Brought to you by the San Diego Clinical Research Network
Program Summary. One of the major challenges of the pharmaceutical industry is to improve R&D productivity. Although pharma companies continue to increase their investments into R&D, the number of drugs gaining approval is in decline. More than $100 billion is spent each year on biomedical research, with clinical trials representing 40% of the R&D budget of the industry. Three San Diego physician scientists and thought leaders in national leadership roles will share their vision, passion, and activities to transform industry practices in drug discovery and development. Marcos Milla, Ph.D. will discuss innovations in drug discovery, with a focus on phenotypic drug discovery and the application of omics technologies to this problem, both for disease profiling and monitoring of drug action. Andreas Koester, M.D., Ph.D., VP of Clinical Trial Innovation at Janssen and an industry thought leader in modernizing clinical trials, will present visions of a more efficient clinical trial process, including novel technologies and processes, and industry collaborative initiatives including TransCelerate. Steven Steinhubl, M.D., Director of Digital Medicine and thought leader on integrating mHealth into clinical practice, will discuss mobile health technologies as a tool that may be used to “creatively disrupt” the current clinical trial paradigm.
Marcos Milla, Ph.D., Scientific Director and Fellow. Janssen, Pharmaceutical Companies of Johnson & Johnson, La Jolla, CA. Immunology Discovery, Janssen Research & Development
Andreas Koester, M.D., Ph.D., VP Clinical Trial Innovation & External Alliances. Janssen, Pharmaceutical Companies of Johnson & Johnson, La Jolla, CA
Steven Steinhubl, M.D., Director of Digital Medicine at Scripps Translational Science Institute. Cardiologist, Scripps Health, Scripps Clinic, San Diego, CA
Who Should Attend. Individuals in the life science and healthcare industries in pre-clinical
roles, clinical research, patient care, and executive management.
5:00-6:00 p.m. Food, drink, networking
6:00-7:00 p.m. Presentations
7:00-7:30 p.m. Questions, Discussion
7:30-8:00 p.m. Dessert, drink
SPONSORSHIP OPPORTUNITIES AVAILABLE
Contact Teresa Gallagher firstname.lastname@example.org
Searching for Drugs (and Patients) by Phenotypes
Marcos Milla, Ph.D.
At the molecular level, diseases represent a constellation of linked “epicenters”, corresponding to common mechanisms of etiology and pathology. A paradigm in drug discovery based on the identification and targeting of single gene products (receptors, enzymes, ion channels and other classes) has proven difficult for addressing the multi-modality of most common diseases.
Advances in our ability to monitor cellular behavior with biosensors and high content imaging, coupled to powerful “omic” methods, are allowing us to profile disease markers and drug action in a holistic fashion, at unprecedented resolution. A brief overview of some of these approaches, with special focus on a novel metabolomic platform, will attempt to portray opportunities for the exploration of patient heterogeneity and drug polypharmacology in the phenotypic space, and challenges ahead.
Clinical Trial Innovation and Cross-Pharma Cooperation to
Bring Medicines to Patients Faster
Andreas Koester, M.D., Ph.D.
The way that clinical trials are conducted has remained largely the same for the last 20 years, and the pharmaceutical industry is undergoing a transformation powered by novel technologies and industry cooperation. There have been many exciting technology innovations including an electronic consent process that improves patient engagement and smart medication packages that increase patient adherence. Cross-pharma collaborations have been established for major companies to work as an industry to simplify and accelerate the delivery of innovative medicines to patients. Most notable is TransCelerate BioPharma Inc. which now has 18 member companies and growing.
Moving the Mountain: Bringing Clinical Trials to the Patient
Steven Steinhubl, M.D.
Over 90% of drug development costs are spent on the Phase 3 clinical trial. Over the last decade the average length of clinical trials has increased by 70%, staff work burden by 67% and number of procedures by 65%, whereas enrollment and retention rates have decreased by 21% and 30%, respectively. In the routine management of clinical trials patients come to study centers multiple times over the duration of a study for routine follow-up visits,, testing, etc… For this reason site payments, monitoring and data management account for well over half of the cost of clinical trials.
What if the clinical trial could come to the patient? Mobile health technologies provide the mechanism necessary to “creatively disrupt” the clinical trial paradigm. Their broad implementation would allow for the development of more pragmatic, substantially less costly, and more convenient clinical trials while capturing more patient-centric, real-world and individualized outcome data.
Marcos Milla, Ph.D.
Marcos Milla is a native of Lima, Peru. He graduated with a Bachelor’s degree in Biology from Universidad Peruana Cayetano Heredia, Lima, Peru in 1985. He obtained his PhD degree in Cell & Molecular Biology from Saint Louis University under the direction of Carlos Hirschberg, working on the mechanism of protein glycosylation in the secretory pathway. He then became a Jane Coffin Childs Postdoctoral Fellow at the Massachusetts Institute of Technology, working under the supervision of Robert Sauer. He used the phage P22 repressor as a model to dissect how the sequence of a protein determines its folding kinetics, thermodynamic stability, DNA binding and repressor function. Then he did a short second postdoctoral training at Duke University, working with Christian Raetz on the biosynthetic pathway of bacterial lipopolysaccharide lipid A.
As an independent scientist, he worked first for at GlaxoSmithKline, on the discovery of the TNF-alpha converting enzyme (TACE) and cloning of its cDNA. After that, he joined the Faculty of the Department of Biochemistry and Biophysics of University of Pennsylvania, keeping a focus on TNF biology, proteases and protein-protein interactions. In 2005 he returned to pharmaceutical industry, joining Roche Pharmaceuticals, where he led efforts in support of multiple projects in the areas of immunology and neurosciences. Since joining Janssen Pharmaceutical Research & Development in 2009 in La Jolla, he led projects within the Immunology Therapeutic Area in early validation, lead discovery and optimization stages. He is now leading exploratory research focusing on protein-protein interactions, and the application of phenotypic approaches to the deconvolution of small molecule pharmacology.
Andreas Koester, M.D., Ph.D.
Andreas Koester has more than 20 years of R&D experience working for pharmaceutical companies and CROs. As head of Clinical Trial Innovation at Janssen Research & Development, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, he is leading the company’s efforts to enhance and optimize the pharmaceutical clinical trial process. Andreas is passionate about pre-competitive cooperation initiatives between pharma companies, e.g. as contributor to Transcelerate Biopharma and co-creator of the Investigator Databank launched in collaboration with Merck and Eli Lilly & Co., to reduce the administrative burden for investigators and making the site selection and start up process more streamlined. Within J&J, he is leading efforts to develop novel tools and technologies that have the potential to transform the clinical trials process and bring medical innovations faster to the patients who need them.
His background is in drug development, spanning first in human, proof of concept and large registration trials. He worked in leadership roles for trials that led to approvals of Prezista®, Intelence® and Reminyl®. Andreas is a graduate of Leipzig Medical School and earned his Ph.D. in Clinical Pharmacology from Humboldt University in Berlin.
Steven Steinhubl, M.D.
Dr. Steinhubl is the Director of Digital Medicine at Scripps Translational Science Institute (STSI) and a cardiologist at Scripps Health, Scripps Clinic. He received his undergraduate training in chemical engineering at Purdue University in Indiana, graduate training in physiology at Georgetown University in Washington, DC, and his medical degree at St. Louis University in Missouri. Steve’s internal medicine residency training was completed at David Grant Medical Center at Travis Air Force Base, California. Following residency, he was a staff internist at Elmendorf Air Force Base Hospital in Anchorage, Alaska. His cardiology and interventional cardiology fellowships were at the Cleveland Clinic Foundation where he was also Chief Cardiology Fellow. Prior to joining Scripps Steve was the Director of Cardiovascular Wellness and the Medical Director for Employee Wellness for the Geisinger Healthcare System. He was also the Cardiology Fellowship Director, a clinician-scientist and a staff cardiologist there.
In the past, beyond his time in the Air Force, Steve has also been a Global Medical Vice-President for The Medicines Company based in Zurich Switzerland and the Director of Cardiovascular Education and Clinical Research at the University of Kentucky in Lexington. Dr Steinhubl’s research activities have covered a broad range of topics in cardiology with a primary early focus on trials of novel antithrombotic therapies for the treatment and prevention of cardiovascular disease, and more recently on the application of an integrated systems-based approach to the optimal identification, communication and treatment of an individual’s risk for various manifestations of cardiovascular disease. He has been principal investigator or helped lead over a dozen large-scale, international randomized trials and has authored nearly 200 peer-reviewed manuscripts as well as numerous book chapters, and abstracts.