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2 July/August 2013 � PharmaVOICE

The Entrepreneurs

tatistical thinking will one day be asnecessary for efficient citizenship as theability to read and write.” This quote

from widely respected statistician SamuelWilks paraphrasing H.G. Wells resonatestoday in biomedical research, particularlywhen affected by truly innovative biostatisti-cians, such as Marc Buyse, Sc.D.Dr. Buyse demonstrates the true value of

statistics in medical research. He is the founderof CluePoints Inc., a company that specializesin central statistical monitoring of clinical tri-als and a subsidiary of the International DrugDevelopment Institute (IDDI). He is also thechairman of IDDI Consultants at the IDDI inHouston, and associate professor of biostatis-tics at the Universiteit Hasselt, Belgium.CluePoints has developed an intelligent

statistical approach — SMART — for an op-timal approach to targeted monitoring and re-duced source data verification (SDV). TheSMART (Statistical Monitoring Applied toResearch Trials) engine — the brainchild ofDr. Buyse is a software solution — patentpending in the U.S. — that allows researchersto assess the quality and integrity of clinicaltrial data. The goal is to provide statisticalmonitoring with an ability to detect the het-erogeneity in the data throughout investiga-tional centers and to create a “quality label” forthese centers.

Dr. Marc BUYSE

Dr. Marc Buyse has successfullylaunched many of his statisticalideas through the creation of companies and hiring young and talented people.

rogate endpoints, and drug development inoncology. Furthermore, he has successfully launched

some of his ideas through the creation of com-panies hiring by young and talented people.Dr. Buyse was president of the International

Society for Clinical Biostatistics, president ofthe Quetelet Society, and Fellow of the Societyfor Clinical Trials. He worked at the EORTC(European Organization for Research and Treat-ment of Cancer) in Brussels and at the Dana-Farber Cancer Institute in Boston before found-ing IDDI in 1991. He currently serves on theeditorial board of the journals Cancer Investiga-tion, Clinical Trials, Biometrical Journal, Jour-nal of Clinical Oncology, Statistical Methods inMedical Research, and Statistics in Biopharma-ceutical Research. He has degrees in engineer-ing and statistics from Brussels University,management from the Cranfield School of Man-agement (UK), and a doctorate in biostatisticsfrom Harvard University. PV

Savvy Statistician

S

SMART has the ability to drive intelligentonsite monitoring strategies that will result insignificant cost and resource savings; improvethe quality and integrity of data; and reduceregulatory submission risk. The engine com-prises a comprehensive range of inter-connectedstatistical tests that make no distributional as-sumptions about the clinical data but, when ag-gregated together, highlight difficult-to-detectissues in the data from specific centers. Despite his high level of statistical knowl-

edge, Dr. Buyse is always able to explainthings in easy-to-understand terms and takesthe time to educate those he is working with.Open-minded and curious about new ways

of applying statistical theory to real-worldproblems, Dr Buyse has worked over the last10 years on demonstrating the role of surro-gate outcome measures in clinical research.Recently, he served as principal statistical ad-visor to the National Cancer Institute ofFrance. In this position, he was able to advancethe practice of oncology clinical trials on an in-ternational basis.Today’s clinical research environment owes

a great deal to biostatistics and bioinformat-ics. The pressures on companies mean there isa need to determine efficacy and risk early inthe development process. This is made possi-ble through the use of biomarkers and surro-gate endpoints; the ability to conduct interimanalyses and adaptations whenever possible;and a focus on endpoints that combine clini-cal relevance and statistical sensitivity. Dr. Buyse also proposed a new method of

analysis that is useful when interest focuses onmultiple, prioritized outcomes. The outcomescan be of any type, such as binary responses,times to event, or even repeated measurementsover time. The method is fully non-parametricand leads to a universal measure of treatmenteffect. He has published extensively in the fields

of clinical trial methodology, meta-analysis,statistical detection of fraud, validation of sur-

OPEN

-MINDED

.DIDACTIC.

Driven to innovate by

POSSIBILITIES

TITLES AND COMPANIES: Founder, CluePoints Inc.and Founder, International Drug DevelopmentInstitute (IDDI)

EDUCATION: Eng, MSc, Statistics, Université librede Bruxelles; MBA, Cranfield School of Management; Sc.D., Harvard University

ASSOCIATIONS: International Society for ClinicalBiostatistics, Quetelet Society, Society for ClinicalTrials, Drug Information Association, AmericanStatistical Association, American Society for Clinical Oncology, American Association for Cancer Research

SOCIAL MEDIA:

Getting to Know...

