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“Good insight into industry knowledge and needs”

SMi Presents the 3rd annual…

ADC Summit 2014
Making your smart bomb smarter
– creating innovative antibody-drug conjugates
Holiday Inn Regents Park Hotel, London, UK

19TH - 20TH

MAY
2014

Conference Chairs
Dr Mahendra Deonarain,
Chief Scientific Officer,
Photobiotics

Dr Adeela Kamal,
Associate Director, R&D,
Oncology Research,
MedImmune

Key Speakers Include:
• Philip Howard, PhD, Chief Scientific Officer, Spirogen Limited
• Dr Trevor Hallam, Chief Scientific Officer, Sutro Biopharma
• Dr Ronald Elgersma, Project Leader, Antibody-Drug Conjugates,
Synthon
• Dr Erica Hong, Scientist, ImmunoGen
• Dr Hagop Youssoufian, Executive Vice President of R&D, Progenics
• Dr Pamela Trail, Vice President Oncology, Regeneron
• And many more!

Benefits of attending:
• Hear cutting edge presentations and key case studies from
leading ADCs experts
• Network and learn from industry and academic opinion leaders
• Learn about latest developments pertaining to the components of
ADCs (payload, antibody and linker)
• Discover what is happening with next generation ADCs

PLUS INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 21st May 2014, Holiday Inn Regents Park Hotel, London, UK

Early phase development considerations for ADCs: Expectations for a first-in-man
Workshop leaders: Dr Gavin Edwards, Manager, PAREXEL Consulting
Dr Amanda Suitters, Principal Consultant, PAREXEL Consulting
8.30am - 5.00pm

Sponsored by

www.adcsummit.com
BOOK BY 28TH FEBRUARY AND RECEIVE A £300 DISCOUNT OR BOOK BY 31ST MARCH AND RECEIVE A £100 DISCOUNT
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ADC Summit 2014
Day One | Monday 19th May 2014
8.30

Registration & Coffee

9.00

Chairman's Opening Remarks
Dr Mahendra Deonarain, Chief Scientific Officer, Photobiotics

1.30

NANOTECHNOLGY

9.10

OPENING ADDRESS
The development of nanobodies and their potential use for
ADC
• An update on the nanobody platform
• Discussing the advantages for ADC
Dr Antonin de Fougerolles, Chief Scientific Officer, Ablynx

Antibody fragment ADCs
• Use of engineered single-chain Fvs
• Light-activated and other payloads
• Comparison with whole antibodies
Dr Mahendra Deonarain, Chief Scientific Officer, Photobiotics
PRE-CLINICAL DEVELOPMENT

10.30

Exploring nano-delivery systems for antibody delivery
• Learning about the emerging applications of
nanotechnologies in ADC.
• Understanding how nanotechnology is at the leading edge
of cancer drug delivery due to its emerging features of:
- controlled release
- antibody-driven specificity
Professor Katherine Vallis, Professor of Experimental
Radiotherapeutics, University of Oxford

Creating effective strategies to reduce toxicity
• Utilizing novel linkers and payloads to improve therapeutic
index
• Examining ways to overcome the resistance developed in
clinical ADCs
• Using site specific antibody modifications to improve efficacy
Dr John Flygare, Project Leader, Discovery Chemistry,
Genentech

2.50

PSMA ADC in prostate cancer: PK/PD analysis from a phase 1
clinical trial
• Introducing novel paradigms to assess the therapeutic
efficacy in prostate cancer
• Implementing population-based model of longitudinal PSA
measurement from phase I clinical trial
• Correlation of exposure and therapeutic effect
Dr Hagop Youssoufian, Executive Vice President of R&D,
Progenics

3.30

Afternoon Tea

3.50

Development of second generation duocarmycin ADCs with
superior therapeutic window
• Developing duocarmycin based linker-drug technology
• Conducting preclinical evaluation with in vitro and in vivo
studies
Dr Ronald Elgersma, Project Leader, Antibody-Drug
Conjugates, Synthon

