Biography

Rocio Lopez is Director of Early Drug Development at Furiex. Dr. Lopez ensures integration of clinical operations, regulatory, data management, biostatistics, and clinical supplies teams to progress clinical trials. She is also responsible for nonclinical strategy and early product development, identifying required nonclinical pharmacology, pharmacokinetic and toxicology studies for first-in-human studies, proof-of-concept and marketing authorizations. Dr. Lopez manages all aspects of nonclinical studies and ensures nonclinical programs support the intended clinical programs and any manufacturing changes. In addition, she generates and reviews the pharmacology/toxicology sections, final clinical study reports, and integrated summaries of safety and efficacy for marketing applications to global regulatory authorities.

Before her work at Furiex, Dr. Lopez was Associate Director of Preclinical Development for PPD. She provided toxicological assessments for small molecules, biologics and medical devices and performed gap analysis activities on nonclinical programs. Dr. Lopez’s prior work experience also includes positions of increasing responsibility at Erimos Pharmaceuticals, where she was responsible for research, early development and clinical pharmacology. She led the pharmacology team screening novel anticancer, antiviral and anti-inflammatory chemical entities.

Dr. Lopez gained first-hand experience with early product development as a research scientist. She has authored several scientific publications and is an inventor on U.S. and worldwide patents. Her scientific background is in hematology and oncology, but she has experience also in other therapeutic areas, including infectious diseases, inflammatory diseases and dermatology.

 

Biography

Dr. Bradwell is an R&D manager in the Bio Production division of Thermo Fisher Scientific leading a team to develop new chromatography resins for downstream purification. Prior to Thermo Fisher, Dr. Bradwell (f/k/a Dr. Nogueira) conducted postdoctoral research at the Massachusetts Institute of Technology working in collaboration with several departments including Materials Science and Engineering, Chemical Engineering and Biological Engineering. Her focus of work was mainly tailoring the surface of different materials in order to obtain the desired functionality. The projects included layer-by-layer assembly of polymer and nanoparticles to create structural colors, hydrogel microarrays for cell culture, and carbon nanotube microfluidic devices to capture targeted molecules or particles. Technical skills on materials characterization include: scanning electron microscopy (SEM), transmission electron microscopy (TEM), confocal microscopy, elipsometry, profilometry, and contact angle measurements. Other skills developed for surface tailoring include softlithography and photolithography, layer-by-layer deposition, and silanization. During her master and PhD, Dr. Bradwell worked developing biomaterials made of natural sources such as silk fibroin (silk protein) and and chitosan (deacetylation of chitin) hydrogels, films and membranes.

Last name before 2014: Nogueira

Selected publications include:

  • Nogueira, G.M., Banerjee, D., Cohen, R.E., Rubner, M.F. Spray-layer-by-layer assembly can more
    rapidly produce optical-quality multistack heterostructure. MLangmuir, v. 27(12) p.7860-7867, 2011.
  • Nogueira, G.M., Swiston A.J., Beppu, M.M., Rubner, M.F. Anisotropic layer-by-layer deposited chitosan/silk fibroin thin films. Langmuir, v. 26(11), p. 8953-8958, 2010
  • Nogueira, G.M., Weska, R.F., Vieira Jr., W.C., Polakiewicz B., Rodas, A.C.D., Higa O.Z., Beppu M.M. A new method to prepare porous silk fibroin membranes suitable for tissue scaffold applications. Journal of Applied Polymer Science, v. 114 (1), p. 617-623, 2009

Selected patents include:

  • Beppu M. M., Nogueira, G. M., Polakiewicz, B. Process to produce silk fibroin porous membranes-3D scaffolds. INPI – PI 0601975-7, 2007
  • Beppu M.M., Nogueira, G.M., Weska R.F., Maçumoto A.C.G., Char, T.B. Incorporation of chitosan particles and chemically modified chitosan to cellulose paste and paper. INPI – PI0905259-3A2, 2009
  • Nogueira G.M., Banerjee D., Rubner M.F., Cohen R.E. Structural colors having UV reflectance via spray layer-by-layer processing. US Patent 8,313,798 Issued: November 20, 2012
Biography

Dr. Radio is a translational research scientist with expertise in pharmacology and toxicology. Dr. Radio earned his Ph.D. from Duquesne University in the School of Pharmacological Sciences where he evaluated the signal transduction cascade responsible for the differentiation of human stem cells into osteoblasts. Dr. Radio then conducted postdoctoral research at the United States Environmental Protection Agency, where he developed in vitro models of developmental neurotoxicity. He then worked as a senior research and development scientist at Cellumen, developing multiplexed cardiac, hepatic and neuronal toxicity models to identify mechanisms of actions of cellular toxicology. Dr. Radio has since served as the Vice President of Research and Development for a medical device biotechnology company, a laboratory director for a CLIA-approved laboratory specializing in clinical diagnostic testing and taught courses at Duquesne University to PharmD students in both Pharmacology and Toxicology.

