Pharma Industry and Medical Devices

Claudio Cerati has completed his degree in Pharmaceutical Sciences at the age of 24 in the University of Buenos Aires (Argentina) and post graduate studies in Pharmaceutical Industry from the same university.He has a huge experience in the pharmaceutical industry with more than 35 years of working experience leading projects in pharma both in Argentina, Brazil, Colombia and Costa Rica, He is director of Polymicrocaps , a technology company devoted to drug dissolution and permeability.

Director
Polymicrocaps
South America

Dr. Jerzy Leszek is full professor of psychiatry at the Medical University in Wroclaw, Poland, vice-director of the Psychiatry Department and head of Alzheimer’s Disease Laboratory. He is author and co-author more than 210 papers(especially from age psychiatry), a lot of chapters to the books published in reputed Polish and international journals and serving as an editorial board member of several journals.He is Scientific Editor and co-author of first Polish academic handbook on Alzheimer’s disease and twenty another academic books from psychogeriatry published in Poland, European countries and in USA. He is member a lot of scientific associations eg. Funder and president of Lower Silesian Association of Families, first of its kind in Poland and Former Member of Board of Directions of International Psychogeriatric Association(IPA).

Professor
Wroclaw Medical University
Poland

Dr. Mohseni received her PhD in Cell Biology from the University of Kiel in Germany, as well as a MS degree in Developmental Biology and a BS degree in Zoology from Shahid Beheshti University in Iran. Dr. Mohseni started her research in the field of antibody engineering, therapeutic development and drug discovery for cancer treatment in the Department of Pathology at the University hospital in Kiel, Germany. She continued her research in the division of Stem Cell Transplantation and Immunotherapy in a prominent antibody engineering lab while receiving her PhD from the University of Kiel in 2011. Her main research focus was to “Improve Antibody-Dependent Cell-Mediated Cytotoxicity of Affinity Maturated and Fc-engineered Antibodies Directed against the Acute Myeloid Leukemia Stem Cell Antigen CD96“. After finishing her PhD she had the opportunity to continue her research in antibody engineering at the UT Southwestern Medical Center in Dallas, Texas. In 2013 she finalized her postdoctoral training and began working as a research scientist in antibody engineering at A & G pharmaceutical in Maryland. Today Dr. Mohseni has commenced with a new position as a senior scientist at Xen Biofluidx in San Diego, CA.

Senior Scientist
Xen Biofluidx
California, USA

Dr. Noreddin received his Ph.D. in Pharmaceutical Sciences from the University of the Pacific, California and received research training as a visiting scholar at the Department of Medicine, Stanford University. He had postdoctoral fellowship (Pharmacokinetics and Pharmacodynamics of Antimicrobials), Department of Medical Microbiology, University of Manitoba followed by an American College of Clinical Pharmacy postdoctoral fellowship (Infectious Diseases). Dr. Noreddin’s research interest includes Pharmacoklinetic/Pharmacodynamic modeling of anti-infective and anti-cancer therapy, clinical simulation and Monte Carlo analysis and bacterial resistance in biofilm studies. Dr. Noreddin has outstanding records of scientific and academic accomplishments with multiple research funding, numerous publications in highly prestigious journals and various presentations in both national and international conferences. He served as a scientific reviewer for the NIH as well as other national and international research institutions. Research Interests: • Pharmacoklinetic/Pharmacodynamic modeling of anti-infective and anti-cancer therapy • Clinical simulation and Monte Carlo analysis • Bacterial resistance in biofilm studies • Minority health care studies Research Focus • Anti-infective translational research in relation to antimicrobial resistance: Our goal is to improve patient care by maximizing clinical outcomes and preventing the development of bacterial resistance. • Anti-Cancer translational research in relation to 3D modeling and epigenetic studies: Our goal is to optimize cancer chemotherapy and overcome/reverse the development of resistance

