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Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
The use of animal models in pre-clinical drug development
Workshop Leaders:
William Weiss, Director, Pre-Clinical Services, UNT Health Science Center
Mark Pulse, Assistant Director, UNT Health Science Center
08.30 - 12.30
PLUS ONE INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP | WEDNESDAY 15TH NOVEMBER 2017, RENAISSANCE WOODBRIDGE HOTEL, ISELIN, NJ, USA
@smipharm
#smibugs
CHAIRS FOR 2017:
•	 Anthony Simon Lynch, Senior Scientific Director, Janssen
•	 William Weiss, Director, Pre-Clinical Services, UNT Health
Science Center
FEATURED SPEAKERS:
•	 John Rex, Chief Medical Officer & Director, F2G; Chief
Strategy Officer, CARB-X
•	 Christopher Houchens, Branch Chief, Antibacterials
Program, BARDA
•	 Annaliesa Anderson, Vice President & CSO Bacterial
Vaccines, Pfizer
•	 Olga Danilchanka, Microbiome Lead, Merck
•	 Christopher McMaster, President & CEO, DemovaMed
•	 Obadiah Plante, Director of Research, Visterrra
•	 Tim Opperman, Senior Research Scientist, Microbiotix
•	 Ken Stover, Senior Director, Infectious Diseases and
Vaccines, MedImmune
•	 Mike Westby, Director, Centauri Therapeutics
HIGHLIGHTS IN 2017:
•	 Tips for successfully seeking funding and partnership,
including updates on the CARB-X initiative
•	 Explore the importance of supporting natural immunity
and the microbiome for reducing infection from
resistant bacteria
•	 Developments for treating gram-negative infections
WORKSHOP: 15TH
CONFERENCE: 13TH-14TH
NOV
2017RENAISSANCE WOODBRIDGE HOTEL, ISELIN, NJ, USA
Strengthening the pipeline; new incentives and approaches to combating bacterial resistance
SMi proudly presents the 2nd annual conference…
Superbugs &
Superdrugs USA
BOOK BY 30TH JUNE AND SAVE $300
BOOK BY 29TH SEPTEMBER AND SAVE $100
SPONSORED BY
Superbugs & Superdrugs USA
Day One | Monday 13th November 2017 	 www.superbugs-usa.com
08.30	 Registration & Coffee
09.00	 Chairs’ Opening Remarks
Anthony Simon Lynch, Senior Scientific Director, Janssen
William Weiss, Director, Pre-Clinical Services, UNT Health Science
Center
REGULATION, INCENTIVES AND PARTNERSHIPS
OPENING ADDRESS
09.10	 Funding, filing, and finance
•	What’s up with funding initiatives: CARB-X update
•	Advances in regulatory tools: Tier C makes headway
•	Paying for it all: Evolving global discussions of payor models
John Rex, Chief Medical Officer & Director, F2G; Chief Strategy
Officer, CARB-X
09.50	 Challenges and opportunities in antibacterial development
•	Why BARDA is interested in antimicrobial resistance (AMR)
•	How BARDA is addressing the issue of AMR
•	Stimulating innovation in antimicrobial research and
development
Christopher Houchens, Branch Chief, Antibacterials Program, BARDA
10.30 	 Morning Coffee
NOVEL TARGETS AND NON-TRADITIONAL APPROACHES
11.00	 Advances towards preventing Clostridium difficile infections
through vaccination
•	C. difficile infections present a healthcare emergency in the
USA
•	Disease is mediated by toxins expressed by the bacterium
•	Toxoid based vaccines are currently in development for disease
prevention
•	The progress and prospects for these vaccines will be discussed
Annaliesa Anderson, Vice President and CSO Bacterial Vaccines,
Pfizer
11.40	 Immunity and antibodies versus multi-drug resistant bacteria
•	Multi-mechanistic antibodies and their potential for serious
bacterial infections
•	Pathogen-specific prophylaxis and treatment and antibody
synergy with antibiotic therapy
•	Challenges for a paradigm shift away from reliance on broad
spectrum antibiotics
Ken Stover, Senior Director, Infectious Diseases and Vaccines,
MedImmune
12.20	 Networking Lunch
13.30	 Supporting the microbiome to reduce infection by resistant
bacteria
•	Patients with a disrupted microbiome (in response to antibiotics)
are more vulnerable to infection from resistant bacteria strains
•	Slowing antibiotic resistance by minimising the microbiome’s
disruption in response to antibacterial treatments
Olga Danilchanka, Microbiome Lead, Merck
14.10	 Innate defense regulators: Broad-spectrum, host-directed therapy
for antibiotic resistant disease
•	Innate immunity is a host-directed approach for treatment of
infectious disease, equally capable of treatment antibiotic
sensitive and antibiotic resistant organisms.
