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Building on 18 Years of Expertise in Europe, SMi Presents...
Superbugs &
Superdrugs USA
CONFERENCE:
14TH - 15TH
WORKSHOP: 16TH
NOV
2016The Global Attack Against Bacteria’s Defensive Walls
Chair:
• William Weiss, Director, Pre-Clinical Services,
UNT Health Science Center
Expert Speakers include:
• Dr Pilar Ramon-Pardo, Advisor on Clinical Management of
Infectious Diseases and Antimicrobial Resistance, PAHO/WHO
• Dr Christopher Houchens, Branch Chief, Antibacterials
Program, BARDA
• Dr Rosemarie Aurigemma, Chief, Biodefense Drug
Development Section, DMID, NIAID, NIH
• Dr John Rex, Senior Vice President and Chief Strategy
Officer, Infection Business Unit, AstraZeneca
• Dr Annaliesa Anderson, Vice President and CSO Bacterial
Vaccines, Pfizer
• Dr Anthony Simon Lynch, Senior Scientific Director, Janssen
Research & Development LLC
• Dr Mahesh Kumar, Vice President, Global Biological
Research and Development, Zoetis
The Use of Animal Models in Pre-Clinical Drug Development
8.30am - 12.30pm
Workshop Leaders:
William Weiss, Director, Pre-Clinical Services, UNT Health Science Center
Mark Pulse, Associate Director, Pre-Clinical Services, UNT Health Science Center
AN INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 16th November 2016, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
@SMIPHARM
#superbugsusa
www.superbugs-usa.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
Key reasons to attend:
CURRENT STATUS: Receive progressive insight
into innovative developments in big pharma
with updates on drug discovery
FAST TO MARKET: Evaluate zoonotic link
between animals and humans to target
emerging infectious diseases
DRUG DISCOVERY: Enable antibiotic drug
development through novel approaches in
treating gram-negative infections
TARGETING MECHANISIMS: Restore antibiotic
sensitivity in multi-drug resistance infections
PREPARE: Prepare for outbreaks with case study
insight into new paradigms for prevention and
industry collaboration
Sponsored by:
Learn about progress in the development of
National Action Plans with exclusive keynotes from
PAHO/WHO, NIAID and BARDA
Renaissance Woodbridge Hotel,
Iselin, New Jersey, USA
Polyphor Ltd is a Swiss Pharma company focusing on the
discovery and development of macrocycle drugs addressing
high unmet medical needs. These macrocycles represent
a new drug class complementary to the classical small
molecules and large biopharmaceuticals. Polyphor’s competitive edge is based on its two
proprietary, innovative and complementary technologies, PEMfinder® and MacroFinder®.
The company is developing a pre-clinical and clinical portfolio of own drug candidates in
important disease areas. In addition, both macrocycle technologies are used in collaborative
drug discovery projects with Pharma companies. Polyphor focuses on the therapeutic benefit
to the patient – the best guarantee for economic success in our view. www. polyphor.com
Superbugs & Superdrugs USA
Day One | Monday 14th November 2016
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
William Weiss, Director, Pre-Clinical Services,
UNT Health Science Center
9.10 Global action plan on antimicrobial resistance
• Strategic lines of action
• Progress in the development of National Action Plans
• Barriers and challenges for implementation of the Global
Action Plan
• The way forward
Dr Pilar Ramon-Pardo, Advisor on Clinical Management of
Infectious Diseases and Antimicrobial Resistance, PAHO/
WHO
OPENING ADDRESS
9.50 NIAID and National Strategy for CARB
• NIAID-supported research on antimicrobial drug
resistance has helped facilitate translation of basic
research discoveries from “bench to bedside”.
• The National Strategy for Combating Antibiotic Resistant
Bacteria has allowed all facets of this drug discovery/
development support to be boosted in order to drive
greater interest and encourage investment and innovation.
• NIAID hopes that the investment made will result in an
upwelling of novel products into the pipeline and lead to new
licensed products to stem the surge of resistant infections.
