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PK-PD in support of accelerated programmes: how much is enough?

William Hope Date : April 22, 2018 This presentation was part of the educational workshop: 'Expediting antibacterial development: core lessons and key tools for a rocky road' at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Madrid, April 21-24, 2018 Co-organized by: GARDP -

PK-PD in support of accelerated programmes: how much is enough? 2018-05-03T13:22:09+00:00

US regulatory tools for expedited antibacterial development programmes

Sumathi Nambiar Date : April 22, 2018 This presentation was part of the educational workshop: 'Expediting antibacterial development: core lessons and key tools for a rocky road' at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Madrid, April 21-24, 2018 Co-organized by: GARDP -

US regulatory tools for expedited antibacterial development programmes 2018-05-03T13:17:28+00:00

EU regulatory tools for expedited antibacterial development programmes

Marco Cavaleri Date : April 22, 2018 This presentation was part of the educational workshop: 'Expediting antibacterial development: core lessons and key tools for a rocky road' at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Madrid, April 21-24, 2018 Co-organized by: GARDP -

EU regulatory tools for expedited antibacterial development programmes 2018-05-03T13:00:08+00:00

Antibacterial drugs: Clinical development for non-developers
Part 1: Traditional development – tiers A and B

REVIVE Webinar Series: Antibacterial drugs: clinical development for non-developers Part 1: Traditional development – tiers A and B Speaker: David Shlaes - Antiinfectives consulting, retired Moderator: Laura Piddock - Head of Scientific Affairs, GARDP In this presentation we introduce the relationship between the discovery phase and later clinical development. We discuss in some depth traditional

Antibacterial drugs: Clinical development for non-developers
Part 1: Traditional development – tiers A and B

Decisions, Decisions: What Makes a Good Hit? A Good Lead? Why Do You Write a TPP? How Do You Write a TPP?

Antibiotic Bootcamps for Developers A collaborative project of CARB-Xed, GARDP, ASM, and ESCMID 5-8 September 2017, ASM-ESCMID Conference, Boston Moderator: Lynn Silver, LL Silver Consulting, LLC Discussants:  Lynn Silver, LL Silver Consulting, LLC Tom Dougherty, Harvard Medical School John Tomayko, Infectious Diseases Consultant Sherman T. Waddell, Prokaryotics, Inc. Date : September 5th, 2017

Decisions, Decisions: What Makes a Good Hit? A Good Lead? Why Do You Write a TPP? How Do You Write a TPP? 2018-04-26T07:32:33+00:00

How Does a Molecule Become a Physical Medicine to be Given to a Human: The Importance of Chemistry, Manufacturing, and Controls

Antibiotic Bootcamps for Developers A collaborative project of CARB-Xed, GARDP, ASM, and ESCMID 5-8 September 2017, ASM-ESCMID Conference, Boston Moderator: Tim Keutzer, Spero Therapeutics Discussants: Tim Keutzer, Spero Therapeutics Evan Hecker, Spero Therapeutics Mike Young, Tedor Pharma Inc Andrew Barlow, Syner-G Pharma Consulting Date : September 5th, 2017

How Does a Molecule Become a Physical Medicine to be Given to a Human: The Importance of Chemistry, Manufacturing, and Controls 2018-04-26T07:32:30+00:00

Clinical Microbiology for a Development Program

Antibiotic Bootcamps for Developers A collaborative project of CARB-Xed, GARDP, ASM, and ESCMID 5-8 September 2017, ASM-ESCMID Conference, Boston Moderator: Judith Steenbergen, Paratek Pharmaceuticals Discussants: Erika Matuschek, EUCAST: Investigational New Drug - Groundwork for in vitro antimicrobial susceptibility testing Kevin Krause, Achaogen: NDA Requirements: Surveillance, Clinical Trial Data, Breakpoints Robin Patel, Mayo Clinic: Making

Clinical Microbiology for a Development Program 2018-04-26T07:32:26+00:00

Jesús Rodríguez-Baño

Jesús Rodríguez-Baño is Professor of Medicine at the University of Seville and Head of the Infectious Diseases division at Hospital Universitario Virgen Macarena in Seville, Spain. He is also Scientific Chair of the Spanish Network for Research in Infectious Diseases (REIPI), which is funded by Instituto de Salud Carlos III, and President-Elect of the European

