2019 AGENDA

 
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San Diego, 3 - 5 March 2019

Schedule

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Mar 409:15
Conference pass

Navigating new terrains in clinical research

Clinical Trials Keynote Plenary
  • Personalisation of research
  • Embracing the digital revolution
  • Research in non-healthcare settings
Mar 409:15
Conference pass

Reserved for sponsor

Immunotherapy Keynote Plenary
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 409:30
Conference pass

Does origin of antibody matter in clinical success?

Keynotes
  • Analysis of ab origin and success in clinic
  • Why origin of ab matters
  • Biophysical attributes related to clinical success of mabs
Mar 409:35
Conference pass

Keynote panel discussion: the future of immunotherapy- what are the advances that need to be made?

Immunotherapy Keynote Plenary
Moderator: Mark Poznansky, Director, Vaccine And Immunotherapy Center, Massachusetts General Hospital
Matthew Hewitt, Director, Tumour Immunology, Bellicum Pharmaceuticals
Mar 409:35
Conference pass

Reserved for platinum sponsor

Clinical Trials Keynote Plenary
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 409:35
Conference pass

International stakeholders panel discussion: What does it take to get biosimilars moving in a country?

Biosimilars - Plenary
    sting of industry panellists, physicians, pharmacists, patient advocacy groups, payers, regulators and health authorities, the 360° Perspective Panel allows the whole industry to come together to discuss and debate the sector’s most pertinent topics of the day.
  • With no guarantee that physicians will prescribe biosimilars interchangeably with reference products, what more does the industry need to do to encourage biosimilar uptake within healthcare?
  • What can we learn from gainsharing practices? Carrot & stick models, which works better?
  • How influential are payers in the speed in which biosimilars are taken up in healthcare systems?
  • How does the industry envisage overcoming the challenge that patient communities are generally unaware of this new, yet important, category of medicines
Mar 409:50
Conference pass

Advancements in antibody drug conjugates: therapeutic challenges of safety and efficacy

Keynotes
  • Next generation ADCs with improved antibodies, payload, linkers, conjugation technology
  • Lessons learned from the clinical development of ADCs
  • Maximizing efficacy while minimizing toxicities
  • ADC disposition, PK-PD challenges
  • Translational challenges to ADC development
  • Looking at the future of ADCs
Mar 409:55
Conference pass

Keynote panel discussion: addressing the key challenges of biologics clinical trials

Clinical Trials Keynote Plenary
Rhonda Pisk, Stanford University School of Medicine
Mar 410:10
Conference pass

Reserved for platinum sponsor

Keynotes
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 411:30
Conference pass

Plenary roundtable session

Keynotes
12 senior level tables hosted by thought leaders on key challenges and opportunities in antibody drug discovery and development. Participants are invited to join the group discussions on a topic of importance to them. The round table session will have two rotations, each lasting 30 minutes.
Table 10: Reserved for supporting partner
Table 11: Reserved for supporting partner
Table 12: Reserved for supporting partner
Table 2: Recent advances in bispecific/multispecific antibodies and their clinical applications
Table 3: Strategies for generating antibodies to challenging targets
Table 4: Clinical assay development for ADCs
Leo Kirkovsky, Director, Pfizer
Table 5: ADCs in an immuno-oncology world - What is the opportunity?
Table 9: Bispecific development
Sheng Yin, Senior Director, I-Mab Biopharma
Mar 411:30
Conference pass

Roundtable discussion session

Biosimilars - Plenary
6 senior level tables hosted by thought leaders on key challenges and opportunities in biosimilar development, manufacturing and market access. Participants are invited to join the group discussions on a topic of importance to them. The round table session will have two rotations, each lasting 30 minutes.
ROUNDTABLE 1 Legal and IP challenges If you are interested in moderating this discussion, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
ROUNDTABLE 2 Dealing with competition in the biosimilar industry
ROUNDTABLE 3 Optimizing Biosimilars´ Studies from a ClinOps Perspective
Bernd Liedert, Senior director biosimilars, Boehringer Ingelheim Pharma Co Gmbh
ROUNDTABLE 4 Market access
Margaret Dolan, Associate Director Market Access EU Biosimilars, Biogen
ROUNDTABLE 5 Agency expectations – Coping with increased quality expectations
Dinesh Kundu, CEO & Co-Founder, QbD Biosciences
ROUNDTABLE 6 Global reference product in biosimilar development
Mareike Ostertag, Director Regulatory and Science Policy, Novartis Pharma AG
Mar 412:30
Conference pass

Speed networking

Keynotes
A fun, exciting and effective way to make a lot of initial connections (in a very different environment from the standard business networking meetings).
Mar 414:20
Conference pass

Developing Antibody-Directed Nanotherapeutics (ADNs): A novel strategy for arming antibodies

Antibodies - Armed Antibodies
  • Approach to engineering ADNs
  • An improved therapeutic window with ADNs
  • Diagnostic strategies for developing ADNs
Mar 414:20
Conference pass

Revolutionizing antibody cancer therapy- Conditionally Active Biologics (CABs)

Antibodies - mAbs and novel modalities
  • Increasing the therapeutic window for biologics for greater efficacy and safety
  • Expanding the number of druggable targets by shifting selectivity from the target to the drug
  • Discovering, engineering and evolving antibodies for their untapped selective and reversible activation in disease microenvironments, while minimizing the risk of immunogenicity
  • Enabling and advancing combination immuno-oncology therapies for more effective therapies
Mar 414:20
Conference pass

Silac-based proteomics screen to select potential ADC targets

Antibodies - Bispecifics
  • Rapid constitutive lysosomal internalization of Prolactin Receptor (PRLR) is the mechanism behind PRLR ADC efficacy.
  • By bridging PRLR, or another high turnover protein, Amyloid Precursor-like Protein 2 (APLP2), with surface tumor target HER2 using bispecific antibodies, HER2 lysosomal degradation can be triggered, and HER2 ADC efficacy can be significantly improved.
  • Our study opens up a possibility to exploit high turnover proteins such as PRLR and APLP2 in combination with bispecific antibodies to enhance efficacy of ADCs
Mar 414:20
Conference pass

Biosimilars: extending sustainability, driving innovation and improving patient care

Biosimilars - Commercialisation
  • Current barriers and opportunities in the US
  • Biosimilars in Non-US vs US
  • Shaping a healthcare environment
Houng Kim, head of the strategy and operations division, Celltrion Healthcare
Mar 414:20
Conference pass

Navigating the development journey - from choosing the right cell line to entering commercialization

Biosimilars - Development and Manufacturing
  • From cell line to commercialization – understanding the questions of which molecules, which markets, how and when
  • Analysing product development - cell lines vs cell lines with process; in-house vs outsourced or combination; case studies/examples from the biosimilar world
  • Increasing quality expectations from Agencies for both analytical & clinical – how small companies cope with that
  • Leveraging the external expertise to help take your products to commercialization quicker – decrease the timeline to commercialization
Mar 414:40
Conference pass

Clinical trial designs for personalized medicine in oncology

Clinical Trials - Trial Design and Adaptability
  • The fundamentals of the personalized medicine design strategies
  • Underlying statistical framework
  • Logistical barriers for implementation of some of these designs
  • The interpretation of the trial results, using NCI precision medicine trials, and other Phase I, II and III trials as examples
Mar 414:40
Conference pass

Driving high T-cell titers to neoantigens in tumors – harnessing immunogenic viral vectors with immune check point modulators

Immunotherapy - Cancer Vaccines
  • Neoantigen prediction
  • Viral vectors as vaccine delivery platform(s)
  • Cancer vaccines in combination with immune checkpoint modulators
Mar 414:40
Conference pass

Evolution and advancements in cancer immunotherapy

Antibodies - Armed Antibodies
Partha Chowdhury, Senior Director and Head, Antibody Discovery, Sanofi Genzyme
Mar 414:40
Conference pass