Research Interests: • Pharmacoklinetic/Pharmacodynamic modeling of anti-infective and anti-cancer therapy • Clinical simulation and Monte Carlo analysis • Bacterial resistance in biofilm studies • Minority health care studies Research Focus • Anti-infective translational research in relation to antimicrobial resistance: Our goal is to improve patient care by maximizing clinical outcomes and preventing the development of bacterial resistance. • Anti-Cancer translational research in relation to 3D modeling and epigenetic studies: Our goal is to optimize cancer chemotherapy and overcome/reverse the development of resistance

Dr. Afouna received his Ph.D. in Pharmaceutics & Pharma. Tech., University of Utah, Salt Lake City, UT, USA & Al-Azhar University, Egypt. He spent up to 3-years as a post-doctoral & research scientist at Department of Pharmaceutical Sciences, College of Pharmacy, University of Arkansas of Medical Sciences (UAMS), Little Rock, AR, USA. He is a highly motivated scientist (teacher, researcher) with extensive expertise in development and optimization of nanoemulsion, nanosuspension, gel/hydrogel & self-nanoemulsifying transdermal, topical, ocular & oral drug delivery systems. Focusing upon development of effective, safe and stable anti-glaucoma, anti-diabetic, hypolipidimic, and antihypertension drugs with great emphasize upon the effects of absorption promoters and other formulation-related factors, the physicochemical properties and chirality, upon the pharmacokinetics and biopharmaceutics of the drug. Moreover, he has focused upon development of non-clinical methodologies to assessing the topical bio-efficacy of various antiviral agents. Dr. Afouna has outstanding teaching capabilities & research experiences in pharmaceutical sciences, development and management of several valuable scientific research projects. He has orally presented many of his work in various inter/national meetings. Furthermore, he has authored & coauthored numerous recent research articles, review articles and chapters of books and textbooks. He is a co-founder College of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia where he worked as Professor for more than 6-years. Currently, Dr. Afouna is the professor & chairman of department of pharmaceutics & pharmaceutical technology, college of pharmacy, Al-Azhar University, Nasr City, Cairo, Egypt, 2012 – Present.

development and optimization of nanoemulsion, nanosuspension, gel/hydrogel & self-nanoemulsifying transdermal, topical, ocular & oral drug delivery systems. Focusing upon development of effective, safe and stable anti-glaucoma, anti-diabetic, hypolipidimic, and antihypertension drugs with great emphasize upon the effects of absorption promoters and other formulation-related factors, the physicochemical properties and chirality, upon the pharmacokinetics and biopharmaceutics of the drug.

George Perry is dean of the College of Sciences and the Semmes Foundation Distinguished Chair in Neurobiology at The University of Texas at San Antonio. Perry is recognized in the field of Alzheimer’s disease research particularly for his work on oxidative metabolism. He is distinguished as one of the top Alzheimer’s disease researchers with over 1,000 publications, and one of the top 100 most-cited scientists in neuroscience and behavior, as well as an Expertscape Leading Expert in Alzheimer’s disease. Perry serves as editor for numerous journals and is editor-in-chief for the Journal of Alzheimer's Disease. He is a fellow of the American Association for the Advancement of Sciences, the Microscopy Society of America, a Fulbright Senior Specialist, as well as a member of the Dana Alliance for Brain Initiatives. Perry is also recognized internationally: he is a Foreign Member of the Spanish Royal Academy of Sciences, the Academy of Science Lisbon, and the Mexican National Academy of Sciences. He is also a recipient of the National Plaque of Honor from the Republic of Panama Ministry of Science and Technology.

Dean & Chair
University of Texas at San Antonio
USA

Prof Dhanjay Jhurry received his PhD in Polymer Chemistry in 1992 from Bordeaux-1 University (France), where he also completed his B.Sc. and M.Sc. Degree in Chemistry. After spending three years as Research Chemist at Flamel Technologies Co. (Lyon in France), he joined the Dept. of Chemistry at the University of Mauritius as Lecturer and was appointed Professor in 2005. He currently holds the position of National Research Chair in Biomaterials and Drug Delivery and also heads the Centre for Biomedical and Biomaterials Research (CBBR) at the University of Mauritius. Prof Jhurry worked on sucrose-based polymers for his PhD and has had a keen interest in the area of biodegradable and biomedical polymers. His mainstream research currently focus on tailoring polymers for use as nanoscaffolds in tissue engineering applications and nanocarriers for controlled drug delivery.