• This presentation will describe NIAID programs that
support antimicrobial product development, the
results of the first year of the CARB initiative and the
opportunities that lay ahead.
Dr Rosemarie Aurigemma, Chief, Biodefense Drug
Development Section, DMID, NIAID, NIH
10.30 Morning Coffee
11.00 BARDA’s end-to-end support of antibacterial product
development
• Launching the Biopharmaceutical Accelerator to
repopulate the antimicrobial pipeline
• Utilizing innovative public-private partnering
mechanisms to stimulate clinical product development
• Expanding the BARDA portfolio to include nontraditional
antimicrobials
• BARDA’s efforts to address objectives in the US National
Action Plan for CARB
Dr Christopher Houchens, Branch Chief, Antibacterials
Program, BARDA
KEYNOTE ADDRESS
11.40 Enabling drug discovery and development to address the
crisis of antimicrobial resistance
• New tools
• New pathways
• Remaining challenges
Dr John Rex, Senior Vice President and Chief Strategy
Officer, Infection Business Unit, AstraZeneca
12.20 Networking Lunch
1.30 POL7080 – Polyphor’s new class of macrocycle antibiotic
• POL7080, Murapavadin, is the frontrunner of a new
class of novel macrocycle antibiotic discovered and
developed by Polyphor
• It is a Pseudomonas-specific antibiotic, highly active on
a broad panel of clinical isolates, including multi-drug
resistant (MDR) strains and colistin-resistant isolates.
• Phase I clinical trial in healthy volunteers in Europe
demonstrated the clinical safety and tolerability of
POL7080 and a Phase II study is on-going in ventilator-
associated pneumonia (VAP)
• Polyphor is developing a novel class of broad-spectrum
Gran-negative antibiotics derived from our macrocycle
technology platform
Dr Daniel Obrecht, Chief Scientific Officer,
Polyphor
KEYNOTE ADDRESS
2.10 Progress towards developing vaccines for the prevention
of Staphylococcus aureus infections
• Staphylococcus aureus causes serious infections in
healthcare settings
• Antibiotic resistance make infections harder to treat and
non-antibiotic prophylactic approaches could address
this unmet medical need
• Approaches to design and develop vaccines for the
prevention of S. aureus infections will be discussed
Dr Annaliesa Anderson, Vice President and CSO Bacterial
Vaccines, Pfizer
2.50 Innovative approaches to treating gram-negative infections
• Turning gram-positive antibiotics into gram-negative
therapeutics
Dr Scott Coleman, Head of Nonclinical Development,
Spero Therapeutics
3.30 Afternoon Tea
4.00 Microbial metagenomics-based antibiotic
discovery
• Accessing the biosynthetic output of
overlooked unculturable microbes for new
medicines
• Surveying natural variants of known secondary
metabolites for improved biological and
pharmaceutical properties
• Synthetic biological manipulation of biosynthetic gene
clusters as a method of lead optimization
Dr David Pompliano, Co-Founder and CSO,
Lodo Therapeutics
4.40 Targeting mechanisms of resistance using
protein resistance neutralizers
• Restoring antibiotic sensitivity in multi-drug
resistance infections
• Direct targeting of resistance gene products using
protein “resistance neutralizers”
• Enhance antibiotic effects, expand efficacy and
maintain clinical usefulness
Dr David Cook, Chief Scientific Officer,
Blueberry Therapeutics Ltd
5.20 Chairman’s Closing Remarks and Close of Day One
PUBLIC AND PRIVATE PARTNERSHIPS
RESEARCH AND DEVELOPMENT UPDATES
Register online at www.superbugs-usa.com
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 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
Official media partners:
EUROPEAN
VIEW
Sponsored by:
*Subject to final confirmation
Superbugs & Superdrugs USA
Day Two | Tuesday 15th November 2016
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
William Weiss, Director, Pre-Clinical Services,
UNT Health Science Center
OPENING KEYNOTE ADDRESS
9.10 First to know and fast to market
• Infectious diseases between animals and people
• First to know and fast to market
• Making a difference
Dr Mahesh Kumar, Vice President, Global Biological
Research and Development, Zoetis
KEYNOTE ADDRESS
9.50 Novel protein-based biologics for the treatment and
prevention of serious bacterial infections
• Bacteriophage-derived lysins, antibody-drug conjugates
and novel protein scaffolds
• Challenges in discovery and development
• Potential for clinical utility as stand-alone agents or as
adjuncts to existing therapies
Dr Anthony Simon Lynch, Senior Scientific Director, Janssen
Research & Development LLC
10.30 Morning Coffee
11.00 Antimicrobial combination therapy: Use and disuse
• Rationale for the use of antibiotic combinations
• Advantages / disadvantages of combining
antimicrobial agents
• Currently used antibiotic combinations
• Novel and non-traditional antimicrobial combinations
William Weiss, Director, Pre-Clinical Services,
UNT Health Science Center
11.40 What can be done in order to be successful?
• Novel approaches and compounds
• New scenarios in innovation
• Rational health system
Dr Domingo Gargallo-Viola, Co-Founder and CSO,
ABAC Therapeutics
12.20 Networking Lunch
1.30 Addressing the evolving challenge of β-lactamase
mediated antimicrobial resistance: ETX2514, a next-
generation BLI with potent broad spectrum activity
against Class A, C and D enzymes
• ETX2514 is a novel diazabicyclooctenone with potent,
broad spectrum inhibitory activity against Class A, C
and D serine β-lactamases
• ETX2514 restores the antimicrobial activity of a variety
of β-lactams against multi-drug resistant Gram-negative
pathogens
• The combination of ETX2514 and sulbactam is highly
effective in vitro and in vivo against clinical MDR and
XDR A. baumannii
Dr Alita Miller, Head of Bioscience, Entasis Therapeutics
2.10 Discovery of novel broad-spectrum carbapenemase
inhibitors (BCIs): Challenges and opportunities
• BCIs background
• Methods used
• Results overview
Dr Olga Lomovskaya, Vice President, Biology,
The Medicines Company*
2.50 Afternoon Tea
3.20 Collaborative development of novel drugs
to prevent infection
• Development of clinical stage assets through
collaborative ventures
• Progression of XF-73, an alternative to traditional
antibiotics
• Preventing infection and addressing resistance
Ian Hayter, Projects Director, Destiny Pharma Ltd
4.00 Novel monoclonal antibodies for the prevention and
treatment of bacterial infections
• Opportunistic approaches for the treatment and
prevention of microbial infections
• New paradigm for prevention
Reserved for a big pharma company
4.40 Chairman’s Closing Remarks and Close of Day Two
NOVEL ANTIBACTERIAL THERAPEUTIC APPROACHES
Supported by
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MARKETING OPPORTUNITIES
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
Official Publications
STRENGTHENING THE PIPELINE
EUROPEAN
VIEW
EUROPEAN
VIEW
The Use of Animal Models in Pre-Clinical
Drug Development
Workshop Leaders:
William Weiss, Director, Pre-Clinical Services,
UNT Health Science Center
Mark Pulse, Associate Director, Pre-Clinical Services,
UNT Health Science Center
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 16th November 2016
08.30 – 12.30
Renaissance Woodbridge Hotel, Iselin,
New Jersey, USA
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 efficacy, 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 should you attend this workshop:
• 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:
8.30 Registration & Coffee
9.00 Opening remarks and introductions
9.10 Session 1: Preclinical Drug Development
• Overview of preclinical testing
• Discovery to lead selection
• The development model: then and now
• Antibacterial research efforts
9.50 Session 2: Experimental Design and Methodology
• Experimental design profoundly influences
the outcome of a research study
• Clearly define the question or problem
being studied
• Realistic objectives (achievable)
• Choose the best research model
10.30 Morning Coffee
11.00 Session 3: Animal Models – Examples
• Acute infection models – Bacteremia, Sepsis
• Chronic infection models – Pneumonia, skin,
abscesses
• GI related – C. difficile, H. pylori
• Device related – Biofilm, endocarditis, prosthetic
joint
11.40 Session 4: 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
12.20 Closing remarks
12.30 End 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. His expertise
encompasses the development and evaluation of animal
models of infectious disease as well as pharmacokinetic and
pharmacodynamic analysis. He has authored / co-authored
over 90 research presentations and journal articles.
