Congress 2015 - TerrapinnSohye Kang, Ph.D., Senior Scientist, Product Attribute Sciences, Amgen...

Congress 2015

May 27-28, 2015Marriott San Diego Mission Valley

San Diego, CA

www.terrapinn.com/cellcultureusa

Organized byCo-located with

North America’s premier conferencefor cell culture optimization & developm

ent.

Everything Heads, PIs, Scientists and Engineers need to know to streamline upstream cell culture

processes cost-efficiently

Where global mAb, ADC and next gen technology stakeholders meet to do business

www.terrapinn.com/americasantibody

Interested in sponsoring or exhibiting?Contact Jose Aguirre at [email protected] or +1 646 619 1781

Co-located with

Where biopharma developing biosimilars gather to access the US

marketwww.terrapinn.com/biosimilarsus

A technical conference for Scientists, Principal Investigators, Managers and Engineers


Where biopharma Engineers and Scientists gather to discuss the latest

strategies in biomanufacturing, bioprocessing and automation

www.terrapinn.com/downstreamusa

Our StoryFollowing 4 years of success, the 5th Annual Cell Culture World Congress 2015 is once again growing.

From humble beginnings as a small conference that brought together the few pioneers spearheading the progress in cell culture processes it became known as the event that brought this community together. In 2015, Cell Culture World Congress is packed with great content exploring Cell Line Development, QbD, Disposability and Single-Use Technology, Process Analytical Technology and Tech Transfer. With out of

the box speakers like Ron Weiss, Professor of Biological Engineering, MIT discussing cell line development with your computer – potential applications of synthetic biology in biomanufacturing,

networking lunches and interactive roundtables, the event offers a truly inspiring environment to help the industry further their business.

Facilitating this year’s discussion will be some of the brightest and recognized names within the industry.

Jose Gomes, Principal Scientist and Manager Bioreactor Process Development at Pfizer and a major player in the Cell Culture space will be joining us to discuss how implementing PAT systems can

optimize bio-manufacturing. Sohye Kang, Ph.D., Senior Scientist, Product Attribute Sciences at Amgen will offer insight into the capabilities of statistical tools and metabolomics in Bioprocess Development,

Scale-up and Transfer. Rüdiger Heidemann, Group Leader Cell Culture Development at Bayer Healthcare will offer his expertise on pptimization of process development through utilization of

disposable bioreactors. David James, Ph.D., Professor of Bioprocess Engineering, Department of Chemical and Process Engineering at University of Sheffield will be highlighting the need to address the

“design gap” to reap the full benefits of genomic knowledge in biologics manufacturing in the post-CRISPR world.

That’s not all! Gain valuable business connections during the networking activities. Co-located with Americas Antibody Congress, World Biosimilar Congress USA and Downstream Processing World USA, we are bringing 4 complementary events together to discuss everything biopharma needs to know about

novel and innovative strategies to streamline and manage cell culture processes better.

You can choose from these conferences:

You will also be part of the wider expo, which will gather over 300 of your peers and their partners.

You should join us too. If you’re not, you’re missing out!

Americas Antibody Congress

Cell Culture World

Congress

World Biosimilar Congress

Downstream Processing

World

For more information, please contact Chris Hackett at + 1 646 619 1803 or [email protected]

Interested in sponsoring or exhibiting?Contact Jose Aguirre at [email protected] or +1 646 619 1781

The conferenceExploring all areas of upstream cell culture – through strategic keynote presentation, focused tracks, collaborative roundtable discussions and abundant 1-2- 1 partnering; Cell Culture World Congress gives you the opportunity to tailor your participation and experience to your needs.

4 co-located conferences

Keynote presentations

1-2-1 partnering

Exhibition

Networking party

2 day Cell Culture conference

1 event

Discover the latest technologies from across the BioPharma industry in our shared exhibition hall

Focus your time on what’s important to your business with two days of upstream cell culture content. Learn from true industry innovators and disruptors

Co-located with Americas Antibody

Congress, World Biosimilar Congress and Downstream Processing World- this event is truly

a unique opportunityto learn and network

across the BioPharma industry

Multiple networking opportunities give you the chance to

meet your peers

Join us in the Terrapinn Garden for

music, dancing and informal networking

Ron Weiss Professor of Biological Engineering, MITCell line development with your computer – potential applications of synthetic biology in biomanufacturingRon is a pioneer in the field of synthetic biology. He has been engaged in research since 1996, when he helped set up a wet-lab in the Electrical Engineering and Computer Science Department. The Weiss lab uses computer engineering principles of abstraction, composition, and interface specifications to program cells with sensors and actuators precisely controlled by analog and digital logic circuitry. The group has built analog circuits that perform signal processing to detect specific chemical gradients and generate pulses in response to cell-cell communication. Ron is going to be giving a ground breaking talk a the conference about how his work in synthetic biology can impact biomanufacturing, and change the face of bioproduction fo the next generation.

