Dr. Ashok Srivastava, Md, Ph.D., Mba

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

President, Chief Medical Officer @ AyurDatta Solutions
New York, NY, US
Dr. Ashok Srivastava, Md, Ph.D., Mba's Location
New York City Metropolitan Area, United States
Dr. Ashok Srivastava, Md, Ph.D., Mba's Contact Details

Dr. Ashok Srivastava, Md, Ph.D., Mba personal email

About Dr. Ashok Srivastava, Md, Ph.D., Mba

Passionate and motivated medical oncologist/hematologist with clinical development expertise in the biotech/pharmaceutical industry. Proven track record for leading global clinical trial programs of solid tumors/hematologic malignancies with innovative targeted therapies, small molecules, CAR-T , ADCs, immuno-oncology, oncolytic virus and chemotherapy from proof of concept through phase 3 and lifecycle management.I currently serve as a Global Medical Lead for novel CAR-T and IO compounds targeting hematologic malignancies and solid tumors. This includes leading efforts as the Global Medical Monitor for first-in-human trials to late stage trials, facilitating interactions with KOLs and investigators, as well as collaborating with a multidisciplinary team to develop long-term program strategy.Successfully achieved drug approval from US FDA; solid tumors and hematologic malignances and supportive care; Belinostat®; Folotyn®; Marqibo®; Melphalan injection®, multiple myeloma; Evoxac®, Sutent®; Latuda® , Caphasol®, Halaven®, Lenvima®. Irinotecan®, CAR-T AUCATZYL® Obe-cel CD19,Trans Atlantic Therapeutics specializes in First-in-Human phase 1-3 solid hematologic malignancies and solid tumors clinical trials, IND/NDA/BLA filing. Unmet medical needs in cancer patients care and end-of-life pain, drug development; CAR-T cell therapy, immuno-oncology, oncolytic virus therapy, ADC therapy and tumor cannot be removed by surgery or metastatic, also combination with checkpoint inhibitors. More than 20 years of experience in Clinical oncology hematology and solid tumors Drug Development, patients’ Safety and Pharmacovigilance, Project Management, Biostatics, Data management, Medical Monitoring, Regulatory Affairs, Clinical Operations, timeline and budget. Collaborate with executive management Provide cancer trial design, medical and safety monitoring of first-in-human phase 1, phase 2 and 3 of ovarian, prostate, breast, colorectal, pancreatic, head and neck cancer, Bladder Cancer-NMIBC, NSCLC, SCLC, glioblastoma, relapse/refractory acute myeloid leukemia, chronic myeloid leukemia, CD19/20 CAR-T adult and pediatric lymphoma, diffuse large B-cell lymphoma and Peripheral T-cell lymphoma (PTCL) a type of non-Hodgkin lymphoma.Cell and Gene Therapy:o CAR T cell therapies Cell o Gene therapies in pediatric and adult settings o Tumor Infiltrating Lymphocyte (TIL) therapyI have deep experience of advanced treatments for relapse/refractory lymphoma and leukemia.

Dr. Ashok Srivastava, Md, Ph.D., Mba's Current Company Details
AyurDatta Solutions

