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25 - 26
MAR2015
Holiday Inn Regents Park Hotel, London, UK
Superbugs &Superdrugs
@SMIPHARM
www.superbugssuperdrugs.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
CHAIR FOR 2015:• Richard Bax, Senior Partner, TranScrip
Partners
KEY SPEAKERS INCLUDE: • Jorge Mestre-Ferrandiz, Director of
Consulting, Office of Health Economics (OHE)
• Shiva Dustdar, Head of Research,Development and Innovation Advisory,European Investment Bank (EIB)
• Fiona Marston, Chief Executive, AbsynthBiologics
• Colin J Suckling, Research Professor ofChemistry, University of Strathclyde
• David Findlay, Commercial Director of II-IDGlobal Franchise, GSK
• William Weiss, Director of Pre-Clinical Services,University of North Texas Health ScienceCenter
PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPSTuesday 24th March, Holiday Inn Regents Park Hotel, London
A: A Vision for the Future; Designing Antimicrobials to Meet Future Needs
Workshop Leader: Dr Keith Williams, Director and Consultant,KW Drug Developments Ltd & Boyd Consultants
8.30am – 12.30pm
B: Technical Aspects of Licensing an AntibioticWorkshop Leader:
David Scott, Consultant, PharmaConsulting
1.30pm – 4.30pm
BUSINESS BENEFITS FOR 2015:• Receive the latest updates and case studies on
preclinical and clinical developments• Scan horizons on anti-microbial resistance and
understand initiatives to control antimicrobial use• Look at alternative approaches including phage
and minor groove binders• Explore the latest updates in funding and
reimbursement • Review the current status of antimicrobial
resistance and the threats and targets landscape• Discuss the potential of rapid point of care
diagnostics
BOOK B
Y
28TH
NOVEM
BER
SAVE £
300
BOOK B
Y 30T
H JANUARY
SAVE £
100
SMi presents the 17th annual conference on…
The Latest in Antibacterial Therapies, Funding and Partnerships
“Very well organised conference” – GSK
“Very good and engaging speakers” – Merck
Register online at: www.superbugssuperdrugs.com • Alternatively fa
Superbugs and Superdrugs Day One | Wednesday 25th March 2015
8.30 Registration & Coffee
9.00 Chairman's Opening RemarksRichard Bax, Senior Partner, TranScrip Partners
PARTNERSHIPS AND PRICING - PART ONE
9.10 Time for the big deal - mission impossible? • Explore models of effective industry incentives • How can new antibiotics be made available
at affordable prices around the world?• Strategies for usage control to avoid development of
resistanceRichard Bergstrom, Director General, EFPIA
9.50 Do we need new business models for rewarding new antibiotics?• Economic challenges - is there a need for a new business
model?• Incentives - what has worked in the past?• Addressing the challenges - what could be the new business
model?• On-going initiativesJorge Mestre-Ferrandiz, Director of Consulting, Office of HealthEconomics (OHE)
10.30 Morning Coffee
11.00 The changing role of academia in antimicrobial drug discovery• Historical perspective of academic involvement in drug
development• Growth of the modern pharmaceutical industry and
detachment from academia• Downturn in antibacterial discovery and development and
current need for increased research capabilities• Collaboration of industry and academia in drug discovery and
development• Novel partnering models to increase innovation in
pharmaceutical R&DWilliam Weiss, Director of Pre-Clinical Services, University of NorthTexas Health Science Center
11.40 SETTING THE AGENDA Partnering and working with BARDA• Discuss recent US government initiatives for
countering antimicrobial resistance• Discuss how those initiatives impact BARDA’s future
investments• Understand BARDA’s research priorities and areas of interest• Learn how BARDA forms partnerships for the development of
antibacterial therapiesMelissa Stundick, Acting Branch Chief, Broad SpectrumAntimicrobials Program, BARDA
12.20 Networking Lunch
RESEARCH AND DEVELOPMENT UPDATES - PART ONE
1.20 Thousands of new antibiotic classes: The road to patients• New small molecule discovery paradigm• The use of new technologies• A novel validated approach to anti-bacterial therapyDavid Williams, Chief Executive Officer, Discuva
2.00 Where have all the bugs gone? Challenges in enrolling resistantpathogen studies• Resistant Gram negative infections are a worldwide threat
however, challenges to conducting acceptable studiesfocused on resistant pathogens are numerous
• Development pathways relying on such studies require flexibility• Potential ways forward are suggestedIan Friedland, Chief Medical Officer, Achaogen, Inc.
