Antibody Therapeutics Xchange East Coast 2019

Target Selection

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote

Balancing Principles and Pragmatism in Antibody Discovery

Marc Damelin, Executive Director, Head of Biology Mersana Therapeutics

9:05am – 10:05am

Single agent vs. combinations; antibody or other platform (fragments, bispecific, etc)

When is the right time to use bispecific technology?
Can predictions be made on targets which are most amenable to bispecific technology?
Cases in which a single agent combination would be optimal?
Would certain targets benefit from more innovative biologic combinations?

Angela Norton

Senior Director, Head of Protein Engineering & Expression
Takeda

Angela began her career working on lysosomal storage disorders at Transkaryotic Therapies which was purchased by Shire in 2005. At Shire, Angela held leadership positions spanning all technical fields involved in designing and testing protein therapeutic development candidates. In 2014 Angela became Head of Protein and Antibody Engineering at Shire, where her team is responsible for delivering comprehensive data packages for optimized protein and antibody therapeutics for a diverse pipeline of rare diseases. Takeda purchased Shire in January 2019. Angela received her bachelors degree from St. Olaf College, and a PhD in Biochemistry and Molecular Biology from the University of New Hampshire.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Implementing discovery strategies to value the therapeutic potential of lead antibody candidates

Optimal discovery method versus available budget – how do we decide the best path?
Animal immunizations, natural human antibody repertoire library selection, or synthetic library selection – what are the pros and cons?
What is the best strategy for choosing the lead candidate selection criteria and at what point should a functional study be integrated – early or later?
What are the ideal immunization and selection tools? If appropriate cell lines and/or recombinant proteins are not available?

Debbie Kruijsen

Head of Contract Research
ImmunoPrecise Antibodies

Debby Kruijsen obtained a PhD in immunology at the University of Utrecht, The Netherlands in 2011, studying the role of antibodies in affecting antigen presentation and subsequent Respiratory Syncytial Virus specific T cell activation. In 2012, Debby joined ModiQuest Research, an ImmunoPrecise Antibodies, Ltd. company, as a scientist supervising hybridoma antibody discovery projects. She was promoted in 2013 to Head of Contract Research for ModiQuest Research were she is responsible for the daily management within the CRO and is a member of the business development group.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

Prioritisation: so many targets, so little time

How does disease indication impact target selection?
What weight do you give to various target identification strategies (e.g. functional screening, gene or protein expression data, pathway analysis, clinical data, etc) for prioritizing targets?
When is it okay to be a follow-on compound?

Matthew Robinson

Vice President R&D
Immunome

Matthew Robinson is VP, Research & Development for Immunome. Immunome is a biotechnology company with a growing pipeline of cancer immunotherapies fueled by the human immune system. Prior to joining Immunome he was on the faculty at Fox Chase Cancer Center and led a research laboratory developing antibody-based molecules for the detection and treatment of cancer. Matthew co-founded RAbD Biotech, a company focused on the computational design of antibodies and served on the Scientific Advisory Boards of a number of antibody-focused biotechnology companies. He earned a Ph.D. from University of Rochester and performed post-doctoral work at Yale University.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session: Novel and unique platform for discovery of human lead antibody molecules utilizing OmniMouse – ImmunoPrecise Antibodies

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

4:15pm – 5:15pm

Off limits or fair game? Antibody drug discovery for complex targets

How has our increased understanding of disease biology, mechanism of action, and molecular players increased our ability to develop biotherapeutics involving targets that were previously thought as undruggable?
What has changed in the antibody technology landscape that has forced drug discovery scientists to think differently about when to use a biologic against a given target?
Are targets in the brain the final frontier, and how will we get there?
Multi-specific conditional targeting half-life extended drug-conjugated biologics? Are we trying to be too clever in our engineering efforts to access difficult drug targets?

