Day 2 :
Keynote Forum
Eliana Silva de Moraes
ABPVS, Brazil
Keynote: Global regulatory challenges and implications
Time : 09:30-10:00
Biography:
Eliana has her expertise in Food and Drug Law. She has 26 years’ experience in helping international pharmaceutical, health and food companies to gain presence in markets of Latin America and Europe, specially. She has an active participation in the harmonization of regulatory affairs process through the organizations that she represents. She has played an active role in setting up Brazil’s Public Health Regulator (ANVISA), organizing the agenda of its first Anvisa’s President in USA to explore the US specially the Food and Drug Administration (FDA) and Paho, in December 1998. She is President of the ABPVS a Regulatory Affairs Organization for Brazil and Latin America Countries and Lawyer at Silva de Moraes, Member of the Brazilian Bar Association and The Portugal Bar Association.
Abstract:
Becoming a global company is an impressive task specially to make strategic decisions for the product approval. One of huge challenges is the lack of uniform standards and regulations when selling and marketing in another country than of the product origin. It is impossible for to standardize a single application form of a product registration for different countries. Because of this the regulatory process can be costly and the product approval can take time. So, companies that intend to launch a product in an international market must think to develop a good regulatory strategy that allows dealing with each country separately (most of the time) and their regulatory staff needs to acquire knowledge to help accomplish with the regulations, locally. The purpose of this topic is to find common elements in the most varied regulatory systems that enable companies to more accurately identify the documents and information required by international regulators and understand technics that can help to reduce cost and time in the registration approval process globally. An analysis of the legislation of the different countries for the approval of registration of medical equipment and an identification the common elements will be discussed in a practical way.
Keynote Forum
Eliana Silva de Moraes
ABPVS, Brazil
Keynote: Global regulatory challenges and implications
Time : 09:30-10:00
Biography:
Eliana has her expertise in Food and Drug Law. She has 26 years’ experience in helping international pharmaceutical, health and food companies to gain presence in markets of Latin America and Europe, specially. She has an active participation in the harmonization of regulatory affairs process through the organizations that she represents. She has played an active role in setting up Brazil’s Public Health Regulator (ANVISA), organizing the agenda of its first Anvisa’s President in USA to explore the US specially the Food and Drug Administration (FDA) and Paho, in December 1998. She is President of the ABPVS a Regulatory Affairs Organization for Brazil and Latin America Countries and Lawyer at Silva de Moraes, Member of the Brazilian Bar Association and The Portugal Bar Association.
Abstract:
Becoming a global company is an impressive task specially to make strategic decisions for the product approval. One of huge challenges is the lack of uniform standards and regulations when selling and marketing in another country than of the product origin. It is impossible for to standardize a single application form of a product registration for different countries. Because of this the regulatory process can be costly and the product approval can take time. So, companies that intend to launch a product in an international market must think to develop a good regulatory strategy that allows dealing with each country separately (most of the time) and their regulatory staff needs to acquire knowledge to help accomplish with the regulations, locally. The purpose of this topic is to find common elements in the most varied regulatory systems that enable companies to more accurately identify the documents and information required by international regulators and understand technics that can help to reduce cost and time in the registration approval process globally. An analysis of the legislation of the different countries for the approval of registration of medical equipment and an identification the common elements will be discussed in a practical way.
Keynote Forum
Stephen F Amato
Northeastern University, USA
Keynote: Convergence of regulatory affairs and reimbursement/market Access
Time : 10:00-10:30
Biography:
Stephen F Amato has over 25 years of experience in the pharmaceutical, biotechnology and medical device industries. He is the Program Director of the Biomedical Regulatory Affairs Program in the Professional Advancement Network (PAN) at Northeastern University. Steve has also been the Managing Director of tJun 17 Life Sciences, LLC, an organization that facilitates the global commercialization of early stage medical technologies. Prior to founding and directing operations at Jun17 Life Sciences, Steve was the Executive Director of Marketing at Anika Therapeutics where he served as the Head of Anika's Marketing Department. In this role he
managed all aspects of the company's product portfolio including market segmentation, targeting, and positioning, pricing and promotional strategies. From 2000 to 2007 he was the Group Director of Knee Repair at Smith & Nephew Endoscopy where he managed a $140 M orthopedic product portfolio. Earlier in his career, Steve worked for Visible Genetics, where he was responsible for developing and launching genomic molecular diagnostics products used for subtyping Human Papilloma Virus (HPV) and other infectious disease agents. He has also worked with Critical Therapeutics on the development and commercialization of treatments for gram-negative sepsis. Steve holds an AB in Biochemical Sciences from Harvard University, a in Molecular and Cellular Biology from Boston College’s Graduate School of Arts & Sciences, and an MBA from the Carroll School of Graduate Management at Boston College. He has also received the US Regulatory Affairs Certification (RAC) designation and is a Consultant for the Regulatory Affairs Professional Society (RAPS).