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 respiratory-
associated infectious diseases, device-associated
(biofilm) 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 established
models 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 specific needs of interested Sponsors.
UNTHSC Pre-clinical Services together has over 33 years of
pharmaceutical and specialized biotech experience in
the performance of therapeutic efficacy models and drug
discovery / development. The group uses this experience to
guide the drug discovery process, through protocol design,
implementation and analysis for compound lead selection.
Studies are conducted in state-of-the-art facilities with
excellent support staff and services.
SMi Pharmceutical
Event Planner 2016
SEPTEMBER
Cancer Vaccines
21st - 22nd September
London, UK
Biosimilars Europe
29th - 30th September
London, UK
OCTOBER
European Market Access, Pricing
& Reimbursement in Pharma
10th - 11th October
London, UK
Orphan Drugs
19th - 20th October
London, UK
NOVEMBER
Superbugs & Superdrugs USA
14th - 15th November
New Jersey, USA
Biosimilars USA
16th - 17th November
New Jersey, USA
3d Cell Culture
28th - 29th November
London, UK
DECEMBER
Cold Chain Distribution
12th - 13th December
London, UK
Why are we coming to the USA?
Superbugs & Superdrugs Europe
Attendees by Region 2015/2016
24%24%24%
31%31%31%
39%39%39%
6%6%6%
Europe
ROW
United Kingdom
USA
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
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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
conferencesdocumentationviatheDocumentPortaltoanydelegatewhohaspaidbutisunable
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
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address on the attached letter.
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
□ Book by July 15th 2016 to receive $400 off the conference price
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□ Book by September 30th 2016 to receive $200 off the conference price
EARLY BIRD
DISCOUNT
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: events@smi-online.co.uk or fax +44 (0) 870 9090 712
Unique Reference Number
Our Reference LVP-193
SUPERBUGS & SUPERDRUGS USA
Conference: Monday 14th & Tuesday 15th November 2016, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Workshop: Wednesday 16th November 2016
4 WAYS TO REGISTER
www.superbugs-usa.com
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
DELEGATE DETAILS
Terms and Conditions of Booking
VENUE Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Payment must be made to SMi Group Ltd, and received before the event, by one of the
following methods quoting reference P-193 and the delegate’s name. Bookings made within
7 days of the event require payment on booking, methods of payment:
A/C Name SMI GROUP LTD Sort Code 300009,
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SMi Group's Superbugs and Superdrugs USA 2016

  • 1. Register by July 15th and save $400 Register by August 31st and save $300 Register by September 30th and save $200 Building on 18 Years of Expertise in Europe, SMi Presents... Superbugs & Superdrugs USA CONFERENCE: 14TH - 15TH WORKSHOP: 16TH NOV 2016The Global Attack Against Bacteria’s Defensive Walls Chair: • William Weiss, Director, Pre-Clinical Services, UNT Health Science Center Expert Speakers include: • Dr Pilar Ramon-Pardo, Advisor on Clinical Management of Infectious Diseases and Antimicrobial Resistance, PAHO/WHO • Dr Christopher Houchens, Branch Chief, Antibacterials Program, BARDA • Dr Rosemarie Aurigemma, Chief, Biodefense Drug Development Section, DMID, NIAID, NIH • Dr John Rex, Senior Vice President and Chief Strategy Officer, Infection Business Unit, AstraZeneca • Dr Annaliesa Anderson, Vice President and CSO Bacterial Vaccines, Pfizer • Dr Anthony Simon Lynch, Senior Scientific Director, Janssen Research & Development LLC • Dr Mahesh Kumar, Vice President, Global Biological Research and Development, Zoetis The Use of Animal Models in Pre-Clinical Drug Development 8.30am - 12.30pm Workshop Leaders: William Weiss, Director, Pre-Clinical Services, UNT Health Science Center Mark Pulse, Associate Director, Pre-Clinical Services, UNT Health Science Center AN INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP Wednesday 16th November 2016, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA @SMIPHARM #superbugsusa www.superbugs-usa.