Jose GomesPrincipal Scientist and Manager Bioreactor Process Development, Pfizer Implementing PAT systems to optimize bio-manufacturingOne of the most influential scientists in the therapeutic antibody space, and author of over 100 scientific articles, John joined the Dana-Farber cancer institute in 1982 to work with Dr. Walter A Blattler on developing anti-cancer therapeutics based on the then-novel ADCs to kill targeted cancer cells. As one of the first scientists to work in the ADC space, John is responsible for the growth of the ADC programs both at Immunogen as well as other companies that then adopted the strategy. At the conference, he will for the first time be revealing some of the new payload classes that his group, the first group in the field, has been developing to help create the next new treatments.

Sohye Kang, Ph.D. Senior Scientist, Product Attribute Sciences, Amgen Exploring the capabilities of statistical tools and metabolomics in Bioprocess Development, Scale-up and Transfer Sohye got her start investigating oncogenic signaling pathways at The Scripps Research Institute before moving to Amgen where she now spearheads research efforts focused on identifying genetic and metabolic markers and pathways associated with biologic productivity and product quality. Towards this end, she has become proficient in applying various systems biology and omics tools to develop practical application strategies to advance cell line engineering and process optimization. Attendees to the conference will get to join her in exploring how these tools impact the development process each step of the way.

Rüdiger HeidemannGroup Leader Cell Culture Development, Bayer HealthcareOptimization of process development through utilization of disposable bioreactorsRüdiger has been at Bayer Healthcare in the Global Biologics Organization since 1997. He is responsible for all cell culture process development projects, including both perfusion and fed-batch processes. Likewise, he has responsibility for full cGMP production of biopharmaceuticals for clinical trials. His nearly twenty years’ experience has made him a resource on how disposable bioreactors impact process development, and attendees of the event will get to discover his perspective on how Bayer achieves their optimization.

David James, Ph.D. Professor of Bioprocess Engineering, Department of Chemical and Process Engineering, University of Sheffield Addressing the “design gap” - reaping the full benefits of genomic knowledge in biologics manufacturing in the post-CRISPR worldDavid is a Royal Society Wolfson Research Merit Award holder for “Research and Training in Biopharmaceutical Bioprocessing for UK Bioindustry”, as well as the Chair in Bioprocess Engineering at Sheffield University. A world-renown expert on genome editing, David poses and interesting question to the bioprocessing industry: we know how to edit, but do we know what to edit? In a first-of-its-kind keynote address, at the conference David will be exploring and tearing apart this “design gap” to help biopharmaceutical companies reap the full benefits of the new genetic technologies that have the potential to change the face of manufacturing for good.

2015 Speakers


Conference Day OneWednesday, May 27th 2015


08:00 Registration & Networking Breakfast

08:55 Chairperson’s Opening Remarks

10:30 Networking coffee break


12:00 Networking Lunch

17:30 End of conference day one & Garden Party Themed Networking Cocktail

Cell Line Development

Roundtables

QbD

Disposability and Single-Use Technology

Process Analytical Technology

Tech Transfer

09:30 Keynote: Addressing the “design gap” - reaping the full benefits of genomic knowledge in biologics manufacturing in the post-CRISPR world • We have the ability to edit cellular genomes – what do we target?• How to maximize the ability of our gene sequencing technologies to influence our manufacturing processes• How “top down” and “bottom up” approaches are looking to solve the problem

David James, Ph.D., Professor of Bioprocess Engineering, Department of Chemical and Process Engineering, University of Sheffield

09:00 Keynote: Cell line development with your computer – potential applications of synthetic biology in biomanufacturing• Construction of synthetic gene networks using modeling and statistics• Improving our understanding of naturally existing regulatory functions within cells using SynBio• New programmed cell applications in drug development and waste product reduction

Ron Weiss, PhD, Professor of Biological Engineering, MIT

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16:30 Exploring the capabilities of statistical tools and metabolomics in bioprocess development, scale-up and transfer • Intrinsic properties associated with culture performance and phenotypes• Microarray-based transcriptomics and LC-MS/MS shotgun proteomics• Expression landscape of different cell lines, including productivity, proliferation rate and cell size