Pluripotent cell-derived off-the-shelf TCR-less CAR-targeted cytotoxic T Cell therapeutic for the allogeneic treatment of B cell malignancies

Immunotherapy - Cell Therapy
  • Several obstacles hamper the range of CAR-T application to a wide patient base
  • FT819 is a first-of-kind off-the-shelf human induced pluripotent stem cell (hiPSC)-derived CAR-T cell product
  • Preclinical studies suggest that FT819 can be effectively and safely used in the treatment of B cell malignancies in allogeneic setting
Dr Bob Valamehr, Vice President of Cancer Immunotherapy, Fate Therapeutics
Mar 414:40
Conference pass

Raising awareness of clinical trials with patients and healthcare providers

Clinical Trials - Patient Engagement and Enrolment
  • Dispelling the “guinea pig” myth by enhancing the image of the profession
  • Enhancing referrals from healthcare providers not usually involved in trials
  • Integrating clinical research into clinical practice
Mar 414:40
Conference pass

Title TBC

Antibodies - mAbs and novel modalities
Reserved for Abcellera
Mar 414:40
Conference pass

Title to be announced

Antibodies - Bispecifics
Teemu Junttila, Postdoctoral Researcher, Genentech
Mar 414:40
Conference pass

Anti-competitive deterrents to market access for biosimilars

Biosimilars - Commercialisation
  • Regulatory Barriers to Market Entry
  • IP Barriers to Market Entry
  • Misinformation Barriers to Market Entry
  • Restricted Access to Reference Product
  • Distribution, Rebate and Contract Barriers
Bruce Leicher, Attorney and Former Senior Vice President and General Counsel, Momenta Pharmaceuticals Inc
Mar 414:40
Conference pass

Case Study: Developing biosimilars with a tobacco plant expression system

Biosimilars - Development and Manufacturing
  • Pros and cons of alternative expression systems for biosimilars
  • Expression and post-translational modification in plant systems
  • Approaches to large scale cGMP manufacturing with plant systems
Don Stewart, President and Chief Executive Officer, PlantForm Corporation
Mar 415:00
Conference pass

Agonist bispecific antibodies delivering the next immune-oncology breakthrough

Antibodies - Bispecifics
  • Targeting T cells via TNFRSF costimulatory pathways has the potential to strongly activate the immune system due to broad expression across multiple immune cells
  • FcɣR-mediated crosslinking is often required for optimal activity, limiting clinical efficiency, due to low affinity of Fc:FcɣR interactions and ADCC-mediated T cell depletion
  • We present novel bispecific programmes that do not bind to FcɣR, but instead crosslink their two targets, resulting in a potent and controlled T cell activation
Mar 415:00
Conference pass

Application of homogeneous time resolved fluorescence in antibody discovery and protein engineering: A case study

Antibodies - mAbs and novel modalities
  • Successful biochemical and mechanistic characterisation of a lead antibody molecule using HTRF
  • Implementation of high throughput HTRF epitope competition assays as a surrogate affinity screen
  • Novel application of HTRF in the reengineering of a lead antibody to address target mediated antibody clearance in vivo
Mar 415:00
Conference pass

Comparative oncology: spontaneous canine cancer as models for human therapy

Clinical Trials - Trial Design and Adaptability
  • Detail the similar tumor pathology and mechanisms between canine and human cancer
  • Summarize ongoing therapeutic trials in canine cancer
  • Introduce data from tumor vaccination and immunotherapy in canine cancer
Mar 415:00
Conference pass

NK-92®: a proven, versatile platform for target-specific NK cell immunotherapy

Immunotherapy - Cell Therapy
  • NK-92® cells scientifically and clinically developed by NantKwest
  • Allows for virus independent genetic manipulation
  • In addition to the parental NK-92 (aNK™), IL-2- independent, high affinity CD16 expressing haNK® cells are in clinical trials
  • Various CAR expressing variants (taNK®) for clinical application
Mar 415:00
Conference pass

PDC*line Pharma semi-allogeneic cancer vaccine: how abortive allogeneic immune response can prime and boost the induction of specific anti-tumor T cells?

Immunotherapy - Cancer Vaccines
  • PDC*line is a new potent and scalable therapeutic cancer vaccines based on a proprietary allogeneic cell line of Plasmacytoid Dendritic Cells
  • PDC*line is much more potent to prime and boost antitumor antigen, including neoantigens, specific cytotoxic T-cells than conventional vaccines and improves the response to checkpoint inhibitors
  • The technology can be applied for any type of cancer
Mar 415:00
Conference pass

Preclinical Validation of a Site-specifically Conjugated, ROR1-specific Anthracycline-ADC with Potent Immune-stimulatory Functions

Antibodies - Armed Antibodies
  • We present a novel ADC based on site-specific conjugation of a derivative of the anthracycline PNU-159682 using the transpeptidase Sortase A
  • The use of a non-cleavable peptide linker provides exquisite stability, whereas the anthracycline payload endows the ADC with superior potency combined with attractive immune-oncology properties intrinsic to this class of payloads
  • Validating data obtained in numerous PDX models, as well as in immunocompetent syngeneic models, will be presented
Mar 415:00
Conference pass

Title TBC

Clinical Trials - Patient Engagement and Enrolment
Brenda Hann, Head of Clinical Trials, Stanford University School of Medicine
Mar 415:00
Conference pass

Achieving broad and sustainable access to biologic medicines through biosimilars

Biosimilars - Commercialisation
Florian Turk, Head of Global Payor Marketing, Sales and Relations, Sandoz
Mar 415:00
Conference pass

Using synergistic antibody screening to develop Herceptin biosimilars

Biosimilars - Development and Manufacturing
SPEAKING OPPORTUNITY AVAILABLEIf you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 415:20
Conference pass

Bispecific antibodies for conditional activation of immune cells

Antibodies - Bispecifics
  • How the formats makes differences for conditional activation
  • How to control toxicity of immune agonists by design
  • How affinity of agonist antibody impact efficacy and toxicity in mouse models
Mar 415:20
Conference pass

Development of monoclonal antibodies as an integrated and layered medical countermeasure

Antibodies - mAbs and novel modalities
  • A DoD approach to the use of next generation antibody formats as a medical countermeasure
  • Standalone therapy vs. an Integrated Layered Defense for the development of Biologics.
  • Application of novel formats and the utility of effector function in order to optimize ADME properties
Mar 415:20
Conference pass

Implementing unequal randomization in clinical trials with heterogeneous treatment costs

Clinical Trials - Trial Design and Adaptability
  • Optimal allocation designs minimizing total study cost under statistical efficiency constraints
  • State-of-the-art restricted randomization procedures to implement optimal allocation in practice
  • Statistical inference following these procedures, using population-based and randomization-based approaches
Mar 415:20
Conference pass

Reserved for sponsor

Clinical Trials - Patient Engagement and Enrolment
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com
Mar 415:20
Conference pass

Reserved for Supporting Partner

Antibodies - Armed Antibodies
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 415:20
Conference pass

Tumor-specific pathways to NK cell activation and how they can be used in the clinic

Immunotherapy - Cell Therapy
  • NK cells have complex activation pathways which differ following ligation by different tumor cells
  • Conventional cytokine activated NK cells are not optimally primed to kill tumour cells
  • Knowledege of NK cell activation pathways can be translated to better cancer therapies
Mar 415:20
Conference pass

Vaccine for early breast lesions

Immunotherapy - Cancer Vaccines
  • Developing T cell-based vaccines targeting a wide variety of tumor antigens, including HER2, CEA, FRa and IGFBP
  • Demonstrating that once administered systemically, the oncolytic virus Reolysin associates with both peripheral blood mononuclear and polymorphonuclear cells to avoid neutralization by antibody
Mar 415:20
Conference pass