Marc Buyse

3PharmaVOICE � July/August 2013

PUBLISHER Lisa BanketEDITOR Taren Grom

CREATIVE DIRECTOR Marah Walsh

MANAGING EDITORDenise Myshko

SENIOR EDITORRobin Robinson

FEATURES EDITORKim Ribbink

DESIGN ASSOCIATEAriel Medel

NATIONAL ACCOUNT MANAGERSTrish KaneCathy Tracy

WEBCAST NETWORK PRODUCERDaniel Limbach

CIRCULATION ASSISTANTKathy Deiuliis

Copyright 2013by PharmaLinx LLC, Titusville, NJ

Printed in the U.S.A.Volume Thirteen, Number Seven

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Letters...

Printed on recycled paper

THE FORUM FOR THE INDUSTRY EXECUTIVE

Volume 13 • Number 7

Their Word...

DENISE MYSHKO

Managing Editor

The PharmaVOICE 100

are hopeful the future

will bring

breakthroughs in many

areas, including HIV, cancer,

neglected diseases, stem cell

research, biomarkers, and

epigenetics.

ROBIN ROBINSON

Senior Editor

This year's group of

PV100 honorees are

prime examples of how

great leaders improve

the world around them through

passion, courage, innovation,

and caring.

KIM RIBBINK

Features Editor

As so many of our PV100

nominees put it,

motivation comes from

within. Each one of

these individuals personifies

that in every way.

COMINGin September> Behavioral Economics: Measuring

Outcomes>Closing the Loop on Marketing> ePatient Recruitment>Where Have All the Investigators

Gone>Global Regulatory Issues>The C-Suite: Digital Marketing>Market Sector: South Korea> Showcase Feature: Marketing

tgrom@pharmavoice.com

Taren GromEditor

Regards,

the 2013 PharmavoiCe 100EACH YEAR WE HAVE THE PRIVILEGE OF SHOWCASING 100 OF THE MOST INSPIRING AND MOTIVATIONAL INDIVIDUALS THROUGHOUT THE LIFE-SCIENCES INDUSTRY.

This special issue, now in its ninth year, once again showcases theindividuals as identified by you, our readers, for being outstandingleaders, providing inspiration and motivation to their teams, peers,and companies; innovators, creating new opportunities and visionary

products and companies to address the future ofhealthcare; and philanthropists, giving back per-sonally and through their companies to local, na-tional, and global organizations that providegoods and services to communities and patientsin need.This year, we asked our leaders to identify in

one word what drives them to innovate. We alsoasked them to provide the two adjectives that bestdescribe them. Their answers provide interestinginsights into their personalities and leadership

styles. We also asked our honorees to identify what they believe will bethe biggest breakthroughs in the industry and in their sphere of influ-ence in the next five years; what their hope is for the future of health-care; what they believe are the biggest challenge(s) facing the industrytoday; their view on the importance of mentoring; and how social mediais changing how they work. Their insights are compiled in several in-formative and exciting articles that can only be found online in ourbonus content; so please log into this month’s issue on www.phar-mavoice.com to read more perspectives from our PharmaVOICE 100honorees. This year’s honorees represent the broadest span of the healthcare and

life-sciences industry to date. We have honorees from consumer pack-aged goods to research foundations to academia, government agencies,big pharma, small pharma, biotech, emerging biotech, consultancies,advertising agencies, technology companies, contract research organiza-tions, etc. This broad and far-reaching representation is a clear indicatorof the ever-expanding ecosystem of the healthcare industry.To navigate this special publication, which has become known as the

feel-good issue of the year, we have divided the honorees into categoriesthat we believe best capture their expertise, which is no easy feat as eachof this year’s honorees could easily fit into several of the following sec-tions: commanders and chiefs, entrepreneurs, change agents, clinical spe-cialists, researchers and scientists, marketers, patient advocates, mentors,and technologists.With thousands of nominations to consider, our editorial team relies

on the personal accounts from our readers that describe why these indi-viduals are special. So we thank all of you who took time out of your busyschedules to nominate the individuals who have made, and continue tomake, a difference in your careers, lives, and organizations. We also wantto thank all of our PharmaVOICE 100 honorees for taking the time toshare their personal stories with us. Please join us in extending warmcongratulations to our esteemed group. I hope you enjoy getting toknow them as much as we did.

Letter from the Editor