Day 1 :
Keynote Forum
Sergey Suchkov
Chair, Moscow State University of Food Industry, Russia
Keynote: Personalized and Precision Medicine (PPM) as a Unique Healthcare Model to Be Set Up through Biodesign, Unique Translational Applications and Upgraded Business Marketing to Secure the Human Healthcare, Wellness and Biosafety
Time : 9:00
Biography:
Abstract:
Keynote Forum
Laila Mahmoud Montaser
Menoufia University School of Medicine, Egypt
Keynote: Mesenchymal Stem Cell Derived-Exosomes as a Novel Nano Podium for Drug Delivery to Treat COVID-19
Biography:
Laila M. Montaser MD is a distinguished Prof. of Clinical Pathology. She served as the Chair Emeritus, Founder leader of Clinical Pathology Department, Faculty of Medicine, Menoufia University, Egypt. Montaser is an internationally recognized stem cell technology professional. She has key competence in stem cell technology and regenerative medicine policy reinforced by global level and international experience in research, formulation and capacity building. In the era of COVID-19, she was awarded twenty one certificates of appreciation for successfully presenting thirty seven Global Webinars 21/37 (56.8%) from her home office amid the lock-down of COVID-19 crisis.
Abstract:
COVID-19 has proved fatal to countless people with a compromised immune system. Similar to the principle mechanisms in treating autoimmune diseases, Stem cell therapy aims to reset and strengthen the compromised immune systems and thereby reduce the high mortality rate among severe COVID-19 patients. Mesenchymal stem cells (MSCs) are the most scientifically studied cells in regenerative medicine, owing to their immunomodulatory and differentiation potential. However, several complications come with their translational application like viability, duration, and degree of expansion, long-term storage, and high maintenance cost. Therefore, drawbacks of cell-based therapy can be overcome by a novel therapeutic modality emerging in translational research and application, i.e., exosomes. Application of MSC derived exosomes has been presented in drug delivery, which has made these Nano-vesicles an attractive clinical tool. The vast advantages of using exosomes over MSCs have shifted the focus on these Nano-platforms. The MSCs derived exosomes can be a novel intervention for treating the current COVID-19 pandemic situation due to their regenerative, immunomodulatory, and antimicrobial properties. With upcoming reports and clinical studies using these proposed novel therapeutic interventions, exosomes can be established as cell-free therapeutics and drug delivery modality worldwide. This is the need of the hour and must be looked into as a potential Nano-intervention for treating critically ill patients. This paper displays such a diverse range of advantageous properties including their spectral curability, and their capability to be used as a drug carrier, make exosomes an ideal candidate for clinical applications, and as an off the shelf therapeutics.
Keynote Forum
Joelle Nohra
Lebanese International University, Lebanon
Keynote: The Digital Marketing, a Competitive Edge for Pharmaceutical Companies
Time : 10.00
Biography:
(Dr.) Joelle Nohra completed her PharmD in pharmaceutical sciences from Saint Joseph University and has three master’s degrees, one in marketing from Montpellier University, one in Health Management from Paris University, and an Executive Master in Business Administration from ESCP Europe. From one achievement to the other in the pharmaceutical field, she was able to meet her commitments and leverage the brand equity of the products in charge. Today, she is responsible for the Global Brand Management and the Social Media Marketing Management in LSI Silderma LTD, a pharmaceutical dermo-cosmetic company based in Ireland and operating worldwide.
Abstract:
In recent times, the permanent growth of online and digital marketing as a means of communicating with and selling to consumers has drastically modified the new rules of doing business. Both marketing and consumer behavior have grown and changed substantially as consumers spend more time and money on internet channels. Nowadays, consumers are playing a more explicit and larger role in any product’s failure or success.
The pharmaceutical industry cannot be set apart from any recent changes, especially the digital transformation which is one of the biggest changes in our actual landscape. Since 2010, the digital health market has tremendously grown and Covid-19 has greatly accelerated digital transformation in the pharmaceutical industry. While respecting the regulatory constraints in the different markets, it really matters to understand what the digital transformation means for the pharmaceutical sector, what such a digital valuable asset has to bring to companies, and how the latest can rely on it and embed it to serve as a competitive edge they can rely on to differentiate themselves in a crowded environment.
