2019 AGENDA

 
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San Diego, 3 - 5 March 2019

Schedule

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Mar 313:00
Conference pass

Progress and challenges in the design and clinical development of microbial therapies

Immunotherapy - Workshops
  • Influence of the gut microbiome on autoimmunity
  • Gut microbes and immunotherapy responses
  • Leaky Gut Syndrome in autoimmune diseases – a potential target for therapy
  • Success in a probiotic trial in Irritable Bowel Syndrome – a new therapeutic perspective targeting the dysbiosis and beyond
  • Designing multi-targeted bacterial therapy – what tools do we need?
Mar 313:00
Conference pass

AI for antibody drug discovery and development

Antibodies - Workshops
  • An overview of how AI is currently used for in silico antibody discovery and development
  • Real life examples of how this is currently used, with challenges and case studies
  • Workshop on how AI can be implemented into the antibody industry
Mar 313:00
Conference pass

Analytics and innovation – The role it plays in the current and future state of biosimilars

Biosimilars - Workshops
Julio Baez, Former Head, Technology, Cipla BioTec
Mar 313:00
Conference pass

Partnering with patient advocacy organizations to bring the patient voice into the development of clinical trials

Clinical Trials - Workshops
  • Strategies for determining which advocacy organizations to partner with
  • Tactics for bringing in the patient voice early and often
  • Getting buy-in from Sr. leadership on the importance of advocacy relationships and inclusion of patient voice
Mar 313:45
Conference pass

Current approaches and future trends in antibody discovery

Antibodies - Workshops
  • Immunization-dependent and -independent Approaches to Ab Discovery
  • Strategies for Early Screening and Assessment of Antibody Candidates
  • Format and Developability Considerations in the Antibody Discovery Process
  • Brainstorming Discovery Approaches for Complex Targets
Mar 313:45
Conference pass

WHAT can the US derive from policy and strategy across Europe in promoting biosimilar uptake?

Biosimilars - Workshops
  • Who are the stakeholders and what benefits are to be gained from a positive approach to biosimilars?
  • How have professional healthcare bodies help deliver the biosimilar agenda in Europe?
  • What policy approaches across Europe have driven market uptake?
  • What are the barriers and how can they be overcome
  • Are their any strategic difference in the delivery of healthcare in the US that need to be considered by biologic companies
Margaret Dolan, Associate Director Market Access Eu Biosimilars, Biogen
Mar 313:45
Conference pass

Reserved for Supporting Partner

Clinical Trials - Workshops
If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 314:00
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SDCPI seminar 1: Immunotherapy for cervical cancer clinical trials: what we know, and what we are still searching for

Immunotherapy - Workshops
  • Rationale for immunotherapy in cervical cancer
  • Review of clinical trial outcomes
  • National clinical trial ongoing design
  • Rationale for immunotherapy biomarkers and early response prediction
Mar 314:30
Conference pass

SCDPI seminar 2: Small molecule biomarkers and modulators of immune related adverse events during immune checkpoint blocker therapy

Immunotherapy - Workshops
  • Review of immune related adverse events and immune checkpoint blockers
  • Discovery based technologies for HT small molecule profiling
  • Preliminary results of a multi cohort analysis
Sonia Sharma, Assistant Professor And Division Of Cell Biology, La Jolla Institute
Mar 314:30
Conference pass

Implementing modern cell engineering and process development approaches for affordable and sustainable biosimilar manufacturing

Biosimilars - Workshops
  • General Overview of Biosimilars/ Biologics and opportunities for the Biopharma players
  • Implementation of Gene editing tools CRISPR and TALENS for cell line engineering and production improvement
  • Modern approaches for high producer cell line and robust upstream process development
  • Use of cutting edge technologies to improve biosimilar development and manufacturing
  • Factors influences protein expression and critical quality attributes including glycosylation of monoclonal antibodies
  • mAb glycosylation and its overall Impact on biosimilarity and product performance
  • Case studies on titer and quality improvement at clone and process level for affordable biosimilar development
Mar 314:30
Conference pass