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 ACADEMIC & GROUP DISCOUNTS AVAILABLE Key reasons to attend: CURRENT STATUS: Receive progressive insight into innovative developments in big pharma with updates on drug discovery FAST TO MARKET: Evaluate zoonotic link between animals and humans to target emerging infectious diseases DRUG DISCOVERY: Enable antibiotic drug development through novel approaches in treating gram-negative infections TARGETING MECHANISIMS: Restore antibiotic sensitivity in multi-drug resistance infections PREPARE: Prepare for outbreaks with case study insight into new paradigms for prevention and industry collaboration Sponsored by: Learn about progress in the development of National Action Plans with exclusive keynotes from PAHO/WHO, NIAID and BARDA Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
  • 2. Polyphor Ltd is a Swiss Pharma company focusing on the discovery and development of macrocycle drugs addressing high unmet medical needs. These macrocycles represent a new drug class complementary to the classical small molecules and large biopharmaceuticals. Polyphor’s competitive edge is based on its two proprietary, innovative and complementary technologies, PEMfinder® and MacroFinder®. The company is developing a pre-clinical and clinical portfolio of own drug candidates in important disease areas. In addition, both macrocycle technologies are used in collaborative drug discovery projects with Pharma companies. Polyphor focuses on the therapeutic benefit to the patient – the best guarantee for economic success in our view. www. polyphor.com Superbugs & Superdrugs USA Day One | Monday 14th November 2016 8.30 Registration & Coffee 9.00 Chairman’s Opening Remarks William Weiss, Director, Pre-Clinical Services, UNT Health Science Center 9.10 Global action plan on antimicrobial resistance • Strategic lines of action • Progress in the development of National Action Plans • Barriers and challenges for implementation of the Global Action Plan • The way forward Dr Pilar Ramon-Pardo, Advisor on Clinical Management of Infectious Diseases and Antimicrobial Resistance, PAHO/ WHO OPENING ADDRESS 9.50 NIAID and National Strategy for CARB • NIAID-supported research on antimicrobial drug resistance has helped facilitate translation of basic research discoveries from “bench to bedside”. • The National Strategy for Combating Antibiotic Resistant Bacteria has allowed all facets of this drug discovery/ development support to be boosted in order to drive greater interest and encourage investment and innovation. • NIAID hopes that the investment made will result in an upwelling of novel products into the pipeline and lead to new licensed products to stem the surge of resistant infections. • This presentation will describe NIAID programs that support antimicrobial product development, the results of the first year of the CARB initiative and the opportunities that lay ahead. Dr Rosemarie Aurigemma, Chief, Biodefense Drug Development Section, DMID, NIAID, NIH 10.30 Morning Coffee 11.00 BARDA’s end-to-end support of antibacterial product development • Launching the Biopharmaceutical Accelerator to repopulate the antimicrobial pipeline • Utilizing innovative public-private partnering mechanisms to stimulate clinical product development • Expanding the BARDA portfolio to include nontraditional antimicrobials • BARDA’s efforts to address objectives in the US National Action Plan for CARB Dr Christopher Houchens, Branch Chief, Antibacterials Program, BARDA KEYNOTE ADDRESS 11.40 Enabling drug discovery and development to address the crisis of antimicrobial resistance • New tools • New pathways • Remaining challenges Dr John Rex, Senior Vice President and Chief Strategy Officer, Infection Business Unit, AstraZeneca 12.20 Networking Lunch 1.30 POL7080 – Polyphor’s new class of macrocycle antibiotic • POL7080, Murapavadin, is the frontrunner of a new class of novel macrocycle antibiotic discovered and developed by Polyphor • It is a Pseudomonas-specific antibiotic, highly active on a broad panel of clinical isolates, including multi-drug resistant (MDR) strains and colistin-resistant isolates. • Phase I clinical trial in healthy volunteers in Europe demonstrated the clinical