1. SMi presents the 4th annual…
PLUS INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 20th May 2014, Holiday Inn Bloomsbury Hotel, London, UK
ADCs: A Journey Through Development
Workshop leaders: Dr Richard Turner, Principal Consultant, Natalie Thomas, Consultant, Simon Bishop, Associate Consultant, BioDesk
8.30am - 12.30pm
18 -19
MAY
2015Holiday Inn Bloomsbury Hotel, London, UK
ADC Summit 2015
Elevating ADCs to peak performance in the clinic
www.drugconjugates.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
REGISTER BY THE 27TH FEBRUARY AND SAVE £300 • REGISTER BY THE 31ST MARCH AND SAVE £100
CONFERENCE CHAIRS:
Mahendra Deonarain, Chief Science Officer,
Antikor Biopharma Ltd.
David Thurston, Professor of Drug Discovery
King’s College London
KEY SPEAKERS INCLUDE:
Angela Romanelli, Senior Director,
Biomarkers ImmunoGen, Inc
Christophe Bonny, Chief Scientific Officer,
Bicycle Therapeutics Limited
Klaus Bosslet, Head Discovery Oncology, Pharma
Research & Early Development, Roche Innovation
Centre Penzberg
Iontcho Vlahov, Vice President of Discovery
Chemistry, Endocyte Inc.
Vijay Chudasama, Research Associate, University
College London
BUSINESS BENEFITS FOR 2015:
• Hear more about the payload developments
• Receive updates on ADCs in clinical trials
• Learn more about biodistribution and tumour
penetrations
• Aim for improvement of the therapeutic index
• Discover strategies for effective targeting and
managing ADC off-target toxicities
• Understand the status of the development of novel
binding moieties
@SMIPHARM

2. Register online at: www.drugconjugates.com • Alternatively fax y
ADC Summit 2015
Day One | Monday 18th May 2015
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Mahendra Deonarain, Chief Science Officer, Antikor Biopharma Ltd.
ADVANCING ADC/RIT THERAPIES - PART 1
OPENING ADDRESS
9.10 Biomarkers: Improving drug development success by linking
ADC therapy to the right patient
•Translating our biological understanding into successful
development of meaningful therapies for patients through
Biomarkers
•Targeting antigen expression is only the starting point, it is
necessary but not sufficient
•Thinking beyond payload delivery: How does tumour
biology impact sensitivity to the ADC payload?
•Building the right biomarker test: The right assay on the right
sample is critical for enabling selection of the right patient
in the clinic
Angela Romanelli, Senior Director of Biomarkers, ImmunoGen, Inc.
9.50 Designing novel warheads for targeted therapies: Efficient strategies
for making natural tubulysins, analogs, and their conjugates
•Any tubulysin is too toxic to be used as antineoplastic
agent itself; instead, they are excellent candidates for the
design of ligand-drug conjugates for cancer targeting
•New methodologies for the synthesis of natural tubulysins
and their analogs
•Design of new tubulysin analogs with improved cytotoxicity
and stability profiles
Iontcho Vlahov, Vice President of Discovery Chemistry,
Endocyte, Inc.
10.30 Morning Coffee
11.00 RG7787, a Mesothelin-binding Pseudomonas exotoxin-based
cytolytic fusion protein
•Pay load delivery
•Tumour selective protein synthesis inhibition and impact on
immune-suppression in tumour mass
•In vitro and in vivo potency and efficacy on very slowly
growing large tumours
•Recombinant fusion protein as advantageous alternative
technology compared to ADCs
Klaus Bosslet, Head Discovery Oncology, Pharma Research
& Early Development, Roche Innovation Centre Penzberg
11.40 Arming disease-targeting ligands with cytokines and with
cytotoxic drugs
•Use of highly validated vascular targeting antibodies for
pharmacodelivery applications.
•Antibody-cytokine fusions: From the bench to the clinic
•Cancer cures with non-internalising antibodies and low-
molecular weight ligands
Giulio Casi, Head of Targeted Cytotoxics Development,
Philochem AG
12.20 Networking Lunch
A MATTER OF SIZE: EXPLORING THE SMALL
KEYNOTE ADDRESS
1.20 High affinity bicyclic peptides:
Application to payloads in oncology
•Scaffold-constrained bicyclic peptides (bicycles) show
target-binding properties similar to antibodies, but in a
100-fold smaller format
•Bicycles penetrate tumours rapidly, delivering high
concentrations of payloads over hours, thus allowing
efficient tumour killing while minimizing systemic toxin exposure
•In vivo POC data using different targets and payloads will
be presented
Christophe Bonny, Chief Scientific Officer,
Bicycle Therapeutics Limited
2.00 The Nanobody® platform: Opportunities for next generation
drug conjugates
•Nanobodies are clinically validated small antibody
fragments derived from heavy-chain only camelid antibodies
•Explore the formatting flexibility allowing full control over
valency and multi-specificity
•Multiple conjugation chemistries possible
•Understand the manufacturing properties
Carlo Boutton, Director of Technology, Ablynx
2.40 Seriously? Folic acid can replace an antibody for targeting
potent warheads to tumours?