Ayurdatta Solutions

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President, Chief Medical Officer
New York, NY, US
Website:
precogllc.org
Employees:
3
Dr. Ashok Srivastava, Md, Ph.D., Mba Work Experience Details
  • Ayurdatta Solutions
    President, Chief Medical Officer
    Ayurdatta Solutions
    New York, Ny, Us
  • Precog Cancer Research Group
    Chief Physician Safety & Medical Monitor; Leukemia, Lymphoma, And Solid Tumors Clinical Trials
    Precog Cancer Research Group Apr 2020 - Present
    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 CIOMS and support Safety Monitoring Committee. Data review in ARGUS, ajudication, signal detection, risk managemnt. • 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• Phase 3. metastatic breast with oncolytic virus therapy combination with anti-PD-1 & paclitaxel • Phase 3. Gilteritinib vs midostaurin in FLT3 mutated acute myeloid leukemia
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  • Trans Atlantic Therapeutics- Oncology/Hematology
    Senior Vice President, Chief Medical Officer, Oncology/Hematology And Supportive Care
    Trans Atlantic Therapeutics- Oncology/Hematology Apr 2017 - Present
    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 induced renal toxicity, cardiac toxicity, hematologic toxicity and liver injuries of individual patients.Lead global clinical development of solid tumors, hematologic tumors and supportive care, Clinical Operations, Regulatory, Biostatistics, Pharmacovigilance, CMC, Imaging, laboratories and Medical Affairs; facilitate interactions with KOLS.Collaborate with Manufacturing functions to support successful trial execution associated project and budget planning and risk management.Lead global CROs, with ICH, FCP guidelinesLead late stage drug trials…• 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:• Ministry of Health Fellow, Japan• United Nation Fellow Award• Best Oncologist of USA, 2017• Best Oncologist of USA, 2011 • Best Clinical Fellow Award: Walter Reed Army Institute of Research and Medical Center, Washington DC , USA
  • Autolus Therapeutics
    Chief Clinical Officer, Cancer Drug Development; Car-T Immunotherapy
    Autolus Therapeutics Aug 2023 - Present
    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 Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia Clinical and safety data review and BLA submissionSafety and efficacy of a CAR-T cell treatment targeting CD19, in adult patients with relapsed or refractory B cell Acute Lymphoblastic Leukemia.Pre-BLA meeting with FDAFile BLAFDA Inspection readiness
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  • Rtr Technovation Corporation
    Co-Founder, Chief Medical Officer
    Rtr Technovation Corporation May 2023 - Present
    Chino, California, United States
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  • Carcinotech Ltd
    Board Of Directors, Medical Oncology And Hematology
    Carcinotech Ltd Sep 2022 - Present
    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.
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  • Calidi Biotherapeutics
    Board Members- Scientific & Medical Advisory Board- Oncolytic Virus Therapy Solid Tumors
    Calidi Biotherapeutics 2018 - Present
    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 program, ImmunoNova, leverages extensive experience in utilizing cells to protect, potentiate and deliver virotherapies. Utilizing an engineered and enveloped vaccinia virus to treat all cancerous tumors.
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  • Pharma Capital Partners
    Director Board Of Directors Oncology
    Pharma Capital Partners Dec 2017 - Present
    Palo Alto, Carifornia, Usa
    Creating Tomorrow's New Cancer Treatment
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  • Oncology Forum- Solid Tumors, Leukemia, Lymphoma
    Founder - Board Member,
    Oncology Forum- Solid Tumors, Leukemia, Lymphoma 2017 - Present
    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 Needs to the patients and specializes in ADC Therapy, CAR-T Therapy, Oncolytic Virus Therapy.-Antibody-drug conjugates as a targeted therapy for treating cancer. Unlike chemotherapy, ADCs are intended to target and kill tumor cells while sparing healthy cells. ADCs are complex molecules composed of an antibody linked to a biologically active cytotoxic (anticancer) payload or drug. Antibody-drug conjugates are examples of bioconjugates and immunoconjugates.Multiple myeloma is the second most common hematologic malignancy worldwide. The treatment of patients with multiple myeloma has changed in the past decade.
  • Targazyme
    Chief Medical Officer, Oncology And Hematology
    Targazyme Nov 2022 - Dec 2023
    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 radical surgery; Lymphoma, Leukemia, Myelodysplastic Syndrome (MDS) and solid tumors; triple negative Breast cancer• 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
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  • Trans Atlantic Therapeutics- Oncology, Hematology And Supportive Care
    Chief Safety Officer-Car-Ts