2.40 PhagoBurn: from cold war to “hot” phage therapy• The band: Pherecydes Pharma and the French Defence
Health Service• The tune: Phage against MDR E. coli and P. aeruginosa bacteria• The gear: PhagoBurn, 1st phage therapy multicentre
European trialJérôme Gabard, CEO, Pherecydes
3.20 There's no escape - single target, multiple effects• A dirty drug to clean up infection?• Catastrophic failure in a bug• Chemical mechanism, biological consequence• Is it safe to target DNA?Colin J Suckling, Research Professor of Chemistry, University ofStrathclyde
4.00 Afternoon Tea
4.30 Superdrugs against multiresistant bacterial strains andsuperinfection: Super disaster for Big Pharma? • The uncontrolled use of antibiotics in animal husbandry
provokes the increase in bacterial resistance, such as seen forMRSA and ESBL
• Primary infection may lead to a superinfection with Herpes orInfluenza viruses
• New 'Superdrugs' are able to block this infection, as shown in acase study patient presenting with a mucosal mouth infection
Klaus Brandenburg, Chief Scientific Officer, BrandenburgAntiinfektiva
5.10 Prevention is better than cure?• Is there a role for vaccines in the fight against microbial drug
resistance?• Why is it proving difficult to develop a Staph. aureus vaccine?• A different approach – to improve chances of success• A platform for other vaccinesFiona Marston, Chief Executive, Absynth Biologics
5.50 Discussion Panel: How to de-risk and optimise clinicaldevelopment of antimicrobialsRichard Bax, Senior Partner, TranScrip Partners
6.20 Chairman's Closing Remarks and Close of Day OneRichard Bax, Senior Partner, TranScrip Partners
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages,uniquely tailored to complement your company’s marketing strategy.
Prime networking opportunities exist to entertain, enhance and expandyour client base within the context of an independent discussion specificto your industry.
Should you wish to join the increasing number of companies benefitingfrom sponsoring our conferences please call:
Alia Malick on +44 (0) 20 7827 6168 or email: [email protected]
KEYNOTEADDRESS
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Official Media Partners
ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Superbugs and Superdrugs Day Two | Thursday 26th March 2015
8.30 Registration & Coffee
9.00 Chairman's Opening RemarksRichard Bax, Senior Partner, TranScrip Partners
RESEARCH AND DEVELOPMENT UPDATES - PART TWO
9.10 50 years of frustration. What have we learned? What can wedo to escape from this nightmare?• Despite the enormous efforts in industry research for
discovering broad-spectrum antibacterials with newmechanisms of action, the newest molecular mechanismof action is 50 years old. What can we do to providesolutions to this dangerous fact?
• Attrition is a major issue in drug discovery anddevelopment, making the drug development processenormously inefficient and costly. Can we be moresuccessful?
• The business opportunities in infectious diseases, necessarilygo through a radical paradigm shift and high doses ofdisruptive innovation.