safety and tolerability of POL7080 and a Phase II study is on-going in ventilator- associated pneumonia (VAP) • Polyphor is developing a novel class of broad-spectrum Gran-negative antibiotics derived from our macrocycle technology platform Dr Daniel Obrecht, Chief Scientific Officer, Polyphor KEYNOTE ADDRESS 2.10 Progress towards developing vaccines for the prevention of Staphylococcus aureus infections • Staphylococcus aureus causes serious infections in healthcare settings • Antibiotic resistance make infections harder to treat and non-antibiotic prophylactic approaches could address this unmet medical need • Approaches to design and develop vaccines for the prevention of S. aureus infections will be discussed Dr Annaliesa Anderson, Vice President and CSO Bacterial Vaccines, Pfizer 2.50 Innovative approaches to treating gram-negative infections • Turning gram-positive antibiotics into gram-negative therapeutics Dr Scott Coleman, Head of Nonclinical Development, Spero Therapeutics 3.30 Afternoon Tea 4.00 Microbial metagenomics-based antibiotic discovery • Accessing the biosynthetic output of overlooked unculturable microbes for new medicines • Surveying natural variants of known secondary metabolites for improved biological and pharmaceutical properties • Synthetic biological manipulation of biosynthetic gene clusters as a method of lead optimization Dr David Pompliano, Co-Founder and CSO, Lodo Therapeutics 4.40 Targeting mechanisms of resistance using protein resistance neutralizers • Restoring antibiotic sensitivity in multi-drug resistance infections • Direct targeting of resistance gene products using protein “resistance neutralizers” • Enhance antibiotic effects, expand efficacy and maintain clinical usefulness Dr David Cook, Chief Scientific Officer, Blueberry Therapeutics Ltd 5.20 Chairman’s Closing Remarks and Close of Day One PUBLIC AND PRIVATE PARTNERSHIPS RESEARCH AND DEVELOPMENT UPDATES Register online at www.superbugs-usa.com 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 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 Official media partners: EUROPEAN VIEW Sponsored by:
  • 3. *Subject to final confirmation Superbugs & Superdrugs USA Day Two | Tuesday 15th November 2016 8.30 Registration & Coffee 9.00 Chairman’s Opening Remarks William Weiss, Director, Pre-Clinical Services, UNT Health Science Center OPENING KEYNOTE ADDRESS 9.10 First to know and fast to market • Infectious diseases between animals and people • First to know and fast to market • Making a difference Dr Mahesh Kumar, Vice President, Global Biological Research and Development, Zoetis KEYNOTE ADDRESS 9.50 Novel protein-based biologics for the treatment and prevention of serious bacterial infections • Bacteriophage-derived lysins, antibody-drug conjugates and novel protein scaffolds • Challenges in discovery and development • Potential for clinical utility as stand-alone agents or as adjuncts to existing therapies Dr Anthony Simon Lynch, Senior Scientific Director, Janssen Research & Development LLC 10.30 Morning Coffee 11.00 Antimicrobial combination therapy: Use and disuse • Rationale for the use of antibiotic combinations • Advantages / disadvantages of combining antimicrobial agents • Currently used antibiotic combinations • Novel and non-traditional antimicrobial combinations William Weiss, Director, Pre-Clinical Services, UNT Health Science Center 11.40 What can be done in order to be successful? • Novel approaches and compounds • New scenarios in innovation • Rational health system Dr Domingo Gargallo-Viola, Co-Founder and CSO, ABAC Therapeutics 12.20 Networking Lunch 1.30 Addressing the evolving challenge of β-lactamase mediated antimicrobial resistance: ETX2514, a next- generation BLI with potent broad spectrum activity against Class A, C and D enzymes • ETX2514 is a novel diazabicyclooctenone with potent, broad spectrum inhibitory activity against Class A, C and D serine β-lactamases • ETX2514 restores the antimicrobial activity of a variety of β-lactams against multi-drug resistant Gram-negative pathogens • The combination of ETX2514 and sulbactam is highly effective in vitro and in vivo against clinical MDR and XDR A. baumannii Dr Alita Miller, Head of Bioscience, Entasis Therapeutics 2.10 Discovery of novel broad-spectrum carbapenemase inhibitors (BCIs): Challenges