Jesús Rodríguez-Baño 2018-03-13T08:16:28+00:00

Michael Barbachyn

Michael Barbachyn is the Brummel Chair and Professor of Organic Chemistry at Calvin College, Michigan, US, and an independent consultant at Barbachyn Consulting. Michael has over 27 years’ experience in medicinal chemistry as a research scientist following periods at Upjohn, Pharmacia & Upjohn, Bristol-Myers Squibb, Pharmacia, Pfizer and AstraZeneca, focused on anti-infectives. Michael also has

Michael Barbachyn 2018-03-26T07:54:34+00:00

Greg Basarab

Greg Basarab is Principal Research Officer and Associate Director at the University of Cape Town (UCT), Drug Discovery and Development Centre (H3D). He is Head of drug metabolism and pharmacokinetics (DMPK) and pharmacology groups located at Groote Schuur Hospital, Head of Institute of Infectious Diseases and Molecular Medicine, and Head of Medicinal Chemistry groups within

Greg Basarab 2018-03-12T13:20:21+00:00

Helen W Boucher

Helen Boucher is currently Director of the Infectious Diseases Fellowship Program, Director of the Heart Transplant and Ventricular Assist Device Infectious Diseases Program, and staff physician in the Division of Geographic Medicine and Infectious Diseases at Tufts Medical Center. She is also Professor of Medicine at Tufts University School of Medicine in Boston, Massachusetts. Helen

Helen W Boucher 2018-03-09T12:32:06+00:00

Pamela Brown

Pamela Brown has over 30 years’ experience in anti-infective drug discovery gained within the biotech and pharmaceutical sectors. She is currently a consultant in Antibacterial Drug Discovery and Medicinal Chemistry offering independent advice and expertise to small and medium-sized enterprises (SMEs), biotechs and academic institutions. Pam was Director, Medicinal Chemistry at Cantab Anti-infectives for five

Pamela Brown 2018-03-08T14:01:34+00:00

Karen Bush

Karen Bush is a PhD graduate in biochemistry from Indiana University (IU). She spent 36 years in pharmaceutical research before joining the IU faculty to continue her focus on antibiotic drug discovery and development, based on her research on antibiotic resistance mechanisms. Karen’s major research has been in the area of beta-lactamases, the enzymes primarily

Karen Bush 2018-03-09T14:47:21+00:00

Ryan Cirz

Ryan Cirz is Vice President of Infectious Disease Research and Head of the Postdoctoral Program at Achaogen, which focuses on discovering, developing and commercializing innovative antibacterials to treat multi-drug resistant (MDR) Gram-negative infections. Ryan has worked on antibacterial discovery and development at Achaogen for 11 years in roles of increasing seniority, focused almost exclusively on

Ryan Cirz 2018-03-26T07:58:45+00:00

Patrice Courvalin

Professor Patrice Courvalin is an internationally recognized expert in the genetics and biochemistry of antibiotic resistance, and in the transfer and heterologous expression of genetic information. He first described and then elucidated, vancomycin resistance in Enterococcus. Patrice’s research has led to a revision of the dogma describing natural dissemination of antibiotic-resistance genes. He and his

Patrice Courvalin 2018-03-12T13:24:47+00:00

Mike Dawson

Mike Dawson is a consultant in antimicrobial research, who has spent the last 14 years working in the biotech sector. Mike also has over 20 years’ experience in the pharmaceutical industry gained at GSK. As Head of Biotransformation and Natural Product Chemistry he played leading roles in natural product based drug discovery and the application

Mike Dawson 2018-03-08T14:14:35+00:00

George L Drusano

George Drusano is director of the Institute for Therapeutic Innovation at the University of Florida, whose mission is to improve the therapy for serious infectious diseases. After graduating magna cum laude from the honours programme at Boston College, George graduated cum laude from the University of Maryland School of Medicine in Baltimore. He completed his

