Dr. Ashok Srivastava, Md, Ph.D., Mba Email & Phone Number

New York, NY, US

New York City Metropolitan Area

• Medical and Safety Physician of solid tumors, lymphoma and leukemia global study medical and safety monitoring and Patients Safety Evaluation of Oncology/Hematology/Oncolytic virus Therapeutics. Review Medwatch and.
• Phase 3. Oncolytic virus intratumoral therapy of glioblastoma Nivolumab, lirilumab in cisplatin-Ineligible muscle-invasive bladder cancer patients
• Phas 3. Venetoclax in combination with obinutuzumab and bendamustine in follicular lymphoma patients
• Phase 3. Ixazomib and Ibrutinib in relapsed/refractory mantle cell lymphoma
• Phase 3. Bendamustine and Rituximab plus Venetoclax in untreated mantle cell lymphoma
• Phase 3. Anti – PD-1, durvalumab, with chemo for treatment of unresectable mesothelioma

Princeton, New Jersey, United States

• Lead global CAR-T CD19 immunotherapy of r/r lymphoma/leukemia, cancer patients’ care, cancer drug development and clinical executive team. Lead global clinical trials, medical monitoring, safety monitoring, manage drug.
• Phase 2 CAR-T therapy of lymphoma and leukemia in USA. Canada, UK, Spain and France
• Phase 2 oncolytic virus therapy of patients with EGFR-mutant metastatic lung cancer in USA, EU,
• Phase 3- ADC/chemotherapy therapy of post-surgery, relapse/refractory Squamous Cell carcinoma in USA, Canada, India, Japan
• Phase 3- Oncolytic Virus Therapy metastatic breast cancer in USA, Canada
• Phase 3- Oncolytic Virus Therapy of glioblastoma, USAAwards:

London, England, United Kingdom

CAR-T cell therapy of lymphoma and leukemia.Highly active T cell therapies for cancer.An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating the Safety and Efficacy of AUTO1, a CAR T Cell Treatment Targeting CD19, in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic LeukemiaA Study of CD19 Targeted CAR T Cell Therapy in Adult.

Chino, California, United States

Edinburgh, Scotland, United Kingdom

Vision is to be at the forefront of cancer drug testing and provide personalized medicine testing to each individual suffering from cancer to better their chance of treatment and survival.

Greater San Diego Area, California, USA

Advance Stem Cell-Based Platforms for the Delivery and Potentiation of Oncolytic Viruses to Treat Cancer.Systemic enveloped oncolytic virotherapy program targeting all tumor types, including advanced metastatic disease, and the clinical development of Calidi’s CLD-101 (NeuroNova) and CLD-201 (SuperNova) programs.Calidi's systemic enveloped virotherapy.

Palo Alto, Carifornia, USA

Creating Tomorrow's New Cancer Treatment

Flemington, New Jersey, USA

Establishing a registry of multiple myeloma -Oncolytic virus trappy of solid tumors-CAR-T therapy of lymphoma and leukemia-Oncology Forum provides global clinical trials; a unique strategy for identification of patients per clinical study protocols, increase the fastest patients’ recruitment and fast regulatory approval. Bring drugs of an Unmet Medical.

California, United States

• Oncology, Hematology and Supportive Care of metastatic cancer patients....Develop immunotherapy for metastatic cancer patients’ own T-cells therapy against cancer, as an alternative to chemotherapy, radiation or.
• Leading global Phase 1 – 3, registration, 3b and 4 clinical trials, medical monitoring, safety monitoring, AEs/SAEs signal detection, risk management, imaging management, and data review.
• Lead global cell therapy of leukemia lymphoma and myelodysplastic syndromes. Responsible for phase 3 study of bone marrow transplant in patients undergoing to transplant in leukemia, lymphoma patients and MDS patients/
• Responsible for successful clinical, medical, operation, regulatory, safety, pts recruitment, CRO and regulatory agency communications

Princeton, New Jersey, Manhattan, New York, USA, Nagasaki, Japan, And New Delhi, India

