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Scientific program

May 26-27, 2021    Berlin, Germany

2nd European Summit of Cancer Pharmacology and Toxicology

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 Ravi Sahu
09:00 AM-09:50 AM

Ravi Sahu

Wright State University United States

Title: Title: Deciphering phospholipid-based signaling mechanisms for lung cancer intervention

Abstract:

Title: Deciphering phospholipid-based signaling mechanisms for lung cancer intervention

 

Ravi P. Sahu

 

Wright State University Boonshoft School of medicine, Dayton, OH 45435, USA

 

 

Abstract

Lung cancer is a highly aggressive and difficult to treat human malignancy with poor prognosis. The development of tumor resistance mechanisms to the known therapeutic options pose major challenges in the treatment of lung cancer, and this provides the impetus for the intervention of new approaches. Among various cellular pathways, the phospholipid mediator, platelet-activator factor (PAF) and PAF-receptor (PAF-R) signaling plays critical roles in tumor development and metastasis as well as limiting the efficacy of therapeutic agents via immune and non-immune mechanisms. Studies, including ours, have demonstrated that exposure to pro-oxidative stressors including both environmental and therapeutic agents produce oxidized PAF and PAF-like ligands non- enzymatically via their ability to generate reactive oxygen species (ROS). Importantly, our previous studies have shown that exposure to cigarette smoke (CS) generates PAF-ligands in a PAF-R- dependent manner via mechanisms involving the induction of cyclooxygenase type 2 (COX-2) and regulatory T cells (Tregs). This CS-mediated PAF- R-ligands generation induced systemic immunosuppression in mice expressing PAF-R (WT), but not in PAF-R-deficient (Ptafr-/-) mice. This CS-induced PAF-ligands generation and systemic immunosuppression were mimicked by a known PAF-R-agonist, CPAF. Notably, the generation of PAF-ligands and induction of systemic immunosuppression were blocked by the

 

 

supplementation of antioxidants, COX-2 inhibitors, PAF-metabolizing, PAF-acetyl hydrolase (PAF-AH) enzyme and depleting antibodies against Tregs, indicating the role of the PAF-R and its downstream effectors in mediating CS-induced effects. As cigarette smoking remains one of the major risk factors for lung carcinogenesis, we hypothesized that the activation of the host-PAF-R that mediates systemic immunosuppression can also modulate the growth of lung cancer in a murine experimental model. To that end, our next studies utilizing WT and Ptafr-/- mice tested if systemic CPAF treatment, which mimicked CS-induced effects, can augment the growth of murine Lewis lung carcinoma (LLC1) cells. We demonstrated that pretreatment of CPAF augmented the growth and metastatic ability of LLC1 tumors in a PAF-R- dependent manner. Analysis of the PAF-R mRNA expression revealed that LLC1 tumor cells lack functional PAF-R expression. This finding was confirmed by the analysis of cell proliferation demonstrating that CPAF failed to induce increased in vitro proliferation of LLC1 tumor cells. While detailed mechanistic studies are warranted, these data indicated that the activation of the host-PAF-R plays an important role in lung cancer development and thus, targeting PAF-R- mediated pathway could be explored as a promising approach for the intervention of lung cancer.

 

 

References

 

  1. Hackler PC, Reuss S, Konger RL, Travers JB, Sahu RP. Systemic Platelet-activating Factor Receptor Activation Augments Experimental Lung Tumor Growth and Metastasis. Cancer Growth Metastasis. 2014;7:27-32.
  2. Thyagarajan A, Saylae J, Sahu RP. Acetylsalicylic acid inhibits the growth of melanoma tumors via SOX2-dependent-PAF-R-independent signaling pathway. Oncotarget. 2017;8(30):49959- 49972.
  3. Sahu RP, Konger RL, Travers JB. Platelet-Activating Factor-Receptor and Tumor Immunity. JSM Cell Dev Biol. 2014;2(1). pii: 1008.

 

 
 
 

 

 

 

Biography:

Ravi P. Sahu has completed his PhD from Sanjay Gandhi Post Graduate Institute of Medical Sciences and postdoctoral studies from the University of Pittsburgh Medical Center, Texas Tech University Health Science Center and Indiana University School of Medicine. He is cuurently an Assistant Professor at the Department of Pharmacology and Toxicology at Wright State University Boonshoft School of Medicine at Dayton, OH. He has published over 50 papers in reputed scientific journals and has been serving as an editorial board member and adhoc reviewer of several journals.