A year to review: 2018, more decisions, more launches, more unanswered questions

Biosimilars - Commercialisation
SPEAKING OPPORTUNITY AVAILABLEIf you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 415:20
Conference pass

How your biosimilars development strategies are translated into a full program management

Biosimilars - Development and Manufacturing
Klemen Spaninger, Director of Project Management, Polpharma Biologics
Mar 415:40
Conference pass

Advancing CAR T cell therapy for brain tumors

Immunotherapy - Cell Therapy
  • Expanding the repertoire of immunologic targets for brain tumors
  • Advantages of locoregional delivery of CAR T cells for brain tumors
  • Combining CAR T cells with anti-PD-1 checkpoint inhibition
  • Lessons learned from on-going clinical trials
Christine Brown, As Associate Director of the T Cell Therapeutics Research Laboratory, City Of Hope National Medical Center
Mar 415:40
Conference pass

Advancing clinical research using data analytics to improve patient engagement and experience

Clinical Trials - Patient Engagement and Enrolment
  • How one can use novel data analytic techniques such as exploratory factor analysis and logistic regression for improving patient participation, engagement and experience in clinical research studies
Mar 415:40
Conference pass

Advancing novel combination vaccines and immunotherapies for cancer

Immunotherapy - Cancer Vaccines
  • Novel cancer vaccines and immunotherapies
  • Novel combination immunotherapy and maximizing efficacy
  • Choosing the safest and most effective immunotherapy and vaccine for the right cancer
Mark Poznansky, Director, Vaccine And Immunotherapy Center, Massachusetts General Hospital
Mar 415:40
Conference pass

Standardization efforts in clinical development focused on the “what” and not the “how”

Clinical Trials - Trial Design and Adaptability
  • CDISC standards, protocol templates, and government registries share what trials are run, data collected, and standardized submissions. Information on how clinical research is designed tends to be captured ad-hoc, making it difficult to find not just externally, but even within organizations
  • Proposal for a clinical development design information model
  • Merits for capturing design thinking in a structured manner
  • Past and current projects ongoing to establish a clinical development design information model, and framework
Mar 416:40
Conference pass

Combinatorial immune checkpoint blockade using bispecific DART© molecules: concepts and applications

Antibodies - Bispecifics
  • Selection and format optimization of PD-1 x CTLA-4 DART molecules (MGD019) for simultaneous blockade of two checkpoint pathways
  • MGD019 pharmacology and IND enabling studies
  • Additional applications of bispecific DART and TRIDENT molecules for tumour immunotherapy
Mar 416:40
Conference pass

Impact of analogue selection, linker chemistry, and conjugation site on antibody-tubulysin conjugate properties

Antibodies - Armed Antibodies
  • ADCs bearing tubulysin payloads are active in MDR+ and bystander activity models
  • Payload stability in vivo can be modulated through selection of conjugation site and linker composition
  • Stabilized antibody-tubulysin conjugates are active in xenograft models at well-tolerated doses
Mar 416:40
Conference pass

New ways for human antibodies - from intracellular applications to switchable affinity

Antibodies - mAbs and novel modalities
  • How to target intracellular antigens with antibodies
  • How to regulate antigen binding affinity of different antibodies with a universal effector
Mar 416:40
Conference pass

The phenomenal uptake of biosimilars in Denmark. What’s the secret?

Biosimilars - Commercialisation
  • The uptake in Denmark of biosimilars has so far not only been very high but also extremely quick. No doubt this will also be the case for the next biosimilars on the verge of entering the market
  • A large number of stakeholders have played a very important part. Who are they, what are their respective roles and how exactly did each of them contribute to the result?
  • Is this only a success story or are there any clouds on the horizon? What can anybody learn from Denmark and what will prove more difficult to copy? Will the Danish market be sustainable in the coming years?
Mar 416:40
Conference pass

How improved analytical techniques and outsourcing manufacturing needs help drive the accuracy in our data

Biosimilars - Development and Manufacturing
  • What technologies will help us learn more about the structural features of biosimilar products?
  • Weighing the benefits of improved analytical techniques such as HR-MS to detect minor protein modifications
  • Evaluating the potentials of outsourcing analytical and manufacturing needs for faster and more accurate analytical data
Parastoo Azadi, Technical Director of Analytical Services and Senior Research Scientist, Complex Carbohydrate Research Center
Mar 416:50
Conference pass

ROR1 targeted CAR-T

Immunotherapy - Cell Therapy
  • ROR1 is an oncofetal antigen expressed on both liquid and solid tumors
  • ROR1 expression is associated with poor outcomes across many cancers
  • ROR1 is a marker of stemness and a de-differentiated state, making it an excellent target
  • CAR-T are being developed to treat both liquid and solid tumors
James Breitmeyer, President and Chief Executive Officer, Oncternal Therapeutics
Mar 416:50
Conference pass

Shaping our dynamic microbiomes for lifelong health

Immunotherapy - Precision immunotherapy and the Microbiombe
  • Through the American Gut Project, we now know about the microbiomes of many types of people, from the healthiest (student-athletes, centenarians) to the sickest (cancer patients, ICU patients, those with depression, those with C. diff)
  • Amazingly, diet has an especially profound effect on our microbiomes, often outweighing the effects of disease or medications.
  • This raises the prospect of a system for real-time analysis of our microbiomes that helps guide our daily decisions in a way that optimizes our microbiomes for extending our healthspan
Mar 417:00
Conference pass

Development of a bispecific antibody therapy for Type I Diabetes

Antibodies - Bispecifics
  • Introduction to Dualogics, a North Carolina based biotech company focused on bispecific antibody therapies
  • Development of OrthoMab, a next-generation bispecific antibody platform
  • Progess on the development of DLA001, a bispecific antibody therapy for the treatment of Type I Diabetes
Mar 417:00
Conference pass

Evidence based site selection tactics & tools driving right site/first time

Clinical Trials - Outsourcing Strategies: Site/Vendor Selection and Monitoring
  • Databases and software available which aggregates site data to enable better decision-making
  • How to effectively utilize data to create an ideal site profile based on feasibility, study start-up data and site experience
  • How can data improve transparency and reduce study start-up time and overall successful trial execution?
Mar 417:00
Conference pass

Identifying unique disease targets and design and engineer effective therapeutics

Antibodies - mAbs and novel modalities
Karthik Viswanathan, Director, Research, Visterra Inc.
Mar 417:00
Conference pass

Partnering with CROs, IRBs and study sites to drive patient recruitment

Clinical Trials - Patient Engagement and Enrolment
  • Once a study has launched, all eyes (and pressure) focus on the patient recruitment team
  • To be effective, the team has to build critical relationships well before study launch and partner with key influencers, including advocacy groups, the IRB and CRO, all while developing a meaningful, comprehensive and sustainable recruitment package
  • This presentation will discuss ways to create an early framework for recruiting, develop important partnerships and leverage already available resources to enable the recruitment team to maximize their time and budget
Mar 417:00
Conference pass

Reserved for Supporting Partner

Antibodies - Armed Antibodies
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 417:00
Conference pass

Sponsored IP & Litigation session - Opportunity available for lawyers to educate the audience on how industry can best navigate the patent/IP landscape

Biosimilars - Commercialisation
SPEAKING OPPORTUNITY AVAILABLEIf you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 417:00
Conference pass

Leveraging technologies during the early development stages to dictate your cost effectiveness in the later stages

Biosimilars - Development and Manufacturing
  • What factors will help us avoid repeated safety and efficacy studies throughout the product lifecycle?
  • Adopting modern manufacturing methods to produce your drugs efficiently and economically
  • Ensuring efficient plant utilization to provide a reasonable cost advantage in the long term
Annick De Vries, Head Diagnostics, Biologics, Sanquin
Mar 417:10
Conference pass

