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MEETING PROSPECTUS

16TH INTERNATIONAL WORKSHOP ON

HIVHepatitis

WASHINGTON DC, USA • 19 - 21 APRIL 2015

CLINICAL PHARMACOLOGYOF HIV & HEPATITIS THERAPY

HIVHepatitis

216th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy 19 - 21 April 2015, Washington DC, USA

CONTENT

Workshop description ........................................................................... 4

Background .............................................................................................4

Meeting Objectives ..................................................................................4

Format ....................................................................................................4

Unique Meeting Features .......................................................................5

Target audience ......................................................................................5

Demographics .........................................................................................5

Geographical distribution last meeting ..................................................6

Program Committee ............................................................................. 7

Organizing Committee .......................................................................... 8

Scientific Committee ............................................................................ 9

Industry Advisory Board ......................................................................10

Participants’ Feedback 2014 ................................................................11

Personal benefits ..................................................................................11

Content ..................................................................................................11

Lectures ................................................................................................12

Quotes ..................................................................................................15

Summary ..............................................................................................16

HIVHepatitis


INTRODUCTION

We are proud to announce the 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy, to be held on 19 - 21 April 2015 in Washington DC, USA.

Understanding the clinical pharmacology of antiretroviral therapy is pivotal to designing optimal treatment and prevention strategies for HIV & Hepatitis infection. Drug exposure is significantly influenced by drug interactions, medication taking behavior, and patients’ physiologic and genetic characteristics. These factors are central to determining therapeutic efficacy, failure or toxicity. Despite great progress, many pharmacologic challenges still exist.

The 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy provides a platform for state-of-the-art discussions of current topics fundamental to the optimal use of antiretroviral therapy including drug-drug interactions, pharmacokinetics of investigational agents and existing drugs, pharmacodynamics, drug dosing in special populations, post-marketing surveillance project, and regulatory considerations.

This meeting prospectus is designed in order to provide information on the meeting set up, demographics and evaluation scores from the 2014 workshop participants. We hope this information is of interest. Please contact us if specific information is missing and we will gladly provide you with additional documentation.

On behalf of the Program Committee,

DAVID BACK, PHD

University of Liverpool, Department of Molecular and Clinical PharmacologyLiverpool, United Kingdom

JÜRGEN ROCKSTROH, MD, PHD

University of Bonn, Germany

Chairs 2015

HIVHepatitis


WORKSHOP DESCRIPTION

BACKGROUNDUnderstanding the clinical pharmacology of antiretroviral therapy is pivotal to designing optimal treatment and prevention strategies for HIV & Hepatitis infection. Drug exposure is significantly influenced by drug interactions, medication taking behavior, and patients’ physiologic and genetic characteristics. These factors are central to determining therapeutic efficacy, failure or toxicity. Despite great progress, many pharmacologic challenges still exist.

The International Workshop on Clinical Pharmacology of HIV Therapy and the International Workshop on Clinical Pharmacology of Hepatitis Therapy have always addressed these challenges for HIV and Hepatitis separately. Over the years, both meetings have become the premier international workshop on clinical pharmacology in their field. In 2014 these two workshops joined forces.

The 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy again provides a platform for state-of-the-art discussions of current topics fundamental to the optimal use of antiretroviral therapy including drug-drug interactions, pharmacokinetics of investigational agents and existing drugs, pharmacodynamics, drug dosing in special populations, post-marketing surveillance project, and regulatory considerations.

MEETING OBJECTIVES• Togatherexpertsinvolvedinclinicalpharmacologyfromdifferentdisciplinesinaninteractiveworkshopsetting

• Toprovideaplatformforpresentationanddiscussionofthelatestdevelopmentsinthefield

• Tomapallcurrentstudiesandresults

• Totranslatenewdatatotreatmentguidelines

• Tostimulatediscussionandconsensusonbestpractice

FORMATThis meeting consists of invited lectures, abstract-driven presentations, roundtable discussions, clinical case presentations and poster viewing sessions.