    Trans Atlantic Therapeutics- Oncology, Hematology And Supportive Care Nov 2016 - Dec 2023
    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 applicable regulation concerning the reporting of AEs/SAEs of all therapies including CAR-T immunotherapies.Leader in CAR-T cell therapy, chemo, Immuno-oncology, oncolytic virus therapy and gene therapy• 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 • Managed a team of more than 150CURRENT ACTIVITY:• Aggregate reporting · MedDRA · WHODD · PSURs · DSUR · Pharmacovigilance · ICSR · Medical • Review · Patient Safety · Clinical Research\• HER3 to overcome treatment failure and improve treatment in breast cancer patients.• HER3-targeting ADC for metastatic Triple-negative breast cancer (TNBC) patients• TNBC, non-small cell lung cancers, H&N - Basket TrialOncolytic virus therapy and Intra-tumoral Injection• Triple-negative breast cancer in combination with Keytruda• Glioblastoma in combination with Keytruda• Pancreatic cancer combination with Keytruda • Monotherapy for prostate cancer • Breast cancer with ductal cell carcinomaGlobal Phase 1 – 3/4 safety monitoring, AEs/SAEs signal detection, risk management, imaging management, and data review. • Lead DSMB and Advisory Boards. Write charters for imaging, radiation, and tumor assessments, KOLs development, support marketing and commercialization. • Lead medical affairs, medical education, sales training, and Life Cycle management• Managing budget of $75 M, supervising team of 47 staff members
  • Rakuten Medical
    Medical Director Oncology, India And United States; Head And Neck Cancer
    Rakuten Medical Sep 2022 - Jul 2023
    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, Erbitux® (Cetuximab) that targets EGFR receptors. EGFR is highly expressed in squamous cell carcinomas of the head and neck.Clinical Development (R&D), Medical Drug-Device, EGFR Targeted, 690 nm Laser-light Activated; Internal & External US & International Interface with Oncologic Surgery, Medical Oncology and Immunotherapy. • 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 Failed or Progressed On or After at Least Two Lines of Therapy- Regulatory approval of phase 3 head and neck cancer study from DCGI-SEC, India- Type-C meeting with FDA for accelerated approval of phase 3 head and neck cancer study in USA- Medical monitor of phase 3 head and neck cancer study in India-Clinical Investigators Training: All India Institute of Medical Sciences, New Delhi; Cancer Institute (WIA), Chennai; HCG Cancer Centre, Ahmedabad; Institute of Medical Sciences and Research Centre, Kochi; Kailash Cancer Hospital and Research Center, Vadodara; Mazumdar Shaw Medical Centre, Bangalore; Tata Medical Center, Kolkata and Tata Memorial Centre, Mumbai• A phase 1 Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors.
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  • Beigene
    Chief Physician, Medical And Safety Monitoring Oncology
    Beigene Sep 2022 - Mar 2023
    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, Japan, Taiwan and China.Patients have a known mutation confirmed histologically or cytologically confirmed advanced tumor; breast cancer, prostate cancer, non-small cell lung carcinoma, colorectal cancer, ovarian cancer, endometrial cancer, thyroid cancer, melanoma, pancreatic cancer, glioblastoma Glioblastoma multiforme (GBM) fast-growing brain cancer that can occur in the brain or spinal cord, and any tumor harboring an oncogenic B-RAF or K-RAS/N-RAS mutation or MAPK and potentially respond to a RAF dimer inhibitor or a MEK inhibitor.  Lead IDSMB. Review safety database of 150 patients enrolled, Finalize DSMB charter  Lead Safety Monitoring Committee. Protocol amendment justification meeting with FDA Dose selection meeting with FDA  Supervise 4 MDs Medical Monitors
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  • Daiichi Sankyo, Inc.
    Chief Clinical And Safety Physician Oncology- Breast Cancer (Enhertu)
    Daiichi Sankyo, Inc. Mar 2021 - Mar 2023
    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 (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER3-positive Metastatic Breast Cancer.Antibody-Drug Conjugate Therapy of Breast Cancer:• 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 antibody-drug conjugate with a membrane-permeable cytotoxic payload which may account for its substantial anti-tumor activity but also may lead to cytotoxic effects on nontumorous tissues. Thus, it has chemotherapy-like side effects that require management, including nausea, neutropenia and gastrointestinal effects such as vomiting and diarrhea.
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  • Worldwide Clinical Trials Early Phase Services
    Vice President Oncology- Solid And Hematologic Melignancies
    Worldwide Clinical Trials Early Phase Services Mar 2021 - Jan 2023