and opportunities • BCIs background • Methods used • Results overview Dr Olga Lomovskaya, Vice President, Biology, The Medicines Company* 2.50 Afternoon Tea 3.20 Collaborative development of novel drugs to prevent infection • Development of clinical stage assets through collaborative ventures • Progression of XF-73, an alternative to traditional antibiotics • Preventing infection and addressing resistance Ian Hayter, Projects Director, Destiny Pharma Ltd 4.00 Novel monoclonal antibodies for the prevention and treatment of bacterial infections • Opportunistic approaches for the treatment and prevention of microbial infections • New paradigm for prevention Reserved for a big pharma company 4.40 Chairman’s Closing Remarks and Close of Day Two NOVEL ANTIBACTERIAL THERAPEUTIC APPROACHES Supported by Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 MARKETING OPPORTUNITIES 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 Official Publications STRENGTHENING THE PIPELINE EUROPEAN VIEW EUROPEAN VIEW
  • 4. The Use of Animal Models in Pre-Clinical Drug Development Workshop Leaders: William Weiss, Director, Pre-Clinical Services, UNT Health Science Center Mark Pulse, Associate Director, Pre-Clinical Services, UNT Health Science Center HALF-DAY POST-CONFERENCE WORKSHOP Wednesday 16th November 2016 08.30 – 12.30 Renaissance Woodbridge Hotel, Iselin, New Jersey, USA 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 efficacy, 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 should you attend this workshop: • 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: 8.30 Registration & Coffee 9.00 Opening remarks and introductions 9.10 Session 1: Preclinical Drug Development • Overview of preclinical testing • Discovery to lead selection • The development model: then and now • Antibacterial research efforts 9.50 Session 2: Experimental Design and Methodology • Experimental design profoundly influences the outcome of a research study • Clearly define the question or problem being studied • Realistic objectives (achievable) • Choose the best research model 10.30 Morning Coffee 11.00 Session 3: Animal Models – Examples • Acute infection models – Bacteremia, Sepsis • Chronic infection models – Pneumonia, skin, abscesses • GI related – C. difficile, H. pylori • Device related – Biofilm, endocarditis, prosthetic joint 11.40 Session 4: 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 12.20 Closing remarks 12.30 End 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. His expertise encompasses the development and evaluation of animal models of infectious disease as well as pharmacokinetic and pharmacodynamic analysis. He has authored / co-authored over 90 research presentations and journal articles. 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 respiratory- associated infectious diseases, device-associated (biofilm) 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 established models 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 specific needs of interested Sponsors. UNTHSC Pre-clinical Services together has over 33 years of pharmaceutical and specialized biotech experience in the performance of therapeutic efficacy models and drug discovery / development. The group uses this experience to guide the drug discovery process, through protocol design, implementation and analysis for compound lead selection. Studies are conducted in state-of-the-art facilities with excellent support staff and services.
  • 5. SMi Pharmceutical Event Planner 2016 SEPTEMBER Cancer Vaccines 21st - 22nd September London, UK Biosimilars Europe 29th - 30th September London, UK OCTOBER European Market Access, Pricing & Reimbursement in Pharma 10th - 11th October London, UK Orphan Drugs 19th - 20th October London, UK NOVEMBER Superbugs & Superdrugs USA 14th - 15th November New Jersey, USA Biosimilars USA 16th - 17th November New Jersey, USA 3d Cell Culture 28th - 29th November London, UK DECEMBER Cold Chain Distribution 12th - 13th December London, UK Why are we coming to the USA? Superbugs & Superdrugs Europe Attendees by Region 2015/2016 24%24%24% 31%31%31% 39%39%39% 6%6%6% Europe ROW United Kingdom USA
  • 6. Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organization: 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. 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