Complex innovative designs in clinical trials

Clinical Trials - Workshops
  • Design, implementation, and oversight of innovative clinical trials
  • Benefits and challenges
  • What makes them more innovative than sequential designs?
  • What can you do now that you couldn’t before?
Smita Asare, Executive Director Clinical Operations, i-Spy trials
Mar 315:00
Conference pass

SDCPI seminar 3: Demystifying the IND: regulatory pathways to accelerate patient care

Immunotherapy - Workshops
  • Learn about the “nuts and bolts” of an IND
  • Learn about expedited regulatory development pathways
  • Discuss regulatory strategies to optimize timelines
Mar 315:15
Conference pass

Investment in antibody therapeutics panel

Antibodies - Workshops
  • Panel session lead by senior investors, actively investing within the biologics industry
  • What do investors look out for in start-ups?
  • What are the current trends for biologics?
  • Where do we see the industry moving to in the next 5-10 years?
  • How can you gain investment?
Mar 315:15
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Panel discussion: Clinical trials – do we need them to get biosimilars approved?

Biosimilars - Workshops
  • 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
Mar 315:30
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SDCPI seminar 4: Clinical trials combining Radiation with Immunotherapy

Immunotherapy - Workshops
  • Goals and future directions

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Mar 409:05
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Chair’s opening remarks

Clinical Trials Keynote Plenary
Smita Asare, Executive Director Clinical Operations, i-Spy trials
Mar 409:05
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Chair's opening remarks

Keynotes
Partha Chowdhury, Senior Director And Head, Antibody Discovery, Sanofi Genzyme
Mar 409:10
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Precision immunotherapy: the San Diego perspective

Immunotherapy Keynote Plenary
Stephen Schoenberger, Professor, La Jolla Institute for Allergy and Immunology
Mar 409:15
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Evolution and advancements in cancer immunotherapy

Keynotes
  • An accidental beginning and the lag phase
  • Checkpoint modulators and establishment of a new treatment paradigm: the growth phase and growth pain
  • Understanding the pitfalls and road blocks: future efforts leading to a new horizon
Partha Chowdhury, Senior Director And Head, Antibody Discovery, Sanofi Genzyme
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
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What do we need to do in order to drive biosimilar sales growth and be seen as positive disruptors?

Biosimilars - Plenary
SPEAKING OPPORTUNITY AVAILABLE If you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 409:30
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Title TBC

Clinical Trials Keynote Plenary
Smita Asare, Executive Director Clinical Operations, i-Spy trials
Mar 409:35
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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
Stephen Schoenberger, Professor, La Jolla Institute for Allergy and Immunology
Mar 409:35
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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
Francis Rienzo, Vice President, Government Relations And Advocacy, Medicaid Health Plans of America
Margaret Dolan, Associate Director Market Access Eu Biosimilars, Biogen
Mar 409:40
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 409:50
Conference pass

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

Clinical Trials Keynote Plenary
Mar 410:05
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Discovery of GDF15 receptor (GFRAL/RET) and its novel biological pathway that controls body weight and its clinical applications

Keynotes
  • Identified GDF15 as a potent hormone for potentially treating diabetes and weight loss. GDF15 regulates food intake, energy expenditure and body weight in response to metabolic and toxin-induced stresses
  • Overview of isolation of GDF15 receptor, mechanistic identification and gaining insight of moleculat interations.
  • Identification of antagonistic antibodies, and co-crystal antibody structures leading to successfully generated antibodies intended for preventing weight loss in cancer cachexia
  • Presently GDF15 for treating diabetes and weight loss is in development by Merck through licensing, and antibody for GFRAL is in phase 1 clinical study by NGM
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 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 6: Advancement in ADCs
Table 7: Just-in-time production of antibodies
Table 9: Manufacture and production of antibodies
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
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, Chief Executive Officer And Co-Founder, QbD Biosciences
ROUNDTABLE 6 Global reference product in biosimilar development
ROUNDTABLE 7 Development and manufacturing
Mar 414:20
Conference pass

Antibody discovery for autoimmune/inflammatory disease

Antibodies - mAbs and novel modalities
  • Agonist anti-checkpoint antibodies may augment endogenous T cell inhibitory signals for treatment of T-cell driven autoimmune and inflammatory diseases
  • Checkpoint agonist antibody discovery and optimization
Bill Boyle, Head of Preclinical Development, Bioatla Llc
Mar 414:20
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
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