•	Preclinical studies demonstrated an ability to combat infection
while modulating inflammation and enhancing tissue healing
•	Clinically, the lead clinical IDR, dusquetide, has been
demonstrated to be safe and efficacious in Phase 1 and 2
studies
•	In a Phase 2 study, dusquetide reduced the duration of severe
oral mucositis in head and neck cancer patients receiving
chemoradiation therapy, while also decreasing the incidence
of bacterial infections
Oreola Donini, Chief Scientific Officer, Soligenix
14.50	 Afternoon Tea
15.20	 Targeting P. aeruginosa with an antibody-drug conjugate
•	Conserved target on the bacterial surface of P. aeruginosa
•	Considerations in the design of an ADC
•	ADCs as a treatment for P. aeruginosa infection
Obadiah Plante, Director of Research, Visterra
16.00	 Targeted lysin therapeutics for serious bacterial infections;
	 bench to bedside
•	What are phage-derived lysins and how can their novel
mechanism of action potentiate conventional antibiotics?
•	What do animal models tell us about the potential for lysins to
treat serious, biofilm dependent infections?
•	What is the therapeutic potential of lysins to combat
antimicrobial resistance and improve clinical outcomes?
Cara Cassino, Executive Vice President of Research and
Development and Chief Medical Officer, ContraFect
16.40	 Chairs’ Closing Remarks and Close of Day One
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
SPONSORED BY
Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and
commercializing products to treat rare diseases where there is unmet medical need, including:
1) a therapeutics segment directed at cutaneous T-cell lymphoma and oral mucositis; and 2) a
biodefense segment directed at ricin exposure, acute radiation syndrome and antibiotic resistant
infectious disease. www.soligenix.com
Superbugs & Superdrugs USA
www.superbugs-usa.com	 Day Two | Tuesday 14th November 2017
08.30	 Registration & Coffee
09.00	 Chairs’ Opening Remarks
Anthony Simon Lynch, Senior Scientific Director, Janssen
William Weiss, Director, Pre-Clinical Services, UNT Health Science
Center
NOVEL TARGETS / NON-TRADITIONAL APPROACHES 2
9.10	 Navigating the pitfalls of early drug discovery – lessons learned
•	Targets and target product profiles
•	Getting the mechanism of action right
•	Resistance considerations
•	Prospects for new agents
Karen Joy Shaw, Chief Scientific Officer, Amplyx
09.50	 A new antibiotic class?
•	De novo computer aided drug design versus a novel target was
used to develop a new antibiotic class
•	652 novel molecules were synthesized with over 20 having
clinically relevant broad specificity Gram positive efficacy in
vitro
•	Efficacy in animal models of infection and preclinical PK/ADME
point to potential clinical utility
•	Thoughts on moving this antibiotic class into Gram negative
bacteria will be discussed
Christopher McMaster, President & CEO, DeNovaMed		
10.30 	 Morning Coffee
11.00	 The medical device approach to preventing hospital acquired
infections and development of superbugs
•	1.7 million Hospital acquired infections occur annually, 70% of
which are related to the use of indwelling medical devices.