Professor and Chair
University of Mauritius
Mauritius

Dr. Eyal S. Ron has over 25 years of experience in the development of drugs, biomaterials and drug delivery systems. He has a record of accomplishments for the creation of effective infrastructure for growth. Dr. Ron is effective in combining science, regulatory polices with innovative business strategies. He has in-depth understanding of total development process including project management, clinical trials, regulatory, formulation, drug delivery, QC and manufacturing scale-up. Dr. Ron has contributed to the formation of Cerebrotec, Combinent Biomedical Systems, eNOS Pharmaceuticals, Focal, GelMed/Gel Sciences, Gelesis, InfiMed, Palmetto Pharmaceuticals, Pharmedica and Sensei Biomaterials. Additionally, Dr. Ron is serving on the board of AcuityBio, Sensei Biomaterials and Pharmedica and serves as a Scientific Advisory Board Member for other companies.

CTO
Gelesis
USA

Michael Zhou, PhD has been associated with life science industries (biotech, biopharma, pharma, etc.) for over 24 years of his career span. He has held various positions with increasing responsibilities for analytical and bioanalytical R&D, clinical operation, and quality control process (CMC, etc.) in support of drug/product R&D and clinical / manufacturing programs under GxP compliance. His career has focused on analytical and bioanalytical method development, validation and transfer for APIs, DSs, and DPs (different dosage forms) and for nonclinical and clinical studies with expertise in regulatory compliance such as GLP, GCP, GCLP, cGMP regulations (or GxPs), EMA, ICH, AMV and BMV guidelines, along with USP standards and ISO certification. He has developed numerous methodologies for potency, stability indicating, degradents, impurities, etc. assays including qualification, validation, transfer and so on. He has been actively involved in laboratory OOS investigations and CAPA remediation processes, and provided training to laboratory personnel on laboratory investigations and reporting. He has also been an important contributor to process quality control, tech transfer, manufacturing, and supplier quality investigations. His experience in developing and executing stability study protocols at both the development and product manufacturing stages has resulted in development of improved packaging of API and various pharmaceutical dosage forms. He is also very knowledgeable in equipment, methods, process qualification, validation and other related quality processes and systems to meet GxPs requirements and compliance. During his career tenure, he has gone through a few FDA audits with great success. He has worked on resolving regulatory compliance issues (FDA Warning Letters and Consent Decrees) with great credentials. He has managed and built excellent quality systems (GxPs) with Six Sigma process excellence and Lean operation. He has gained a great deal of experiences in management (functional and operational aspects), technical and regulatory compliance expertise from global perspectives since 1988. He has been actively involved in organizing conferences, speaking at presentations and sharing his knowledge at workshops for numerous national and international proceedings as Keynote Speakers, Invited Speakers, workshop and short course leaders.

Senior Associate
Lachman Consulting Services
United States

Dr Zhou is presently a Professor, Associate Vice President of Global Medical Development, Associate Dean of International Research, and Chair of the Department of Pharmaceutical Sciences, College of Pharmacy & Morsani College of Medicine, University of South Florida, Tampa, Florida 33612. Professor Zhou completed his clinical medical training in China in 1989 and obtained his PhD in 2001 from the Faculty of Medicine and Health Sciences, the University of Auckland, Auckland, New Zealand. He continued his postdoctoral training at the University of Auckland until November 2002. Since 2002, Dr Zhou has served as a faculty member for the National University of Singapore, Queensland University of Technology (Australia), RMIT University (Australia), and now University of South Florida. Dr Zhou’s major research interests are drug discovery/systems pharmacology, drug metabolism/drug transport & pharmacokinetics, pharmacogenomics/pharmacogenetics, nanomedicine and Chinese medicine. Professor Zhou has published more than 330 peer-reviewed papers in various pharmacology and medical journals including New England Journal of Medicine, Cancer Research, Journal of Biological Chemistry, Clinical Pharmacology and Therapeutics, Carcinogenesis, JPET, Drug Metabolism & Disposition, and Clinical Cancer Research. He has also published 16 books and book chapters and more than 310 conference abstracts.

