5th BIOPHARM DAY SEMINARBRIDGING EARLY TO LATE PHASE CLINICAL TRIALS, FROM VOLUNTEERS TO PATIENTSOCTOBER 25TH, 2016 – ANTWERP, BELGIUM

VENUE:LINDNER HOTELLANGE KIEVITSTRAAT 125 BE-2018 ANTWERP, BELGIUM

SGS LIFE SCIENCES I 5th ANTWERP BIOPHARM DAY I 2016 2

PROGRAM

REGISTRATION BREAKFAST -

WELCOME AND OPENING SESSION9:00 – 9:30

Jean-Luc Marsat

Managing Director - Clinical Research

SGS

KEY RULES, TIPS AND TRICKS ON MAXIMIZING REGIONAL AND

EUROPEAN R&D FUNDING POSSIBILITIES, GIVEN THE DRUG

DEVELOPMENT PROCESS

9:30 – 9:50

Maarten Van Doorslaer

Consultant

LEYTON

FDA/EMA INSPECTION READINESS - ANTICIPATE AND BE READY

FOR GROWING REGULATORY EXPECTATIONS IN EARLY PHASE

CLINICAL TRIALS

9:50 – 10:10

Annick van Riel

Director

SGS CPU, Antwerpen

SPONSOR/CRO & VENTURE CAPITALIST APPROACHES ABOUT

HOW REGULATORS PERCEIVE THE RISK TODAY FOR A NEW

COMPOUND

10:10 – 10:50

Bruno Speder

Head Clinical Regulatory

Affairs, Head Registration &

Post Marketing

Regulatory Affairs, SGS

Filip Goossens

Senior Business &

Investment Manager

Sopartec

COFFEE BREAK 10:50 – 11:20

PHASE 1 STUDIES: MOVING FROM FIRST DRUG DESIGN OVER

FIRST PRE-CLINICAL DATA INTO FIRST IN HUMAN STUDIES11:20 – 11:40

Patricia De Cock

Head Investigators

CPU and Senior Investigator

SGS

INNOVATIVE HOSPITAL PARTNERSHIP MODEL FOR HIGH

QUALITY PATIENT CLINICAL TRIALS – CENTRAL & EASTERN

EUROPE ONCOLOGY TRIALS CASE STUDY

11:40 – 12:00

Istvan Udvaros

Medical and Project Director

Oncology

SGS

Bela E Toth

CEE Expert,

Senior Consultant for

SGS

SKIPPING PHASE IIB TRIALS – ACCELERATING THE FLU PIPELINE

– PROOF OF EFFICACY FROM HUMAN CHALLENGE TRIALS12:00 – 12:20

Adrian Wildfire

Project Director

Infectious Diseases & Viral Challenge Unit

SGS

NETWORKING LUNCH BREAK 12:20 – 14:00

HOW SMALL/MID SIZED BIOTECH COMPANIES DEVELOP

INNOVATIVE THERAPIES AND WHAT ARE THEIR EXPECTATIONS

FROM A CRO

14:00 – 14:20

Sofia Côrte-Real, PhD

R&D Director

TechnoPhage, SA

RECENT TRENDS & INNOVATIONS IN CLINICAL TRIALS AND THEIR

RELEVANCE IN RESPIRATORY DRUG DEVELOPMENT14:20 – 14:40

Robert Lins

Respiratory Project Director

SGS

HOW MODELING & SIMULATION CAN OPTIMIZE A

CLINICAL TRIAL14:40 – 15:00

Ir. Ruben Faelens,

SGS Scientist - Modeling & Simulation

SGS Exprimo

Q&A AND CLOSING REMARKS 15:00 – 15:30

Jean-Luc Marsat

Managing Director - Clinical Research

SGS

OPTIONAL – TRANSFER AND VISIT OF THE SGS CLINICAL

PHARMACOLOGY UNIT - ANTWERP15:30 – 17:00

Annick van Riel

Director

SGS CPU, Antwerpen

It is a great pleasure to invite you to the 5th SGS Clinical Research seminar. The aim of this scientific meeting is to discuss advances in R&D

biopharmaceutical development and discuss the latest regulatory, early and late phase clinical trials solutions. This one-day event will include a

selection of scientific talks, case studies, and face-to-face meetings with some of our experts and key industry players.

3

ABSTRACT

FDA, EMA and other regulatory agencies routinely perform both announced and unannounced phase I clinical investigator inspections,

in order to verify the accuracy and reliability of data that has been submitted to the agency, and to provide real-time assessment of the

investigator’s conduct of the trial to ensure human safety.