Abstract:
The purpose of this study is to describe the evolution of convergence drivers between global regulatory science and reimbursement paradigms, outline the similarities and differences between 'safety and efficacy' and 'reasonable and necessary and to explain how cost effectiveness variables can be considered during evaluation of drug approval applications. In the European Union, specifically the UK and Germany, regulatory approval and reimbursement determination for biomedical products goes hand in hand. But few biomedical product companies in the US have taken advantage of the pilot programs that enable, for example, the parallel pursuit of both FDA approval and CMS national coverage determinations. These are
intended to alleviate some of the process heavy FDA and CMS requirements that the industry often views as hampering innovation. At the same time, pursuing both approvals to market and universal coverage with Medicare in parallel can seem daunting to biomedical product developers. It calls for smarter study design that matches the expectations of the FDA, CMS and private payers. That means not only focusing on clinical endpoints that prove the products to be safe and effective, but also demonstrating that the product is reasonable and necessary, and superior to others in its category. This presentation will outline both the benefits to the parallel review pilot program on the device side and the key factors device developers need to consider when pursuing a joint approval, including: Advocate for more transparency in the process – medical device
companies often shy away from opening the door to a conversation with the FDA, but in this case, dialog and gathering as much information as possible is key; establish guiding principles – timelines and expectations for both the FDA and CMS need to be clearly defined before trials begin; know when to call it quits–device developers can withdraw from the process at any time and need to see and interpret signs for decoupling the pursuit of both milestones. Through better design of the clinical development process, biomedical product manufacturers can address both regulatory science as well as payer standards during the commercialization process.
- Good Laboratory Practices | Good Pharmacovigilance Practices| Audits and inspections | Regulatory & Pharmacovigilance|FDA and related regulatory agencies
Location: Zurich
Chair
Eliana Silva de Moraes
ABPVS, Brazil
Co-Chair
Diadelis Remirez Figueredo
Devices and medical equipments (CECMED), Cuba
Session Introduction
Parminder Kaur
RegPak BioPharma Consulting, Netherlands
Title: Medical device vigilance in EU
Time : 13:50-14:10
Biography:
Parminder Kaur is a regulatory expert and a QPPV having 19 years of recognised global expertise in a broad range of therapy areas. She has also played a major role in setting the in-house RA and PV systems in compliance with the European regulations at various companies; assisted various companies during Inspections and Audits conducted by EU Regulatory Authorities. Parminder was awarded Sikh Business Women of the year award in 2014. In 2011, she led an IMI Project on combination therapy at EFPIA, in close collaboration with Research & Development Group (RDG) at European Commission. In March 2007, Mrs. Kaur had been selected by the European Federation of Pharmaceutical Industries and Association (EFPIA) for her global expertise and also had an honour to be the Scientific Representative from India for the year 2000-2001, duly sponsored by UNESCO. Parminder had also been a speaker, panellist and Masterclass provider at various National and international Conferences. Parminder is currently running her own regulatory affairs and pharmacovigilance consultancy, RegPak BioPharma
Consulting based in Amsterdam
Abstract:
Medical device vigilance is the monitoring of the safety profile of medical devices, from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action.This to ensure that patient’s and healthcare professional’s safety is monitored and action taken as soon as a safety concern with a medical device arises. Manufacturers are obliged to maintain robust medical device vigilance and post marketing surveillance systems in order to attain and maintain their CE certificate. This session will focus on requirements for a robust medical device
vigilance system in EU and how to achieve a strong QMS.
R C Jagessar
University of Guyana, Guyana
Title: Antimicrobial activity of the ethanolic and aqueous extract of Vicia faba L. (Fabaceae)
Time : 14:10-14:30
Biography:
R C Jagessar has obtained his BSc in Chemistry/Biology from the University of Guyana in 1992. He has then proceeded on a scholarship to pursue his PhD in the UK which he obtained in 1995. He pursued his Postdoctoral Research in the USA at the University of South Carolina, Wichita State University and later at the University of the West Indies, UWI. His research interests are broad, covering the spectrum of pure and applied chemistry, chemical biology, pharmaceutical and medicinal chemistry. He has won several international awards such as the Chartered Chemist, Chem of the Royal Society of Chemistry, Fellow of the Royal Society of Chemistry, FRSC, Royal Society Chemistry Research Grants etc. He is currently one of the recipients of the World Bank Grant from the University of Guyana Science & Technology Support Project Research Grant (2014-2016), UGSTSP. He has published 65 full peer reviewed papers, inclusive of four book chapters, exclusive of research abstracts, presented at conferences, both locally and internationally and has been a Reviewer of several international journals. He is currently a Lecturer of Chemistry in the Department of Chemistry.