Re-visiting Benefits of Biosimilars in the Era of Value-based Care

Biosimilars - Commercialisation
  • Improving patient access
  • Biologics in earlier stage
  • Impact of biosimilars in oncology
  • Value addition
Houng Kim, Head Of The Strategy And Operations Division, Celltrion Healthcare
Mar 414:20
Conference pass

Navigating the biosimilar development journey for the emerging markets

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

High-throughput single-cell screening for deep mining of natural immune repertoires

Antibodies - mAbs and novel modalities
  • High-throughput single-cell screening enables the discovery of unique antibodies from natural immune systems
  • Complex selection assays allow for the identification of antibodies against challenging targets
  • AbCellera’s pipeline integrates a dynamic, interactive visualization bioinformatic tools enable the exploration of large panels of antibodies and select lead candidates
Mar 414:40
Conference pass

Optimization of preclinical safety and efficacy of anti-HER2/CD3 TDB

Antibodies - Bispecifics
  • We have investigated how affinity to HER2 and CD3 impacts anti-tumor efficacy, distribution and pre-clinical safety of anti-HER2/CD3 TDB and describe that affinity has a major impact on preclinical tolerability.
  • Strategies aiming to increase tolerability of anti-HER2/CD3 TDB are discussed
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
John Neal, Chairman, A.C.R.P.
Mar 414:40
Conference pass

Turbocharging antibodies with pClick technology

Antibodies - Armed Antibodies
  • Antibody conjugate
  • Proximity effect, Site-specific conjugation
  • No antibody engineering
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

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

High quality antibodies for therapeutic applications

Antibodies - mAbs and novel modalities
  • AbCheck discovers and optimizes human antibodies for therapeutic applications leveraging several proprietary platforms including in vitro and in vivo technologies
  • In this talk, AbCheck will present new technological developments regarding its versatile human antibody discovery and optimization platform with a focus on Rabbit Mass Humanization and AbAccelTM
  • Both technologies can be combined with AbCheck’s yeast display platform AbSieveTM and deliver high quality leads with subnanomolar affinities and good stabilities which are compatible with different antibody designs including bispecifics
Mar 415:00
Conference pass

NBE-002, 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

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

Operationalizing a clinical trial at an academic

Clinical Trials - Patient Engagement and Enrolment
  • Successful patient enrolment
  • Study feasibility review
  • Accrual goals
  • Special equipment/procedure
  • Department feedback
  • Resourcing
  • Clinical Research Group Review
  • Faculty review and group approval
  • Submission of clinical research protocol for review and approvals IRB/SRC/Finance
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

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 415:00
Conference pass

Multi-attribute monitoring for biosimilar development

Biosimilars - Development and Manufacturing
  • Learn about requirements for successful biosimilar development
  • Understand how to build an effective CMC biosimilar strategy
  • Discover forced degradation approaches to challenge CMC methodologies appropriate for the whole of your biosimilar development
Sian Estdale, Global Scientific Head, Covance
Mar 415:20
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 415:20
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

Recombinant snakebite antivenom based on human oligoclonal antibodies

Antibodies - Armed Antibodies
  • Experimental antivenom against black mamba venom
  • The first discovery of human monoclonal IgG antibodies against animal toxins
  • The first use of oligoclonal antibodies against experimental snakebite envenoming
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

Achieving broad and sustainable access to biologic medicines through biosimilars

Biosimilars - Commercialisation
  • Market opportunities
  • Pricing strategies
  • Patient discount programs
  • Potential Gains From Competition
Mar 415:20
Conference pass

Optimization project timelines and costs of biosimilar development

Biosimilars - Development and Manufacturing
  • Decision on the development of biosimilar candidate development is based on timelines assessed, needed for the development, and costs associated with the development. On top of this all this is driving the business case.
  • Optimization can be done on different levels of development, cell line development, where you can influence the titer, process development, influencing total yield, clinical strategy in order to optimize number of trials and number of subjects
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 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

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 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?
Dorthe Bartels, Strategic Adviser, Amgros
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

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 417:00
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 417:00
Conference pass

Understanding amino acid contributions to monoclonal antibody drug design success