Sohye Kang, Ph.D., Senior Scientist, Product Attribute Sciences, Amgen

17:10 Changing tech transfer: how U. Cincinnati’s novel approach will change the academic role • Transition from tech transfer to commercialization as a business decision• Financial advantages of converting to the commercial approach – for academia and industry• Redirecting funds to commercially viable technologies and catering to success

Dorothy Air, PhD, Associate Vice President for Entrepreneurial Affairs and Technology Commercialization, University of Cincinnati

15:50 Utilizing disposability to increase high throughput productivity • Eliminating necessity for cleaning and sterilization expediting transitions and research• Reduction of cross-contamination risks• Flexibility, cost and time savings, and the pitfalls of the approach

Gregg Nyberg, Director, Process Development, Amgen

11:30 Genome sequencing as a tool in cell line development • How understanding CHO cell genetic makeup will allow for rapid early pathway selection• Speed and cash investment advantages stemming from sequencing CHO cells before production• How genomic analysis can enable powerful editing tools to eliminate byproducts and faulty attributes

Nathan Lewis, Assistant Professor, Department of Pediatrics, University of California San Diego

14:30 QbD Panel: Speeding up regulations • How to meet the regulators and manufacturers QbD expectations• What is the impact we’re seeing of the 2011 Process Validation Guideline?• Experiences with QbD in the commercial phase

Eric Dollins, CMC Reviewer, FDA Jose Gomes, Principal Scientist and Manager Bioreactor Process Development, Pfizer

16:10 Implementing PAT systems to optimize bio-manufacturing • Employing continuous monitoring systems as an analytical tool• Benefits of PAT in a QbD approach: understanding each step of the process• Recent technological and scientific achievements in PAT: metabolomics and statistics

Jose Gomes, Principal Scientist and Manager Bioreactor Process Development, Pfizer

16:50 Applying engineering principles to minimize capital investment in the tech transfer process• Appropriate principles to apply to scale up from small scale environments• Bringing in new techniques from academia• Considerations for CMC

Bruno Figueroa, Senior Principal Scientist Bioprocess Research and Development and Culture Process, Pfizer

15:30 Optimization of process development through utilization of disposable bioreactors • Single use technologies and their importance in clinical trial development• How fed-batch processes can excel through single use technology• Perfusion techniques and disposable technologies – Not sure about that yet

Rüdiger Heidemann, Group Leader Cell Culture Development, Bayer Healthcare

11:00 Lowering cost and decreasing time investment using insect cell culture for protein expression • Unique maintenance factors for insect cell culture vs. mammalian cell culture• Regulatory and access hurdles using the insect approach• Comparing protein efficacy and production over mammalian and bacterial counterparts

Jamal Meghrous, Cell Culture Specialist, Protein Sciences Corporation

14:10 Where do current regulatory guidelines stand for improving quality while expediting process development for biologics?• Updates on key recent regulatory developments relevant to cell therapy manufacture and development• Regulatory expectations for cell therapy product characterization• Development of lot release specifications

Eric Dollins, CMC Reviewer, FDA

10:00 Speed Networking

13:30

Roundtable 1: High-throughput automation solutions in bioprocess developmentGregory Keil, Senior Scientist, Merck

Roundtable 2: Bioreactor scale up and maintaining robustnessAshley Witmer, Senior Staff Engineer, Regeneron

Roundtable 3: Development beyond CHO cells: next stepsScott Estes, Director, Cell Culture Development, Biogen Idec

Roundtable 4: Genome sequencing of CHO cells helping cell line developmentMatthew Marrichi, Senior Engineer, Biogen Idec

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Conference Day TwoThursday, May 28th 2015 Thursday, May 28th 2015



End-to-End and Continuous Bioprocessing

09:30 Keynote: How streamlining existing processes and revisiting of simple technology solutions from the bulk-chemical industry are helping solve the scale-up productivity dilemma

• Addressing increasing productivity in a field with limited economy of scale

• Overcoming inherent limits of productivity based on mass and chemistry through contract manufacturing andthe limits of the approach

• How simpler technologies may be more amenable to bioprocessing than initially believed

Albert Hentschel, Senior Engineer, Boehringer Ingelheim

09:00 Keynote: The dawn of true continuous processing in downstream manufacturing – understanding the communication and development required to bring bioprocessing into the 21st Century

• How clearing of regulatory and technical hurdles has enabled the advent of truly automated systems

• Bringing automation to GMP: getting internal buy-in and understanding

• How the synergy between vendors and pharma can evolve to meet the growing automation

