Paya, MD, PhD, CEO, Immune Design

Krista Hessler Carver, Associate, Covington & Burling LLP

Dr B. Kim Lee Sim, President & Chief Scientifi c Offi cer, Protein Potential LLC

• Pipeline strategy: Is a diverse portfolio achievable? Or is big pharma locked into the antibody paradigm?

• Targets: What novel targets are the big players interested in and how do they assess biological relevance?

• Platforms: How do companies evaluate novel engineered antibodies and experimental protein therapeutic candidates?

• Reimbursement: In a rapidly changing healthcare environment what do biologics R&D leaders need to focus on?

• Collaboration: How do you facilitate large molecule combination development that is contrary to all business teaching?

• Developability: How do big pharma / big biotech resource and platform experimental technologies?

• Biosimilars: How do you approach it competitively?

• Infectious diseases: Weighing up therapeutic versus prophylactic approaches for high risk patient groups

• Oncology: Sharing understanding of the broader picture of anti-cancer agents and how to elicit an optimal immune response

• Bio-delivery and devices tool box: Optimizing routes of administration for protein therapeutics of all classes

Learn from and network with 40+ senior level decision makers in the protein therapeutics and antibody sectors including

10 key strategic information sharing opportunities that won’t be found on the agenda at any other protein therapeutics meeting

Excellent meeting bringing together stakeholders in small biotech, big pharma, regulatory agencies and the business community.

Mark Esser, Medimmune


7.30 Registration & buffet breakfast in the exhibition area

Big pharma / big biotech pipeline strategy for protein therapeutics Is a diverse portfolio achievable?Or, are companies locked into the antibody paradigm?

9.00 Chair’s introduction

9.05 Antibodies and Fc fusion proteins vs the alternatives: Biological considerations

• Antibodies and Fc fusion proteins are dominant in sales and approaches in 2013 and should remain so for next decade

• Alternative scaffolds, peptides, modifi ed toxin proteins and other approaches have signifi cant value in niche applications for which antibodies are not the best answer

• How do we decide between an antibody approach vs an alternative protein or peptide approach?


9.25 Questions & discussion

9.30 Regulatory perspective • How are development pathways evolving to respond to: o Non-classic antibodies and novel protein therapeutic formats o Novel combination products (including protein-drug conjugates) o Biobetters o Biosimilars o Companion diagnostics for novel protein therapeutics • How can regulators and industry work together to bring more effi cacious (and

safe) novel protein therapeutics to market quicker?Dr Kathleen Clouse, Director, Division of Monoclonal Antibodies, The Offi ce of Biotechnology Products, CDER, FDA


Industry Keynotes:

9.55 Protein therapeutic pipelines: a look into the future of fi rst-in-class, best-in-class, and biosimilars

Dr Richard Murray, Senior Vice President, Biologics & Vaccines Research & Development, Merck Research Laboratories

10.15 Building a competitive biologics pipeline portfolio through novel technologies

• Describing the limitation of monoclonal antibodies • Discussing the feasibility of creating biologics with novel modalities • Balancing biologics portfolio through fi rst-in-class, best-in-class and biosuperior

moleculesDr Herren Wu, Vice President R&D, Head, BioSuperiors & Head, Antibody Discovery & Protein Engineering, MedImmune LLC

10.40 Industry panel discussion• How are the big players refi lling their pipelines - how are they diversifying beyond

their existing monoclonal antibody investment?• How is the large molecule / small molecule balance evolving?• What orphan indication opportunities are being considered?• Are the next generation products follow-ons, or will they be novel protein

therapeutics? • What has recently gone through phase I /IIa - what patterns are emerging?• How can protein therapeutics continue to compete in markets that already have

very effective therapeutics?

• Novel therapeutic area focus – beyond oncology and autoimmune diseases• What “lifecycle drugs” are in pipelines?

Panellists: Leopold Bertea, PhD, Vice President Governance & Bio-Business, Sanofi Global BiotherapeuticsDr Uma Kuchibhotla, Chief Scientifi c Offi cer, Biotherapeutics Lead Optimization, Eli Lilly

11.15 Morning coffee in the exhibition area

Global economics & reimbursement in a changing healthcare environment - Sanity check for scientists


12.00 Payer perspective • Defi ning and assessing value in a time of escalating healthcare costs • What is the payers’ appetite for biosimilars and biobetters?

