Title: A novel affimer® drug conjugate platform to modulate the TME

Abstract:

The Affimer platform is an antibody mimetic scaffold based on the human protease inhibitor, Stefin A and we have generated a range of antagonists against several key checkpoints such PD-L1. With our anti-PDL1 Affimer Fc we have demonstrated total tumour regression in mouse syngeneic models in combination with Talabostat and immunity to rechallenge with tumour cells, showing that we have achieved an immune memory response. Conjugating talabostat to an affimer antagonist using a novel FAP-alpha cleavable linker (TMAC™), we have demonstrated tolerability and efficacy in mouse syngeneic models.

Biography:

Amrik has a PhD in biochemistry/protein engineering from the university of leicester after which he spent 6 years at the Institute of Biotechnology, Cambridge University investigating bacterial pathways involved with the metabolism of illicit drugs and high explosives. In 2002, Amrik joined domantis Ltd developing domain antibodies. Following the acquisition of domantis by GSK, he became head of topical delivery (Biopharm Discovery Unit), supporting the development of biotherapeutics for delivery into the eye, skin and lung. In 2013 he joined Avacta as chief scientific officer to develop the Affimer platform for therapeutic use.

Title: Industrial Practices for Determining Biopharm Products’ Critical Quality Attributes (CQAs)

Abstract:

Analytical methods have been playing a major role in creating in vitro and in vivo product characterization packages. Compiling both sets of data helps in-depth understanding of product’s quality attributes (QA) and helps in the determination of product’s CQAs. It is proven that some CQAs have impact on the product’s safety and biological profiles. Biopharm industry is now revising their testing strategies to accelerate product development. This talk will connect analytical, CQAs, and clinical outcomes in product’s development.      Analytical methods have been playing a major role in creating in vitro and in vivo product characterization packages. Compiling both sets of data helps in-depth understanding of product’s quality attributes (QA) and helps in the determination of product’s CQAs. It is proven that some CQAs have impact on the product’s safety and biological profiles. Biopharm industry is now revising their testing strategies to accelerate product development. This talk will connect analytical, CQAs, and clinical outcomes in product’s development.      

Title: Hot melt extrusion an emerging drug delivery technology of 21st Century

Abstract:

Hot melt extrusion (HME) is emerging technology which is gaining high importance in the pharmaceutical industry as a novel technique for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. It is a fast growing technology platform that is utilized to solve difficult formulation challenges, primarily in the area of solubilization. Due to fast processing, high degree of automation, absence of solvents, simple and continuous operation and ability to process poorly compactable material into tablet form are some of the main advantages offered over conventional processing by this emerging technique. Applications of HME in pharmaceutical industry continues to grow and recent success of this technique have made it a useful tool of consideration as a drug delivery solution. The use of hot-melt extrusion (HME) within the pharmaceutical industry is steadily increasing, due to its proven ability to efficiently manufacture novel products. . HME involves the application of heat, pressure and agitation through an extrusion channel to mix materials together, and subsequently forcing them out through a die. Twin-screw extruders are most popular in solid dosage form development as it imparts both dispersive and distributive mixing. It blends materials while also imparting high shear to break-up particles and disperse them. HME extrusion has been shown to molecularly disperse poorly soluble drugs in a polymer carrier, increasing dissolution rates and bioavailability. The utilization of hot-soften expulsion (HME) inside the pharmaceutical business is consistently expanding, because of its demonstrated capacity to productively make novel items. The procedure has been used promptly in the plastics business for longer than a century and has been utilized to make clinical gadgets for a very long while. The improvement of novel medications with poor dissolvability and bioavailability brought the use of HME into the domain of medication conveyance frameworks. This has explicitly been appeared in the advancement of medication conveyance frameworks of both strong dose structures and transdermal patches. HME includes the utilization of warmth, weight and tumult through an expulsion channel to combine materials, and along these lines driving them out through a kick the bucket. Twin-screw extruders are generally well known in strong measurement structure advancement as it gives both dispersive and distributive blending. It mixes materials while additionally granting high shear to separation particles and scatter them. HME expulsion has been appeared to molecularly scatter ineffectively dissolvable medications in a polymer bearer, expanding disintegration rates and bioavailability. The most widely recognized trouble experienced in delivering such scatterings is adjustment of shapeless medications, which keeps them from recrystallization during capacity. Pharmaceutical mechanical providers, of the two materials and gear, have expanded their improvement of hardware and synthetic concoctions for explicit use with HME. Unmistakably, HME has been distinguished as a significant and huge procedure to additionally upgrade tranquilize solvency and strong scattering creation. The pharmaceutical improvement of nebulous strong scatterings (ASDs) by hot-liquefy expulsion (HME) is quickly evaluated. A deliberate bit by bit approach is introduced, where thermodynamics, polymer screening, multivariate measurements and procedure enhancement are consolidated, to expand the accomplishment of HME-based medication item advancement. The quality by structure (QbD) idea is acquainted and applied with HME. Steps and devices for its successful execution are given, including hazard evaluation featuring pivotal focuses. The specialized and logical specificities of HME-based ASDs are talked about considering the current worldview of medication advancement and in-accordance with administrative rules from the ICH areas. Contextual investigations of as of late affirmed HME items are introduced. Pharmaceutical improvement expects to give vigorous information through the utilization of deliberate methodologies that permit planning a quality item and its assembling procedure reliably. The data and information gathered from improvement and creation ought to give the logical comprehension to help a plan space, sedate item particulars and procedure controls. The total comprehension of the plan and procedure is united in the Common Technical Document and afterward used to present another medication application to the capable specialists . In HME-based medication items, a powerful pre-definition appraisal is the way in to a fruitful turn of events. A bit by bit approach, beginning with the thermodynamic assessment of a few frameworks, trailed by a polymer screening test combined with multivariate measurable investigation, is helpful to quickly recognize the most encouraging HME frameworks. This is the best approach to abstain from sitting around idly, cash and exertion in bombed synthesis