Selected publications include:

  • Radio NM. Neurite outgrowth assessment using high content analysis methodology. Methods in Molecular Biology. Humana Press. Stephen Skaper, editor. 2012; 247-260.
  • Sethi S, Radio NM, Kotlarczyk MP, Chen CT, Wei YH, Jockers R, Witt-Enderby PA. Determination of the minimal melatonin exposure required to induce ostebolast differentiation from human mesenchymal stem cells and these effects on downstream signaling pathways. J Pineal Res. 2010;49(3):222-238.
  • Radio NM, Doctor JS, and Witt-Enderby PA. Melatonin enhances alkaline phosphatase activity in differentiating human adult mesenchymal stem cells grown in osteogenic medium via MT2 melatonin receptors and the MEK/ERK (1/2) signaling cascade. J Pineal Res. 2006 May; 40(4): 332-42.
Biography

Dr. Kimmel is Director of New Technology at ALung Technologies, where he leads research and development of novel artificial lung devices, and directs strategic technology planning for the company. Prior to joining ALung, Dr. Kimmel completed PhD and postdoctoral research at the University of Pittsburgh, where he was an NIH Clinical Bioengineering Fellow. Dr. Kimmel’s research focused on blood purification, biomaterials, and computational modeling of medical devices. Dr. Kimmel has extensive experience in the development of extracorporeal devices for the treatment of sepsis, respiratory failure and mechanical circulatory support, whereby he leverages his knowledge and experience in clinical bioengineering to develop novel technologies for unmet clinical needs. Prior to his work at the University of Pittsburgh, Dr. Kimmel developed filtration and purification technologies for the biopharmaceutical industry at Pall Corporation. Dr. Kimmel also maintains an adjunct faculty appointment in the Department of Bioengineering at the University of Pittsburgh.

Biography

Jaime Rivera is a recent PhD graduate from the biological engineering department at MIT. Dr. Rivera specialized in protein engineering strategies for improvement of musculoskeletal regenerative technologies. Most of his thesis efforts were focused on creating bioactive bone grafts using growth factor, substrate-binding fusion proteins that would target early stages of stem and progenitor cell responses (survival and proliferation) for improvement of cell-mediated bone regeneration. He formed part of a multi-project, collaborative team that included faculty, primary care physicians and, orthopedic surgeons from top hospitals and educational institutions within the US. These efforts led to testing these novel grafts in small and mid-size animal models.

During his time at MIT, Jaime also collaborated on various projects that polished his skillset in imaging and polymer synthesis (antimicrobial coatings). He took various lab-centric and hands-on courses at MIT, Harvard Medical School and abroad that focused on biological instrumentation, electron microscopy, biophysical chemistry techniques, micro/nano fabrication and 3D printing, regenerative medicine manufacturing and, genetic analysis on model organisms. He interned at Novartis Vaccines & Diagnostics division working on production of influenza virus vaccine during the H1N1 pandemic of 2009 and has consulted for ABR-HealthCo in the past, working on a project related to a renown polymer therapeutic.

 

Biography

Dr. Farraro is a post-doctoral researcher at the Musculoskeletal Research Center (MSRC) at the University of Pittsburgh. Her research focuses on the development of novel resorbable devices for the regeneration of injured ligaments and tendons. During her time as a Ph.D. student, she gained an interest in the clinical translation and commercialization of academic research, which she explored further through coursework and numerous elevator and business plan competitions using her Ph.D. work, called “LigaMend.” Katie and her team won first place at the McGowan Institute for Regenerative Medicine’s Perfect Pitch Competition (2013), Randall Family Big Idea Competition (2014), and Health 2.0: The Winner’s Circle Pitch Competition (2014). In 2015, she also led the “LigaMend” team to be selected for funding from the Coulter Translational Research Partners II Program. She has also served as a consultant for Fourth River Solutions (4RS).