    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 efficacy of administered poxvirus oncolytic virus intratumorally, Safety and efficacy of oncolytic virus therapy as monotherapy and in combination with an anti-PD-1/PD-L1 monoclonal antibody to small cell lung cancer, and multiple myelomao Safety and efficacy of patients with metastatic pancreatic adenocarcinoma responding after administration of folfirinox as first line therapy, oncolytic virus Intratumoral injection.o Efficacy and safety of genetically modified, next-generation of HSV- oncolytic virus Intravenous Infusion in Combination with Keytruda in patients with metastatic solid tumorso MTD of devimistat and hydroxychloroquine in relapsed/refractory clear cell sarcoma patients • Provided KoLs, and high performing global investigators• Awarded 3 global trials total; 57 million $• Supported President and CEO for oncology business
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  • Astrazeneca
    Global Medical And Safety Physician- Small Cell Lung Cancer And Metastatic Breast Cancer
    Astrazeneca Sep 2019 - 2021
    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, -Assess tumor hyper progression -AEs of special interest (systemic steroid therapy, endocrine therapy)-Immune mediated AEs in immunotherapy (systemic steroid therapy, endocrine therapy)
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  • Moderna
    Vice President Patients Safety And Pharmacovigilance
    Moderna Jan 2019 - Dec 2020
    London, Canada, Usa Metropolitan Area
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  • Taiho Oncology Inc
    Physician Medical Oncology, Medical Affairs; Colorectal Cancer And Breast Cancer- Chemotherapy
    Taiho Oncology Inc 2017 - 2018
    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. Medical Affairs, Life Cycle Management and Investigator Sponored Triatls of Trifluridine/Tipiracil (Lonsurf) for colorectal cancer.
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  • Spectrum Pharmaceuticals, Inc.
    Vice President Oncology, R&D, Med Affairs/Clinops; Lymphoma Ptcl, Leukemia, Breast, Lung, Bladder
    Spectrum Pharmaceuticals, Inc. 2015 - 2017
    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 leukemia oncology assets. Supported the CEO in quarterly reporting and board of director presentations.I built global development, medical, regulatory and safety team. Led R&D, medical affairs, regulatory approval of hematologic, solid tumors, immuno-oncology, supportive care for chemotherapy, targeted therapy. Supervisory leadership; R&D, PVG, Clinical Operations, Medical Affairs Directors reported to me (total 45 reports).Led Spectrum and Hanmi Pharmaceuticals, South Korea, joint breast cancer supportive care phase 3 registration trial.Global clinical trials.• 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 management of:• Fusilev (Levoleucovorin) combination with 5-FU treatment of metastatic colorectal cancer• Folotyn (pralatrexate)- for relapsed or refractory peripheral T-cell lymphoma • Zevalin (ibritumomab)- relapsed/refractory non Hodgkin's lymphoma• Marqibo for adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL) in relapse or refractory patients leukemia • Marqibo for adult patients with diffuse large B cell lymphoma • Beleodaq (belinostat) HDAC inhibitor for relapsed/refractory peripheral T-cell lymphoma• Evomela (melphalan) for multiple myelomaProvided global clinical strategy, IND, NDA submission.FDA ODAC presentation for Bladder Cancer Led scientific advisory boards.
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  • Eisai Us
    Global Executive Director, Medical Affairs Oncology, Breast Cancer Her2+, Triple Negative & Sarcoma
    Eisai Us Jan 2014 - 2015
    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 regimen Development of Halaven in combination of anti PD-1 (Pembrolizumab) in triple negative breast cancer patients in collaboration with Merck.Launched Halaven for sarcoma- liposarcoma. Medical Affairs; Phase 3b and 4 clinical trials; outcomes research; publications; medical; continuing education; oversight to the field-based Medical Liaison group; and medical review of promotional materials, and grants for IITs.
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  • Global Pharma, Ny
    Chief Executive Officer, Chief Medical Officer And Owner, Oncology, Hematology And Supportive Care
    Global Pharma, Ny 2009 - 2014
    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 ODAC, FDA presentations. Leader is Phase 1 to 3b/4; hematologic, non-hematologic, radiopharmaceutical, chemotherapy, immuno-oncology drug development; breast cancer (HER2-negative, HER2-positive, ER/PR/HER2 negative- triple negative), prostate cancer, lung cancer, ovarian cancer, colorectal cancer, gastrointestinal stromal tumors, pancreatic cancer, bladder cancer, and supportive care; chemotherapy and radiation therapy induced oral mucositis, chemotherapy and radiation therapy induced xerostomia in head and neck cancer patients, and chemotherapy induced neutropenia in breast cancer patients, Diffuse Large B Cell Lymphoma, Leukemias and multiple myeloma.Lead phase 1 QTc study in cancer patients.Expert in clinical and medical strategy, study design, DSMBs, Imaging Charter, Cardiac Safety Committee, Tumor Assessment Committee, and KoL management.Medical and safety monitoring of cancer drugs in research & development and post marketing.Licensing, mergers/acquisitions and investment.
