This document provides information about the ADC Summit conference to be held on May 23-24, 2016 in London. It includes:
- An agenda for the two-day conference featuring presentations and workshops on topics related to antibody-drug conjugates (ADCs), including developments, innovations, challenges and lessons learned.
- Information about two half-day post-conference workshops on May 25th regarding ADC payloads and developments in high potency API manufacturing.
- Details on registration, discounts, speakers, sponsors and exhibition opportunities for the conference.
PEGS Europe Protein & Antibody Engineering Summit 2014 AgendaNicole Proulx
PEGS Europe is the largest European event covering all aspects of protein and antibody engineering. With two consecutive years of 40% growth in attendance, and another year of expanded program coverage, this year’s event will feature:
•500 attendees
•150 technical presentations
•70+ scientific posters
•40+ sponsors & exhibitors
•Dedicated networking opportunities
•Exclusive exhibit & poster hours
•Interactive roundtable, breakout & panel discussions
PEGS Europe Protein & Antibody Engineering Summit 2014 AgendaNicole Proulx
PEGS Europe is the largest European event covering all aspects of protein and antibody engineering. With two consecutive years of 40% growth in attendance, and another year of expanded program coverage, this year’s event will feature:
•500 attendees
•150 technical presentations
•70+ scientific posters
•40+ sponsors & exhibitors
•Dedicated networking opportunities
•Exclusive exhibit & poster hours
•Interactive roundtable, breakout & panel discussions
The only event in Asia bringing global oligonucleotide and peptide leaders together to discuss current strategies and trends to accelerate promising molecules from research to commercialization.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
Comparing and Contrasting Leading Tools for Evaluating ChemicalsSustainable Brands
Brands are increasingly concerned about the chemicals used in their products. Transparency is growing, but knowing something is there doesn't mean you know how it will affect your customers. To fill this void, a number of chemical evaluation tools (e.g. GreenScreen, GoodGuide, GreenWERCS) and product evaluation certifications have emerged. Expert Tony Kingsbury and his team looked at 32 of these tools and certifications to determine how robust their evaluation is, how many hazard endpoints they take into account, how costly they are, how transparent they are, and whether you need a PhD to use them. Find out which tools are right for your organization and what limitations they carry.
SMi’s 4th annual Peptides conference will give you the perfect platform to network, collaborate and learn over 2 days, featuring various key presentations by senior level industry professionals. With topics such as peptide formulation and delivery, as well as new advances in alternative peptide analysis technologies, Cell Penetrating Peptides, enhancements in synthesis mechanisms, analytical monitoring techniques, and many more.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. Merck’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
SMi is proud to present the 2017 19th annual Superbugs & Superdrugs conference, taking place on 20th and 21st March in Central London.
Expanding horizons on the growing threat of anti-microbial resistance for almost two decades, the flagship show in the global Superbugs portfolio of events will once again play host to an international audience of scientific leaders, funding bodies and drug discovery specialists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.
The only event in Asia bringing global oligonucleotide and peptide leaders together to discuss current strategies and trends to accelerate promising molecules from research to commercialization.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
Comparing and Contrasting Leading Tools for Evaluating ChemicalsSustainable Brands
Brands are increasingly concerned about the chemicals used in their products. Transparency is growing, but knowing something is there doesn't mean you know how it will affect your customers. To fill this void, a number of chemical evaluation tools (e.g. GreenScreen, GoodGuide, GreenWERCS) and product evaluation certifications have emerged. Expert Tony Kingsbury and his team looked at 32 of these tools and certifications to determine how robust their evaluation is, how many hazard endpoints they take into account, how costly they are, how transparent they are, and whether you need a PhD to use them. Find out which tools are right for your organization and what limitations they carry.
SMi’s 4th annual Peptides conference will give you the perfect platform to network, collaborate and learn over 2 days, featuring various key presentations by senior level industry professionals. With topics such as peptide formulation and delivery, as well as new advances in alternative peptide analysis technologies, Cell Penetrating Peptides, enhancements in synthesis mechanisms, analytical monitoring techniques, and many more.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. Merck’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
SMi is proud to present the 2017 19th annual Superbugs & Superdrugs conference, taking place on 20th and 21st March in Central London.
Expanding horizons on the growing threat of anti-microbial resistance for almost two decades, the flagship show in the global Superbugs portfolio of events will once again play host to an international audience of scientific leaders, funding bodies and drug discovery specialists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.
Providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities, SMi presents the 20th annual Superbugs & Superdrugs conference which will return to Central London on 19th and 20th March 2018.
The threat of AMR is regularly making front page news but what is the industry actually doing? Are drug manufacturers any closer to finding a solution and how is the government helping? These will be just some of the questions answered through powerful keynote addresses delivered by an expert panel of scientific leaders, drug discovery specialists and government bodies such as MHRA and DNDi.
SMi’s 3rd annual conference
Immunogenicity
13th and 14th June 2016, Holiday In Kensington Forum, London, UK.
Immunogenicity of an antigen is frequently encountered in the context of vaccine development, an area of intense interest currently due to the emergence or re-emergence of infectious pathogens with the potential for worldwide spread. With the global vaccine market expected to reach $84.44 billion by 2022, now is the time engage with industry experts to addresses the real challenges with immunogenicity including assay assessment, the role of aggregation, the introduction of nanobodies and many more!
For further information or to register please visit the event website www.immuno.co.uk or contact Matthew Apps on +44 (0) 207 827 6093 or mapps@smi-online.co.uk
CHI's 10th Annual Next Generation Dx Summit, August 20-24, 2018, Washington, DCJames Prudhomme
Next Generation Dx Summit has grown to more than 1,000 international diagnostic professionals working in the field and offers unparalleled insight from the comprehensive programming and networking with key opinion leaders in the industry. The event is unique in the marketplace. This year the coverage spans cell- and cell-free biopsies, commercialization, reimbursement, biomarkers and companion diagnostics for immunotherapy, point-of-care testing, infectious disease, microfluidics and precision medicine. Now in its tenth year, Next Generation Dx Summit is a must-attend event with complete coverage of the most timely and important issues for the industry.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
2024.06.01 Introducing a competency framework for languag learning materials ...
SMi Group's ADC Summit 2016
1. www.adcsummit.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
A: ADC payloads: Availability and
mechanisms of action
Workshop Leaders:
David Thurston, Professor of Drug Discovery, King’s College London
Paul Jackson, Project Manager, Femtogenix
08.30 – 12.30
B: Developments in high potency
API manufacturing
Workshop Leaders:
Richard Denk, Head Sales Containment, SKAN AG
Martin Glaettlim, Sales Engineering Containment, SKAN AG
13.30 – 17.30
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 25th May 2016, Holiday Inn Kensington Forum, London, UK
REGISTER BY 29TH FEBRUARY AND RECEIVE A £400 DISCOUNT
REGISTER BY 31ST MARCH AND RECEIVE A £200 DISCOUNT
@SMIPHARM
#SMiADC
SMi Present the 5th Annual Conference on…
ADC Summit
Holiday Inn Kensington Forum, London, UK
23 - 24
MAY
2016
Exploring the latest innovations in conjugation approaches and
technologies for the development of next generation ADCs
Highlights for 2016:
• Takeda presents how ADCETRIS® (brentuximab vedotin)
developed to treat Hodgkin Lymphoma
• Advancement in ADCs:
A step closer to magic bullets in war against cancer
• Safety at the forefront - homogeneity of ADCs for highly
effective and safer cancer therapy
Sponsored by
Chairs for 2016:
Rakesh Dixit,
Vice President, R & D,
MedImmune
Mahendra Deonarain,
Chief Science Officer,
Antikor Biopharma Ltd
Featured Speakers:
• Ashish Gautam, Global Medical Lead – ADCETRIS, Takeda
• Ben-Fillippo Krippendorff, Principal Scientist, Roche
• Jeremy Parker, Principal Scientist, Pharmaceutical
Development, AstraZeneca
• Debbie Meyer, Senior Principal Scientist, Pfizer
• Jens Lohrmann, Senior Global Program Manager, Novartis
2. ADC Summit
Day One | Monday 23rd May 2016 www.adcs
Register online at: www.adcsummit.com • Alternatively fax yo
Sponsored by
08.30 Registration and Coffee
09.00 Chairman’s opening remarks
Rakesh Dixit, Vice President, R & D, MedImmune
OPENING ADDRESS
09.10 Advancement in antibody drug conjugates: A step closer to
magic bullets in war against cancer
• The 5 Rs of ADCs: the right target, the right linker, the right
warhead, the right antibody, the right site of conjugation
• Recent developments with site-specific conjugation
improving the therapeutic index of ADCs
• Exploring how reducing hydrophobicity of homogeneous
ADCs can improve therapeutic index
• Discussing how the stability of the linker can improve
therapeutic index
• Discussing the on- and off-target toxicity issues
• Clinical development of ADCs
Rakesh Dixit, Vice President, R D, MedImmune
INNOVATIONS IN ADC
09.50 Warheads for targeted therapies of cancer: Strategies for
designing and efficient synthesis of DNA cross-linkers
• Some DNA cross-linkers are too toxic to be used as
antineoplastic agents; instead, they are excellent
candidates for the design of ligand-drug conjugates for
cancer targeting
• New concept for design of DNA cross-linkers
• Efficient total synthesis of cross-linker derivatives for
conjugation
Iontcho Vlahov, VP Discovery Chemistry, Endocyte, Inc.
