Building on almost two decades worth of expertise in fighting the growing threat of antimicrobial resistance (AMR), SMi Group are thrilled to announce the return of Superbugs and Superdrugs USA which arrives to Iselin, New Jersey on November 13th & 14th 2017.
Antimicrobial resistance has sparked an urgency in the development of new drugs as the industry strives for novel solutions to fight infectious diseases. Innovation and collaboration is requested at every level making Superbugs & Superdrugs USA, the perfect platform to strengthen knowledge in key principles such as funding incentives and global strategy, whilst honing in on clinical developments in areas such as immunotherapy, toxoid based vaccines and anti-body drug conjugates.
As methods move away from traditional small molecule antibiotics, this is critical time for AMR experts, government bodies and industry leaders, to come together and share ideas on the latest developments in treatment and prevention. Featured speakers include: Janssen, UNT Health Science Center, John Rex from CARB-X, BARDA, Pfizer, Merck, DemovaMed, Visterrra, Microbiotix more.
January 26, 2018
In the United States, two major federal laws apply to vertebrate animals used in laboratory research. The first of these two statutes, the Animal Welfare Act (AWA, under the US Department of Agriculture), celebrated its fiftieth anniversary in 2016. The second statute, the Health Research Extension Act of 1985 (also referred to as the Public Health Services Act, or PHS Act), which is similar to the AWA, applies specifically to work funded by the US Public Health Service (i.e., agencies under the Department of Health and Human Services). Understanding laboratory animal law is necessary and fundamental for all researchers relying on results from animal research, laboratory animal veterinarians, institutional officials, Institutional Animal Care and Use Committee (IACUC) members and veterinarians in training. They require familiarity with both the scope and particulars of these laws. Different parties interested in or impacted by laboratory animal laws can have significantly different perspectives about the scope or efficiency of the regulations or their implementation.
The Roundtable on Science and Welfare in Laboratory Animal Use of the Institute for Laboratory Animal Research, the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, and the Animal Law and Policy Program of Harvard Law School convened this pre-workshop webcast and a workshop to discuss the future of federal laboratory animal law in the United States.
For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/future-directions-for-laboratory-animal-law-in-the-united-states
January 26, 2018
In the United States, two major federal laws apply to vertebrate animals used in laboratory research. The first of these two statutes, the Animal Welfare Act (AWA, under the US Department of Agriculture), celebrated its fiftieth anniversary in 2016. The second statute, the Health Research Extension Act of 1985 (also referred to as the Public Health Services Act, or PHS Act), which is similar to the AWA, applies specifically to work funded by the US Public Health Service (i.e., agencies under the Department of Health and Human Services). Understanding laboratory animal law is necessary and fundamental for all researchers relying on results from animal research, laboratory animal veterinarians, institutional officials, Institutional Animal Care and Use Committee (IACUC) members and veterinarians in training. They require familiarity with both the scope and particulars of these laws. Different parties interested in or impacted by laboratory animal laws can have significantly different perspectives about the scope or efficiency of the regulations or their implementation.
The Roundtable on Science and Welfare in Laboratory Animal Use of the Institute for Laboratory Animal Research, the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, and the Animal Law and Policy Program of Harvard Law School convened this pre-workshop webcast and a workshop to discuss the future of federal laboratory animal law in the United States.
For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/future-directions-for-laboratory-animal-law-in-the-united-states
Dr. Benjamin Park - Antimicrobial Resistance in Humans and the Global Health ...John Blue
Antimicrobial Resistance in Humans and the Global Health Security Agenda - Dr. Benjamin Park, Senior Advisor for International Healthcare Quality, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention (CDC), from the 2015 NIAA Antibiotic Symposium - Stewardship: From Metrics to Management, November 3-5, 2015, Atlanta, Georgia, USA.
More presentations at http://swinecast.com/2015-niaa-symposium-antibiotics-stewardship-from-metrics-to-management
The 10 Most Impactful Leaders in Life Science.pdfTHECIOWORLD
This edition features a handful of The Most Impactful Leaders in Life Science that are leading us into a better future
Read More: https://thecioworld.com/the-10-most-impactful-leaders-in-life-science-september2023/
Tackling the U.S. Healthcare System’s Infectious Disease Management ProblemViewics
The United States healthcare system has a serious infectious disease management problem. The antibiotic resistance crisis is widespread, serious, costly, and deadly. Delays in pathogen identification lead to poor clinical outcomes, including increased mortality risk. And, optimally managing outbreaks is critical to health systems whose reimbursement is tied to the health of a population, such as ACOs.
Eleanor Herriman, MD, MBA, Chief Medical Informatics Officer at Viewics led an informative panel discussion with industry leaders on the issues surrounding the infectious disease management crisis. Margret Oethinger, MD, Ph.D., Medical Director of Providence Health & Services, and Susan E. Sharp, Ph.D., DABMM, FAAM, Regional Director of Microbiology and the Molecular Infectious Disease Laboratories, Department of Pathology, Kaiser Permanente and President-Elect, American Society for Microbiology cover the current state of infectious disease management in the U.S., and what can be done to improve it.