• To improve productivity and delivery, it is necessary toreview topics such as: target product profile, drugdiscovery strategy and collaborations
Domingo Gargallo-Viola, Chief Scientific Officer, ABAC Therapeutics
9.50 Novel inhibitors of topoisomerases for drug-resistant bacteria• Strategies for new antibacterial discovery• Gram-positive inhibitors with potent activity against MRSA• Broad-spectrum agents for MDR Gram-negatives• Innovative partnerships in antibiotic developmentNeil Stokes, Head of Biology, Redx Anti-Infectives
10.30 Morning Coffee
11.00 Search for new antibacterials using diversity-oriented synthesis• The discovery of antibacterials with a novel mode of action
is needed• Current small molecule screening collections are not
structurally diverse• The efficient synthesis of structural diversity followed by
antibacterial phenotypic screening can be a successfulapproach
• Target identification from phenotypic hit compounds is stilla challenge
David Spring, Professor of Chemistry, Cambridge University
11.40 Debio1450: Another drug against Staphylococci?• Description of the mechanism of action of a new antibiotic
with narrow specificity• To understand the impact of antibiotics on the human
microbiome• Understand the current status of development of Debio1450Frederick Wittke, Medical Director, Debiopharm International
12.20 Networking Lunch
1.20 Proof of concept investigation of intravenous MGB-BP-3, anew class of anti-bacterial• New class of anti-infectives for the treatment of C. difficile
infections• Efficacy: MGB-BP-3 v’s gold standard • Benefits to NHS and patients• Use in line with antibiotic stewardship to combat resistanceDawn Firmin, Head of Project Management, MGB Biopharma
2.00 Anti-gram-negative drug discovery: A humbling test ofperseverance• What to target (and how that reveals the limitations of our
scientific creativity)• Why is it so difficult to find the right chemistry and achieve
potency?• Key challenges in translationRyan Cirz, Director of Biology, Achaogen, Inc.
2.40 Round Table: How to best ensure a reliable pipeline of appropriate drugs?Richard Bax, Senior Partner, TranScrip Partners
PARTNERSHIPS AND PRICING - PART TWO
3.20 DRIVE-AB: An industry perspective• The need for delivery of a new commercial model• Objectives and structure of DRIVE-AB• Partnership approach to delivering a new commercial model• Beyond DRIVE-ABDavid Findlay, Commercial Director of II-ID Global Franchise, GSK
4.00 Afternoon Tea
4.30 Antibiotics and their alternatives – fixing and feeding the pipeline• Research strategy and actions• Collaboration across countries, sectors and disciplines• New funding instruments for SME’sLine Matthiessen, Head of Infectious Diseases and PublicHealth Unit, European Commission
5.10 Antibiotics and their alternatives - Is there a need for innovative finance?• EIB’s financing mechanisms supporting R&D
investments• Overview of InnovFin Programme under Horizon 2020Shiva Dustdar, Head of Research, Development andInnovation Advisory, European Investment Bank (EIB)
5.50 Wellcome Trust funding opportunities• Introducing Wellcome Trust Innovations - What is our mission? • How we are seeking innovative therapeutics and diagnostics
to transform the treatment of infectious diseases • Examples of success• The selection process and a view of the investment
selection criteriaTimothy Jinks, Senior Business Analyst, Wellcome Trust Innovations
6.30 Chairman's Closing Remarks and Close of Day TwoRichard Bax, Senior Partner, TranScrip Partners
Interested in promoting your services to this market?Contact Teri Arri, SMi Marketing on +44 (0) 207 827 6162 or email [email protected]
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HALF-DAY PRE-CONFERENCE AM WORKSHOPTuesday 24th March 2015
8.30am - 12.30pmHoliday Inn Regents Park Hotel, London, UK
A: A Vision for the Future; DesigningAntimicrobials to Meet Future Needs
Workshop Leader: Dr Keith Williams, Director and Consultant, KW Drug
Developments Ltd & Boyd Consultants
Overview of workshop:Strategic vision and advice, target selection and leadoptimisation, building in all requirements early. Gettingthe PK/PD and dose right to take account of variability,optimal early development and patient selection.Global trials, databases, regulatory submissions andinteractions - insights from a Global Product Director.
Who should attend this workshop:All those involved in drug development of antimicrobials.The main focus is on antibacterials but the speaker hasexperience of viral and fungal diseases, even vaccines,malaria and TB. Gain insights from someone who has runinternational clinical trials, Global Product teams, workedin a CRO and as a consultant, has published andpresented widely.
