th international workshop on clinical...

EVALUATION REPORT

19TH INTERNATIONAL WORKSHOP ON

BALTIMORE, MD, USA • 22 - 24 MAY 2018

CLINICAL PHARMACOLOGYOF ANTIVIRAL THERAPY

www.virology-education.com

The 19th International Workshop on Clinical Pharmacology of Antiviral Therapy was organized from 22-24 May 2018 in Baltimore, MD, USA. It attracted 116 participants from 14 countries. The majority of the attendees were from the US (62.9%). This high-profile conference brought together important stakeholders to share the most recent advances in clinical pharmacology for antiviral therapies.

The program featured plenary lectures, abstract and poster presentations, along with discussion, providing a unique opportunity to interact with colleagues in a focused setting.

During the event, evaluations were conducted in order to gather the attendees’ feedback on the program and to measure the effectiveness of the activity.

38% indicated their occupation as Pharmacologist, 28% are Pharmacists, and 8% Medical Doctors. 94 % of the respondents agreed that the single meeting objectives were met. 98% of the respondents reported that their general experience in this event was good/excellent.

PROGRAMThe program included 15 invited lectures, 13 oral abstract presentations, 2 “Best of Posters” sessions and a round-table discussion. Ample time was allocated for Q&A and discussion after the presentations. The evaluation scores of the presentations can be found on pages 16 - 20

In order to allow healthcare professionals working in the field to benefit from the content. Presentation materials and videos from 2018 have been posted on www.InfectiousDiseasesOnline.com

ABSTRACTSThe meeting provided an excellent platform for young investigators to present their research through abstract presentations. To ensure the quality of the accepted abstracts, all submitted abstracts went through a blind, peer-reviewed process conducted by the members of the Organizing Committee.

The Organizing Committee received 47 abstracts, of which 13 were accepted for an oral presentation and 33 were accepted as a poster presentation. Of the poster presentations, 8 were selected to present in the “Best of Posters” presentations.

NEEDS ASSESSMENTA needs assessment was conducted during the meeting. 94% of the respondents (strongly) agreed that there is a need for a research program on clinical pharmacology of infectious diseases. The respondents indicated that the scientific/research gaps they feel need to be addressed most urgently are research on novel formulations/delivery methods (32%), education of junior pharmacologists (19%), research on basic pharmacological parameters (18%), pharmacological research other than anti-HIV/Hep compounds (13%), and novel validation approaches (12%).

INTENT TO CHANGEThe workshop was very well received and this is reflected by the evaluation results.

95% of the respondents indicated that the lectures have increased their knowledge, 93% agreed that the program was beneficial for the clinical management of their patients, and 89% reported that they intend to incorporate the new information from the workshop into the care of their patients.

FUTUREThe majority of the respondents appreciated the conference to such an extent that they would recommend the meeting to their colleagues (88%) and plan to attend the next meeting (88%).

Next year, we will hold the 20th edition in Amsterdam, the Netherlands. This exciting installment will celebrate those who have contributed to this workshop over the last 20 years, as well as highlight new developments in the field.

GOING GREENThis was the first meeting where Virology Education did not print program or abstract books and did not print bags. The primary sources of information were via the app and the Virology Education event website. This medium of information was successful and Virology Education will look into how these mediums can be implemented into future workshops.

EXECUTIVE SUMMARY

Executive summary ..................................................................................................... 2

Table of contents .......................................................................................................... 3

Meeting description ..................................................................................................... 4

Committees ...............................................................................................................5-7

Registration demographics ........................................................................................ 8

Participants’ feedback ................................................................................................. 9

Professional Background .............................................................................9-10

Number of attendees per session ................................................................... 11

Needs Assessment .......................................................................................... 12

Registrant Demographics ................................................................................ 13

Invited Lectures Feedback ..........................................................................14-18

Meeting Objectives, Learning Objectives ........................................................ 18

Dinners, Poster Sessions & Organization ....................................................... 29

General Conference Experience ...................................................................... 20

Additional Feedback ........................................................................................ 21

Conclusion ................................................................................................................. 22

Acknowledgements ................................................................................................... 23

TABLE OF CONTENTS

NEEDS ASSESSMENT

BACKGROUNDThe International Workshop on Clinical Pharmacology of Antiviral therapy is pivotal to designing optimal treatment and prevention strategies. 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 pharmacological challenges still exist.