These add billions to annual health care costs
•	The endotracheal tube is a common breeding ground for MDR
strains. Polymicrobial biofilm allows horizontal gene transfer and
development of new MDR strains. Overuse of antibiotics also
allows development of fungal pathogens such as Candida auris
•	Patients at high risk of infection are usually immune-
compromised; elderly, neonates, diabetics, cancer patients
•	The use of innate immune mimic synthetic molecule to coat
ETTs and other medical devices prevents bacterial and
fungal colonization and growth of biofilms, reducing HAIs and
development of superbugs
Carl Genberg, CEO, N8 Medical
FOCUSING ON GRAM NEGATIVE BACTERIA
11.40	 The Gram-negative challenge: An early discovery perspective
•	The scope of the challenge
•	Re-tracing the past 15 years of successes and failures
•	First-principal challenges in discovery of new chemical classes
•	First-principal challenges in the discovery of new modes of
action
Ryan Cirz, Senior Director of Early Research, Achaogen
12.20	 Networking Lunch	
13.30	 Evaluating immunotherapeutics as alternatives to antibiotics to
treat Gram-negative infections
•	Targeting specific pathogens
•	Recruiting natural immunity
•	Preclinical challenges
•	Next steps
Mike Westby, Director, Centauri Therapeutics
14.10		Repositioning an older class of drugs: Development of macrolides
for the treatment of serious Gram-negative infections
•	Challenges in repositioning a Gram-positive drug to be active
against Gram-negative pathogens
•	Overcoming the restrictions of natural product semi-synthesis to
increase compound diversity
•	Identifying and addressing any pre-existing pool of resistance in
target pathogens
Richard Alm, Vice President Biology, Macrolide Pharmaceuticals
14.50	 Afternoon Tea
15.20	 Multiple strategies to address the problem of MDR Gram-negative
pathogens
•	Overview of three discovery projects illustrating different
approaches to tackling the problem of Gram-negative
pathogens
•	Virulence. A novel series phenoxyacetamide series exhibits
potent activity against type 3 secretion in Pseudomonas
aeruginosa (IC50s as low as 20 nM) by targeting the assembled
needle protein PscF, and have demonstrated proof-of-principle
efficacy in murine infection models. This project is funded by
CARB-X
•	Intrinsic resistance. Novel pyranopyridine inhibitors of RND-
type efflux pump inhibitors exhibit broad spectrum activity
against pathogens of the Enterobacteriaceae, favourable
pharmacokinetics in mice, and efficacy in a murine infection
model
•	Novel essential target. A series of novel oxadiazoles bind to
a unique site on the ribosome, resulting in potent inhibition
of the essential non-stop ribosome rescue pathway in Gram-
positive and –negative pathogens, including MDR Neisseria
gonorrhoeae and Francisella tularensis. These compounds
exhibit potent antibacterial activity, oral bioavailability, and
efficacy in murine models of infection
Tim Opperman, Senior Research Scientist, Microbiotix
16.40	 Chairs’ Closing Remarks and Close of Day Two
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
OFFICIAL MEDIA PARTNERS
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Teri Arri, SMi Marketing on
++44 20 7827 6162 or email: tarri@smi-online.co.uk
SUPPORTED BY
HALF DAY POST-CONFERENCE WORKSHOP
Wednesday 15th November 2017,
Renaissance Woodbridge Hotel, Iselin, NJ, USA
08.30 - 12.30
The use of animal models in
pre-clinical drug development
Workshop Leaders:
William Weiss, Director, Pre-Clinical Services,
UNT Health Science Center
Mark Pulse, Assistant Director, UNT Health Science Center
Workshop overview:
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.