• Global leader of optimizing patients’ safety, by monitoring and analyzing potential safety signal. Support clinical development process by leading the structured benefit-risk process and assures compliance with.
• Obtained Seven-drug approval and commercialization in USA< Japan and EU
• Led 37 phase 1 trial, 40 phase 42 trials, and 37 phase 3 trials of solid and hematologic tumors
• Submitted 23 INDs, 9 NDAs, 3 sNDAs, 4 (505b2), BLAs, to US FDA
• Phase 3 protocol of head and neck cancer, and breast cancer approval from DCGI-India
• Made FDA-ODAC presentations

San Diego, California, USA And Tokyo, Japan

• Responsible for phase 3 global clinical trial execution in Japan, USA, Taiwan and India.LuminoxTM - Photoimmunotherapy (PIT) is a targeted technology; a formulation of a conjugate of the dye IR700 with antibody.
• A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have.
• A phase 1 Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors.

New Jersey, USA

Responsible for medical and safety monitoring of Phase 1, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of B-RAF Dimer Inhibitor Lifirafenib (BGB-283) in Combination with a MEK inhibitor mirdametinib (PD-0325901) in Patients with Advanced or Refractory Solid Tumors in Australia, USA.

New Jersey, United States And Tokyo, Japan

• Breast CancerR&D and Medical Affairs Metastatic Breast Cancer Treatment-Antibody-drug conjugate (ADC) therapy of HER2+ and HER3+ metastatic breast cancer- ADC Therapy of metastatic breast cancer: Trastuzumab Deruxtecan.
• Antibody-Drug Conjugate therapy for HER3 positive breast cancer to overcome treatment failure.
• HER3 overexpression are associated with poor prognosis of breast, lung, gastric, ovarian cancer and melanoma.
• Pertuzumab and trastuzumab; a HER2-targeting antibody which inhibits the dimerization of HER2 with other HER family receptors including HER3, is clinically available for patient with HER2-positive breast cancer.
• An effective treatment required for HER3 positive breast cancer therapy.These therapies have adverse events that require monitoring and proactive management in order to optimize patient quality of lifeT-DXd is an.

Research Triangle Park, NC

• Built oncology portfolio; Safety and Pharmacovigilance, study design, trial execution of global trials. Provide protocol consideration, RFP preparation, budget, clinical sites, KoLs and led bid defenseo Safety and.
• Provided KoLs, and high performing global investigators
• Awarded 3 global trials total; 57 million $
• Supported President and CEO for oncology business

New Jersey, Maryland, USA

A phase 3b, open-label, multi-center, study to assess the safety of durvalumab monotherapy in advanced solid malignancies in Canada, France, Germany, Italy, Netherlands, South Korea, Switzerland, UK and USA-Lead Data Safety Monitoring Committee.-Review safety database of 700 patients enrolled, -Finalize DSMB charter and manage DSMB committee meeting.

London, Canada, USA Metropolitan Area

Princeton, New Jersey, USA

As Vice President Oncology reporting to the CMO. I am senior physician responsible for all medical safety, which employs 5000 people and conducts clinical research in 42 countries around the world. In additional I have direct line management responsibilities of all Oncology- medical / clinical aspects of the company and the overall clinical strategy..

Irvine, California, USA And Henderson, Nevada, USA

• Reported to the President, Chief Operating Officer, as Vice President Oncology, Clinical, Medical Affairs and Clinical Operations, development strategy and co-led global commercialization for solid tumors, lymphoma and.
• Synthetic bio-reductive prodrug for non-invasive bladder cancer post TURBT in bladder cancer patients, phase 3 registration trial
• Rolontis (eflapegrastim) chemotherapy-induced neutropenia in breast cancer patients, P 3 trial
• Poziotinib- quinazoline-based pan-HER inhibitor that blocks signaling through HER tyrosine-kinase receptors HER1 (erbB1; EGFR), HER2, (erbB2) & HER4 (erbB4), in breast cancer patients, P 2 trialLed IITs, life cycle.
• Fusilev (Levoleucovorin) combination with 5-FU treatment of metastatic colorectal cancer
• Folotyn (pralatrexate)- for relapsed or refractory peripheral T-cell lymphoma

Global Executive Medical Director, Medical Affairs, New Jersey, USA, UK, Singapore, India, Japan;

Global Medical Affairs Brand Leader of Halaven (Eribulin Mesylate). Led Life Cycle Management, medical directors, and MSLs and Global Team Leaders. Halaven to treat metastatic breast cancer. Global Eribulin (Halven) versus decarbazine in previously treated unrespectable or metastatic liposarcoma in patients who received a prior anthracycline-containing.