MEETING OBJECTIVESThe aim of this workshop is :

• To gather experts involved in clinical pharmacology from different disciplines in an interactive workshop setting

• To provide a platform for presentation and discussion of the latest developments in the field

• To share information on ongoing pharmacological studies

• To translate new data to treatment guidelines

• To stimulate discussion and consensus on best practices

LEARNING OUTCOMES

Participants of this workshop will able to incorporate the new information into clinical guidance for improved disease management of their patients. The knowledge on drug efficacy/toxicity and potential drug interactions will enable clinicians to better manage treatment related complications and, thereby, further optimize antiviral treatment and prevention.

LEARNING OBJECTIVESAfter participation, delegates will be able to:

• Outline new developments in antiviral therapy

• Identify treatment options for hepatitis infected patients

• Reflect on the role of pharmacogenomics in clinical management

• Describe the various pharmacological parameters of Integrase Inhibitors

5Evaluation Report - VE Internal - International Workshop on Clinical Pharmacology of Antiviral Therapy 22-24 May 2018, Baltimore, MD, USA

COMMITTEES

PROGRAM COMMITTEE

Angela KashubaPharmD

University of North Carolina Eshelman School of

Pharmacy, United States

Courtney FletcherPharmD

University of Nebraska School of Pharmacy

United States

Jonathan Schapiro, MD

Sheba Medical Center Isreal

Charles Boucher, MD, PhD

Erasmus University

Terrence Blaschke, MD

Stanford UniversityUnited States

David Burger, PharmD, PhD

Radboud University Medical Center, The Netherlands


COMMITTEES

ORGANIZING COMMITTEE

Jürgen Rockstroh, MD

University of Bonn Germany

Jennifer Kiser,PharmD

University of Colorado Skaggs School of Pharmacy

United States

Charles Flexner,MD

Johns Hopkins University School of Medicine

David Back,PhD

University of Liverpool United Kingdom

Shirley Seo, PhD

Food and Drug Administration United States

Giovanni Di Perri,PhD

University of Turin Italy


Scientific CommitteePeter Anderson, MD - University of Colorado, Denver, USAMarta Boffito, MD - St. Stephen’s Center, UKStefano Bonora, MD - University of Torino, ItalyRaffaele Bruno, MD - University of Pavia, ItalyDario Cattaneo, MD, PhD - University of Liverpool, UKTim Cressey, BSc, MSc, PhD - Chiang Mai University, ThailandRodolphe Garraffo, PharmD, PhD - Hopital Pasteur, FranceDavid Haas, MD - Vanderbilt University Medical Center, USASaye Khoo, MD, PhD - University of Liverpool, UKMichael Kurowski - Therapia GmbH, GermanyMohammed Lamorde, PhD - Infectious Diseases Institute, UgandaJacob Langness, PharmD - Abbott Northwestern Hospital, Minneapolis, USALawrence Lee, MBBS PhD - National University of Singapore, SingaporeHelen McIlleron, MBChB, PhD - University of Cape Town, South AfricaJosé Moltó, MD, PhD - Hospital Universitari Germans Trias I PujolPeytavin Gilles, PharmD - Hopital Bichat, FranceElizabeth Phillips, MD, FRCPC, FRACP - Vanderbilt University School of Medicine, USAMassimo Puoti, MD - Niguarda Ca’Granda HospitalKellie Schoolar-Reynolds, PharmD - Food and Drug Administration, USAKimberly Scarsi, PharmD, MS - University of Nebraska Medical CenterKimberly Struble, PharmD - Food and Drug Administration, USASteve Taylor, MRCP, PhD - Birmingham Heartlands Hospital, UKAlice Tseng, PharmD - Toronto General Hospital, CanadaStefan Zeuzem, MD - University of Frankfurt, Germany