4.30

9.50

2.10

Let’s have a debate! Discussing creative ways to make
the ‘smart bomb’ more intelligent when building your
oncology arsenal
• Discussing latest challenges and improvements to various
pieces of the of ADC technology puzzle pertaining to:
- Antibodies
- Drugs
- Linkers that bond them together
Philip Howard, PhD, Chief Scientific Officer, Spirogen Limited

Morning Coffee

10.50

Producing Better Antibody-Drug Conjugates (ADCs) Using
ThioBridge™ Conjugation
• Site-specific conjugation to disulfide bonds of antibodies
and antibody fragments reduces ADC heterogeneity
• ThioBridge™ linkers provide stable conjugates and can be
used with a variety of payloads
• ThioBridge™ technology can be used to create novel ADC
formats
• In vitro and in vivo data demonstrates good efficacy for
mAb and Fab conjugates with an established payload
George Badescu, PhD, Director of Scientific Affairs Bioconjugation & Protein Engineering, PolyTherics Ltd, UK

11.30

Working in perfect harmony - selecting the right target and
the right antibody
• Understanding lessons learned from target identification
and validation
• Realizing the importance of target expression and
internalization
• Reviewing approaches to select a lead ADC: a case study
Dr Adeela Kamal, Associate Director, R&D, Oncology
Research, MedImmune

12.10

Networking Lunch

ROUNDTABLE

MANUFACTURING ADCs

5.10

Chairman's Closing Remarks and Close of Day One

Sponsored by

SPONSORSHIP AND EXHIBITION OPPORTUNITIES
PolyTherics offers proprietary site-specific ThioBridge™
conjugation technology for creation of antibodydrug conjugates with greater stability and reduced
heterogeneity as well as site-specific conjugation
technologies for pegylation. In addition, through
recent acquisition, Antitope provides proprietary
technologies
for
preclinical
prediction
of
immunogenicity, and for the generation of nonimmungenic humanized antibodies. To date, we
have entered into multiple agreements with
pharmaceutical and biotechnology companies.
www.polytherics.com

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

Want to know how you can get involved?
Interested in promoting your services to this market?
Contact Teri Arri, SMi Marketing on +44 (0) 207 827 6162,
or email: tarri@smi-online.co.uk

Register online at: www.adcsummit.com • Alternatively fax you
Day Two | Tuesday 20th May 2014
8.30

Registration & Coffee

9.00

2.10

Chairman's Opening Remarks
Dr Adeela Kamal, Associate Director, R&D, Oncology
Research, MedImmune
NEXT GENERATION ADCs

9.10

OPENING ADDRESS
The development of the pyrrolobenzodiazepine ADC platform
• Introduction to the pyrrolobenzodiazepine antitumor
antibiotics
• Pyrrolobenzodiazepine antibody conjugates
• Development of synthetic pyrrolobenzodiazepines
Philip Howard, PhD, Chief Scientific Officer, Spirogen Limited

9.50

Addressing tumor heterogeneity and resistance: production
of homogeneous bispecific ADCs with combination warheads
• Cell–free protein synthesis methods have been developed
for production of homogeneous therapeutic proteins,
including ADCs
• Many variants can be expressed in hours and rapidly
assessed for function. Within days, production of chosen
variants can be scaled using the same platform to
generate material for clinical studies.
• The power and utility of the platform to design and
manufacture single species bispecific and multispecific
antigen-targeted antibodies with conjugated combination
warheads will be described
Dr Trevor Hallam, Chief Scientific Officer, Sutro Biopharma

2.50

Realizing the importance of occupational health and safety
in ADC projects
• Examining biopharmaceutical compound hazards –
biological, small molecule and others
• ADC facility design elements; facilities, layouts and
equipment
• Occupational hygiene analytical (bio)chemistry
• Building confidence that the working environment is safe
and that containment equipment is working
Justin Mason-Home, Managing Director, SafeBridge Europe,
Limited

3.30

Afternoon Tea

Morning Coffee

10.50

SAFETY AND DESIGN

Fleximer-based ADCs: Overcoming common hurdles
• Improving DAR without sacrificing PK and tolerability
• Maximizing efficacy of ADCs targeting low expression
targets
• Broadening the diversity of payloads amenable to ADCs
Dr Tim Lowinger, Chief Scientific Officer, Mersana

