Using Biomarkers to Shorten Clinical Development Cycles

With only 2 Weeks to Go, Do Not Miss your Opportunity to Attend the Industry’s Leading Clinical Biomarker Conference

ExL Pharma has developed this intensive 2-Day program which will enable you to learn fundamental aspects of reducing cycle time through novel biomarker tools and strategies.

Join 60+ executives from over 35 leading organizations to discuss and hear future novel biomarker strategies and techniques which are being adopted within early clinical development. The forthcoming Using Biomarkers to Shorten Clinical Development Cycles Conference will provide you with unique take-home examples, case studies and multiple clinical development strategies to assist in shortening clinical phases, reducing costs, increasing approval rate, and time-to-market on your future drug products.

Hear directly from the US FDA on improving clinical drug development and drug approval with biomarkers, focusing on past and recent trends in approval rates, evidence of effectiveness in new population for an approved drug, and understanding why failed or inconclusive biomarker-outcome studies do not necessarily prove problems with biomarkers.

Additionally, do not miss our keynote, Don Berry (MD Anderson) discuss the I-SPY2 case study and approach for incorporating biomarkers into clinical trial designs.

Attend and hear influential examples and strategies, including:

• Effectively using non-invasive biomarkers for early clinical decision making
• Developing proof-of-pharmacology biomarkers
• Biomarkers in early stage CNS clinical drug development
• Oncology biomarker studies within early stage clinical trials
• Examining the challenges of companion diagnostics in pharmaceutical development

Who is attending?

• Abbott Labs
• Adlyfe
• Amgen
• AstraZeneca
• Banyan Biomarkers
• BD Diagnostics
• Biogen Idec
• Boehringer Ingelheim
• Bristol-Myers Squibb
• Celgene
• Clovis Oncology
• COPD Foundation
• Duke Clinical Research Institute
• Endo Pharmaceuticals
• Evotech AG
• FDA
• Huntington Life Sciences
• Janssen Scientific Affairs
• Johnson & Johnson
• John Wayne Cancer Institute
• Lundbeck Research
• MD Anderson Cancer Center
• MedImmune
• Merck & co.
• Millenium Pharmaceuticals
• MorphoSys
• Myriad RBM
• NIH National Cancer Institute
• Novartis Pharmaceuticals
• Pfizer, Inc.
• Plasma Proteome Institute
• Roche Diagnostics
• Sanofi
• Somalogic
• Takeda Pharmaceuticals North America
• USAMRIID
  And many more.

With special thanks to our program advisory members who assisted with program themes and development:

• Raj Bandaru, PhD, Associate Director, Oncology Biometrics and Data
• Management, Novartis Pharmaceuticals
• Rakesh Dixit, PhD, Vice President, Head, Biologics Safety Assessment, Pathology & LAR, MedImmune
• Nicholas C. Dracopoli, PhD, Vice President, Centocor R&D, Johnson & Johnson
• Giora Feuerstein, PhD, CSO and Vice President, Translational Medicine, Adlyfe, Inc.
• Mark Fidock, PhD, Director, Translational Medicine, Clinical Research, Pfizer, Inc.
• Pravin Jadhav, PhD, Team Leader, Division of Pharmacometrics, CDER, FDA
• Andreas Jeromin, PhD, Director, Business Development, Banyan Biomarkers
• John Wagner, PhD, Vice President, Clinical Pharmacology, Merck & Co.
• Terry Walker, PhD, Director, Translational Immunology, Pfizer, Inc.

Why Should you Attend?

1. This conference will assist participants in understanding and teaching novel strategies on how biomarkers can improve early clinical drug development cycle times, and drug approval rates within a series of therapeutic areas.
2. Hear directly from the United States Food and Drug Administration on improving clinical drug development and drug approval with biomarkers, focusing on past and recent trends in approval rates, evidence of effectiveness in new population for an approved drug, and understanding why failed or inconclusive biomarker-outcome studies do not necessarily prove problems with biomarkers.
3. Hear leading examples and case studies from leadging pharmaceutical and biotech companies on early-clinical biomarker development, and biomarker validation and qualification.
4. The program will cover indepth examples regarding both using biomarkers for an accelerated path to proof-of-concept in drug development and developing proof-of-pharmacology biomarkers. This will span on multiple therapeutic areas including Oncology, Respiratory, Inflammation, Immunology, Metabolic and Neurology.
5. Analysis of clinical biomarkers for the study of Alzheimer’s Disease will be presented along with examining biomarkers of brain health, examining diagnostics aspects and safety assessment.