Day 2 :
Keynote Forum
Abdeen M Omer
Ministry of Health and Social Welfare, Sudan
Keynote: Medicines distributions and financing alternatives
Time : 10:50-11:30
Biography:
Abdeen M Omer, BSc, MSc, PhD is an Associate Researcher at Occupational Health Administration, Ministry of Health and Social Welfare, Khartoum, Sudan. He has been listed in the book Who’s Who in the World 2005, 2006, 2007 and 2010. He has published over 300 papers in peer-reviewed journals, 200 review articles, 7 books and 150 chapters in books.
Abstract:
The strategy of price liberalization and privatization had been implemented in Sudan over the last decade, and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatization policy, the government introduced radical changes in the pharmacy regulations. To improve the effectiveness of the public pharmacy, resources should be switched towards areas of need, reducing inequalities and promoting better health conditions. Medicines are financed either through cost sharing or full private. The role of the private services is significant. A review of reform of financing medicines in Sudan is given in this study. Also, it highlights the current drug supply system in the public sector, which is currently responsibility of the Central Medical Supplies Public Corporation (CMS). In Sudan, the researchers did not identify any rigorous evaluations or quantitative studies about the impact of drug regulations on the quality of medicines and how to protect public health against counterfeit or low quality medicines, although it is practically possible. However, the regulations must be continually evaluated to ensure the public health is protected against by marketing high quality medicines rather than commercial interests, and the drug companies are held accountable for their conduct. The study reveals the need for further research to find out how efficient the regulatory authorities at both federal and state levels are. The research also needed to discover whether or not counterfeit medicines are sold on the Sudanese market. From the data obtained in this article some general inferences could be made: The broad outlines remain intact, but preventing drug smuggling across national borders (Sudan shares frontiers with 9 countries) is hard to police. The enforcement of the Act and its regulation governing the manufacture, importation, sale, distribution and exportation of medicines are not adequate enough to control the illegal importation and sale of medicines in Sudan. The splitting of the drug regulatory authority between two ministries and the marketing of unregistered medicines by public drug suppliers (namely the CMSPO and RDFs), and NGOs undermine the quality of medicines and ultimately jeopardize the health of the people taking medication.
- Emerging Biosimilars in Therapeutics | Biosimilars Analytical Strategies | Regulatory Approach for Biosimilars
Location: Sierra
Chair
Mayra Liz Guzman-Kaslow
GK Regulatory Compliance & Engineering Consulting Corporation
Session Introduction
Asif Mahmood
Pfizer, USA
Title: Biosimilars: Challenges in safety and risk management
Time : 11:50-12:20
Biography:
Asif Mahmood has diverse leadership experience as a health services professional with significant accomplishments in all aspects of pharmacovigilance, clinical development, medical affairs, regulatory affairs, primary health care, project management & international health programs. He is currently working as Disease Area Cluster Lead for Biosimilars & Drug Delivery Devices at Pfizer. His past experience includes working as Associate Vice President PV and Therapeutic Area Head (Rare Diseases) for Sanofi
Genzyme, working as Senior Director & Director for vaccines PV at Sanofi Pasteur and working as Medical Consultant for Apotex Inc., Canada. Prior to joining industry, he has worked as Joint Executive Director for Pakistan Institute of Medical Sciences, Registrar of the Post-graduate Medical Institute PIMS and as Deputy Director General of Ministry of Health, Pakistan. He has also worked on various primary healthcare, public health, and health planning & development programs as well as on World Food, UNICEF; WHO & JICA assisted programs on drug safety, emergency preparedness and primary healthcare.
Abstract:
Advances in biotechnology have ensured a world of opportunities for biosimilars to enter the market and serve the needs of patients in a cost-effective manner. However, pharmacovigilance and risk management for biosimilars present a significant challenge that arise from their unique characteristics as biologics as well as from their differences with the reference innovator products. Traditional PV processes may not incorporate sufficient provisions to meet the particular requirements for biosimilars. While a biosimilar and its reference drug can show similar efficacy, it can exhibit a different safety profile with respect to the nature, seriousness or incidence of reported adverse events (AEs). Therefore, there is a need to clearly identify the specific product associated with the AE. Hence, product naming is an important consideration for biosimilars traceability. The potential for immunogenicity represents an important safety concern with all biologics, including biosimilars. The nature and severity of immunogenic reactions
may differ from those observed for the reference innovator and immunogenicity data from the reference product may not be directly
extrapolated to the biosimilar. Given the relatively small number/size of clinical trials required for regulatory approval of biosimilars,
full characterization of the immunogenicity profile of a biosimilar may not be established at the time of regulatory approval. Continued post-marketing surveillance of biosimilars is critical for effective risk management. Also, the unique nature of biosimilars requires a labeling approach that combines data on the reference product with data specific to the biosimilar due to differences in their source materials, manufacturing processes and impurities. Finally, the safety specifications in the RMP of a biosimilar should include the identified and potential risks of the reference innovator product as well as risks identified from studies on the specific biosimilar product.