Reasons to attend:
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
08.30	 Registration & Coffee
09.00	Introduction
09.10	 Preclinical animal models
• Opening remarks and introduction
• History / Rationale for animal testing
• Animal use in research
• Predictability of animal models
09.30		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)
• Design the best research model
10.30	 Morning Coffee
11.00	 Animal models – examples
• Acute infection models – Bacteremia, sepsis
• Tissue specific infection models – Pneumonia, UTI,
skin, abscess, thigh
• GI related – C. difficile, H. pylori
• Device related – biofilm, endocarditis, prosthetic
joint
• Antifungal – Systemic candidiasis
• Pharmacokinetics / Pharmacodynamics
12.00	 Animals in research
• Institutional animal care and use committee
(IACUC)
• Justify why animals are necessary, minimise pain
and distress, husbandry and care
• Use of appropriate euthanasia methods
• The 3 R’s
12.30 	 Final discussion and close of the workshop
About the Workshop Leaders:
William Weiss: Before leading the PreClinical Services group, Bill
was Director of Drug Evaluation at Cumbre Pharmaceuticals
Inc. where he was responsible for all pre-clinical microbiology
research and development efforts focused on the discovery
& development of new antimicrobial agents. Prior to this,
he was a Group Leader in Infectious Disease Discovery
Research at Wyeth Research (Pfizer), Lederle Laboratories
and Schering-Plough (Merck). He has worked on numerous
antibacterial programs including the development of the
marketed antibiotics; Suprax, Zosyn and Tygacil. His expertise
encompasses the development of animal research models,
evaluation of new and novel therapeutic agents as well as
pharmacokinetic/pharmacodynamic analysis.
Mark Pulse: Mark holds a MSc in molecular microbiology
and immunology, his early research at the University of North
Texas Health Science Center primarily focused on bacterial
pathogenesis and pre-clinical drug evaluation within in vivo
models. For the last 12 years he has been directly involved
in the development of multiple in vivo models that have
included GI- and respiratory-associated infectious diseases,
device-associated (biofilm) infections and pharmacokinetic
studies. In addition, his in vitro experience has involved the
use of multiple molecular techniques to determine important
virulence pathways associated with Staphylococcus aureus
infections.
About the organisation:
The Pre-Clinical Services group in the UNT System College of
Pharmacy at the University of North Texas Health Science
Center conducts industry sponsored research studies
utilizing established models of both acute and chronic
bacterial infections in several different animal species
including pharmacokinetic/pharmacodynamic studies with
bioanalyticalLCMS/HPLCanalysis.Infectionmodelsorprotocols
other than those described herein can also be develop and
validated as required to meet the more specific needs of
interested Sponsors. UNTHSC Pre-clinical Services together
has over 35 years of direct pharmaceutical and specialized
biotech experience in the performance of therapeutic
efficacy models and drug discovery/development. The group
utilizes this experience to guide the drug discovery process,
from protocol design to implementation and analysis for
compound lead selection. Studies are conducted in state-of-
the-art laboratory and vivarium facilities with excellent support
staff and services.
SMi PHARMACEUTICAL
EVENT PLANNER 2017
JUNE
Pre-Filled Syringes West Coast
5th - 6th June 2017, San Diego, USA
Microbiology USA
8th - 9th June 2017, San Diego, USA
Immunogenicity
12th - 13th June 2017, London, UK
BioBanking
14th - 15th June 2017, London, UK
In Vitro Diagnostics
14th - 15th June, London, UK
JULY
Allergies
6th - 7th July 2017, London, UK
Peptides
6th - 7th July 2017, London, UK
SEPTEMBER
Cancer Vaccines
27th - 28th September 2017, London, UK
Biosimilars and Biobetters
27th - 28th September 2017, London, UK
OCTOBER
European Pharmaceutical Pricing
& Reimbursement
11th - 12th October 2017, London, UK
Orphan Drugs and Rare Diseases
18th - 19th October 2017, London, UK
NOVEMBER
USA WEEK
Superbugs & Superdrugs USA
13th - 14th November 2017, New Jersey, USA
Pharmaceutical Microbiology East Coast
13th - 14th November 2017, New Jersey, USA
Lyophilization USA
16th - 17th November 2017, New Jersey, USA
Biosimilars North America
15th - 16th November 2017, New Jersey, USA
Opthalmic Drug Development
28th - 29th November 2017, London, UK
DECEMBER
Cold Chain Distribution