Justin Pritchard, Senior Scientist, Vertex Pharmaceuticals

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11:30 The interface between upstream and downstream: bridging the gap between the cell process and protein extraction

• How increasing automation and PAT application in upstream development is allowing for greater translation todownstream processes

• Understanding the impact of variations in the cell culture process on the final product

• Building a sustainable end-to-end biomanufacturing process through upstream-downstream synergy

Jose Gomes, Principal Scientist and Manager Bioreactor Process Development, Pfizer

12:00The myth of regulatory hurdles to downstream continuous processing

• Continuous processing’s advancement in biomanufacturing and articulation of the control

• Understanding the regulatory perspective on automation and continuous processing

• The harsh realities of overzealous risk management, both in company and career

Jeff Baker, Deputy Director, Office of Biological Products (OBP), FDA

11:00Using commercial control strategy to grow continuous processing for GMP manufacturing

• Development and implementation of PAT methods for real-time-release testing

• Process understanding in support of continuous drug product processing

• Validation of chemometric models for GMP manufacturing

Eager to speak on manufacturing strategies and technologies before a large audience of the industry? Contact Jose Aguirre at +1-646-619-1781 or by email at [email protected]

17:00 Chairperson’s closing remarks

16:00Scale-up of your downstream process: optimization strategies for large scale UF and chromatography

• Recent changes that have led to an upswing in downstream automation investment

• Getting it done right: analytics as an enabling technology for continuous manufacturing

• How understanding the process will enable upstream-like continuity

Jonathan Antonizio, Senior Process Engineer, Shire

16:30New methods in purification of complex molecules, ADC and vaccines using single use technologies

• Complex molecule purification using membrane technologies

• Single-use as a device to enable enhanced purification

• Pitfalls of the single use method

Adam Goldstein, Senior Manager Technical Operations, Genentech

15:30 Afternoon Refreshments

Protein Purification and Chromatography

12:30 Networking Lunch

10:00 Morning refreshments and Speed Networking

Roundtables

14:00

Roundtable 1: Real-time analytics for downstream processing: bioreactor measurements speeding up purificationTim Stevens, Principal Scientist, BMS

Roundtable 2: Supporting clinical and commercial requirements: purification process scale-up into a GMP facilityJoseph Revello, Manager, Downstream Manufacturing, Protein Sciences Corporation

Roundtable 3: Impurity monitoring and other PAT methodologiesSyed Hasan, Senior Biotech Manufacturing Specialist, Shire

Roundtable 4: Continuous chromatography for mAbs purificationAndrew Zydney, Distinguished Professor of Chemical Engineering, Pennsylvania State University

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Conference Day Two




08:50 Terrapinn Welcome Remarks



12:00 Networking Lunch 17:35 End of conference day one & Garden Party Themed Networking Cocktail

ADCs and Immunoconjugates

Roundtables and Workshop

Antibodies and Bispecifics

Roundtables and Workshop

09:30 Keynote: Lessons from Ebola - Pandemic preparedness and antibodies against infectious diseases

• Preventing antigenic escape and mimicking polyclonal preparations using cocktail combinations

• Broadening potency and reducing cost of mAb therapies for infectious disease

• Analyzing the recent Ebola outbreak and zMapp treatment as a case study for future mAb-treated infections

Andrew Hiatt, Chief Scientific Officer, Mapp Biopharmaceuticals

11:00 Advancements in Pfizer ADC technology

• Novel linker-payload development and matching linker payload design with target biology

• Modeling as a substitute for upstream engineering, and the benefits to research

• Highlights from late stage preclinical & clinical ADCs

Puja Sapra, Senior Director, Pfizer Biotherapeutics

11:20 New innovations in ADC payloads: a new class to improve efficacy

• Previous ADC payload innovations, shortfalls and efficacy, and the path to improvement

• Varying potency through linker selection and the advantages in clinical development

• How conjugation chemistry impacts ADC design, including stoichiometry and dosing

Dr. John Lambert, EVP and Chief Scientific Officer, Immunogen

11:40Generation of stable and homogenous ADCs with reduced risk of clinical immunogenicity

• Process for generating antibodies with a reduced risk of clinic immunogenicity for use as ADC candidates.

