Future Pharma and Innovations

Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. As the co-founder and primary author of Hyman, Phelps & McNamara’s FDA Law Blog, Mr. Karst often leads the response to new rules and regulations, sharing his interpretation with the broader legal community. Mr. Karst clerked for Hyman Phelps & McNamara while attending law school and served as articles editor for the American University Law Review. Before joining the firm, Mr. Karst lobbied for F. Hoffmann-La Roche Inc. In 1995, he was awarded a Fulbright Scholarship for post-graduate studies in Germany.

Pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.

Volkmar Weissig, Sc.D., Ph.D. is a Tenured Full Professor of Pharmacology and Chair of the Department of Pharmaceutical Sciences. Dr. Weissig received his B.S., M.S. and Ph.D. degrees in Chemistry and his postdoctoral Sc.D. degree in Biochemistry and Pharmaceutical Biotechnology from the Martin-Luther University in Halle (Germany). Combined he completed several years of postdoctoral fellowships at the Cardiology Research Center in Moscow (Russia), at the Academic Department of Medicine at the Royal Free Hospital School of Medicine in London (UK), at the Institute of Organic Chemistry at the Czechoslovakian Academy of Science in Prague (CSFR), at the College of Pharmacy and the College of Medicine at the University of Florida, Gainesville, FL and at Harvard Medical School and Massachusetts General Hospital in Boston, MA. Before joining the faculty at Midwestern University, Dr. Weissig was an Assistant Professor of Pharmaceutical Sciences at Northeastern University in Boston, MA. Dr. Weissig holds 16 patents and he has published 98 research papers, review articles and book chapters, mostly in the area of nano drug delivery systems. He also edited and published 8 books. He serves as the Associate Editor of the Journal of Liposome Research and he is member of several other Editorial Boards. In July 2009 Dr. Weissig was inducted into the World Technology Network as a Fellow. In October 2014 Dr. Weissig was elected President of the World Mitochondria Society.

Dr. Weissig’s major research interests lie in the areas of Mitochondrial Medicine and Pharmaceutical Nanotechnology. In particular, his laboratory has pioneered the design and development of mitochondria-targeted nano drug delivery systems, which have opened new strategies for mitochondrial gene therapy, for apoptosis-based anticancer chemotherapies and for controlling and manipulating the redox status of mammalian mitochondria.

Radostina Alexandrova Graduated with honors in Biochemistry and Microbiology, Sofia University “St. Kl. Ohridski” (SU); MSc and PhD in Virology, lecturer in SU and PhD School of BAS; > 160 publications, > 550 abstracts, 3 Book chapters; Postdoctoral training in Slovakia, Hungary, Denmark; Leading researcher in 5 national and 10 bilateral projects; MC Member of five COST Actions; Member of Union of Scientists in Bulgaria, Bulgarian Society of Anatomy, Secretary-Treasurer of the Immunological Society; Member of the Organizing/Scientific Committees of 45 scientific forums; Editor/Member of editorial boards of 2 national and 4 international journals; Editor of the proceeding books of two Workshops.

Biochemistry and Microbiology

Naji Najib completed his Ph.D. at the age of 28 years from Nottingham University and postdoctoral studies at College of Pharmacy, University of Michigan, Ann Arbor, Michigan 48109, U.S.A and Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, Kansas 66044, U.S.A. He is the CEO of the International Pharmaceutical Research Center (IPRC), a Clinical Research Organization (CRO). He has published more than 100 papers in reputed journals and serves as an editorial board member of reputed journals.

Pharmaceutics, Pharmaceutical Chemistry, and Clinical Research

Mircea Ciuca, MD is currently Global Head of Medical & Clinical Drug Safety at Vifor Pharma in Switzerland. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings. Mr. Ciuca has about 13 years of experience in drug safety. Prior to joining Vifor Pharma, he held various positions (Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large pharmaceutical companies in The Netherlands, after successfully establishing and leading the medical-scientific department of a medium-sized CRO in Rotterdam.

Clinical Drug Safety, clinical practice, Pharmacovigilance

Dorota Dobler, Institute of Bioprocess Engineering and Pharmaceutical Technology, Technische Hochschule Mittelhessen-University of Applied Sciences, Wiesenstr. 14, 35390, Giessen, Germany.