13th - 14th December 2017, London, UK
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
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
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SUPERBUGS & SUPERDRUGS USA
Conference: 13th -14th November 2017, Renaissance Woodbridge Hotel, Iselin, NJ, USA Workshop: 15th November 2017, Renaissance Woodbridge Hotel, Iselin, NJ, USA
4 WAYS TO REGISTER
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
ONLINE at www.superbugs-usa.com
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Payment: If payment is not made at the time of booking, then an invoice will be issued and must
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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
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Superbugs and Superdrugs USA

  • 1. www.superbugs-usa.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 The use of animal models in pre-clinical drug development Workshop Leaders: William Weiss, Director, Pre-Clinical Services, UNT Health Science Center Mark Pulse, Assistant Director, UNT Health Science Center 08.30 - 12.30 PLUS ONE INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP | WEDNESDAY 15TH NOVEMBER 2017, RENAISSANCE WOODBRIDGE HOTEL, ISELIN, NJ, USA @smipharm #smibugs CHAIRS FOR 2017: • Anthony Simon Lynch, Senior Scientific Director, Janssen • William Weiss, Director, Pre-Clinical Services, UNT Health Science Center FEATURED SPEAKERS: • John Rex, Chief Medical Officer & Director, F2G; Chief Strategy Officer, CARB-X • Christopher Houchens, Branch Chief, Antibacterials Program, BARDA • Annaliesa Anderson, Vice President & CSO Bacterial Vaccines, Pfizer • Olga Danilchanka, Microbiome Lead, Merck • Christopher McMaster, President & CEO, DemovaMed • Obadiah Plante, Director of Research, Visterrra • Tim Opperman, Senior Research Scientist, Microbiotix • Ken Stover, Senior Director, Infectious Diseases and Vaccines, MedImmune • Mike Westby, Director, Centauri Therapeutics HIGHLIGHTS IN 2017: • Tips for successfully seeking funding and partnership, including updates on the CARB-X initiative • Explore the importance of supporting natural immunity and the microbiome for reducing infection from resistant bacteria • Developments for treating gram-negative infections WORKSHOP: 15TH CONFERENCE: 13TH-14TH NOV 2017RENAISSANCE WOODBRIDGE HOTEL, ISELIN, NJ, USA Strengthening the pipeline; new incentives and approaches to combating bacterial resistance SMi proudly presents the 2nd annual conference… Superbugs & Superdrugs USA BOOK BY 30TH JUNE AND SAVE $300 BOOK BY 29TH SEPTEMBER AND SAVE $100 SPONSORED BY
  • 2. Superbugs & Superdrugs USA Day One | Monday 13th November 2017 www.superbugs-usa.com 08.30 Registration & Coffee 09.00 Chairs’ Opening Remarks Anthony Simon Lynch, Senior Scientific Director, Janssen William Weiss, Director, Pre-Clinical Services, UNT Health Science Center REGULATION, INCENTIVES AND PARTNERSHIPS OPENING ADDRESS 09.10 Funding, filing, and finance • What’s up with funding initiatives: CARB-X update • Advances in regulatory tools: Tier C makes headway • Paying for it all: Evolving global discussions of payor models John Rex, Chief Medical Officer & Director, F2G; Chief Strategy Officer, CARB-X 09.50 Challenges and opportunities in antibacterial development • Why BARDA is interested in antimicrobial resistance (AMR) • How BARDA is addressing the issue of AMR • Stimulating innovation in antimicrobial research and development Christopher Houchens, Branch Chief, Antibacterials Program, BARDA 10.30 Morning Coffee NOVEL TARGETS AND NON-TRADITIONAL APPROACHES 11.00 Advances towards preventing Clostridium difficile infections through vaccination • C. difficile infections present a healthcare emergency in the USA • Disease is mediated by toxins expressed by the bacterium • Toxoid based vaccines are currently in development for disease prevention • The progress and prospects for these vaccines will be discussed Annaliesa Anderson, Vice President and CSO Bacterial Vaccines, Pfizer 11.40 Immunity and antibodies versus multi-drug resistant bacteria • Multi-mechanistic antibodies and their potential for serious bacterial infections • Pathogen-specific prophylaxis and treatment and antibody synergy with antibiotic therapy • Challenges for a paradigm shift away from reliance on broad spectrum antibiotics Ken Stover, Senior Director, Infectious Diseases and Vaccines, MedImmune 12.20 Networking Lunch 13.30 Supporting the microbiome to reduce infection by resistant bacteria • Patients with a disrupted microbiome (in response to antibiotics) are more vulnerable to infection from resistant bacteria strains • Slowing antibiotic resistance by minimising the microbiome’s disruption in response to antibacterial treatments Olga Danilchanka, Microbiome Lead, Merck 14.10 Innate defense regulators: Broad-spectrum, host-directed therapy for antibiotic resistant disease • Innate immunity is a host-directed approach for treatment of infectious disease, equally capable of treatment antibiotic sensitive and antibiotic resistant organisms. • Preclinical studies demonstrated an ability to combat infection while modulating inflammation and enhancing tissue healing • Clinically, the lead clinical IDR, dusquetide, has been demonstrated to be safe and efficacious in Phase 1 and 2 studies • In a Phase 2 study, dusquetide reduced the duration of severe oral mucositis in head and neck cancer patients receiving chemoradiation therapy, while also decreasing the incidence of bacterial infections Oreola Donini, Chief Scientific Officer, Soligenix 14.50 Afternoon Tea 15.20 Targeting P. aeruginosa with an antibody-drug conjugate • Conserved target on the bacterial surface of P. aeruginosa • Considerations in the design of an ADC • ADCs as a treatment for P. aeruginosa infection Obadiah Plante, Director of Research, Visterra 16.00 Targeted lysin therapeutics for serious bacterial infections; bench to bedside • What are phage-derived lysins and how can their novel mechanism of action potentiate conventional antibiotics? • What do animal models tell us about the potential for lysins to treat serious, biofilm dependent infections? • What is the therapeutic potential of lysins to combat antimicrobial resistance and improve clinical outcomes? Cara Cassino, Executive Vice President of Research and Development and Chief Medical Officer, ContraFect 16.40 Chairs’ Closing Remarks and Close of Day One 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 SPONSORED BY Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is unmet medical need, including: 1) a therapeutics segment directed at cutaneous T-cell lymphoma and oral mucositis; and 2) a biodefense segment directed at ricin exposure, acute radiation syndrome and antibiotic resistant infectious disease. www.soligenix.com
  • 3. Superbugs & Superdrugs USA www.superbugs-usa.com Day Two | Tuesday 14th November 2017 08.30 Registration & Coffee 09.00 Chairs’ Opening Remarks Anthony Simon Lynch, Senior Scientific Director, Janssen William Weiss, Director, Pre-Clinical Services, UNT Health Science Center NOVEL TARGETS / NON-TRADITIONAL APPROACHES 2 9.10 Navigating the pitfalls of early drug discovery – lessons learned • Targets and target product profiles • Getting the mechanism of action right • Resistance considerations • Prospects for new agents Karen Joy Shaw, Chief Scientific Officer, Amplyx 09.50 A new antibiotic class? • De novo computer aided drug design versus a novel target was used to develop a new antibiotic class • 652 novel molecules were synthesized with over 20 having clinically relevant broad specificity Gram positive efficacy in vitro • Efficacy in animal models of infection and preclinical PK/ADME point to potential clinical utility • Thoughts on moving this antibiotic class into Gram negative bacteria will be discussed Christopher McMaster, President & CEO, DeNovaMed 10.30 Morning Coffee 11.00 The medical device approach to preventing hospital acquired infections and development of superbugs • 1.7 million Hospital acquired infections occur annually, 70% of which are related to the use of indwelling medical devices. These add billions to annual health care costs • The endotracheal tube is a common breeding ground for MDR strains. Polymicrobial biofilm allows horizontal gene transfer and development of new MDR strains. Overuse of antibiotics also allows development of fungal pathogens such as Candida auris • Patients at high risk of infection are usually immune- compromised; elderly, neonates, diabetics, cancer patients • The use of innate immune mimic synthetic molecule to coat ETTs and other medical devices prevents bacterial and fungal colonization and growth of biofilms, reducing HAIs and development of superbugs Carl Genberg, CEO, N8 Medical FOCUSING ON GRAM NEGATIVE BACTERIA 11.40 The Gram-negative challenge: An early discovery perspective • The scope of the challenge • Re-tracing the past 15 years of successes and failures • First-principal challenges in discovery of new chemical classes • First-principal challenges in the discovery of new modes of action Ryan