Title: Breast Cancer Treatment, nanoparticle encapsulated doxorubicin and Drug Safety

Abstract:

Breast cancer is the most common cancer in women worldwide. It is also the principal cause of death from cancer among women globally. Despite the high incidence rates, in Western countries, 89% of women diagnosed with breast cancer are still alive 5 years after their diagnosis, which is due to detection and treatment. Breast cancer incidence has been increasing. In 2015, an estimated 231,840 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S., along with 60,290 new cases of non-invasive (in situ) breast cancer. About 2,350 new cases of invasive breast cancer are expected to be diagnosed in men in 2015. A man’s lifetime risk of breast cancer is about 1 in 1,000. Breast cancer incidence rates in the U.S. began decreasing in the year 2000, after increasing for the previous two decades. They dropped by 7% from 2002 to 2003 alone. One theory is that this decrease was partially due to the reduced use of hormone replacement therapy (HRT) by women after the results of a large study called the Women’s Health Initiative were published in 2002. These results suggested a connection between HRT and increased breast cancer risk. About 40,290 women in the U.S. are expected to die in 2015 from breast cancer, though death rates have been decreasing since 1989. Women under 50 have experienced larger decreases. These decreases are thought to be the result of treatment advances, earlier detection through screening, and increased awareness. White women are slightly more likely to develop breast cancer than African-American women. However, in women under 45, breast cancer is more common in African-American women than in white women. Overall, African-American women are more likely to die of breast cancer. The risk of developing and dying from breast cancer is lower in Asian, Hispanic, and Native-American women. About 5-10% of breast cancers can be linked to gene mutations (abnormal changes) inherited from one’s mother or father. Mutations of the BRCA1 and BRCA2 genes are the most common. On average, women with a BRCA1 mutation have a 55-65% lifetime risk of developing breast cancer. For women with a BRCA2 mutation, the risk is 45%. Breast cancer that is positive for the BRCA1 or BRCA2 mutations tends to develop more often in younger women. Increased ovarian cancer risk is also associated with these genetic mutations. In men, BRCA2 mutations are associated with a lifetime breast cancer risk of about 6.8%; BRCA1 mutations are a less frequent cause of breast cancer in men.  All drugs for breast cancer treatment developed and on the market cause mild to several side effects, and the safety, pharmacovigilance, signal detection, and risk management of breast cancer drugs are difficult to report and manage.  A series of challenges of breast cancer therapy and drug safety will be reported and discussed at the meeting along with liposomal nanoparticle encapsulated doxorubicin.

Biography:

Ashok Srivastava is the Chief Medical Officer of Trans Atlantic Therapeutics  Oncology,   He was the Chief Medical Officer of CareBeyond - A Radiation Therapy Cancer Center, New Jersey, USA. He has more than 15 years of experience in drug development, medical affairs, and commercialization of cancer drugs including radiopharmaceutical and supportive care; Phase I – 4, and marketing commercialization of  Hematology, Oncology, and radiopharmaceutical drugs in the USA, EU, and Japan.  He is the leader in Cancer Drug Development  Worldwide large and complex Phase 3 Clinical Trials in many countries.  He contributed to 21-INDs and 7-NDAs of Cancer Drugs, the acquisition /merger of a company and drug for more than $300 million. He received his clinical, and medical training  & worked at renowned medical centers and pharmaceutical institutions worldwide; Walter Reed Army Institute of Research and Medical Center,  Daiichi, Sumitomo, Pharmacia, Pfizer, Eisai Oncology, and Spectrum Pharmaceuticals. He received his Clinical, Medical & Business educations from All India Institute of Medical Sciences, New Delhi, India; the Academy of Medical Sciences, Czechoslovakia; the School of Medicine Nagasaki University, Japan, and Pharmaceutical Business at Rutgers University Business Management, New Jersey, USA. He played a key role in a dramatic expansion of oncology drug–developed cancer drugs- Sutent (Sunitinib), Evoxac (Cevimeline HCl), and liposomal doxorubicin (Myocet) in combination with Herceptin & Paclitaxel for HER2 positive metastatic breast cancer patients and latuda (Lurasidone) for schizophrenia   He is one of the inventors of Japanese encephalitis vaccine (IXIARO). He has published more than 85 papers in National and International Journals, more than 120 abstracts, 3 book chapters, and 2 patents. He is the recipient of numerous National & International prestigious medical awards and recognitions from the United Nations, Ministry of  Health, Japan, Department of Army, Walter Reed Army Medical Center, and Walter Reed Army Institute of Research, Washington DC, USA. He served as a medical advisor to Poniard Pharmaceutical for small-cell lung cancer in the USA, EU, and India. Srivastava is a member of numerous prestigious organizations; America’s Top Oncologist of the years 2007, 2008, and 2011, Breast Cancer Foundation, Indian Society of Oncology, American Society of Clinical Oncology, American Society for Therapeutic Radiology & Oncology, American Association of Cancer Research, and International Society of Lung Cancer.  Dr. Srivastava is a strategic medical advisor and Board Member to several pharma in the USA for clinical, regulatory, and supervises cancer drug development. Recently Dr. Srivastava was awarded membership in Japan External Trade  Organization, USA. Dr. Srivastava is a Leader in Drug Safety, pharmacovigilance of  Oncology, hematology, and immuno-oncology and built global drug safety and pharmacovigilance companies in the USA, and India. Dr. Srivastava was invited as an honorable speaker at the drug safety & Pharmacovigilance congress in London, UK, China, India, and Washington, DC, USA in Jan 2012, 2013, and 2017.  Dr. Srivastava brought 2 cancer drugs & a vaccine to a global market for approx  3 – 3.5 billion $ in global sales.  He serves on the board of directors for oncology virtual pharma companies in the USA. He is on the Board of advisors to Calidi Biotherapeutics. 