 

  • Full Name: Ravi P. Sahu
  • Personal Email: [email protected]
  • Mobile Number: +1-937-775-4603
  • Category: (Oral presentation)
  • Postal Address: Department of Pharmacology and Toxicology, 230 Health Sciences Bldg. 3640 Colonel Glenn Hwy, Dayton, Ohio 45345, USA

 

Email: [email protected]

Biography:

Ravi P. Sahu has completed his Ph.D. from Sanjay Gandhi Post Graduate Institute of Medical Sciences and postdoctoral studies from the University of Pittsburgh Medical Center, Texas Tech University Health Science Center and Indiana University School of Medicine. He is currently an Assistant Professor at the Department of Pharmacology and Toxicology at Wright State University Boonshoft School of Medicine at Dayton, OH. He has published over 50 papers in reputed scientific journals and has been serving as an editorial board member and Adhoc reviewer of several journals.

 Wael Mohamed Fathy Abdelnaeem Ahmad
10:20 AM-10:50 AM

Wael Mohamed Fathy Abdelnaeem Ahmad

Egypt

Title: Forensic Chemistry Consultant – Center of Forensic and Digital Science, Judicial Department, Abu Dhabi, UAE

Abstract:

Abstract

Forensic Toxicology Laboratory Guidelines

Dr. Wael M. Fathy (Ph.D.)

Forensic Chemistry Consultant – Center of Forensic and Digital Science, Judicial Department, Abu Dhabi, UAE

Laboratory and Personnel: means and equipment for toxicological analysis should meet an acceptable scientific standard. Laboratory procedures must ensure the safety handling of any hazards (toxic, biological samples, and prohibit), access for the laboratory, must be for only authorized persons (director, quality manger  analysts, consultant, evidence officer,..) and an adequate detection, and quantification must be performed for all substances under laboratory scope. Laboratory personnel (director, consultant, analysts) are sufficient trained and experienced to conduct their work and maintained the competency of laboratory. Sample and Receiving: Proper and sufficient samples must be taken to get accurate results. Laboratory director or his designee should develop and provide detailed guidelines and instructions to all agencies which the laboratory serve. Specimens received by the laboratory must identified and store in a good and secure place such that the integrity of the specimens is safeguarded. Acceptable written standard operating procedures (SOP) should be followed. Practical work: All samples and extracts must be labeled in a good manner to ensure the integrity of the analytical results. Chain of custody (COC) very important to document the path of the specimen through the laboratory. Methods and procedures in (SOP) manual must be validated and written in clear manner ,and contain sufficient information, that the analysts can follow them. All documents should be approved by laboratory director or his designee. Any changes in documents (method or procedure) must be clearly documented, stating the reasons for the changes, must be approved also by the director of the laboratory or his designee. Detection by screening techniques (ex: Immunoassay) can apply first, after that confirmatory techniques (Chromatographic Techniques) with proper validated methods, quantitation, and calibration must apply for interpretation of the results. Review and Documentation of The Results: It’s very important for the laboratory to have their own internal quality program, and depending on the type of the laboratory analysis the laboratory should participate in external quality assurance and proficiency testing programs. All analysis results must be documented. This record should include all information necessary to identify the case (name of agency, name of accused person, case number, description, and number of exhibits,…). Review of the results should be run in two steps technical and administrative. The final report must answer all the requesting from all agencies or parties (Request Form) which the laboratory serve. Reference TIAFT-Bulletin XXXI Number 4 p. 23-26

 

Biography:

• Post-Doctoral Fellowship (2014-2015), Texas Southern University, School of Public Affair, Forensic Department, Houston, Texas, United States of America. • Ph.D. Biochemistry - Faculty of Science -University of Cairo 2009. • Master Biochemistry - Faculty of Science- University of Cairo 2004. • Diploma of the training program for Arab anti-drug - National Center for Social Research and the Criminal - Egypt • Bachelor of Science Department of Chemistry -Faculty of Science South Valley University 1995. • Forensic Chemistry Consultant – Center of Forensic and Digital Science, Judicial Department, Abu Dhabi, UAE. ( present). • Forensic Toxicologist Technical Supervisor- Forensic and Toxicology Laboratory, Forensic Medicine Authority Cairo – Egypt. (October 2001 – Present). • Ass. Professor (part-time) - Forensic and Toxicology Department, Faculty of Medicine - Beni Suef University-Egypt. (2012- 2017). • Forensic Toxicologist - Forensic and Toxicology Laboratory Forensic Medicine Authority Cairo – Egypt. (October 1998 – October 2001)

Geert C Mudde
11:10 AM-11:50 AM

Geert C Mudde

Vienna, Austria

Title: Forensic Toxicology Laboratory Guidelines

Abstract:

Abstract

Forensic Toxicology Laboratory Guidelines

Dr. Wael M. Fathy (Ph.D.)