Cirz, Senior Director of Early Research, Achaogen 12.20 Networking Lunch 13.30 Evaluating immunotherapeutics as alternatives to antibiotics to treat Gram-negative infections • Targeting specific pathogens • Recruiting natural immunity • Preclinical challenges • Next steps Mike Westby, Director, Centauri Therapeutics 14.10 Repositioning an older class of drugs: Development of macrolides for the treatment of serious Gram-negative infections • Challenges in repositioning a Gram-positive drug to be active against Gram-negative pathogens • Overcoming the restrictions of natural product semi-synthesis to increase compound diversity • Identifying and addressing any pre-existing pool of resistance in target pathogens Richard Alm, Vice President Biology, Macrolide Pharmaceuticals 14.50 Afternoon Tea 15.20 Multiple strategies to address the problem of MDR Gram-negative pathogens • Overview of three discovery projects illustrating different approaches to tackling the problem of Gram-negative pathogens • Virulence. A novel series phenoxyacetamide series exhibits potent activity against type 3 secretion in Pseudomonas aeruginosa (IC50s as low as 20 nM) by targeting the assembled needle protein PscF, and have demonstrated proof-of-principle efficacy in murine infection models. This project is funded by CARB-X • Intrinsic resistance. Novel pyranopyridine inhibitors of RND- type efflux pump inhibitors exhibit broad spectrum activity against pathogens of the Enterobacteriaceae, favourable pharmacokinetics in mice, and efficacy in a murine infection model • Novel essential target. A series of novel oxadiazoles bind to a unique site on the ribosome, resulting in potent inhibition of the essential non-stop ribosome rescue pathway in Gram- positive and –negative pathogens, including MDR Neisseria gonorrhoeae and Francisella tularensis. These compounds exhibit potent antibacterial activity, oral bioavailability, and efficacy in murine models of infection Tim Opperman, Senior Research Scientist, Microbiotix 16.40 Chairs’ Closing Remarks and Close of Day Two Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 OFFICIAL MEDIA PARTNERS Want to know how you can get involved? Interested in promoting your services to this market? Contact Teri Arri, SMi Marketing on ++44 20 7827 6162 or email: tarri@smi-online.co.uk SUPPORTED BY
  • 4. HALF DAY POST-CONFERENCE WORKSHOP Wednesday 15th November 2017, Renaissance Woodbridge Hotel, Iselin, NJ, USA 08.30 - 12.30 The use of animal models in pre-clinical drug development Workshop Leaders: William Weiss, Director, Pre-Clinical Services, UNT Health Science Center Mark Pulse, Assistant Director, UNT Health Science Center Workshop overview: 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. Reasons to attend: 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 08.30 Registration & Coffee 09.00 Introduction 09.10 Preclinical animal models • Opening remarks and introduction • History / Rationale for animal testing • Animal use in research • Predictability of animal models 09.30 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) • Design the best research model 10.30 Morning Coffee 11.00 Animal models – examples • Acute infection models – Bacteremia, sepsis • Tissue specific infection models – Pneumonia, UTI, skin, abscess, thigh • GI related – C. difficile, H. pylori • Device related – biofilm, endocarditis, prosthetic joint • Antifungal – Systemic candidiasis • Pharmacokinetics / Pharmacodynamics 12.00 Animals in research • Institutional animal care and use committee (IACUC) • Justify why animals are necessary, minimise pain and distress, husbandry and care • Use of appropriate euthanasia methods • The 3 R’s 12.30 Final discussion and close of the workshop About the Workshop Leaders: William Weiss: Before leading the PreClinical Services group, Bill was Director of Drug Evaluation at Cumbre Pharmaceuticals Inc. where he was responsible for all pre-clinical microbiology research and development efforts focused on the discovery & development of new antimicrobial agents. Prior to this, he was a Group Leader in Infectious Disease Discovery Research at Wyeth Research (Pfizer), Lederle Laboratories and Schering-Plough (Merck). He has worked on numerous antibacterial programs including the development of the marketed antibiotics; Suprax, Zosyn and Tygacil. His expertise encompasses the development of animal research models, evaluation of new and novel therapeutic agents as well as pharmacokinetic/pharmacodynamic analysis. Mark Pulse: Mark holds a MSc in molecular microbiology