Industry Liason BoardTim Eley, PhD - ArbutusYash Gandhi, PhD - BMS Joseph Frippo PhD - Hoffmann - La Roche Daria Hazuda PhD - MerckJulie Jordan, MD - Teva Pharmaceuticals Thomas Kakuda, PhD - Alio BioPharmaCharles La Porte, PhD - Janssen BiologicsWei Liu, PhD - AbbVieAnita Mathias, PhD - GileadJohn McHutchison, MD - GileadParul Patel, PharmD - GSK/ViiV HealthcareManoli Vourvahis, PharmD - Pfizer

REGISTRANT DEMOGRAPHICS

NUMBER OF REGISTRATIONSIn total 116 participants from 14 different countries attended the meeting.

GEOGRAPHICAL DISTRIBUTION OF REGISTRANTSGeographical distribution per country:

Country No.

United States 73

France 15

United Kingdom 6

Canada 6

The Netherlands 5

Italy 2

Belgium 2

Uganda 1

Nigeria 1

Spain 1

Switzerland 1

Thailand 1

Israel 1

Chile 1

NUMBER OF ABSTRACTSAbstracts 20

Accepted 46

Oral 13

Poster 25

“Best of Poster” 8

PROFESSIONAL BACKGROUND - RESPONDENTS36% percent of the respondents work at a Hospital, followed by University (28%), Industry (23%), Government Agency (10%) and NGO (16%).

Type of organization

N = 145

38% indicated their occupation as Pharmacologist, 28% are Pharmacists, 8% are Medical Doctors, 8% are researchers, 7% are Corporate Professionals, 6% are Government Officials or representatives, 3% are medical students, and 2% are “Other.”

Occupation

N = 145

RESULTS OF MEETING EVALUATION

Pharmacologist38%

Pharmacist28%

MD8%

Researcher8%

Corporate Professional

7%

Gov Official or Rep6%

Med Student3%Other

2%

Hospital36%

University28%

Industry23%

Gov Agency10%

NGO3%

PROFESSIONAL BACKGROUND - RESPONDENTS52% percent of the respondents have indicated that their primary area of expertise was HIV (52%) followed by Pharmacology (38%), Hepatitis (7%), Other (2%) and Oncology (1%). Multiple answers were possible.

Area of Expertise (Multiple answers possible)

N = 183

Pharmacology38%

HIV52%

Hepatitis7% Oncology

1%

Other2%

56% indicated they do not treat any patients, followed by more than 250 patients per year (23%), 1-50 patients per year (9%), 51-100 patients per year (9%) 51-100 patients per year (6%), 101-150 pateints per year (3%) and 201-250 patients per year (3%).

Number of patients

N = 140

None56%

1-509%

51-1006%

101-1503%

201-2503%

more than 25023%

RESULTS OF MEETING EVALUATION

ATTENDEE DEMOGRAPHICS

Tuesday, 22 May Participants

Session 1 92

Wednesday, 23 May Participants

Session 2 86

Session 3 96

Session 4 83

Session 5 79

Thursday 24 May Participants

Session 6 87

NUMBER OF RESPONDENTSTuesday, 22 May 53

Wednesday, 23 May 55

Thursday, 24 May 59

NUMBER OF PARTICIPANTS PER SESSION

NUMBER OF REGISTRANTS116

NEEDS ASSESSMENT

40% Pharmacologist

40% Pharmacologist

A needs assessment was conducted during the meeting. 94% of the respondents (strongly) agreed that there is a need for a research program on clinical pharmacology of infectious diseases. The respondents indicated that the scientific/research gaps they feel need to be addressed most urgently are research on novel formulations/delivery methods (32%), education of junior pharmacologists (19%), research on basic pharmacological parameters (18%), Pharmacological research other than anti-HIV/Hep compounds (13%), and novel validation approaches (12%).