George L Drusano 2018-03-08T14:30:28+00:00

Jacques Dumas

Jacques Dumas is a trained chemist with over 20 years’ experience in discovery to clinical proof-of-concept in infectious diseases and oncology. He has been Chief Scientific Officer (CSO) of Tetraphase Pharmaceuticals since July 2015, where he oversees non-clinical sciences and CMC (Chemistry, Manufacturing and Controls) activities to support the company’s product pipeline. Jacques became CSO

Jacques Dumas 2018-03-12T07:45:59+00:00

Barry I Eisenstein

Barry Eisenstein is the chair of the Scientific and Business Advisory Board of CARB-X, a public-private partnership based at Boston University, devoted to new antimicrobial drug and diagnostic development. Barry received his medical degree from Columbia University and subsequently trained in internal medicine and infectious diseases at the University of North Carolina. He has spent

Barry I Eisenstein 2018-03-09T07:08:05+00:00

Domingo Gargallo-Viola

Domingo Gargallo-Viola is a co-founder and Chief Scientific Officer at ABAC Therapeutics, a leader in pathogen-specific antibiotics that was formerly part of Grupo Ferrer Internacional based in Spain. Domingo has over 30 years’ experience in the discovery and development of anti-infective drugs. At ABAC Therapeutics he is focused on the discovery and development of first-in-class,

Domingo Gargallo-Viola 2018-03-13T12:16:35+00:00

Olga Genilloud

Olga Genilloud, Scientific Director and Head of the Microbiology Department at Fundación MEDINA, has over 25 years’ extended research experience in the discovery and biosynthesis of novel natural products antibiotics, obtained in the academic, clinical environment and pharmaceutical sectors. Olga has a PhD in chemistry from the Complutense University of Madrid and has a solid

Olga Genilloud 2018-03-16T10:48:28+00:00

Mark J Goldberger

Mark Goldberger is an independent consultant at Mark Goldberger MD MPH LLC Maryland, USA, where he advises pharmaceutical and biotech companies on the development of infectious diseases products. Before retiring in 2014 and becoming a consultant, Mark spent seven years at AbbVie - formerly part of Abbott - in various senior positons including vice president

Mark J Goldberger 2018-03-27T12:07:07+00:00

Bob Hancock

Bob Hancock is a leading microbiologist in Canada, who has researched and taught at the University of British Columbia (UBC) for nearly 40 years. Bob is currently UBC Killam Professor of Microbiology and Immunology, an Associate Faculty Member at the Wellcome Trust Sanger Institute in the UK, and a Canada Research Chair in Health and

Bob Hancock 2018-03-12T13:58:07+00:00

Stephen Hawser

Stephen is Chief Executive Officer of IHMA Europe Sàrl based in Switzerland, a wholly owned affiliate of International Health Management Associates. Since it began operating in 2009, under Stephen’s leadership, IHMA has focused on providing a full suite of technical capabilities and domain expertise in all phases of antimicrobial drug development: drug discovery, clinical development,

Stephen Hawser 2018-03-26T08:12:05+00:00

Deborah Hung

Deborah Hung is a trained physician, chemist and geneticist. She is currently an associate professor in the Department of Molecular Biology at Massachusetts General Hospital and in the Department of Genetics at Harvard Medical School. She is Director of the Infectious Disease and Microbiome Program, Broad Institute of MIT and Harvard, an infectious disease physician

Deborah Hung 2018-03-08T15:19:10+00:00

Khalid Islam

Khalid Islam is the owner of Life Sciences Management GmbH, which consults with start-ups, emerging biotechs and pharma on drug discovery and development. He is also a founding partner of Sirius Healthcare Partners, an advisory boutique in the healthcare sector. Khalid is the Chairman of the Board of Directors of Fennec Pharma and Minoryx Therapeutics,

Khalid Islam 2018-03-26T11:27:44+00:00

Nachum Kaplan

Nachum Kaplan is a co-founder of Nobelex Biotech and has been the Chief Scientific Officer (CSO) since its inception in 2014. Nachum leads on the discovery of new drugs, including overseeing antibacterial compound progression relative to milestone criteria and target product profiles. Nachum is also responsible for all in vitro microbiology studies, in vivo efficacy