However, despite all the advantages digital marketing is offering to pharmaceutical companies, still, it is a double-edged sword that marketers should wield properly to serve their companies’ growth and reputation.
Keynote Forum
Obaid Ali
O.R. Centre for Quality Sciences, Pakistan
Keynote: Pandemic Response created Gulf between Science and Scientific Methods
Biography:
Obaid Ali, a graduate of Biological Sciences and Bachelor of Pharmacy earned his MPhil in Neuropharmacology and completed his Ph.D. in Pharmaceutical Chemistry. He served Government of Pakistan as a Civil Service Officer in Drug Regulatory Authority of Pakistan for more than two decades on different key leading positions. He was an alumni of international regulatory forums of CDER, US-FDA and HPFB, Health Canada. He was a Training Consultant of WHO and completed his assignments in different countries. He is on board of different academic institutions.
Abstract:
Data is the active raw material for quality product that can deliver desired output every time consistently. Information is derived from data and experience of feelings convert data into knowledge that upon practice increase wisdom and keep decisions within sensible space. Integrity of the data and its connection with the object may not be understood if relation is not established between them. To know the unknowns and to understand them is indispensable in science and scientific conclusions. Use of reliable methods, appropriate approach in scientific experiments creates certainty and uphold promises. From testing reliability of pandemic to prevention through vaccine and treatment via chemical, biological and blood products are not proven strong enough to answer the concerns and questions already set in the 21st century of pharmaceutical sciences. Multidisciplinary approach and open discussions on scientific methods used to develop and approve products among the scientific individuals are the only way to maintain grace of science and trust of common man. Focusing on expansion of learning space and feeling space in dynamic reshaping technological world can maintain the momentum of development and progress.
Keynote Forum
T. R. Bhardwaj
Baddi University of Emerging Sciences & Technology, India
Keynote: Emergence of India as a Global Health Provider and its Impact on Pharmaceutical Education
Biography:
Prof. T. R. Bhardwaj is renowned pharmaceutical academician, scientist and presently working as Advisor to Chancellor (Former Vice Chancellor), Baddi University of Emerging Sciences & Technology, Baddi. He has also been Dean, School of Pharmacy and Emerging Sciences since September, 2014. Prof. Bhardwaj has obtained M. Pharm. and Ph.D. degrees from University Institute of Pharmaceutical Sciences (UIPS), Panjab University, Chandigarh and served his alma matter for around 32 years under various capacities such as Dean-Faculty of Pharmaceutical Sciences, Chairman-UIPS. He has also been International Research Fellow, SRI-International (Formerly Stanford Research Institute), California, USA from August, 1988 to January, 1996 (around 4 years). Prof. Bhardwaj has 17 patents including 9 US patents and more than 200 publications in reputed International/National journals. He has guided 15 Ph.D. and 90 M. Pharm. Students. Dr. Bhardwaj is recipient of GP Srivastava Memorial Award, Association of Pharmaceutical Teachers of India, December, 2017, Teacher of Excellence Award, Golden Jubilee Celebrations, APTICON 2016 and recently has received ET (Economic Times) Inspiring Leaders Award in Education in December, 2021.
Abstract:
India has emerged as global health provider, having expertise in manufacturing of generics. This drug industry flourished after the passage of the Drug Price Competition and Patent Term Restoration Act of 1984. Fifty years later, the generic drug industry has achieved remarkable success in getting affordable medicines to patients. The generic products typically cost 50 to 70 percent less than their brand-name counterparts-while meeting the very same standards for safety, quality, and effectiveness as innovator drugs. Global pharmaceutical market is undergoing rapid transformation. The products manufactured by the Indian pharmaceutical industry can be broadly classified into active pharmaceutical ingredients and formulations. India is one among the largest API manufacturers in terms of volume and value. Out of the total number of pharmaceutical manufacturers, about 77% produce formulations and remaining 23% manufacture bulk drugs. In 2001, CIPLA introduced the world first ever recommended fixed dose combination (Stavudine + Lamivudine + Neviropine) to fight AIDS. It was made available at less than $1 per day compared to over $12,000 per patient per year prevailing in most countries.