Bioprocess Engineering and Pharmaceutical Technology

Wei-Chiang Shen is currently John A. Biles Professor in Pharmaceutical Sciences at the University of Southern California School of Pharmacy. Dr. Shen's research interests focus on the development of novel systems for improving peptide and protein drug delivery. Current research projects in Dr. Shen's laboratory at USC include (1) recombinant fusion proteins for improving peptide and protein drug delivery, and (2) cell-penetrating peptides for cytosolic or nuclear delivery of macromolecular drugs. Dr. Shen has published 150 papers in different areas of biomedical sciences, including biochemistry, cell biology, pharmaceutics, and immunology. He is an inventor or co-inventor of 16 issued and 2 pending US patents in drug delivery and a co-author of the textbook Immunology for Pharmacy Students and a co-editor of the book Antibody-Drug Conjugates – the 21st Century Magic Bullets for Cancer. Dr. Shen was elected to Fellow of the American Association of Pharmaceutical Scientists (AAPS) in 1992 and Fellow of the American Association for the Advancement of Sciences (AAAS) in 2000, and was the recipient of the Grand Prize of Eurand Award for Outstanding Novel Research in Oral Drug Delivery from Controlled Release Society in 2002.

Pharmaceutics, Drug Delivery, Controlled Release

Vladimir P. Torchilin is a University Distinguished Professor and Director, Center for Pharmaceutical Biotechnology and Nanomedicine, Northeastern University, Boston. He graduated from the Moscow University with MS in Chemistry, and obtained there his Ph.D. and D.Sc. in Polymer Chemistry and Chemistry of Physiologically Active Compounds in 1971 and 1980, respectively. In 1991, Dr. Torchilin joined MGH/Harvard Medical School as the Head of Chemistry Program, Center for Imaging and Pharmaceutical Research, and Associate Professor of Radiology. Since 1998 Dr. Torchilin is with Northeastern University. He was the Chair of the Department of Pharmaceutical Sciences from 1998- 2008. His research interests include drug delivery and targeting, and pharmaceutical nanocarriers. He has published more than 350 original papers, more than 150 reviews, and book chapters, wrote and edited 10 books, including Immobilized Enzymes in Medicine, Targeted Delivery of Imaging Agents, Liposomes, Nano particulates as Pharmaceutical Carriers, and holds more than 40 patents. He is Editor-in-Chief of Current Drug Discovery Technologies and of Drug Delivery and on the Editorial Boards of many journals including Journal of Controlled Release (Review Editor), Bioconjugate Chemistry, and Advanced Drug Delivery Reviews. Among many awards, Professor Torchilin was the recipient of the 1982 Lenin Prize in Science (the highest award in the USSR). He is a Member of the European Academy of Sciences. He is also a Fellow of AIMBE, AAPS, and CRS, and received the 2005 Research Achievements in Pharmaceutics and Drug Delivery Award from the AAPS, 2007 Research Achievements Award from the Pharmaceutical Sciences World Congress, 2009 AAPS Journal Award, 2009 International Journal of Nanomedicine Distinguished Scientist Award, 2010 CRS Founders Award, and 2012 Alec Bangham Award. From 2005-2006 he was a President of the Controlled Release Society. In 2011, Times Higher Education ranked him number 2 among top world scientists in pharmacology for the period of 2001-2010.

Physiologically active polymers and their use as drug carriers, Targeted delivery of therapeutic and diagnostic agents, Experimental diagnostic imaging, Experimental tumor immunology and therapy, and Micellar tumor targeting.

Dr. Amgad M. Rabie, Professor & Researcher of Pharmaceutical Organic (Medicinal) Chemistry & Drug Design/Discovery, Department of Pharmaceutical Organic Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.

Pharmacovigilance, Pharmaceutical Industry, Clinical Research, Organic Chemistry, Drug Design, Drug Discovery

Dr Shruti Chopra acquired her PhD and M.Pharm degrees from Katholieke Universiteit Leuven, Belgium and B. Pharm from Birla Institute of Technology, Mesra, India. She is currently working as Assistant Professor at Amity Institute of Pharmacy, Amity University, Noida, India. She is handling various UG, PG and PhD projects. She is recipient of “Young Scientist” project grant from Science and Engineering Research Board, Department of Science and Technology, Government of India. Her area of research is pharmaceutical analysis particularly liquid chromatography and mass spectroscopy. She is also working on development some novel formulations and strategies for delivery of anti-infective agents.