Abstract:
The aqueous and ethanolic extract of Vicia faba L. (Fabaceae) exhibited antimicrobial activity against the pathogenic microorganisms: E. coli, S. aureus, K. pneumoniae and C. albicans. This was evaluated using the Disc Diffusion Assay under aseptic conditions. Antimicrobial activity was not induced by the solvent, ethanol nor water as the diameter zone of inhibition (DZOI) was less than 5 mm. The highest area of zone of inhibition (AZOI) was 153.9 mm2 and the lowest 12.56 mm2. Negligible Zone of Inhibition (ZOI) was observed in several instances. The aqueous extract of the fruit also induced negligible zone of inhibition. In comparison to the reference, Ampicillin and Nystatin, values are less. As the concentration of the metal salt, Zn(OAc)2.2H2O and ethanolic extract increases, there seem to be a variation in antimicrobial activity. Zn(OAc)2.2H2O appears to intensify the antimicrobial activity of Vicia faba L. ethanolic and aqueous extract. Zn(OAc)2.2H2O in the absence of any extracts exhibited antimicrobial activity, the AZOI range from 47.2 mm2 to 117.8 mm2. Antimicrobial selectivity was also observed in several instances, for example, the ethanolic extract induces AZOI of 50 mm2 against C. albicans whereas negligible AZOI was obtained against K. pneumoniae and E. coli.
Michael Drues
Vascular Sciences, USA
Title: The many connotations of risk and the consequences of getting them wrong
Time : 14:30-14:50
Biography:
Michael Drues, is a regulatory strategy consultant specializing in designing novel regulatory strategies to bring new and innovative medical products to market and in developing effective communication strategies between companies and regulatory agencies to minimize time to market and avoid delays Dr. Drues received his B.S., M.S.,. degrees in Biomedical Engineering from Iowa State University. He works with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration, Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services and other regulatory and governmental agencies around the world. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and shortcourses
for medical device, pharmaceutical and biotechnology companies, the FDA, Health Canada, the US and European Patent Offices, CMS and other regulatory and governmental agencies around the world. Finally, Dr. Drues is an Adjunct Professor of Regulatory Affairs, Medicine and Biomedical Engineering at several universities and medical schools. He regularly teaches graduate courses in Regulatory Affairs and Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs and Product Development, Combination Products and Pathophysiology.
Abstract:
Risk is a topic of importance from both regulatory and quality perspectives. However, despite have systems and standards in place, not dealing with risk appropriately continues to be a frequent cause of problems to the industry. Risk mitigation typically starts with a brainstorming session: the product development team randomly rattles off risks and writes them down.
This “cherry-picking” approach is a haphazard process because whether you spend an hour or a year, you can never be certain you have captured all the important risks. This workshop is not the typical ISO14971, QMS or Design Control approaches which although commonly followed, all take a very limited view of risk and is simply not adequate! During this workshop, a
systematic, engineering-minded approach to risk is presented. Multiple examples of devices are used to demonstrate:
What are the three buckets of risk and how to apply them?
What’s the difference between a risk mitigation strategy and a risk management plan?
How to deemphasize or not draw attention to certain risks?
What’s the relationship between risk mitigation and product liability?
How to handle risks in off-label uses without creating product liability nightmares?
How to factor regulatory risk into the equation?
Ultimately risk is not a simple matter. Manufacturers need to understand the impact of risk mitigation strategy on a regulatory submission as it can make or break a submission, especially a 510(k) or de novo. Your risk management plan is also very important, not just to meet the design control requirements, but in terms of product liability, as well. A successful medical device manufacturer must carefully consider not only what you say regarding risk and how you say it, but also what you don’t say and how you don’t say it! What to know more? See: How to Think Outside the Checkboxes of Risk Management.
Using the Bucket Method for Medical Device Risk Management. Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? Risk Management from a Regulatory & Product Development Perspective. Intersection of Usability and Risk Management (April, 2017). The Many Connotations of Risk and Consequences of Getting Them Wrong. Risk Management for Medical Device Manufacturers
P Brindha
Sastra University, India
Title: Traditional plant drugs as potential immunomodulators
Time : 14:50-15:10
Biography:
Abstract:
Management of various diseases through immunomodulation is the current trend and recent researchers worldwide are focusing their research towards developing immunomodulating plant drugs that act as prophylactic or therapeutic agents. Adverse side effects such as kidney failure, anemic conditions, bone marrow disorders and sudden decrease in platelet counts which are often encountered due to the longer administration of synthetic immunomodulatory agents have forced researchers to take up researches on immunomodulatory drug development. Besides synthetic immunomodulatory agents are costly, hence there is a need for an alternative cost effective human friendly plant based immunomodulatory agents. A review is carried out on traditional Ayurveda and Siddha literature to suggest natural herbal sources that could enhance immune system either as immunostimulator or as immune suppressor and contribute towards the health care of human society. These plant drugs could be used successfully in the management of various immune dysfunctions or in case of residual cancer. Several molecules have also been isolated from these plant sources which stimulate immune responses. In the present paper various immunomodulatory plant sources available in India are discussed and presented.
