November 2-3, 2015: New York, New York

Increasing Drug Development Success: Understanding Drug-Disease Interactions Through Quantitative Systems Pharmacology At Roche Pharma Research and Early Development (pRED), finding innovative solutions for unmet medical needs is at the heart of what we do. That’s why we are excited to present this unique symposium designed to unite key global leaders in the field of quantitative systems pharmacology.

Quantitative systems pharmacology is a rapidly growing discipline that incorporates computational modeling and experimental methods to investigate drug action. It has shown great promise in critical components of drug discovery and development, including:

• Enhancing target identification

• Predicting safety and efficacy

• Understanding disease and drug response variability

• Identifying appropriate patient populations

• Characterizing biomarkers of response

• Improving drug development success rates

At this exciting interactive forum, experts from a variety of specialties—including computational methods, mathematical modeling, clinical investigation, and experimental medicine—will come together to explore how to leverage the interfaces of theoretical and experimental pharmacology for ultimately increasing drug development success rates. The symposium is designed to inspire new research directions as thought leaders with various viewpoints collaboratively analyze the connectivities among different disciplines and disease areas to determine the optimal applications of quantitative systems pharmacology.

Attendance will be limited to 100 experts from key disciplines. If you would like to participate, please register your interest at http://tinyurl.com/pREDsymposium. The scientific organizing committee will review all applications and inform you as soon as possible about your application.

Sincerely,

John C. Reed, MD, PhD Richard Peck, MB, FRCPHead, Roche Pharma Research and Early Development Global Head Clinical PharmacologyMember of the Enlarged Corporate Executive Committee Roche Pharma Research and Early Development

Scientific Organizing Committee

Richard Peck, MB, FRCP (chair)pRED, Roche Innovation Center; Basel, Switzerland

Jean-Eric Charoin, PharmDpRED, Roche Innovation Center; Basel, Switzerland

Mark Coles, PhDUniversity of York; York, United Kingdom

Don Mager, PharmD, PhDState University of New York at Buffalo; Buffalo, New York

Franziska Michor, PhDHarvard University; Cambridge, Massachusetts

Alex Phipps, PhDpRED, Roche Innovation Center; Welwyn, United Kingdom

Antje Walz, PhDpRED, Roche Innovation Center; Basel, Switzerland

Increasing Drug Development Success: Understanding Drug-Disease Interactions Through Quantitative Systems Pharmacology November 2-3, 2015: New York, New York

See how you can be part of the movement to enhance the process of drug discovery and development

November 39:00 am to 10:20 am Session 3 (part 1): The challenge of treatment failure and the emergence of resistance

• Modeling immune cell systems, dynamics and response to infection Ronald Germain, MD PhD—National Institute of Allergy and Infectious Diseases; Bethesda, Maryland

• The biological basis of resistance to novel antibiotics Karen Bush, PhD—Indiana University Bloomington; Bloomington, Indiana

10:20 am to 10:40 am Break

10:40 am to noon Session 3 (part 2)

• Network biology approaches to study antibiotic action, bacterial defense mechanisms, and the emergence of resistance James Collins, PhD—Boston University; Boston, Massachusetts

• Antibiotic PK-PD to guide dose and regimen selection for reducing resistance development to antibiotics Elisabet Nielsen, PhD—Uppsala University; Uppsala, Sweden

Noon to 2:00 pm Lunch and posters

2:00 pm to 4:00 pm Session 4: The challenge of treatment failure and the emergence of drug resistance (continued)

• The use of viral kinetic models to select drug combinations and minimize resistance emergence Alan Perelson, PhD—Los Alamos National Laboratory; Los Alamos, New Mexico

• The potential challenge of resistance to immunotherapeutics in the treatment of cancer William Pao, MD, PhD—pRED, Roche Innovation Center; Basel, Switzerland

• Modeling the emergence of resistance to anti-cancer treatments to develop improved treatment regimens Franziska Michor, PhD—Harvard University; Cambridge, Massachusetts

4:00 pm to 4:15 pm Closing remarks

Agenda

November 28:00 am to 8:30 am Introduction

8:30 am to 10:30 am Session 1 (part 1): Modeling biology with mathematics and applying it to drug development

• The application of systems pharmacology to drug discovery and developmentPiet van der Graaf, PhD—Leiden University; Leiden, Netherlands

• Application of QSP in understanding and predicting toxicity or adverse drug eventsBen-Fillippo Krippendorff, PhD—Roche; Basel, Switzerland

• Mathematical models of complex biological systems: making them robust and transparentMark Coles, PhD—University of York; York, United Kingdom

10:30 am to 11:00 am Break

11:00 am to 1:00 pm Session 1 (part 2)

• Network analysis to identify multi-scale mechanisms of drug actionRavi Iyengar, PhD—Mount Sinai Hospital; New York, New York

• Mechanism-based pharmacodynamics: systems biology of anti-cancer drugs Don Mager, PharmD, PhD—State University of New York at Buffalo; Buffalo, New York

• Modelling the immuno-oncology cycle: insights into drug combinations and dose regimen selectionBen Ribba, PhD—Roche; Basel, Switzerland

1:00 pm to 3:00 pm Lunch and poster viewing

3:00 pm to 5:00 pm Session 2: Investigating disease and drug response heterogeneity

• Modelling disease and drug response heterogeneity Philippe Sanseau, PhD—GlaxoSmithKline; Stevenage, United Kingdom

• Multi-scale modelling for temporal patterns in tumor biology: the impact of heterogeneity on temporal dynamics of tumour growth Philip Maini, DPhil—University of Oxford; Oxford, United Kingdom

• A systems approach to investigating drug response variability in rheumatoid arthritis John Isaacs, PhD, FRCP—Newcastle, United Kingdom

5:00 pm to 10:00 pm Evening event

Increasing Drug Development Success: Understanding Drug-Disease Interactions Through Quantitative Systems Pharmacology November 2-3, 2015: New York, New York