Forensic Chemistry Consultant – Center of Forensic and Digital Science, Judicial Department, Abu Dhabi, UAE

Laboratory and Personnel: means and equipment for toxicological analysis should meet an acceptable scientific standard. Laboratory procedures must ensure the safe handling of any hazards (toxic, biological samples, and prohibit), access for the laboratory, must be for only authorized persons (director, quality manger analysts, consultant, evidence officer,..) and an adequate detection, and quantification must be performed for all substances under laboratory scope. Laboratory personnel (director, consultant, analysts) are sufficient trained and experienced to conduct their work and maintained the competency of laboratory. Sample and Receiving: Proper and sufficient samples must be taken to get accurate results. Laboratory director or his designee should develop and provide detailed guidelines and instructions to all agencies which the laboratory serve. Specimens received by the laboratory must identified and store in a good and secure place such that the integrity of the specimens is safeguarded. Acceptable written standard operating procedures (SOP) should be followed. Practical work: All samples and extracts must be labeled in a good manner to ensure the integrity of the analytical results. Chain of custody (COC) very important to document the path of the specimen through the laboratory. Methods and procedures in (SOP) manual must be validated and written in clear manner ,and contain sufficient information, that the analysts can follow them. All documents should be approved by laboratory director or his designee. Any changes in documents (method or procedure) must be clearly documented, stating the reasons for the changes, must be approved also by the director of the laboratory or his designee. Detection by screening techniques (ex: Immunoassay) can apply first, after that confirmatory techniques (Chromatographic Techniques) with proper validated methods, quantitation, and calibration must apply for interpretation of the results. Review and Documentation of The Results: It’s very important for the laboratory to have their own internal quality program, and depending on the type of the laboratory analysis the laboratory should participate in external quality assurance and proficiency testing programs. All analysis results must be documented. This record should include all information necessary to identify the case (name of agency, name of accused person, case number, description, and number of exhibits,…). Review of the results should be run in two steps technical and administrative. The final report must answer all the requesting from all agencies or parties (Request Form) which the laboratory serve. Reference TIAFT-Bulletin XXXI Number 4 p. 23-26

 

Biography:

Dr. Geert C. Mudde received a Ph.D. in immunology from the University of Utrecht in 1985 and started his international professional career at the Swiss Institute for Asthma and Allergy Research in Davos in 1989. In 1992 he joined the pharmaceutical/biotech industry, where he held several senior management positions at the Novartis Research Institute in Vienna, Austria, the Parke Davis Research Institute in Fresnes, France, Ingenium Pharmaceuticals, Martinsried, Germany, and at igeneon AG, Vienna, Austria. Finally, in 2006, while joining Baxter BioScience in Vienna as interim manager, Dr. Mudde co-founded the biotech company f-star Biotechnology, where he served as “Chief Scientific Officer” from 2007 to 2009. In 2009, together with Christof Langer, he started to develop the S-TIR™ technology platform for human-specific therapeutic vaccines which led to the foundation of S-TARget therapeutics GmbH in 2010. Since then he serves as CSO and managing director for S-TARget therapeutics as well as for the S-TIR™ technology spin-off companies OncoQR ML GmbH and TYG oncology Ltd., which were both founded in 2013

 Alberto Morisetti
11:50 AM-12:30 AM

Alberto Morisetti

Italy

Title: Title: Pitfalls In Nonclinical Safety Data Evaluation

Abstract:

 

Title: Pitfalls In Nonclinical Safety Data Evaluation

 

Alberto Morisetti

BSc, ERT. Senior Pharmatox Advisor

 

Abstract

 