  • Sopherion Therapeutics
    Executive Medical Director Oncology And Deputy Chief Medical Officer, Metastatic Her2+ Breast Cancer
    Sopherion Therapeutics Apr 2006 - Apr 2009
    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 cancer chemotherapy:Led global phase 3 randomized registration trial in 17 countries of myocet- liposome formulation of doxorubicin hydrochloride, and an anthracycline cytotoxic agent in combination with or without paclitaxel and trastuzumab in HER2 positive metastatic breast cancer patients first line therapy. Led R&D, Medical Affairs and pharmacovigilance. Led Cardiac Safety Committee, Radiology Committee, Oncology and Tumor Assessment; Cardiac safety- Congestive Heart Failure examined by MUGA and ECHO. Led global CROs. Led investigators meetings in Miami, USA; Barcelona, and Singapore, and led advisory committee meetings. Led group of 7 MDs. Led end of life pain, oral mucositis and xerostomia program in combination of chemotherapy program in breast cancer, prostate cancer, lung cancer and multiple myeloma patients.
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  • Sumitomo Pharma America, Inc.
    Director Neuropsychiatry And Oncology; Adult Schizophrenia And Small Cell Lung Cancer
    Sumitomo Pharma America, Inc. 2003 - 2006
    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) receptors and moderate antagonistic activity at alpha2C- and alpha2A-adrenergic receptors and partial agonist at 5-HT1A. receptors. I led lurasidone drug development for schizophrenia, cognition and bipolar clinical and approval program and licensed out to Merck.Led phase 1- BA/BE, dedicated QTc, D-2 receptor-PET, MTD, DDI, RI-AME, renal and hepatic impaired patients, PK/PD study.Phase 2/2b dose finding study in 45 sites in USA, long-term 52 weeks safety, and phase 3 registration trials and, long-term safety trials in USA, Europe and Japan, medical and safety monitoring of clinical trials.Managed advisory boards of Lurasidone development-IND filing-FDA Meeting to discuss the QTc study design-End of Phase 2 FDA Meeting-NDA filing planning -Outlicensing of Lurasidone to Merck-Member of Steering Committee of Dianippon Sumitomo (now Sunovion) and Merck acquisition CommitteeLatuda has been approved for schizophrenia and selling 1.4 Billion$ drug as "BEST PRESCRIBED DRUG"
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  • Pharmacia Corporation/ Pfizer
    Medical Director Oncology- Gist (Gastrointestinal Stromal Tumor)
    Pharmacia Corporation/ Pfizer 2000 - 2003
    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 SU11248 (sunitinib) in imatinib-resistant gastrointestinal stromal tumor patients, and Phase 2 clinical trial of SU11248 (sunitinib) in advanced unresectable neuroendocrine tumor patients and sunitinib (Sutent) in multiple indicationsLed the Sutent (sunitinib malate) an oral multi-kinase inhibitor development program and approval in USA for Gastrointestinal Stromal Tumor (GIST). Led lead group of 5 MDs.
  • Daiichi Pharmaceutical Co., Ltd.
    Medical Director R&D & Med Affairs Oncology- Head & Neck, Breast. Pancreatic And Colorectal Cancers
    Daiichi Pharmaceutical Co., Ltd. 1997 - 2000
    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 Prostate CancerSupportive care: Cevimeline HCl (Evoxac) a muscarinic agonist with particular effect on M3 receptors; Phase 3 trial and regulatory approval for xerostomia in post radiation H&N cancer patients.Phase 3 trial of transplant recipients develop acute Graft-versus-host disease (GVHD). GVHD can lead to permanent impairment of quality of life, and in many cases even to death. Patients with GVHD often require prolonged immunosuppressive treatment which increases the risks for infections, organ damage, secondary malignancies and other complications.Chemotherapy and radiation therapy induced oral mucositis in cancer patientsQTc prolongation study in cancer patientsIrinotecan (Camptosar®, CPT-11) Life cycle management; o front-line irinotecan-based combination chemotherapy regimens and integration of irinotecan into combined modality regimens. o IISs of irinotecan in treating colorectal and other gastrointestinal cancers, small cell and non-small cell lung cancers.Led DSMB, Safety Monitoring, Medical Monitoring and Imaging group
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  • Walter Reed Army Institute Of Research
    Resident
    Walter Reed Army Institute Of Research 1990 - 1997
    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 dengue DNA recombinant vaccine; I am one of the patent holders.Oncology: Remote Diagnosis of Breast Cancer
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  • Nagasaki University　(長崎大学)
    Clinical And Medical Fellow
    Nagasaki University　(長崎大学) Jan 1985 - Mar 1990
    Nagasaki School Of Medicine, Nagasaki, Japan
    Nagasaki School of Medicine, Nagasaki, Japan
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Dr. Ashok Srivastava, Md, Ph.D., Mba Skills

