Antimicrobial Resistance: Stepping up to the Challenge

Eleanor Malone

Editor, Scrip Intelligence

Eleanor Malone is Editor of Scrip Intelligence, the leading source of news and
analysis for the global pharmaceutical industry. For the past 15 years she has
written widely about the many different aspects of the biopharmaceutical and
medical technology industries, and has appeared on TV and radio to comment
on developments ranging from M&A to Ebola. Scrip takes a special interest in
the issue of antimicrobial resistance. It participates in the BioInfect conference
in the UK and has created a dedicated microsite on the topic,
http://www.scripintelligence.com/amr/ .

Mario Ottiglio

Director, Public Affairs, Communications & Global Health Policy at the IFPMA

Mario Ottiglio is Director, Public Affairs, Communications & Global Health Policy
at the IFPMA where he has been working since 2007 in positions of increasing
responsibility. At IFPMA, Mr. Ottiglio leads on interactions with key stakeholders
such as governments, international organizations and civil society and
coordinates IFPMA Members’ policy positioning on current global health issues.
He is also the IFPMA policy lead on the WHO Global Strategy and Plan of Action
for Public Health, Innovation and IP. Prior to joining the IFPMA, he worked as a
consultant, both for governments and private firms. An Italian national, he holds
an MA in Political Science from the Naples Eastern University.

Stephan Harbarth

Infection Control Programme, Geneva University Hospitals

Stephan Harbarth earned in 1993 his medical degree from Ludwig-Maximilians-University in Munich, Germany, and completed his residency in internal medicine and tropical medicine at Munich University Hospitals. After serving as a clinical fellow in the Infectious Diseases Division and Infection Control Program in the Department of Internal Medicine at Geneva University Hospitals, Dr Harbarth completed his master’s degree in epidemiology at Harvard University in Cambridge, Massachusetts. He is board certified in infectious diseases and was appointed associate professor in 2010. Dr Harbarth’s work has garnered several awards, including the ICAAC Young Investigator Award from ASM (2003), the Young Investigator Award from ESCMID (2006), the Swiss Society for Infectious Diseases Award for epidemiological research (2008), and the SHEA Investigator Award in 2011.

Control of MRSA and multidrug-resistance
Over the last two decades many institutions around the globe have experienced an increase in hyperendemic multidrug-resistant microorganisms such as MRSA and ESBL-producing enterobacteriacae. Our group is currently conducting several clinical and epidemiological studies to evaluate key questions related to the control of the acquisition, transmission and infection by multidrug-resistant microorganisms. We participate in several large-scale EU-funded studies (SATURN, R-GNOSIS, Rapp-ID, AIDA, COMBACTE) to address this important public health threat. We collaborate closely with the Genomics Research Laboratory at HUG, based on a productive translational research platform. The most notable examples of our research are the evaluation of different MRSA control interventions (JAMA 2008, BMJopen 2013), the advanced analysis of epidemiologic trends and the burden of multiresistant microorganisms (JAC 2011, ICHE 2013), the conduct of epidemiologic studies linking patient data with molecular investigations (Clin Infect Dis 2011, ICHE 2014), the evaluation of antibiotic stewardship interventions (Lancet Infect Dis 2010, JAC 2011) and several placebo-controlled, randomised clinical trials to decolonise MRSA and ESBL carriers (JAC 2013).

Marie-Françoise Gros

Head of Medical Affairs, bioMérieux

Marie-Françoise Gros has a primary degree in Medicine (Grenoble University)
and a MBA (Lyon Business School). After a first experience as a medical doctor
both in hospital and in private practice (as a General Practitioner), she joined
the in vitro diagnostics industry: Abbott Diagnostics where she was in charge
of blood banks, and then bioMerieux. After an experience in strategic
marketing (molecular diagnostics/ DNA chip technology), she took the
responsibility of Corporate Director of Medical Affairs and Communications. As
Head of Medical Affairs, she is managing a team that is in charge of clinical
trials, assessment of medical value of new product opportunities, medical &
scientific communication, Medical Scientific Liaison, product safety/ patient risk
management and Global Health. Her primary focus and interest is antimicrobial
resistance: she coordinates the AMR initiatives within the company, working
closely with R&D and Marketing to help define the future products, develop
internal awareness about AMR, as well as developing education/
communication strategies for external audience (healthcare workers, General
Public).