Blaine Stine

Senior Director, Discovery Biologics
Abbvie

Blaine Stine has over 18 years of research and leadership experience in the biopharmaceutical industry with broad experience in protein biochemistry, protein analytics, CMC, and biologics discovery. He currently leads a team of 40 scientists in Worcester MA responsible for antibody discovery, engineering, production and screening supporting all AbbVie therapeutic areas. Prior to his current role as Senior Director in Global Biologics R&D, Blaine has held strategic positions at AbbVie including Principle Research Scientist Protein Analytics, and Associate Director Biologics CMC.

Blaine attended the University of California San Diego (B.A. Molecular Biology) and Northwestern University (Ph.D. in Biochemistry).

5:15pm – 5:45pm

Closing Keynote & Address

Therapeutic antibodies: line of sight

Partha Chowdhury, Senior Director & Head, Antibody Discovery, Sanofi-Genzyme

5:45pm

Canape/Drinks Reception

Antibody Optimization

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote

Balancing Principles and Pragmatism in Antibody Discovery

Marc Damelin, Executive Director, Head of Biology Mersana Therapeutics

9:05am – 10:05am

Antibody developability – from inherent sequence to phenotypic effects

How and why is developability related to successful transition of antibodies from bench to bedside
What are the current models, criteria for developability analysis and mitigation?
What tools are used to evaluate developability properties of biologics? Is there a hierarchy of tools?
Can something equivalent to Lipinski’s rule of 5 for small molecules be formulated for antibodies?
How does in silico analysis and machine learning help developability studies?

Partha Chowdhury

Senior Director & Head, Antibody Discovery
Sanofi

Partha Chowdhury is a Senior Director of Biologics Research in Sanofi and Head of the Antibody Discovery group in the US hub. He has been involved with different aspects of therapeutic antibody discovery, engineering, technology development including bi-specific design and translation of molecules into the clinic for more than 20 years. Focusing on a variety of platforms, Partha and his group have addressed and published on some of the key problems of antibody drug development technologies and in engineering them for greater translational success. Prior to Sanofi, Partha had held various positions within MedImmune, Human Genome Sciences and The NIH.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

How to define requisite affinity for antibody therapeutics?

Mechanism of action (MOA) drives affinity decisions – how do you determine this? What if MOA is not clear?
Select appropriate epitope then affinity-mature to gain maximal efficacy? How/when is epitope selected?
How do you balance affinity v avidity? What assays do you do to inform this decision?

Noah Ditto

Senior Applications Scientist
Carterra

Noah T. Ditto, MS, MBA is a Senior Applications Scientist at Carterra. Prior to joining Carterra in 2014, Noah supported Drug Discovery and Early Clinical Development for nearly a decade at Bristol-Myers Squibb in Princeton, NJ with a focus on biophysical characterization of protein and peptide-based biomarkers, drug targets, and therapeutics. Noah earned his MS from The Pennsylvania State University developing chromatography-based fractionation techniques to isolate relevant serum biomarkers in Dengue infection and more recently has completed his MBA at West Chester University concentrating on Business Analytics.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

Antibody optimization: is higher affinity always best?

Cases in which higher affinity is NOT best: artifact or reality?
When are in vitro assays adequate for determining the optimal antibody, and when are in vivo studies needed?
When and how can PK/PD modeling accurately predict the optimal antibody affinity?
Is antibody optimization derailed by faulty preclinical models?

Marc Damelin

Executive Director, Head of Biology
Mersana Therapeutics

Marc Damelin is Executive Director and Head of Biology at Mersana Therapeutics, where is he focused on ADC discovery and development for oncology. Prior, he spent 10 years at Pfizer, where he led ADC project teams, oversaw the ADC portfolio and mentored two postdoctoral fellows. He is the Editor of “Innovations for Next-Generation ADCs,” a volume to be published by Springer in 2018. Marc received his Ph.D. in Biophysics from Harvard University and was a Postdoctoral Fellow of the Damon Runyon Cancer Research Foundation at Columbia University.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session: Accelerating the discovery of therapeutic antibodies using high throughput SPR – Carterra

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

4:15pm – 5:15pm

How to address introduction of polyreactivity/non-specificity, how to screen for it, how to deselect for it?

What type of assay data may give you the earliest signs of polyreactivity/non-specificity?