10.30

11.30

Targeted Thorium Conjugate Platform
• Targeted delivery
• Cancer
• Alpha emitter
• Preclinical in vitro and in vivo models
Dr Andreas Menrad, Chief Scientific Officer, Algeta

12.10

Arming disease-targeting antibodies with cytotoxic drugs
and with cytokines
• Antibody-cytokine fusions: From the bench to the clinic
• Cancer cures with non-internalising antibodies
• Applications of armed antibodies beyond oncology
Dr Giulio Casi, Head of Antibody-Drug Conjugates
Development, Philochem

PAYLOAD, LINKER & TRAFFICKING STRATEGIES
3.50

Implementing strategies to ensure successful linker selections
for ADCs
• Analysing the selection criteria for choosing the right linker
technology for ADCs
• Exploring the development of linkers that show improved
activity
• Utilizing novel linker molecules
Dr Erica Hong, Scientist, ImmunoGen

4.30

Programming the GPS system for maximum target strikes!
Evaluating latest approaches for trafficking and binding to
the antigen
• Discussing formats that can assess ADC trafficking from the
perspective of:
- Screening
- Mechanistic
• Assessing intracellular trafficking, internalization, and
metabolism of the parent antibody
• Understanding how trafficking processes should allow the
use of more stable linkers, which are generally less toxic
Nathan Scott, Principal Scientist, Biotherapeutic Discovery &
Engineering, Global Biotherapeutic Technologies, Pfizer

5.10

Chairman’s Closing Remarks and Close of Day Two

Networking Lunch

1.30

Official Media Partners

Design and development of effective ADCs: putting the
pieces together
• Target selection: tumor versus normal tissue expression,
when is enough enough?
• Selection of antibodies optimized for use in ADCs
• Linker selection: ADC internalization and intracellular
trafficking
• Drug selection: potency and mechanism of action of
antibody-targeted drugs
Dr Pamela Trail, Vice President Oncology, Regeneron

Supported by

ur registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 21st May 2014
8.30am - 5.00pm
Holiday Inn Regents Park Hotel, London, UK

Early phase development considerations
for ADCs: Expectations for a first-in-man
Workshop Leaders:
Dr Gavin Edwards, Manager, PAREXEL Consulting
Dr Amanda Suitters, Principal Consultant, PAREXEL
Consulting
Overview of workshop:
The development of existing or novel monoclonal
antibodies as drug-conjugates to increase the targeted
clinical effect of these proteins has rapidly increased in
recent years. Over 30 antibody-drug conjugates (ADCs)
are being tested in the clinic in a range of oncology
indications. In the absence of specific guidance on the
development of antibody-drug conjugates. This workshop
aims to help participants understand the regulatory
requirements for the early phase of ADC development to
support first-in man clinical trials.
Why you should attend:
• Understand the CMC challenges and regulatory
expectations during early stage development of ADCs,
with a particular focus on product characterisation,
stability testing and control
• Identify key parameters/requirements for non-clinical
studies to support a Phase 1 clinical trial
• Learn how to create an early phase product
development plan that meets regulatory expectations
• Partake in Interactive case studies and group tasks that
will illustrate the points made
Programme
8.30 Registration and coffee
9.00

Welcome and Introductions

9.10

Session 1 CMC expectations applicable to early stage ADC
development (including interactive case studies)

10.30 Coffee break
11.00 Session 2 CMC expectations applicable to early stage ADC
development (including interactive case studies)
12.30 Lunch
1.30

Session 3 Nonclinical expectations/studies applicable to
early stage ADC development

3.00

Coffee Break

3.30

Session 4 Interactive case studies to evaluate nonclinical
studies to facilitate early stage ADC development