Reed V. Tuckson, MD, FACP, Executive Vice President & Chief, Medical Affairs, UnitedHealth Group

12.25 Panel discussion with industry • As comparative effectiveness / cost effectiveness spreads beyond NICE – how

will the affordability and pricing of protein therapeutics be affected? - European environment - North American environment • If pipelines are to be at least 25% from protein therapeutics – who will pay?• Comparing different pharma / biotech approaches to health economics• What are the emerging ‘proof points’ that innovators need to consider in terms

of health economics?• Is personalized medicine more or less cost-effective?

Panellists:

Dr Richard Murray, Senior Vice President Biologics & Vaccines Research & Development, Merck Research Laboratories


Biosimilars - how do you approach it competitively?

2.25 Chair’s introductionJohn L. Marquardt, Jr, JD, MBA, PhD, Principal, Marquardt Law

2.35 Hot topics in FDA implementation of the Biologics Price Competition and Innovation Act

• FDA’s approach to characterization and testing requirements for biosimilars• Use of foreign data to support biosimilars• The higher bar for interchangeability and implications for substitution• Intellectual property provisions of the BPCIA and their effect on life cycle

management strategiesKrista Hessler Carver, Associate, Covington & Burling LLP


Protein Therapeutics Forum 2013 Agenda

DAY 1 – Monday, January 28th 2013

1.15 Buffet lunch in the exhibition area


3.00 Regulatory considerations in global biosimilar development• Key issues in biosimilar development: o Extrapolation of indications o Naming conventions• Global reference product considerations – when can one use a non-approved

reference product in a given jurisdiction to support approval?• Interchangability – what are the standards and prospects? F. Owen Fields, PhD, Vice President, Regulatory Strategy, Worldwide R&D, Pfi zer

3.20 Panel discussion• What’s the perceived regulatory and commercial risk? Is collaboration a pre-

requisite for success?• If development takes as long as novel drugs – what’s the cost benefi t?• What does it take to show that biosimilars are equivalent to innovator product? o Is PK / PD assessment suffi cient? o Does immunogenicity have to be equivalent? How does one consider the

regulatory impact of possible immunogenicity differences? o What are your standards for comparability as regards purity or differences in

glycosylation and other post-translational modifi cations? • Cost effectiveness – what can be done in discovery so that the innovator drug

has less concern for biosimilar competition? • Pricing - what discounts will be expected on biosimilars – estimates vary from

5-50%!• Challenges of quality and licenseability of products created offshore - what’s the

role of emerging market players?

Panellists:Dr Herren Wu, Vice President, R&D, Head of BioSuperiors & Head, Antibody Discovery & Protein Engineering, MedImmune LLCDr Kathleen Clouse, Director, Division of Monoclonal Antibodies, The Offi ce of Biotechnology Products, CDER, FDADr Arne Skerra, Professor, TUM & Founder, Pieris AG

Afternoon plenaryLarge molecule collaboration models – how to facilitate combined development that is contrary to all business teaching


4.50 Keynote presentation Sanofi ’s diverse biologics pipeline and platform approach - the growing role of development collaborations

Leopold Bertea, PhD, Vice President Governance & Bio-Business, Sanofi Global Biotherapeutics

5.15 Using antibodies to induce antigen specifi c immunity: a case study in combinatorial immunotherapy of cancer

• Mobilizing cancer specifi c immunity is a proven treatment strategy• Most vaccine and antigen specifi c immunotherapies have failed in advanced clinical

trials despite good bioactivity• Homeostatic Forces of Immune regulation and Standard of Care Practices Need

to be considered in a disease specifi c manner• Oregovomab clinical development is being advanced through academic and

multi-organizational collaboration to establish a new paradigm for antigen specifi c combinatorial immunotherapy of cancer

Christopher F. Nicodemus,MD, FACP, Chairman, AIT Inc

5.35 Panel discussion• Sea change will come from combinatorial therapeutic approaches – but how can

out of the box thinking be encouraged?• The system facilitates the development of monotherapies – but the science tells

us that combinations / cocktails are critical• Inventiveness - is there a way to have set of rules for more than two partners

with proprietary components when you don’t know the fi nal formulae? • Can you have a structure where you don’t predetermine values?

• Learning from the many failures

Panellists:Dr Jerald Sadoff, Senior Advisor, Crucell Vaccine InstituteF. Owen Fields, PhD, Vice President, Regulatory Strategy, Worldwide R&D, Pfi zerCarsten Olbrich, PhD, Senior Scientist Formulation Development Liquids, Bayer Pharma AGDr Arthur Tzianabos, Vice President & Head, Research & Early Development, Shire HGT

7.30 Registration & buffet breakfast in the exhibition area

Developability toolbox – how do you resource and platform your experimental technology?• How are companies improving research to yield better clinical outcomes and reduce the rate of attrition of proteins earlier?