Research areas: • Development and validation of chromatographic methods for the assessment of quality and content of antibiotics, amino acids and various other drug substances using liquid chromatography in combination with various detection techniques such as ultra-violet detection, pulsed electrochemical detection, evaporative light scattering detection and capacitively coupled contactless conductivity detection. • Assessing the content of the antibiotics in the biological samples of patients undergoing therapy at the university hospital. • Drug regulatory affairs – India and international regulation. • Ungual & transungual drug delivery systems and strategies

Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. As the co-founder and primary author of Hyman, Phelps & McNamara’s FDA Law Blog, Mr. Karst often leads the response to new rules and regulations, sharing his interpretation with the broader legal community. Mr. Karst clerked for Hyman Phelps & McNamara while attending law school and served as articles editor for the American University Law Review. Before joining the firm, Mr. Karst lobbied for F. Hoffmann-La Roche Inc. In 1995, he was awarded a Fulbright Scholarship for post-graduate studies in Germany.

Pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.

Volkmar Weissig, Sc.D., Ph.D. is a Tenured Full Professor of Pharmacology and Chair of the Department of Pharmaceutical Sciences. Dr. Weissig received his B.S., M.S. and Ph.D. degrees in Chemistry and his postdoctoral Sc.D. degree in Biochemistry and Pharmaceutical Biotechnology from the Martin-Luther University in Halle (Germany). Combined he completed several years of postdoctoral fellowships at the Cardiology Research Center in Moscow (Russia), at the Academic Department of Medicine at the Royal Free Hospital School of Medicine in London (UK), at the Institute of Organic Chemistry at the Czechoslovakian Academy of Science in Prague (CSFR), at the College of Pharmacy and the College of Medicine at the University of Florida, Gainesville, FL and at Harvard Medical School and Massachusetts General Hospital in Boston, MA. Before joining the faculty at Midwestern University, Dr. Weissig was an Assistant Professor of Pharmaceutical Sciences at Northeastern University in Boston, MA. Dr. Weissig holds 16 patents and he has published 98 research papers, review articles and book chapters, mostly in the area of nano drug delivery systems. He also edited and published 8 books. He serves as the Associate Editor of the Journal of Liposome Research and he is member of several other Editorial Boards. In July 2009 Dr. Weissig was inducted into the World Technology Network as a Fellow. In October 2014 Dr. Weissig was elected President of the World Mitochondria Society.

Dr. Weissig’s major research interests lie in the areas of Mitochondrial Medicine and Pharmaceutical Nanotechnology. In particular, his laboratory has pioneered the design and development of mitochondria-targeted nano drug delivery systems, which have opened new strategies for mitochondrial gene therapy, for apoptosis-based anticancer chemotherapies and for controlling and manipulating the redox status of mammalian mitochondria.

Radostina Alexandrova Graduated with honors in Biochemistry and Microbiology, Sofia University “St. Kl. Ohridski” (SU); MSc and PhD in Virology, lecturer in SU and PhD School of BAS; > 160 publications, > 550 abstracts, 3 Book chapters; Postdoctoral training in Slovakia, Hungary, Denmark; Leading researcher in 5 national and 10 bilateral projects; MC Member of five COST Actions; Member of Union of Scientists in Bulgaria, Bulgarian Society of Anatomy, Secretary-Treasurer of the Immunological Society; Member of the Organizing/Scientific Committees of 45 scientific forums; Editor/Member of editorial boards of 2 national and 4 international journals; Editor of the proceeding books of two Workshops.

NO

Naji Najib completed his Ph.D. at the age of 28 years from Nottingham University and postdoctoral studies at College of Pharmacy, University of Michigan, Ann Arbor, Michigan 48109, U.S.A and Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, Kansas 66044, U.S.A. He is the CEO of the International Pharmaceutical Research Center (IPRC), a Clinical Research Organization (CRO). He has published more than 100 papers in reputed journals and serves as an editorial board member of reputed journals.

Pharmaceutics, Pharmaceutical Chemistry, and Clinical Research

Mircea Ciuca, MD is currently Global Head of Medical & Clinical Drug Safety at Vifor Pharma in Switzerland. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings. Mr. Ciuca has about 13 years of experience in drug safety. Prior to join Vifor Pharma he held various positions (Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large pharmaceutical companies in The Netherlands, after successfully establishing and leading the medical- scientific department of a medium-size CRO in Rotterdam.

Clinical Drug Safety, clinical practice,Pharmacovigilance

Dorota Dobler, Institute of Bioprocess Engineering and Pharmaceutical Technology, Technische Hochschule Mittelhessen-University of Applied Sciences, Wiesenstr. 14, 35390, Giessen, Germany.