Occupation

N=53 (Multiple Answers Possible)

(Strongly) Agree Neutral (Strongly) Disagree N/A

There is a need for a program on clinical pharmacology of infectious diseases 94% 6% 0% 0

Educational needs/gaps Number of responses %

Research on basic pharmacological parameters 18 18.2%

Research on novel formulations/ delivery methods 32 32.3%

Novel validation approaches 12 12.1%

Pharmacological research other than anti-HIV/Hep compounds 13 13.1%

Education of junior pharmacologists 19 19.2%

Other needs 5 5.1%

Pharmacologist40%

Pharmacist26%

MD7%

Researcher7%

Corporate Professional8%

Gov Official or Rep6%

Other6%

PROFESSIONAL BACKGROUND 25% of the registrants work at a (university) hospital, 25% a in Industry, 16% at a university, 14% at a government agency, and 20% at “other” which includes NGO, laboratory, research institute, and more.

Type of organization Occupation

N= 108 N= 103

Primary Area of Expertise Prescriber Status

N= 145

Non Prescriber75%

Prescriber25%

REGISTRANT DEMOGRAPHICS

Pharmacist (PharmD)26%

Pharmacologist22%

Researcher (PhD)17%

Medical doctor (MD)14%

Corporate Professional6%

Student5%

Governmental Official or Representative

5%Other

5%

(University) Hospital25%

Industry25%University

16%

Government Agency14%

Other12%

Laboratory3%

Research Institute3%

NGO2%

HIV45%

Hepatitis12%

Pharmacology31%

Other9%

Tuberculosis3%

N = 102

PARTICIPANTS’ FEEDBACK

TUESDAY 22 MAYSession 1 - New technologies and formulations N=53

How to End the Global HCV Epidemic - The role of injectables

David ThomasJohns Hopkins School of Medicine


Topic is interesting 89% 8% 4% 0

Content is relevant to my work 61% 31% 8% 2

Clinical Development of Long-Acting Broadly Neutralizing Monoclonal Antibodies: Lessons Learned Thus Far

Richard Koup, MDVaccine Research Center NIAID / NIH




Viral Dynamics and the Search for an HIV Cure

Steven Becker, MDBryoLogyx Inc.




Poster Viewing Session I & Reception

WEDNESDAY 23 MAYSession 2 - Treatment of Hepatitis virus N=55

The use of DAA’s in pregnancy in HCV infected mothers

David Burger, PharmD, PhDRadboud University Medical Center




Clinical Case Presentation

David ThomasJohns Hopkins School of Medicine




INVITED LECTURES & ABSTRACT PRESENTATIONS


Abstract #1: Tenofovir exposure during pregnancy and postpartum in hepatitis B mono-infected women on TDF monotherapy compared to HIV-infected women on TDF-containing antiretroviral therapyTim Cressey, PhD




Abstract #2: Intracellular 007-TP Concentrations are Associated with Gradients of Adherence to Ledipasvir/Sofosbuvir

Leah Jimmerson, PhD


Topic is interesting 56% 35% 9% 0% 0


Abstract #3: A Pharmacometabolomics Approach for Predicting Tenofovir diphosphate (TFV-DP) Concentrations in Dried Blood Spots (DBS)

Ibrahim Mustafa




Coffee Break & Poster Viewing Session II

Session 3 - Round table discussion: validation of physiologically based pharmacokinetic (PBPK) modeling

N=55

Application of Physiologically based pharmacokinetic (PBPK) Modelling to Drug Development Decisions

Joga Gobburu, PhDUniversity of Maryland




Application of PBPK modelling for assessment of DDI liability in combination therapies

Karen Yeo, PhDSimcyp (Certara)




Physiologically based pharmacokinetic modeling and simulation in drug product development and review

Xinyuan Zhang, PhDDPM/OCP/OTS/CDER/FDA





Lunch

Session 4 - Towards Precision Medicine

How/when will pharmacogenomics translate into improved clinical care?