Antibodies - mAbs and novel modalities
  • New ideas on how to objectively assess biologics candidate assets and liabilities
  • Propose a more efficient process that allows scientists to more easily align their antibodies, analyze CDR regions without extracting them, and directly correlate specific amino acids with desirable characteristics
  • Examples, including those showing surface plasmon resonance, of how humans are more efficient at analyzing visual representations of information rather than textual ones
  • Suggest a new method that can drive biologic therapeutic development much more quickly, efficiently, and accurately
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
SPEAKING OPPORTUNITY AVAILABLEIf you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
Mar 417:10
Conference pass

Reserved for sponsor

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

Advancing 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
Bill Boyle, Head of Preclinical Development, Bioatla Llc
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

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 417:20
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 417:20
Conference pass

Pharmacokinetics and disposition of immunocytokines

Antibodies - Bispecifics
  • Multifunctionality of the next generation scaffolds introduce novel drug disposition.
  • Disposition of multifunctional protein therapeutics may be driven by single domains or a combination of the various targeting domains
  • Characterization of drug disposition is a critical step to understanding the PK/PD relationship
  • Early ADME/PK studies are essential to guide the design and selection of optimal clinical candidates
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 And 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
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
Jan Zhang, Senior Associate Scientist, Amgen Inc
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

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

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Mar 508:55
Conference pass

Chair's day 2 opening remarks

Clinical Trials Keynote Plenary
Mar 509:00
Conference pass

Commerical updates on Kymriah

Immunotherapy Keynote Plenary
William Chou, Vice President, Global Commercial Disease Leader, Novartis
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

Increasing the potency of antiviral immunotherapeutics via engineered Fc regions

Antibodies - Armed Antibodies
  • Teaching potent neutralizing mAbs to hemorrhagic fever viruses new tricks
  • Second-generation ebolavirus cocktail, MBP134, with optimized Fc effector functions enhances protection
  • A single 25-mg/kg dose of MBP134 protects non-human primates challenged with EBOV, SUDV, and BDBV
Mar 509:00
Conference pass

Modulation of antibody tyrosine sulfation in CHO cell culture

Antibodies - CMC, developability and manufacturing
  • Tyrosine Sulfation is a novel PTM found on therapeutic antibodies
  • Correlation of tyrosine sulfation with other PTMs
  • Sulfation inhibitors can be used to modulate tyrosine sulfation in CHO cell culture
Mar 509:00
Conference pass

The future of healthcare: humans and machines partnering for better outcomes

Clinical Trials Keynote Plenary
  • We live in a world where data can help us make more informed decisions about how to navigate traffic, who to date, what to buy, who to network with and how to better manage our finances. But when it comes to our personal health and wellness, we have no roadmap
  • We need something to show us where we are in terms of our health, with landmarks for risks and opportunities. A GPS that makes it easier to move toward our personal health goals. A new way to look at health and life
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

Engineering HIV broadly neutralizing antibodies (ebnAbs) for improved neutralization breadth, potency and developability

Antibodies - CMC, developability and manufacturing
  • Interdisciplinary design approach that combines yeast display, deep sequencing, structure-based prediction and antibody lineage analysis to create new antibody variants
  • Diverse panels of HIV Env used to select antibody variants with globally increased affinity
  • High-throughput expression and characterization used to screen for reduced polyspecificity and improved biochemical stability
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

The use of predictive algorithms to identify markers in tumors

Clinical Trials Keynote Plenary
Mar 509:20
Conference pass

Ensuring biosimilar sustainability and market access in the USA and in EU

Biosimilars - Plenary
  • How the US and EU biosimilar market conditions compare
  • Key takeaways the US market can learn from the latest years and from the EU to increase adoption of biosimilars
  • The outlook for biosimilars in the US
Mar 509:25
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

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

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 509:40
Conference pass

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

Clinical Trials Keynote Plenary
Nancy Lutz Paynter, FORMER Director, Learning and Clinical Integration, Genentech
Mar 509:40
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 509:40
Conference pass

Biosimilars: state of clinical and regulatory science

Biosimilars - Plenary
Mar 509:40
Conference pass

Tackling regulatory and market access hurdles for biosimilars in the USA

Biosimilars - Plenary
  • Barriers to Entry
  • FDA approval
  • Litigation Issues
  • Originator’s Response
  • Return on Investment
Mar 510:00
Conference pass