The microbiome in cancer

Immunotherapy - Precision immunotherapy and the Microbiombe
  • Review of the current understanding of how the microbiome influences response to immune checkpoint blockade in cancer
  • A summary of potential mechanisms of microbial pathogenesis in cancer
  • Highlighting the future directions for microbiome science in cancer immunotherapy
Mar 417:10
Conference pass

Therapeutic strategies based on Innate Immunity and Affimed’s ROCK® platform

Immunotherapy - Cell Therapy
  • Harnessing innate immunity by immune cell engagement is a promising approach for the therapy of cancer patients
  • Affimed has developed a differentiated modular antibody platform, ROCK® (redirected optimized cell killing), which enables the development of high affinity engagers of innate immune effector cells (NK cells and macrophages) and targeting specific receptors on cancer cells
  • Promising clinical efficacy and safety data as single agents and in combination with the checkpoint inhibitor pembrolizumab will be discussed in addition to further combination of ROCK®-based bispecific antibodies with other IO agents
Mar 417:20
Conference pass

Antibody discovery and pre-clinical development for autoimmune/inflammatory disease

Antibodies - mAbs and novel modalities
  • Immune checkpoint molecules on T cells function to down regulate antigen-specific immune responses
  • Agonist anti-checkpoint antibodies are anticipated to augment endogenous inhibitory signals and be efficacious for treatment of T-cell driven autoimmune and inflammatory diseases
  • Checkpoint agonist antibody discovery, affinity maturation and functional requirements will be presented
  • Optimization of biophysical characteristics of candidates prior to pre-clinical development will be presented, including thermal stabilization and high concentration pre-formulation
Mar 417:20
Conference pass

Antibody oligonucleotide conjugates for the treatment of muscle disorders

Antibodies - Armed Antibodies
  • Targeted delivery of oligonucleotides
  • Non-hepatic delivery of oligonucleotides using antibody oligonucleotide conjugates
  • Avidity’s plans to develop antibody oligonucleotide conjugate drug candiates for multiple disease indications
Mar 417:20
Conference pass

Clinical trial agreements: closing the deal

Clinical Trials - Outsourcing Strategies: Site/Vendor Selection and Monitoring
Mar 417:20
Conference pass

Patient partnering in clinical development: a UCB case study

Clinical Trials - Patient Engagement and Enrolment
  • Patient Value Strategy of UCB, a global biopharmaceutical company
  • UCB’s quest of achieving patient-preferred clinical studies
  • Case study offering successes, challenges and learnings within one of UCB’s clinical development programs
Mar 417:20
Conference pass

Reserved for Supporting Partner

Antibodies - Bispecifics
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 417:20
Conference pass

Understanding the main barriers to approval and market entry and analyzing partnerships that will help us address them

Biosimilars - Commercialisation
  • Delays in market entry – Addressing where we are today and analyzing current affairs
  • Reviewing new guidelines, current pipelines and the patent landscape
  • What kinds of partnerships will help us speed up approval and market entry?
Chrys Kokino, Head Global Bioloigcs & Insulins - Commercial, Mylan Inc.
Mar 417:20
Conference pass

Panel discussion: Critical attributes to consider when choosing an appropriate CDMO to manufacture your products

Biosimilars - Development and Manufacturing
  • Critical Attributes to Consider When Choosing an Appropriate CDMO
  • Regulatory and Quality Challenges
  • Effective International Sourcing and how to work with Partners?
  • Why culture and flexibility is important for biosimilars
Vimal Gandhi, Director, Global Biosimilar Operations and Strategy, AstraZeneca
Parastoo Azadi, Technical Director of Analytical Services and Senior Research Scientist, Complex Carbohydrate Research Center
Mar 417:30
Conference pass

Reserved for sponsor

Immunotherapy - Precision immunotherapy and the Microbiombe
If you are interested in being involved, please contactDerek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 417:30
Conference pass

Switchable CAR-T cell therapy

Immunotherapy - Cell Therapy
  • Calibr’s unique switchable CAR-T cell platform affords dose-titratable control over activity.
  • Temporal control over activation enables in vivo formation and recall of memory CAR-T cells.
  • The switchable CAR-T cell platform is universal; redirection to multiple targets allows a robust response against antigen loss in preclinical models
Mar 417:40
Conference pass

Development of antibody conjugates for targeted delivery of siRNA

Antibodies - Armed Antibodies
  • Preparation and characterization of well-defined antibody-siRNA conjugates
  • Demonstration of in vitro and in vivo activities
  • PK analysis of antibody-siRNA conjugates
Mar 417:40
Conference pass

Modulating antibody activity through chemical biology

Antibodies - mAbs and novel modalities
  • Systemic administration of antibodies can lead to dose-limiting on-target toxicities
  • We therefore sought to design small-molecule control into existing antibodies, to allow for precise spatial and temporal activation
  • By incorporating a specific mutation in the heavy chain - light chain interface, we have created antibodies that require an exogenous small-molecule for antigen binding
  • Because of the conservation at this site, the same mutation/activator pair can be transferred and used in other antibodies
Mar 417:40
Conference pass

Panel discussion: choosing and working with CROs - how much should you take on?

Clinical Trials - Outsourcing Strategies: Site/Vendor Selection and Monitoring
  • Multiple vs singular CRO input
  • Finding the balance between expertise and ethos
  • Pros and cons of different approaches
Kenneth Wilson, Director, Sourcing Operations, Pfizer
Neda Rashti, Group Lead, Clinical Program Management, Pfizer
Mar 417:40
Conference pass

Panel discussion: transforming clinical trials with patient partnerships and collaboration

Clinical Trials - Patient Engagement and Enrolment
  • The crucial role patients play in improving the clinical trial enterprise
  • Barriers to successful engagement
  • Collaboration between patient groups and trial sponsors
Mar 417:40
Conference pass

Targeting solid tumors with bispecific antibody armed activated T cells (BATs)

Antibodies - Bispecifics
  • Bispecific antibodies can be used to retarget effector T cells to tumor antigens
  • Clinical targeting of solid tumors induces adaptive cellular and humoral immunity
  • Targeting of tumors induces Th1 cytokines in patients
  • Immunotherapy with BATs is non-toxic and may improve survival in metastatic breast and pancreatic cancer patients
Mar 417:50
Conference pass

Developing and evaluating CAR-T therapies for T-cell malignancies

Immunotherapy - Cell Therapy
  • Strategies to overcome fratricide of CAR T cells specific to T-cell antigens
  • Limiting off-tumor toxicity in patients
  • Current results and future directions
Mar 417:50
Conference pass

Harnessing nanotechnology to program immune function

Immunotherapy - Precision immunotherapy and the Microbiombe
  • Use of nanotechnology and engineered materials to understand immune processes
  • Programmable activation of combinations of immune pathways for synergistic potency
  • Generation of antigen-specific tolerance to combat multiple sclerosis and type 1 diabetes

Create your personal agenda –check the favourite icon

Mar 509:00
Conference pass

Digital innovation in clinical development: adopt or die

Clinical Trials Keynote Plenary
Mar 509:00
Conference pass

Engineering of a T-cell dependent bispecific to broaden the therapeutic index for solid tumors

Antibodies - Bispecifics
  • Engineering and fine-tuning of the bispecific to achieve selective binding to tumor cells
  • Data demonstrating improved TI in in vitro and in vivo tumor models
  • Preclinical safety studies supporting tolerability
Mar 509:00
Conference pass

New payloads for antibody-drug conjugates

Antibodies - Armed Antibodies
  • Exploring drugs with novel mechanisms of action and learning the requirements for effective ADC payloads
  • Impact of drug load on ADC activity
  • The importance of payload metabolism and how to avoid using antibody or small molecule engineering
Mar 509:00
Conference pass

Reserved for supporting partner

Antibodies - CMC, developability and manufacturing
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 509:00
Conference pass

The New FDA Biosimilars Action Plan—What to Expect?

