Day 2 :
Keynote Forum
Bahubali G Nagavi
Ras al-Khaimah Medical and Health Sciences University, UAE
Keynote: Benchmarking and assessing attitude and behavior of pharmacy students – An innovative & quantitative approach
Time : 09:30-10:30
Biography:
Bahubali G Nagavi has completed his PhD from BITS, Pilani, India. He has more than 36 years of teaching & research experience. Since 2007, he is working as Professor and Dean, RAK College of Pharmaceutical Sciences, RAK Medical & Health Sciences University, RAK, UAE. He has guided 35 PG and 5 PhD students. He was Editor of Indian Journal of Pharmacy Education and Research (IJPER) from 1997 to 2007. He has about 67 national and 12 international publications. He is a recipient of Distinguished Teacher Award of Assoc. of Pharm Teachers of India (APTI) in 1998 and has a Patent and Trademark registration to his credit.
Abstract:
Benchmarking of attitude & behavior of students has been done for the purpose of comparison and as a good educational practice. It helps to raise the level of student’s attitude & behavior and also the standard and quality of education. It is a voluntary, internal and results benchmarking. Attitude, Communication Skill, Team Work, Appearance and Punctuality were the parameters considered for self-assessment of students and faculty assessment of the students taught. About 240 students of B. Pharm participated in the computer based study. Self-assessment of students was compared with the faculty scores. Results were also compared with the University bench mark of 3.5. There was a minimum expectation gap between students & faculty scores in 1st year students followed by 2nd & 3rd years. Maximum gap was found in final year students in their attitude & behavior compared to the expectation of the faculty. It is expected that the students will improve their competency & behavior after the measured data was given to individual students as an “Attitude & Behavior Score Card” and it is measured at the end of every semester during the 08 semester study period. Radar diagrams of the 5 competencies of students & faculty scores for every class will be explained and interpreted. Benchmarking of attitude & behavior establishes a framework for change and raises quality as well as standard of education.
- Track 13: Drug Development and therapeutics Track 14: Pharmacovigilance Track 15: Pharmaceutical Analysis
Chair
Shinichiro Akiyama
Saisei Clinic, Japan
Session Introduction
Alok Bandyopadhyay
AB Consulting, USA
Title: Biosimilar of protein therapeutics¬
Time : 10:45-11:25
Biography:
Alok Bandyopadhyay is a Senior Global Consultant at AB consulting. He started his scientific career working on immunoglobulin and received his PhD from University of Calcutta. Later he came to USA to work on molecular biology of proteins using Fulbright Travel grant. He took training as a Post-doctoral fellow from US universities. After training, he held several academic positions and worked in molecular biology of proteins. He published several scientific papers in various peer reviewed journals and received awards. In 1990s, he joined industry in drug development area and at the same time, he held Adjunct Faculty Position in Medicine at Thomas Jefferson Medical College, and subsequently Stony Brook University Medical College, NY. He worked with various famous people in the protein research. After joining industry, he gained experience in project management, advancing product innovation from conception through commercialization. He worked in various areas of drug development including Research, Quality and Regulatory. He was involved in various global submissions of IND, NDA, BLA, ANDA, pre-approval, and post approval. He worked in drug development of CNS, immunology, endocrinology, and oncology. He is a certified regulatory professional and proficient in US/EU regulations. He is successful interfacing with FDA reviewers. He is attached with several professional associations e.g. RAPS, DIA and AAPS.
Abstract:
Biopharmaceuticals like monoclonal antibodies are widely used in clinical medicine for various therapies e.g. cancer, inflammatory and autoimmune diseases. Several biosimilar drugs, supposed to be economical version of branded biological drugs, are in the process of drug development for market approval. Unfortunately, biosimilar manufacturing is often different from the brand name drug due to variation in manufacturing processes. As a result, such variations may trigger unwanted clinical issues, which may limit the use of biopharmaceuticals. Well engineered cells, well designed formulation coupled with good manufacturing scheme may sometimes reduce some of the extrinsic and intrinsic factors and increase the stability of drug product. One of the proposals for remedies is to purify the drug product to homogeneity or near homogeneity retaining its stability and functional activity. Due to its low or negligible content of impurities clinical issues may not be triggered and may get a relief from rigorous clinical studies. In addition, incorporation of risk based approach, which considers both probability of induction of clinical issues and expected clinical consequences followed by risk mitigation during drug development, may provide better regulatory pathway for market approval.
Suzan Marwan Ramadan Shahin
United Arab Emirates University , United Arab Emirates
Title: New opportunities in the UAE through essential oil-based research: Native plants as natural resources for future drugs after the oil era
Time : 11:25-12:05
Biography:
Suzan M Shahin is a Lead Ambassador of the United Arab Emirates Unviersity (UAEU) graduate students. She is a researcher and PhD candidate in the Aridland Agriculture Department, College of Food and Agriculture, UAEU. Her research interests are the UAE indigenous plants, essential oil extraction and analysis, natural resources, natural drugs, environmental sciences and sustainable environmental approaches.
Abstract:
The United Arab Emirates (UAE) is a young country, with an oil-based economy, that has limited lifetime expectancy. Although the UAE is located in the arid regions, however, the native wildlife is considered to be rich in biodiversity. Also, throughout history, the traditional folk medicine, through the use of the local medicinal plants, has proven its effectiveness and efficiency. The main purpose of this work is to shed the light on new opportunities in the aromatherapy field based on the UAE native essential oil-bearing plants. This initiative “named as Aroma Niche” was adopted recently by the United Arab Emirates University (UAEU) science and innovation park, and currently in the pipelines for implementation. It is significant to fill the gaps between the traditional folk practices, research and technology; in order to build a concrete base ground for new natural derived drugs. The whole process is seeking for professional experts in the field of aridlands agriculture, chemical engineering and pharmacognosy. This initiative believing that, desert plants, who survive the arid conditions, capable of providing high quality ingredients with potential applications in aromatherapy. The promising company will provide 100% certified organic products “chemicals free”, and will follow the US Food and Drug Administration (FDA) regulations. The extraction process would be done by hydrodistillation, and product quality will be monitored by the analytical technology of the Gass Chromatography/Mass Spectrometry (GC/MS). There is a crucial necessity to implement this idea; in order to sustain the local economy after the oil peak.