9.00 Chair’s introductionDr Neil Weir, Senior Vice President Research, UCB

9.05 Reducing the rate of attrition by understanding the biology and developability earlier

• Importance of understanding mechanism of effi cacy and liabilities• Understanding and reducing risk• Finding and fi xing liabilities early• Selecting well behaved protein therapeutics in discoveryJames W. Bryson, PhD, Executive Director, Protein Science & Structure, Bristol-Myers Squibb


9.35 Preclinical pharmacokinetics – pharmacodynamics aspect of protein therapeutics development

• Target mediated disposition for biologics• PK-PD modeling.• Human dose projectionQin Wang, PhD, Principal Scientist, Preclinical Pharmacokinetics & in vitro ADME, Biogen Idec, Inc


10.05 It’s not just the biology, you have to be able to develop it too – how to select the optimal therapeutic antibody candidate

• The crucial step in successful development of biologics is the selection of the right molecules early on. This selection is a multifunctional scientifi c exercise requiring a focused and integrated team operating across the R / D interface.

• Thus, thorough characterization of a variety of properties of therapeutic antibody candidates is a prerequisite for selecting the best antibody for further development into a viable drug.

Great topics and VERY well organized.Nick Marsh, Adnexus, BMS

DAY 2 – Tuesday, January 29th 2013

6.00 Close of day 1, followed by a cocktail reception in the exhibition area

4.05 Close of session, followed by afternoon tea in the exhibition area


• Integrated profi ling results in reduced development risks for molecules taken into clinical development and establishes clarity for back up programs.

• The talk will illustrate how various methods are used at Novartis to characterize physicochemical as well as ‘in vivo fi tness’ parameters in order to allow selecting the optimal candidate

Stefan Wildt, Vice President, Head of Integrated Biologics Profi ling, Novartis Pharma AG / Novartis Institutes for Biomedical Research

10.30 Panel discussionHow do companies evaluate novel engineered antibodies and experimental protein therapeutic candidates? How should small biotech respond?

• What’s their biological relevance?• What differentiation and value do they bring? o Where is the evidence they make superior drugs? o Are they solving a problem or making incremental improvement? o Is there still a place for the ultimate scaffold? o Does the value outweigh the additional development challenges?• What’s the most common reason for failure? o How to ensure a better therapeutic margin for targeted therapies• How do you drive for effi cacious biologics when using alternative monoclonals /

alternative scaffolds / multispecifi cs• Understanding why companies are pursuing novel scaffolds instead of mAbs

despite the risks

Panellists:Dr William Strohl, Vice President, Biologics Research, Janssen Research & Development LLC, Pharmaceutical Companies of Johnson & JohnsonDr Arne Skerra, Professor, TUM & Founder, Pieris AGDaniel E. Schaufelberger, PhD, Scientifi c Director, CMC Leader, Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development LLC; Member of the J&J Pediatric Center of ExcellenceLeopold Bertea, PhD, Vice President Governance & Bio-Business, Sanofi Global BiotherapeuticsDr Arthur Tzianabos, Vice President & Head, Research & Early Development, Shire HGT


11.35 Protein optimization: balancing pharmaceutical and pharmacological properties

Dr Uma Kuchibhotla, Chief Scientifi c Offi cer, Biotherapeutics Lead Optimization, Eli Lilly


12.05 Managing costs during drug development - a CMC perspective• Development of a new molecular entity is still characterized by relevant attrition

along the different development phases the majority of which is linked to lack of expected effi cacy and / or required safety

• As supply of appropriate investigative drug product is prerequisite to clinical studies, signifi cant investment in technical development and clinical manufacturing is often required prior to availability of relevant clinical data

• With increasing cost pressure in R&D the ability to manage technical R&D costs in the face of uncertainties of drug development are of increasing interest, particularly for biologics and monoclonal antibodies

• These possibilities include postponement of technical activities, selecting optimal scale for clinical manufacturing, establishment of standard platform, or technical solutions such as automation or use of single use equipment

• The talk will discuss benefi ts and risks of these measures based on various examples



12.35 Increasing single-use facility intelligence: the advent of SMART technologies

• SmartParts: auto-recognition with distributed control• SmartSystems: universal controllers, modularity and scalability• SmartFactories: resource optimisation, harmonisation and qualityDr Barbara Paldus, CEO, Finesse


What novel target types are the companies interested in? How are they going about fi nding targets that are biologically relevant?