Regulatory safety assessment is based on validated methods and standard procedures within the frame of quality (Good Laboratory Practices). However, when applying the standard methods to obtain and evaluate results in toxicology and safety pharmacology, a thorough critical approach should be applied, as misleading conclusions can result from pitfalls in data collection and subsequent analyses. In fact, nonclinical safety reports should refer data and relevant evaluation in a non-ambiguous manner, to allow go/no-go decision by the sponsor, and finally a positive acceptance by the authorities. Review of dozens of reports revealed a general good appraisal to safety evaluation under different type of studies and in different animal species, however in some cases statements had to be corrected to be consistent with the meaning of the results collected. Statistics is not the only criterion for data evaluation and redundancy of observations (for example daily body weight / food consumption) are often confounding factors owing to a number of significant findings which are meaningless, and sometimes related to changes/errors in procedures. Also, comparison to a control group makes sense in rodent studies, when for many parameters no pre-dose data are available, as is the case in non-rodents. Intra-individual variations (pre- vs post-dose effects) are in fact to be considered in principle, as this comparison more closely reflects the clinical situation. This holds true for both toxicological and pharmacological investigations, the latter being possibly more affected by the complexity of techniques and the amount of data to be evaluated, for example in continuous 24-h ECG telemetry determinations. In conclusion, the present investigation techniques in preclinical studies provide huge amount of data and the automated evaluation tools help the scientists to assess the toxicological profile of the drug under test. A critical evaluation of the applicability of conditions for data analysis coupled with the full knowledge of experimental phases is recommended for a better reliability of the results and to avoid uncertainties and misunderstandings.

 

 

 

 

Biography

Alberto Morisetti has graduated in 1980 in Biological Sciences in Milan, Italy and is European Registered Toxicologist. Up to 2009 he worked as Study Director, Study Monitor, Head of Test Facilities for PharmaTox research and development. He is author/co-author of more than 30 scientific publications in the field of regulatory toxicology and pharmacology, mainly related to contrast media, imaging by different techniques, and regulatory issues, anticancer drugs. From 2010 he started the activity of consultancy in R&D for different Italian and foreign pharma companies, working on regulatory as well as industrial toxicology. His activity consists of drawing the nonclinical development plan, CRO selection, study monitoring and reviewing study reports, CTD and participating to meetings with regulatory authorities for anticancer, antibiotic, corticosteroid, medical device projects. Recent activities include EU Commission participation as nonclinical expert.

•           Full Name: Alberto Morisetti

•           Personal Email: [email protected]

•           Mobile Number: +393288692548

•           Category: Speaker

•           Date of Birth: 20/02/1954

•           Postal Address: via Bitonto 23, 20159, Milano (Italy)

 

Email: [email protected]

 

Biography:

Alberto Morisetti has graduated in 1980 in Biological Sciences in Milan, Italy and is European Registered Toxicologist. Up to 2009, he worked as Study Director, Study Monitor, Head of Test Facilities for PharmaTox research and development. He is author/co-author of more than 30 scientific publications in the field of regulatory toxicology and pharmacology, mainly related to contrast media, imaging by different techniques, and regulatory issues, anticancer drugs. From 2010 he started the activity of consultancy in R&D for different Italian and foreign pharma companies, working on regulatory as well as industrial toxicology. His activity consists of drawing the nonclinical development plan, CRO selection, study monitoring and reviewing study reports, CTD and participating in meetings with regulatory authorities for anticancer, antibiotic, corticosteroid, medical device projects. Recent activities include EU Commission participation as the nonclinical expert.

Alexei G Basnakian
12:30 PM-01:00 PM

Alexei G Basnakian

University of Arkansas for Medical Sciences United States

Title: Evaluation of microscopy-based approaches for the assessment of nanomaterial toxicity

Abstract:

Evaluation of microscopy-based approaches for the assessment of nanomaterial toxicity

Shijie Liu1, Steven Angtuaco1, Alena Savenka1, Todd Fite1, Mariya Khodakovskaya2, Alexei G. Basnakian1

1University of Arkansas for Medical Sciences, 2University of Arkansas at Little Rock, Arkansas, USA  

Wide use of nanomaterials may eventually cause an environmental poisoning, including the contamination of food. However, methods for the assessment of nanomaterial toxicity are not well developed. The goal of the current study was to develop a technique to measure toxicity of multiwall carbon nanotubes (MWCNTs) in vivo by applying a combination of fluorescent microscopy, terminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL) assay, dark-field microscopy (DFM) and electron microscopy (EM). For this, male CD-1 mice were fed by oral gavage with a water suspension of MWCNTs at varying doses up to 10 mg/kg/day. Twenty-four hours later, blood chemistry testing showed elevation of aspartate aminotransferase (AST), a liver injury marker, at the highest used dose. The liver damage was confirmed by the TUNEL assay. Our further analysis included the application of DFM for (a) the colocalization between MWCNTs and TUNEL-positive cells and (b) development of a method to quantify MWCNTs burden in liver tissue. DFM clearly showed some elevation of particulate material in the liver with occasional association with TUNEL-positive cells, but it did not seem to allow precise quantification of nanoparticle aggregates due to low sensitivity of DFM at the concentration observed in the liver. However, we discovered that CNT gavage increased the percentage of nuclei colocalized with DF objects by systematically counting the number of liver cell nuclei in contact with dark-field (DF) objects. TUNEL-positive nuclei were photographed, analyzed at 100-fold magnification and sorted by CNT treatment category. The process was repeated for DAPI nuclei to serve as a control, and the percentage of nuclei with DF colocalization was recorded per group. Our results indicate that the rate of colocalization between DF objects and nuclei appears to correlate directly with CNT-gavage treatment. Another important observation confirmed by an electron microscopy was that there were many alive TUNEL-negative cells containing MWCNTs. Overall, our data indicate that the DFM method designed for particle toxicology has only limited potential for measurement of nanoparticle toxicity, while a combination of methods may be useful for the toxicity evaluation, and also, that some mouse liver cells are capable of accumulating MWCNTs without inducing immediate cell death.  