Biosimilars - Plenary
  • Time to revisit the scientific rationale for approving generics and biosimilars—breaking out from tradition and rote practice
  • Encouraging fast to market approaches—a challenge for both developers and FDA
  • Making “what is clinically meaningful” truly meaningful-- a new class of substitutable biosimilars and compliant generics
Sarfaraz Niazi, Chairman, Professor, Karyo Biologics/UIC
Mar 509:20
Conference pass

Just-in-time production of bispecific antibodies and other IgG scaffolds for rapid screening

Antibodies - Bispecifics
  • Modular and rapid assembly of antibody scaffolds
  • Bispecific, IgG-like, and ADC formats
  • Enabling faster screening and concept validation studies
Mar 509:20
Conference pass

MGC018: A duocarmycin-based antibody drug conjugate targeting B7-H3

Antibodies - Armed Antibodies
  • Introduction of duocarmycin-based linker payload
  • Antibody discovery and target validation
  • Preclinical profiling of MGC018
Mar 509:20
Conference pass

Reserved for sponsor

Immunotherapy Keynote Plenary
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 509:20
Conference pass

Reserved for supporting partner

Antibodies - CMC, developability and manufacturing
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 509:40
Conference pass

AI for tumour profiling

Clinical Trials Keynote Plenary
Mark Poznansky, Director, Vaccine And Immunotherapy Center, Massachusetts General Hospital
Mar 509:40
Conference pass

Bispecific antibodies as immunotherapies for emerging viruses

Antibodies - Bispecifics
  • Bispecific antibodies (bsAbs) are a promising platform for development of novel immunotherapies
  • Ebola virus and other emerging viruses are suitable targets for blabs
  • We will discuss design and evaluation of bsAbs as candidate immunotherapies for Ebola virus and other emerging pathogens
Mar 509:40
Conference pass

Integrating new biophysical and structural biology methods to improve Biologics

Antibodies - CMC, developability and manufacturing
  • New low protein consuming, high throughput biophysical methods for mAbs, ADCs, multi-specific Biologics
  • Computational biophysics to predict biologics long terms stability
  • Structural biology for Ab-Ag affinity modulation, biologics stability optimization
Mar 509:40
Conference pass

New technology leading to better antibody-drug conjugates

Antibodies - Armed Antibodies
    New payloads offering improved efficacy and stabilityAdvantages of a cross-reactive in vivo model systemOptimizing DAR & dosing of ADCs
Mar 509:40
Conference pass

PROVENGE®: Hits and misses, now success

Immunotherapy Keynote Plenary
  • Navigating the transition from clinical promise to commercial success
  • Marketplace challenges facing PROVENGE
  • Orchestrating a successful turnaround
  • What PROVENGE has taught us about the promise of immunotherapy
Mar 509:40
Conference pass

Keynote interview: Balancing biosimilars, biobetters and new molecular entities – discussing Pfenex’s next move

Biosimilars - Plenary
  • How past experiences play a vital role in the current and future state of biosimilar products
  • How recent advances in regulatory science and guidance are influencing the development of biosimilars and complex generics: case study with teriparatide
  • How Pfenex looks to drive its current pipeline and evolve its resources to enter new avenues
  • How to maintain the right balance between adding more novel proteins and maintaining a presence in biosimilars/complex generics space
Hubert Chen, Chief Medical and Scientific Officer, Pfenex Inc
Mar 510:00
Conference pass

Panel discussion: what’s slowing down uptake of technology?

Clinical Trials Keynote Plenary
Mar 510:00
Conference pass

Reserved for supporting partner

Antibodies - Armed Antibodies
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 510:00
Conference pass

Reserved for supporting partner

Antibodies - CMC, developability and manufacturing
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 510:00
Conference pass

Targeted bispecific for treatment of inflammatory diseases

Antibodies - Bispecifics
  • Improving therapeutic potential of bio-therapeutics by increasing drug concentrations to target tissues and limiting systemic exposure
  • A case study using a preclinical model of arthritis will be presented
  • Proteogenomic analysis of inflamed tissues for new targets and biomarkers identification
Mar 511:20
Conference pass

Amunix XTEN® polypeptides and THIOMAB™ antibodies to enable site-specific high-DAR ADCs with acceptable pharmacokinetics and efficacy

Antibodies - Armed Antibodies
  • Conjugation and analytics development for THIOMAB™ antibody-XTEN®-drug conjugates (TXCs)
  • In vitro and in vivo validation of high-DAR TXC platform
Mar 511:20
Conference pass

Effective CMC Development for Bispecific Antibodies: DuoBody technology: A versatile platform for generating bispecific antibodies

Antibodies - CMC, developability and manufacturing
  • Platform-based approaches for development and manufacture of Bispecifics
  • Highlighting streamlined approach from DNA to FIH GMP manufacturing processes
  • Case studies detailing recent CMC approaches in the development of a range of bispecific therapeutics
Martin Hangler, CMC Project Manager, Genmab
Mar 511:20
Conference pass

IgM as highly potent, cross-linking antibodies for T cell engagement or as agonists of TNF family receptors

Antibodies - Bispecifics
  • IgM as a platform for high avidity, bi-specific and strong agonist antibodies
  • oLow expression and difficult targets accessed by IgM
  • Potent and safer bispecific anti-CD20xCD3 IgM for relapsed or refractory lymphoma treatment
  • IgM for cross-linking of DR5 for enhanced apoptosis
Mar 511:20
Conference pass

Switching, Interchangeability and Substitution in the in the US and in Europe

Biosimilars - Commercialisation
  • Two years of experience with the draft FDA Guidance on Demonstrating Interchangeability
  • Acceptance of switching and substitution in countries of the European Community
  • Multiple switching and hypothetical implications for clinical performance
  • VOLTAIRE-X, a study designed to support the claim of interchangeability
Bernd Liedert, Senior director biosimilars, Boehringer Ingelheim Pharma Co Gmbh
Mar 511:20
Conference pass

Clinical development of biosimilars - the importance of making your clinical trials as specific, consistent and sensitive as possible

Biosimilars - Development and Manufacturing
  • Case study example of pegfilgrastim biosimilar clinical trial design
  • Understanding how we can build a bridge between the originator and biosimilar product using a specific, consistent and tailor-made approach
  • The importance of study population, study design, endpoints and statistics
  • Collaborating with regulatory affairs and making clinical studies as sensitive to differences as possible
Mar 511:40
Conference pass

Bispecific antibodies for tumor-directed blockade of CD47, the antiphagocytic “don't-eat-me” signal

Antibodies - Bispecifics
  • To evade anti-tumor immunity cancer cells overexpress CD47, a ubiquitous phagocytosis inhibitor and immune checkpoint.
  • We have generated bispecific antibodies that allow selective targeting of CD47 in cancer cells expressing a tumor associated antigen, CD19 or mesothelin.
  • These dual-targeting kappa-lambda bodies are fully human immunoglobulins of the IgG1 subtype. As such, they induce strong Fc-mediated tumor cell killing in vitro and in vivo.
  • They also promote T cell mediated anti-tumor immunity through the enhancement of antibody-directed tumor cell phagocytosis and antigen cross-presentation by professional APCs.
Mar 511:40
Conference pass

Engineering antibody conjugates for delivery of novel payload classes

Antibodies - Armed Antibodies
  • Antibody and linker design considerations for novel payload classes
  • Challenges to capturing complex MoA in vitro
  • In vivo payload target validation in tumor models
Mar 511:40
Conference pass

Logistics and supply chain management for cell therapy

Immunotherapy - Manufacturing and Logistics
  • Shipper suitability, features and options
  • Maintaining chain of custody for starting material and product
  • Logistics reliability and options
  • Supply chain sustainability and scale-out
Mar 511:40
Conference pass

Reserved for Supporting Partner

Antibodies - CMC, developability and manufacturing
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 511:40
Conference pass