Biography:

Rashid Mahmood has master degree in analytical chemistry and MS in total quality management. He has 15 years of experience of pharmaceutical quality operations and has participated in many international conferences as a keynote speaker. He has presented various talks in USA, Canada, UK & UAE on cleaning validation, cGMP guidelines, quality risk management,role of mass spectrometry in pharmaceuticals and on new drug delivery dystems. Currently he is working as a General manager technical operations for Surge Lab. which is the best export oriented company of pakistan..

Title: TOWARDS NOVEL POST-AUTHORIZATION PHARMACOVIGILANCE SYSTEMS TO IMPROVE VACCINE CONFIDENCE

Abstract:

Vaccines against the SARS-CoV-2 virus have proven to be very effective in preventing severe forms of the COVID-19 disease. While around more than 15 billion doses have been administered worldwide, available data indicates that their safety profile is excellent. However, current post-authorization pharmacovigilance systems are not adapted for the efficient detection of rare severe adverse reactions. Using the examples of the atypical thrombocytopenic thromboses caused by adenoviral-vector based vaccines and mRNA vaccine-induced myocarditis, I will discuss the need to launch programs specifically designed to confirm or rule out the cause-and-effect relationship between vaccination and very rare complications. The gathered information will allow to better assess the risk-benefit balance of vaccines when the pandemic phase of COVID-19 is under control. It will be essential to communicate in a transparent way on the information that will be collected, so as not to leave the monopoly of these subjects to the opponents of vaccination and improve vaccine confidence.

Biography:

Michel Goldman graduated as a medical doctor 1978 from Université Libre de Bruxelles (ULB), Belgium, and received his PhD in medical sciences in 1981 from Université de Genève, Switzerland. He is board certified in internal medicine in 1984. From 1990 to 2008, he heads the Department of Immunology-Hematology-Transfusion at Erasme Hospital in Brussels, and from 2004 to 2009 serves as the first Director of the Institute for Medical Immunology built on the Charleroi campus of ULB, with the support of GSKBiologicals and the Walloon Region.

In 2009, Michel Goldman becomes the first executive director of the Innovative Medicines Initiative (IMI) a joint undertaking between the European Commission and the European Federation of Pharmaceutical Industries and Associations.

Title: Pharmacovigilance Industry Is worth Usd 6 Billion and Is Expected to continue to grow at 12% Per Year

Abstract:

The current trends are as follows

Increased Focus on Quality, Compliance and Quality Management System, Requirements of Audit and Inspection readiness Process Enhancements, Changes, Improvements Further adoption of Technology and Tools, Database migrations Focus on Data Analytics and Trends

Organisational Culture Enhancement –Focus on People Development, Training and Retention Change Management – Mergers / Acquisitions and Integrations  The Challenges are as follows Requirement of skilled resources Retention of talent People Development Needs Standard Operating Procedures Better quality and compliance Need for better productivity Adoption of Technology Reduce cost per transaction Improve Efficiency The Opportunities are as follows People (Organisation Culture) Process (Operational Excellence) Technology (Digital Transformation)

Biography:

Gurpreet Singh is currently the Vice President, Global Head of Pharmacovigilance at Freyr. He is based in UK and has a total of 17+years' experience in Pharma Industry of which 16+ years have been in Global Drug Development. During these years he has had the opportunity to work with some top Global companies like Cognizant, Tata Consultancy, Novartis and Parexel.  At Novartis he was the Global Head of PV Operations managing all Global PV activities. At Parexel he was the Senior Director PV Operations responsible for managing PV projects of top Global Pharma and Biotech companies. Gurpreet is a certified Six Sigma and Project Management Professional. He has keen interest in Digital Transformation and Organization Culture and has successfully led various projects during his tenure in the Pharma Industry. He is an avid runner and a speaker at various PV conferences.