5.00

End of workshop

About the workshop hosts:
Dr Gavin Edwards, Manager, PAREXEL Consulting
Dr Edwards is a PhD Molecular and Cellular
Biologist; he earned is PhD working within the
world renowned Tyrrell Research Group based
within the Department of Pharmacy and Pharmacology,
University of Bath, UK. Following this, Dr Edwards spent time
working within the New Product Development Group of a
multi-national biologics manufacturer; here much of his
work involved the commercialisation of a CHO cell-line
capable of generating afucosyl monoclonal antibodies.
Since that time Dr Edwards has held senior posts within a
number of leading biopharmaceutical consultancies. Dr
Edwards currently serves as a Manager, PAREXEL
Consulting (UK); his consulting activities are primarily
focussed on the development and regulation of biotech
products. Dr Edwards is frequently invited to speak at
industry events and is a recognised figure within his field.
Dr Amanda Suitters, Principal Consultant,
PAREXEL Consulting
Dr Amanda Suitters is an experienced
postdoctoral research scientist/immunologist
having worked in both academia and the
biopharmaceutical industry for over twenty years and
utilizes her experience to assist biopharmaceutical and
biotechnology companies in relation to nonclinical
development, regulatory submissions, biosimilars, PIPs and
orphan drugs. She has expertise in the preparation of
nonclinical drug development documents particularly in
the field of biopharmaceutical and biosimilar
development globally. Dr Suitters assists companies in their
interactions with regulatory agencies throughout the
product development process, including Scientific Advice,
EU registration procedures & MAA submissions.
SMi PHARMACEUTICALS
FORWARD PLANNER 2014
JANUARY
Pharmaceutical Microbiology
20 – 21 January 2014, London
Social Media in the Pharmaceutical Industry
22 – 23 January 2014, London
Pre-Filled Syringes
27 – 28 January 2014, London
FEBRUARY
Parallel Trade
10 – 11 February 2014, London
Advances and Progress in Drug Design
17 – 18 February 2014, London
Quality By Design
24 – 25 February 2014, London
MARCH
Superbugs and Superdrugs - A Focus on
Antibacterials
5 – 6 March 2014, London
Imaging in Cancer Drug Development
12 – 13 March 2014, London
Controlled Release
12 – 13 March 2014, London
Adaptive Designs
24 – 25 March 2014, London
Paediatric Clinical Trials
31 – 1 April 2014, London
Pre-Filled Syringes USA
31 March – 1 April 2014, USA
APRIL
Asthma & COPD
2 – 3 April 2014, London
Biosimilars USA
7 – 8 April 2014, USA
MAY
Big Data in Pharma
12 – 13 May 2014, London
Pain Therapeutics
19 – 20 May 2014, London
ADC Summit
19 – 20 May 2014, London
Clinical Trial Logistics
21 – 22 May 2014, London
JUNE
Biobanking
23 – 24 June 2014, London
ADMET
30 June – 1 July 2014, London
Peptides
30 June – 1 July 2014, London
JULY
Lyophilisation
7 – 8 July 2014, London
BioNetworks
7 – 8 July 2014, London
Allergies
9 – 10 July 2014, London
Immunogenicity
14 – 15 July 2014, London

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 Sponsorship Director on +44 20 7827 6168
or email: amalick@smi-online.co.uk
ADC SUMMIT 2014
Conference: Monday 19th May & Tuesday 20th May 2014, Holiday Inn Regents Park Hotel, London, UK

Workshop: Wednesday 21st May 2014, London

4 WAYS TO REGISTER
www.adcsummit.com
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711

POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor
South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

EARLY BIRD □
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Book by 28th February to receive a £300 discount off the conference price
Book by 31st March to receive a £100 discount off the conference price

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England

□ Please contact me to book my hotel
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email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712

Terms and Conditions of Booking
Payment: If payment is not made at the time of booking, then an invoice will be issued and must be
paid immediately and prior to the start of the event. If payment has not been received then credit
card details will be requested and payment taken before entry to the event. Bookings within 7 days
of event require payment on booking. Access to the Document Portal will not be given until payment
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Regretfully cancellation after this time cannot be accepted. We will however provide the
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SMi Group's 3rd annual ADC Summit

