Day 1 :
Keynote Forum
Shinichiro Akiyama
Saisei Mirai Clinic
Keynote: Clinical experience of colostrum derived protein against solid cancer
Time : 09:40-10:40
Biography:
Shinichiro Akiyama currently is General Director of the Saisei Mirai Clinic in Tokyo, Japan. He had been a fellow in oncology at Sapporo Medical University School of Medicine. This led to clarify intracellular TNF as a resistant factor by chemotherapeutic agents. He joined the Cancer Immune Cell Therapy Center of Kudan Clinic in 2009. There he had applied cancer gene profiling as therapeutic effect of peptide-pulsed dendritic cell therapy. He was selected as “Featured Global Expert Cancer Researcher of Marquis Who's Who” in 2015.
Abstract:
Recently immunotherapy has become an attractive new strategy in the treatment of cancer, boosting the patient's own immune system to eradicate cancer cells. The toxicities of immunotherapy for cancer are as diverse as the type of treatments that have been devised. Immune surveillance by macrophage is critical for the immune integrity since invertebrates has evolved and is imposed through an intricate armory of functions that can infiltrate into tumors tissue. Oral colostrum macrophage-activating factor (MAF) produced from bovine colostrum derived vitamin D binding protein has shown high macrophage phagocytic activity as well as anti-tumor activities. Oral colostrum MAF stimulates macrophage whereas its precious mechanism has not yet been understood. It is administered orally in an acid-resistant enteric capsule to activate macrophages in the gut-associated lymphoid tissue and as a powder in the mouth to activate macrophages in the lymphoid tissue of the Waldeyer's tonsillar ring. In terms of practical clinical use, oral colostrum MAF has certain advantages over MAF produced from serum because it is derived from bovine colostrum and it is administered orally and sub-lingually instead of injection. We propose that oral colostrum MAF and MAF produced from serum could demonstrate a greater immunotherapeutic activity than that of serum MAF alone. We have also treated cancer patients with oral colostrum MAF in combination with cancer gene therapy and/or NK cell therapy so as to induce higher potential benefit of solid cancer therapy.
Keynote Forum
Carmen Popescu
Roquette America Inc. USA
Keynote: Cyclodextrins as reliable solubilization tools for BCS class II and IV drugs
Time : 11:00-12:00
Biography:
Carmen Popescu received her BS degree in Physics and PhD in Biophysics at University of Bucharest, Romania. She is a Senior Project Coordinator at Roquette America Inc. and Adjunct Associate Professor with University of Illinois at Chicago, Roosevelt University, University of Tennessee, University of Maryland. She has published over 120 research papers, book chapters and presentations on classic and new drug delivery dosage for small and large molecules. Additionally, she is a Reviewer for the International Journal of Pharmaceutics, Journal of Pharmaceutical Sciences, European Journal of Pharmaceutics and Biopharmaceutics, Journal of Pharma & Pharmaceutical Science and an active member of AAPS and CRS.
Abstract:
Formulation scientists have reported myriad of conventional and advanced formulation strategies to improve the bioavailability of rate limited dissolution drugs through efficient solubilization. However, many of them are still at bench stage because industrial scale equipment is not yet available and financially difficult to be sustained. In recent years, formulator’s attention was focusing on cyclodextrins as a solubilizing tool for their stubborn like bricks APIs (BCS class II and IV)). The reason is obvious: Easy to scale up and a successful presence, of both liquid and solid dosage form, on the commercially available brands. This presentation is centered on a coherent approach of insoluble APIs solubilization by cyclodextrin complexation in liquid phase as well as solid dispersions (by kneading, spray drying, lyophilization and physical mix) through an extensive array of case studies (carbamazepine, danazol, albendazole, furosemide, zotepine, zaleplon, lorazepam, progesterone, celecoxib, furosemide, valsartan and NSAIDs (flurbiprofen, ibuprofen, ketoprofen, naproxen, piroxicam). They are useful tools in solubilizing drugs delivered in high dose by IV route or at low dose by solid dosage forms. If your API good performance does not require solubilization optimization, you still wonder why cyclodextrin complexation? One should not forget that they can offer: Increased stability (physical, chemical), masked taste/odor, convert liquid forms into amorphous powders, new formulation, new routs of administration, patent extension increased shelf life, etc.
