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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
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
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