  • 1. 2 BO AN 8T BO O D H F OK A K SA EB B N BY V R Y D U SA 31 E £ AR VE ST M 30 Y £1 AR 0 00 CH “Good insight into industry knowledge and needs” SMi Presents the 3rd annual… ADC Summit 2014 Making your smart bomb smarter – creating innovative antibody-drug conjugates Holiday Inn Regents Park Hotel, London, UK 19TH - 20TH MAY 2014 Conference Chairs Dr Mahendra Deonarain, Chief Scientific Officer, Photobiotics Dr Adeela Kamal, Associate Director, R&D, Oncology Research, MedImmune Key Speakers Include: • Philip Howard, PhD, Chief Scientific Officer, Spirogen Limited • Dr Trevor Hallam, Chief Scientific Officer, Sutro Biopharma • Dr Ronald Elgersma, Project Leader, Antibody-Drug Conjugates, Synthon • Dr Erica Hong, Scientist, ImmunoGen • Dr Hagop Youssoufian, Executive Vice President of R&D, Progenics • Dr Pamela Trail, Vice President Oncology, Regeneron • And many more! Benefits of attending: • Hear cutting edge presentations and key case studies from leading ADCs experts • Network and learn from industry and academic opinion leaders • Learn about latest developments pertaining to the components of ADCs (payload, antibody and linker) • Discover what is happening with next generation ADCs PLUS INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP Wednesday 21st May 2014, Holiday Inn Regents Park Hotel, London, UK Early phase development considerations for ADCs: Expectations for a first-in-man Workshop leaders: Dr Gavin Edwards, Manager, PAREXEL Consulting Dr Amanda Suitters, Principal Consultant, PAREXEL Consulting 8.30am - 5.00pm Sponsored by www.adcsummit.com BOOK BY 28TH FEBRUARY AND RECEIVE A £300 DISCOUNT OR BOOK BY 31ST MARCH AND RECEIVE A £100 DISCOUNT Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
  • 2. ADC Summit 2014 Day One | Monday 19th May 2014 8.30 Registration & Coffee 9.00 Chairman's Opening Remarks Dr Mahendra Deonarain, Chief Scientific Officer, Photobiotics 1.30 NANOTECHNOLGY 9.10 OPENING ADDRESS The development of nanobodies and their potential use for ADC • An update on the nanobody platform • Discussing the advantages for ADC Dr Antonin de Fougerolles, Chief Scientific Officer, Ablynx Antibody fragment ADCs • Use of engineered single-chain Fvs • Light-activated and other payloads • Comparison with whole antibodies Dr Mahendra Deonarain, Chief Scientific Officer, Photobiotics PRE-CLINICAL DEVELOPMENT 10.30 Exploring nano-delivery systems for antibody delivery • Learning about the emerging applications of nanotechnologies in ADC. • Understanding how nanotechnology is at the leading edge of cancer drug delivery due to its emerging features of: - controlled release - antibody-driven specificity Professor Katherine Vallis, Professor of Experimental Radiotherapeutics, University of Oxford Creating effective strategies to reduce toxicity • Utilizing novel linkers and payloads to improve therapeutic index • Examining ways to overcome the resistance developed in clinical ADCs • Using site specific antibody modifications to improve efficacy Dr John Flygare, Project Leader, Discovery Chemistry, Genentech 2.50 PSMA ADC in prostate cancer: PK/PD analysis from a phase 1 clinical trial • Introducing novel paradigms to assess the therapeutic efficacy in prostate cancer • Implementing population-based model of longitudinal PSA measurement from phase I clinical trial • Correlation of exposure and therapeutic effect Dr Hagop Youssoufian, Executive Vice President of R&D, Progenics 3.30 Afternoon Tea 3.50 Development of second generation duocarmycin ADCs with superior therapeutic window • Developing duocarmycin based linker-drug technology • Conducting preclinical evaluation with in vitro and in vivo studies Dr Ronald Elgersma, Project Leader, Antibody-Drug Conjugates, Synthon 4.30 9.50 2.10 Let’s have a debate! Discussing creative ways to make the ‘smart bomb’ more intelligent when building your oncology arsenal • Discussing latest challenges and improvements to various pieces of the of ADC technology puzzle pertaining to: - Antibodies - Drugs - Linkers that bond them together Philip Howard, PhD, Chief Scientific Officer, Spirogen Limited Morning Coffee 10.50 Producing Better Antibody-Drug Conjugates (ADCs) Using ThioBridge™ Conjugation • Site-specific conjugation to disulfide bonds of antibodies and antibody fragments reduces ADC heterogeneity • ThioBridge™ linkers provide stable conjugates and can be used with a variety of payloads • ThioBridge™ technology can be used to create novel ADC formats • In vitro and in vivo data demonstrates good efficacy for mAb and Fab conjugates with an