Nachum Kaplan 2018-03-08T15:05:49+00:00

Jennifer Leeds

Jennifer Leeds is Executive Director and Head of Antibacterial Discovery in the infectious diseases area of the Novartis Institutes for Biomedical Research (NIBR). She is responsible for the strategy and execution of the new antibacterial portfolio from target discovery through pre-clinical validation, and the clinical microbiology strategy and resources in clinical development. Jennifer co-invented and

Jennifer Leeds 2018-03-09T14:40:05+00:00

Sergio Lociuro

Sergio Lociuro is Chief Scientific Officer (CSO) at BioVersys AG where he leads the research and development of novel chemical entities that, upon binding to bacterial transcription regulators, are able to control/inhibit expression of resistance to given antibiotic classes, biofilm formation and virulence factors. Sergio has over 30 years’ experience in applied sciences and drug

Sergio Lociuro 2018-03-09T13:10:50+00:00

Stefan Miller

Stefan Miller is a scientific consultant at Lysando AG and an independent consultant. He has significant experience as a chief scientific officer (CSO) and chief executive officer (CEO) in biotech companies and focuses on technology and product development including intellectual property strategy. Stefan co-founded Lysando AG in 2009 where he worked as CSO and led

Stefan Miller 2018-03-26T08:28:40+00:00

Malcolm Page

Malcolm Page, PhD, studied Biochemistry in the U.K. and worked at the EMBL Heidelberg and the Biozentrum, Basel. He joined Roche in 1990, working on the discovery of β-lactamase inhibitors and anti-MRSA cephalosporins. He subsequently became responsible for exploratory projects in the Infectious Diseases therapeutic area and worked on the validation and screening of novel

Malcolm Page 2018-03-08T08:47:30+00:00

Antonio Perez

Antonio (Toni) Perez is chief medical officer (CMO) and chairman of advisory boards in several pharmaceutical companies. In December 2017, he became CMO at MaxiVAX SA, a private Swiss clinical stage biotech company developing novel anti-cancer vaccines. He is also CMO for the development of agents in several infectious diseases (ID) at LASCCO/Combioxin in Geneva.

Antonio Perez 2018-03-09T13:19:35+00:00

David Pompliano

David Pompliano is Founding Chief Scientific Officer (CSO) of Lodo Therapeutics, a drug discovery company based in New York. Since its inception in 2015, the company has focused on microbial metagenomics-based discovery, and synthetic biological manipulation of novel secondary metabolite biosynthetic pathways to produce new medicines. Lodo, backed by the Gates Foundation and the Accelerator

David Pompliano 2018-03-16T10:44:30+00:00

Michael Pucci

Michael Pucci is Executive Director of Early Drug Discovery at Spero Therapeutics in Cambridge, Massachusetts. In addition to providing input into current R&D programmes, he explores potential new anti-infective programmes for the company pipeline and gathers competitive intelligence in the field. He also oversees non-dilutive funding opportunities and assists in the preparation of grant and

Michael Pucci 2018-03-09T13:33:51+00:00

Céline Pulcini

Céline Pulcini is Full Professor of Infectious Diseases at Nancy University Hospital and leads a research team on stewardship at the University of Lorraine, Nancy, France. Her research focuses on antimicrobial stewardship and vaccination practices, with the aim of preventing the emergence of bacterial resistance to antibiotics. Céline is Secretary of ESGAP, the European Society

Céline Pulcini 2018-03-26T10:52:25+00:00

Hans-Georg Sahl

Hans-Georg Sahl is Emeritus Professor at the University of Bonn. He has held various roles at the university since 1980 including research assistant, Assistant Professor for Medical Microbiology and was Professor of Medical and Pharmaceutical Microbiology until 2017. Hans-Georg has authored over 200 papers, mostly on the mechanisms of action of new antibiotic compounds. He

Hans-Georg Sahl 2018-03-09T13:38:58+00:00

Sameeh M Salama

Sameeh M Salama is the Vice President (VP) of Business Development at Fedora Pharmaceuticals, VP of Business Development at the management and business consultancy firm, Brass Dome Ventures, and was formerly VP of NAEJA Pharmaceuticals. Since his move to industry in 1994, he has been heavily involved in antibacterial and antifungal research. His most recent

