Roberta Bursi has obtained her PhD in Computational Chemistry at the University of Southern California, Los Angeles, USA. She is a Biopharmaceutical Professional with twenty years experience in modeling and simulation implementation and deployment across research and development organizations of medium- and largesized multinational pharma companies aiming at delivering innovative medicines to patients. She is the author of more than 30 peer-reviewed scientific publications, inventor of 4 patents and Project Management Professional (PMP) certified by the Project Management Institute, USA. She is currently the Vice President Model Informed Drug Discovery Development at InsilicoTRIALS LLC.

Computer simulations are considered standard technology in many industries like Automotive, Engineering and Aeronautics, but they are generally poorly established in the healthcare sector. At the same time, pharmaceutical and medical device companies are facing the challenges of exponential growth of research and development costs, of high attrition rates and of inefficient development processes. Since more than a decade, the US Food and Drug Administration agency has indicated Modeling and Simulation as a technological solution which can help to contain development costs and which can enable data-driven decisions and the optimization of development plans. InsilicoTRIALS is the first web-based, cloudbased platform that provides healthcare companies and researchers with easy-access and ready-to-use computational models to perform simulations for pharmaceutical and medical device development and approval processes. The features of the platform ensure that no highly-specialistic knowledge is required to run the models, leading to a democratization of the simulations. Individualized simulations and post-processing are performed in public or private cloud, to streamline the design and development process. Users can securely share their data models with project partners, simulation parameters, and results through the digital library. Use case examples pertaining the pharmaceutical area of biologics including, but not limited to an estimation model for colloidal interactions and protein aggregation propensities will be presented and discussed.

Victor Tsetlin has got PhD and DSci degrees in Chemistry (1973, 1987) at the Shemyakin-Ovchinnikov Institute; now Head of the Department of Molecular Basis of Neurosignaling; Professor (1996) and Corresponding Member of the Russian Academy of Sciences (2006). He received the following awards: Russian State Prize in Science and Technology (1985), and the Humboldt Prize (1992). He is an Invited Scientist at the Uppsala University, Imperial College (London), Institute of Protein Research (Osaka), Free University (Berlin). He is a Member of the Advisory Board of FEBS J (2000-2011), Biochem. J. (2013-present). He has published over 200 papers: in PNAS, Neuron, Nature Str. Mol. Biol., J. Biol. Chem., J. Neurochemistry, TIPS, Sci. Rep., Neuropharmacology.

In the frames of the organized conference the term “biosimilar” is apparently most applicable to compounds which in principle should be identical but, especially if produced by heterologous expression in different laboratories, may differ in the degree of purification or other properties which are difficult to control. On the other hand, of great interest is “biosimilarity” as a manifestation of similar biological activity produced by compounds of absolutely different structure. In the proposed lecture it will be illustrated by interaction of various naturally-occurring and designed/ synthesized compounds with various subtypes of nicotinic acetylcholine receptors (nAChRs). The similarity in the effects of various compounds appears when they attach roughly at the same binding site at the nAChRs. α-Neurotoxins from snake venoms have played a crucial role in earlier isolation of muscle-type nAChRs and at present are a good pharmacological tool for identifying muscle-type and neuronal α7 nAChRs. Their binding site is situated in the receptor ligand-binding domain (LBD) at the interfaces between the subunits, as earlier shown by “wet” biochemistry and then confirmed by the X-ray analysis. Another class of sophisticated tools for research on nAChRs are α-conotoxins, neurotoxic peptides from Conus marine snails which not only allow to distinguish muscle nAChRs from the neuronal ones, but also help to identify individual subtypes of neuronal receptors. α-Conotoxins as such or as modified forms are considered as promising drugs, in particular those selective for the α9 nAChR may give new analgesics. The deviations from “biosimilarity” might arise if some of the structurally similar compounds have additional targets: for example, we found that α-cobratoxin, a classical blocker of muscle and neuronal α7 nAChR can also inhibit certain subtypes of GABA-A receptor and weak inhibitory activity against this receptor was manifested by several α-conotoxins. Some activities, when measured by one method may be similar, but differ when tested by another method. For example, α-cobratoxin, such α-conotoxins as PnIA analogs and Ly-6 proteins ws-Lynx1 and SLURP-1 (these proteins have the same three-finger folding as α-cobratoxin) inhibit ion currents in the α7 nAChR (with the affinity decreasing in this series) according to electrophysiology experiments, while radioligand analysis revealed that α-cobratoxin and α-conotoxins bind to the orthosteric site in the receptor, but the Ly-6 proteins attach in the allosteric one.