Programme:8.30 Registration and coffee
9.00 Opening remarks
9.15 Creating a target product profile • Defining what is needed - definition of
spectrum, indications and route ofadministration
10.15 Pre- clinical work to enable human studies • What is specific to antimicrobials
10.45 Coffee break
11.15 Into man and defining the dose, PK/PD andrestrictions of use
11.45 Clinical trials, indications, geographicconsiderations, databases and registration
12.15 Closing remarks
12.30 End of workshop
About Dr Keith WilliamsGlaxo, AZ and Consulting - clinical trials of cefuroxime &axetil, ceftazidime (Fortum), cefotetan, meropenem,oxazolidinones, lipopeptides, quinolones etc. HIVtherapies, antivirals, vaccines. Honorary Fellow of Instituteof Biology, historian of the pharmaceutical industry andclinical trials. Strategy team member and Global ProductDirector at ICI/AZ. Drugs from research to patent expiry.
About KW Drug Developments Ltd & Boyd Consultants:Aim to look at strategic objects andhow they can be worked into a TPP togive directional leads to research, howproduct characters need to be built in
early. Common mistakes and strategies for efficientdevelopment. Attendees should gain insights into thewhole development process.
HALF-DAY PRE-CONFERENCE PM WORKSHOPTuesday 24th March 2015
1.30pm - 4.30pmHoliday Inn Regents Park Hotel, London, UK
B: Technical Aspects of Licensing an Antibiotic
Workshop Leader: David Scott, Consultant, PharmaConsulting
Overview of Workshop:Learn about the key R&D-related elements involved inthe inward or outward licensing of antibiotics. Theworkshop will cover an outline of the licensing process,what technical data is needed as part of a productlicensing prospectus, what big pharma looks for andthe product evaluation and due diligence processes.
Why should you attend this workshop:Anyone likely to be involved in the preparation ofscientific material for an outward license or inevaluating inward licensing opportunities will benefitfrom this workshop, which will cover all the key scientificdrivers and issues that need to be considered
Programme:1.30 Registration and coffee
2.00 Introduction to licensing• Overview of the licensing process• Who should be included in the licencing
team
2.30 Preparing a product dossier format• What are the key elements and issues• What big pharma says it wants
3.00 Coffee break
3.30 Product evaluation and due diligence• 4-step process• Key technical issues to consider
4.15 Open discussion
4.30 End of workshop
About the workshop leader: David Scott is a freelance healthcare consultant and askilled negotiator who has closed a number of majordeals for inward and outward licensing forpharmaceutical products, delivery systems andtechnologies. He has published widely (he is the authorof the best-selling report, Scrip’s Practical Guide toPharmaceutical Licensing”) and also provides licensingtraining for a number of organizations includingC.E.L.forpharma. David has a BSc in Chemistry as wellas post-graduate qualifications in marketing and is anaccredited Certified Licensing Professional. Following22 years working in big pharma David has spent thepast 18 years as a freelance consultant and hasprovided strategic advice and successfully concludedboth inward and outward licensing agreements onbehalf of a range of worldwide clients. His client baseincludes top-ranking global companies, Europeanregional companies, biotech companies, technologystart-ups and universities. He currently sits on the boardsof two UK-based pharmaceutical businesses.
About The European ScreeningPort:PharmaConsulting is thebusiness organisation for David Scott, a freelance
licensing and business development consultant.www.pharmaconsulting.co.uk
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 FloorSouth, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
SUPERBUGS AND SUPERDRUGS Conference: Wednesday 25th & Thursday 26th March 2015, Holiday Inn Regents Park Hotel, London, UK Workshops: Tuesday 24th March 2015, London
4 WAYS TO REGISTERwww.superbugssuperdrugs.com
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email [email protected]
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CONFERENCE PRICESI would like to attend: (Please tick as appropriate) Fee Total□ Conference and 2 Workshops £2697.00 +VAT £3236.40□ Conference and 1 Workshop £2098.00 +VAT £2517.60□ AM □ PM□ Conference only £1499.00 +VAT £1798.80□ 2 Workshops £1198.00 +VAT £1437.60□ 1 Workshop only £599.00 +VAT £718.80□ AM □ PMPROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80The conference fee includes refreshments, lunch, conference papers, and access to theDocument Portal. Presentations that are available for download will be subject todistribution rights by speakers. Please note that some presentations may not be availablefor download. Access information for the document portal will be sent to the e-mailaddress provided during registration. Details are sent within 24 hours post conference.