10.30 Morning Coffee
11.00 Development of best-in-class, homogeneous ADCs for highly
effective and safer cancer therapy
• Sortase-mediated antibody conjugation (SMAC™): A robust
and efficient means to attach toxic payloads to antibodies
• Highly site-specific conjugation yields homogenous drug
product with defined efficacy, PK properties and safety
profile
• Peptide-based linker structure circumvents IP issues and
provides superior serum stability
• In vivo data on lead ADCs generated using site-specific
SMAC™ - technology will be presented
Roger R. Beerli, Chief Scientific Officer, NBE-Therapeutics Ltd.
11.40 Preclinical efficacy of a novel anti-C4.4a (LYPD3) antibody
drug conjugate BAY 1129980 for the treatment of lung cancer
• C4.4a (LYPD3) is a novel targeting antigen overexpressed in
several cancer indications
• Design of BAY 1129980 employing a novel auristatin
• Discuss the in vitro and in vivo efficacy profile
• Phase 1 clinical studies updates (NCT02134197)
Joerg Willuda, Senior Scientist, Bayer
12.20 Networking Lunch
13.50 Producing better ADCs using ThioBridge™ conjugation
• Disulfide re-bridging conjugation to reduce ADC
heterogeneity
• ThioBridge™ linkers provide stable conjugation
• PK profiles of ThioBridge™ ADCs vs maleimide conjugation
• Development of more efficacious ADCs
George Badescu, Director of Scientific Affairs, Abzena
14.30 Novel site-specific conjugation tools
• N-terminal serine modification for antibody conjugation:
SeriMabs
• Excellent in vitro activity achieved through site-specific
conjugation
• Site-specific conjugates are stable and efficacious in vivo
Thomas A. Keating, Director, Biochemistry, ImmunoGen, Inc.
15.10 Afternoon Tea
NOVEL ADC TECHNOLOGIES
15.50 A Novel FRET reagent reveals the intracellular processing of
antibody-drug conjugates
• Our FRET assay provides a facile and robust assessment of
intracellular ADC activation
• The antigen-mediated antibody internalization is determined
by the nature of cell, not by the nature of antigen
• A certain tumor cell showed a limited cytosolic transport of
the payload despite the efficient linker cleavage
Byoung-Chul Lee, Scientist, Protein Chemistry, Genentech
16.20 Expanding the scope of ADC targets through novel
conjugation technologies
• APN linkers with increased serum stability
• New generation of DM1- and MMAE-based payloads
• Expanding the scope of ADC targets by fine-tuning the drug
release mechanism
Oleksandr (Sasha) Koniev, CEO Founder, Syndivia
17.00 Platform technologies for homogeneous and versatile protein
modification
• Functional disulfide re-bridging
• Controlled dual “click” functionalisation
• Site-selective antibody conjugation
• Photodynamic therapy
• Reversible and irreversible cysteine modification
Vijay Chudasama, Lecturer Organic Chemistry and Chemical
Biology, University College London
17.40 Chairman’s Closing Remarks and Close of Day One
Rakesh Dixit, Vice President, R D, MedImmune
Abzena offers a suite of complementary services and technologies.
Its range of technologies include immunogenicity assessment,
antibody drug conjugation, protein engineering, PEGylation, cell
line development, GMP manufacturing and a range of bespoke
assays to enables the development of better biopharmaceuticals
which will have a greater chance of reaching the market.
www.abzena.com
Sponsorship and Exhibition Opportunities
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your
company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base
within the context of an independent discussion specific to your industry.
Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call:
Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
Official Media Partners
3. ADC Summit
Day Two | Tuesday 24th May 2016summit.com
08.30 Registration and Coffee
09.00 Chairman’s opening remarks
Mahendra Deonarain, Chief Science Officer, Antikor Biopharma Ltd
LEARNING FROM KADCYLA AND ADCETRIS
OPENING ADDRESS / KEYNOTE ADDRESS
09.10 ADCETRIS® (brentuximab vedotin) developed to treat
Hodgkin Lymphoma
• Development of ADCETRIS® - Takeda and Seattle Genetics
alliance
• Exploring the mechanism pathway of ADCETRIS®
• Data published to date from ADCETRIS® registration studies
• Ongoing ADCETRIS® clinical development
Ashish Gautam, Global Medical Lead - ADCETRIS, Takeda
09.50 Predicting tissue distribution and clearance of antibody
formats to improve selectivity of targeted therapies
• Estimating the tissue distribution of antibodies and antibody
fragments based on plasma pharmacokinetics
• Estimation of ADC distribution and tissue specific clearances
that influence the therapeutic window
• Optimise biotherapeutic modalities with optimal
biodistribution properties to target (and avoid) specific tissues
Ben-Fillippo Krippendorff, Principal Scientist, Roche
10.30 Morning Coffee
CHALLENGES AND LESSONS LEARNT
11.00 Impact of drug loading on ADC target binding and cytotoxicity
• Demonstrating the impact of different levels of drug loading
• ADC target binding and cytotoxicity
• Case studies
Debbie Meyer, Senior Principal Scientist, Pfizer
11.40 Targeting Cadherin-6 (CDH6) with a novel ADC for the
treatment of ovarian and renal cancers
• ADC lead selection covering optimal choice of antibody
and linker/payload
• PK/PD studies to evaluate MoA and projected efficacious
dose
• Population-scale in vivo assessment in ovarian cancer PTX
clinical trial
Carl Uli Bialucha, Senior Investigator,
Novartis Institutes For Biomedical Research
12.20 Networking Lunch
13.50 Engineering and development of novel immunotargeted
nanotherapeutics
• Engineering considerations for a novel antibody directed
nanotherapeutic
• Target expression and demonstration of targeting
• Preclinical demonstration of activity and altered tox profile
• Diagnostic development and clinical trial design for
upcoming Phase I
Daryl Drummond, Senior Director, Nanotherapeutics,
Merrimack Pharmaceuticals Inc
14.30 The design, synthesis and scale-up of an ADC tubulysin
payload
• Development of novel ADC payloads based on Tubulysins
• Identification and development of synthetic routes
• Scale up of chemistry to deliver material for toxicology and
clinical studies
Jeremy Parker, Principal Scientist, Pharmaceutical
Development, AstraZeneca
15.10 Afternoon Tea
15.50 Challenges and lessons learnt in ADC CMC development and
outsourcing
• Buy vs. make: Considerations and critical success factors
• Scale-up and site transfer of a conjugation process with
impact on key product quality attributes: case studies
• Analytical transfers: considerations and lessons learned from
a challenging assay transfers
Jens Lohrmann, Senior Global Program Manager, Novartis
16.20 Fragment drug conjugates (FDCs): A unique drug class or just
smaller ADCs?
• Using optimised single chain Fvs to obtain high
drug-to-antibody ratio (DAR)
• Impact of drug/linker structure on FDC properties
• Dosing, PK and penetration issues
Mahendra Deonarain, Chief Science Officer, Antikor Biopharma Ltd
17.00 Chairman’s Closing Remarks and Close of Day Two
Mahendra Deonarain, Chief Science Officer, Antikor Biopharma Ltd
our registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Honey De Gracia, SMi Marketing on +44 (0) 207 827 6102 or email: hdegracia@smi-online.co.uk
Supported by
4. A: ADC payloads: Availability
and mechanisms of action
Workshop Leaders:
David Thurston, Professor of Drug Discovery,
King’s College London
Paul Jackson, Project Manager, Femtogenix
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 25th May 2016
08.30 – 12.30
Holiday Inn Kensington Forum, London, UK
Overview of workshop
This workshop will focus on the variety of chemical and
biological payloads available for attaching to antibodies,
and those in the discovery and/or development
phase. Discussion will be based on how the structure
and mechanism of action of payloads can affect
their toxicities and clinical activities when attached to
antibodies, and how the best payload can be identified
for a particular cancer type and/or antibody.