Rashid Mahmood
Surge Laboratories Private Limited., Pakistan
Title: Cleaning validation in pharmaceuticals
Time : 15:10-15:30
Biography:
Rashid Mahmood has completed Master’s degree in Analytical Chemistry and in Total Quality Management. He has 13 years of experience of Pharmaceutical Quality Operations and has attended many international conferences as a keynote speaker. Currently he is working as a Senior Executive Manager Quality
Operations for Surge Laboratories Pvt. Ltd, Pakistan
Abstract:
In the manufacturing of the pharmaceutical products, it is very necessary to reproduce consistently the desired quality of product. The current Good Manufacturing Practice (cGMP) regulations recognize that cleaning is a critical issue to ensure product quality. The control of cross contamination plays a critical role in maintaining the quality of the product. The manufacturing of API and pharmaceutical products involves series of processing steps and use of various equipments. In many cases, the same equipment may be used for processing different products. Residual materials from the previous batch of the same product or from different product may be carried to the next batch of the product, which in-turn may alter the quality of the subjected product. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product including intermediates and impurities, cleaning agents and extraneous material into subsequent product to a level which is below predetermined level. The documented evidence of the consistent performance of the cleaning process is given by the validation process. It ensures safety, efficacy and quality of the subsequent batches of the drug product. In this article the various aspects of the cleaning validation such as different types
of contaminants, sampling procedures, analytical techniques and regulatory requirements are discussed in detail.
Muhammad Naeem,
Indus Pharma (Pvt.) Ltd, Pakistan
Title: Roadmap to pharmaceutical regulatory harmonization in Pakistan
Time : 15:50-16:10
Biography:
Muhammad Naeem has more than 19 years diversified experience in quality operations, regulatory affairs, research and development. He has done certificate courses on cGMP, GLP, Process Validation, ISO/IEC 17025:2005, 14001:2004, OHSAS 18001:2007, SA 8000 and 9001:2008. He is a Member of International Society for Pharmaceutical Engineering (ISPE) and Regulatory Affairs Professional Society (RAPS), USA. He has extensive knowledge of ICH, USP, BP, ASTM, and HACCP and has led several investigational/developmental and technical/analytical projects at CMOs in USA, Europe and Pakistan. Some of the major pharmaceuticals he served are Pfizer & Takeda (USA), CCL Pharmaceuticals and INDUS Pharma, Pakistan. He has strong scientific, analytical, planning, managerial and training skills.
Abstract:
Introduction: Provision of affordable quality pharmaceuticals is an integral part of every national health policy. Attaining optimal quality standards for pharmaceutical products is impossible without an effective pharmaceutical regulation regime that protects public health by ensuring safe, effective and quality pharmaceuticals and detecting illegal manufacturing and
trade. Pakistan, despite having a large Pharmaceutical sector (over 600 manufacturing units; market size of around 3 billion dollars) has not realized its true potential in the area due to non-adherence to globally accepted quality standards. There is a huge unexploited potential for export of the country's pharmaceutical products especially in the context of the GSP Plus status
granted to Pakistan by the European Union. History & Challenges: In Pakistan, the ministry of health (MoH) used to regulate drug manufacturing and pricing at the federal level. After the decentralization of the Health Ministry (2011), Drug Regulatory Authority of Pakistan (DRAP) came into being (December 2012). DRAP has been continuously evolving and advancing in its vision and procedures; there is still a long way to go in order to overcome its current challenges like premarket evaluation and registration, post-market surveillance, cost recovery, price control, international harmonization, access to regulated markets and capturing the scientific advancements for modernization of act and regulations etc.
Recommendations: Promote harmonization of regulatory processes by adopting globally harmonized standards; establish targeted capacity-building for quality APIs; introduce an online submission system for dossiers/query responses etc., train the regulators; hire more staff and set transparent pricing rules.
Conclusion & Significance: Pharma regulatory authorities all over the world are rapidly advancing. Likewise, DRAP is already on its way for reformation and improvement. The recommendations in this presentation may prove helpful for DRAP in its journey towards excellence.
Parminder Kaur
RegPak BioPharma Consulting, Netherlands
Title: Early access to unapproved medicines in EU
Time : 16:10-16:30
Biography:
Parminder Kaur is a Regulatory Expert and a QPPV having 19 years of recognized global expertise in a broad range of therapy areas. She has also played a major role in setting the in-house RA and PV systems in compliance with the European regulations at various companies; assisted various companies during inspections and audits conducted by EU Regulatory Authorities. She was awarded Sikh Business Women of the year award in 2014. In 2011, she led an IMI Project on combination therapy at EFPIA, in close collaboration with Research & Development Group (RDG) at European Commission. In March 2007, she was selected by the European Federation of Pharmaceutical Industries and Association (EFPIA) for her global expertise and also had an honor to be the Scientific Representative from India for the year 2000-2001, duly sponsored by UNESCO. She is currently running her own regulatory affairs and pharmacovigilance consultancy, RegPak BioPharma Consulting based in Amsterdam.
Abstract:
Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs. EAPs offer ethical, compliant and controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. In addition to the development of positive relationships with key opinion leaders (KOL), patients, advocacy groups and regulators, the data captured from the implementation of EAPs supports in the formulation of global
commercialization strategies. This session outlines various circumstances to be considered for the implementation of EAPs named patient programs, EU regulatory landscape, the benefits and challenges associated with implementing these programs and the key considerations for their successful implementation.
