Superbugs & Superdrugs 2017

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PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 22nd March 2017, Copthorne Tara Hotel, Kensington, London, UK

@SMIPHARM#smibugs

SMi Present the 19th Annual Conference on…

Superbugs &Superdrugs Pushing Industry Collaboration to Facilitate the Global Action Plan on Antimicrobial Resistance

COPTHORNE TARA HOTEL, KENSINGTON, LONDON, UK

Highlights in 2017: • First time ever keynote address from the FDA on the antibiotic

resistance landscape • Hear BARDA discuss how to strengthen the antibiotic pipeline

through portfolio partnerships • Spero Therapeutics showcase novel approaches to enabling

antibacterial activity against Gram-negative pathogens • Discuva present fast and effi cient ways to fi nd new antibiotic

chemotypes • Gain insights into a discovery of a novel class of antibiotics

with Auspherix

CHAIRMEN: • Richard Bax, Senior Partner, TranScrip • Lloyd Czaplewski, Director, Chemical Biology Ventures

FEATURED SPEAKERS: • Sumathi Nambiar, Director, Division of Anti-Infective

Products, FDA • Chris Houchens, Branch Chief, BARDA • James Anderson, Head of Corporate Government

Affairs , GlaxoSmithKline • Aileen Rubio, Head of Biology, Spero Therapeutics • David Williams, Chief Executive Offi cer, Discuva • Martin Everett, Chief Scientifi c Offi cer, ANTABIO SAS • Jean de Gunzburg, Scientifi c Director, Da Volterra • William J Weiss, Director, Pre-Clinical Services,

UNT System College of Pharmacy

WORKSHOP AThe Use of Animal Models in Pre-Clinical

Drug Development08.30 – 12.30

Workshop Leaders: William Weiss, Director, Pre-Clinical Services, UNT System College of Pharmacy

Mark Pulse, Assistant Director, Pre-Clinical Services, UNT System College of Pharmacy

WORKSHOP BPractical Challenges in Developing

Novel Antimicrobials13.30 – 17.50

Workshop Leader: Keith Williams, Director, KW Drug Developments Ltd, ex Global Product Director

(Infection) at AstraZeneca, Hon FICR

REGISTER BY 30TH NOVEMBER FOR A £400 DISCOUNTREGISTER BY 16TH DECEMBER FOR A £200 DISCOUNTREGISTER BY 31ST JANUARY FOR A £100 DISCOUNT

CONFERENCE: 20TH - 21ST

WORKSHOPS: 22ND

MAR 2017

First time ever FDA present at our annual Superbugs &

Superdrugs conference

Superbugs & Superdrugs Day One | Monday 20th March 2017

8.30 Registration & Coffee

9.00 Chairman’s Opening Remarks Richard Bax, Senior Partner, TranScrip

OPENING ADDRESS 9.10 Antibiotics: Current situation and the way forward • Future challenges in antibiotic R&D and regulation? • Do national research strategies make sense. • What is missing? • What is next? Richard Bax, Senior Partner, TranScrip

KEYNOTE ADDRESS09.50 Regulatory perspective on antibacterial

drug development • Discuss streamlined development programs • Activities to facilitate antibacterial drug development • Discuss some remaining challenges in antibacterial drug

development Sumathi Nambiar, Director, Division of Aniti-Infective Products, FDA

10.30 Morning Coffee

10.50 Extending portfolio partnerships to strengthen the antibiotic pipeline • Ongoing and future research and development partnerships • BARDA’s efforts to address goals in the U.S. National Plan to

Combat Antibiotic Resistant infections • Establishing a biopharmaceutical incubator to meet short

and long term goals • BARDA funding opportunities Chris Houchens, Branch Chief, BARDA

11.30 Statistical and design approaches to allow more feasible antibiotic drug development

• An outline of alternative statistical approaches and study designs are being considered and actively discussed with global regulatory agencies

• How likely they are to be possible going forward • Discussion of which approaches can already be applied

and which require further work before being considered part of routine practice

Aaron Dane, Director, Danestat Consulting

12.10 Networking Lunch

13.30 The use of in vivo models for infectious disease research • Experimental Design of Animal Models • Bridging the gap – in vitro activity to in vivo effi cacy • Where to start / What model to use • What does the data tell us William J Weiss, Director, Pre-Clinical Services, UNT System