Title: Tendon regeneration and functional enhancement for physical performance via Piezo1-Mkx axis

Abstract:

Tendons and ligaments are tough tissues that precisely connect muscle to bone and bone to bone, respectively. Once damaged; however, they are difficult to heal, and secondary osteoarthritis is known to occur in approximately 60% of cases. However, the development of treatment methods in current medicine has been challenging. One of the reasons for this is that the master transcription factors, the Operation System of our genome, that produce tendons have long been unknown. We created an expression catalog of all 1600 transcription factors and identified Mkx as the central transcription factor for tendons. First, we showed that Mkx could promote the differentiation into tenocytes (tendon cells) from human iPS cells. Using these tenocytes, we could produce tendon-like tissues and show the therapeutic effect of its transplantation in the tendon injury model. Next, we analyzed the potential function of Piezo1, mechano-sensor, and an Mkx upstream activator in tenocytes, by generating the mice in which an active type of Piezo1 was introduced into tenocytes. Surprisingly, in the tendon-specific gain of function Piezo1 mice, jumping ability and Max speed were significantly enhanced. Based on the results in mice, the role of Piezo1 in human athletic performance was tested. In collaboration with the Athrome Consortium, an international athlete genomics organization, we investigated the frequency of active PIEZO1 E756del in Olympic-level sprinters and the general population in Jamaica. Although the analysis is limited to a small number, the results showed that Jamaican sprinters had a significantly increased ratio of functional polymorphism compared to the general population. These discoveries in tendons have allowed us to understand the entire motor function system, contributing healthy society and medical care.

Biography:

Hiroshi Asahara was trained as an Orthopedic Surgeon after graduating from Okayama University Medical School. His career as a researcher led him to be a postdoctoral fellow at Harvard Medical School and a staff scientist at Salk Institute, under Prof. Marc Montminy. Asahara now organizes his own lab as a Professor of Molecular Medicine at The Scripps Research Institute, USA, and as Professor at Tokyo Medical and Dental University, Japan. Based on his unique Systems Biomedicine approaches combining a novel strategy and database, he and his lab are trying to uncover molecular mechanisms of musculoskeletal development and identify the critical pathway to regulate inflammatory diseases, including rheumatoid arthritis.

Title: Personalized and Precision Medicine (PPM) as a Unique Healthcare Model to Be Set Up via Biodesign, Bio- and Chemical Engineering, Translational Applications, and Upgraded Business Modeling to Secure the Human Healthcare, Wellness and Biosafety

Abstract:

Traditionally a disease has been defined by its clinical presentation and observable characteristics, not by the underlying molecular mechanisms, pathways, and systems of biology-related processes specific to a particular patient (ignoring persons at risk). A new systems approach to subclinical and/or diseased states and wellness resulted in a new trend in healthcare services, namely, personalized and precision medicine (PPM).
To achieve the implementation of the PPM concept, it is necessary to create a fundamentally new strategy based upon the biomarkers and targets to have a unique impact on the implementation of the PPM model into the daily clinical practice and pharma. In this sense, despite breakthroughs in research that have led to an increased understanding of PPM-based human disease, the translation of discoveries into therapies for patients has not kept pace with medical needs. It would be extremely useful to integrate data harvesting from different databanks for applications such as prediction and personalization of the further treatment to thus provide more tailored measures for the patients and persons at risk resulting in improved outcomes and more cost-effective use of the latest health care resources including diagnostic (companion ones), preventive and therapeutic (targeted molecular and cellular), etc.
Translational researchers, bio-designers, and manufacturers are beginning to realize the promise of PPM, translating to direct benefit to patients or persons at risk. For instance, companion diagnostics tools and targeted therapies and biomarkers represent important stakes for the pharma, in terms of market access, return on investment, and image among the prescribers. At the same time, they probably represent only the generation of products resulting in translational research and applications. So, developing medicines and predictive diagnostic tools require changes to traditional clinical trial designs, as well as the use of innovative (adaptive) testing procedures that result in new types of data. Making the best use of those innovations and being ready to demonstrate results for regulatory bodies requires specialized knowledge that many clinical development teams don’t have. The areas where companies are most likely to encounter challenges are data analysis and workforce expertise, biomarker and diagnostic test development, and cultural awareness. Navigating those complexities and ever-evolving technologies will pass regulatory muster and provide sufficient data for a successful launch of PPM, which is a huge task. So, partnering and forming strategic alliances between researchers, bio-designers, clinicians, businesses, regulatory bodies, and government can help ensure an optimal development program that leverages the Academia and industry experience and FDA’s new and evolving toolkit to speed our way to getting new tools into the innovative markets.
Healthcare is transforming, and it is imperative to leverage new technologies to support the advent of PPM. This is the reason for developing global scientific, clinical, social, and educational projects in the area of PPM and TraMed to elicit the content of the new trend. The latter would provide a unique platform for dialogue and collaboration among thought leaders and stakeholders in government, academia, industry, foundations, and disease and patient advocacy with an interest in improving the system of healthcare delivery on one hand and drug discovery, development, and translation, on the other one, whilst educating the policy community about issues where biomedical science and policy intersect

Biography:

Sergey Suchkov was born in the City of Astrakhan, Russia, in a family of dynasty medical doctors. In 1980, graduated from Astrakhan State Medical University and was awarded MD. In 1985, Suchkov maintained his Ph.D. as a Ph.D. student of the I.M. Sechenov Moscow Medical Academy and Institute of Medical Enzymology. In 2001, Suchkov maintained his Doctor Degree at the National Institute of Immunology, Russia. From 1989 through 1995, Suchkov was being the Head of the Lab of Clinical Immunology, at Helmholtz Eye Research Institute in Moscow. From 1995 through 2004 - a Chair of the Dept for Clinical Immunology, Moscow Clinical Research Institute (MONIKI). From 1993-1996, Suchkov was a Secretary-in-Chief of the Editorial Board, of Biomedical Science, an international journal published jointly by the USSR Academy of Sciences and the Royal Society of Chemistry, UK.

Title: Breast Cancer Treatment, nanoparticle encapsulated doxorubicin and Drug Safety

Abstract:

Breast cancer is the most common cancer in women worldwide. It is also the principal cause of death from cancer among women globally. Despite the high incidence rates, in Western countries, 89% of women diagnosed with breast cancer are still alive 5 years after their diagnosis, which is due to detection and treatment. Breast cancer incidence has been increasing. In 2015, an estimated 231,840 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S., along with 60,290 new cases of non-invasive (in situ) breast cancer. About 2,350 new cases of invasive breast cancer are expected to be diagnosed in men in 2015. A man’s lifetime risk of breast cancer is about 1 in 1,000. Breast cancer incidence rates in the U.S. began decreasing in the year 2000, after increasing for the previous two decades. They dropped by 7% from 2002 to 2003 alone. One theory is that this decrease was partially due to the reduced use of hormone replacement therapy (HRT) by women after the results of a large study called the Women’s Health Initiative were published in 2002. These results suggested a connection between HRT and increased breast cancer risk. About 40,290 women in the U.S. are expected to die in 2015 from breast cancer, though death rates have been decreasing since 1989. Women under 50 have experienced larger decreases. These decreases are thought to be the result of treatment advances, earlier detection through screening, and increased awareness. White women are slightly more likely to develop breast cancer than African-American women. However, in women under 45, breast cancer is more common in African-American women than in white women. Overall, African-American women are more likely to die of breast cancer. The risk of developing and dying from breast cancer is lower in Asian, Hispanic, and Native-American women. About 5-10% of breast cancers can be linked to gene mutations (abnormal changes) inherited from one’s mother or father. Mutations of the BRCA1 and BRCA2 genes are the most common. On average, women with a BRCA1 mutation have a 55-65% lifetime risk of developing breast cancer. For women with a BRCA2 mutation, the risk is 45%. Breast cancer that is positive for the BRCA1 or BRCA2 mutations tends to develop more often in younger women. Increased ovarian cancer risk is also associated with these genetic mutations. In men, BRCA2 mutations are associated with a lifetime breast cancer risk of about 6.8%; BRCA1 mutations are a less frequent cause of breast cancer in men. All drugs for breast cancer treatment developed and on the market cause mild to several side effects, and the safety, pharmacovigilance, signal detection, and risk management of breast cancer drugs are difficult to report and manage.  A series of challenges of breast cancer therapy and drug safety will be reported and discussed at the meeting along with liposomal nanoparticle encapsulated doxorubicin.