Oncology Clinical Trials Clinical Research Clinical Development Pharmaceutical Industry Cro Pharmacovigilance Cancer Drug Development Cardiology Medicine Medical Affairs Hematology Infectious Diseases Palliative Care Hospitals Protocol Fda Neuropsychiatry Hematologic Malignancies Edc Life Sciences Vaccines Medical Education Clinical Study Design Treatment Radiation Oncology Neuroscience Merger And Acquisition Of Pharma Companies Internal Medicine Product Launch Thought Leader Oncology Immuno Oncology

Dr. Ashok Srivastava, Md, Ph.D., Mba Education Details

Frequently Asked Questions about Dr. Ashok Srivastava, Md, Ph.D., Mba

What company does Dr. Ashok Srivastava, Md, Ph.D., Mba work for?

Dr. Ashok Srivastava, Md, Ph.D., Mba works for Ayurdatta Solutions

What is Dr. Ashok Srivastava, Md, Ph.D., Mba's role at the current company?

Dr. Ashok Srivastava, Md, Ph.D., Mba's current role is President, Chief Medical Officer.

What is Dr. Ashok Srivastava, Md, Ph.D., Mba's email address?

Dr. Ashok Srivastava, Md, Ph.D., Mba's email address is as****@****ail.com

What schools did Dr. Ashok Srivastava, Md, Ph.D., Mba attend?

Dr. Ashok Srivastava, Md, Ph.D., Mba attended Nagasaki University, Harvard University, Harvard Business School Executive Education, Nagasaki University, Institute Of Tropical Medicine, Nagasaki, Japan, Rutgers University, School Of Medicine Nagasaki University, Japan; All India Institute Of Medical Science New Delhi India; Rutgers U. Business, Nj, Usa;, Czechoslovak Academy Of Medical Sciences, Prague, Czechoslovakia, All India Institute Of Medical Sciences, United Nations, Georgetown University School Of Medicine, Tufts University, Accreditation Council For Medical Affairs, New York, Ny, Year, Usa, Professional Membership, Esmo.

What skills is Dr. Ashok Srivastava, Md, Ph.D., Mba known for?

Dr. Ashok Srivastava, Md, Ph.D., Mba has skills like Oncology, Clinical Trials, Clinical Research, Clinical Development, Pharmaceutical Industry, Cro, Pharmacovigilance, Cancer, Drug Development, Cardiology, Medicine, Medical Affairs.

Who are Dr. Ashok Srivastava, Md, Ph.D., Mba's colleagues?

Dr. Ashok Srivastava, Md, Ph.D., Mba's colleagues are Judy D'antuono, Anita Kalavar.

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Works directly on LinkedIn - no copy/paste needed
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Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.