Thomas Zahel has completed his PhD in Applied Statistics for Biopharmaceutical Development and Manufacturing at Vienna Technical University, Austria. Since 2014, he is leading an innovation group devloping novel multivariate statistical methods for biosimilarity testing and process validation at the data science and software company Exputec, located in Vienna, Austria.

Biosimilar development is seeking to identify clones and manufacturing process conditions that are most likely to yield similar quality profiles as the originator product. However, during clone screening and process development, sufficient repetitions of experiments is not feasible in order to perform scientific and statistically sound bioequivalence analysis according to FDA guidelines. Although sample size of biosimilar experiments of a specific clone at a specific process condition is limiting, data is usually rich in redundant critical quality attributes (CQAs). Taking advantage of that situation, we want to present a novel multivariate statistical approach to identify lead clones and optimal process conditions that will later on increase the chance of passing bioequivalence assessment. Moreover, we want to present a successful implementation of a biosimilarity software application that helps operators to identify biosimilar clones and process conditions and even enables them to take counter actions within their process development. This ultimately leads to a more robust and data driven process development of biosimilars.

Eraldo Guerra has completed his Master Science Computer at the age of 36 years from C.E.S.A.R (Center for the Study of Advanced Systems of Recife) and It has more than 40 awards in innovation, entrepreneurship, technology for health, two awards from the United Nations in 2017 and participated in the BID. He is an expert in distance education by SENAC, research professor of the Faculty São Miguel. Has published articles in several countries and participates in a number of initiatives of research and development enterprise

Autism is a mental disorder of neurodevelopment in which there occurs a break in the fundamental processes of socialization, communication and learning. These disorders are collectively known as disorders of development. Which the multidisciplinary approaches are effective for not only the issue of education and socialization, but mainly the social

question and the attempt to establish etiologies and clinical well defined, capable of accurate prognostications and therapeutic approaches, effective. Understand what pharmacological interventions are most widely used in Brazil as: Risperidona, an antipschycotic atypical, followed by benzodiazepines (Tranquilizers Sedatives) and of the heterocyclic compounds (other antipsychotics or neuroleptics) associated with the use of technology. Can contribute to better results in the treatment and cognitive development of autism. The technology adopted was the Cangame, by the various services offered as: personalization and customization of content, monitor the entire stage of life of autistic (children through adult), scheduling activities and preparation of monitoring reports. This intervention seal can contribute to better outcomes in the treatment and cognitive development of the autistic. For such a survey and survey data found in the literature and in oturas research, together with the tests and aplciabilidade technology. are the target of this research, with the aim of promoting new studies and processes that can reduce time and cost in relation to the treatment and learning of autistic.

Eraldo Guerra has completed his Master Science Computer at the age of 36 years from C.E.S.A.R (Center for the Study of Advanced Systems of Recife) and It has more than 40 awards in innovation, entrepreneurship, technology for health, two awards from the United Nations in 2017 and participated in the BID. He is an expert in distance education by SENAC, research professor of the Faculty São Miguel. Has published articles in several countries and participates in a number of initiatives of research and development enterprise

Autism is a mental disorder of neurodevelopment in which there occurs a break in the fundamental processes of socialization, communication and learning. These disorders are collectively known as disorders of development. Which the multidisciplinary approaches are effective for not only the issue of education and socialization, but mainly the social

question and the attempt to establish etiologies and clinical well defined, capable of accurate prognostications and therapeutic approaches, effective. Understand what pharmacological interventions are most widely used in Brazil as: Risperidona, an antipschycotic atypical, followed by benzodiazepines (Tranquilizers Sedatives) and of the heterocyclic compounds (other antipsychotics or neuroleptics) associated with the use of technology. Can contribute to better results in the treatment and cognitive development of autism. The technology adopted was the Cangame, by the various services offered as: personalization and customization of content, monitor the entire stage of life of autistic (children through adult), scheduling activities and preparation of monitoring reports. This intervention seal can contribute to better outcomes in the treatment and cognitive development of the autistic. For such a survey and survey data found in the literature and in oturas research, together with the tests and aplciabilidade technology. are the target of this research, with the aim of promoting new studies and processes that can reduce time and cost in relation to the treatment and learning of autistic.

Padma Priya Anand Baskaran completed her MSc Biotechnology from Saint-Petersburg State Chemical Pharmaceutical Academy (Russia). She has her research experience, and history of working in the hospital & health care industry. She is skilled in Stem Cells Therapy protocol from preparation to treatment and has established efficacy of stem cells in clinical research. She has 15 scientific publications to her credit. Her field of interest includes: Ageing, Prenatal Stem Cells, Exosomes, 3D Progenitor Cell Cultures, and Stem Cell Niche Modeling.