The meeting is abstract-driven. It is known as an excellent platform for young investigators to present their research. To ensure the quality of accepted abstracts, all submitted abstracts go through a blind, peer-reviewed process conducted by the members of the Program Committee, the Organizing Committee and the Scientific Committee. The tables show the abstract submission statistics from the past three years for each workshop:

2012 2013 2014

13th HIVPK 7th HEPPK 14th HIVPK 8th HEPPK 15th HIVHEPPK

# abstracts 68 16 55 22 64 (accepted)

# invited lectures 12 5 14 3 17

# oral abstracts 24 16 18 22 16

# best of posters 6 6 5

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UNIQUE MEETING FEATURESThe Clinical Pharmacology workshop:

• IsthepremierHIV&HepatitisPharmacologyMeetingintheworld

• Hasastrongcommunityofclinicalpharmacologistsandotherhealthcareprofessionalsinvolvedinthisfield

• Isanindependentscientificplatformfordiscussionanddebate

TARGET AUDIENCEThe target audience of this workshop consist of experts in HIV and Hepatitis, clinical pharmacologists, pharmacists, educated clinicians, industry representatives, government representatives, PhD students and others involved in clinical pharmacology of HIV and Hepatitis therapy.

DEMOGRAPHICS2013 2014

14th HIVPK 8th HEPPK

University researcher 34% 22% 27%

Hospital 33% 5% 19%

Industry researcher 26% 73% 43%

Other 7% 0% 11%

Returning participants 40% 34% 46%

New participants 60% 66% 54%

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GEOGRAPHICAL DISTRIBUTION LAST MEETING

Year 2012 2013 2014

Edition 13th HIVPK 7th HEPPK 14th HIVPK 8th HEPPK 15th HIVHEPPK

Location Barcelona, Spain Cambridge, USA Amsterdam, NL Cambridge, USA Washington DC, USA

# of partipants 141 80 127 58 164

Europe 58 5 57 7 42

USA + Canada 69 75 63 50 117

Africa 2 0 2 0 1

Australia 2 0 2 1 1

Middle-East 1 0 1 0 1

South-America 4 0 0 0 1

Asia 5 0 2 0 1

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PROGRAM COMMITTEE

DAVID BACK, PHD

University of Liverpool, Department of Molecular and Clinical PharmacologyLiverpool, United Kingdom

CHARLES FLEXNER, MD

Johns Hopkins University, Division of Clinical PharmacologyBaltimore, Maryland, USA

JENNIFER KISER, PHARMD

University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences Denver, Colorado, USA

JÜRGEN ROCKSTROH, MD, PHD

University of Bonn, Germany

ANGELA KASHUBA, PHARMD

University of North Carolina at Chapel Hill Chapel Hill, North Carolina, USA

JONATHAN SCHAPIRO, MD

Sheba Medical CenterTel Hashomer, Ramat Gan, Israel

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ORGANIZING COMMITTEE

TERRENCE BLASCHKE, MD, PHD

Bill and Melinda Gates Foundation Seattle, Washington, USA

CHARLES BOUCHER, MD, PHD

Erasmus Medical Center Rotterdam, the Netherlands

JEAN-MICHEL PAWLOTSKY, MD, PHD

Hôpital Henri Mondor, Université Paris XII Paris, France

SHIRLEY SEO, PHD

U.S. Food & Drug Administration Silver Spring, USA

DAVID BURGER, PHARMD, PHD

RadboudumcNijmegen, the Netherlands

GIOVANNI DI PERRI, MD, PHD

University of Turin, Infectious Diseases, Ospedale Amadeo di SavoiaTurin, Italy

COURTNEY FLETCHER, PHARMD

University of Nebraska, Medical Center, College of PharmacyOmaha, Nebraska, USA

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SCIENTIFIC COMMITTEE

Francesca Aweeka . . . . . . . . . . . . . . . . . . . . . . . . . . University of California (UCSF), USA

Marta Boffito . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . St. Stephen’s Center, United Kingdom

Ferrucio Bonino . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ospedale Maggiore di Milano, Italy

Stefano Bonora . . . . . . . . . . . . . . . . . . . . . . . . . . . . . University of Torino, Italy

Raffaele Bruno . . . . . . . . . . . . . . . . . . . . . . . . . . . . . University of Pavia, Italy

Rodolphe Garraffo . . . . . . . . . . . . . . . . . . . . . . . . . . Hôpital Pasteur Nice, France