College of Pharmacy

14.10 The development of antimicrobial peptides (AMP) as new antibacterial drugs

• Exploring AMP as a viable alternative to antibiotics • Utilising an AMP different mode of action • Latest developments in antimicrobial peptides Deborah O’Neil, Chief Executive & Scientifi c Offi cer,

Novabiotics Ltd

14.50 Afternoon Tea

15.10 Short antimicrobial peptides - their potential to treat bacterial MDR infections

• Screening approach and separation of antimicrobial activity and haemolytic activity

• Their action against MDR strains • Preventing biofi lms and destroying existing biofi lms • Immunomodulatory activities Kai Hilpert, Director, TiKa Diagnostics Ltd

15.50 Novel oligonucleotide antimicrobials against Gram-negative infections

• Rational design of oligonucleotide antimicrobials to target transcription factors

• Identifi cation of a new Gram-negative therapeutic target • Validation in microbiome and animal models Michael McArthur, Chief Scientifi c Offi cer, Procarta

16.30 Novel approaches to enabling antibacterial activity against Gram-negative pathogens

• Combating Gram negative pathogens require innovative approaches in addition to the standard small molecules

• We have identifi ed an outer membrane permeabilizer,SPR741, that helps otherwise impermeant antibiotics entry into the Enterobacteriaecaea.

• Improvements in activity can be observed both in vitro and in vivo when SPR741 is combined with rifampin or other antibiotics

Aileen Rubio, Head of Biology, Spero Therapeutics

17.10 Chairman’s Closing Remarks and Close of Day One

TRANSITION FROM ANIMALS INTO HUMANS

Register online at www.superbugssuperdrugs.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 specifi c to your industry. Should you wish to join the increasing number of companies benefi ting from sponsoring our conferences please call:

Alia Malick on +44 (0) 20 7827 6168 or email: [email protected]

Supported by

NON-COMPOUND APPROACHES

Offi cial Media Partner Offi cial Publications

Welcome Letter from our 2017 Chairs Dear Colleagues,It is with great pleasure that we welcome you to participate in the 19th Annual Superbugs & Superdrugs Conference taking place on20th - 21st March 2017, Central London, UK.In 2016 antimicrobial resistance achieved remarkable global attention. For a decade the community talked about the need for industry, academia and government to act on an international level to address the scientifi c challenges of antibiotic discovery, diagnosis, addressing the economics of antibiotics and to invest in unprecedented ways. In 2016 we may have witnessed change.We are delighted to chair this annual industry meeting in 2017 again, which will gather a high level of international experts and project decision makers to review the successes of 2016 and look into the future of AMR. Please take time to peruse the conference agenda which has been drafted with great care to give you the very best opportunity to benchmark and learn from subject matter experts in infectious diseases, health economics and advanced technologies and solutions.Networking and learning with our peers is the secret to improving the drug development pipeline.

Yours Sincerely,

Richard Bax, Senior Partner, TranScrip

Lloyd Czaplewski, Director, Chemical Biology Ventures

Superbugs & Superdrugs Day Two | Tuesday 21st March 2017


9.00 Chairman’s Opening Remarks Lloyd Czaplewski, Director, Chemical Biology Ventures

OPENING ADDRESS9.10 How the pharmaceutical industry is helping address AMR? • The role of the pharmaceutical industry in combating

AMR goes beyond investing in R&D for new antibiotics • Companies are partnering with healthcare systems globally

to help ensure antibiotics are manufactured cleanly, available to patients where needed and used appropriately

• We seek further progress on implementation of new economic models to deliver sustainable solutions for all

James Anderson, Head of Corporate Government Affairs, GlaxoSmithKline

9.50 Exploiting DNA topoisomerases as targets for antibacterial chemotherapy

• AMR is a serious and growing problem • DNA topoisomerases (e.g. DNA gyrases) are successful and

well-validated targets for antibiotics • Fluoroquinolones are highly-successful antibacterial agents,

but resistance is a serious problem • Approaches to discover new gyrase inhibitors • Topoisomerases present new opportunities for antibiotic targeting Anthony Maxwell, Professor, Head of Department Biological

Chemistry, John Innes Centre


10.50 Finding new small molecule antibiotics • Fast and effi cient ways to fi nd new antibiotic chemotypes • Ways to focus rational chemical optimisation • Selection of the best clinical candidates • Management of clinical resistance David Williams, Chief Executive Offi cer, Discuva