 

Biography:

Alexei Basnakian received his MD in Internal Medicine from Sechenov Moscow Medical Academy, and PhD and DSc degrees from the Russian Academy of Medical Science, both in the field of DNA-degrading enzymes. He had postdoctoral trainings in molecular biology at the Harvard Medical School and in toxicology/cancer research at the National Center for Toxicological Research/US Food and Drug Administration. Dr. Basnakian is a tenured Professor at the Department of Pharmacology and Toxicology, and Director of the DNA Damage and Toxicology Core Center at the University of Arkansas for Medical Sciences in Little Rock, Arkansas, USA. He is an author of 89 peer-reviewed papers and 14 reviews or book chapters. Dr. Basnakian is an Editorial Board member of 4 biomedical journals, and a member of NIH, AHA and VA grant study sections. His research interests are in DNases/endonucleases and DNA damage associated with toxicity, anti-cancer therapy, tissue injury and cell death.

01:00 PM-02:00 PM

Title: Lunch Break

Ms Benjaporn Buranrat
02:30 PM-03:00 PM

Ms Benjaporn Buranrat

Mahasarakham University Thailand

Title: Title: Pamidronate inhibits cholangiocarcinoma cells proliferation and migration

Abstract:

Title: Pamidronate inhibits cholangiocarcinoma cells proliferation and migration

 

Benjaporn Buranrat1

 

1Faculty of Medicine, Mahasarakham University, Thailand

 

Abstract

 

Pamidronate is predicted to effectively inhibit cancer cell growth or metastatic in bone tissue. However, pamidronate has direct effects against cancer cell growth and migration. Therefore, this study needed to explore the mechanism of pamidronate effects on cholangiocarcinoma (CCA) cells on their proliferation and migration. We used KKU-100 to study the pamidronate effects on cell death and migration using sulforhodamine B (SRB), colony formation, flow cytometry, reactive oxygen species (ROS) production and caspase 3 activity. In addition, the effects of the test compound on the mevalonate (MVA) pathway by Western blotting and RT-PCR. Cell migration was observed by wound healing, matrigel zymography and gelatin zymography. Pamidronate stimulated CCA cell death and inhibited colony formation in a dose-dependent manner. Further, pamidronate induced CCA cell death with IC50 values at 444.67+44.05 uM for 24 h and 147.33+17.01 uM for 48 h. Moreover, we found the result that pamidronate suppressed colony formation with a lower concentration than growth inhibition with IC50 values at 5.36+0.31 uM. The mechanism of growth inhibition could be correlated with the increasing ROS generation, stimulating caspase 3 enzyme activity and leading to apoptosis. In addition, pamidronate interfered with the MVA pathway by reducing MVA products, especially for Rac1 protein levels. Finally, pamidronate suppressed the CCA cell migration by decreasing the MMP 2 and MMP 9 expression levels. Pamidronate activated CCA cell death and inhibited migration at quite low concentrations. Lastly, pamidronate significantly decreased the Rac1 protein expression in the MVA pathway. Pamidronate may be beneficial for developing a novel chemotherapy method for CCA.

 

 

References

1.         Fleisch, H., Development of bisphosphonates. Breast Cancer Res 2002. 4(1):  30-34.

2.         Iguchi, K., Y. Tatsuda, S. Usui, and K. Hirano, Pamidronate inhibits antiapoptotic bcl-2 expression through inhibition of the mevalonate pathway in prostate cancer PC-3 cells. Eur J Pharmacol 2010. 641(1):  35-40.