The UN Secretary-General, Antonio Guterres has applauded India for supplying COVID-19 doses to nations around the world to combat the catastrophic global health crisis. India has played a major role in ensuring a global vaccination to fight the pandemic. Guterres said, “I would like to say how much we count on India, I mean, India has one of the most advanced pharmaceutical industries. India played a very important role in the production of generics for use that was a very important element of democratisation all over the world”. Taking into consideration the above mentioned India’s potential and capabilities with respect to global healthcare, opportunities, challenges and their impacts on pharmaceutical education will be discussed.
Keynote Forum
Raweesh Chaudhary
Biogen Inc., USA
Keynote: Digital Transformation in Omnichannel era: It is people that need transformation not technology
Time : 9:30
Biography:
Raweesh Chaudhary is a pharmacist and an MBA with over 27 years in the pharmaceutical insdustry spread across three different countries and two different continents, in multiple roles with progressive responsibilities (Product management, field based commercial and medical roles and strategic medical director roles). Raweesh currently works as a strategy director of Medical Excellenc at Biogen inc. Based out of USA.This presentation is Raweesh’s personal opinion and he is not speaking on behalf of Biogen.
Abstract:
Digital technology has emerged as a powerful solution enabler of three major confounders of pharma industry’s scientific communication problems: (a) Proximity of the communicators (b) Synchronicity at the time of communication and (c) Amplification of the message.
However as messaging becomes more amplified, asynchronous and proximity independent, it has an inverse effect on message clarity and personalization that often leads to lack of credibility of the message.
This presentation aims to define the changing OMNICHANNEL communication landscape, as it applies to the Pharmaceutical industry, identify various communications tools available within each channel and attempts to define strategies on customer preference to specific types of channels aligned to their particualar communication needs.
It will also make the case that, it is not the availability of technological solutions within each channel that should define how we communcate with our scientific peers, rather the preference and appropriateness of the tools available, to the people we are communicating with.
The presentation will also discuss strtrategies on how to diffrentiate between Virtual platforms (which are often just surrogate for realtime physical presence) and true Digital platforms which are both independent of geographical proximity and time, as it applies to Pharmaceutical communication.
The presentation will finally make the case that, the focus of Digital transformation in the context of the Pharmaceutical industry, should be on Transformation of PEOPLE to accept digital technology rather than the transformation of technology itself.
Keynote Forum
Jeanne Moldenhauer
C-POLAR Technologies, Inc., USA
Keynote: Changing the Face of Contamination Control
Biography:
Jeanne Moldenhauer has extensive experience in pharmaceuticals and medical devices. She has worked in microbiological development, contamination control, quality, regulatory, aseptic processing, sterilization, sterile process validation, and compliance. Her major area of study in college and graduate school was microbiology and virology. She serves as the Chief Science Officer of C-POLAR Technologies, Inc. and also consults with the pharmaceutical industry. She has published more than 40 technical books through PDA-DHI and CRC Press. She has also published more than 100 articles. She has served on the scientific advisory board, and the regulatory affairs and quality advisory board of the Parenteral Drug Association (PDA).
Abstract:
With the most recent update of the European Union’s (EU) Annex 1 to the GMPs for Manufacture of Sterile Products, there is an increased focus by regulatory agencies on the contamination control practices used in facilities. While many companies chose to focus on traditional methodologies, there are many new technologies that greatly exceed the potentials available with new technologies. This talk will focus on some new technologies which can be used to improve older methods for contamination control. For example, new filtration systems that can eliminate viruses and microorganisms will be discussed. This filtration technology has been adapted to provide many different applications in clean rooms and hospitals. Consider the possibilities of improving the health of your employees and protecting your products from many more contaminants than in the past. Many of these products have been developed utilizing an international consortium of researchers.
- Advanced Pharmaceutical Analytical Techniques
Session Introduction
Harshkumar Brahmbhatt
Sumandeep Vidhyapeeth, India
Title: Development of rapid and sensitive spectrofluorimetry method for determination of polysorbate 80 from pharmaceutical formulation
Biography:
Mr.Harshkumar Brahmbhatt has completed his Master of Pharmacy from CHARUSAT University, Changa, Gujarat, India. He has 1 year and 7months of experience as Trainee Scientist II at Torrent Pharmaceuticals Ltd, Gandhinagar, India and from September 2019 onwards he is working as an Assistant Professor at School of Pharmacy, ITMBU, Vadodara, India. He has received grant from GUJCOST(a state government body) for the research work. He is director of Aryan crop Protection Pvt Ltd. based in Nadiad, Gujarat, India -A agricultural Products manufacturing company. In the past he has presented at several platforms including Boston International Conference.
