13^th International Conference on Biosimilars and Biologics March 18-19, 2019 Holiday Inn Amsterdam - Arena Towers

Biography:

Yashwant Pathak has completed his education (MS and PhD) in Pharmaceutical Technology from India and EMBA and MS Confl ict Management from Sullivan University, USA. He is a Professor and Associate Dean for Faculty Affairs College of Pharmacy, University of South Florida. Tampa, Florida. With extensive experience in Academia and Industry, he has over 150 publications research papers, abstracts, chapters and reviews, edited over 25 books. Some of his titles include “Nutraceuticals and Health: Handbook of Metallo-Nutraceuticals”, “Nanotechnology in Nutraceuticals: Production to Consumption” and the recent most is “Nutrigenomics and Nutraceuticals: Clinical Relevance and Disease Prevention”. His areas of research include Drug Delivery Systems, Nanotechnology Applications in Pharmacy and Nutraceuticals. He is a Series Editor for “Nutraceuticals: Basic Research and Clinical Applications” published by CRC Press. He has travelled extensively over 80 countries and is actively involved with many Pharmacy Colleges in different countries.

Abstract:

Biography:

Rodica Olteanu is a Dermatologist and Medical Director of Colentina Clinical Hospital, Bucharest, Romania. She has received her PhD on lupus research in 2007, in collaboration with Hamburg University. She is involved in autoimmunity and immunogenicity of biologics and biosimilars and published more than 100 papers on lupus and psoriasis. She is an Alumni EADV Club, rewarded winner of many international grants, Member in EADV Project Committee, AAD, GRAPPA, EuSCLE, SRD, ILDS Member and Member in Editorial Board of SRD and LAJPPA. She has completed her educational training by participating at Master Class on Psoriasis- Barcelona, Center for Excellence in Psoriasis-Vienna, Pearls in Lisbon and Bucharest- as Invited Speaker and also at Harvard. She supports the idea of a collaborative work group of specialists in different areas for autoimmune diseases also with patient’s participation and she intent to create an Autoimmune Diseases Center in Colentina Hospital.

Abstract:

Introduction: Biosimilars represent a challenge in the daily clinical practice and they have demonstrated their effi  cacy and good tolerance in a context of limited budget. Our health policy and Romanian protocols regarding the biosimilars does not recommend the pharmaceutical-nonmedical switch. Th e medical switch is permitted only by doctor’s prescription. Methods: In our hospital (Colentina Clinical Hospital, Bucharest, Dermatology Department), we treat patients with moderate to severe psoriasis with biologics according to the European and also Romanian Consensus (etanercept, adalimumab, infl iximab, ixekizumab, secukinumab, ustekinumab-originals or biosimilars) in a number of 290 patients on biologic therapy. From these 290 patients, 50 patients (17.24%) - are on biosimilars (Infl ectra, Remsima, Benepali) as they have been registered on the national program for psoriasis. Th e patients (23 women-46% and 27 men-54%) were studied for 12 months (January 2017-December 2017). Results: We compared the biosimilars patients with 50 patients on originals: etanercept (18 patients) and infl iximab (32 patients). From those 50 patients, fi ve dropped out from adverse reactions (tuberculosis, myocardial infarction etc.) and nine were switched because of ineffi  cacy. As the remaining 36 patients, they were switched on other biologics (mainly on other biosimilars). For the patients on originals, at 12 months: 13 patients-26% (12 on Remicade and one on Enbrel) developed adverse reactions or lost PASI 50 (one dropped out and 18 were switched mainly on other originals: etanercept, adalimumab, ustekinumab, ixekizumab). Conclusions: Comparing the two groups, we did not fi nd any signifi cant diff erences (26% lost PASI 50 or had adverse reactions on originals and 28% on biosimilars) regarding maintaining the same therapy because of the adverse reactions or ineffi  cacy at 12 months. In our study, the biosimilars demonstrated the same behavior as the originals. 

