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Novartis Oncology’s David Epstein discusses the growing relevance of diagnostics in drug development. Mr. Epstein credits breakthroughs in biology and bioinformatics with an increased understanding of the genome that will enable developers to do a better job of matching the right drug with the right patient. As head of Novartis Oncology and the company’s new Molecular Diagnostics unit, David Epstein is striving to help the Novartis pipeline move closer to the goal of personalized medicine. Mr. Epstein and Novartis Oncology recognize that molecular diagnostics is becoming an important tool for improving patient outcomes and allowing for more personalized medicines. CAREER Highlights David Epstein is Head of Novartis Oncology and Head of Molecular Diagnostics, Novartis. He has been a permanent attendee of the Executive Committee of Novartis since Dec. 1, 2008. Mr. Epstein launched Novartis Oncology in 2000. Before joining Novartis, Mr. Epstein was an associate in the strategy practice of the consulting firm Booz Allen Hamilton in the United States. He joined Sandoz, a predecessor company of Novartis, in 1989 and held various leadership positions of increasing responsibility for the company, including Chief Operating Officer of Novartis Pharmaceuticals in the United States and head of Novartis Specialty Medicines. He graduated with a B.S. in pharmacy from Rutgers University College of Pharmacy in 1984 and received an MBA in finance and marketing from the Columbia University Graduate School of Business in 1987. In 2004, Mr. Epstein was recognized by the Healthcare Businesswomen’s Association as Honorable Mentor of the Year. Improving Efficiency What were the drivers, internal and external, for the recent launch of Novartis Molecular Diagnostics? Epstein: Because emerging sciences are now playing an important role in driving patient outcomes, we decided to establish a molecular diagnostics unit to develop biomarkers for diagnostic tools, which would allow better patient selection. Internally, we organize our research to focus on molecular pathways that may be shared by various diseases. We have captured a wealth of new targets through the systematic mining of molecular pathways. This approach to research has enabled us to better understand the genetic underpinnings of diseases, and we can create diagnostics out of the markers already being used. We hope molecular diagnostics tools will allow us to improve the efficacy of medicines, more accurately determine dosing and dose schedules, and identify patients who may have negative side effects to treatment. Additionally, we believe that over time, it will become more difficult to achieve regulatory approval without a diagnostic tool that identifies patients appropriate for treatment and optimal outcomes. Drawing on Strengths How closely will the diagnostics unit work with the rest of Novartis’ businesses? Epstein: We will draw on strengths from across Novartis’ research capabilities, including biomedical research, genomics, oncology, and pharma. In the past, the efforts of the biomarker/diagnostics area were fragmented across several areas, such as research, vaccines, pharmaceutical development, and oncology. The new unit brings together these competencies under one umbrella. Our first products are likely to be in the oncology field, as we have the necessary information to create companion diagnostics for many of our targets in oncology. Because cancer is primarily caused by genetic disruption, having the ability to test for these anomalies allows us to create drugs that target the exact problem. By using molecular diagnostics in this way, the right patient can be put on the right therapy, which can enhance treatment outcomes. While our early molecular diagnostics portfolio will be about 50% focused on oncology, we do expect to have diagnostics for all of our therapeutic areas. Diagnostic kits will be developed on the same timeline as our medicines, so the drug and the companion diagnostic can reach the market simultaneously. We also will develop and market stand-alone diagnostics to predict, diagnose, and stage disease, as well as provide treatment information. While the companion diagnostics will often help make our medicines more competitive, these stand-alone diagnostics could well deliver the largest new revenue stream for Novartis. New Technologies What are some of the scientific advances that are making molecular diagnostics possible for the detection and treatment of disease? Epstein: The most relevant scientific advances involve understanding the pathways and biomarkers of disease. In the past, there were very few targeted therapies, because we didn’t fully understand these markers; now we are able to develop a personalized diagnostic kit that helps determine a patient’s exact disease marker and which therapy would best treat him or her. New technologies are also now making it possible to better detect and quantify disrupted genes and their proteins. Furthermore, there have been a host of new technologies beyond the genome — epigenomic, such as methylation, and in vivo, such as fMRI — that have improved our understanding of how medicines work. Additionally, these advances can improve the safety and efficacy of medicines, for example, through optimal dosing.F PharmaVOICE welcomes comments about this article. E-mail us at feedback@pharmavoice.com. New Novartis unit to focus on Next-Generation Medicines David Epstein leads Novartis’ Molecular Diagnostics unit, which was formed in December 2008 to improve the codevelopment of companion diagnostics and drugs. On Dec. 1, 2008, Novartis launched a new healthcare business, Novartis Molecular Diagnostics. The unit focuses on areas that are relevant to the next generation of medicine, such as the identification and validation of novel genes and biomarkers, and advancement of new technologies. Furthermore, the new MDx unit is a critical business to improving patient outcomes and helping Novartis better predict, diagnose, and monitor diseases and therapies. Novartis Molecular Diagnostics is pulling together, under one strategy and structure, diagnostic efforts that have been fragmented across Novartis Institutes for BioMedical Research (NIBR), Pharma, and Oncology to help realize the promise of personalized medicine. According to David Epstein, who leads the unit as well as heads Novartis Oncology, external and cross-company partnerships will be important to the success of the new business. “We will seek to engage in partnerships and acquisitions in areas where it makes sense for our strategy and pipeline,” he says. “For instance, we’ll look to partner with smaller organizations that have particular technologies or areas where we believe we can be of assistance. We are eager to work with diverse partners to realize the potential of this exciting area of scientific discovery and development.” The Molecular Diagnostic unit, colocated in Cambridge, Mass., and Basel, Switzerland, will have specialized diagnostics capabilities responsible for sourcing, developing, registering, and commercializing products across the entire Novartis Group. The unit is expected to address the challenges involved with a move to personalized medicine and achieving advances in targeted therapeutics. “At Novartis we have been at the forefront of this movement; for instance Glivec (Gleevec), our targeted medicine for chronic myeloid leukemia, was developed using a C-KIT expression biomarker,” he says. Genomic biomarkers can play an important role in identifying responders and non-responders, avoiding toxicity, and adjusting the dosage of drugs to optimize their efficacy and safety. Mr. Epstein says there are a lot of potential biomarkers, but more work needs to be done to evaluate and validate these markers. “We can use this knowledge to integrate diagnostics into the clinical development for each drug,” he says. “Additionally, diagnostics have a very different regulatory pathway from therapeutics, so we have to work across functions to ensure that the diagnostic will be available at the same time as the drug’s approval. We will also work to get a seat at the table so that we can positively influence the evolving regulatory requirements and reimbursement environment.” The Novartis Pharmaceuticals clinical pipeline holds a broad stream of about 140 future projects, including both new molecular entities and additional indications or formulations for marketed products. F Novartis Pharma Pipeline: Planned Filings 2009 to 2012 and Beyond AGO178 Depression LBH589 CTCL1 ABF656 Hepatitis C FTY720 Multiple sclerosis RAD001 NET2 Tekturna FDC Hypertension Tasigna GIST3 Tobramycin dry powder inhaler Cystic Fibrosis MFF258 Asthma MFF258 COPD4 EPO906 Ovarian cancer SOM230 Cushing’s disease SBR759 Hyperphosphatemia Certican Liver transplantation Tasigna nd-CML5 Lucentis DME6 Tekturna FDC Hypertension SOM230 NET2 Zometa Adjuvant breast cancer LBH589 Hodgkin‘s lymphoma ASA404 Nonsmall cell lung cancer PTZ601 Hospital bacterial infection PKC412 ASM7 NVA237 COPD4 SMC021 Osteoarthritis SMC021 Osteoporosis QVA149 COPD4 ACZ885 SJIA8 SOM230 Acromegaly Glivec Pulm. arterial hyperten. LCI699 Heart failure ATI355 Spinal cord injury CAD106 Alzheimer’s TKI258 Solid tumors HCD122 Hem. tumors AFQ056 PD-LID9 LCQ908 Type 2 diabetes ACZ885 Rheumatoid arthritis RAD001 Solid tumors Mycograb Meningitis QMF149 COPD4 QMF149 Asthma AEB071 Kidney & heart transpl. NIC002 Smoking cessation QAX028 COPD4 Mycograb Severe fungal infection LCZ696 Heart failure AIN457 Psoriasis BAF312 Multiple sclerosis AEB071 Liver transplantation AEB071 Psoriasis LBH589 Hemat. & solid tumors PKC412 AML10 Notes: 1 Cutaneous T-cell lymphoma 2 Neuroendocrine tumor 3 Gastrointestinal stromal tumor 4 Chronic obstructive pulmonary disease 5 Newly diagnosed chronic myeloid leukemia 6 Diabetic macular edema 7 Aggressive systemic mastocytosis 8 Systemic onset juvenile idiopathic arthritis 9 Parkinson’s disease L-dopa induced dyskinesia 10 Acute myeloid leukemia Source: Novartis. For more information, visit novartis.com.

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