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T ECHNOLOGY, PRODUCTS, MA RKETS AND SERVICE OPPORTUNITIES A NEW MEDICINE PUBLICATION VOLUME 3, NUMBER 1-12 INDEX MAY 1998 TABLE OF CONTENTS Ingenex 584 HEAD AND NECK CANCER — PART II STATE-OF-THE-ART IN THE MANAGEMENT OF CANCER IMMUNOTHERAPY/VACCINES 584 DIAGNOSIS, STAGING, PROGNOSIS, OVARIAN CANCER — PART III AltaRex 584 AND TREATMENT CURRENT TREATMENT APPROACHES AVAX Technologies 585 DIAGNOSIS, SCREENING AND STAGING 626 Biomira 585 Panendoscopy 626 CYTOREDUCTIVE SURGERY 545 Corixa 586 Non-invasive Imaging 627 Second Look Surgery 546 Trilex Pharmaceuticals 586 In vitro Tests 627 Prophylactic Oophorectomy 547 Other 586 Human papillomavirus (HPV) 627 RADIATION THERAPY 548 SMALL MOLECULE DRUGS 586 Epstein-Barr virus 628 CHEMOTHERAPY 548 CDR Therapeutics 586 Telomerase 628 Primary Disease 549 Sugen 587 Cytology 629 Single-agent chemotherapy 549 RADIOISOTOPES/RADIOIMMUNOCONJUGATES 587 Biological Staging 629 Combination chemotherapy 549 Cancer Therapeutics 587 PROGNOSIS 629 Drug Resistance 551 Immunomedics 588 p53 629 Recurrent/Refractory Disease 551 NeoRx 588 Growth Factors 631 High-Dose (Density) Chemotherapy with Autologous Bone Marrow and/ University of Alabama 588 Cyclin D1 631 or Stem Cell Transplants 557 University of Chicago 589 Eukaryotic Initiation Factor 4E 631 Drug Administration Routes 561 PHOTODYNAMIC THERAPY 589 HPV Infection 631 INHIBITION OF METASTASIS 589 Multiple Markers 631 OVARIAN CANCER — PART IV Anika Therapeutics 589 TREATMENT OPTIONS BY SITE OF CANCER 632 NOVEL THERAPEUTIC APPROACHES MOLECULAR APPROACHES TO Oral Cavity and Oropharynx 633 IN DEVELOPMENT MANAGEMENT OF OVARIAN CANCER 589 Nasopharynx and Hypopharynx 633 BRCA1/BRCA2 590 ANALOGS, DERIVATIVES AND FORMULATIONS Second Primary Tumors 633 OF AGENTS APPROVED FOR THE TREATMENT p53 590 MULTIMODALITY THERAPY 633 OF OVARIAN AND OTHER CANCERS 570 ras 590 Anthracyclines 570 Cortecs International 590 HEAD AND NECK CANCER — PART III Anthra Pharmaceuticals 570 Her-2/neu (erbB-2) 590 NOVEL THERAPEUTIC AND Platinum Analogs 571 Anti-erbB-2 sFv (Ad21) 590 CHEMOPREVENTIVE APPROACHES Oxaliplatin 571 Epidermal Growth Factor Receptor IN DEVELOPMENT (EGFr) 590 Taxanes 571 RADIATION THERAPY 646 Paclitaxel 571 RADIOSENSITIZATION/ENHANCEMENT 646 Docetaxel 581 HEAD AND NECK CANCER — PART I Pharmacyclics 647 Topoisomerase I Inhibitors 581 EPIDEMIOLOGY, ETIOLOGY AND Enzon 647 GW211 581 MOLECULAR MARKERS Vion Pharmaceuticals 648 Gemcitabine 581 EPIDEMIOLOGY 606 PHOTODYNAMIC THERAPY 648 DRUG RESISTANCE 581 International Epidemiology 606 QLT PhotoTherapeutics 648 Methionine 581 USA Epidemiology 606 Scotia 648 