David Haas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Vanderbilt University Medical Center, USA

Rick Haubrich . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . University of California (UCSD), USA

Saye Khoo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . University of Liverpool, United Kingdom

Michael Kurowski . . . . . . . . . . . . . . . . . . . . . . . . . . . Auguste-Victoria Hospital, Germany

Patrick Marcellin . . . . . . . . . . . . . . . . . . . . . . . . . . . Hôpital Beaujon, France

José Moltó . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Germans Trias I Pujol, Spain

Avidan Neumann . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bar Ilan University, Israel

Gilles Peytavin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Hôspital Bichat-Cl. Bernard, France

Elizabeth Phillips . . . . . . . . . . . . . . . . . . . . . . . . . . . Royal Perth Hospital, Australia

Mario Regazzi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IRCCS-Policlinico San Matteo, Italy

Kellie Reynolds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Food and Drug Administration, USA

Kimberly Scarsi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . University of Nebraska, USA

Kimberly Struble . . . . . . . . . . . . . . . . . . . . . . . . . . . . Food and Drug Administration, USA

Steve Taylor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heartland Hospital, United Kingdom

Alice Tseng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Toronto General Hospital, Canada

Stefan Zeuzem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . University of Frankfurt, Germany

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INDUSTRY ADVISORY BOARD

Richard Bertz . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BMS, USA

Barbara Brennan . . . . . . . . . . . . . . . . . . . . . . . . . . . Roche, USA

Joan Butterton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Merck, USA

Varun Garg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Vertex, USA

Daria Hazuda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Merck, USA

Thomas Kakuda . . . . . . . . . . . . . . . . . . . . . . . . . . . . Janssen Pharmaceuticals, USA

Charles La Porte . . . . . . . . . . . . . . . . . . . . . . . . . . . . Janssen, The Netherlands

Anita Mathias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Gilead, USA

John McHutchison . . . . . . . . . . . . . . . . . . . . . . . . . . . Gilead, USA

Rajeev Menon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Abbvie, USA

Stephen Piscitelli . . . . . . . . . . . . . . . . . . . . . . . . . . . GlaxoSmithKline, USA

Manoli Vourvahis . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pfizer, USA

Xiao Jian Zhou . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Idenix, USA

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PARTICIPANTS’ FEEDBACK 2014

PERSONAL BENEFITSI will change my daily practice as a result of attending this meeting: 50%

I would recommend this meeting to my colleagues: 98%

I plan to attend this meeting again next year: 91%

CONTENTAgree Neutral Disagree

The content of the meeting met my expectations 100% 0% 0%

Sufficient time allocated for discussion during the meeting 100% 0% 0%

The allocated time per presentation was sufficient 94% 6% 0%

I perceived no commercial bias at the workshop 94% 6% 0%

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LECTURES

MONDAY, 19 MAYOpening session

Opening lecture: The DAIDS research agenda for HIV and related infections

Emily Erbelding, MD, MPH, DAIDS, USA

Excellent/Good Average Fair/Poor

Content 66% 32% 2%

Presentation 82% 18% 0%

Abstract - driven presentations Excellent/Good Average Fair/Poor

Content 87% 11% 2%

Session 1: Clinical Pharmacology of Novel Drugs / ARV delivery systems

Development of long-acting ARVs and broadly neutralizing antibodies for HIV prevention - a funders perspective

Stephen Becker, MD, Bill & Melinda Gates Foundation, USA


Content 72% 22% 6%


FDA perspective

Kimberly struble, PharmD, US Food & Drug Administration, USA


Content 83% 17% 0%


TUESDAY 20 MAY

Session 2: Management of HIV/HCV Coinfection


Content 96% 4% 0%

Clinical Case presentation

Jürgen Rockstroh, MD, University of Bonn, Germany


Content 88% 8% 4%


State of the art lecture on treatment challenges for HIV/HCV coinfected patients

Mark Sulkowski, MD, Johns Hopkins University, USA


Content 90% 10% 0%


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Session 3: Round Table Discussion: Renal transporters and Biomarkers