established payload George Badescu, PhD, Director of Scientific Affairs Bioconjugation & Protein Engineering, PolyTherics Ltd, UK 11.30 Working in perfect harmony - selecting the right target and the right antibody • Understanding lessons learned from target identification and validation • Realizing the importance of target expression and internalization • Reviewing approaches to select a lead ADC: a case study Dr Adeela Kamal, Associate Director, R&D, Oncology Research, MedImmune 12.10 Networking Lunch ROUNDTABLE MANUFACTURING ADCs 5.10 Chairman's Closing Remarks and Close of Day One Sponsored by SPONSORSHIP AND EXHIBITION OPPORTUNITIES PolyTherics offers proprietary site-specific ThioBridge™ conjugation technology for creation of antibodydrug conjugates with greater stability and reduced heterogeneity as well as site-specific conjugation technologies for pegylation. In addition, through recent acquisition, Antitope provides proprietary technologies for preclinical prediction of immunogenicity, and for the generation of nonimmungenic humanized antibodies. To date, we have entered into multiple agreements with pharmaceutical and biotechnology companies. www.polytherics.com 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 Want to know how you can get involved? Interested in promoting your services to this market? Contact Teri Arri, SMi Marketing on +44 (0) 207 827 6162, or email: tarri@smi-online.co.uk Register online at: www.adcsummit.com • Alternatively fax you
  • 3. Day Two | Tuesday 20th May 2014 8.30 Registration & Coffee 9.00 2.10 Chairman's Opening Remarks Dr Adeela Kamal, Associate Director, R&D, Oncology Research, MedImmune NEXT GENERATION ADCs 9.10 OPENING ADDRESS The development of the pyrrolobenzodiazepine ADC platform • Introduction to the pyrrolobenzodiazepine antitumor antibiotics • Pyrrolobenzodiazepine antibody conjugates • Development of synthetic pyrrolobenzodiazepines Philip Howard, PhD, Chief Scientific Officer, Spirogen Limited 9.50 Addressing tumor heterogeneity and resistance: production of homogeneous bispecific ADCs with combination warheads • Cell–free protein synthesis methods have been developed for production of homogeneous therapeutic proteins, including ADCs • Many variants can be expressed in hours and rapidly assessed for function. Within days, production of chosen variants can be scaled using the same platform to generate material for clinical studies. • The power and utility of the platform to design and manufacture single species bispecific and multispecific antigen-targeted antibodies with conjugated combination warheads will be described Dr Trevor Hallam, Chief Scientific Officer, Sutro Biopharma 2.50 Realizing the importance of occupational health and safety in ADC projects • Examining biopharmaceutical compound hazards – biological, small molecule and others • ADC facility design elements; facilities, layouts and equipment • Occupational hygiene analytical (bio)chemistry • Building confidence that the working environment is safe and that containment equipment is working Justin Mason-Home, Managing Director, SafeBridge Europe, Limited 3.30 Afternoon Tea Morning Coffee 10.50 SAFETY AND DESIGN Fleximer-based ADCs: Overcoming common hurdles • Improving DAR without sacrificing PK and tolerability • Maximizing efficacy of ADCs targeting low expression targets • Broadening the diversity of payloads amenable to ADCs Dr Tim Lowinger, Chief Scientific Officer, Mersana 10.30 11.30 Targeted Thorium Conjugate Platform • Targeted delivery • Cancer • Alpha emitter • Preclinical in vitro and in vivo models Dr Andreas Menrad, Chief Scientific Officer, Algeta 12.10 Arming disease-targeting antibodies with cytotoxic drugs and with cytokines • Antibody-cytokine fusions: From the bench to the clinic • Cancer cures with non-internalising antibodies • Applications of armed antibodies beyond oncology Dr Giulio Casi, Head of Antibody-Drug Conjugates Development, Philochem PAYLOAD, LINKER & TRAFFICKING STRATEGIES 3.50 Implementing strategies to ensure successful linker selections for ADCs • Analysing the selection criteria for choosing the right linker technology for ADCs • Exploring the development of linkers that show improved activity • Utilizing novel linker molecules Dr Erica Hong, Scientist, ImmunoGen 4.30 Programming the GPS system for maximum target strikes! Evaluating latest approaches for trafficking and binding to the antigen • Discussing formats that can assess ADC trafficking from the perspective of: - Screening - Mechanistic • Assessing intracellular trafficking, internalization, and