Development of antibody drug conjugates to novel embryonic targets in metastatic cancers

Antibodies - Armed Antibodies
  • Our drug development strategy is driven by the concept that aggressive/metastatic cancers originate from primitive malignant cells created by cellular reprogramming
  • Our platform generates highly specific antibodies to novel cancer targets not expressed in normal tissues
  • CureMeta develops novel therapeutic antibody-drug-conjugates to treat patients with aggressive and metastatic cancers
Mar 510:00
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 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
Neelie Zacharias, Scientific Researcher, Genentech
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

Genomics and clinical trials: an opportunity for precision medicine

Clinical Trials Keynote Plenary
  • Genomic science is mature enough to include in patient treatment
  • Old style randomized clinical trials in oncology are very difficult to justify
  • A new era of open data collaboration between clinicians and molecular biology must be envisioned
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

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

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

Inactivating Treg cells in tumor microenvironment to improve efficacy of checkpoint inhibitors

Immunotherapy - Checkpoint Inhibitors
  • Treg play an important role in intratumoral resistance to checkpoint inhibitors
  • Bifunctional antibodies can deliver intratumoral cytokines with Treg modulating function while inhibiting immune checkpoints
  • Bifunctional checkpoint inhibitors powerfully resume exhausted T cell responses
Nicolas Poirier, Chief Scientific Officer, O.S.E. Immunotherapeutics
Mar 512:00
Conference pass

Planning biomarker-enriched clinical trials and evidence synthesis to improve precision medicine practice

Clinical Trials Keynote Plenary
  • Successful personalization of medicines requires unbiased data collection from prospectively planned biomarker-enriched clinical studies, objective evidence synthesis utilizing pre-specified statistical analyses, and practical presentation and communication of such evidence
  • In this presentation, I will illustrate how such clinical studies can be planned to optimize probability of trial success and to generate evidence of both therapeutic clinical efficacy and probability of meaningful clinical benefits to individual patients
  • Such well-considered planning will allow efficient development of precision medicines to satisfy multiple stakeholders including regulators, prescribers, payers and, ultimately, to benefit individual patients
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

Case Study: Zarxio, how to improve access for patients and the value proposition of biosimilar products

Biosimilars - Development and Manufacturing
  • Key factors that contributed to Zarxio becoming the only biosimilar to surpass its reference biologic in the US market and the impact on patient access
  • How real world evidence is vital to building the biosimilar value proposition
  • The ways in which clinical research and RWE can substantiate biosimilars in the U
Mar 512:20
Conference pass

Deploying gene editing in the manufacturing of clinical “off-the-shelf” engineered allogeneic CAR-T therapies

Immunotherapy - Manufacturing and Logistics
  • Lessons learned in taking gene-edited T-cell product candidates to the clinic
  • Specificities of manufacturing allogeneic CAR-T products
  • Perspective on how gene editing is transforming cell therapy and enables synthetic biology to become a reality
Mar 512:20
Conference pass

Developability assessment: Selecting the best product candidate for manufacture

Antibodies - Armed Antibodies
  • Understand the latest series of in silico computational models, analytics, in vitro and ex vivo experiments used in developability assessment
  • Characterise a molecules Specificity, Immunogenicity, Safety, Functionality and Manufacturability
  • Data generated informs sequence, structural, formulation and process refinements to select the best candidate for manufacture
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

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

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

Clinical Trials Keynote Plenary
  • 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 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

Transforming clinical trials using RWD

Clinical Trials Keynote Plenary
  • Trial design
  • Lessons learned
  • Regulatory perspective
Mar 512:40
Conference pass

Biosimilars in the UK's National Health Service: Trials, Access, Uptake

Biosimilars - Plenary
  • Experience from routine diagnostics on concentration and ADA measurements
  • One dose/ multitude of serum levels; impact of immunogenicity on PK
  • Validation of PK/ADA assays for originators for biosimilars; routine diagnostics vs. FDA/EMA registration
Mar 512:40
Conference pass

Biosimilars: Current requirements and experience with regulatory approvals

Biosimilars - Commercialisation
Panel Discussion on regulation followed by questions from the audienc
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