Abstract:
Polysorbate 80 is a nonionic surfactant derived from polyethoxylated sorbitan. It is often used in the pharmaceutical formulation for solubility and stability of the product. An optimal concentration of polysorbate 80 is required for its effect. The methods reported for the determination of polysorbate 80 are based on HPLC separation with evaporative light scattering detection or charged aerosol detection. A simple, rapid and sensitive pectrofluorimetry method was developed for the determination of a non-ionic surfactant polyoxyethylene sorbitan monooleate (Polysorbate 80) from a pharmaceutical formulation. The proposed method is based on a fluorescence enhancement of the probe 4',5’- dibromo-2’,7’-dinitro-fluorescein disodium salt (Eosin B, 4µg/mL) in the presence of a surfactant (polysorbate 80). The fluorescence intensity was recorded using excitation wavelength (λex) at 545nm and emission wavelength (λem) at 580nm. The solutions were adjusted to pH 4.0 using a citric acid buffer. The calibration curves were obtained in the range of 16 µg/mL to 80 µg/mL of polysorbate 80 with a regression coefficient >0.99. The developed method was validated as per the ICH Q2 (R1) guideline in terms of linearity, precision, accuracy, robustness, detection limit and quantification and specificity. The limit of detection and limit of quantification for polysorbate 80 was found to be 2µg/mL and 16µg/mL, respectively. The developed method was successfully applied for the determination of polysorbate 80 in marketed ophthalmic solution and in-house prepared microemulsion containing polysorbate 80.
Tamar Gilon
Azrieli College of Engineering, Israel
Title: Educating Pharmacuetical Engineers in Preparation for the Biopharmaceutical drugs Industry
Biography:
Tamar Gilon has completed her PhD from The Hebrew University from The Department of Biochemstry and Molecular Biology The Hebrew Universty Jerusalem. From the year 2008 Tamar has been a faculty member at The Department of Pharmaceutical Engineering, Azrieli College of Engineering, Jerusalem and part of the developing team that build a unique pharmaceutical engineering multidisciplinary B.Sc degree. Academic activity performed include; Head of the Center for Promotion of Teaching & Learning, Member of the Departmental Pedagogical Committee, Tamar is an active researcher at the college in the field of fermentation of geneticly
Abstract:
Biopharmaceutical drugs and biomanufacturing are a rapidly growing industry. Education and training for production and processing in these field are lagging. As part of the Pharmaceutical Engineering B.Sc. undergraduate program at Azrieli College of Engineering Jerusalem a hands on fourth year student laboratory training course was developed that centers on biotechnology methods and operating a bioreactor. This newly developed course applies pharmaceutical engineering knowledge, practical and theoretical, in the bioprocess and biopharmaceutical industry, including upstream optimization, fermentation and downstream process, based on the unique multidisciplinary curriculum of the Pharmaceutical Engineering degree. The aims of the course are to equip the pharmaceutical engineering students with the necessary knowledge and skills to function effectively within any area of the biopharmaceutical sector, with the adaptability to respond to the needs of a rapidly evolving industry and to facilitate the transition from academia to industry. At the core of the course, student preform a lab scale fermentation process for the production, purification and analysis of a recombinant active Tyrosinase enzyme. Tyrosinase can then be used to manufacture L-DOPA drug from L-tyrosine. The course is constructed of 6 hours of lectures following 22 hour of laboratory work. Student assessment are based on quizzes containing both theoretical and practical questions, laboratory work, learning skills and one cohesive report for the whole process, summarizing all the experiment data, results as well as calculation.