Hydrophobicity, charge/pI, cell lysate binding, cell binding, FcRn binding, other?

Do you use non-specific binding assays to rank order or to eliminate therapeutic candidates?
How can you distinguish specific off-target binding from non-specific binding?
Do you have procedures to avoid introduction of non-specific binding during antibody
generation / engineering?

Trudi Veldman

Executive Director, Biologics
Abbvie

Trudi Veldman Ph.D. is Executive Director Biologics at AbbVie in Worcester, MA heading up a group of 40+ scientists responsible for production of therapeutic antibodies and protein reagents in support of biologics drug discovery across all therapeutic areas of AbbVie, including immunology, oncology, and neuroscience. Prior to 2003, Trudi spent 20 years at Wyeth (formerly Genetics Institute) in Cambridge, MA where she was the Director of the Antibody Technology Group. She received her Ph. D. in Biochemistry from the Free University in Amsterdam, The Netherlands, and received her post-doctoral training at the Imperial Cancer Research Fund in London and at Genetics Institute in Cambridge, MA.

5:15pm – 5:45pm

Closing Keynote & Address

Therapeutic antibodies: line of sight

Partha Chowdhury, Senior Director & Head, Antibody Discovery, Sanofi-Genzyme

5:45pm

Canape/Drinks Reception

Alternative Formats

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote

Balancing Principles and Pragmatism in Antibody Discovery

Marc Damelin, Executive Director, Head of Biology Mersana Therapeutics

9:05am – 10:05am

Improving binding affinity of Fc regions to optimise therapeutic activity

Role of Fc gamma receptors in immunomodulation mediated by antibody-based therapeutics
Engineering strategies to modulate Fc gamma receptor binding of antibody-based therapeutics
Preclinical models to test contribution of Fc gamma receptors to efficacy of cancer therapies

Madan Katragadda

Head Antibody Discovery
Elstar Therapeutics

Madan Katragadda heads Antibody Discovery group at Elstar Therapeutics. He has over 15 years of experience developing biologics encompassing a wide variety of modalities including peptides, Fc fusions, monoclonal antibodies and derivatives, Antibody drug conjugates, bi and multi-specifics. His most advanced asset is an anti-complement peptide called compstatin that is being tested in Phase II for auto-immune diseases. Prior to joining Elstar, Madan led antibody engineering team developing multi-specific modalities for a range of indications spanning autoimmune diseases, Oncology and rare diseases at Pfizer. In addition, he also led several antibody-based projects to preclinical phase where he successfully integrated end-to-end development mindset and methodologies.

Madan earned his Ph.D. in biochemistry from University of Connecticut, Storrs and later pursued postdoctoral training at the University of Pennsylvania.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Antibody Optimization topic: Unwanted Immunogenicity: A multifaceted approach to minimize it early on

Why immunogenicity can be assessed early on?
What are the strengths and weaknesses of the different approaches?
When is it considered acceptable or unacceptable?
How are the regulatory bodies interpreting the data?

Amin Osmani

Business Development Manager
ImmunXperts

Amin holds a Bachelor of Science degree in Biology from McGill University, a Graduate Diploma in Biotechnology & Genomics, and a Master of Science degree in Cell & Molecular Biology both from Concordia University.

Early in his career, Amin worked on the cell cycle genetics of the fungal pathogen Candida albicans, characterizing the role a protein plays in modulating response to the environment. His passion for entrepreneurship led him to a business development role in the personalized medicine field before joining the contract research industry to help bring safe and effective medical innovations to patients.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

Use of single domain antibody to build bispecifics and multifunctional therapeutics

How to quickly generate diverse sdAb binders
How to build bispecific Ab and multifunctional therapeutics from sdAb binders
Bioassay development and animal model selection

Zhinan Xia

Founder & President
Abimmune Bio

Zhinan Xia received his Ph.D. degree in Biochemistry and Molecular Biology from the University of Kentucky and got his postdoc training at Harvard Medical School in molecular immunology/oncology. He is the first scientist expressed active form of human granzyme B. Dr. Xia was Staff Scientist/Instructor at Dana-Farber Cancer Institute for 4 years, and moved to biopharma industry, as a principal scientist first at Wyeth then Pfizer, focusing on antibody discovery and human coagulation factor bioengineering. He has played a critical role in the development of orphan drug Kanuma (FDA designated breakthrough therapy and product approval in 2015) when he worked at Synageva as the Director of Protein Engineering. He authored more 35 peer-reviewed articles, 10 US and international patents, and two-chapter books. He held multiple guest professor appointments with several prestigious universities in Nanjing and Shanghai.