•The folate receptor is a tumour biomarker target
•What are small molecule drug conjugates (SMDC)?
•Use of companion imaging for selection of biomarker
positive patients
•16 years of SMDC clinical development
Christopher P. Leamon, VP, Research, Endocyte, Inc.
3.20 Afternoon Tea
3.50 Round Table Discussion: A matter of size: Is the future small?
•Does size matter?
•What size do you need and why?
•How best can you use the consequences of size?
•Discuss the data that is available to prove it
Peter Bach, Director, BioPharmaLogic Ltd.
4.20 Can You Handle Highly Potent Compounds Safely?
Are You Sure?
•Biological and chemical substance occupational hazards
•Facilities, features and equipment for handling ADC
components
•How do you know if it’s safe for your workers?
•Integration of health and safety into ADC projects
Justin Mason-Home, Managing Director, SafeBridge Europe
5.00 Using IP to benefit from ADC technologies
•Types of patent protection available for ADC
technologies
•Data requirements for ADC patents and when to file
•Freedom to operate challenges for ADC
•How to benefit from IP transactions - legal challenges and
opportunities
James Legg, Patent Attorney, Boult Wade Tennant
5.20 Chairman's Closing Remarks and Close of Day One
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3. your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
ADC Summit 2015
Day Two | Tuesday 19th May 2015
Supported by
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
David Thurston, Professor of Drug Discovery, King’s College
London
ADVANCING ADC/RIT THERAPIES - PART 2
KEYNOTE ADDRESS
9.10 The onward march of ADCs – How near the end are we?
•How do ADC technologies compare to other types of
anticancer therapies?
•What are the pros and cons of ADCs vs. other therapies?
•What are the likely new developments in ADC technologies
to help them stay ahead?
•What are the major competitors for ADCs in the coming
decades?
David Thurston, Professor of Drug Discovery, King’s College
London
9.50 Small is beautiful-antibody-targeted nanomedicines
•Nanomedicine is a rapidly developing field of
macromolecular drug development
•Advances in industrial production mean that more of these
experimental agents can be translated to the clinic
•Antibodies can modify the characteristics of
nanomedicines and improve therapeutic effects
•Recent work in the field from ourselves and others will be
discussed, highlighting how antibody-nanoparticles may
represent a novel ADC platform
Chris Scott, Chair of Pharmaceutical Biosciences, Queens
University Belfast
10.30 Morning Coffee
11.00 Opti-linked antibody fragments as ADCs
•Optimizing single chain Fvs for bioconjugation
•High DAR
•Maintaining good PK
•Ensuring good QA
Mahendra Deonarain, Chief Scientific Officer, Antikor
Biopharma Ltd
11.40 From modified peptides to modified proteins:
New approaches to immunological recognition
•Application of sortase as a convenient approach to
quantitative modification of proteins
•Alternative approaches to the generation of multicyclic
peptides
•Selection and application of affimers as alternatives to
antibodies in diagnostic applications.
Michael Webb, Associate Professor, University of Leeds
12.20 Networking Lunch
LINKING AND LOADING
1.20 Robust disulfide bridging reagents enable delivery of a
well-characterised and multi-functional ADC platform
•Homogeneous ADCs
•Site-selective modification
•Bispecifics
•Orthogonal click functionalisation
Vijay Chudasama, Research Associate, University College London
2.00 Click chemistry-triggered activation of ADCs in vivo
•New linker concept to expand the range of ADC targets to
poorly internalizing receptors, extracellular matrix
constituents and stroma
•ADC administration followed by chemical probe that reacts
with the linker on the tumour-bound ADC, releasing the
drug in the extracellular matrix
•Maximized bystander effect: Potentially advantageous in
heterogeneous or poorly penetrated tumours
•Proof of principle data in tumour-bearing mice with anti-
TAG72 ADC comprising CC49 mAb and model drug
doxorubicin
Marc Robillard, CEO, Tagworks Pharmaceuticals
2.40 Sortase-mediated antibody conjugation (SMAC™):
Generation of homogeneous, site-specifically conjugated
antibody drug conjugates
•Sortase enzymes provide 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 is
expected to provide superior serum stability.