metabolism of the parent antibody • Understanding how trafficking processes should allow the use of more stable linkers, which are generally less toxic Nathan Scott, Principal Scientist, Biotherapeutic Discovery & Engineering, Global Biotherapeutic Technologies, Pfizer 5.10 Chairman’s Closing Remarks and Close of Day Two Networking Lunch 1.30 Official Media Partners Design and development of effective ADCs: putting the pieces together • Target selection: tumor versus normal tissue expression, when is enough enough? • Selection of antibodies optimized for use in ADCs • Linker selection: ADC internalization and intracellular trafficking • Drug selection: potency and mechanism of action of antibody-targeted drugs Dr Pamela Trail, Vice President Oncology, Regeneron Supported by ur registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
  • 4. HALF-DAY POST-CONFERENCE WORKSHOP Wednesday 21st May 2014 8.30am - 5.00pm Holiday Inn Regents Park Hotel, London, UK Early phase development considerations for ADCs: Expectations for a first-in-man Workshop Leaders: Dr Gavin Edwards, Manager, PAREXEL Consulting Dr Amanda Suitters, Principal Consultant, PAREXEL Consulting Overview of workshop: The development of existing or novel monoclonal antibodies as drug-conjugates to increase the targeted clinical effect of these proteins has rapidly increased in recent years. Over 30 antibody-drug conjugates (ADCs) are being tested in the clinic in a range of oncology indications. In the absence of specific guidance on the development of antibody-drug conjugates. This workshop aims to help participants understand the regulatory requirements for the early phase of ADC development to support first-in man clinical trials. Why you should attend: • Understand the CMC challenges and regulatory expectations during early stage development of ADCs, with a particular focus on product characterisation, stability testing and control • Identify key parameters/requirements for non-clinical studies to support a Phase 1 clinical trial • Learn how to create an early phase product development plan that meets regulatory expectations • Partake in Interactive case studies and group tasks that will illustrate the points made Programme 8.30 Registration and coffee 9.00 Welcome and Introductions 9.10 Session 1 CMC expectations applicable to early stage ADC development (including interactive case studies) 10.30 Coffee break 11.00 Session 2 CMC expectations applicable to early stage ADC development (including interactive case studies) 12.30 Lunch 1.30 Session 3 Nonclinical expectations/studies applicable to early stage ADC development 3.00 Coffee Break 3.30 Session 4 Interactive case studies to evaluate nonclinical studies to facilitate early stage ADC development 5.00 End of workshop About the workshop hosts: Dr Gavin Edwards, Manager, PAREXEL Consulting Dr Edwards is a PhD Molecular and Cellular Biologist; he earned is PhD working within the world renowned Tyrrell Research Group based within the Department of Pharmacy and Pharmacology, University of Bath, UK. Following this, Dr Edwards spent time working within the New Product Development Group of a multi-national biologics manufacturer; here much of his work involved the commercialisation of a CHO cell-line capable of generating afucosyl monoclonal antibodies. Since that time Dr Edwards has held senior posts within a number of leading biopharmaceutical consultancies. Dr Edwards currently serves as a Manager, PAREXEL Consulting (UK); his consulting activities are primarily focussed on the development and regulation of biotech products. Dr Edwards is frequently invited to speak at industry events and is a recognised figure within his field. Dr Amanda Suitters, Principal Consultant, PAREXEL Consulting Dr Amanda Suitters is an experienced postdoctoral research scientist/immunologist having worked in both academia and the biopharmaceutical industry for over twenty years and utilizes her experience to assist biopharmaceutical and biotechnology companies in relation to nonclinical development, regulatory submissions, biosimilars, PIPs and orphan drugs. She has expertise in the preparation of nonclinical drug development documents particularly in the field of biopharmaceutical and biosimilar development globally. Dr Suitters assists companies in their interactions with regulatory agencies throughout the product development process, including Scientific Advice, EU registration procedures & MAA submissions.
