Date post: | 13-Apr-2017 |
Category: |
Documents |
Upload: | kiran-bains |
View: | 55 times |
Download: | 3 times |
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, Femtogenix08.30 – 12.30
B: Developments in high potency API manufacturing
Workshop Leaders: Richard Denk, Head Sales Containment, SKAN AG
Martin Glaettlim, Sales Engineering Containment, SKAN AG13.30 – 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 DISCOUNTREGISTER BY 31ST MARCH AND RECEIVE A £200 DISCOUNT
@SMIPHARM #SMiADC
SMi Present the 5th Annual Conference on…
ADC SummitHoliday Inn Kensington Forum, London, UK
23 - 24
MAY2016
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 Offi cer, 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, Pfi zer • Jens Lohrmann, Senior Global Program Manager, Novartis
ADC SummitDay One | Monday 23rd May 2016 www.adcsummit.com
Register online at: www.adcsummit.com • Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Sponsored by
08.30 Registration and Coffee
09.00 Chairman’s opening remarks Rakesh Dixit, Vice President, R & D, MedImmune
OPENING ADDRESS09.10 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 OpportunitiesSMi 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: [email protected]
Official Media Partners
ADC SummitDay Two | Tuesday 24th May 2016 www.adcsummit.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 ADDRESS09.10 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
Register online at: www.adcsummit.com • Alternatively fax your 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: [email protected]
Supported by
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 WORKSHOPWednesday 25th May 2016
08.30 – 12.30Holiday Inn Kensington Forum, London, UK
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: [email protected]
Overview of workshopThis 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 identifi ed 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 fi rst degree in pharmacy and a PhD in synthetic medicinal chemistry. David is one of the scientifi c co-founders of Spirogen Ltd (recently acquired by AstraZeneca), and acted as CSO for the company from its formation in 2000 until 2011. He is also a co-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). He has extensive experience in in silico methods, 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.
B: Developments in high potency API manufacturing
Workshop Leaders: Richard Denk, Head Sales Containment, SKAN AGMartin Glaettlim, Sales Engineering Containment,
SKAN AG
HALF-DAY POST-CONFERENCE WORKSHOPWednesday 25th May 2016
13.30 – 17.30Holiday Inn Kensington Forum, London, UK
Overview of workshopADC 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 R&D, analytical, production, storage.
Programme13.30 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 AGRichard 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.
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
Department/Division:
Company/Organisation:
Email:
Company VAT Number:
Address:
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Mobile:
Switchboard:
Signature: Date:I agree to be bound by SMi’s Terms and Conditions of Booking. ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
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 [email protected] or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter.
Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-172 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment:
□ UK BACS Sort Code 300009, Account 00936418□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18□ Cheque We can only accept Sterling cheques drawn on a UK bank.□ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges.
Card No: □□□□ □□□□ □□□□ □□□□Valid From □□/□□ Expiry Date □□/□□CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card
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 at 20% is charged on the attendance fees for all delegates. VAT is also charged on 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 [email protected]
□ Book by 29th February 2016 to receive £400 off the conference price
□ Book by 31st March 2016 to receive £200 off the conference price
EARLY BIRD DISCOUNT
I would like to attend: (Please tick as appropriate) Fee Total□ Conference & 2 Workshops £2697.00 + VAT £3236.40□ Conference & 1 Workshop A □ B □ £2098.00 + VAT £2517.60□ Conference only £1499.00 + VAT £1798.80□ 2 Workshops £1198.00 + VAT £1437.60□ 1 Workshop only £599.00 + VAT £718.80Workshop A □ Workshop B □
PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional
literature to all conference attendees £999.00 + VAT £1198.80
The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. Presentations that are available for download will be subject to distribution rights by speakers. Please note that some presentations may not be available for download. Access information for the document portal will be sent to the e-mail address provided during registration. Details are sent within 24 hours post conference.
□ Please contact me to book my hotelAlternatively call us on +44 (0) 870 9090 711, email: [email protected] or fax +44 (0) 870 9090 712
I cannot attend but would like to purchase access to the following Document Portal/paper copy documentation Price Total□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80□ The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
Unique Reference Number
Our Reference LVP-172
DELEGATE DETAILS
Terms and Conditions of Booking
PAYMENT
VAT
CONFERENCE PRICES
DOCUMENTATION
VENUE Holiday Inn Kensington Forum, 97 Cromwell Rd, London SW7 4DN, UK
5th ANNUAL ADC SUMMITConference: 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
FAX your booking form to +44 (0) 870 9090 712PHONE 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