Biography:
Dr. Sunit was trained as Developmental/Cardiovascular Biologists in Leuven, Belgium where he received his PhD. He worked in industry (Mermaid Pharmaceuticals, Hamburg Germany) for several years where he was involved in target identification using model system. He has spent time at Max Planck Institute where he was involved in the CNS development related project. After coming back to India in 2007, he joined Avesthagen where he headed the biosimilar group. He was responsible for development of biologics including recombinant protein and monoclonal antibodies using mammalian expression system. He is associated with Zumutor Biologics since its inception and
currently heads the Product Development team.
Abstract:
Monoclonal antibodies are high molecular weight proteins (~150 kDa). As is common for biotech-derived molecules of this size, they have highly complex secondary and tertiary structures, subject to post-translational modifications. Heterogeneity of monoclonal antibodies due to the vast number of modifications presents great challenge to the thorough characterization of the molecules. Different orthogonal techniques are required to understand the structure and stability of the molecules thoroughly. The major challenge in developing biosimilar monoclonal antibody is to evaluate what impact certain quality attributes do have on clinical efficacy and safety, and what level of difference is acceptable from a biosimilarity perspective. Different modifications and challenges in developing biosimilar monoclonal antibody will be discussed.
K Aftab
Isra University Karachi, Pakistan
Title: Biosimilars: Challenges in safety and risk management
Biography:
K Aftab, PhD, Pharmacologist, graduated from Department of Pharmacology, Faculty of Pharmacy, University of Karachi, Pakistan in 1995. He worked for pharmaceuticals industry as Quality Control & Quality Assurance Professional and was actively involved in research & development of pharmaceutical preparations. He has worked in few medical & dental colleges & universities as Assistant, Associate and became Full Professor of Pharmacology in 2005 and also worked as Visiting Professor in different universities & research institutions. From 2009-2011, he worked in KSA as a Full Professor of Pharmacology. Now, he has published more than 35 papers in scientific journals of international repute and presented many lectures & poster presentations throughout the world; most awards to him were for the science and technology success. He was involved in drug discovery and the scientific evaluation of traditional remedies used in different disorders. His group has developed expertise in a wide range of activities and made valuable contributions on medicinal value of plants by providing pharmacological basis for their usefulness as antihypertensive, cardio-tonic, laxative, antispasmodic
and anti-diarrheal. In recent years, he focused on the biodiversity & pharmacological activities of marine organisms.
Abstract:
Holarrhena pubescens belongs to the family Apocynacea, commonly known as “Kurchi” is highly reputed in traditional medicine as a remedy for amoebic dysentery and other intestinal ailment. Bioassay-directed fractionation of the ethanolic extract of Holarrhena pubescens resulted in the isolation of steroidal alkaloids i.e. holamide and pubscinine. Holamide showed a three proton
doublet at 1.45 (J=6.56 Hz) and two AB doubles at 3.17 and 3.00 each for on proton (J=12.06 Hz) in the 1H NMR spectrum suggested that it belongs to conanine series of alkaloid (A class of compound with the steroid nucleus and a five members heterocyclic ring with nitrogen). In contrast, pubscinine showed one methyl at 1.28 while the doublet is missing a three proton singlet was observed at 2.28 due to a vinylic methyl indicated a double bond in the 18,20–epimino ring of the conanine series of alkaloids. In anaesthetized rats,
the holamide and pubscinine caused a fall in blood pressure in a dose-dependent manner. Pretreatment of animals with atropine completely abolished the hypotensive response of acetylcholine; whereas hypotensive effect of holamide and pubscinine were not modified by atropine. Similarly, acetylcholine produced contractile effect in guinea-pig ileum, which was antagonized by atropine, however both (holamide and pubscinine) failed to produce any stimulant response on guinea-pig ileum. These data indicate that the steroidal alkaloids i.e. holamide and pubscinine from Holarrhena pubescens mediated hypotensive response through a mechanism different to that of acetylcholine.