Yavuz S SILAY
ICG (Istanbul Consulting Group), USA
Title: Strategic trends, current and future competitive landscape in biologics and biosimilars (follow-on biologics) drug development in USA and emerging markets-a brief snapshot from 2012 through 2022
Time : 16:30-16:50
Biography:
Dr. Silay serving as the Chairman of Labiopharma, LLC in US, providing clinical trial administration, market access, medical writing, patient recruitment, retention, regulatory and medical affairs support, drug repositioning for hospitals, academic institutions and pharmaceutical companies from preclinical to post marketing stages for several years. Dr. Silay is also providing comprehensive and strategic consulting services for the approval of Drugs and Medical Devices and attended several meetings with FDA, EMA, Health Canada and Turkish Health authorities and social security institute. Dr. Silay in US, most recently worked as the Vice President, Medical Affairs, and head of Medical Affairs Neurology in the US headquarters Basking Ridge, New Jersey reporting to the President and CEO of Ipsen
North America where he was key in building a Neurology Franchise by hiring many employees. He has Proven ability to build high performing teams and productive organizations, turn around brands, and build revenue in diverse markets. As the former director, Market Access & Health Policy for AIFD( Research Based Pharmaceutical Companies) which the 40 members represent all major global pharmaceutical companies, 650 billion dollars of 1 billion dollar Global Pharmaceutical market. He represented pharmaceutical companies and was in discussion with all ministerial levels, including ministry of health, finance, labor, development and science& technology in Turkey.
Abstract:
A presence in biologics and biosimilars has become a strategic priority for nearly all the world’s leading and emerging pharmaceutical companies. Below is an approximate snapshot of biologic drug sales for top 10 pharmaceutical companies during last five years and future five years will be discussed. Biosimilars or follow-on biologics are similar terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. The following topics during this presentation will be briefly discussed; Historical growth of the biologics market, Leading players, Changes to the competitive landscape 2017-2022 and Outlook for the biologics market, Leading players in 2016 vs 2022. Subsequently; Some examples of biosimilars and how it may affect the biologics will be briefly explained. While the FDA designates interchangeability, states control drug substitution laws. Once an interchangeability designation is acquired, a biosimilar may be substituted for the reference product by the pharmacist at the retail or specialty pharmacy without the intervention of the prescriber in states that have approved legislation or regulation establishing state standards for biosimilar substitution. As of January 2017, there are no interchangeable biologics approved in the U S. Biologics generally exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes, unlike the more common small-molecule drugs. The follow-on manufacturer may not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product. Differences in impurities and/or breakdown products may have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the product. While summarizing above dynamics, the status and most recent developments in biologics and biosimilar (follow-on) drug development in United States of America and global trends will be explained.
- Global Regulatory Affairs | Regulatory Enforcement & Inspection | Audits and inspections | Good Laboratory Practices| Good Pharmacovigilance Practices
Location: Zurich
Chair
Stephen F Amato,
North Eastern University, USA
Co-Chair
Eliana Silva de Moraes
ABPVS, Brazil
Session Introduction
Diadelis Remirez Figueredo
Devices and medical equipments (CECMED), Cuba
Title: Pharmacogenetic: Regulatory considerations, cuban guidance
Time : 12:20-12:40
Biography:
Diadelis Remirez Figueredo has received her BA in Biochemistry from Havana University, Cuba and both her MSc in Biomedicine and PhD in Pharmaceutical
Sciences from National Center for Scientific Research in Havana and most of the results were done in the Department of Toxicology at the Free University in
Amsterdam. Her Postdoctoral training in Molecular Toxicology and Pharmacology was completed at the Faculty of Pharmacy in Toronto, Canada. She has been a referee of scientific journals. She has been the recipient of National Award of Pharmacology twice from the Cuban Pharmacology Society. She has worked as an expert for the evaluation of preclinical platform in South Africa (CSIR). She is currently the Vice President of Cuban Pharmacology Society. Presently she works in the Cuba Regulatory Agency and she is one of the Reviewers for authorization of clinical trials. She is the Project Leader about Pharmacogenetic guideline. She belongs to Iberoamerican Pharmacogenetic Network (RIBEF) since 2008 and recently obtained Master degree in Clinical Trials. Her research is described in over 30 published research reports.
Abstract:
The science of pharmacogenomics has advanced significantly in the last five years. The Pharmacogenomics helps identify inter-individual variability in drug response (both toxicity and effectiveness). This information will make it possible to individualize therapy with the intent of maximizing effectiveness and minimizing risk. This discipline is a big challenge for regulatory authorities. The aim of this work is to present the bases of pharmacogenetic, the state of art and implications of this discipline for Latin-American countries and to show the Cuban Guidance for Industry. International literature was reviewed about the existing regulations, guidance, concept paper, scientific articles and the national regulations related with the topic. The results showed that there are several normative and guidance related with pharmacogenomic; the increase of biological product registration and authorized clinical trials in Cuba and the necessity for carrying out pharmacogenetic studies during the clinical phases of our products. We will show the main biomarkers for pharmacogenetics studies and a Cuban general
guidance for submission of this type of research. It is divided mainly in four sections: Introduction, objectives and scope, terms and definition and regulatory recommendations (reception, codification and sample storage biomarkers, and ethical considerations). This Cuban guidance will be considered the first guidance related with pharmacogenomic in Latin America.