Renal transporters

Kathleen M. Giacomini, PhD, UC San Francisco, USA


Content 86% 12% 2%


FDA perspective

Vikram Arya, PhD, FCP, US Food & Drug Administration, USA


Content 82% 18% 0%


Session 4: Role of Physiologically Based Pharmacokinetics (PBPK)

FDA perspective on PBPK

Ping Zhao, BS, PhD, US Food & Drug Administration, USA


Content 98% 2% 0%


Use of mechanistic PBPK modeling to predict the potential for renal transporter DDIs between Dolutegravir-Tenofovir & Dolutegravir-Metformin

Grant genereaux, BS, MS, GlaxoSmithKline, USA


Content 96% 4% 0%


The use of PBPK to characterize the interplay between metabolism and transport in the disposition of simeprevir in healthy volunteers and HCV infected patients

Sivi Ouwerkerk-Mahadevan, PhD, Janssen Infectious Diseases, Belgium


Content 98% 2% 0%


Session 5: Abstract driven session (PK/PD in HIV prevention)

The role of PK/PD tissue models for Prevention

Lisa Rohan, PhD, University of Pittsburgh, USA


Content 88% 12% 0%



Content 93% 7% 0%

Best of posters Excellent/Good Average Fair/Poor

Content 92% 8% 0%


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WEDNESDAY, 21 MAY

Session 6: Transporter-Mediated Drug Interactions with Antivirals

Bristol-Myers Squibb HCV DAAs: Review of Interactions Involving Transporters

Tim Eley, BS, PhD, Bristol-Myers Squibb, USA


Content 96% 4% 0%


AbbVie: Drug interactions with AbbVie HCV DAAs

Rajeev Menon, PhD, AbbVie, USA


Content 96% 4% 0%


Gilead: Transporters: role in clinical development of HCV compounds

Brian kirby, PhD, Gilead, USA


Content 90% 10% 0%


DDIs in the evolving HCV treatment landscape (session supported by AbbVie)

Saye Khoo, MD, PhD, University of Liverpool, United Kingdom


Content 100% 0% 0%


Session 7: Clinical Case presentations

Case-Based DDI: Oncology

Alice Tseng, B.Sc.Phm., PharmD, FCSHP, AAHIVP, Toronto General Hospital, Canada


Content 82% 14% 4%


Case-Based DDI: Transplantation

Saye Khoo, MD, PhD, University of Liverpool, United Kingdom


Content 96% 4% 0%


Session 8: Abstract driven session - PK/PD Assessment of drugs for HCV and HIV


Content 93% 7% 0%


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QUOTES

• I really liked the combination of HIV and HCV and hope the same for the future meetings

• Great meeting, thank you!

• The combination of HCV and HIV really enhanced not only the conference but the discussion and Q and A

• Excellent workshop. I will not attend next year only because of other obligations/new responsibilities

• Level of science was excellent. Combined HCV/HIV was very successful. Meeting staff and facilities great again

• Balance. A good amount of primary research with clinical application/relevance discussed

• One of the best PK workshops to date

• Great program, FDA contribution highly appreciated

• All the feedback I have gotten from my FDA colleagues has been extremely positive for this meeting. The talks were very relevant and the quality of the posters was excellent. The fact that HIV and HCV were combined and also the fact that it took place in DC really aided in our high attendance. For last year’s meeting in Boston, I think I was the only FDA attendee. This year, we had 7 (including the speakers)!

• I was very honored to have the chance to present this year, and it was an outstanding meeting by all accounts

• Thanks! It was truly an honor to participate in the meeting and learn from other experts in the field. The team did a fantastic job to coordinate all the logistics!

• Great location

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It can be concluded that the participants were very pleased with the communication, logistics and content of the meeting. All invited lectures were well-recieved, especially the presentation of Saye Khoo on DDIs in the evolving HCV treatment landscape, which was supported by AbbVie.

Many very positive remarks were given, most of which are mentioning the quality of the program and the success of combining HIV and Hepatitis.

98% of the participants would recommend this workshop to their colleagues and more than 90% plans to attend this workshop again next year.

The Organizing Secretariat and the Organizing Committee are very pleased with these results. The 16th edition of the International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy will be organized 19-21 April 2015 in Washington DC, USA.

SUMMARY

international workshop on clinical …€¦ · the international workshop on clinical pharmacology...

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