- Track 2: Fundamentals of Pharmacy Track 3: Pharmacy Field Track 4: Pharma Clinical Trials
Location: Hall B
Chair
Carmen Popescu
Roquette America Inc.
Session Introduction
Laetitia Devy-Dimanche
EMD Serono, Inc., USA
Title: The translational medicine guide: “asking the right question at the right timeâ€
Time : 12:00-12:40
Biography:
Laetitia Devy-Dimanche is the Head of Global Early Stage (Discovery to Proof of Concept) Project Management. She ensures with her team that projects are executed on time, within budget and with high quality. She is a professional with 12+ years’ experience working in Biotech and Biopharmaceutical industry focusing in the area of novel drug development including antibody and small protein drugs. She has a Pre-Graduate Research Degree in Clinical Pharmacology and a PhD in Biochemistry and Molecular Biology. During her PhD and Post-doctoral fellow, she has acquired extensive expertise in tumor microenvironment, proteolysis and angiogenesis leading to the publication of 28 papers in peer-review journals.
Abstract:
The translational Medicine Guide (TxM guide) has been developed to help each project team maximize success in achieving clinical Proof of Concept (cPoC) by considering multiple aspects of drug discovery and development. The TxM Guide is a forward looking strategic planning framework for teams to ask “the right questions at the right time” for each of the 3 categories - Target, Dose and Patient: • Target: The target pillar focuses on the critical need to identify the right biological target and increase the understanding of its role in a particular disease. The goal is to identify the right biological target for the selected disease. • Dose: The dose pillar addresses dose, regimen and drug (molecule), focusing teams on the importance of identifying the right molecule for a given biological target that will have the right therapeutic window. The goal is to identify right molecule that delivers the right exposure at the target site of action and elicits the desired target modulation over the stated time period, without compromising patient safety. • Patient: The patient pillar underscores the importance of selecting the right sub-patient population for the investigational drug and identifying the potential use of a companion diagnostic test to select an appropriate sub-disease population. The goal is to identify the right patient group in the selected disease. The presentation will outline how the TxM guide helps teams to build a body of scientific & medical evidence to be better positioned to achieve positive cPoC.
Jill E Lavigne
St. John Fisher College, USA
Title: Suicidal ideation and behavior as adverse events of prescribed medications: An update for pharmacists
Time : 13:30-14:10
Biography:
Jill Lavigne, PhD, MPH is a health services researcher by training and is participating in post-market safety research related to suicide adverse events at the US Department of Veterans Affairs’ Center of Excellence in Public Health Approaches to Suicide Prevention. She is Professor, Pharmacy Practice and Administration at the Wegmans School of Pharmacy, St. John Fisher College.
Abstract:
Suicide is the tenth leading cause of death in the US. The Food and Drug Administration has labeled more than 125 prescription drugs for potential adverse effects of suicidal ideation and behavior, including all antidepressants and anti-epileptics, an antibiotic and smoking cessation agents, among others. Questions persist about causality (pharmacological provocation of suicide) in the context of psychiatric treatment response (treatment emergence) and the multi-factorial pathogenesis of suicidal behavior, which is distinct from suicidal ideation. Pharmacists may play a key role in the identification and management of these complex adverse events. Pharmacists should file MedWatch Reports even when information is incomplete or uncertain. Resources to support pharmacists managing patients at risk include hotlines, chat-lines, texting and free federally-funded on-line training. In the future, innovative data systems and approaches in the US Department of Veterans Affairs may provide additional insight into the complex causes of these adverse events.
Yutaka Hara
Orion Japan Corporation, Japan
Title: Unique approach of Orion Bioscan (Non-Linear Analizing System-NLS) for comprehensive diagnosis and treatment
Time : 14:10-14:50
Biography:
Mr. Hara currently is CEO of the Orion Japan Corporation in Tokyo, Japan. Orion Japan Corporation has been established since 2012 most advanced and innovative technology applied to Bio Conditioning facility where provides Oxygen Chamber simultaneously with Nonlinear analysis systems (NLS) are the most advanced information technologies that can, at the outset of the century, be considered the most remarkable and advantageous accomplishment of modern natural science. This unique invention created by Mr. Hara advised over 900 patients and clinical test covered over 1,200 sessions in worldwide. Health and wellness related business venture "Nonlinear Analysis Systems"(NLS) His research interest includes vortex magnetic fields processing and biological systems in 2009.