Pharmacogenetic has several advantages in order to get rational use of drugs but still there are many challenges. The hope for the future is that through personalized medicine, doctors and patients will be able to make better-informed choices about treatment.
Young Kee Shin
Seoul National University, Korea
Title: Development of the molecular diagnostics considering the quality of damaged nucleic acids from formalin-fixed paraffin-embedded tissue samples
Time : 14:30-14:50
Biography:
Abstract:
Cancer molecular diagnostics has rapidly grown through the utilization of the prognostic algorithm and the predictive biomarker for patients. Nucleic acid extracted from formalin-fixed, paraffin-embedded tissues (FFPET) is frequently subjected to dispute because it causes extensive damage and produces imprecise diagnostic result, while it is the most widely used resource for molecular diagnostic analysis. Moreover, the false result of mutation analysis by damaged nucleic acids could cause serious problems in diagnostic fields. Artifactually sequence variants arising from nucleic acid damage in FFPET will be more frequently detected because of stochastic enrichment in the low copy number context increases the risk of false positives. A large amount of previous clinical researches have neglected the quality of samples yielded controversial results. Thus, the evaluation and standardization for the quality of nucleic acid samples should be considered to apply nucleic acids
from FFPET to the molecular diagnostics. In the last ten years, we have tried to reflect the quality of nucleic acids from FFPET for prognostic and molecular diagnostic use. First, we developed a novel prognostic model using measurement of RNA expression in FFPET by quantitative real-time RT-PCR to predict the risk of distant metastasis of pN0-N1, hormone receptorpositive,
HER2-negative (HR+/HER2−) breast cancer patients. In this development, we applied novel FFPET-specific reference genes to calculate the relative mRNA expression levels of six prognostic genes and standardized mRNA expression value were reflected to its algorithm. Second, we established sample criteria for the minimum DNA quality from FFPET suitable for application to ddPCR-based EGFR mutation test and developed a novel follow-on companion diagnostics kit applying this sample criteria. In summary, the establishment of a robust standard for FFPET-derived nucleic acids would be the most critical
point in development of molecular diagnostics and this effort could contribute to mitigation of the molecular diagnostic risk.
Olorunfunmi
Bingham University, Nigeria
Title: Prevalence of anemia in pregnancy among women visiting antenatal clinic in bingham university teaching hospital
Time : 14:50-15:10
Biography:
Olorunfunmi is a Clinician working in Bingham University Teaching Hospital, Jos, Nigeria. His research interest is in maternal and child health, noncommunicable diseases and health policy development in developing countries.
Abstract:
Background: In developing countries such as Nigeria, anemia in pregnancy is thought to be commonest problem affecting pregnant women accounting for a significant level of maternal mortality.
Objectives & Method: This study was carried out to determine the prevalence of anemia in Pregnancy among Women Visiting Antenatal Clinic (ANC) in Bingham University Teaching Hospital (BHUTH). This is a cross sectional descriptive study conducted from 24th August to 28th September, 2015 on 237 women. A semi-structured interviewer-administered questionnaire was used to obtain socio-demographic, obstetric, nutritional and some hematological (blood group and genotype) information from the pregnant women who gave consent at each antenatal clinic day (Mondays and Thursdays). Packed Cell Volume was used to assess the level of anemia.
Result: The prevalence of anemia in pregnancy was found to be 43.5%. Amongst all women who were anemic, 83.9%, 8.7% and 2% were found to have mild, moderate and severe anemia respectively. Also, 0.9%, 35.9%, 52.4% of these women were found to be in their first, second and third trimesters respectively; 61.2% were multi-parous women (para 2-4); 24.3% women had only two antenatal clinic visits; 66.2% women had tertiary level of education; 99% women were married; 29.1% women were within the age group 34-39 years; 89.3% women had been taking balanced diet; 89.3% women were on their routine drugs; 66.0% women used insecticide treated net; 66.0% women had taken anti-malarial prophylaxis. Reduced ANC visits and increasing age where significant factors associated with anemia in pregnancy.
Conclusion: Prevalence of anemia amongst pregnant women in BHUTH was 43.5%. Commonest type of anemia in this study is mild anemia. Emphasis should be made on adequate nutrition and use of haematinics especially in late trimester as well as compliance with ANC visit among pregnant women in developing countries.
R C Jagessar
University of Guyana, Guyana
Title: Antimicrobial activity of the ethanolic and aqueous extract of passion fruit (Passiflora edulis Sims) in the absence and presence of transition metal salts
Time : 15:10-15:30
Biography:
R C Jagessar has obtained his BSc in Chemistry from the University of Guyana in 1992 and pursued his PhD in the UK which he obtained in 1995. He did
Postdoctoral Research in the USA at the University of South Carolina, Wichita State University and later at the University of the West Indies, UWI. His research interests are broad, covering the spectrum of pure and applied chemistry, chemical biology, pharmaceutical and medicinal chemistry. He has won several international awards such as the Chartered Chemist, CChem of the Royal Society of Chemistry, Fellow of the Royal Society of Chemistry, FRSC, Royal Society Chemistry Research Grants etc. He has published 65 full peer reviewed papers, inclusive of four book chapters, exclusive of research abstracts, presented at conferences, both locally and internationally and has been a Reviewer of several international journals. He is currently working as a Lecturer of Chemistry in the Department of Chemistry, University of Guyana.