Ivan Kahwa
Mbarara University of Science and Technology, Uganda
Title: Pharmacognostic studies, Total Flavonoid Content and Artemisinin concentration in Artemisia vulgaris L. leaves grown in Kamwenge District, Western Uganda
Biography:
Ivan Kahwa completed his Msc.in Pharmacognosy and Medicine Science from Mbarara University of Science and Technology and has attended several trainings in natural products from different institutions. He is the director of KivanWoods Herbal Products and also a part time lecturer at Mbarara University of Science and Technology. He has published more than 10 papers in reputed journals
Abstract:
Artemisia vulgaris L. is used for treatment of malaria in Western Uganda instead of Artemisia annua L. Until to date no scientific evaluation has been reported on whether the leaves of the two species have similar physical and chemical characters.The present study evaluated the botanical, physicochemical, and chemical characters of leaves of A. vulgaris L. Macroscopy and microscopy studies, histochemical, physicochemical properties, and chemical parameters were carried out using standard procedures. Macroscopically, the leaves are dark green, with a sweet, strong and aromatic odor, pleasant, tangy and bitter taste. Microscopically, epidermis is amphistomatic, has anomocytic stomata on both adaxial and abaxial leaf surfaces and bicellular, biseriate glandular trichomes and unicellular T-shaped non-glandular trichomes. Histochemical studies showed the presence of cell wall materials and cell inclusions. Leaf constants revealed stomatal number (10.0), stomatal index (32.6), palisade ratio (7.8), vein islet number (15.0) and vein termination number (17.0). Physiochemically, moisture content (8.10 %), total ash (10.30 %), acid-insoluble ash (1.60 %), and sulphated ash (13.90 %), water-soluble ash (5.02%), alcohol-soluble extractive (9.73 %) and water-soluble extractive (19.9 %). Chemically, all the preliminary secondary plant metabolites were present except saponins and anthraquinones. Major fingerprints of extracts were showed at nine (9) Rf values. Artemisinin concentration was 1.72% w/w and total flavonoid contents were 1.10 and 0.84 mg QE/g in diethyl ether and methanol extracts respectively. These findings are of importance in the establishing diagnostic features of A.vulgaris L. which could be used for identification and preparation of its monograph.
Sarnai Sukhbaatar
Mongolian national university of medical science, Mongolia
Title: Adverse Drug Reactions in the Elderly
Biography:
Sarnai Sukhbaatar has completed a master's degree in 2015 from the Mongolian National University of Medical Sciences (MNUMS) and is now doctoral studies at MNUMS. She successfully defended clinical medicine with a dissertation on “Result of silymarin liver protection in anti-tuberculosis treatment”. She is fully capable of conducting clinical medicine experiments independently, well versing in clinical pharmacological research methods, and summarizing the results. Now her research area is adverse drug reactions.
Abstract:
Drug induced disorders incidence is increasing year by year and severe cutaneous adverse drug reactions (CADRs) are rare and life threating. The incidence of adverse effects is known higher in elderly people but in Mongolia, studies on drug have been used in elderly patients were treated in the National Dermatology Center of Mongolia (NDCM) have not yet been conducted.
The purpose of this study is to reveal the medicines affecting the development adverse reaction from 2013 to 2021 and aging groups’ specialty.
We conducted a study on the medical histories who were hospitalized at the NDCM from 2013 to 2021. We used retrospective design in the medical histories with L23, L27, and L50-53 diagnosis (ICD classification) and were selected medical histories that were patients were above 55 years. The age group classification was based on the “National Strategy for Population Ageing 2009-2030”. We analyzed total 170 elderly patients with CADRs (45.3%) were treated in that hospital during 2013-2021 and other patients dermatitis (approximately 55%) causes were food and chemical substances. In the 2013, geriatric CADRs cases were 20, in the 2021 were 31, therefore CADRs are likely to increase year by year. The common offending drug groups were antimicrobials (40%), and central nervous system drugs (1.4%). In the old age groups CADRs cases were 89 (55%), and young old group 46 (28.7%). The common offending drug groups were antimicrobials and central nervous system drugs for elderly patients. The most common adverse drug reactions of old age group.