• Site-specific conjugation to disulfide bonds of antibodies and antibody fragments using ThioBridgeTM technology in order toreduce ADC heterogeneity of these antibodies

• Using ThioBridgeTM linkers provide stable conjugates that can be used with a variety of payloads

Dr. George Badescu, Scientific Director – Conjugation and Protein Engineering, Abzena

09:00 Keynote: 3D Antibody Modeling – The importance of high quality structures in antibody drug development

• How Janssen’s two software assessments have deconstructed the advances in modeling systems

• Modeling as a substitute for upstream engineering, and the benefits to research

• Why modeling and statistics can be more powerful than in vitro testing to find unknown targets

Juan Carlos Almagro, PhD., Senior Director, CTI-Boston, Pfizer

Jeffrey Luo, Associate Scientific Director, Janssen

13:30 Roundtable 1: Increasing potency and specificity in antibody cancer drugsPuja Sapra, Senior Director, Pfizer Biotherapeutics

Roundtable 2: ADC efficacy and linker impactRobert Garbaccio, Senior Research Fellow, Merck

Roundtable 3: CMC and development considerations for mAbs and ADCsSushma Shivaswamy, Director of Research and Development, XBiotech

16:30 Roundtable 1: Immune-mediated and immune-modulatory therapies for cancerSteve Coats, Senior Director of Research and Development, MedImmune

Roundtable 2: Complex targets and the utility of antibodiesDavid Szymkowski, Senior Director Biotherapeutics, Xencor

Roundtable 3: Immunogenicity testing strategy & bioanalytical assaysSarah Hoofring, Associate Scientist, Amgen

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15:30 Multi-specific antibodies targeting several pathways for a single indication: smart engineering

• How engineering can limit off target effects when targeting a broad array of pathways

• Using metabolomics to decide on best targets within complicated pathways for your indication

• Post-translational modifications and downstream considerations

Dr. Syd Johnson, Vice President of Antibody Engineering, Macrogenics

16:00 Reducing off-target effects when modulating targets and receptors expressed in multiple cell types

• Engineering antibodies targeting one receptor on multiple cell types

• Implications of off-target effects, and discriminating your targeted pathways

• Utilizing in-vitro target data to help expedite clinical trial scrutiny

Steve Sazinsky, Senior Scientist, Jounce Therapeutics

10:00 Speed Networking

Workshop: 3D Antibody ModelingGary Gilliand, Director of Structural Biology Biologics Research Biotechnology Center of Excellence, Janssen

Jeffrey Luo, Associate Scientific Director, Janssen Research & Development

Choose to attend either the entirety of the workshop or two 40-minute roundtables

Workshop: Platform TechnologiesLuc Desnoyers, Director of Cell Biology, CytomxSushma Shivaswamy, Director of Research and Development, XBiotechDesmond Mascarenhas, Chief Executive Officer, TransporinDavid Poon, Director, External R&D and Alliances, Zymeworks

Choose to attend either the entirety of the workshop or two 30-minute roundtables



Conference Day TwoThursday, May 28th 2015



08:55 Chairperson’s opening remarks

Characterization

09:00Addressing translational questions in ADC design using mathematical modeling

• How ADC design choices impact the therapeutic index

• Antigen and tumor characteristics connected to sensitivity to ADCs

• Short-term and long-term responses to ADCs apparent using mathematical modeling

Arijit Chakravarty, Ph.D, Director of Modeling and Simulation, Takeda Pharmaceuticals

09:30How sampling and characterization of human antigens changes how we produce therapeutic antibodies

• The utility of antibody characterization in vaccine research for therapeutic mAbs

• The interface between vaccines and therapeutic antibodies helping combat infectious diseases

• Interface between vaccines and antibodies: how success can grow from synergy

Kalpit Vora, Director, Vaccine Basic Research, Merck

15:00 Afternoon networking refreshmentsRoundtables

12:30 Networking Lunch 17:00 End of Conference

11:00

Roundtable 1: Profiling drug distribution in the bodyWilliam Zamboni, Director, GLP Analytical Facility, University of North Carolina

Roundtable 2: Mathematical engineering for bispecific antibody and bispecific ADC designsArijit Chakravarty, Senior Scientist, Takeda

Roundtable 3: Immune system-recruiting bispecifics for haematological cancers and solid tumorsMichael Stecher, Medical Director, XBiotech

Roundtable 4: Interface between vaccines and antibodiesKalpit Vora, Director, Vaccine Basic Research, Merck

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Roundtables

15:30Roundtable 1: Beyond clinical data – what’s next for therapeutic antibodies?Tariq Ghayur, Senior Research Fellow, AbbVie

Roundtable 2: Glyco-engineered anti-EFRG mAbs irrespective of chemotherapyTBD, Roche

Roundtable 3: Simultaneous multi-parametric optimization of antibody v-domains for multiple speciesDan Sikkema, Executive Director, Biopharma R&D, GlaxoSmithKline

Roundtable 4: De-risking your antibody engineering and development – upstream and downstreamKatharine Bray-French, Roche Pharmaceutical Research and Early Development, Roche

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Clinical Development

14:00 Advances in therapeutic antibody assays – bridging engineering and clinical development

• Are current clinical assays functioning as necessary to acquire the most relevant data?