2.20 What would a genuinely new target look like?Dr Neil Weir, Senior Vice President Research, UCB

2.45 Presentations and panel discussion• How to mine the genome to fi nd different classes of antibody and natural

proteins that are still out of reach• If you stick with antibodies how does that limit the novel target types you can

go after?• How do you measure target engagement and biological effect in inaccessible

organs like the brain?• Are intracellular targets just too diffi cult?• Novel ways to think about target discovery• Serendipity / empirical methods have created all the value so far – are we now

being overly rational in our approach to innovation?

Panellists:Robert Kastelein, PhD, Associate Vice President, Biologics Strategy, Merck Research Labs Dr Arthur Tzianabos, Vice President & Head, Research & Early Development, Shire HGTCarsten Olbrich, PhD, Senior Scientist Formulation Development Liquids, Bayer Pharma AG

Afternoon plenary

Protein therapeutic start-ups executive briefi ng• Examining cutting edge protein therapeutic approaches in research

4.55 Chair’s introductionDr Barbara Paldus, CEO, Finesse

A glimpse of the future for protein therapeutics; 5 leading early-stage biotech companies engaged in discovering innovative new protein therapeutic products will each briefl y outline their cutting edge technology, data generated to date, and ongoing R&D strategy

5.00 – 5.10 Making GPCRs accessible for antibody therapyKlaus Schwamborn, PhD, Chief Development Offi cer, Pepscan Therapeutics

Are you an early stage biotech company who would like to have a platform to discuss your products? We have room for four more showcase presentations - contact us for more information. Additional speakers will be announced online soon.

1.05 Buffet lunch in the exhibition area

5.50 Close of day 2, followed by a cocktail reception in the exhibition area

4.15 Close of session, followed by afternoon tea in the exhibition area


Very timely for my needs and provided a nice overview of the current state of affairs.

Charles Conover, Enzon Inc

DAY 3 – Wednesday, January 30th 2013

• Nosocomial/Hospital Acquired Infectious diseases• Chronic viral infectious diseases

9.00 Moderator’s introduction JoAnn Suzich, PhD, Vice President, Infectious Disease / Vaccines Research, MedImmune LLC

Nosocomial diseases

9.05 Staph aureus vs. vaccines and antibodies: the “Superbug” is winning so far

Timothy Cooke, PhD, Chief Executive Offi cer, NovaDigm Therapeutics, Inc


9.30 MRSADr Annaliesa Anderson, Senior Director Bacterial Vaccine Research, Pfi zer - pending fi nal confi rmation

9.55 DMID/EHDB public health focus: vaccine strategies for Hepatitis C and Clostridium diffi cile

Dr Fred J. Cassels, Chief, Enteric and Hepatic Diseases Branch (EHDB), DMID, NIAID, NIH

10.15 Questions for the speakers & discussion

• cancer vaccines• multispecifi c targeted therapies • immunotherapy • combination / conjugation approaches

9.00 Moderator’s introduction: Therapeutic cancer vaccines: current understanding, future strategies

Ravi A. Madan, MD, Assistant Clinical Investigator, Medical Oncology Branch & Affi liates, National Cancer InstituteSharing our understanding of the broader picture of anti-cancer agents and how to elicit an optimal immune response

9.20 Immunotherapy with recombinant poxviral vaccines

Reiner Laus, MD, President & Chief Executive Offi cer, BN ImmunoTherapeutics


9.45 Tapping the potential of DNA vaccines using electroporation – Cervical dysplasia and cancer

Dr Mark Bagarazzi, Chief Medical Offi cer, Inovio Pharmaceuticals


10.10 Immunotherapy

9.00 Moderator’s introduction Carsten Olbrich, PhD, Senior Scientist Formulation Development Liquids, Bayer Pharma AGWorking party A - Protein therapeutics

9.05 From the children’s tool box – optimizing routes of administration for pediatrics

Daniel E. Schaufelberger, PhD, Scientifi c Director, CMC Leader, Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development LLC; Member of the J&J Pediatric Center of Excellence


9.30 Oral anti-CD3 MAb immunotherapy – clinical proof of principle

Dr Ronald Ellis, Senior Vice President, Research & Development & CTO, NasVax Ltd


9.55 Injectable combination products - challenges and opportunities


10.20 Presentation and discussion Carsten Olbrich, PhD, Senior Scientist Formulation Development Liquids, Bayer Pharma AG

Chronic viral infectious diseases What are the criteria by which you determine that prevention or treatment is the optimal approach?• What novel opportunities does it open up for

monoclonal antibodies, engineered protein therapeutics and immunotherapeutics?