Abstract:
The aqueous and ethanolic extract of passion fruit (Passiflora edulis Sims) was investigated in the absence and presence of transition metal salts using the Disc Diffusion Assay under aseptic conditions. For the ethanolic extracts 1-3, the highest AZOI of 153.9 mm2 was induced by sample 1; 0.015 g/ml of extract against C. albicans. The lowest AZOI of 15.9 mm2 was also induced by sample 3; 0.1 g/ml of ethanolic extract against K. pneumoniae. There seems to be a general increase in AZOI as the concentration of ethanolic extract increases. From the ethanolic extract, a white isolate crystallized and its antimicrobial
activity was investigated at increasing concentration (sample 4-5). For sample 4-5, the highest AZOI of 149.5 mm2 was induced by the aqueous solution at a concentration of 0.026 g/ml against P. aeruginosa. The lowest AZOI of 30.7 mm2 was induced by the white isolate at a concentration of 0.052 g/ml against K. pneumoniae. For sample 6 and 7, 0.1g of Zn (OAc)2.2H2O in 10 ml aqueous extract and 1.0 g of Zn(OAc)2.2H2O in 10 ml of aqueous extract, it was observed that the highest AZOI of 67.2 mm2 was observed against E. coli, whereas, the lowest AZOI of 21.6 mm2 was observed against C. albicans. The AZOI induced by sample 8, 1.0 g of Zn (OAc)2.2H2O in 10 ml of aqueous solution is greater than sample 7, suggesting that Zn(OAc)2.2H2O augment the antimicrobial activity of the aqueous passion fruit extract. Antimicrobial selectivity was also observed. For example, against S. aureus, sample 1 exhibit AZOI of 32.2 mm2 whereas against C. albicans, AZOI of 153.9 mm2 was observed. For all experiments conducted, antimicrobial activity seems to be less than that of the standard antibiotics like Ampicillin and Nystatin. Nevertheless, the ethanolic and aqueous extracts of green passion fruit can be used as a natural antibiotic against a range of bacteria induced diseases.
Farah Khalil Yousef
Damascus University, Syria
Title: Formulation and evaluation of herbal tablets and capsules containing Urtica dioica extract
Time : 15:30-15:50
Biography:
Abstract:
Urtica dioica (Stinging Nettle) is one of the most popular plants, whose dietary and therapeutic benefits have been known since ancient times. The therapeutic activity of nettle leaves extracts in arthritis and osteoarthritis is related basically to the presence of phenolic compounds and their antioxidant activity. Literatures indicate that plants maturation leads to changes of their chemical composition. So firstly, we compared number of extracting methods to determine the one that gives the highest total content of phenolic compounds for which Folin-Ciocalteu method was applied. Secondly, the prepared soft extract was inserted in tablets and capsules formulations. Results showed that the optimal extracting method was in using fresh young leaves with ethanol 95% as extracting liquid at 70° C with reflux condenser, for five hours. We successfully developed the Urtica dioica herbal tablets using the wet granulation method. The best pharmaceutical formulation, contained calcium carbonate as filler, magnesium stearate and sodium benzoate as lubricants, sodium carboxy methyl cellulose (CMCNa) as disintegrating agent and alcoholic polyvinyl pyrolidone solution as binder. These granules formulation components were also successfully prepared to be filled later in hard capsules.
Hanaa A M Elgailany
Sudan University of Science and Technology, Sudan
Title: Antibacterial activity of lawsonia inermis (Sudanese Henna) leaves extracts against staphylococcus aureus, escherichia coli and pseudomonas aeruginosa among recurrent urinary tract infection patients
Time : 16:30-16:50
Biography:
Hanaa A M Elgailany was graduated from College of Medical Laboratory Science (Microbiology) and has been awarded MSc degree in the same discipline. She is very enthusiastic, very competent and popular among her colleagues. She works as a Cooperator with Sudanese Red Crescent and other medical camps.