Zhinan is currently the founder and CEO of AbImmune Biotherapeutics (A new startup in Kendall sq Cambridge) after a multi-year tenure as the Head of Biotherapeutics of Moderna. His new venture will be at the forefront of fighting cancer by immobilizing the human immune system through novel target discovery and new biology enabling bispecific antibody design and engineering.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session (Antibody Optimization topic) – Case Study: Early immunogenicity assays for candidate selection & optimization – ImmunXperts

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

4:15pm – 5:15pm

Using multispecific antibodies to fine-tune T cell function in immuno-oncology

Should multispecific antibodies target several antigens on the cancer cell for increased specificity of T cell redirection?
Or should multispecific antibodies target various antigens on the T cell to reduce inhibition and/or increase activation of T cells?
Or should we use multi specificity for more selective redirection of T cells instead of all CD3+ cells?
Are these decisions cancer-specific?

Eugene Zhukovsky

Chief Scientific Officer
Biomunex

Eugene Zhukovsky has over two decades of experience in the biotherapeutics R&D. He applies optimized monospecific and novel bispecific antibody platforms to the development of immunotherapeutics for cancer, with a particular focus on leveraging the biology of immune checkpoint modulators. He is the CSO of Biomunex Pharmaceuticals, and also a Manager and Partner at ZM Scientific, a consultancy firm that advises other biotechnology companies.

Previously, Eugene served as the CSO of Affimed. Prior to that he was a Senior Research Fellow in the Biotherapeutics Department at Boehringer Ingelheim Pharmaceuticals, Inc., and an Associate Director at Xencor, Inc. He performed a postdoctoral fellowship at Genentech, Inc. and received a PhD in biochemistry from Brandeis University.

5:15pm – 5:45pm

Closing Keynote & Address

Therapeutic antibodies: line of sight

Partha Chowdhury, Senior Director & Head, Antibody Discovery, Sanofi-Genzyme

5:45pm

Canape/Drinks Reception

Targeted Immunotherapies

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote

Balancing Principles and Pragmatism in Antibody Discovery

Marc Damelin, Executive Director, Head of Biology Mersana Therapeutics

9:05am – 10:05am

Monoclonal antibodies in cancer immunotherapy

Structural /functional characteristics of checkpoint inhibitors: are correlations to clinical safety/efficacy understood?
What are some of the recent trends in target selection and mechanism of action?
How are biomarkers being used in targeted immunotherapies?
How are monoclonal antibody therapies being used in combination with other therapeutic modalities?

Yune Kunes

Vice President, Analytical Development
TG Therapeutics

Yune Kunes is Vice President, Analytical Development at TG Therapeutics, a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. She is responsible for strategy and execution of analytical development, enabling clinical drug supply and commercialization. She is also responsible for Bioanalysis and PK/PD and ADA data, enabling non-clinical and clinical development. Previously, as Sr. Director, Director, AD, and PhD scientist at Fortress Biotech, Shire, AbbVie, and Taketa, she played significant roles in moving candidates through clinical development and into approval. Yune has devoted her career to bringing treatment options to patients in the most timely and cost-efficient manner by leveraging scientific insights on mechanisms of action, and team knowledge of technological and regulatory approaches.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Next generation of targeted immunotherapies: beyond CTLA-4 and PD-1

Targeting T cell exhaustion
Targeting the tumour microenvironment
Bispecifics vs. combination therapies
Balancing efficacy and safety

Agapitos Patakas

Associate Director, Translational Immunology
Antibody Analytics

Agapitos joined Antibody Analytics in 2018 from a biotechnology company where, as Head of Product Development, he led discovery and development of cellular therapies for cancer treatment. As an author of more than 10 publications within the field of DC-T cell interactions and autoimmunity and was integral in securing patents within CAR-T therapeutics. Prior to this, he completed his PhD at University of Glasgow focusing on Th17 biology in rheumatoid Arthritis. He continued his scientific career in Glasgow University from 2010 to 2015 investigating DC-T cell interactions.

