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.