Biography:

Pawan Saharan has completed his MS in Life Sciences (JNU), PhD in Medicine (WVU) and Post-doctoral at Stanford University. He has several international publications/presentations including in top scientifi c journal Nature from the age of 21. He was nominated for several Global awards including by New Drug Discovery Programme of Department of Science & Technology (GoI) funded US$ three million grant and the best US Scientist award at age 22 years by AAAS, Washington DC. He has been CSO & CEO for large MNC and Founder of Biomix Network Inc., USA and India. He has global experience in running Healthcare Industry, including the Pharmaceuticals MNCs and Hospitals at the top management level in USA and India. He created the fi rst truly Nano-Bio-IT Helix via inventing Radha 108 Nano-Peptides for AIDS therapy: RECEPTOL® along with reusable micro-chip diagnostics for AIDS, Cancer, TB and other infections, costing a fraction of current tests creating a paradigm shift in healthcare and bringing smile on billion faces who could not afford modern treatment.

Abstract:

Pawan Saharan has invented Radha108 Nano Peptides that naturally producing new generation antibodies and their biosimilar like cytokine (interleukin & interferon) by secretion from cytotoxic T-cells of the innate immune system, which was increased by fi ve times due to Radha 108 Nano Peptide that get absorbed in the blood through buccal mucosa and crosses the blood brain barrier. Radha108 act on pituitary gland that in turn promotes diff erentiation of B cells, maturation of macrophages and monocytes and stimulates production of cytokines IL-1 to IL-11, TNF-α, INF–γ and maturation of immature thymocytes into either helper or suppressor T cells that helps building body's immune system strongly to fi ght any infection and immune disorders like asthma, allergy, URTI, carcinomas and type 2 diabetes saving hundreds of billions of $ that are spent in treating such ailments with little or no effi  cacy. Th e mode of action of Receptol® is based on API Radha 108 Nano-informational peptides proteins which are active in mitigating cell fusion and docks on Gp120, 180, 160 Receptor CD4, CD8 on the cell surface closing entry of virus like foreign antigen and allergens. Radha108 functions as a molecular signaling device which works through receptors on target cell surfaces. Radha108 Nano Peptides SEQ ID 1-8 extracted from Bovine Colostrum with the Granted US patent (U.S. Patent No. 9,249,188 & 8,518,454 B2) consist of ELVPGVPRGTQL (DNA-binding Protein Inhibitor ID-3), VAIIQHMIKKLR (EpsteinBarr virus induced gene-2), LPQEVLNENLLRF (Alpha S1-Casein), RLNARMAELR (S-adenosylmethionine synthetase isoform type-1), SSLQVLNMSHN(Toll- like receptor -4), EYQELMNVK (Keratin type II cytoskeletal 59 kDa component IV), VDTLNDEINFLR (Keratin type II cytoskeletal 7), DGIVNENLAER ( Ribonucleosidediphosphate reductase small chain). Th us, Radha 108 Nanopeptides stimulate the secretion of bio- similar (wide range of cytokines like interleukins, interferon) that are very eff ective in treating all viral and immune disorders like HIV, swine fl u, allergy, asthma, arthritis, diarrhea, fever, fatigue-malaise, anemia, endometriosis, cold and fl u by playing a crucial role. 

Biography:

Abstract:

Most patients still have limited or no access to life-changing therapeutic proteins in the treatment of their cancer or autoimmune disorders. Th e current clinical development model of biosimilars is expensive, and in most cases, large, phase 3 trials do not provide meaningful information on the clinical equivalence of biosimilars and reference compounds. At the same time, the development of state-of-the-art orthogonal analytical methods has enabled a better understanding of the structure and structure–function relationship of biotherapeutics. Hence, we suggest here that a solid chemistry, manufacturing, and controls (CMC) package and meaningful phase 1 studies will leave limited uncertainty on biosimilarity, which can be addressed— if needed—by post-approval, long-term follow-up studies (post-approval studies, pharmacovigilance, real world evidence data and registries, and possibly new postapproval models to be developed). We believe that this new approach may be more appropriate than 600- to 1000-patient, phase 3 trials in assessing biosimilarity and therapeutic equivalence, under the condition that the administered biosimilar given to individual patients can be clearly identifi ed. Obviously, there will probably never be a “one size fi ts all” development model, and an individualized, risk-based approach to biosimilar development will always have to be considered and discussed early with regulators.