Within his current role at Antibody Analytics, Agapitos is responsible for establishing new methods and capabilities with our newly established Translational Immunology business unit. He works with customers and internal operations to keep Antibody Analytics are the fore of method development for immuno-oncology, cell therapy and autoimmunity divisions of the biopharmaceutical industry.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

Use of cytokines fused to antibody fragments allows lower dosage while increasing therapeutic effect for targeted cancers

What is recent progress of immunocytokines in clinical studies?
What are the major challenges of immunocytokines?
Can the antibody moiety achieve the goal of tumor targeting with a fully active cytokine component?
What are the emerging strategies to avoid over-activation of the pathway and consequently systemic toxicity?
What are the approaches to address potential stoichiometric imbalance between antibody and cytokine components?

Lingyun Rui

Senior Director, Head of Protein Sciences
Cugene

Lingyun Rui received her Ph.D. degree (Protein Engineering) in 2005 from the University of Connecticut.

Thereafter she worked as a postdoctoral fellow in Brandies University, where she expanded her research knowledge to structural biology until joining ImmunoGen in 2006. During her 10-year tenue at ImmunoGen, she progressed to be the Head of Antibody Engineering, and was responsible for antibody lead humanization & optimization, production and developability assessment of various projects. After joining Cugene in 2016, she initiated multiple projects for both immuno-oncology and autoimmune indications, and played instrumental role in leading project progression.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session: A biologically relevant model to study T cell exhaustion in vitro – Antibody Analytics

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

4:15pm – 5:15pm

Antibody Optimization topic: Impact of next generation sequencing on antibody discovery and optimization

What is the advantage of using NGS for antibody discovery?
Therapeutic antibody in NGS repositories
The functional repertoire of rabbit antibodies and antibody discovery via NGS

Li Hui

Senior Principal Scientist
ABclonal

Li Hui has a decade of experience in leading antibody discovery and development projects that target key signaling pathways in cancer cell biology, metabolism, immunology and neurodegenerative diseases. Currently she leads efforts to optimize rabbit monoclonal antibody discovery technology at ABclonal for large scale and efficient development of both customized and catalog monoclonal antibody products.

5:15pm – 5:45pm

Closing Keynote & Address

Therapeutic antibodies: line of sight

Partha Chowdhury, Senior Director & Head, Antibody Discovery, Sanofi-Genzyme

5:45pm

Canape/Drinks Reception

Cell Line Development

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote

Balancing Principles and Pragmatism in Antibody Discovery

Marc Damelin, Executive Director, Head of Biology Mersana Therapeutics

9:05am – 10:05am

Strategies for achieving high expression levels in bispecifics

What are the major challenges and bottlenecks in BisAb cell line development? How do you overcome them?
What titers are achievable for BisAb? Are higher titers often counterbalanced by lower PQ? Are low titers format driven?
What assays give you the most confidence for the identification of the clones with the best titers and PQ? What is the right stage to engage extended panel of protein analytics?
What are some current approaches to address potential stoichiometric imbalance between chains in BisAb CLD?
What are the best tools that you have in your tools box to develop robust and high quality BisAb CL? Codon optimization, vector elements; promoter strength, selection markers, new cell lines, gene editing?