• Determining the correct assay for your research indication

• Breaking down common engineering phase issues and how they impact the clinical functions

Dan Sikkema, Executive Director, Biopharma R&D, GlaxoSmithKline

14:20 Clinical considerations for therapeutic antibody production

• Therapeutic antibodies from engineering to the clinic

• New data from Regeneron’s therapeutic antibody pipeline

• Clinical considerations in novel bispecifics

Pam Trail, Vice President, Oncology, Regeneron

14:40 Strategies and concepts for de-risking your therapeutic antibody molecules

• How de-risking earlier in the process can aid in clinical development

• What resources are currently available in the realm of de-risking

• Engineering principles and considerations

Katharine Bray-French, Toxicology Project Leader, Roche

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10:00 Morning refreshments







10:00 Speed Networking & Morning refreshments

12:00 Lunch

Global Regulatory Perspective

Biosimilars in the US

Roundtables

11:00 Biosimilars on the horizon: opportunities and challenges in the United States

• What are the myths and realities about biosimilars?

• How can we increase understanding of biosimilars among physicians, patients, and other key stakeholders?

• Why do biosimilars require a paradigm shift in our approach to evaluating clinical data?

Ira Jacobs, Oncology Portfolio Global Medical Lead-Biosimilars, Pfizer

11:20 Institutional experiences in preclinical evaluation of biosimilars in Mexico

• What has Mexico learned from regulation and development of biosimilars thus far?

• What are the similarities and differences between the Mexican and the United States market?

• What challenges do research centers and public institutions face to collaborate effectively and meet the demands of thepharma industry?

Francisco Kuribreña, Director of New Development, Landsteiner Scientific

15:00 Networking Coffee Break


17:30 End of conference and Garden Themed Reception

Global Regulatory Perspective

Modeling & Efficacy

16:30 Complex Biological Models in Biosimilar Development

• Determining risk of anaphylaxis, autoimmunity, and anti-drug antibodies

• Assessing impact of subtle recognized differences in quality attributes extrapolated over time, and across aheterogeneous population

• Exploring the utility of models in the science of comparison in the context of difficult challenges in biosimilar development

Jan Hillson, Senior Director of Clinical Research Development, Momenta Pharmaceuticals

11:40 How will the entry of biosimilars into the US market change the global industry?

• What will be the impact of the price of non-innovator drugs in the US on the global market?

• Arguments for and against pricing of biosimilars – understanding the validity

• What are the opportunities and challenges in the biosimilars market to date

Yariv Hefez, Vice President, Business Development and Alliance Management, Biosimilars, Merck

09:00 Keynote: Approaching the approval of the first biosimilar in the United States

• What has been the regulatory experience of Sandoz in other markets?

• How should the industry prepare?

• Peculiarities of submitting the first IND application for biosimilar approval

Mark McCamish, Head of Global Biopharmaceutical Development, Sandoz

09:30 Keynote: Pure-play biosimilars and the challenges of building brand without an infrastructure

• How pure-play biosimilars are changing the market and changing with ittics

• Advantages of pure-play in the competitive landscape

• Branding, regulatory, and access hurdles

Dr. Sarfaraz Niazi, Chief Executive Officer, Therapeutic Proteins International

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15:30 Complying with regulations for successful approval of biosimilars in India

• What can the US learn from biosimilar approval in India?

• What are some peculiarities of the regulatory pathway in India?

• How is biosimilars uptake in the market encouraged?

Nitesh Dave, Chief Scientific Manager – Research and Development, BioCon

16:00 Brazil’s paradigm in biosimilar development and regulation

• How does ANVISA collaborate with the industry?

• How can collaboration between industry, government, and investors grow the pharma industry?

• What are the advantages of partnering up with your competitor?

Andrew J. G. Simpson, Scientific Director, Orygen

13:30 Roundtable 1: Recruiting patients for biosimilar clinical trialsCristina-Dana Calciu, Medical Director, Pfizer Canada

Roundtable 2: Commercialization of biosimilars through physician and consumer education programsShanaya Deboo, Director, Commercial Development, Pfizer Inc.