Abstract:
This was a descriptive and cross sectional study conducted from May to August 2015 to determine the antibacterial activity of Lawsonia inermis (Henna) leaves extract against Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa among recurrent urinary tract infection patients. A total of 100 urine samples were collected and inoculated on to Cystine Lactose Electrolyte Deficiency (CLED) media and identified by conventional method. 32 (32%) out of 100 investigated samples showed bacterial growth. Out of 32 isolated bacteria, 4 were Staphylococcus aureus (12.5%), 16 Escherichia coli (50%) and 3 Pseudomonas aeruginosa (9.4%). The reminder 9 (28%) were other bacteria. The antibiotic susceptibility testing was performed using standard disk diffusion method. The results showed that all S. aureus isolates were resistant to penicillin, 2 (50%) were susceptible to oxacillin while 2 (50%) were oxacillin resistance. Susceptible E. coli were 12 (75%), (88%) showed resistance to Nalidixic acid followed by Ceftriaxone (81%), Ciprofloxacin (75%) and Gentamicin (69%). P. aeruginosa susceptibility results showed high resistance to Nalidixic acid (100%) followed by Gentamicin (67%), Ceftriaxone (33%) and was susceptible to Ciprofloxacin. The antibacterial activity of Lawsonia inermis water and methanol leaves extract against selected organisms and standards was performed at different concentrations using the agar dilution method. Methanol extract of Lawsonia inermis showed antibacterial activity against S. aureus, S. aureus ATCC29213, E. coli, E. coli ATCC25922, P. aeruginosa and P. aeruginosa ATCC27853 also water extract showed antibacterial activity against all strains except E. coli and E. coli ATCC25922. The MIC of Henna methanol and water extracts obtained by agar diffusion method for S. aureus isolates were 12.5 mg/ml and 25 mg/ml, P. aeruginosa isolates were 6.25 mg/ml and 12.5 mg/ml respectively, E. coli isolates was 25 mg/ml in methanol but resistance to water extract. Gas chromatography analysis revealed that L. inermis has 51 chemical compounds, 30 of them have antibacterial activity
Anil Batta
GGS Medical College, India
Title: Biochemical diagnosis of acute pancreatitis
Time : 16:50-17:10
Biography:
Anil Batta is presently a Professor and Senior Consultant in Baba Farid University of Health Sciences/GGS Medical College, India. He did his MBBS and MD in Medical Biochemistry from Government Medical College, Patiala in 1984 and 1991, respectively. His research interest is mainly in clinical application especially cancer and drug de-addiction. He has published more than 30 international research papers. He is the Chief Editor of American Journal of Biochemistry. He is also working as an Advisor to the Editorial Board of International Journal of Biological and Medical Research. Recently, he has been deputed advisor to Pakistan Medical Journal of Biochemistry.
Abstract:
The diagnosis of acute pancreatitis requires the presence of at least two of the three diagnostic criteria; characteristic abdominal pain, elevated serum amylase or lipase and radiological evidence of pancreatitis. Serum concentrations of
amylase and lipase rise within hours of the pancreatic injury. A threshold concentration 2-4 times the upper limit of normal is recommended for diagnosis. Serum lipase is now the preferred test due to its improved sensitivity, particularly in alcoholinduced pancreatitis. Its prolonged elevation creates a wider diagnostic window than amylase. Laboratory testing of serum amylase and/or lipase levels are central to the diagnosis of acute pancreatitis (AP) as these tests are quick, cheap, reliable and perhaps the only objective criteria available at the bedside at the time of initial presentation. It is important to understand the physiology and biochemistry of these tests in order to get a clear grasp of their diagnostic utility. Lipase is more specific than
amylase and stays elevated longer than amylase due to its longer half-life in serum resulting from renal tubular reabsorption. There is no advantage of testing lipase and amylase, as well as no advantage in serially trending them for monitoring the clinical progress of the patient. They have no role in determining the etiology or severity of acute pancreatitis. If the clinical suspicion for acute pancreatitis is high, imaging studies should be performed to confirm or rule out the diagnosis of acute pancreatitis even with low elevation or no elevation of these enzymes. This article is a comprehensive review of the existing literature on serum lipase and amylase as diagnostic tools for AP and their cut off levels used for the diagnosis of AP. Neither enzyme is useful in monitoring or predicting the severity of an episode of pancreatitis in adults. New biomarkers including trypsinogen and elastase have no significant advantage over amylase or lipase.
Lisette Pérez Ojeda
CECMED, Cuba
Title: Strengthening health regulation in the americas: The experience of N the national regulatory authorities of regional reference
Time : 17:10-17:30
Biography:
Lisette Perez Ojeda is a Professional in Pharmaceutical Sciences with 20 years of experience, 15 of them in the sector of Health Regulation of Medicines, focused mainly on the management of international cooperation from the National Regulatory Authorities, networking, project management, negotiation and implementation of agreements, the construction and monitoring of action plans, intellectual property and its linkage with access to medicines and other health technologies and the development and publication of scientific publications. She is also a Member of the Secretariat of the Regional Reference Regulatory Authorities.
Abstract:
The regulation and quality assurance of health technologies is a crucial element in the development of national pharmaceutical policies and the national regulatory authorities are responsible for implementing these actions; of its development and level of maturity will depend on the quality, safety and effectiveness of the medical products that are made available to the
populations. In the Americas region, since 2009, an evaluation and certification process has been developed that allows the designation of Regulatory Authorities of Regional Reference for medicines and biological products. To date, eight authorities have been certified and work together to achieve regulatory convergence through information exchange to streamline regulatory
decision-making and regional cooperation to promote development of other authorities in the region, actions that have a direct impact on access to effective health technologies of guaranteed quality. The networking work has allowed the development of an important group of cooperation activities towards other NRAs in the region for the development and strengthening of their regulatory capacities, as well as a mutual recognition work that allows timely access to health technologies such as safety, quality and effectiveness guaranteed.