Abstract:
The concept of medicine follows logically from the observation that certain diseases caused by the single functionally defective gene. Its gene alternation progress cellular defects, theoretically then. As it turns out, these changes become tissue level of damages. On the other hand, Orion Bioscan® is practical use of quantum physics to analyze Terahertz electromagnetic signal of brain cortex. Recent advances of these novel physiological approaches allow detecting abnormality of organ by using headphone examination and cortex scanning. Not only does Orion Bioscan® provides an ideal source for determining candidate drug targets but also monitor real time hazard such as allergic food and local infection. Based on this application, many interventions to date in whole body abnormalities classified. We show several interventions including medical examinations as well as treatment by Orion Bioscan® apparatus.
Suzan Marwan Ramadan Shahin
United Arab Emirates University, UAE
Title: The comprehensive guidance in essential oil research to discover the undiscovered areas in the UAE
Time : 14:50-15:10
Biography:
Suzan M Shahin is a Lead Ambassador of the United Arab Emirates University (UAEU) graduate students. She is a researcher and PhD candidate in the Aridland Agriculture Department, College of Food and Agriculture, UAEU. Her research interests are the UAE indigenous plants, essential oil extraction and analysis, natural resources, natural drugs, environmental sciences, sustainable environmental approaches.
Abstract:
The first data bank for the native essential oil-bearing plants in the United Arab Emirates (UAE) had been established. The database was constructed based on different methodologies, including, extensive literature review “for around 800 species”, frequent field survey and specimen display approach. It includes collection of extensive knowledge for 135 native and naturalized species. Also, it provides a solid base ground to take quick decisions in plant selection, and to start up an innovative essential oil-based research pathway, that can lead to new chemotypes, and potential discoveries. In addition, the databank offers the essential oil research centers, universities and manufacturing companies, the opportunity to highlight the most important indigenous species in the UAE, which have the capability to produce expensive raw materials and is highly recommended to be conserved from decision maker for sustainability purposes. The national essential oil database is a friendly and easy use excel software, with filtering options, demonstrating much detailed information for the 135 plant species (e.g. scientific name “in Arabic & English”, family name “in Arabic & English”, plant form, life cycle, characteristics, difficulties, status, availability in the country, economical value, functional parts for essential oil extraction, essential oil yield, essential oil extraction method, extract biological activity). The established database is the first of its kind in the UAE, and would accelerate the research, discoveries and investments in the essential oil field.
Suzan Marwan Ramadan Shahin
United Arab Emirates University , United Arab Emirates
Title: The comprehensive guidance in essential oil research to discover the undiscovered areas in the UAE
Time : 14:50-15:30
Biography:
Suzan M Shahin is a Lead Ambassador of the United Arab Emirates University (UAEU) graduate students. She is a researcher and PhD candidate in the Aridland Agriculture Department, College of Food and Agriculture, UAEU. Her research interests are the UAE indigenous plants, essential oil extraction and analysis, natural resources, natural drugs, environmental sciences, sustainable environmental approaches.
Abstract:
The first databank for the native essential oil-bearing plants in the United Arab Emirates (UAE) had been established. The database was constructed based on different methodologies, including, extensive literature review “for around 800 species”, frequent field survey and specimen display approach. It includes collection of extensive knowledge for 135 native and naturalized species. Also, it provides a solid base ground to take quick decisions in plant selection, and to start up an innovative essential oil-based research pathway, that can lead to new chemotypes, and potential discoveries. In addition, the databank offers the essential oil research centers, universities and manufacturing companies, the opportunity to highlight the most important indigenous species in the UAE, which have the capability to produce expensive raw materials and is highly recommended to be conserved from decision maker for sustainability purposes. The national essential oil database is a friendly and easy use excel software, with filtering options, demonstrating much detailed information for the 135 plant species (e.g. scientific name “in Arabic & English”, family name “in Arabic & English”, plant form, life cycle, characteristics, difficulties, status, availability in the country, economical value, functional parts for essential oil extraction, essential oil yield, essential oil extraction method, extract biological activity). The established database is the first of its kind in the UAE, and would accelerate the research, discoveries and investments in the essential oil field.