Preparing for a clinical inspection involves making sure that all aspects of your clinical trial are up to code. This includes being able to

provide all required documents that prove that your trial is GCP compliant. A short summary of SGS CPU experience in ensuring site

compliance prior to/during an agency inspection, as well as the importance of conducting site internal quality management will be

presented.

ABSTRACT

Today, regional and European R&D funding possibilities are all around us, although it’s hard to see the wood for the trees. Moreover,

success chances are rather limited. In this seminar, LEYTON BELGIUM will give insights on what parts of the drug development

process could be eligible for funding, in what way, and to what extent. Is getting an R&D grant just a question of luck, or the result of

a well-executed and thoughtful cost benefit analysis? LEYTON BELGIUM is an operational consultancy firm, specialized in obtaining

grants and financial incentives.

SPEAKER ABSTRACTS

SGS LIFE SCIENCES I 5th ANTWERP BIOPHARM DAY I 2016

KEY RULES, TIPS AND TRICKS ON MAXIMIZING REGIONAL AND EUROPEAN R&D FUNDING POSSIBILITIES, GIVEN THE DRUG DEVELOPMENT PROCESS

MAARTEN VAN DOORSLAER

Consultant

LEYTON

FDA/EMA INSPECTION READINESS - ANTICIPATE AND BE READY FOR GROWING REGULATORY EXPECTATIONS IN EARLY PHASE CLINICAL TRIALS

ANNICK VAN RIEL

Director

SGS CPU Antwerp

ABSTRACT

Numerous studies have found that the drug development process is highly expensive and that these costs have trended significantly

upward for decades. Many factors affect the cost of drug development, but two of the basic elements are time and risk.

The development risk, is the likelihood that development of a drug will be terminated early owing to efficacy, safety, or commercial

concerns.

This risk needs to be managed well, both from a scientific and medical perspective, as from a financial point of view. This

presentation will outline how Regulators look at risk and which strategies from sponsors, CROS and venture capitalists are available to

mitigate and manage this risk.

SPONSOR/CRO & VENTURE CAPITALIST APPROACHES ABOUT HOW REGULATORS PERCEIVE THE RISK TODAY FOR A NEW COMPOUND

BRUNO SPEDER

Head Clinical Regulatory Affairs, Head Registration & Post

Marketing Regulatory Affairs

SGS

FILIP GOOSSENS

Senior Business & Investment Manager

Sopartec

4SGS LIFE SCIENCES I 5th ANTWERP BIOPHARM DAY I 2016

ABSTRACT

The biopharmaceutical industry has a growing need for patient trials, even in early phase, to support an early go-no go decision in

compound development. Secured access to the patient population, a professional Clinical Pharmacology Unit environment with

trained and experienced medical professionals, expertise in early phase project management and clinical operations are key factors for

success. To meet this industry demand, SGS has invested in SGS operated patient units located in hospital partners both in Belgium

and Hungary. These centers are also used to build up further cooperation with neighboring early phase sites. SGS staff are involved in

the qualification and tailor-made support of sites to achieve SGS quality and operational requirements. This presentation will present

how this partnership model works and why it is so beneficial for all parties.

INNOVATIVE HOSPITAL PARTNERSHIP MODEL FOR HIGH QUALITY PATIENT CLINICAL TRIALS – CENTRAL & EASTERN EUROPE ONCOLOGY TRIALS CASE STUDY

ISTVAN UDVAROS

Medical and Project Director Oncology

SGS

BELA E TOTH

CEE Expert, Senior Consultant for

SGS

ABSTRACT

Some challenge viruses show evidence of excessive attenuation. Data from challenge trials using such agents may provide poor proof

of efficacy where peak viral loads and mild symptomologies evidence little deviation from baseline. Choosing the optimal challenge

agent is integral to demonstrating the efficacy of new antivirals and vaccines where correlates of protection are lacking or of poor

prognostic value. Newly drifted strains with strong, measurable signs of upper respiratory tract disease make good challenge agents

but care should be taken during manufacture if passage-associated attenuation is to be avoided or minimised. This presentation will

discuss some of the issues associated with objectives and outcomes and how a newly drifted strain can help achieve such aims.