You’ll learn about:
• The magnitude of the U.S. health system’s infectious disease management problem
• The most serious concerns and trends for healthcare institutions and communities across the nation
• The most promising solutions to health systems’ most urgent infectious disease management challenges
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
Building on the sell-out success of the launch event, SMi Group is delighted to announce the return of 3D Cell Culture, taking place on 21st and 22nd of February 2018, in London UK.
3D Cell Culture is rapidly growing with incredible potential for industrial application and a widespread reach that can be seen across many different fields, such as 3D bioprinting and microfluidics.
The 2nd annual conference will explore these overlapping areas and will combine pioneering breakthroughs with scientific research to strengthen your commercial success. Join us for exclusive insight into key topics such as disease models, organoids, organ-on-a-chip technologies, Ipsc advances and CRISPR technology. Notable speakers on the agenda for 2018 will include experts from Aurelia Bioscience, ReInnervate Ltd, Cell and Gene Therapy Catapult, University College London, Novartis Institutes for Biomedical Research, Kugelmeiers, GSK, AstraZeneca, Roche and more!
Providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities, SMi presents the 20th annual Superbugs & Superdrugs conference which will return to Central London on 19th and 20th March 2018.
The threat of AMR is regularly making front page news but what is the industry actually doing? Are drug manufacturers any closer to finding a solution and how is the government helping? These will be just some of the questions answered through powerful keynote addresses delivered by an expert panel of scientific leaders, drug discovery specialists and government bodies such as MHRA and DNDi.
SMi Group presents the 23rd annual industry leading summit on Pharmaceutical Pricing & Market Access, 11 – 12 Oct 2017, London, UK.
Pharmaceutical Pricing & Market Access 2017 will tackle industry challenges head on by preparing attendees to develop a successful market access strategy for the ever changing pharmaceutical and payer landscape. Join us this autumn for insight into how manufactures plan to limit further price increase; a progressive outlook into the future of pharmaceutical pricing & reimbursement (P&R); stakeholder collaboration; meaningful patient engagement opportunities; and discuss what can be done for the industry to achieve efficient reimbursement and for patients to gain access to affordable medication.
Highlights will include an exclusive opening keynote from the FDA and interactive training on Real World Evidence (RWE). Featured Speakers include: Lundbeck, FDA, Shire, Sobi, Teva, Grifols, Allergan, Sanofi and more!
Pre-Filled Syringes East Coast takes place next week in Boston, MA. Record breaking attendance from an audience of device manufactures, medical device experts and heads of parenteral drug delivery.
SMi's 7th annual conference on Biobanking will bring together Europe’s leading biorepositories, regulatory representatives and scientific pioneers to strengthen knowledge in biosample management as well as explore future advances in areas such as mobile bio-banking and cloud based sample management.
Understanding the ethical and regulatory framework as well as the impact of the General Data Protection Regulation (GDPR) on collaborative science in Europe will be a major focus. Plus, don’t miss keynote addresses from a selection of European biobanks currently adding value to clinical research through successful biobanking strategies including the European Sperm Bank, UK Biobank, UCL Baby Biobank, Auria Biobank and more.
Exclusive updates from the European Commission and NIBSC-MHRA, will be just some of the event highlights for 2017. Join us this June for innovative discussions through a series of interactive presentations, panel discussions and roundtables, and address relevant and critical issues on how to improve your biobanking practice.
SMi Group are thrilled to announce the return of Pre-Filled Syringes West Coast 2017 which arrives to California on June 5th & 6th.
Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will once again gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advances, keeping you at the forefront of a booming industry.
The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing and complex biologics, whilst honing in on emerging trends for parenteral devices, including auto injectors, pens, pumps and smart devices.
SMi’s 17th annual Pain Therapeutics conference will hone in on the latest innovations and novel approaches to pain therapy and analgesic drugs as well as look at the practicalities of using animal models and translational biomarkers in pain research. Aimed at an audience of senior specialists in neurology, CNS, clinical sciences and pharmacology, Pain Therapeutics 2017 will keep attendees at the forefront of scientific breakthroughs to adapt to the growing need towards minimising opioid dependency and new drug discovery. Presentations from a selection of leading pharmaceutical companies currently developing novel analgesic treatments including Nektar Pharmaceuticals, Janssen, MSD USA, Grunenthal GmbH, Lilly UK and Mundipharma, will provide delegates with an understanding on key topics such as product formulation; opioid addiction; translational pain research; and breakthroughs in drug discovery.
Gathering a room of Senior Scientists and Heads of Pharmaceutical Engineering, the 5th annual show provides an ideal forum to discuss the latest advancements in pharmaceutical lyophilisation, welcoming regulatory guidance from the NIBSC-MHRA and expertise from the likes of Sanofi, Boehringer Ingelheim, Roche, Novo Nordisk and more!
9th Annual Energy from Waste Conference | 8th & 9th Dec 2016Teri Arri
Now in its 9th year, Energy from Waste 2016 returns to London to discuss the latest industry updates whilst keeping attendees at the forefront of technological breakthroughs to adapt to the growing need for greener energy.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journey
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
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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
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NOVEMBER
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15th - 16th November 2017, New Jersey, USA
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28th - 29th November 2017, London, UK
DECEMBER
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13th - 14th December 2017, London, UK
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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
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VENUE Renaissance Woodbridge Hotel, Iselin, NJ, USA
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