Sameeh M Salama 2018-03-09T13:55:43+00:00

William Shafer

William (Bill) Shafer is Professor of Microbiology and Immunology at Emory University School of Medicine. He is a senior research career scientist at the Atlanta Veterans Affairs Medical Center, Director of the Antimicrobial Resistance and Therapeutic Discovery Training Program and Co-Director of the Emory Antibiotic Resistance Center. Bill has been on the faculty of Emory

William Shafer 2018-03-12T14:49:43+00:00

Karen J Shaw

Karen Joy Shaw is Chief Scientific Officer at Amplyx Pharmaceuticals, a biotechnology company developing the first-in-class broad spectrum antifungal agent APX001, which has completed phase I intra-venous/oral clinical studies. She is also President of Hearts Consulting Group, where she consults on infectious disease drug discovery and development. Karen was previously Senior Vice President of Biology

Karen J Shaw 2018-03-13T08:47:16+00:00

David Shlaes

David Shlaes, author of Antibiotics, The Perfect Storm (Springer) and The Drug Makers (Lulu), has had a 30-year career in anti-infectives spanning academia and industry - with a long-standing scientific interest in antimicrobial resistance. David graduated with a PhD and MD from Case Western Reserve University (CWRU) in Cleveland and after completing his post-graduate training

David Shlaes 2018-03-09T14:32:01+00:00

Lynn L Silver

Lynn Silver is the owner of the independent consultancy LL Silver Consulting, where she advises the pharmaceutical industry on antibacterial discovery and preclinical development. Lynn is an expert in antibacterial agents, screen design and execution, microbiological evaluation of hits and leads, and studies of mechanism of action and resistance. Lynn set up her consultancy business

Lynn L Silver 2018-03-16T10:51:35+00:00

Jared A Silverman

Jared Silverman joined the Bill & Melinda Gates Medical Research Institute in January 2018 as Head of Translational Discovery. He was previously Senior Vice President of Research at Kaleido Biosciences, responsible for building a drug discovery pipeline to identify novel modulators of the human microbiome to treat and prevent disease. Jared’s whole career has focused

Jared A Silverman 2018-03-09T13:55:13+00:00

Joyce Sutcliffe

Joyce Sutcliffe is an independent consultant with more than 35 years’ experience in antibiotic research and development. She is the former Senior Vice President (SVP) of Tetraphase Pharmaceuticals where she was responsible for managing discovery biology and preclinical development internally and with external contractors. She was part of the executive team involved in developing clinical strategies,

Joyce Sutcliffe 2018-03-13T15:18:15+00:00

Glenn S Tillotson

Glenn Tillotson is a Partner at GST Micro, and a consultant to the pharmaceutical and diagnostic industries, providing advice on a range of topics covering preparatory and post-approval activities. Glenn has over 30 years’ pharmaceutical experience in clinical research, commercialization and, scientific communications including publications planning, strategic drug development, life cycle management and global launch

Glenn S Tillotson 2018-03-16T10:39:53+00:00

Paul M Tulkens

Paul Tulkens is a member of the Louvain Drug Research institute and Emeritus Professor at the Université catholique de Louvain (UCL) in Brussels where his research focuses on cellular biology and toxicology, antibiotic pharmacodynamics and cellular pharmacokinetics and, new antibiotic discovery and development. As Professor of Pharmacology and Pharmacotherapy, Paul has also taught drug discovery

Paul M Tulkens 2018-03-13T12:38:14+00:00

Peter Warn

Peter Warn is Senior Vice President of Anti-infective Discovery at Evotec, where he leads antimicrobial discovery programmes and has scientific oversight of external client contracts. Peter was a founder and Chief Scientific Officer of Euprotec before the company was acquired by Evotec. Previously he was a senior lecturer at the University of Manchester, running a

Peter Warn 2018-03-12T15:44:34+00:00

Mark Wilcox

Mark Wilcox is a Consultant Microbiologist and Head of Research and Development in Microbiology at the Leeds Teaching Hospitals (LTHT). He is also Professor of Medical Microbiology at the University of Leeds where he heads the Healthcare Associated Infection research team comprising around 30 doctors, scientists and nurses. Their projects consider multiple aspects of Clostridium

Mark Wilcox 2018-03-13T09:21:35+00:00