The TESLA consortium: Relevant parameters for neoepitope selection

Immunotherapy - Checkpoint Inhibitors
  • TESLA integrates multiple, independent computational pipelines and tests the predictions using several validation assays
  • Differences and common features are apparent
  • This community-based approach may act as a paradigm for shared progress in cancer therapy
Mar 511:40
Conference pass

Transforming clinical trials using RWD

Clinical Trials - Real World Evidence
  • Trial design
  • Lessons learned
  • Regulatory perspective
Mar 511:40
Conference pass

Hurdles on Blocking Biosimilar Development

Biosimilars - Commercialisation
  • FDA/EMA/WHO/NMPA Guidelines on Biosimilar Development
  • Current Trends in Biosimilars
Alvin Luk, Senior Vice President and Chief Medical Officer, Shanghai Henlius Biotech
Mar 511:40
Conference pass

Exploring the need for additional clinical trial experience (post-marketing and/or ISS) and real-world data to establish clinical confidence among US HCPs

Biosimilars - Development and Manufacturing
  • Exploring components that are necessary to establish clinical confidence in biosimilar products
  • What additional clinical information is needed to help establish clinical confidence among US HCPs?
  • Implementation of strategies to disseminate clinical data on biosimilars for awareness and familiarization of HCPs
Gerry Hoehn, Medical Director, Oncology, Teva Pharmaceuticals U.S.A.
Mar 512:00
Conference pass

Development of modern biologics through global CMOs

Antibodies - CMC, developability and manufacturing
  • Process developmend and GMP manufacturing
  • Dealing with CMOs – how to select the best
  • CMO selection and due diligence process
  • Process development strategy
Mar 512:00
Conference pass

Evidence-based decisions in developing next generation immunotherapies

Clinical Trials - Real World Evidence
Emmanuel Fombu, Director, Digital Medicines and Innovation, Novartis
Mar 512:00
Conference pass

ImmTACT TM: novel strategies to increase immunotherapy efficacy

Immunotherapy - Checkpoint Inhibitors
  • Generating high-affinity, bi-specific TCR-molecules for cancer therapy
  • Addressing intra-tumour heterogeneity
  • Strategies to enhance tumour immunogenicity
Mar 512:00
Conference pass

Repurposing an imaging agent ligand for prostate cancer I/O

Antibodies - Bispecifics
  • Calibr has developed a small molecule antibody conjugate that functions as a bispecific antibody.
  • The molecule has the structure of an antibody drug conjugate and the function of a T cell recruiting bispecific antibody.
  • Through use of the Fab format, the molecule has excellent stability and favorable exposure in vivo.
  • Complete elimination of tumors in both xenograft and primary, patient derived models.
Mar 512:00
Conference pass

Reserved for sponsor

Immunotherapy - Manufacturing and Logistics
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 512:00
Conference pass

Turning native antibodies into homogeneous ADCs without antibody engineering

Antibodies - Armed Antibodies
  • A new site-specific method to generate homogeneous ADCs will be introduced that does not require antibody engineering
  • Versatility of method will be shown
  • Comprehensive characterization of generated ADCs will be presented
Mar 512:00
Conference pass

Biosimilars: Current requirements and experience with regulatory approvals

Biosimilars - Commercialisation
Panel Discussion on regulation followed by questions from the audienc
Mareike Ostertag, Director Regulatory and Science Policy, Novartis Pharma AG
Mar 512:00
Conference pass

Panel discussion: Clinical trials – do we need them to get biosimilars approved?

Biosimilars - Development and Manufacturing
  • Clinical trials vs pharmacology studies, what does the current FDA and EU guidance say?
  • Clinical pharmacology studies: efficacy & safety
  • Future possibilities
  • Q + A with the audience
Gerry Hoehn, Medical Director, Oncology, Teva Pharmaceuticals U.S.A.
Mar 512:20
Conference pass

Engineering STRO-002: A SARbodyTM conjugate targeting folate receptor alpha

Antibodies - Armed Antibodies
  • STRO-002 is a homogeneous, site-specific ADC targeting folate receptor alpha which is widely expressed in ovarian and endometrial cancers
  • STRO-002 contains an antibody engineered using Fab-based ribosome display conjugated to a tubulin-targeting 3-aminophenyl hemiasterlin warhead via a cleavable linker
  • DAR, warhead, linker, and conjugation sites were optimized using Sutro’s Xpress CF+ platform to yield a potent ADC with a favorable pharmacological profile
Mar 512:20
Conference pass

Identifying critical receptors and screening for target specificity using human cell microarray technology

Immunotherapy - Checkpoint Inhibitors
  • A powerful approach to identify primary receptors for phenotypic antibodies and immune checkpoint ligands
  • Efficient off-target profiling of biotherapeutics (antibodies, ADCs, scFvs) and cell therapies (including CAR T)
Mar 512:20
Conference pass

Lessons learned from bringing allogeneic adoptive T-cell immunotherapies to the clinic

Immunotherapy - Manufacturing and Logistics
Mar 512:20
Conference pass

New scaffold of bispecific antibodies and their applications

Antibodies - Bispecifics
  • A new platform of generating bispecific antibodies
  • Using a heterodimeric bispecific antibody to recruit T cells against tumor
Mar 512:20
Conference pass

Panel discussion: How can Blockchain can Transform the Pharmaceutical and Healthcare Industry?

Clinical Trials - Innovation in Clinical Technology
Disa Lee Choun, Head of Innovation, GCSO, UCB
Adama Ibrahim, Senior Clinical Operations Lead, Biogen
Mar 512:20
Conference pass

Reserved for sponsor

Clinical Trials - Real World Evidence
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 512:20
Conference pass

Reserved for supporting partner

Antibodies - CMC, developability and manufacturing
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 512:40
Conference pass

Delivering PROVENGE® – An operational success story

Immunotherapy - Manufacturing and Logistics
  • Logistical challenges of delivering an autologous cell therapy
  • Building blocks for operational success
  • Developing an integrated system
Mar 512:40
Conference pass

Targeting Immune Checkpoints with Humabody VH Therapeutics

Immunotherapy - Checkpoint Inhibitors
  • Crescendo Biologics develops Humabody VH products, small highly adaptable and flexible proteins which can be developed into differentiated therapeutics
  • Crescendo’s approach to developing differentiated Immuno oncology therapeutics
Dr James Legg, Vice President, Research and Development, Crescendo Biologics Ltd
Mar 512:40
Conference pass

SPEAKING OPPORTUNITY AVAILABLE

Biosimilars - Commercialisation
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 512:40
Conference pass

SPEAKING OPPORTUNITY AVAILABLE

Biosimilars - Development and Manufacturing
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 514:00
Conference pass

Identifying neoantigens for patients

Immunotherapy - Neoantigens
  • Identifying the neoantigens expressed in murine and human tumors and optimizing methods for their specific targeting by various targeted vaccines or through adoptive cellular therapy (ACT) with neoantigen-specific T cells
  • Our discovery that a patient’s tumor cells can be converted to cancer stem cells that retain expression of the neoantigens identified in the original cancer and which can form tumors in immunodeficient mice.
Stephen Schoenberger, Professor, La Jolla Institute for Allergy and Immunology
Mar 514:00
Conference pass

Preclinical Evaluation of an Agonist GITR Ligand

Immunotherapy - Checkpoint Inhibitors
  • A linker-less GITRL trimer-Fc fusion protein was generated by OncoMed’s TNF superfamily ligand engineering platform
  • GITRL demonstrated a robust preclinical anti-tumor activity in syngenic mouse tumor models
  • GITRL also showed anti-tumor activity in aging mice
Mar 514:00
Conference pass

Rationale for developing imaging criteria for immunotherapy

Clinical Trials - Regulation, Safety and Efficacy
  • Key concepts of iRECIST
  • The need for industry-wide image data collection
Mar 514:00
Conference pass