3.         Iguchi, T., Y. Miyakawa, K. Saito, C. Nakabayashi, M. Nakanishi, H. Saya, Y. Ikeda, and M. Kizaki, Zoledronate-induced S phase arrest and apoptosis accompanied by DNA damage and activation of the ATM/Chk1/cdc25 pathway in human osteosarcoma cells. Int J Oncol 2007. 31(2):  285-291.

4.         Molinuevo, M.S., L. Bruzzone, and A.M. Cortizo, Alendronate induces anti-migratory effects and inhibition of neutral phosphatases in UMR106 osteosarcoma cells. Eur J Pharmacol 2007. 562(1-2):  28-33.

 

 

dummy

Biography:

Benjaporn Buranrat is a Asst. Prof. at the Faculty of Medicine at the Mahasarakham University. She studied Public Health Science at the Khon Kaen University, and received her Ph.D. in  Pharmacology from Faculty of Medicine at the Khon Kaen University, working on mevalonate pathway inhibitors and cancer. She did her postdoctoral work at Penn State University, USA, working on ferritin effects and MCF-7 cancer cells. She has authored or co-authored over 15 manuscripts. Her laboratory has worked in cancer cells death, cell apoptosis, mevalonate pathway.

 

•           Full Name: Benjaporn Buranrat

•           Personal Email: [email protected]

•           Mobile Number: +66815462151

•           Category: (Poster presentation)

•           Date of Birth: 06/11/1980

•           Postal Address:  Faculty of Medicine, Mahasarakham University, Thailand

 

Email: [email protected]

 

Biography:

Benjaporn Buranrat is a Asst. Prof. at the Faculty of Medicine at the Mahasarakham University. She studied Public Health Science at the Khon Kaen University and received her Ph.D. in Pharmacology from Faculty of Medicine at the Khon Kaen University, working on mevalonate pathway inhibitors and cancer. She did her postdoctoral work at Penn State University, USA, working on ferritin effects and MCF-7 cancer cells. She has authored or co-authored over 15 manuscripts. Her laboratory has worked in cancer cells death, cell apoptosis, mevalonate pathway.

04:30 PM-05:10 PM

Title: Title: Pitfalls In Nonclinical Safety Data Evaluation

Speakers

Muhammad Waqas
10:50 AM-11:10 AM

Muhammad Waqas

University of Lahore Pakistan

Title: NEW APPROACHES TO THE EVALUATION OF HERBAL DRUG EFFICACY IN TREATMENT OF CHRONIC RHINOSINUSITIS

Abstract:

Alberto Morisetti

BSc, ERT. Senior Pharmatox Advisor

 

Abstract

 

Regulatory safety assessment is based on validated methods and standard procedures within the frame of quality (Good Laboratory Practices). However, when applying the standard methods to obtain and evaluate results in toxicology and safety pharmacology, a thorough critical approach should be applied, as misleading conclusions can result from pitfalls in data collection and subsequent analyses. In fact, nonclinical safety reports should refer data and relevant evaluation in a non-ambiguous manner, to allow go/no-go decision by the sponsor, and finally a positive acceptance by the authorities. Review of dozens of reports revealed a general good appraisal to safety evaluation under different type of studies and in different animal species, however in some cases statements had to be corrected to be consistent with the meaning of the results collected. Statistics is not the only criterion for data evaluation and redundancy of observations (for example daily body weight / food consumption) are often confounding factors owing to a number of significant findings which are meaningless, and sometimes related to changes/errors in procedures. Also, comparison to a control group makes sense in rodent studies, when for many parameters no pre-dose data are available, as is the case in non-rodents. Intra-individual variations (pre- vs post-dose effects) are in fact to be considered in principle, as this comparison more closely reflects the clinical situation. This holds true for both toxicological and pharmacological investigations, the latter being possibly more affected by the complexity of techniques and the amount of data to be evaluated, for example in continuous 24-h ECG telemetry determinations. In conclusion, the present investigation techniques in preclinical studies provide huge amount of data and the automated evaluation tools help the scientists to assess the toxicological profile of the drug under test. A critical evaluation of the applicability of conditions for data analysis coupled with the full knowledge of experimental phases is recommended for a better reliability of the results and to avoid uncertainties and misunderstandings.