Title: Why Oncology Global Safety Teams Should Develop the Safety Section of the Study’s Target Product Profile (TPP)

Abstract:

A Target Product Profile (TPP) highlights the clinical and safety attributes of a developmental product that if realized would enable successful marketing.  A TPP can be developed for a study or even for the addition of a study arm.  The TPP, in essence, establishes boundaries for Go-No Go decisions around a product or products in combination treatment.  The World Health Organization (WHO) has adopted the TTP to attempt to define characteristics required in new health products that if realized would address the greatest public need for developing nations.  The Food and Drug Administration (FDA) has attempted to generate guidance to industry related to TPP development.  Involvement of the Oncology Global Safety Team in producing a well-researched and evidenced based TPP safety section allows the team to develop knowledge around the drug(s) studied or added to a study arm.  The increased use of umbrella and platform studies for early phase oncology trials allows an excellent resource for the use of clinical data to estimate the risk of developmental drugs combined to treat a given oncology indication.  To shorten time to marketing, companies are including developmental products with novel mechanisms early within their development cycles.  Antibody Drug Conjugates (ADCs) and Bi-Directional Antibodies are a few examples of products combined in arms of a platform or umbrella study early and: therefore, with only immature clinical data available.  This talk will share a novel analytical approach for safety teams to develop a well thought-out and defendable safety section to the TPP.  Strategies to estimate the risks associated with combination therapies will be brought forward.  The advantages of having the safety team involved early in the benefit/risk, Go-No Go decisions for a study or the addition of a study arm will be detailed.

Biography:

Michael Kieffer is a Pharm.D. with 12 years of experience in patient safety, pharmacovigilance and clinical trial oversight obtained from serving in positions at the Food and Drug Administration, Amgen, and AstraZeneca.   He has a proven tract record of driving safety enhancements, leading cross functional teams, leading risk mitigation efforts, and improving safety functional teams.  Throughout his career, he has enthusiastically honed his skills in safety signal detection, safety assessment, and regulatory compliance to ensure the highest standards of patient safety across all stages of drug development.  He is currently a freelance consultant and President of his own business, Focused Consulting, Staffing, and Drug Safety.  In this capacity, he has consulted on topics centering around risk management and trial safety. 

Title: Patterns of Adverse Drug Reactions in Jordan: A Retrospective Analysis of the National Pharmacovigilance Data Registry (2015-2021)

Abstract:

Background: Post-marketing surveillance of drugs is a cornerstone of pharmacovigilance. This study was conducted to characterize patterns of adverse drug reactions (ADRs) reporting in Jordan.  

Research design and methods: ADR reports submitted to the pharmacovigilance database of the Jordan Food and Drug Administration during 2015-2021 were retrospectively analyzed. The most commonly reported drugs, drug classes, ADRs, and ADRs consequences were explored. Logistic regression identified possible predictors of reporting serious ADRs.

Results: A total of 2744 ADR reports were included, among which 28.4% were classified as serious. An annual increase in ADR reporting was observed. The most commonly implicated drug classes were antineoplastic and immunomodulating agents (24.0%), anti-infectives for systemic use (14.2%), and alimentary tract and metabolism (12.1%). Covid-19 vaccination was the most reported drug (22.8%). Fatigue (6.3%), injection site pain (6.1%), and headache (6.0%) were the top three common ADRs. Among ADRs with outcome information, 4.7% were fatal. Patient’s age and intravenous medication use largely predicted reporting serious ADRs.

Conclusions: This study provides contemporary insights into the post-marketing surveillance of drugs in Jordan. The findings are foundational for future studies exploring drug-ADRs causality relationships. Efforts that promote pharmacovigilance concepts should be sustained and enhanced at the national level.

Biography:

Hayaa Banat Senior pharmacovigilance specialist and the Head of Pharmacovigilance Section in JFDA. Clinical Pharmacist Hayaa Banat received her Pharm.D. Degree from Jordan University of Science and Technology and is currently working at Jordan food and Drug Administration (JFDA) as the head of pharmacovigilance section. A strong advocate of increasing awareness of the importance of rational drug use, Pharmacovigilance and drug safety. Hayaa participated in several national and international meetings and conferences regarding Pharmacovigilance, quality use of medicines, effective communication. She has an active role in risk management plan (RMP) evaluation, risk minimization measures (RMM) implementation, patient leaflet updates. Hayaa is anxious in encouraging health care providers to build a culture based on patient safety. Has a good experience in clinical practice mainly in critical care units (ICU, CCU) as she worked as a clinical pharmacist in two of the biggest hospitals in Jordan, King Hussein Cancer Center and Jordan university Hospital.