11.30 Fighting back against MBL mediated CREs: development of metallo-beta-lactamase inhibitors for use in combination with carbapenems

• MBL-mediated CRE are already endemic in many countries and rapidly spreading world-wide

• Antabio have identifi ed a potent and selective lead series with excellent drug-like properties

• Lead compounds show broad spectrum potentiation of meropenem against clinical CRE isolates and demonstrate effi cacy in animal models of infection

Martin Everett, Chief Scientifi c Offi cer, ANTABIO SAS

12.10 Networking Lunch

13.30 Microbome-targeted products: Spare vs repair

• Antibiotic-induced dysbiosis and its consequences

• FMT and microbiota-derived products aimed at C. diffi cile

infections

• Pharmacological interventions targeting the gut microbiome

• Protecting the intestinal microbiome during antibiotic

treatments

Jean de Gunzburg, Scientifi c Director, Da Volterra

14.10 Afternoon Tea

14.30 Anti-infective monoclonal antibodies against multi-drug

resistant pathogens

• The benefi t of mAbs with multiple modes of action and

multi-specifi city

• Pre-emptive approach for high-risk patients is highly

attractive

• mAb therapy to increase antibiotic effectiveness with

directly anti-bacterial and/or anti-virulence mechanisms

Eszter Nagy, Co-Founder and CSO, Arsanis, Inc;

Managing Director, Arsanis Biosciences GmbH

15.10 Discovery of a novel class of antibiotics

• Identifi cation of a new class of broad-spectrum

antibacterials

• Antimicrobial profi les (Gram-positive & Gram-negative)

• In-vitro characterisation and mechanistic insights

Neil Miller, Chief Executive Offi cer, Auspherix

15.50 Chairman’s Closing Remarks and Close of Day Two

Lloyd Czaplewski, Director, Chemical Biology Ventures

Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

MARKETING OPPORTUNITIESWant to know how you can get involved? Interested in promoting your services to this market?

Contact – Teri Arri SMi Marketing on +44 (0) 20 7827 6162 or email: [email protected]

Supported by

COMPOUND APPROACHES

NOVEL CASE STUDIES

The Use of Animal Models in Pre-Clinical Drug Development

Workshop Leaders: William Weiss, Director, Pre-Clinical Services,

UNT System College of PharmacyMark Pulse, Assistant Director, Pre-Clinical Services,

UNT System College of Pharmacy

HALF-DAY POST-CONFERENCE WORKSHOP AWednesday 22nd March 2017

08.30 – 12.30Copthorne Tara Hotel, Kensington, London, UK

Overview of Workshop:The workshop will provide an overview of the use of animal models in preclinical drug development. We will focus on the transition from in vitro activity to in vivo effi cacy, the choice of the right animal model for proof of concept studies, provide examples of relevant animal models with supportive data and interpretation of results as it relates to the clinical condition.

Why you should attend this workhshop:• To gain an understanding of what animal models can and

cannot provide • To learn how animal model endpoints relate to clinical endpoints• In depth discussion of how models are performed• Regulations and constraints in the performance of these models

Programme:


09.00 Opening remarks and introductions

09.10 Pre-Clinical Drug Development • Overview of preclinical testing • Discovery to lead selection • The development model: then and now • Antibacterial research efforts

09.50 Experimental Design and Methodology • Experimental design profoundly infl uences

the outcome of a research study • Clearly defi ne the question or problem

being studied • Realistic objectives (achievable) • Choose the best research model


11.00 Animal Models – Examples • Acute infection models – Bacteremia, Sepsis • Chronic infection models – Pneumonia, skin,

abscesses • GI related – C. diffi cile, H. pylori

12.20 Animals in Research • Institutional Animal Care and Use Committee

(IACUC) • Justify why animals are necessary, minimize pain

and distress, husbandry and care • Use of appropriate euthanasia methods • The 3 R’s

12.30 Close of Workshop

About the Workshop Leaders:William Weiss is currently the Director of Preclinical Services at the University of North Texas Health Science Center in Fort Worth. He uses his 33 years of experience and expertise in infectious disease research to direct the evaluations of antibacterial agents, including established models of both acute and chronic bacterial infections in several different animal species as well as pharmacokinetic studies and HPLC or LCMS analysis in collaboration with large pharmaceutical companies, the biotech industry as well as academia.