Asya Grinberg

Head of Biologics
Dragonfly Therapeutics

Asya Grinberg is the Head of Biologics at Dragonfly Therapeutics, where she is leading a team developing multispecific therapeutics engaging innate immune system to fight cancer. Her expertise covers the fields of protein engineering, antibody discovery, cell line development, protein production and analytics. Prior to her current role Asya has held leadership positions at Acceleron Pharma. Her efforts were instrumental to the discovery and development of five clinical candidates including Luspatercept (currently in Phase III). Asya is the key inventor of the IntelliTrap™ drug discovery platform of selective therapeutic candidates targeting the TGF-β superfamily.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Antibody Optimization topic: Choosing the right platform for developability optimization

How to optimize antibody sequence without introducing unnatural mutations?
How to thoroughly explore natural antibody sequence space around your lead?
Humanizing and optimizing your lead at the same time – pitfalls?
How do you exclude potential developability dipeptide motifs from your library?

Aaron Sato

Chief Scientific Officer
Twist Bioscience

Aaron is Chief Scientific Officer of the Biopharma Vertical at Twist Bioscience. Prior to Twist, he served as Chief Scientific Officer of LakePharma, leading the California Antibody Center, which discovers novel antibody therapeutics for its clients. He also oversaw all discovery research functions both as Vice President of Protein Sciences at Surrozen, and previously, as Vice President of Research at Sutro Biopharma, Inc. He also held director level positions at both Oncomed and Dyax Corp.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

Generating stable and high-performing manufacturing cell lines in a short time with high productivity levels

What are the key acceleration-enabling components of manufacturing cell line platforms?
Decision making: internal development vs. outsourcing?
Foreseeing the potential risks involved in CLD – how to mitigate them?
The demand for high productivity: weighing the importance of clone number, medium and process optimization
Material production for early / preclinical development from stable pool vs RCB: what are the challenges, how to balance the risk and benefit?

Faneng Sun

Senior Director, Cell Line & Upstream Process Development
QLB Biotherapeutics

Faneng obtained his Ph.D at Iowa State University in 2007. He currently serves as a Sr. Director (Cell Line & Upstream Process Development) at QLB Biotherapeutics, where he has built internal CLD capacity, and successfully developed multiple RCB/process for BsAb and mAb. He also oversees internal antibody production (flasks to bioreactors) to support early discovery and pre-clinical development. During his prior employment at LakePharma (a CRO company), Faneng established GS-/- CHO CLD platform, oversaw all clients’ CLD projects, and successfully delivered large number of RCB with the targets spanning mAb, BsAb, IgM, and Fc fusions etc.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session (Antibody Optimization topic): Twist antibody optimization platform: Creating higher affinity antibody variants that follow the natural repertoire – Twist Bioscience

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

4:15pm – 5:15pm

How to verify single cell origin of the final cell line

What do the regulatory agencies expect for manufacturing cell lines, and do those expectations match the science?
What has your experience with the FDA been regarding the clonality of cell lines used for manufacturing your antibodies and other biologics?
Can you have both speed-to-clinic and a commercially-viable manufacturing cell line without changing you cell line/bank during clinical development?
What strategies do you currently utilize for single-cell cloning and to verify clonality?
What are the advantages/disadvantages of the currently available technologies for assuring single-cell origin?

Joel Goldstein

Senior Director, R&D
Celldex Therapeutics

Joel Goldstein received his PhD in molecular biology from the University of Medicine and Dentistry of New Jersey (UMDNJ) in 1991. He then did his postdoctoral work at Bristol-Myers Squibb (BMS) on antibody fusion proteins prior to joining Medarex in 1994. His role at Medarex was initially to develop bispecific antibodies and fusion proteins, which then evolved into developing antibody production platforms for manufacture. Joel moved back to BMS in 2009 where he continued to lead a team developing manufacturing cell lines for the company’s biologics programs. He then joined Celldex Therapeutics in 2014 to help manage R&D efforts, including establishing antibody engineering and bispecific antibody design strategies for the company’s pipeline.

5:15pm – 5:45pm

Closing Keynote & Address

Therapeutic antibodies: line of sight

Partha Chowdhury, Senior Director & Head, Antibody Discovery, Sanofi-Genzyme

5:45pm

Canape/Drinks Reception

Antibody Therapeutics Xchange East Coast 2019

Target Selection

Antibody Optimization

Alternative Formats

Targeted Immunotherapies

Cell Line Development

Partners

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