Ashok Srivastava
Clinfomatrix Oncology, USA
Title: Breast cancer treatment and global cancer drug safety
Biography:
Dr. Ashok Srivastava is Chief Executive Officer and Chief Medical Officer of Cure Pharmaceuticals, and ClinFomatrix Oncology CRO, He was founder, Chief Executive Officer and 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 1 – 4, and marketing commercialization of Hematology, Oncology and radio-immuno-oncology drugs in USA, EU and Japan. He is leader in Cancer Drug Development Worldwide large and complex Phase 3 Clinical Trials. He contributed to 21-INDs and 7-NDAs of Cancer Drugs, acquisition /merger of company and drug for more than $900 million. He received his clinical, medical training & worked at renowned medical centers and pharmaceutical institutions worldwide at various executive leadership positions; Walter Reed Army Institute of Research and Medical Center, Daiichi Pharmaceuticals, Sumitomo Pharmaceuticals, Pharmacia, Pfizer, Eisai Oncology, Spectrum Pharmaceuticals and Taiho Oncology. He received his Clinical, Medical & Business educations from All India Institute of Medical Sciences, New Delhi, India; Academy of Medical Sciences, Czechoslovakia; School of Medicine Nagasaki University, Japan, and Pharmaceutical Business at Rutgers University Business Management, New Jersey, USA. He played key role in 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 for metastatic breast cancer patients and Latuda (Lurasidone) for schizophrenia. He has published more than 85 papers in National and International Journals, more than 120 abstracts, 3 book chapters and 2 patents. He is recipient of numerous National & International prestigious medical awards and recognitions from United Nations, Ministry of Health, Japan, and Department of Army, Walter Reed Army Medical Center and Walter Reed Army Institute of Research, Washington DC, USA. He served as medical advisor to Poniard Pharmaceutical for small cell lung cancer and Taiho Oncology in USA, EU and India. Dr. Srivastava is member of numerous prestigious organizations; America’s Top Oncologist of the years 2017, 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 USA for clinical, regulatory and supervises cancer drug development. Recently Dr. Srivastava was awarded membership of Japan External Trade Organization, USA. Dr. Srivastava is a Leader in Drug Safety, pharmacovigilance of Oncology, hematology, immuno-oncology and built global drug safety and pharmacovigilance companies in USA, and India. Dr. Srivastava was invited as an honorable speaker at drug safety & Pharmacovigilance congress in London, UK, India and Washington, DC, USA in 2017. Dr. Srivastava brought 2 cancer drugs & a vaccine in global market for approximately 3 – 3.5 billion $ in global sales. He serves as board of directors for oncology pharma companies in USA.
Abstract:
Breast cancer is the most common cancer in women worldwide. It is also the principle 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, 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. One theory is that this decrease was partially due to the reduced use of hormone replacement therapy (HRT) 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 5-10% of breast cancers can be linked to gene mutations. 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. An 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 in market cause mild to several side effects, and the safety, pharmacovigilance, signal detection and risk management of breast cancer drugs are difficult to manage. A series of challenges of breast cancer therapy and the drug safety will be discussed at the meeting.