Day 1 :
Jazz Pharmaceuticals, USA
Karen L Smith joined Jazz in 2015 as Global Head R&D and CMO and is also a member of Jazz’ Executive Committee. She Chairs the R&D Development and Portfolio Committees and is accountable for the strategy and execution of all pre-clinical and clinical programs, overseeing staff in the UK, Ireland, Canada and the USA. She brings significant experience running large R&D organizations and has previously held a variety of physician executive and R&D positions in Australia, Japan, Canada, Europe and the US, working for companies including Bristol-Myers Squibb, AstraZeneca and Allergan. She has been extensively involved in launch planning/execution as well as business development, including numerous acquisitions, integrations and joint venture deals. Her experience also extends across several patent litigation proceedings. During her 20 years in industry, she has been instrumental in over 15 major drug and device product approvals in multiple therapeutic areas including cardiology, oncology, neuroscience/CNS, hematology, anti-infectives, rheumatology, dermatology, diabetes/metabolics and aesthetic medicine. She is also a published Scientist, Reviewer for several clinical journals, and has been an Advisor for various academic, government and corporate entities including the Institute of Medicine and PhRMA. Her qualifications include an MD degree in Cardiology, PhD in Molecular Genetics and Breast Cancer, an MBA, and a Master’s in Law. She has Board experience on both private and public companies as well as not-for-profits, and is currently a Board Director for Forward Pharma (NASDAQ: FWP) and on the Advisory Board for Ironman Inc.
Vyxeos (cytarabine:daunorubicin) liposome for injection, also known as CPX-351, is a nano-scale co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio. Vyxeos represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nano-scale liposome in order to maintain the desired ratio following administration. The FDA granted Breakthrough Therapy designation to Vyxeos for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos was granted orphan drug status for the treatment of AML by the FDA and the European Commission. Vyxeos was also granted Fast Track designation for the treatment of elderly patients with secondary AML by the FDA. Taking two cytotoxic agents that are currently standard of care (known as 7+3) and encapsulating into a liposomal formulation produced statistically significant results with a 3.6 month improvement in favor of Vyxeos. The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3. This review will focus on the potential for drug liposomal encapsulation and utilizing this approach for better patient outcomes.
Beirut Arab University, Lebanon
Maha Ahmed Aboul Ela has completed her PhD from Department of Pharmacognosy, Faculty of Pharmacy, University of Alexandria, Egypt in collaboration with Institute for Organic Chemistry, Technical University of Berlin, Germany. Her specialty is Phytochemistry and Phytotherapy. She has obtained a Post-doctoral fellowship from School of Pharmacy, University of London, UK. Currently she is the Head of Pharmaceutical Sciences Department, Faculty of Pharmacy, Beirut Arab University, Lebanon. She has more than 60 publications in national and international journals and conferences.
Various plants species are used in traditional folk medicine for their anti-diabetic, anti-oxidant effects and for certain gastric disorders. Examples of plants are salvia species, which have a reputation for memory enhancement. An infusion of the Salvia leaves is widely used as a mouthwash or gargle, for the treatment of inflammation of the mouth and throat. The leaves are used also as carminative and antispasmodic. Another example is Centaurea species that has been used in folk medicine for many purposes as diuretic, mild astringent, bitter tonic, digestive, emmenagogue and in cosmetics. Previous reports pointed out that, the activities of most of the examined plants are due to their contents of volatile oils and phenolic compounds obtained from different extracts. Accordingly, the current work comprises phytochemical study of some selected Lebanese medicinal plants to investigate their constituents and to explore the biological activities of the extracts of the chosen plants. The chemical structures of the isolated compounds, from two plants belonging to different species, were determined by application of different spectroscopic techniques. Furthermore, the volatile oil constituents of other Lebanese plants were investigated. The biological activities of plants’ extracts revealed promising results. This work represents a collection of the research activities performed at the department aiming to add more natural drug candidates, with potential biological activities, which could serve the pharmaceutical industry.
TATA Consultancy Services Ltd., India
Keynote: Drug regulatory affairs
Time : 11:40-12:20
Vishal Mhatre is a career oriented Pharmacist with 23 years of experience in Pharma Industry and Domain Consultant with substantial expertise in Regulatory Project Management, Strategy Development and Operations. He has knowledge and understanding of applicable pharmaceuticals, biological/biotech rules & regulations covering different types of submission procedures during Product Lifecycle Management with 19+ years of experience in Regulatory Affairs covering regulatory strategy development for Global submission, preparation of regulatory submissions and product lifecycle management across the Globe. He has demonstrated project management skills managing multiple assignments in regulatory operations involved in competency development of regulatory team through developing extensive training program covering current regulations & HA expectations on product development. Also, he is responsible for regulatory business strategy development and process improvement activities in current role.
Drug regulatory affairs cater by interpretation of Health Authority expectations for product development & accordingly dossier building for Regulatory Submission. Marketing Authorization granted by HA is the result of sufficient data generated to meet HA expectations considering quality, efficacy and safety aspects of drug product. This helps to market product as per target HA expectations and extends the product to international markets based on business strategy. Understanding of science behind product & developed product meeting minimum expectations of ICH standards, will ensure successful regulatory path for product registration. As we move from major markets, documentation requirements may go down as the international markets or emerging markets are more dependent on reference countries for first level evaluation. Industry is now aligning with ICH guidelines for product development which help to meet expectations of majority of the international markets or emerging markets. But it puts pressure on Pharma industry in the emerging markets to reconsider product develop strategy.