Marco Cavaleri

Head of Anti-infectives and Vaccines, Scientific and Regulatory management Department at EMA

Marco Cavaleri, Head of Anti-infectives and Vaccines, Scientific and Regulatory
management Department at EMA, is responsible for the management of preand
post-authorisation activities of centralised applications/marketing
authorisations, and particularly the Safety and Efficacy part, related to
medicinal products in the above-mentioned therapeutic areas.
Marco Cavaleri is a Pharmacologist who spent several years in industry in R&D
mainly in the area of antibacterials and antifungals covering different positions
in preclinical and clinical development. In 2005 he joined the EMEA as
Scientific Administrator in the Scientific Advice and Orphan Drugs Sector,
specifically being in charge of anti-infectives and vaccines scientific advice
procedures. He returned to the Agency in 2008 as Group Leader Anti-infectives
in the Safety & Efficacy Sector, Pre-Authorisation Human Unit following a short
period in industry leading clinical and preclinical development in the area of
Gastroenterology and Infectious Diseases. In 2009 he was appointed as Head of
Section for Anti-infectives and vaccines in the Safety & Efficacy Sector, Human
Medicines Development and Evaluation Unit.

Charles Penn

Coordinator, Antimicrobial Drug Resistance, World Health Organization

Charles Penn joined the World Health Organization, Geneva at the start of the 2009 influenza pandemic, and was initially responsible for the use of antivirals in influenza management. He currently oversees programmes on antimicrobial resistance, and clinical management and infection prevention and control, particularly for outbreaks and epidemics caused by respiratory viruses. He also chairs WHO’s Guidelines Review Committee, which monitors the quality of all of WHO’s health guidelines.

Charles has extensive experience in infectious diseases, gained through a PhD in virology from the University of Cambridge, followed by research on human and avian influenza viruses at Cambridge University and the UK Institute for Animal Health. In 1988 Charles joined Glaxo (now GSK) to lead research on influenza and HIV, first as a Senior Research Associate and later as Senior Medical Strategy Head. During this time he saw two new antiviral medicines from discovery through to regulatory approval (lamivudine for HIV, and zanamivir for influenza),

In 1998 he moved to the (now) Public Health England Centre for Emergency Preparedness and Response, as Director for Research and Development. Activities included infectious disease diagnosis through the Special Pathogens Reference Unit, vaccines research and development, and epidemic and intervention modelling in infectious diseases.

John H. Rex

Senior Vice President and Head of Infection, Global Medicines Development, AstraZeneca Pharmaceuticals

John H. Rex, MD is Senior Vice President and Head of Infection, Global
Medicines Development at AstraZeneca Pharmaceuticals. Since September
2012, Dr. Rex has also been a Non-Executive (Independent) Director, F2G, Ltd.
Based in Manchester, UK, F2G Ltd is dedicated to discovery and development
of new and clinically superior drug classes to treat life-threatening systemic
fungal infections in at-risk patient populations. Through his work at AZ and
F2G, Dr. Rex and his colleagues have antibacterial and antifungal molecules in
all phases of development from Phase 1 through registration and marketing.
During his time in Industry, Dr. Rex has led multiple Industry interactions with
FDA, EMA, and other external groups with a focus on enhancing available
development pathways and the approaches to value for antimicrobial agents.
His key activities have included lead authorship of a publication describing an
updated approach to regulatory paradigms for antibacterial agents,coauthorship
of other publications on the challenge of antimicrobial
resistance,founding and ongoing participation in creation and implementation
of the New Drugs For Bad Bugs (ND4BB) program within the Innovative
Medicines Initiative (IMI) in Europe (including founding participation in the
design of DRIVE-AB, a new ND4BB topic focused on evaluation and
implementation of novel business models for antibiotics), a 4-year term as
Industry Representative on the FDA Anti-Infective Drugs Advisory Committee
(AIDAC, 2007-2011), ongoing active leadership within the antimicrobial
working groups for EFPIA and PhRMA, ongoing roles (currently Vice-Chair of
the Area Committee on Microbiology) with the Clinical Laboratory Standards
Institutes (CLSI), membership in the Brookings Council on Antimicrobial Drug
Development, and (2014) a role as an advisor on Antimicrobial Resistance to
PCAST, the President’s Council of Advisors on Science and Technology.
Dr. Rex is also a Highlights Advisor for Nature Reviews Microbiology, is a
member of the Wellcome Trust Seeding Drug Discovery Committee, serves on
several editorial boards, was formerly an Editor for Antimicrobial Agents and
Chemotherapy, and is an Emeritus Editor for www.doctorfungus.org, a nonprofit
web site devoted to dissemination of information about medical
mycology.
Dr. Rex has an MD from Baylor College of Medicine and is board-certified in
Internal Medicine and Infectious Diseases. Before moving to Industry in 2003,
Dr. Rex was Professor of Medicine at UT Medical School-Houston with a focus
on translational studies of novel antifungal agents and hospital epidemiology.