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.