  • 5. SMi PHARMACEUTICALS FORWARD PLANNER 2014 JANUARY Pharmaceutical Microbiology 20 – 21 January 2014, London Social Media in the Pharmaceutical Industry 22 – 23 January 2014, London Pre-Filled Syringes 27 – 28 January 2014, London FEBRUARY Parallel Trade 10 – 11 February 2014, London Advances and Progress in Drug Design 17 – 18 February 2014, London Quality By Design 24 – 25 February 2014, London MARCH Superbugs and Superdrugs - A Focus on Antibacterials 5 – 6 March 2014, London Imaging in Cancer Drug Development 12 – 13 March 2014, London Controlled Release 12 – 13 March 2014, London Adaptive Designs 24 – 25 March 2014, London Paediatric Clinical Trials 31 – 1 April 2014, London Pre-Filled Syringes USA 31 March – 1 April 2014, USA APRIL Asthma & COPD 2 – 3 April 2014, London Biosimilars USA 7 – 8 April 2014, USA MAY Big Data in Pharma 12 – 13 May 2014, London Pain Therapeutics 19 – 20 May 2014, London ADC Summit 19 – 20 May 2014, London Clinical Trial Logistics 21 – 22 May 2014, London JUNE Biobanking 23 – 24 June 2014, London ADMET 30 June – 1 July 2014, London Peptides 30 June – 1 July 2014, London JULY Lyophilisation 7 – 8 July 2014, London BioNetworks 7 – 8 July 2014, London Allergies 9 – 10 July 2014, London Immunogenicity 14 – 15 July 2014, London 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 Sponsorship Director on +44 20 7827 6168 or email: amalick@smi-online.co.uk
  • 6. ADC SUMMIT 2014 Conference: Monday 19th May & Tuesday 20th May 2014, Holiday Inn Regents Park Hotel, London, UK Workshop: Wednesday 21st May 2014, London 4 WAYS TO REGISTER www.adcsummit.com FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK EARLY BIRD □ DISCOUNT □ Book by 28th February to receive a £300 discount off the conference price Book by 31st March to receive a £100 discount off the conference price CONFERENCE PRICES Unique Reference Number Our Reference I would like to attend: (Please tick as appropriate) LV P-105 DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Fee Total □ Conference & Workshop □ Conference only □ Workshop only £2098.00 + VAT £2517.60 £1499.00 + VAT £1798.80 £599.00 + VAT £718.80 £999.00 + VAT £1198.80 PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional Surname: Job Title: literature to all conference attendees Department/Division: Company/Organisation: The conference fee includes refreshments, lunch, conference papers and access Email: to the Document Portal containing all of the presentations. Company VAT Number: Address: LIVE STREAMING/ON DEMAND/ DOCUMENTATION Unable to travel, but would like to watch the conference live, ask questions, participate as if you were in the room. Price Total Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: □ Live Streaming □ On demand Mobile: (available 24 hours after the event) □ Access to the conference documentation Switchboard: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT Title: on the Document Portal £499.00 + VAT £499.00 (or only £300 if ordered with the Document Portal) □ The Conference Presentations - paper copy £598.80 £499.00 Forename: Surname: PAYMENT Email: Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-105 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. Please indicate method of payment: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: □ UK BACS □ Wire Transfer Direct Fax: VENUE £999.00 + VAT (UK) £1198.80 £599.00 + VAT (UK) £718.80 Holiday Inn Regents Park Hotel, Carburton Street, London W1W 5EE England □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712 Terms and Conditions of Booking Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received. Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate. Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or the Document Portal as these are reproduced specifically to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other products and services. Unless you tick here □ we may also share your data with third parties offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter. □ Cheque □ Credit Card Sort Code 300009, Account 00936418 Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18 We can only accept Sterling cheques drawn on a UK bank. □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Card No: Cardholder’s Name: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. Card Billing Address (If different from above): VAT VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on live Streaming, on Demand, Document portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here. ______________________________________________________________________________________________ If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk