Seminar on FDA: Dr. Caicedo, Johnson & Johnson

Fall 2016 Seminar Series Fall 2016 Seminar Series Department of Biomedical Engineering Wednesday, Nov. 30 @ 3PM in Steinman Hall Rm 402

Patient-centric innovation intersection

Dr. Hugo Caicedo

Janssen-Johnson & Johnson Pharmaceutical R&D

Abstract: The current FDA-based roadmap to drug and product development as well as regulatory decision- making and labeling, is based on four Clinical outcome assessments (COAs): Patient-reported outcome (PRO) measures, Clinician-reported outcome (ClinRO) measures, Observer-reported outcome (ObsRO) measures, and Performance outcome (PerfO) measures. In general, COAs are used to determine whether or not a therapy has demonstrated a net clinical benefit in a disease or health condition, in other words COAs assess safety and efficacy of a therapy. Under these conditions, individuals are subjected to “adequate and well-controlled studies”. The gap, however, is that in real life patients, in their natural environments, are under neither adequate nor well-controlled conditions, which limits both our capacity to understand the patient experience and our ability to develop innovated & targeted healthcare solutions. Additionally, current highly homogeneous and randomized clinical trials (RCTs) do not shed light on patient adherence to those therapies; about 50% of the patients with chronic diseases do not comply with medication therapy. During my presentation, I will talk about how three paradigms (Real World Evidence (RWE), Digital Analytics and Design Thinking) can converge and form a model that I created, the “Patient-centric innovation intersection”, to enable actionable insights for the development of targeted healthcare solutions, with particular focus in Diabetes therapy adherence.

Biosketch: Dr. Hugo Caicedo is a scientist subject matter expert in microfluidics, biomedical engineering and consumer healthcare at Janssen-Johnson & Johnson Pharmaceutical R&D in the Philadelphia area. There, he conducts preclinical research on drug discovery as well as strategic design on healthcare innovation to translate relevant science and technology into high-value partnerships that enable differentiated healthcare solutions. Currently, he is also a scholar trainee at the Corporate Sustainability and Innovation program at Harvard University. Dr. Caicedo holds a B.S in Electronics Engineering from the Universidad del Valle (Cali-Colombia) and a Ph.D. in Biomedical Engineering from the University of Illinois at Chicago (UIC). He was the recipient of MIT, Bogazicy University, Antalya University (Turkey) and UniversitéPierre and Marie Curie (France) pre-doctoral fellowships as well as one Harvard-MIT/HST post-doctoral fellowship. Dr. Caicedo has multiple publications including several peer-reviewed papers, two book chapters and a provisional patent application. Additionally, he has been awarded more than 20 recognition awards including: 2011, Ph.D student, African Colombian of the year in academia; 2012, Mayor’s Civic Merit Medal of Cali given directly by the President of Colombia; 2012, Distinguished PhD Student speaker at the 3rd US-Turkey Advanced Study Institute on Global Healthcare Challenges; 2015, BMES4SUCCESS, highlighted by the US Biomedical Engineering Society, as one of three —and the only member from industry— successful earlier career members in biomedical engineering; and 2016 Honorable Speaker invitation at the Biotechnology World Convention in Sao Paulo, Brazil.