Mark Pulse has primarily been focused on bacterial pathogenesis and pre-clinical drug evaluation within in vivo models. For the last 10years he has been directly involved in the development of several in vivo models that have included GI- and respiratoryassociated infectious diseases, device-associated (biofi lm) infections, and pharmacokinetic studies within multiple animal species. He also has experience with survival surgery in multiple animal species, including USDA species.

About the Pre-Clinical Services:The Pre-Clinical Services group at the University of North Texas Health Science Center conducts studies utilizing establishedmodels of both acute and chronic bacterial infections in several different animal species. In addition, pharmacokinetic studies with accompanied bioanalytical LCMS / HPLC analysis can be performed in-house for submitted compounds. Infection models or protocols other than those described herein can also be established or adapted as required to meet the more specifi c needs of interested Sponsors. UNTHSC Pre-clinical Services together has over 33 years of pharmaceutical and specialized biotech experience in the performance of therapeutic effi cacy models and drug discovery / development.

Practical Challenges in DevelopingNovel Antimicrobials

Workshop Leader: Keith Williams, Director, KW Drug Developments Ltd,

ex Global Product Director (Infection) at AstraZeneca, Hon FICR

HALF-DAY POST-CONFERENCE WORKSHOP BWednesday 22nd March 2017

13.30 – 17.50Copthorne Tara Hotel, Kensington, London, UK

Overview of Workshop:For a decade there have been limited new antimicrobials and yet resistance is on the rise. New economic models and incentives have been proposed and yet many major Pharma fi rms focus on chronic diseases so much expertise in Infection has been lost.This interactive workshop will focus on the practical challenges of developing a range of antimicrobials for the global market and to address resistance.

The course leader has developed narrow and broad spectrum antibiotics and has coordinated their overall and clinical developments.

Who should attend:Anyone directly or indirectly involved in antibacterial drug development. Most will be from individual departments, whether research, toxicology, pharmaceutical, medical, regulatory, commercial, market research, patents or manufacturing.

Programme:


13.45 Opening remarks and introductions

14.00 Target product profi les - what new products are needed and how are TPPs created. Advisory boards, market research, planning for 10-15 years ahead

15.00 Afternoon Tea

15.30 Selecting drug targets and evaluating hits & optimising potential lead compounds

16.00 Getting into man and setting the therapeutic dose

17.00 Global clinical developments - challenges

17.30 Regulatory and international hurdles: Reasons drugs fail in development

17.50 Close of Workshop

About the Workshop Leaders:Keith Williams has a background in biochemistry (Sheffi eld University) and Clinical Medicine research (Oxford University, Nuffi eld Orthopaedic centre) has worked in antimicrobial drug development since 1980, initially in Clinical research at Glaxo, ICI, then Zeneca, as a Clinical project manager, then as a Global Product Director at AstraZeneca. For the last 11 years he has worked as an independent consultant working with Biotechs , Pharma and Universities. He was Chairman of the Institute of Clinical Research and is an honorary member, and he is an honorary lecturer leading the PIAT drug development course for 10 years. He has published extensively including the Challenges of developing antimicrobials. He is also a medical historian with a focus on the history of the pharmaceutical industry and clinical trials. He has developed a drug development training game Test Tubes to Tablets.

The organisations mentioned are as follows:• Glaxo, now GSK - clinical trials • ICI, Zeneca, now part of Astra Zeneca - European

Coordinator, Antibiotics and Clinical project manager• Institute of Clinical Research, UK ex Secretary and

Chairman• PIAT at University of Manchester - Lecturer, course leader• University of Manchester - PhD in History of Medicine• Keith Williams Drug Developments Ltd working with

many clients• Boyd Consulltants - Keith Williams has worked on their

behalf on numerous projects• Medscape - Keith Williams was Infection consultant on

a number of projects

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VENUE Copthorne Tara Hotel, Kensington, Scarsdale Place Kensington London, W8 5SR, UK

SUPERBUGS & SUPERDRUGSConference: Monday 20th & Tuesday 21st March 2017, Copthorne Tara Hotel, Kensington, London, UK

Workshops: Wednesday 22nd March 2017, London, UK

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Fateja Begum

Health & Medicine

Superbugs & Superdrugs 2017