Programme
08.30 Registration
09.00 Mechanisms of actions
• The range of payload types commercially
available and their mechanism of actions
• Payloads at the discovery or development
stages
10.00 Molecular modelling technique
• Molecular modeling approaches to
payload discovery
• Designing maximum cytotoxicity into
payloads
11.00 Morning Coffee
11.30 Design and engineering of payloads
• Engineering payloads to not release
prematurely
• Strategies to minimise the hydrophobicity
• Ensuring maximum resistance to
P-glycoprotein pumps in payload design
12.30 End of Workshop A
About the workshop leaders:
David Thurston is a Professor of Drug Discovery in the
Institute of Pharmaceutical Science at King’s College
London. He has a first degree in pharmacy and a PhD
in synthetic medicinal chemistry. David is one of the
scientific co-founders of Spirogen Ltd (recently acquired
by AstraZeneca), and acted as CSO for the company
fromitsformationin2000until2011. Heisalsoaco-founder
of Transcriptogen Ltd, which focusses on the discovery
and development of small-molecule transcription factor
inhibitors as oncology agents, and Femtogenix Ltd which
is involved with the discovery of novel DNA Minor Groove
Binding Agents (MGBAs) with potential application as
ADC payloads. David has published widely in medicinal
chemistry/chemistry journals, is author of the textbook
“Chemistry and Pharmacology of Anticancer Drugs”,
and Editor-in-Chief of the Drug Discovery book series of
the Royal Society of Chemistry.
Dr. Jackson holds an undergraduate degree in
the pharmaceutical sciences (LJMU), an MSc in
Bioinformatics (University of Liverpool) and a PhD in
Computational Drug Discovery (King’s College London).
Hehasextensiveexperienceininsilicomethods,including
structure-, ligand- and fragment-based drug design. He
has also been involved in the development of QSAR,
lead optimization and molecular docking techniques.
Both his PhD and post-doctoral research have involved
the development of novel computational chemistry
methods (e.g., molecular dynamics simulation
techniques) for the design and evaluation of ADC
payloads, which has contributed to Femtogenix’s novel
payload discovery platform.
5. B: Developments in high potency
API manufacturing
Workshop Leaders:
Richard Denk, Head Sales Containment, SKAN AG
Martin Glaettlim, Sales Engineering Containment,
SKAN AG
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 25th May 2016
13.30 – 17.30
Holiday Inn Kensington Forum, London, UK
Overview of workshop
ADC payloads typically present high toxicity at extremely
low doses when unconjugated, resulting in very low
Occupational Exposure Levels (OEL). Their production
requires chemistry carried out at small scale under high
containment in a GMP compliant environment. For
these reasons, any activity related to ADC payloads
production requires a contained and specially designed
environment, including those for RD, analytical,
production, storage.
Programme
13.30 Registration
14.00 What does containment mean for very low
OEL’s
• Containment in low nanogram levels
requires a new approach how to design the
containment and the process
• What technologies are on the market
• How to design the containment for the
API production as well as for the aseptic
processing
16.00 Afternoon Tea
16.30 Case study on a low OEL aseptic processing
solution
• Important considerations and parameters
during design of low OEL aseptic processing
• How to combine EHS and GMP
• Final design implementation
17.30 End of Workshop B
About the workshop leaders:
Richard Denk, Head Sales Containment, SKAN AG
Richard Denk has studied mechanical engineering and
is working at the company SKAN AG, headquartered
in Allschwil in the position of Head Containment Group.
Mr. Denk founded 8 years ago the expert Containment
group of the ISPE D / A / CH. The Containment Group
published the Containment Manual in September 2015.
The Containment Manual does provide a full overview
on Containment. Furthermore, Mr. Denk has spent nearly
20 years with the subject production of highly active /
highly hazardous substances and has developed the
containment pyramid.
Martin Glättli is the Sales Engineer for containment at
SKAN AG in Switzerland. He is a frequent speaker at
industry events, and writes articles for pharmaceutical
engineering journals on a regular basis.For over 10 years
Martin has acquired in-depth knowledge of environment-
protected process design and realized state-of-the-art
solutions for various well-known companies. His current
work focuses on offering solutions for cleaning and
maintenance-friendly containment design, as well as
closing the gap between the requirements of contained
processing and sterile processing technology.
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VENUE Holiday Inn Kensington Forum, 97 Cromwell Rd, London SW7 4DN, UK
5th ANNUAL ADC SUMMIT
Conference: Monday 23rd Tuesday 24th May 2016, Holiday Inn Kensington Forum, London, UK Workshops: Wednesday 25th May 2016, London, UK
4 WAYS TO REGISTER
www.adcsummit.com
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