• How can different modalities coexist and be complementary, particularly when dealing with high risk population groups: elderly, HIV/AIDS patients, cancer patients, COPD patients

10.50 Nanoemulsion formulated RSV mucosal vaccine: An intranasal vaccine formulation that elicits robust mucosal and systemic immunity and protection with a balanced Th1/Th2 and Th17 immune response

Ali Fattom, PhD, Senior Vice President Vaccine Research & Development, NanoBio Corporation

11.15 Questions for the speakers & discussion

12.00 How to shape the role of cellular immunity in the control of chronic viral infections

Carlos V. Paya, MD, PhD, CEO, Immune Design

12.20 Panel discussion, summary, conclusions and action plan

• How can the protein therapeutics sector further its understanding of immunogenicity by working more closely with the vaccines industry?

Dr Axel Hoos, Vice President, Oncology R&D, DPU Head, Combination Therapies, GlaxoSmithKline

10.35 Panel discussion

12.00 Human bispecifi c antibodies and single cell-derived combinations of antibodies for cancer therapy

Mark Throsby, PhD, COO, Merus


12.25 Anticalins and PASylation: novel concepts for advanced cancer biotherapeutics and beyond

Dr Arne Skerra, Professor, TUM & Founder, Pieris AG


12.50 Concept to clinic in 365 days; design and production of optimized ADCs

Trevor J. Hallam, PhD, Chief Scientifi c Offi cer, Sutro Biopharma, Inc


Panellist:Christopher F. Nicodemus, MD, FACP, Chairman,AIT Inc

10.50 Needle free delivery of vaccinesDr Derek O’Hagan, Vice President & Global Head of Vaccine Delivery Research, Novartis Vaccines & Diagnostics


12.00 Developing enhanced biologics through use of PRINT particle engineering platform

Neal Fowler, CEO, Liquidia Technologies, Inc


12.25 Recombinant attenuated salmonella typhi for oral immunization against anthrax, plague, and shigellosis: an approach applicable to multiple diseases

Dr. B. Kim Lee Sim, President & Chief Scientifi c Offi cer, Protein Potential LLC


• What can vaccine and protein communities gain from each other’s tool box?

• What do we want from the next generation of delivery and device tools?

Workshop 1Capitalizing on vaccine and protein therapeutic approaches for infectious diseases and high risk patient groups

Workshop 2 Tackling oncology from all directions: big picture SWOT analysis of:

Workshop 3Bio-delivery and devices tool box – optimizing routes of administration for protein therapeutics of all classes

Working party B – Vaccines

1.30 Close of the Washington Vaccine Forum 2013

7.30 Registration & buffet breakfast in the exhibition area. Followed by a choice of 3 parallel breakout sessions: All sessions are shared with The Protein Therapeutics Forum





3 co-located sector leading meetings:

9th Cell & Gene Therapy Forum www.cgt-forum.com

From promise to products

11th Vaccine Forum www.vaccine-forum.com

Driving progress

2nd Protein Therapeutics Forum www.proteins-forum.com

Strategic direction

Strategic analysis of the competitive landscape for antibodies and other therapeutic proteins in an off patent world. Industry leaders will critique portfolio strategies, novel targets, lifecycle management, biosimilar opportunities, collaboration models and relevance of emerging platform technologies. Take home your SWOT analysis to drive differentiation, developability and reimbursement.

Firmly focused on translating unmet medical need into national and global public health benefi t. Take home the strategic playbook for innovation in vaccine design, development and delivery.

The preeminent industry led meeting place pushing the maturation of regulatory, manufacturing, R&D and commercial strategies. Delivering the information and contacts you need to drive your cell and gene therapy products forward.