David Haas, MDVanderbilt University Medical Center




Latest advances in HIV pharmacogenomics

Andrea Calcagno, MDUniversity of Torino




Abstract # 4: SLC22a2 genetic variants and dolutegravir trough concentrations correlate with specific psychiatric symptoms in hiv-positive patients on dolutegravir





Abstract # 5: Age, Inflammation, Blood Brain Barrier Permeability and Single Nucleotide Polymorphisms in Transporters May Influence Cerebrospinal Fluid Antiretrovirals’ Concentrations





Coffee Break & Poster Viewing Session III

Session 5 - HIV related topic - Integrase Inhibitors

Clinical Pharmacology of Integrase Inhibitors

Giovanni Di Perri, MD, PhDUniversity of Turin

Strongly Agree Neutral Strongly Disagree N/A



Clinical case presentation

Marta Boffito, PhDSt. Stephen’s Center





Abstract #11: Pharmacokinetics of dolutegravir 100 mg once-daily with rifampicinMarta Boffito, PhD




Abstract #7: Pharmacokinetic and virological efficacy of dolutegravir (50 mg BID) containing regimen in association with rifampin in HIV-infected patients using Dried Blood Spot: ANRS-12313 NAMSAL sub-study in Cameroon

Minh Le




Abstract #8: First report of dolutegravir unbound plasma concentrations during pregnancy in HIV-positive women

Pauline Bollen




Workshop Dinner

THURSDAY 24 MAYSession 6 - Drug - Drug Interactions related session

Update on DDI guidelines of the FDA - in vitro

Xinning Yang , PhDU.S. Food & Drug Administration




Update on DDI guidelines of the FDA - in vivo

Kellie Schoolar-Reynolds, PharmDU.S. Food & Drug Administration




Abstract #9: Medication safety issues associated with currently used first-line antiretroviral regimens in Uganda

Kay Seden




Abstract #10: Medication safety issues associated with currently used first-line antiretroviral regimens in Uganda

Kimberly Scarsi, PharmD, MS




Abstract #12: Rifabutin (RBT) Decreases Cabotegravir (CAB) Exposure following Oral Co-administrationParul Patel, PharmD




Abstract #13: ifabutin PK and Safety among HIV/TB Coinfected Children Receiving Lopinavir

Holly Rawizza, MD




Coffee BreakClinical Pharmacology of HIV Pre-Exposure Prophylaxis (PrEP) – Where are we now

Craig Hendrix, MDJohns Hopkins University




Round Table Discussion: Round Table discussion: Two-drug regimens

Moderator: Giovanni di PerriPanel members: Jonathan Schapiro & Saye Khoo




Closing Remarks

MEETING OBJECTIVES(Strongly) Agree Neutral (Strongly) Disagree N/A

To gather experts involved in clinical pharmacology from different disciplines in an interactive workshop setting 94% 6% 0% 0

To provide a platform for presentation and discussion of the latest developments in the field 93% 7% 0% 0

To share information on ongoing pharmacological studies 94% 4% 2% 0

To translate new data to treatment guidelines 87% 11% 2% 0

To stimulate discussion and consensus on best practices 92% 6% 2% 0

LEARNING OBJECTIVES(Strongly) Agree Neutral (Strongly) Disagree N/A

Outline new developments in antiviral therapy 92% 8% 0% 0

Identify treatment options for hepatitis infected patients 76% 20% 4% 2

Reflect on the role of pharmacogenomics in clinical management 90% 10% 0% 1

Describe the various pharmacological parameters of Integrase Inhibitors 96% 4% 0% 1


INTENT TO CHANGE(Strongly) Agree Neutral (Strongly) Disagree N/A

The lectures given in this workshop have increased my knowledge of Clinical Pharmacology 94% 6% 0% 0

This program is beneficial for the clinical management of my patients. 91% 7% 4% 17

I intend to incorporate the new information into the care of my patients. 89% 11% 0% 21

I have utilized this information in treatment strategies for my patients prior to this meeting 94% 6% 0% 1