•Production of dual payload ADCs may help address
resistance and provide opportunity to tackle tumour
heterogeneity and quiescence
Roger Beerli, Vice President Research & Development,
NBE-Therapeutics AG
3.20 Afternoon Tea
4.00 Clinical development of ADCs: The EU landscape, trial design
and the impact of the new clinical trial regulation
•Overview of the landscape of clinical studies on ADCs in
Europe
•Clinical trial design considerations: Patient population,
endpoint selection, comparator choice, dose regimen
selection.
•The impact of implementation of the Clinical Trial
Regulation on conduct of clinical studies in Europe
•Regulatory strategies in Europe to expedite time to market
Natalie Thomas, Consultant, Clinical Network Services (UK) Ltd
4.20 Chairman’s Closing Remarks and Close of Day Two
David Thurston, Professor of Drug Discovery, King’s College
London

4. HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 20th May 2014
8.30am - 12.30pm
Holiday Inn Bloomsbury Hotel, London, UK
ADCs: A Journey Through Development
Workshop Leaders:
Dr Richard Turner, Principal Consultant, BioDesk
Dr Natalie Thomas, Consultant, BioDesk
Dr Simon Bishop, Associate Consultant, BioDesk
Overview of workshop:
This workshop will provide attendees with an overview of
data requirements for ADCs through the development
lifecycle, outlining the key CMC challenges and mitigation
strategies for the product types, and first-in-man enabling
preclinical development activities to ensure a smooth
transition from bench to bedside. Clinical study designs from
Phase 1 will be discussed through the use of case studies. The
workshop will then take attendees on a journey through the
additional data requirements to support Phase II and III
clinical development. At each stage the differences in data
requirements between the US and EU will be discussed. The
final component of the workshop will introduce the route to
ultimate approval of an ADC in the US and EU.
Why should delegates attend this workshop:
Delegates will gain an understanding of:
• Regulatory and product development requirements for
entry in to the clinical and marketing authorisation
• Common pitfalls and mitigation strategies in ADC
development to allow anticipation of regulators’
concerns at clinical trial application and marketing
authorisation application stages
• Regulatory requirement distinctions between the US and
EU, and regulatory options available to expedite time to
market
Programme
8.30 Registration and coffee
9.00 Opening Remarks
9.15 CMC Development: ADC Specifics
10.15 Enabling First-in-Human Studies
• Pre-clinical data requirements
• Trial design to maximise knowledge gained from
early stage clinical studies
10.45 Coffee break
11.15 Beyond Phase I Clinical Studies
• Clinical case studies – successful and less
successful approaches.
• Key recommendations for trial design to maximise
the likelihood of success
11.45 Key regulatory drivers for an expedited global
development
• Regulatory considerations for a global
development program including key differences
for US and EU approvals
• Regulatory strategies to maximise efficiency to
market
12.15 Closing remarks
12.30 End of workshop
About the workshop hosts:
Dr Richard Turner, BioDesk's Principal Consultant in the UK
office, has been working in biopharmaceutical
development for over 20 years. Richard is a former
pharmaceutical and scientific assessor at the Medicines
Control Agency (now known as the UK MHRA) and has
worked in senior Regulatory positions in a number of
biopharmaceutical development companies and
consultancies including Daiichi Sankyo, Lonza Biologics, ERA
Consulting, Elan and Antisoma.
Dr Natalie Thomas is a Consultant with CNS (UK) and has
over ten years’ pharmaceutical industry and consulting
experience, initially in early stage oncology drug
development and more recently in regulatory affairs.
Natalie has worked on products at all stages of
development, supporting companies from discovery
through to marketing authorisation.
Dr Simon Bishop is an Associate Consultant with three years’
experience in technical writing. At CNS, Simon works with
clinical documentation, including protocols, Investigator’s
Brochures and study reports, marketing authorisation
applications and regulatory documentation regarding
paediatrics and orphan drugs. Simon has a PhD in
developmental neurobiology and previously worked for the
Nature Publishing Group as a scientific literature editor.
About the Clinical Network Services:
Clinical Network Services (CNS) is a
uniquely integrated service group focused
on product development headquartered
in Australia with offices in New Zealand,
the UK and the USA. Through BioDesk we
provide a comprehensive range of services in the strategic
planning and delivery of CMC/non-clinical development
programs, then, leveraging our extremely pragmatic
regulatory environment, we can rapidly initiate phase 1 & 2
clinical trials in Australia/New Zealand.

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ADC SUMMIT 2015
Conference: Monday 18th May & Tuesday 19th May 2015, Holiday Inn Bloomsbury Hotel, London, UK Workshop: Wednesday 20th May 2015, London
4 WAYS TO REGISTER
www.drugconjugates.com
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