New Jersey, USA

I built global clinical research organization including clinical medical sciences, clinical operations, regulatory affairs, biometrics, pharmacovigilance, medical affairs, pharmacology, toxicology, and medical affairs.Leader in cancer drug development and medical affairs; IND, Phase 1-3, Special Protocol Assessment (SPA) FDA protocols, NDA submission and.

Princeton, New Jersey, USA

Reported to the Chief Executive Officer and Chief Medical Officer Officer as Senior Director Oncology, for Clinical development strategy and co-led global commercialization for Myocet (liposomal Doxorubicin) for HER+ breast cancer and NHL globally.Myocet is a liposome formulation of doxorubicin hydrochloride; an anthracycline cytotoxic agent for breast.

New Jersey, USA, Tokyo And Osaka, Japan

Dainippon Sumitomo - Now Sunovion:Oncology:Amerubicin, third-generation anthracycline and potent topoisomerase II inhibitor. I led phase 3 registration trial in small cell lung cancer patients in 11 countries, second line therapy.Neuro-psychiatry:I developed- Lurasidone (Latuda) an antagonist at dopamine type-2 (D2) and 5-hydroxytryptamine (5-HT2A).

New Jersey And New York, USA

Led SU011248- Sutent® phase 2/3 Efficacy and safety in GIST patients; a randomized, double-blind placebo-controlled trial in patients who had disease progression during prior imatinib treatment or who were imatinib-intolerant.Conducted Phase 3 clinical trial of SU5416 (semaxanib) in metastatic colorectal cancer patients, Phase 1-2 clinical trials of.

Montevale, New Jersey, USA

Filed 7 INDs filed; 9 trials initiated; advanced drugs from Phase 1 - 3; potential deal with SnoBrand Pharmaceuticals, Japan to co-develop and co-commercialize 63 drug candidates.I led late stage clinical trials of chemotherapy agents: Paclitaxel, Docetaxel and Irinotecan for Breast Cancer, Colorectal Cancer, NSCLC, SCLC, Gastric Cancer, Pancreatic and.

Walter Reed National Military Medical Center, Washington DC, USA

Infectious Diseases and Virus Diseases:Developed Japanese Encephalitis Vaccine- RNA vaccine Inactivated Japanese encephalitis virus vaccine: Inventor and Developer of Japanese encephalitis (JE) vaccine IXIARO®. Approved in more than 55 countries and sales $40-45 million per year globally. I am one of the patent holders and Inventors.Dengue vaccineDeveloped.

Nagasaki School Of Medicine, Nagasaki, Japan

Nagasaki School of Medicine, Nagasaki, Japan

Doctor Of Medicine - Md, School Of Medicine, Nagasaki, Japan, Medicine

Clinical And Medical Oncology, Medical Oncology At Dana Farber Cancer Center

Re-fresher course in medical and clinical oncology certification

Management Developing Leadership

Diploma In Tropical Medicine, Oncology, Hematology, Internal Medicine, Infectious Diseases

Activities and Societies: Nagasaki Cancer Hospital

Executive Mba

Md, Ph.D., Mba, Medical Oncology And Hematology

Activities and Societies: Medical Oncology and Hematology. Pharmaceutical Business Management • School of Medicine Nagasaki University.

Ph.D., Immunology And Onco-Virology

Activities and Societies: Onco-virology

Medicine

Medical Officer, Pediatric Health Care In Europe

Fellwoship Clinical Pharmacology

Tufts Center For The Study Of Drug Development, Tufts Center For The Study Of Drug Development

Professional Certification In Medical Affairs Oncology Board, Pediatric Hematology-Oncology Residency Program

Education record

•American Association of Clinical Oncology • Head and Neck cancer Foundation • Breast Cancer Foundation • International Society of Lung.

Oncology