and immunology, his early research at the University of North Texas Health Science Center primarily focused on bacterial pathogenesis and pre-clinical drug evaluation within in vivo models. For the last 12 years he has been directly involved in the development of multiple in vivo models that have included GI- and respiratory-associated infectious diseases, device-associated (biofilm) infections and pharmacokinetic studies. In addition, his in vitro experience has involved the use of multiple molecular techniques to determine important virulence pathways associated with Staphylococcus aureus infections. About the organisation: The Pre-Clinical Services group in the UNT System College of Pharmacy at the University of North Texas Health Science Center conducts industry sponsored research studies utilizing established models of both acute and chronic bacterial infections in several different animal species including pharmacokinetic/pharmacodynamic studies with bioanalyticalLCMS/HPLCanalysis.Infectionmodelsorprotocols other than those described herein can also be develop and validated as required to meet the more specific needs of interested Sponsors. UNTHSC Pre-clinical Services together has over 35 years of direct pharmaceutical and specialized biotech experience in the performance of therapeutic efficacy models and drug discovery/development. The group utilizes this experience to guide the drug discovery process, from protocol design to implementation and analysis for compound lead selection. Studies are conducted in state-of- the-art laboratory and vivarium facilities with excellent support staff and services.
  • 5. SMi PHARMACEUTICAL EVENT PLANNER 2017 JUNE Pre-Filled Syringes West Coast 5th - 6th June 2017, San Diego, USA Microbiology USA 8th - 9th June 2017, San Diego, USA Immunogenicity 12th - 13th June 2017, London, UK BioBanking 14th - 15th June 2017, London, UK In Vitro Diagnostics 14th - 15th June, London, UK JULY Allergies 6th - 7th July 2017, London, UK Peptides 6th - 7th July 2017, London, UK SEPTEMBER Cancer Vaccines 27th - 28th September 2017, London, UK Biosimilars and Biobetters 27th - 28th September 2017, London, UK OCTOBER European Pharmaceutical Pricing & Reimbursement 11th - 12th October 2017, London, UK Orphan Drugs and Rare Diseases 18th - 19th October 2017, London, UK NOVEMBER USA WEEK Superbugs & Superdrugs USA 13th - 14th November 2017, New Jersey, USA Pharmaceutical Microbiology East Coast 13th - 14th November 2017, New Jersey, USA Lyophilization USA 16th - 17th November 2017, New Jersey, USA Biosimilars North America 15th - 16th November 2017, New Jersey, USA Opthalmic Drug Development 28th - 29th November 2017, London, UK DECEMBER Cold Chain Distribution 13th - 14th December 2017, London, UK 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
  • 6. 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: SUPERBUGS & SUPERDRUGS USA Conference: 13th -14th November 2017, Renaissance Woodbridge Hotel, Iselin, NJ, USA Workshop: 15th November 2017, Renaissance Woodbridge Hotel, Iselin, NJ, USA 4 WAYS TO REGISTER FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 ONLINE at www.superbugs-usa.com POST your booking form to: Events Team, SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk 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 databasemanager@smi-online. co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter. Unique Reference Number Our Reference P-226 Terms and Conditions of Booking DELEGATE DETAILS Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-226 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. Please indicate method of payment: □ UK BACS Sort Code 300009, Account 11775391 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB75 LOYD 3000 0911 7753 91 □ 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): DOCUMENTATION 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) PAYMENT VAT VAT at 20% is 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. CONFERENCE PRICES GROUP DISCOUNTS AVAILABLE I would like to attend: (Please tick as appropriate) Fee TOTAL □ Conference Workshop $2398.00 □ Conference only $1899.00 □ Workshop only $499.00 PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees $1598 + VAT $1917.60 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. VENUE Renaissance Woodbridge Hotel, Iselin, NJ, USA □ 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 □ Book by 30th June to receive $300 off the conference price □ Book by 29th September to receive $100 off the conference price EARLY BIRD DISCOUNT