Proliferation and differentiation of stem cells requires a specific microenvironment – “stem cells niche”. For in vivo modulation of organ-specific niches during SCs transplantation could be useful Fetal Tissue Extracts (FTEs). In the stage of organogenesis microenvironment in each of the organs must be specific and stable enough to generate constant signal for the final differentiation of organ-specific progenitor cells. The purpose of this study is to test and validate this hypothesis. We investigated the content and concentrations of growth factors in FTEs of various organs; and studied the efficacy of FTEs in liver cirrhosis and chronic non-healing wounds patients who did not respond to stem cells treatment. Transplantation of prenatal hepatoblasts, hematopoietic stem cells, and 3 weeks of daily fetal liver extracts injections showed effectiveness in 75% of this liver cirrhosis cases that is characterized by significant decrease of liver fibroscan density, decrease of portal hypertension and ascites, decrease or normalization of biochemical markers of liver damage. Connective tissue metabolism showed increase of

fibrinolytic and collagenolytic activity. In patients with chronic non-healing wounds who do not have any improvement after previous stem cells treatment, administration of FTEs (skin, muscle) activated the wound epithelialization with completely healing of Thus, FTEs obtained from the stage of incomplete organogenesis can be useful for in vivo modulation of organspecific niches for transplanted stem cells.

Tsachi Shaked graduated in Master’s in Business Administration with expertise in Marketing from Bar-Ilan University in Ramat-Gan, Israel. He is a Chief Marketing Officer at E3D (Elcam Drug Delivery Devices) a subsidiary of Elcam Medical. As part of the company's portfolio, he is deeply involved with the development of the new version of drug delivery devices that includes connectivity and electronic applications. He is with the company from 2006.

The purpose of this presentation is to identify and present a cost-effective method and devices to self-administration of biosimilar drugs and molecules while keeping the entire process safe and easy to use. Disposable auto-injectors have their advantages of safe and simplicity but pose an additional cost of materials to a bio-similar drug/molecule. Reusable auto injectors are more cost effective, but the ones in the market are complicated, are not easy to use and not completely safe. In this presentation we will present a new, innovative, method for easy and safe yet cost-effective way for self administration of biosimilar drugs/ molecules. These innovative devices might be a perfect partner with the biosimilar drug as they are not only cost effective, safe and easy to use, but also have a lower environmental impact of plastic parts and trash. We will discuss mechanical auto-injectors and electronic auto-injectors while in both the only disposable part is the cassette that holds the PFS (Progression-free survival) with the drug inside.

Regulatory affairs professional for over 30 years. Has particular expertise in monoclonals and biosimilars, having worked on over 20 such programs, engaged in over 50 interactions and meetings with regulatory agencies in the EU, US, Canada, Australia, Mexico, Brazil and supported 6 submissions in the EU and US. He has also participated extensively in Industry and International meetings on the subject. Prior to joining PAREXEL, Cecil served as Regulatory Manager at Novo Nordisk Ltd. Fellow of TOPRA and has been a guest lecture at Cardiff University MSc in Clinical Research and Greenwich University MSc in Pharmaceutical Sciences courses and Biotech Module leader for the TOPRA MSc course. He was on the editorial panel of SCRIP Clinical Research and has authored many articles on regulatory and clinical development issues. Holds BSc (Hons) in Biochemistry from the University of Cape Town.

This presentation addresses the challenges sponsors face in developing biosimilars for the global market amidst a myriad of varying regulatory requirements. Differences in approach between CHMP and FDA will be considered with respect to the impact of variances in the regulatory frameworks and conflicting quality and clinical data requirements. Consideration will then be given to the need for inclusion of local patients in order to gain regulatory marketing approval as is the case for example in China, Japan, Russia and India. Also in some regions there is the need compare the biosimilar against reference product sourced from specific regions at the quality and sometimes the clinical level. The timings for clinical trial approval and potential for interaction with regulatory authorities in order to seek feedback on the suitability of the proposed development program will also be discussed.

Padma Priya Anand Baskaran completed her MSc Biotechnology from Saint-Petersburg State Chemical Pharmaceutical Academy (Russia). She has her research experience, and history of working in the hospital & health care industry. She is skilled in Stem Cells Therapy protocol from preparation to treatment and has established efficacy of stem cells in clinical research. She has 15 scientific publications to her credit. Her field of interest includes: Ageing, Prenatal Stem Cells, Exosomes, 3D Progenitor Cell Cultures, and Stem Cell Niche Modeling.