Biography:

Pallavi Dhillon

Trans Atlantic Therapeutics, LLCUSA

Title: Breast Cancer Treatment, nanoparticle encapsulated doxorubicin and Drug Safety

Abstract:

Breast cancer is the most common cancer in women worldwide. It is also the principal cause of death from cancer among women globally. Despite the high incidence rates, in Western countries, 89% of women diagnosed with breast cancer are still alive 5 years after their diagnosis, which is due to detection and treatment. Breast cancer incidence has been increasing. In 2015, an estimated 231,840 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S., along with 60,290 new cases of non-invasive (in situ) breast cancer. About 2,350 new cases of invasive breast cancer are expected to be diagnosed in men in 2015. A man’s lifetime risk of breast cancer is about 1 in 1,000. Breast cancer incidence rates in the U.S. began decreasing in the year 2000, after increasing for the previous two decades. They dropped by 7% from 2002 to 2003 alone. One theory is that this decrease was partially due to the reduced use of hormone replacement therapy (HRT) by women after the results of a large study called the Women’s Health Initiative were published in 2002. These results suggested a connection between HRT and increased breast cancer risk. About 40,290 women in the U.S. are expected to die in 2015 from breast cancer, though death rates have been decreasing since 1989. Women under 50 have experienced larger decreases. These decreases are thought to be the result of treatment advances, earlier detection through screening, and increased awareness. White women are slightly more likely to develop breast cancer than African-American women. However, in women under 45, breast cancer is more common in African-American women than in white women. Overall, African-American women are more likely to die of breast cancer. The risk of developing and dying from breast cancer is lower in Asian, Hispanic, and Native-American women. About 5-10% of breast cancers can be linked to gene mutations (abnormal changes) inherited from one’s mother or father. Mutations of the BRCA1 and BRCA2 genes are the most common. On average, women with a BRCA1 mutation have a 55-65% lifetime risk of developing breast cancer. For women with a BRCA2 mutation, the risk is 45%. Breast cancer that is positive for the BRCA1 or BRCA2 mutations tends to develop more often in younger women. Increased ovarian cancer risk is also associated with these genetic mutations. In men, BRCA2 mutations are associated with a lifetime breast cancer risk of about 6.8%; BRCA1 mutations are a less frequent cause of breast cancer in men. All drugs for breast cancer treatment developed and on the market cause mild to several side effects, and the safety, pharmacovigilance, signal detection, and risk management of breast cancer drugs are difficult to report and manage.  A series of challenges of breast cancer therapy and drug safety will be reported and discussed at the meeting along with liposomal nanoparticle encapsulated doxorubicin.

Biography:

Pallavi Dhillon, PharmD, Ph.D., is working at ClinFomatrix, NJ, USA, and New Delhi, India, and Trans Atlantic Therapeutics, New Jersey, USA,  Director and Head of Clinical Operations and Drug Safety, USA, for more than 5 years and managing drug safety program globally, Quality Review of ICSRs, write and review safety narratives, pharmacovigilance Control document, monitoring of the compliance of outsourced pharmacovigilance activities. Lead concepts of quality management and inspection readiness within the study Clinical project monitoring and management to ensure that clinical trial project and process work was conducted to internal and external standards. This included ensuring that all colleagues, both internal as well as preferred CROs and partners, were regulatory inspection ready and staff were compliant with ICH GCP and relevant national and international regulations and guidelines and corporate policies and SOPs. Conducting clinical site feasibility studies as well as clinical site identification starting from Phase-I to Phase IV. Monitoring the clinical sites as per the monitoring plan to ensure that Principal Investigator(s) are conducting the study as per Protocol, ICH-GCP & SOPs. Pallavi Dhillon have experience in neuroscience drug development and safety: schizophrenia, depression, mania, bipolar disorder, pediatric bipolar, pediatric schizophrenia, neuropathic pain, inflammation; osteoarthritis in CNS patients. Pallavi Dhillon also have significant experience in Oncology: Phase 1-3 clinical trials, Solid tumor studies; lung cancers, head and neck, breast, liver, colorectal, prostate, and ovarian; hematologic tumors, leukemia, and myeloma blood disorders. Pallavi Dhillon also led the Cardiovascular: Lipid studies, Women's health: Osteoporosis; migraine, non-interventional studies, Infectious disease: HIV/AIDs; vaccine; upper respiratory tract infections, pediatric sinusitis, Specialty Care/Other Therapy Areas: Inflammation, rheumatology, urology. Pallavi Dhillon completed my doctor of philosophy, master and Bachelor's in pharmacy, at MDU Rohtak, India. Pallavi Dhillon worked at leading pharmaceutical companies; Baxter Healthcare India, Pharmacovigilance Specialist, India, and Pfizer Pharmacovigilance Officer, New Delhi, India, and was responsible for all AEs, SAEs, medication errors, and product complaints. Differentiating between Initial and Follow-up reports using ARGUS Working on database Pfoenix and ARGUS for comparison of Adverse Events and completing follow-up reports. QC of cases, AEM report forms for any kind of errors. Undergo client mentorship as designated by the project manager. I also worked as Clinical Research Associate, at Sir Ganga Ram Hospital, New Delhi, and managed phase 3 protocols, recruitment, patient screening, patient consent forms and follow-up management with Investigator. Maintained source documentation and drug accountability, SAEs reporting, maintained site master file. HIPPA inclusions for IRB/IEC submission. Pallavi Dhillon was a Trainee Clinical Research Associate, at Clinsys CRO, Noida, India and Assisted in the conduction of BA/BE studies. To prepare readiness of the clinical facility and all study/system-related documents for the audit process (QA audit, any regulatory Sponsor audit, etc) at all / times. Pallavi Dhillon completed an internship at Clinsys Clinical Research Organization as, Clinical Research Coordinator, Retention/recruitment Patients in India. Pallavi Dhillon am a member of the Pharmacy Associations of India and a registered pharmacist in India.

Title: Meta-Analysis Shows that Mesenchymal Stem Cells Therapy can be a Possible Treatment for Diabetes and Diabetic Kidney Disease

Abstract:

Premature ovarian failure (POF) affects 1% of women under 40, leading to infertility. The clinical symptoms of the POF include hypoestrogenism, lack of mature follicles, hypergonadotropinism, and amenorrhea. POF can be caused due to genetic defects, autoimmune illnesses, and environmental factors. The conventional treatment of POF remains a limited success rate. Therefore, an innovative treatment strategy like the regeneration of premature ovaries by using human umbilical cord mesenchymal stem cells (hUC-MSCs) can be a choice. To summarize all the theoretical frameworks for additional research and clinical trials, this review article highlights all the results, pros, and cons of the hUC-MSCs used to treat POF. So far, the data shows promising results regarding the treatment of POF using hUC-MSCs. Several properties like relatively low immunogenicity, multipotency, multiple origins, affordability, convenience in production, high efficacy, and donor/recipient friendliness make hUC-MSCs a good choice for treating basic POF. It has been reported that hUC-MSCs impact and enhance all stages of injured tissue regeneration by concurrently stimulating numerous pathways in a paracrine manner, which are involved in the control of ovarian fibrosis, angiogenesis, immune system modulation, and apoptosis. Furthermore, some studies demonstrated that stem cell treatment could lead to hormone-level restoration, follicular activation, and functional restoration of the ovaries. Therefore, all the results in hand regarding the use of hUC-MSCs for the treatment of POF encourage researchers for further clinical trials, which will overcome the ongoing challenges and make this treatment strategy applicable to the clinic shortly.

Biography:

Greene is a residency and fellowship-trained orthopedic surgeon who has shifted completely into business. He started a healthcare internet marketing company, US Lead Network, that helps medical and dental practices acquire patients on the web in a pay-for-performance manner. The company is now using Artificial Intelligence for marketing which is lowering the cost per lead substantially. He has written two books on Healthcare Internet Marketing that are available for purchase on Amazon. He has been featured as a Top 20 Expert Author by Ezines.com, the top article directory site in the world. Out of over 470,000 authors, Greene ranks #15 as an Expert Author and #1 in the Pain Management category. He also started a regenerative medicine company, R3 Stem Cell, that offers marketing, an IRB-approved protocol, and top products for practices nationwide. R3 offers stem cell training courses that are second to none at https://stemcelltrainingcourse.org