Bioprocess Engineering and Pharmaceutical Technology

Wei-Chiang Shen is currently John A. Biles Professor in Pharmaceutical Sciences at the University of Southern California School of Pharmacy. Dr. Shen's research interests focus on the development of novel systems for improving peptide and protein drug delivery. Current research projects in Dr. Shen's laboratory at USC include (1) recombinant fusion proteins for improving peptide and protein drug delivery, and (2) cell-penetrating peptides for cytosolic or nuclear delivery of macromolecular drugs. Dr. Shen has published 150 papers in different areas of biomedical sciences, including biochemistry, cell biology, pharmaceutics, and immunology. He is an inventor or co-inventor of 16 issued and 2 pending US patents in drug delivery and a co-author of the textbook Immunology for Pharmacy Students and a co-editor of the book Antibody-Drug Conjugates – the 21st Century Magic Bullets for Cancer. Dr. Shen was elected to Fellow of the American Association of Pharmaceutical Scientists (AAPS) in 1992 and Fellow of the American Association for the Advancement of Sciences (AAAS) in 2000, and was the recipient of the Grand Prize of Eurand Award for Outstanding Novel Research in Oral Drug Delivery from Controlled Release Society in 2002.

Pharmaceutics, Drug Delivery, Controlled Release

Vladimir P. Torchilin is a University Distinguished Professor and Director, Center for Pharmaceutical Biotechnology and Nanomedicine, Northeastern University, Boston. He graduated from the Moscow University with MS in Chemistry, and obtained there his Ph.D. and D.Sc. in Polymer Chemistry and Chemistry of Physiologically Active Compounds in 1971 and 1980, respectively. In 1991, Dr. Torchilin joined MGH/Harvard Medical School as the Head of Chemistry Program, Center for Imaging and Pharmaceutical Research, and Associate Professor of Radiology. Since 1998 Dr. Torchilin is with Northeastern University. He was the Chair of the Department of Pharmaceutical Sciences from 1998- 2008. His research interests include drug delivery and targeting, and pharmaceutical nanocarriers. He has published more than 350 original papers, more than 150 reviews, and book chapters, wrote and edited 10 books, including Immobilized Enzymes in Medicine, Targeted Delivery of Imaging Agents, Liposomes, Nano particulates as Pharmaceutical Carriers, and holds more than 40 patents. He is Editor-in-Chief of Current Drug Discovery Technologies and of Drug Delivery and on the Editorial Boards of many journals including Journal of Controlled Release (Review Editor), Bioconjugate Chemistry, and Advanced Drug Delivery Reviews. Among many awards, Professor Torchilin was the recipient of the 1982 Lenin Prize in Science (the highest award in the USSR). He is a Member of the European Academy of Sciences. He is also a Fellow of AIMBE, AAPS, and CRS, and received the 2005 Research Achievements in Pharmaceutics and Drug Delivery Award from the AAPS, 2007 Research Achievements Award from the Pharmaceutical Sciences World Congress, 2009 AAPS Journal Award, 2009 International Journal of Nanomedicine Distinguished Scientist Award, 2010 CRS Founders Award, and 2012 Alec Bangham Award. From 2005-2006 he was a President of the Controlled Release Society. In 2011, Times Higher Education ranked him number 2 among top world scientists in pharmacology for the period of 2001-2010.

Physiologically active polymers and their use as drug carriers, Targeted delivery of therapeutic and diagnostic agents, Experimental diagnostic imaging, Experimental tumor immunology and therapy, and Micellar tumor targeting.

Dr Shruti Chopra acquired her PhD and M.Pharm degrees from Katholieke Universiteit Leuven, Belgium and B. Pharm from Birla Institute of Technology, Mesra, India. She is currently working as Assistant Professor at Amity Institute of Pharmacy, Amity University, Noida, India. She is handling various UG, PG and PhD projects. She is recipient of “Young Scientist” project grant from Science and Engineering Research Board, Department of Science and Technology, Government of India. Her area of research is pharmaceutical analysis particularly liquid chromatography and mass spectroscopy. She is also working on development some novel formulations and strategies for delivery of anti-infective agents.

Research areas: • Development and validation of chromatographic methods for the assessment of quality and content of antibiotics, amino acids and various other drug substances using liquid chromatography in combination with various detection techniques such as ultra-violet detection, pulsed electrochemical detection, evaporative light scattering detection and capacitively coupled contactless conductivity detection. • Assessing the content of the antibiotics in the biological samples of patients undergoing therapy at the university hospital. • Drug regulatory affairs – India and international regulation. • Ungual & transungual drug delivery systems and strategies