SKIPPING PHASE IIB TRIALS – ACCELERATING THE FLU PIPELINE – PROOF OF EFFICACY FROM HUMAN CHALLENGE TRIALS

ADRIAN WILDFIRE

Project Director - Infectious Diseases & Viral Challenge Unit

SGS

ABSTRACT

The start up and conduct of a phase one study is a process where a lot of aspects need to be taken into consideration such as: the

IMP dose selection to be delivered, how many volunteers are needed, sample size, what kind of a study design will fit best the

objectives? But also what are the potential risks and how can we prevent them? What specific parameters need to be monitored? All

these and more will be tackled in the presentation.

PHASE 1 STUDIES: MOVING FROM FIRST DRUG DESIGN OVER FIRST PRE-CLINICAL DATA INTO FIRST IN HUMAN STUDIES

PATRICIA DE COCK

Head Investigators CPU and Senior Investigator

SGS

5SGS LIFE SCIENCES I 5th ANTWERP BIOPHARM DAY I 2016

ABSTRACT

In July 2016, the FDA published its development targets for 2018-2022. Among its goals, model-informed drug development

and complex innovative design is seen as a key challenge for improving the drug development process. Using statistical and/or

pharmacokinetic/pharmacodynamic (PK/PD) approaches, prior understanding of concentration (dose)-efficacy and of concentration

(dose)-safety relationship can be integrated to ensure the right dose is being studied, for the right indication and in the right patient

population.

This session will feature a case study of model-informed drug development in Early Phase. The key advantages and challenges will be

reviewed, empowering you to detect where model-informed drug development can provide a real benefit to clinical trials, helping you

to reduce development time, cost and late stage failures.

HOW MODELING & SIMULATION CAN OPTIMIZE A CLINICAL TRIAL

IR. RUBEN FAELENS

SGS Scientist

Modeling and Simulation

SGS Exprimo

ABSTRACT

The last 50 years have shown a constant decline in approval rates for new therapeutic compounds across all medicine subspecialties.

Also in developing new respiratory drugs, the ever-rising costs and attrition rate makes it mandatory to increase the performance

of clinical trials. This presentation will cover recent trends & innovations in clinical trials such as : proof-of-concept studies, adaptive

designs through the use of modeling and simulation techniques, the inclusion of targeted patient populations to improve recruitment

with consistent data acquisition through the use of dedicated satellite centres, use of innvovative PD techniques and biomarkers etc.

RECENT TRENDS & INNOVATIONS IN CLINICAL TRIALS AND THEIR RELEVANCE IN RESPIRATORY DRUG DEVELOPMENT

ROBERT LINS

Respiratory Project Director

SGS

ABSTRACT

In today’s pharmaceutical industry where biotech companies account for much of the creativity, innovation and agility, R&D is key to

maintaining this structural asset. This presentation will cover how small/mid sized biotech companies partner with CROs to quickly and

safely develop innovative therapies.

HOW SMALL/MID SIZED BIOTECH COMPANIES DEVELOP INNOVATIVE THERAPIES AND WHAT ARE THEIR EXPECTATIONS FROM A CRO

SOFIA CÔRTE-REAL, PhD

R&D Director

TechnoPhage, SA

6SGS LIFE SCIENCES I 5th ANTWERP BIOPHARM DAY I 2016

VENUE ADDRESS

Lindner Hotel

Lange Kievitstraat 125

BE-2018 Antwerp, Belgium

CONTACT SGS

Wendy Crauwels

Phone: +32 15 40 50 82

E-mail : wendy.crauwels@sgs.com

COST & ACCOMMODATION

The seminar is offered free of charge.

However, only pre-registered attendees

will be admitted.

CONTACT US

REGISTER : www.sgs.com/AntwerpBiopharm2016

ABOUT SGS LIFE SCIENCES

SGS is a leading life science CRO providing clinical research , biologics characterization, biosafety, and quality control testing.

Delivering solutions in Europe and in the US, SGS provides clinical trial management (Phase I to IV) services encompassing clinical

project management and monitoring, data management, biostatistics, medical writing, pharmacovigilance, PK/PD Modeling &

simulations and regulatory consultancy. SGS has its own clinical unit with a total of 88 hospitalization beds in Belgium and has a

wealth of expertise in FIH studies, human viral challenge testing, biosimilar and complex PK/PD trials, as well as other regulatory and

exploratory trials. SGS has a large database of investigators and key opinion leaders with therapeutic focuses in Infectious Disease,

Vaccines, Oncology, and Respiratory.

www.sgs.com/CROwww.linkedin.com/company/sgs-life-sciences

WWW.SGS.COM

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