Roundtable 3: Regulatory and IP considerations when bringing a biosimilar to a new marketYariv Hefez, Vice President, Business Development and Alliance Management, Biosimilars, Merck

Roundtable 4: Evolving comparability for biosimilars Dr. Daniel Galbraith, Chief Scientific Officer, BioOutsource

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08:00 Breakfast and registration

08:55 Chairperson’s opening remarks

10:00 Morning refreshments

Commercialization

R&D

09:20 Importance of implementing rigorous clinical studies to prove biocomparability

• What are the current challenges to prove biosimilarity?

• Does biosimilarity prove biocomparability?

• How can strong data from clinical studies fast track approval process?

Malcolm Mitchell, Senior Medical Fellow, Eli Lilly

09:40 The scientific perspective: Is biocomparability equal to biosimilarity by default?

• What does biocomparability mean in chemical terms?

• How can PK and PD studies be used to understand biosimilarity?

• Using biological effects to define bounds in efficacy and toxicity

Marleby Garcia, Director of Biotechnology, PiSA Farmaceutica

10:30 Understanding the physician and patient perspective on biosimilars

• What would a physician take into consideration when prescribing a biosimilar?

• How can physicians be educated about biosimilar development?

• How can their safety concerns be addressed effectively? Who should do this?

Harry Gewanter, Chairman, Alliance for Safe Biologic Medicines

11:00 Interchangeability – clinical and patient considerations

• How can interchangeability improve the acceptance of biocomparables?

• What can we learn from the way pharmacovigilance is conducted in other countries?

• Educating physicians about pharmacovigilance in the United States

Jaap Venema, Therapeutic Area Lead Biotherapeutics, Global Medical Affairs, AbbVie

12:30 Lunch

15:30 Afternoon refreshments

17:05 End of conference


Intellectual Property

09:00 Designing meaningful biosimilar development programs: structure, function, and the science of biosimilarity

• What is the importance of having an internal regulation committee for new molecules?

• How can your staff stay on top of new product developments?

• Insights on interchangeability given in clinical trials

Vladimir Hanes, Medical Director – Oncology/Biosimilars, Amgen

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Reimbursement

11:30 The impact of biosimilars on private reimbursement strategies

• Interchangeable vs substitutable – investigating the terminology

• Including biosimilars in payer formulary structure and the tools currently in place for managing therapies

• The positioning question: before or after the innovator product?

Doug Monroe, Project Manager, Biotechnology, Emerging Technology, and Specialty Pharmacy, Kaiser Permanente



Roundtables

Reimbursement

12:00 Perspectives on public reimbursement for biosimilars in the US

• Categorizing biosimilars: taking the payer’s perspective

• How will biosimilars affect the reimbursement industry in the United States: pricing and access viewpoints

• Response of the global payer marketplace to changes in the U.S.

Jeff Myers, President and CEO, Medicaid Health Plans of America

16:00 Legal strategies behind biosimilars

• Detailing the 351(I) regulatory path

• Inter Partes Review (IPR)

• Process development approaches

Patrick Lucy, Chief Business Officer, Pfenex

16:30 How does biosimilar naming affect acceptance and uptake of these drugs?

• Under what circumstances should biosimilars be labelled with the same INN as the innovator drug?

• How will patients learn about biosimilars availability in the United States?

• What can be done to encourage uptake of safe biosimilars?

Lauren Ingram, Senior Manager, Worldwide Regulatory Strategy, Pfizer Inc.

14:00 Roundtable 1: International biosimilar experienceAndrew J. G. Simpson, Scientific Director, Orygen

Roundtable 2: Encouraging biosimilar uptake Patrick Lucy, Chief Business Officer, Pfenex

Roundtable 3: Exploring US Biosimilar entryJim Roach, SVP pf Development and CMO, Momenta Pharmaceuticals

Roundtable 4: Next generation of biosimilars: looking aheadMichael Fleming, Senior Vice President, Commercial Strategy, Coherus

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The Exhibition

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Our packages offer high value including

• The chance to show over 300biopharma what you are doing tohelp speed biologics/biosimilardevelopment

• The opportunity for you to inviteyour customers and prospects

• A 1-2-1 partnering service, wherewe set up meetings for you

• The opportunity to raise yourcredibility and establish thoughtleadership

Why exhibit?

• Debut new products

• Demonstrate existing andcomplicated processes

• Provide a meeting branded placefor clients at the event

• Keeping your brand front of mind

• Brand and marketing exposure

• Raise credibility

• Generate leads and make sales

Who you will meet?