- Track 13: Drug Development and therapeutics Track 14: Pharmacovigilance Track 15: Pharmaceutical Analysis
Chair
Shinichiro Akiyama
Saisei Clinic, Japan
Session Introduction
Alok Bandyopadhyay
AB Consulting, USA
Title: Biosimilar of protein therapeutics¬
Time : 10:45-11:25
Biography:
Alok Bandyopadhyay is a Senior Global Consultant at AB consulting. He started his scientific career working on immunoglobulin and received his PhD from University of Calcutta. Later he came to USA to work on molecular biology of proteins using Fulbright Travel grant. He took training as a Post-doctoral fellow from US universities. After training, he held several academic positions and worked in molecular biology of proteins. He published several scientific papers in various peer reviewed journals and received awards. In 1990s, he joined industry in drug development area and at the same time, he held Adjunct Faculty Position in Medicine at Thomas Jefferson Medical College, and subsequently Stony Brook University Medical College, NY. He worked with various famous people in the protein research. After joining industry, he gained experience in project management, advancing product innovation from conception through commercialization. He worked in various areas of drug development including Research, Quality and Regulatory. He was involved in various global submissions of IND, NDA, BLA, ANDA, pre-approval, and post approval. He worked in drug development of CNS, immunology, endocrinology, and oncology. He is a certified regulatory professional and proficient in US/EU regulations. He is successful interfacing with FDA reviewers. He is attached with several professional associations e.g. RAPS, DIA and AAPS.
Abstract:
Biopharmaceuticals like monoclonal antibodies are widely used in clinical medicine for various therapies e.g. cancer, inflammatory and autoimmune diseases. Several biosimilar drugs, supposed to be economical version of branded biological drugs, are in the process of drug development for market approval. Unfortunately, biosimilar manufacturing is often different from the brand name drug due to variation in manufacturing processes. As a result, such variations may trigger unwanted clinical issues, which may limit the use of biopharmaceuticals. Well engineered cells, well designed formulation coupled with good manufacturing scheme may sometimes reduce some of the extrinsic and intrinsic factors and increase the stability of drug product. One of the proposals for remedies is to purify the drug product to homogeneity or near homogeneity retaining its stability and functional activity. Due to its low or negligible content of impurities clinical issues may not be triggered and may get a relief from rigorous clinical studies. In addition, incorporation of risk based approach, which considers both probability of induction of clinical issues and expected clinical consequences followed by risk mitigation during drug development, may provide better regulatory pathway for market approval.
Suzan Marwan Ramadan Shahin
United Arab Emirates University , United Arab Emirates
Title: New opportunities in the UAE through essential oil-based research: Native plants as natural resources for future drugs after the oil era
Time : 11:25-12:05
Biography:
Suzan M Shahin is a Lead Ambassador of the United Arab Emirates Unviersity (UAEU) graduate students. She is a researcher and PhD candidate in the Aridland Agriculture Department, College of Food and Agriculture, UAEU. Her research interests are the UAE indigenous plants, essential oil extraction and analysis, natural resources, natural drugs, environmental sciences and sustainable environmental approaches.
Abstract:
The United Arab Emirates (UAE) is a young country, with an oil-based economy, that has limited lifetime expectancy. Although the UAE is located in the arid regions, however, the native wildlife is considered to be rich in biodiversity. Also, throughout history, the traditional folk medicine, through the use of the local medicinal plants, has proven its effectiveness and efficiency. The main purpose of this work is to shed the light on new opportunities in the aromatherapy field based on the UAE native essential oil-bearing plants. This initiative “named as Aroma Niche” was adopted recently by the United Arab Emirates University (UAEU) science and innovation park, and currently in the pipelines for implementation. It is significant to fill the gaps between the traditional folk practices, research and technology; in order to build a concrete base ground for new natural derived drugs. The whole process is seeking for professional experts in the field of aridlands agriculture, chemical engineering and pharmacognosy. This initiative believing that, desert plants, who survive the arid conditions, capable of providing high quality ingredients with potential applications in aromatherapy. The promising company will provide 100% certified organic products “chemicals free”, and will follow the US Food and Drug Administration (FDA) regulations. The extraction process would be done by hydrodistillation, and product quality will be monitored by the analytical technology of the Gass Chromatography/Mass Spectrometry (GC/MS). There is a crucial necessity to implement this idea; in order to sustain the local economy after the oil peak.