The Cancer Genome Atlas: molecular characterisation of tumours

Clinical Trials - Data and Analytics
Mar 514:00
Conference pass

Case Study: Biosimilar development in Russia and EuroAsian Union

Biosimilars - Commercialisation
Roman Drai, Director, Clinical Development, Geropharm
Mar 514:10
Conference pass

Coiled coil antibody masking domains: A modular approach towards selective activation

Antibodies - Non-antibody approaches and small peptide formats
  • Self-associating coiled-coil peptides were used to impede antibody binding when fused to the antibody N-termini
  • The same peptides could be readily applied to multiple antibodies
  • Inclusion of a protease-cleavable sequence allows for reversible control of antibody function
  • Coiled-coil masked antibodies and antibody-drug conjugates were tested in multiple in vivo models and shown to have improved pharmacologic and activity profiles
Mar 514:10
Conference pass

Predictive tools for developability assessment of antibody therapeutics

Antibodies - Computational tools for antibody engineering and characterisation
  • Protein therapeutics is the fastest-growing class of pharmaceutical agents
  • Exploring the application of computational tools for the optimization and development of biologics
  • Identification of manufacturability hot-spots and mitigation via protein engineering solutions that enhance the protein’s properties, such as its activity, affinity, specificity, and stability
  • Approaches that examine protein aggregation and estimate physical stability of proteins, and identify intrinsic liabilities with regard to safety, efficacy, and manufacturability
Mar 514:10
Conference pass

Strategic CMC approaches for mAb purification process development and manufacturing

Antibodies - CMC, developability and manufacturing
  • Platform and/or case-by-case based approach for process development and manufacturing will be applied.
  • New Technologies, methods and equipment are essential.
  • A robust, scalable, reproducible, flexible, controllable, and cost-effective process is designed and executed.
  • Challenges from biological complexity, impurity removal, adventitious agent control and manufacture facility fit will be discussed
Mar 514:20
Conference pass

Biomarker-stratified clinical trial designs

Clinical Trials - Data and Analytics
Deepak Khatry, Science Associate Director And Team Leader, Personalized Health Care, MedImmune Inc
Mar 514:20
Conference pass

Reserved for sponsor

Immunotherapy - Neoantigens
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 514:20
Conference pass

Reserved for sponsor

Clinical Trials - Regulation, Safety and Efficacy
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 514:20
Conference pass

Targeting Myeloid deprived suppressor cells (MDSC) to improve efficacy of checkpoint inhibitors

Immunotherapy - Checkpoint Inhibitors
  • Cancer causes chronic inflammation which promotes the development of MDSC
  • MDSC are the “Queen Bee” of the TME and a major cause of resistance to CPI
  • Eliminating MDSC should improve the response to CPI and eliminate one of the major resistance factors
Mar 514:20
Conference pass

Brazilian Experience in development of biosimilar products

Biosimilars - Commercialisation
  • Regulatory overview and pathways and Safety
  • Challenges to the Tech Transfer
  • Public Policy and Market Access
Vanessa Schiavo, Head of Regulatory Affaris and CMC Docs, Libbs Farmaceutica
Mar 514:20
Conference pass

Improving the eventual chances of success in the clinic by evaluating the doses and affinities required for engaging tissue-embedded targets during the pre-clinical stages of development

Biosimilars - Development and Manufacturing
SPEAKING OPPORTUNITY AVAILABLEIf you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 514:30
Conference pass

Exploration of small protein folds and their defining features

Antibodies - Computational tools for antibody engineering and characterisation
  • We developed a computational platform that enables us to efficiently sample and design any given topologies with high structural diversity to serve as new scaffolding proteins, guide future design efforts and help our general understanding of stability
  • Using a high-throughput stability screen, we evaluated 45,000 of 9 topologies designed with our new pipeline and derived stability prediction models using machine learning algorithms
Mar 514:30
Conference pass

From constrained peptides to biologics

Antibodies - Non-antibody approaches and small peptide formats
  • Highly potent macrocyclic peptides against various targets selected by an in vitro display system
  • Dimerization of macrocyclic peptides making them with antibody-like potency
  • Converting them into another modality
Mar 514:30
Conference pass

Reserved for Supporting Partner

Antibodies - CMC, developability and manufacturing
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 514:40
Conference pass

FDA panel discussion: Immunotherapy regulatory considerations and means to accelerate approval

Clinical Trials - Regulation, Safety and Efficacy
Rhonda Pisk, Stanford University School of Medicine
Francis Kalush, Health Program Coordinator,, FDA
Mar 514:40
Conference pass

Personalized adoptive cellular therapy targeting myelodysplastic syndrome (MDS) stem cell neoantigens (PACTN)

Immunotherapy - Neoantigens
  • Scientific rationale and approach to personalized, neoantigen-driven adoptive immunotherapy
  • Evidence for neoantigen-reactive T cell specificity for MDS stem cells
  • Feasibility of the PACTN approach in a phase 1 clinical trial
Mar 514:40
Conference pass

Reserved for sponsor

Immunotherapy - Checkpoint Inhibitors
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 514:40
Conference pass

Reserved for sponsor

Clinical Trials - Data and Analytics
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 514:40
Conference pass

Biosimilar regulations in non- US/ Non- EU/ Non- Japan, ROW markets

Biosimilars - Commercialisation
  • Pharmacovigilance in Biosimilar development and post marketing
  • Clinical Development of Biosimilars
Mar 514:40
Conference pass

QA Controls and Operations: Validation Qualification & Regulatory

Biosimilars - Development and Manufacturing
Nacer Hedroug, VP of Operations, APS Pharma
Mar 514:50
Conference pass

Protein analogous micelles: versatile, modular nanoparticles

Antibodies - Non-antibody approaches and small peptide formats
  • Peptides are functional modules of protein macromolecules that can be displayed apart from the whole protein to create biofunctional surfaces and interfaces, or can be re-assembled in new ways to create synthetic mimics of protein structures
  • This is what we call protein analogous micelles
  • Examples of work from our laboratory in this area using peptide-lipid or peptide-polycation conjugate molecules (peptide amphiphiles) include: multi-bio-functional surfaces, DNA-binding peptide assemblies, synthetic vaccines, and protein analogous micelles for cancer and cardiovascular therapeutics
Mar 514:50
Conference pass

Reserved for Supporting Partner

Antibodies - Computational tools for antibody engineering and characterisation
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 514:50
Conference pass

Reserved for Supporting Partner

Antibodies - CMC, developability and manufacturing
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 515:00
Conference pass

An HLA-agnostic, mutation-burden independent, personalized neoantigen vaccine strategy

Immunotherapy - Neoantigens
  • We developed an HLA-agnostic methodology that does not depend on in silico prediction models
  • This novel method reliably and consistently finds neoantigens for both Class I and II MHC presentation
  • We have started a personalized synthetic long peptide vaccine clinical trial in patients with advanced solid tumors to validate this approach and test the immunogenicity of a vaccine in combination with PD1 blockade
Dr Ezra Cohen, Associate Director of Moores Cancer Center, U.C. San Diego Moores Cancer Center
Mar 515:00
Conference pass

Two ACTive Immunotherapies (TACTI): Results of a Phase I trial with metastatic melanoma patients

Immunotherapy - Checkpoint Inhibitors
  • LAG-3/MHC class II interactions and their modulation in both cancer and auto-immune diseases
  • Combination therapy with eftilagimod alpha (LAG-3Ig) and chemotherapy or anti-PD-1 mAb
  • Highlighting in vitro and in vivo preclinical data along with emerging clinical data
Mar 515:00
Conference pass

Using big data to help design and execute efficient, innovative clinical trials

Clinical Trials - Data and Analytics
  • Demonstration of how the use of big data can help you find the right patients and decrease the timeline to your endpoints
  • Presentation of a case example of how big data directly influence the overall design of the clinical program
  • Using data sources to collect prospective, external control cohorts for non-randomized studies
Mar 515:00
Conference pass