BIOPHARMA/PHARMA

• Upstream/Cell Culture Managers, Investigators, Scientists and Engineers

• Biomanufacturing and Bioprocessing Heads, Managers, Scientists and Engineers

• Biosimilar/Generic Biopharma CEOs, CSOs and Heads of Business Development, Corporate Strategy, R&D

• Vaccine and antibody biopharma/pharma Heads, Directors, Managers and Scientists

Pursue and partner

• 200+ of partnering meetings in 2days

• 300 + attendees

• 5+ hours of assisted networkingduring 40-minute coffee breaksand 1 ½ hour lunch breaks

• Over 8 intimate roundtable,focus-group discussions toparticipate in

• 1-2-1 Speed Networkingsessions

• An end of day one Garden-themed Cocktail Party!

Who should sponsor and exhibit?

• Platform technology

• Consumables

• CMO

• Analytical technology

• CRO

• Laboratory services

• Equipment manufacturers

• Biopharma/biotech

• Consultants

Break out your finest frocks and join us at the

beautiful Terrapinn terrace for a lawn party you won’t

forget.

The Terrapinn Garden Party

The freshest cocktails,

Swingiest tunes, And competitive

games …will keep you

mingling long after the day’s program

is done.

We recognize the importance of networking and offers an experience which allows you to do just that. In addition, to being given the printed onsite agenda and brochure, delegates will have the opportunity to join speed networking, dedicated Networking Managers for sponsors, peer-to-peer partnering and of course our Terrapinn Garden Party! To really take advantage of your time at the event you can also use the bespoke Total BioPharma mobile app.

YOUR NETWORKING MANAGER

As a sponsor, you can also take advantage of our dedicated and personalized meeting service. Hold meetings with pre-qualified partners in the Sponsor Networking Zone arranged by your Networking Manager on your behalf.

It’s a Networking Event

Keep all your messages, appointments and favorites at your fingertips and continue networking whilst you’re there. You can still use the networking tool within the app for a full year after the event so you can follow up with anybody you’ve missed months down the line.

The link to our networking app will be made available from our website closer to the event.

Download our networking app to get organised and get in touch with all attendees before the event

USE THE TOTAL BIOPHARMA PORTAL TO

• Plan your sessions• Build a personalised agenda• Identify exhibitors to visit• Set up onsite meetings with key

executives• Network with other attendees

DOWNLOAD OUR NETWORKING APP


Discover the power of gene sequencing as a tool in cell line development and maximizing the manufacturing process by enabling understanding of cell backgrounds from Dr. David James and Nathan Lewis.

1

Hear from Ron Weiss at MIT in a historic keynote about how synthetic biology can revolutionize biotherapeutic development.2

8 Join in on the conversation about easing the transition between upstream and downstream with the Manager of Bioreactor Process Development of Pfizer.

9 Our Garden-themed Cocktail event will be a great place for you to network with key stakeholders, like the FDA, Pfizer, Amgen, Sanofi, Bayer and more.

10 Enjoy our full suite of networking tools and opportunities, including 1-2-1 networking and a personal networking manager to help you get introduced to who you want to meet.

7 See how Dan Sikkema at GSK is advancing in therapeutic assays for antibody development.

6 Find out how upstream cell culture development is changing for biosimilar production from Amgen, Eli Lilly, and others industry leaders.

5 Explore the capabilities of statistical tools and metabolomics as process analytical technology in bioprocess development from industry titans like Pfizer.

4Understand in-depth how Bayer Healthcare and Amgen utilize disposability and single-use technology to optimize process development and high throughput productivity.

3Learn for the first time why The University of Cincinnati is changing up tech transfer, leading the way in academic efforts to expedite the process of bringing novel technologies and new treatments from scale-up to the clinic.

Reasons to Attend10


Reserve your spot today

The earlier you book the more you’ll save.

For the latest price see


Don’t forget to enter special code BD2015 to

claim the Early Bird discount.

BOOK NOWRegister at www.terrapinn.com/americas-antibody or call + 1 212 379 6320

BRING YOUR TEAMWith one day packed full of great content and networking opportunities, you can’t possibly cover it all alone!

Bring your team and get an extra discount. Call +1 212 379 6320

PACKAGE

2 dayconference

Before March 6, 2015

$2,000SAVE $500

Before April 17, 2015

$2,250SAVE $250

Before May 18, 2015

$2,365SAVE $135

Final Price

$2,500

DELEGATE BOOKING


2015 Event Partners

Sponsors

Exhibitors

Media Partners


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Congress 2015 - TerrapinnSohye Kang, Ph.D., Senior Scientist, Product Attribute Sciences, Amgen...

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