IMPLEMENTATION Yes No N/A

I will be able to implement the knowledge without any problems 90% 10% 3

The following factors may prevent me from the implementation (multiple answers possible)

#

My patient population may not be appropriate for the implementation. 7

My current office and practice systems may not accommodate the changes. 8

My patients may have trouble complying with these changes/ strategies. 0

The medications/ procedures discussed may not be available for my patients. 4

These changes may be too time consuming. 1

Other 1

WORKSHOP DINNER(Strongly) Agree Neutral (Strongly) Disagree N/A

The reception/workshop dinner is a valuable element to the meeting. 88% 8% 4% 26

The reception/workshop dinner is a great opportunity for networking. 88% 8% 4% 26

POSTER VIEWING SESSIONS(Strongly) Agree Neutral (Strongly) Disagree N/A

The poster sessions are a valuable element to the program. 91% 9% 0% 1

The combination of the poster sessions and breaks are well scheduled. 82% 8% 12% 0


BEST-OF-POSTER SESSIONS(Strongly )Agree Neutral (Strongly)

DisagreeN/A

The Best of Poster sessions are a valuable element to the program. 100% 0% 0% 0

Too much Sufficient Not Enough

There was sufficient time to view all posters 2% 80% 19%

GENERAL CONFERENCE EXPERIENCEExcellent/Good Average N/A

Overall event experience 98% 2% 0

Opportunity to network 92% 8% 0

Content was presented clearly 94% 6% 0

Content is relevant to my practice/research 94% 4% 0

Content was free from commercial bias (product selling) 92% 0% 1

0% 25% 50%

What perentage of the content was new for you? 2% 25% 53%

Too Much Sufficient Not Enough

Time allocation for discussion 4% 85% 12%

Time allocation per presentation 4% 92% 4%(Strongly) Agree Neutral (Strongly) Disagree N/A

I plan to attend this event next time 88% 10% 2% 0

I would recommend this workshop to my peers 88% 10% 2% 0


REMARKS

HOW WOULD YOU DESCRIBE THIS WORKSHOP TO YOUR COLLEAUGES?

• Focused, dedicated group

• An arousing pharmacology update.

• A pharmaceutical company-sponsored workshop combining industry, academic and FOA expertise in antiviral drug development

• Best event to stay up-to-date in the field of HIV Pharmacology

• Chance to get information from the best experts in the field

• Opportunity to meet with like-minded researchers with similar research interests for the purpose of sharing new research findings to share learning. Provides a chance to share expertise and perspectives

• Great information for clinicians and clinical researchers.

• Highly scientific with mostly niche expertise in pharmacokinetics and drug-drug interaction studies and study methodology

• Small, Interactive, focused discussion with key AUCP Investigations

• Small workshop focusing specifically on application of pharmacology to patients and vulnerable populations

GENERAL

• Fantastic! Well organized workshop

• Paperless program is good!

• It was great to have the abstract book in advance

• Very good meeting for focused HIV research (and Hep). But not successful in expanding to broader antivirals

• A fantastic workshop! A lot of new advances in the field to learn from this workshop. Excellent presentation and discussions after each presentation


CONCLUSION

The Organizing Secretariat is pleased with the results of The 2018 International Workshop on Clinical Pharmacology

of Antiviral Therapy. Most of the participants were impressed by the quality of the scientific content and the interaction

during discussions. The majority also reported that their overall event experience was very good and that they plan to

attend this meeting again next year. Both the evaluation results and the participants’ feedback proved the success and

importance of this meeting.

The Organizing Secretariat will request the Organizing Committee to review the evaluation report and start the preparation

and development of the scientific program for 2019 under the new name of the International Workshop on Clinical

Pharmacology of Hepatitis, HIV & Other Viral Drugs.

ACKNOWLEDGEMENTS

SPONSORS

TITANIUM LEVEL

GOLD LEVEL

SUPPORTER LEVEL

CONTRIBUTOR LEVEL

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