 

 

 

 

Biography:

Muhammad Waqas has completed his PhD from IMBB, University of Lahore, Pakistan. He is the director of Johar Institute of Professional Studies, a premier Pharmacy Institute. He has published more than 15 papers in reputed journals and has been serving as an editorial board member of reputed Journals

Shereen N Raafata
09:50 AM-10:20 AM

Shereen N Raafata

The British University in Egypt Egypt

Title: The sole and combined effect of simvastatin and platelet rich

Abstract:

The sole and combined effect of simvastatin and platelet rich fibrin as a filling material in induced bone defect in tibia of albino rats Shereen N Raafata,⁎, Reham M Aminb, M M Elmazarc, Mahmoud M Khattabd, Aiman S. ElKhatibd a Department of Pharmacology and Toxicology, Faculty of Dentistry, The British University in Egypt (BUE), Egypt b Department of Oral Biology, Faculty of Dentistry, The British University in Egypt (BUE), Egypt c Department of Pharmacology and Toxicology, Faculty of Pharmacy, The British University in Egypt (BUE), Egypt d Department of Pharmacology and Toxicology, Faculty of Pharmacy, Cairo University, Egypt A B S T R A C T Statins like simvastatin (SIM) have demonstrated to have pleiotropic actions other than their conventional use as antilipidemic drugs. Also, nowadays natural scaffolds like platelets rich fibrin (PRF) showed promising results on bone regeneration. Aim: This study compares the regenerative power of SIM and PRF added locally each as a sole filling material on induced bone defect and evaluate the combined effect using PRF loaded with SIM. Materials and methods: A critical size bone defect was induced in 48 male albino rats of average weight 150–200 g and were divided into 4 groups according to the filling material. Control, PRF, SIM, and SIM/PRF group. Each group was subdivided according to the sacrificing period into two subgroups (one and two-months postoperatively). Tibial specimens were evaluated histologically using masson trichrome (MT) special stain to detect areas of new bone formation, immunohistochemically using anti- BMP2 and anti-VEGF, serum levels of Osteoprotegerin (OPG), RANKL, osteocalcin and alkaline phosphatase enzyme (ALP) were measured one and two months postoperatively using ELISA, finally bone mineral density (BMD) at the bone defect area was analyzed using digital X-ray one and two-months postoperatively. Results: The percentage of newly formed bone increased significantly in the three groups vs the control group with the highest significant increase (p < 0.001) in the SIM/PRF group one month postoperatively. Also, SIM/ PRF group was the only group which showed significant bone maturation two-months postoperatively compared to the other groups. Immunohistochemical analysis showed significant increase in positively stained BMP-2 and VEGF expression (p < 0.001) in the three groups vs the control group with the highest significant increase (p < 0.001) in the SIM/PRF group. Serum bone anabolic markers increased significantly in the SIM and SIM/ PRF groups. In contrast, RANKL serum level decreased significantly in the SIM and SIM/PRF group one month postoperatively with no significant decrease in the PRF group vs the control group. Digital X-ray results revealed the highest BMD percent change was found in the SIM/PRF group and showed complete bone healing two months postoperatively. Keywords: Bone regeneration Simvastatin PRF Scaffold Bone markers

Dr Russell Bialecki
03:10 PM-04:00 PM

Dr Russell Bialecki

Greater Philadelphia Area

Title: Janssen Pharmaceutical Companies of Johnson Johnson

Biography:

I am a highly accomplished, published, top-performing Scientist/Director with 20+ years of high-impact, non-clinical research and development experience spanning the pharmaceutical and chemical industries. I bring proven Expertise in pharmacology, toxicology, non-clinical and commercial drug development. My record includes cultivating strong team building and leadership, organizational development, Good Laboratory Practices (GLP), non-GLP and delivering significant results. Recognized with earned accolades as an energetic, intuitive and articulate communicator, continually focused on building and strengthening relationships across all organizational levels to drive consensus for unified strategies that further enterprise goals. Successes Include: • Designing, implementing and interpreting nonclinical safety studies to support project progression. • Problem-solving to clarify underpinning mechanisms of action and mitigating potential issues. • Placing results in the context of relevant regulatory guidelines and the human condition. • Analyzing operation budgets, P&L and forecasting book of work. • Mentoring team and cross-functional teammates to increase delivery. • Managing time to strategically organize and lead projects over $7MM. • Facilitating company integration to increase operational efficiency by 40% during a merger. • Providing support and communications to ensure delivery of studies on time, on budget and to quality. Expertise Includes: Director of Toxicology & Pharmacology | Pharmaceuticals & Biotechnology

Poster

Muhammad Waqas
02:30 PM-03:00 PM

Muhammad Waqas

University of Lahore Pakistan

Title: Title: MANIFESTATION OF PREDICTIVE VARIABLES AND THEIR RELATIONSHIP TO ESTABLISH ANEMIA IN TRAFFIC WARDENS OF LAHORE CITY

Abstract:

Alberto Morisetti

BSc, ERT. Senior Pharmatox Advisor

 

Abstract

 

Regulatory safety assessment is based on validated methods and standard procedures within the frame of quality (Good Laboratory Practices). However, when applying the standard methods to obtain and evaluate results in toxicology and safety pharmacology, a thorough critical approach should be applied, as misleading conclusions can result from pitfalls in data collection and subsequent analyses. In fact, nonclinical safety reports should refer data and relevant evaluation in a non-ambiguous manner, to allow go/no-go decision by the sponsor, and finally a positive acceptance by the authorities. Review of dozens of reports revealed a general good appraisal to safety evaluation under different type of studies and in different animal species, however in some cases statements had to be corrected to be consistent with the meaning of the results collected. Statistics is not the only criterion for data evaluation and redundancy of observations (for example daily body weight / food consumption) are often confounding factors owing to a number of significant findings which are meaningless, and sometimes related to changes/errors in procedures. Also, comparison to a control group makes sense in rodent studies, when for many parameters no pre-dose data are available, as is the case in non-rodents. Intra-individual variations (pre- vs post-dose effects) are in fact to be considered in principle, as this comparison more closely reflects the clinical situation. This holds true for both toxicological and pharmacological investigations, the latter being possibly more affected by the complexity of techniques and the amount of data to be evaluated, for example in continuous 24-h ECG telemetry determinations. In conclusion, the present investigation techniques in preclinical studies provide huge amount of data and the automated evaluation tools help the scientists to assess the toxicological profile of the drug under test. A critical evaluation of the applicability of conditions for data analysis coupled with the full knowledge of experimental phases is recommended for a better reliability of the results and to avoid uncertainties and misunderstandings.

 

 

 

 

Biography:

Muhammad Waqas has completed his PhD from IMBB, University of Lahore, Pakistan. He is the director of Johar Institute of Professional Studies, a premier Pharmacy Institute. He has published more than 15 papers in reputed journals and has been serving as an editorial board member of reputed Journals

E-Poster

Muhammad Waqas
04:30 PM-05:00 PM

Muhammad Waqas

University of Lahore Pakistan

Title: Title: MANIFESTATION OF PREDICTIVE VARIABLES AND THEIR RELATIONSHIP TO ESTABLISH ANEMIA IN

Abstract:

Alberto Morisetti

BSc, ERT. Senior Pharmatox Advisor

 

Abstract

 

Regulatory safety assessment is based on validated methods and standard procedures within the frame of quality (Good Laboratory Practices). However, when applying the standard methods to obtain and evaluate results in toxicology and safety pharmacology, a thorough critical approach should be applied, as misleading conclusions can result from pitfalls in data collection and subsequent analyses. In fact, nonclinical safety reports should refer data and relevant evaluation in a non-ambiguous manner, to allow go/no-go decision by the sponsor, and finally a positive acceptance by the authorities. Review of dozens of reports revealed a general good appraisal to safety evaluation under different type of studies and in different animal species, however in some cases statements had to be corrected to be consistent with the meaning of the results collected. Statistics is not the only criterion for data evaluation and redundancy of observations (for example daily body weight / food consumption) are often confounding factors owing to a number of significant findings which are meaningless, and sometimes related to changes/errors in procedures. Also, comparison to a control group makes sense in rodent studies, when for many parameters no pre-dose data are available, as is the case in non-rodents. Intra-individual variations (pre- vs post-dose effects) are in fact to be considered in principle, as this comparison more closely reflects the clinical situation. This holds true for both toxicological and pharmacological investigations, the latter being possibly more affected by the complexity of techniques and the amount of data to be evaluated, for example in continuous 24-h ECG telemetry determinations. In conclusion, the present investigation techniques in preclinical studies provide huge amount of data and the automated evaluation tools help the scientists to assess the toxicological profile of the drug under test. A critical evaluation of the applicability of conditions for data analysis coupled with the full knowledge of experimental phases is recommended for a better reliability of the results and to avoid uncertainties and misunderstandings.

 

 

 

 

Biography:

Muhammad Waqas has completed his PhD from IMBB, University of Lahore, Pakistan. He is the director of Johar Institute of Professional Studies, a premier Pharmacy Institute. He has published more than 15 papers in reputed journals and has been serving as an editorial board member of reputed Journals

Sponser Session

04:00 PM-04:30 PM break

Title: Title: MANIFESTATION OF PREDICTIVE VARIABLES AND THEIR RELATIONSHIP TO ESTABLISH ANEMIA IN