Platinum and Academic Sponsor:

EMD Millipore, a division of Merck KGaA, Darmstadt, Germany, offers solutions that enable scientists to conduct life science research easily, effi ciently and economically. With a range of more than 40,000 products, EMD Millipore is one of the top three suppliers of tools to

the life science industry. We are deeply committed to providing novel cell culture systems and characterization tools for stem cell research and primary cell culture. Our highly validated, optimized products provide convenient solutions to many cell culture challenges, so you have the time to focus on your research

Platinum Sponsor:

California-based Finesse Solutions, Inc, has established a proven record in providing turnkey, scalable solutions for single-use upstream bioprocessing. The Finesse product platform includes an extensive portfolio of novel disposable sensors,

modular confi gure-to-order automation hardware, and intelligent software that can harmonize global bioprocess information and technology transfer. Finesse also offers a complete set of services including startup, commissioning, and validation for rapid and reliable deployment of single-use equipment into cGMP manufacturing applications. Visit www.fi nesse.com

Sponsors

BIOLEADERS

Who will you meet?Network with 600+ R&D, business development, bioprocessing and regulatory leaders from across the cell & gene therapy, regenerative medicine, vaccine and protein therapies sectors.

President/chairman/managing director/cxo - 18%

Seniority

Vice president/senior vice president/executive vice president - 21%

Director.executive director/parter - 30%

Manager/senior manager - 15%

Other - 16%

Job FunctionBusiness Development/corporate, partnering, licensing - 55%

R&D - 24%

Manufacturing - 15%

Reg affairs - 6%

Industry BreakdownPharma/biotech - 54%

Investors and analysts - 5%

Governments, academics, NGO’s - 14%

Supplier of products and services - 27%

Geographical BreakdownNorth America - 74%

Europe - 17%

ROW - 9%

Job FunctionCorporate Management - 22%

R&D - 33%

Manufacturing/Product Development/Operations - 10%

Regulatory Affairs/Quality - 10%

Business Development/Corporate Development/Marketing - 20%

Other/Unknown - 5%


Seniority




Other - 16%


R&D - 24%

Manufacturing - 15%

Reg affairs - 6%






Europe - 17%

ROW - 9%


R&D - 33%




Other/Unknown - 5%


Seniority




Other - 16%


R&D - 24%

Manufacturing - 15%

Reg affairs - 6%






Europe - 17%

ROW - 9%


R&D - 33%




Other/Unknown - 5%

There are a limited number of sponsorship and exhibit only options still available, any of which can be tailored to your aims.

For more information on exhibiting or sponsoring, or to view the full fl ooplan, please contact us on +44 (0)20 7384 8046 or email: [email protected]

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Booth 9 Paragon Bioservices

Booth 11 Reserved

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Booth 13 TAP Biosystems

Booth 14 Finesse, Inc

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Booth 18 Pfenex, Inc

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Booth 20 CellGenix

Booth 21 Life Technologies, Inc

Booth 22 Biotec Services International

Booth 23 Thermo Scientific

Booth 24 Lonza Walkersville, Inc

Booth 25 LABS Inc

Booth 26 Vaxnet

Booth 32 Biolife Solutions Inc


Booth 34 Protein Sciences

Booth 37 Progenitor Cell Therapy (PCT)

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Booth 11 Reserved

Booth 10 Reserved



Booth 17 Reserved


Booth 19 Reserved

Booth 20 CellGenix





Booth 25 LABS Inc

Booth 26 Vaxnet






Booth 39 Terumo BCT

Booth 40 Aptar

Booth 47 Reserved

Booth 48 Reserved

Booth 49 Reserved


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Booth

Booth Booth

Booth13


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43

40

29

35

45

46

15 16

28 26 25

1819 20

23

10Refreshment Point

Refreshment Point

Refreshment Point

11

17

47 48

14

9Booth

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21

12

30 31 32

36 34 33

39

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Booth 11 Reserved

Booth 10 Reserved



Booth 17 Reserved


Booth 19 Reserved

Booth 20 CellGenix





Booth 25 LABS Inc

Booth 26 Vaxnet






Booth 39 Terumo BCT

Booth 40 Aptar

Booth 47 Reserved

Booth 48 Reserved

Booth 49 Reserved


Booth

Booth

Booth Booth

Booth13


Booth

Booth

Booth

Booth

Booth

Booth

Booth

Booth

Booth

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Booth

Booth

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Booth

Booth

49

43

40

29

35

45

46

15 16

28 26 25

1819 20

23

10Refreshment Point

Refreshment Point

Refreshment Point

11

17

47 48

14

9Booth

Booth

Designed to maximize your exposure to senior decision makers of 1, 2 or all 3 areas, Phacilitate’s Bioleaders 2013 is the place for you to do businessin 2013. Delegates register for one event, get unlimited access to all 3 conferences and all networking takes place in the shared exhibit hall.

where thought leaders meet! meet and network with over 40 speakers including · 2012-12-04 ·...

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