Support biosimilar acceptance by giving clinician and patient control using routine diagnostics Serum concentrations measurements for biologics/biosimilars- real life data

Biosimilars - Plenary
  • Experience from routine diagnostics on concentration and ADA measurements
  • One dose/ multitude of serum levels; impact of immunogenicity on PK
  • Validation of PK/ADA assays for originators for biosimilars; routine diagnostics vs. FDA/EMA registration
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 514:20
Conference pass

Comprehensive Immunogenomics for Biomarker Discovery from a Single Sample

Immunotherapy - Neoantigens
  • While the success of checkpoint blockade has been promising, it’s increasingly apparent that predicting patient response to immunotherapies requires a more robust approach to tumor immunogenomics.
  • By combining highly sensitive, exome-scale DNA and RNA sequencing with advanced analytics, ImmunoID NeXT provides a multidimensional view of the tumor and the tumor microenvironment (TME) from a single sample preparation.
  • In this presentation, we’ll discuss the benefits of this unique, innovative design for immuno-oncology translational research including mastering challenging samples, utilizing optimized algorithms, and obtaining accurate genomic data for identifying novel biomarker signatures
Mar 514:20
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 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

Increasing the use of Biosimilars- the Australian experience

Biosimilars - Commercialisation
  • The Australian government’s Pharmaceutical Benefits Scheme provides all Australians with access to safe, effective and cost effective medicines
  • The long term sustainability of the PBS relies on access to and uptake of generic and biosimilar medicines
  • Regulatory, pricing and behavioural levers are being used to increase the uptake of biosimilars
  • It will take some time to evaluate the success of these strategies which continue to evolve
Mar 514:20
Conference pass

QA Controls and Operations: Validation Qualification & Regulatory

Biosimilars - Development and Manufacturing
Nacer Hedroug, Vice President Of Operations, APS Pharma
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 514:40
Conference pass

Case Study: working with collaborators in combination studies – CIT and beyond

Clinical Trials Keynote Plenary
  • Looking at combination studies – CIT and beyond
  • Working with collaborators in order to optimize performance
  • Highlighting the key factors in making all collaborations successful
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 Immuntics

Immunotherapy - Checkpoint Inhibitors
Title and speaker TBA
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

Case study on the development and regulatory strategy of PF708, a biosimilar candidate to Forteo

Biosimilars - Development and Manufacturing
  • Comparing/contrasting biosimilars vs. 505(b)(2) regulatory pathway for recombinant peptides in the US
  • Development of PF708, a therapeutic equivalent/biosimilar candidate to Forteo
  • Comparative nonclinical and clinical results between PF708 and Forteo
Hubert Chen, Scientific & Medical Advisor, Pfenex Inc
Mar 514:50
Conference pass

Computational design of functional, multi-specific and epitope-specific antibodies

Antibodies - Computational tools for antibody engineering and characterisation
  • We use AI to design and engineer antibodies that bind to a predetermined epitope
  • These antibodies can be Multi-specific binding more than one epitope on more than one target, while maintaining fully human, natural format
  • The approach can be used to improve characteristics of existing antibodies: refine specificity and affinity, thermo-stability and developablility
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 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

Panel discussion: industry collaboration

Clinical Trials Keynote Plenary
  • Bridging the gap between industry and academia
  • How can we encourage collaboration and data sharing in the industry?
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

Case study: Spanish biosimilar developer

Biosimilars - Commercialisation
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

RosettaAntibodyDesign (RAbD): a general framework for computational antibody design

Antibodies - Computational tools for antibody engineering and characterisation
  • RAbD samples CDR conformations from structural clusters of CDRs
  • Sequence design based on the CDR sequence profiles and structural refinement is performed in Rosetta
  • RAbD is highly tailorable for different antibody optimization problems
  • RAbD was computationally benchmarked on redesigning 60 antibodies and tested experimentally on two antibody/antigen systems
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 516:30
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

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

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

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 516:55
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 516:55
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 517:20
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 517:20
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 517:45
Conference pass

Closing remarks

Keynotes
Closing remarks from the chair and from Terrapinn
last published: 22/Feb/19 16:26 GMT
 
 

 

 

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