Proliferation and differentiation of stem cells requires a specific microenvironment – “stem cells niche”. For in vivo modulation of organ-specific niches during SCs transplantation could be useful Fetal Tissue Extracts (FTEs). In the stage of organogenesis microenvironment in each of the organs must be specific and stable enough to generate constant signal for the final differentiation of organ-specific progenitor cells. The purpose of this study is to test and validate this hypothesis. We investigated the content and concentrations of growth factors in FTEs of various organs; and studied the efficacy of FTEs in liver cirrhosis and chronic non healing wounds patients who did not respond to stem cells treatment. Transplantation of prenatal hepatoblasts, hematopoietic stem cells, and 3 weeks of daily fetal liver extracts injections showed effectiveness in 75% of this liver cirrhosis cases that is characterized by significant decrease of liver fibroscan density, decrease of portal hypertension and ascites, decrease or normalization of biochemical markers of liver damage. Connective tissue metabolism showed increase of fibrinolytic and collagenolytic activity. In patients with chronic non-healing wounds who do not have any improvement after previous stem cells treatment, administration of FTEs (skin, muscle) activated the wound epithelialization with completely healing of Thus, FTEs obtained from the stage of incomplete organogenesis can be useful for in vivo modulation of organspecific niches for transplanted stem cells.

Mohammed H. Alwan has completed his Bachelor degree from Baghdad University/ Iraq in 2004 then studied for M.Sc degree in Al-Nahrain University/ Iraq in 2015. He spent ten years serving as Biomedical Engineer at the Ministry of Health institutes/ Iraq started at 2005 in Al-Karamaa general Hospital and in Ibn-Al-Bitar Center for Cardiac and Vascular Diseases and Al-Sadr General Hospital then at 2015 in the Middle Euphrates center for oncology at Al-Najaf health directorate.

X-ray medical imaging is one of the most important imaging techniques because of its low cost and reachable technique. But it has poor ability to depict soft tissues and small details between soft tissues at the borders of interference. This limitation was overcome by using iodine-based contrast agent but this chemical compound has limitations for use due to its toxicity and side effects. Ten years ago, a new variant contrast agent of medical X-ray imaging was discovered, developed and understudy to date. The new variance factor is gold nanoparticles, which may overcome these limitations because of its excellent properties, where the biological distribution of these particles is higher than iodine compounds. The interaction between bones and soft tissue is more apparent, stay longer at the targeted site which allows for a longer imaging time and all of the above factors enhance the X-ray diagnostic ability. This study consists of the synthesis of gold nanoparticles, animal preparation (which includes a selection of animal type, housing, preparing the tumor and tumor implantation), intravenous administration of gold nanoparticles to infected mice then X-ray imaging was taken by conventional X-ray unit. The resulted X-ray images demonstrated that gold nanoparticles were attractive to move towards tumor site through the general circulation and spent more time at the tumor site (inverse the iodine contrast agent) which allows for a longer time of imaging, lower levels of toxicity and side effects. All of the mentioned factors lead to enhancement of X-ray diagnostics (i.e. obtained X-ray images contain the site of abnormality, two dimensions abnormality map, extra details of bone-soft tissue interference and high contrast level)

Mourad F Rezk is the Global Head of Medical Affairs for Biogen’s biosimilars portfolio He is an MD with more than 25 years of industry experience in medical affairs and R&D roles. Along the course of the last 10 years, he has been quite involved in evolving the understanding of the biosimilars role in improving access to high quality biologics and has been frequently invited as a Speaker to international congresses on biosimilars and has also published a sizable number of publications addressing different biosimilars scientific topics

Many theories have tried to explain the well-known placebo effect of some inactive ingredients as an outcome of patient’s expectations. The expanded use of generics and now the increasing use of biosimilars have brought a new definition to the attention of clinicians who tend to describe the correlation between negative expectations or negative communications with negative subjective treatment outcomes as the nocebo effect, a phenomenon that can cause the induction or the worsening of symptoms by sham or active therapies may account for some adverse events (AEs) reported by patients following treatment. Nocebo responses may occur as unintended result of the requirement for healthcare professionals to explain possible complications and side effects when initiating treatment. Misleading or over negative communications may set negative expatiations at the patients’ level which may ultimately trigger negative perceptions of treatment outcomes and a tendency to overreport adverse events and to withdraw from treatment regimens. Proper fact-based explanations by health care professionals coupled with strategies to reassure and engage patients upon initiating or switching to a biosimilar are key in ensuring better treatment outcomes and sustainability on biosimilars to ensure broader access for patients to complex biologics and reduce the financial burden on health care systems.