- Pharma Industry and Bioindustry
- Pharmaceutical Engineering
Session Introduction
Tamar Gilon
Azrieli College of Engineering, Israel
Title: Educating Pharmacuetical Engineers in Preparation for the Biopharmaceutical drugs Industry
Biography:
Tamar Gilon has completed her PhD from The Hebrew University from The Department of Biochemstry and Molecular Biology The Hebrew Universty Jerusalem. From the year 2008 Tamar has been a faculty member at The Department of Pharmaceutical Engineering, Azrieli College of Engineering, Jerusalem and part of the developing team that build a unique pharmaceutical engineering multidisciplinary B.Sc degree. Academic activity performed include; Head of the Center for Promotion of Teaching & Learning, Member of the Departmental Pedagogical Committee, Tamar is an active researcher at the college in the field of fermentation of geneticly engineered bacteria for production of recombinant proteins
Abstract:
Biopharmaceutical drugs and biomanufacturing are a rapidly growing industry. Education and training for production and processing in these field are lagging. As part of the Pharmaceutical Engineering B.Sc. undergraduate program at Azrieli College of Engineering Jerusalem a hands on fourth year student laboratory training course was developed that centers on biotechnology methods and operating a bioreactor. This newly developed course applies pharmaceutical engineering knowledge, practical and theoretical, in the bioprocess and biopharmaceutical industry, including upstream optimization, fermentation and downstream process, based on the unique multidisciplinary curriculum of the Pharmaceutical Engineering degree. The aims of the course are to equip the pharmaceutical engineering students with the necessary knowledge and skills to function effectively within any area of the biopharmaceutical sector, with the adaptability to respond to the needs of a rapidly evolving industry and to facilitate the transition from academia to industry. At the core of the course, student preform a lab scale fermentation process for the production, purification and analysis of a recombinant active Tyrosinase enzyme. Tyrosinase can then be used to manufacture L-DOPA drug from L-tyrosine. The course is constructed of 6 hours of lectures following 22 hour of laboratory work. Student assessment are based on quizzes containing both theoretical and practical questions, laboratory work, learning skills and one cohesive report for the whole process, summarizing all the experiment data, results as well as calculation.
- Pharmacognosy and Medicine Science
Session Introduction
Ivan Kahwa
University of Science and Technology, Uganda
Title: Pharmacognostic studies, Total Flavonoid Content and Artemisinin concentration in Artemisia vulgaris L. leaves grown in Kamwenge District, Western Uganda
Biography:
Ivan Kahwa completed his Msc.in Pharmacognosy and Medicine Science from Mbarara University of Science and Technology and has attended several trainings in natural products from different institutions. He is the director of KivanWoods Herbal Products and also a part time lecturer at Mbarara University of Science and Technology. He has published more than 10 papers in reputed journals
Abstract:
Artemisia vulgaris L. is used for treatment of malaria in Western Uganda instead of Artemisia annua L. Until to date no scientific evaluation has been reported on whether the leaves of the two species have similar physical and chemical characters.The present study evaluated the botanical, physicochemical, and chemical characters of leaves of A. vulgaris L. Macroscopy and microscopy studies, histochemical, physicochemical properties, and chemical parameters were carried out using standard procedures. Macroscopically, the leaves are dark green, with a sweet, strong and aromatic odor, pleasant, tangy and bitter taste. Microscopically, epidermis is amphistomatic, has anomocytic stomata on both adaxial and abaxial leaf surfaces and bicellular, biseriate glandular trichomes and unicellular T-shaped non-glandular trichomes. Histochemical studies showed the presence of cell wall materials and cell inclusions. Leaf constants revealed stomatal number (10.0), stomatal index (32.6), palisade ratio (7.8), vein islet number (15.0) and vein termination number (17.0). Physiochemically, moisture content (8.10 %), total ash (10.30 %), acid-insoluble ash (1.60 %), and sulphated ash (13.90 %), water-soluble ash (5.02%), alcohol-soluble extractive (9.73 %) and water-soluble extractive (19.9 %). Chemically, all the preliminary secondary plant metabolites were present except saponins and anthraquinones. Major fingerprints of extracts were showed at nine (9) Rf values. Artemisinin concentration was 1.72% w/w and total flavonoid contents were 1.10 and 0.84 mg QE/g in diethyl ether and methanol extracts respectively. These findings are of importance in the establishing diagnostic features of A.vulgaris L. which could be used for identification and preparation of its monograph.