Case study: Spanish biosimilar developer

Biosimilars - Commercialisation
Andreu Soldevila, Chief Executive Officer, Syna Therapeutics
Mar 515:00
Conference pass

Understanding high productivity cultures and innovative manufacturing for the production of affordable biosimilars

Biosimilars - Development and Manufacturing
  • Utilizing high productivity culture and single-use technology to achieve required costs
  • Implementing a distributed manufacturing approach and modular construction to enable global commercialization
  • Integrating bioanalytics and bioprocessing to achieve required quality
Julio Baez, Former Head, Technology, Cipla BioTec
Mar 515:10
Conference pass

e Novo MS/MS sequencing of native human antibodies

Antibodies - Computational tools for antibody engineering and characterisation
Adrian Guthals, Bioinformatics Scientist, Mapp Biopharmaceutical, Inc.
Mar 515:10
Conference pass

Reserved for Supporting Partner

Antibodies - Non-antibody approaches and small peptide formats
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 515:10
Conference pass

Reserved for Supporting Partner

Antibodies - CMC, developability and manufacturing
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 515:50
Conference pass

Non-profit-academic-industry collaboration: accelerating research for patients

Clinical Trials Keynote Plenary
  • Landscape context for need to collaborate on clinical trials and translational research and to unite leading experts
  • Need for more efficient collaborative clinical trials, especially basket and umbrella platforms, to efficiently evaluate emerging novel therapies that will hopefully lead to faster approval of better treatments
  • Pros and cons to collaboration (for both industry and academia)
  • Challenges to and key factors in successful collaboration & partnership, including role of non-profits in fostering and facilitating collaboration
Mar 515:50
Conference pass

Multi-stakeholder biosimilar reimbursement policy development: A societal benefit approach

Biosimilars - Plenary
Biologic biosimilars offer public and private drug plans the opportunity to realize significant cost savings on off-patent biologic originators, maintain quality continuum of care and deliver societal benefit. This presentation will review the process for developing biosimilar public drug plan policy in the Canadian provincial context.
  • Review the most recent biosimilar transition studies and real-world experience of transitioning from North America and Europe;
  • How to meaningfully engage stakeholders in the development of biosimilar reimbursement policy (perspectives and process);
  • Communication strategies to avoid nocebo effect* associated with transitioning patients from biologic originators to biologic biosimilars
Cheryl Koehn, President, Arthritis Consumer Experts
Mar 516:10
Conference pass

Reserved for sponsor

Clinical Trials Keynote Plenary
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 516:30
Conference pass

Adding to the efficacy of PD-1 based therapies

Keynotes
  • Immune checkpoint inhibition has been transformational in the treatment of cancer
  • Despite the success, many patients and tumor types do not respond to current marketed immunotherapies
  • Patient selection strategies and combining therapeutic approaches have important roles in enhancing the reach of PD-1-based immunotherapy
Mar 516:30
Conference pass

Clinical data sharing by industry and academia

Clinical Trials Keynote Plenary
  • Purpose and History
  • Methods
  • Results and Challenges
Mar 516:30
Conference pass

Title TBC

Keynotes
Speaker to be announced
Mar 516:30
Conference pass

Anti-biosimilars or pro-safety? Addressing the truth about ensuring cost savings and patient safety

Biosimilars - Plenary
  • Cost savings vs patient safety – How can we sustain a balance between the two?
  • Understanding the need for robust and comprehensive post-market tracking and reporting systems
  • Incorporating the patient voice into the development of biosimilar drugs to ensure a promising future
Lawrence Lamotte, Principal Consultant, Advocacy Options
Mar 516:50
Conference pass

Adding to the efficacy of PD-1 based therapies

Keynotes
  • Immune checkpoint inhibition has been transformational in the treatment of cancer
  • Despite the success, many patients and tumor types do not respond to current marketed immunotherapies
  • Patient selection strategies and combining therapeutic approaches have important roles in enhancing the reach of PD-1-based immunotherapy
Mar 516:50
Conference pass

Reserved for sponsor

Keynotes
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 516:50
Conference pass

Patient advocacy panel – Providing balanced and consistent information to patients and healthcare professionals

Biosimilars - Plenary
  • Understanding how to collaborate with payers and PBMs to create greater patient access
  • Evaluating appropriate avenues that will enable us to continue providing balanced and consistent information to patients and providers
  • The importance of patient advocacy groups as a vehicle to translate information and portray a balanced message to patients
  • Exploring innovative approaches to market the benefits of biosimilars to the healthcare industries
Cheryl Koehn, President, Arthritis Consumer Experts
Lawrence Lamotte, Principal Consultant, Advocacy Options
Mar 517:10
Conference pass

T-SIGn viruses: systemic delivery of localized combination immuno-gene therapy within the tumor microenvironment

Keynotes
  • T-SIGn platform: transgene-bearing genetically modified variants of enadenotucirev, an oncolytic chimeric group B adenovirus with clinical data demonstrating virus delivery to tumors following systemic dosing
  • Up to 4 different transgenes have been encoded in a single virus, enabling the design of candidates expressing combinations of biological agents for targeted immunotherapy
  • Local production of therapeutic combinations by tumor cells infected with the T-SIGn virus enables high local production for increased activity while minimizing systemic exposure for improved safety
Mar 517:10
Conference pass

T-SIGn Viruses: systemic delivery of localized combination immuno-gene therapy within the tumor microenvironment

Keynotes
  • T-SIGn platform: transgene-bearing genetically modified variants of enadenotucirev, an oncolytic chimeric group B adenovirus with clinical data demonstrating virus delivery to tumors following systemic dosing
  • Up to 4 different transgenes have been encoded in a single virus, enabling the design of candidates expressing combinations of biological agents for targeted immunotherapy
  • Local production of therapeutic combinations by tumor cells infected with the T-SIGn virus enables high local production for increased activity while minimizing systemic exposure for improved safety
Mar 517:30
Conference pass

Title TBC

Keynotes
Bullet points to be announced
Mar 517:30
Conference pass
Mar 517:50
Conference pass

Combining antibody and targeted therapies: Cirmtuzumab and ibrutinib - novel synergistic combination for CLL and mantle cell lymphoma

Keynotes
  • Cirmtuzumab targets ROR1, an oncofetal antigen expressed on both liquid and solid tumors
  • Cirmtuzumab inhibits Wnt5a signalling and reverses stemness in CLL
  • The ROR1 pathway is not inhibited by BTK inhibitors such as ibrutinib
  • Cirmtuzumab and ibrutinib are synergistic for CLL and MCL, and a clinical trial of the combination is under way
Mar 517:50
Conference pass

Combining antibody and targeted therapies: Cirmtuzumab and ibrutinib - novel synergistic combination for CLL and mantle cell lymphoma

Keynotes
  • Cirmtuzumab targets ROR1, an oncofetal antigen expressed on both liquid and solid tumors
  • Cirmtuzumab inhibits Wnt5a signalling and reverses stemness in CLL
  • The ROR1 pathway is not inhibited by BTK inhibitors such as ibrutinib
  • Cirmtuzumab and ibrutinib are synergistic for CLL and MCL, and a clinical trial of the combination is under way
Mar 518:10
Conference pass

Closing remarks

Keynotes
Closing remarks from the chair and from Terrapinn
last published: 12/Nov/18 11:06 GMT
 
 

 

GET INVOLVED AT THE  FESTIVAL OF BIOLOGICS USA

 

To Sponsor Or Exhibit

 

Derek Cavanagh
derek.cavanagh@terrapinn.com
t/ +44 (0)207 092 1297

 

 

 

To Speak

 

Joan Shutt
joan.shutt@terrapinn.com
t/ +44 (0)207 092 1134

 

 

 

To Register

 

Tayyab Abbasi
Tayyab.Abbasi@terrapinn.com
t/ +44 (0)207 092 1210