Chair & Professor
University of South Florida
USA

Christophe Serra was born in 1968 and graduated in 1992 from the Engineering School of Chemical Engineering (ENSIC) in Nancy (France).He received his Ph.D. in 1996 from the University Paul Sabatier in Toulouse (France) with a work on “Hollow-fibre dead-end ultrafiltration: module design and process simulation in water treatment”Since 1998, he has been a faculty member of the University of Strasbourg (France) teaching chemical engineering at the European Engineering School of Chemistry, Polymers and Materials Science (ECPM). His researches concern the development of new microfluidic-assisted polymer processes for the synthesis of architecture-controlled polymers and functional microstructured polymer particles. In 2009 he took the head of the Group for the Intensification and Integration of Polymer Processes (G2IP) within the Laboratory of Polymer Engineering for High Technologies (LIPHT) and then within the Institute of Chemistry and Processes for Energy, Environment and Health (ICPEES). In 2010 he was appointed Full Professor at the University of Strasbourg. In 2014 he moved to Charles Sadron Institute (ICS) to join the group of Precision Macromolecular Chemistry.

Professor
University of Strasbourg
France

Dr. Csaba Hetenyi is a Research Associate Professor, a Qualified Chemist, and a PhD in Pharmacy. He has co-authored research articles in prestigious journals such as J Am Chem Soc, EMBO Reports, FASEB J, etc., and is also a co-inventor of three US patents. Dr. Hetenyi has already received more than one thousand citations for his research results and his works were favorably evaluated by several review articles. In 2011, Dr. Hetenyi won a Talentum Academy Award of 20000 EUR for his research achievements. His primary interest is focused on chemical biophysics, computational and medicinal chemistry, structural bioinformatics, molecular pathomechanisms of diseases, and he has also contributed to publications in the fields of chromatography and capillary electrophoresis. At present, Dr. Hetenyi works in Hungary with three PhD and two BSc students.

Research Associate Professor
Hungarian Academy of Sciences
Hungary

Ahmed S Zidan Ph.D., is an associate professor of Pharmaceutics and Industrial Pharmacy in Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy at both King Abdulaziz University, Jeddah, Saudi Arabia and Zagazig University, Zagazig, Egypt. Prior to joining King Abdulaziz University in 2012, Dr. Zidan was a postdoc fellow at Division of Product Quality Research in the Center for Drug Evaluation and Research (CDER) in FDA, USA. He has earned his Ph.D. degree in Pharmaceutics from the Zagazig University faculty of Pharmacy in 2007 through a scientific mission at School of Pharmacy, Howard University, Washington DC, USA. He has published over 46 peer-reviewed manuscripts, 2 book chapters, and has been invited to give different presentations locally and internationally. Dr. Zidan’s research focuses primarily in the area drug formulations design and development of challenging vectors for drug delivery. It encompasses pediatric dosage forms, nanoparticles, modified release dosage forms, particulate engineering, and scientific underpinnings of Quality by Design utilizing novel Process Analytical Technologies. As a coordinator of graduate studies and research at Faculty of pharmacy, King Abdulaziz University, Dr. Zidan serves as the faculty advisor on all matters related to planning and conducting research to study the impact on product quality, changes in bulk drug substances, formulation component and composition, and manufacturing equipment and processes. As a recognized expert, Dr. Zidan participates as an editorial board member and reviewer in different international leading journals.

Associate Professor
King Abdulaziz University
Saudi Arabia