AntiCancer 581 ETIOLOGY AND RISK FACTORS 607 COMMERCIALLY AVAILABLE AGENTS IN Molecular Markers 582 Oral Cancer 608 CLINICAL TRIALS IN HNSCC 650 Resistance to Platinum-based/ Nasopharyngeal Cancer 610 Gemcitabine 650 Alkylating Agents 582 MOLECULAR MARKERS 610 Vinorelbine 650 Intracellular glutathione 583 Oncogenes and Tumor Taxanes 650 Metallothioneins 583 Suppressor Genes 610 NOVEL CHEMOTHERAPEUTICS 650 Resistance to Taxanes 583 Growth Factors 611 Thymidylate Synthase Inhibitors 650 SDZ PSC 833 583 Matrix Metalloproteinases 612 Retinoids 650 Chemoprotection 584 Other Molecular Factors 613 ALRT1550 650 Genetix Pharmaceuticals 584 MOLECULAR EPIDEMIOLOGY 613 GENE THERAPY 651 COPYRIGHT © 1998 NEW MEDICINE, INC. UNAUTHORIZED PHOTOCOPYING, DISTRIBUTION OR ELECTRONIC STORAGE IS PROHIBITED BY LAW. FUTURE ONCOLOGY VOLUME 3, NUMBER 1-12 INDEX MAY 1998 p53 651 Scintigraphy 683 UPDATE OF PROSTATE CANCER — Introgen Therapeutics 651 In Vitro Tests 683 PART I Schering-Plough Research Institute 651 TUMOR STAGING 683 EPIDEMIOLOGY p16 651 PROGNOSIS 684 USA Epidemiology 731 Suicide Genes 651 Onyx-015 654 CANCER OF THE CENTRAL CANCER OF THE CENTRAL Human Papillomavirus (HPV) 654 NERVOUS SYSTEM — PART II NERVOUS SYSTEM — PART III GROWTH FACTORS/CYTOKINES 654 CURRENT THERAPEUTIC NOVEL THERAPEUTIC APPROACHES APPROACHES Epidermal Growth Factor (EGF) NOVEL CHEMOTHERAPEUTICS 731 Receptor Inhibitors 654 SURGERY 702 9-aminocamptothecin (9-AC) 731 Quinazolines 654 Conventional Surgery 702 Alanosine 731 MDX-447 655 Stereotaxic Radiosurgery 702 Diaziquone 733 MAb ICR62 655 RADIOTHERAPY 703 Dibromodulcitol (DBD) 733 Interferon as Adjuvant Therapy 655 Conventional Radiation Therapy 703 Fluorodeoxyuridine (FdUrd) 734 Tumor Necrosis Factor α (TNF-α) 655 Interstitial Radiation or Brachytherapy 703 Hypericin 734 IMMUNOTHERAPY/VACCINES 655 Mivobulin Isethionate 734 Cel-Sci 655 International Isotopes 705 O(6)-benzylguanine 734 GeneMedicine 656 Boron Neutron Capture Therapy (BNCT) 706 Phenylacetate 735 University of Pittsburgh 656 Boron Biologicals 706 Phenylbutyrate 735 MANAGEMENT OF TREATMENT-RELATED Radiosensitizers 707 Rebeccamycin Analog 735 COMPLICATIONS 656 Cisplatin or carboplatin 707 Suramin 735 Amifostene 656 Etanidazole 707 Temozolomide 736 Lisofylline 656 Gadolinium texaphyrin UCN-01 736 Oralease 656 (Gd-Tex) 707 RECEPTOR TARGETING STRATEGIES 737 DRUG DELIVERY 657 Halogenated pyrimidine CEP751 737 Genetronics 657 analogs 707 IL4 (38-37)-PE38KDEL 737 CHEMOPREVENTION 657 Neu-Sensamide 709 IL13-PE38QQR 738 Tirapazamine 709 2 SU101 738 CANCER OF THE CENTRAL NERVOUS HYPERTHERMIA 709 SYSTEM — PART I THERAPY ENHANCEMENT 738 PHOTODYNAMIC THERAPY 709 Radiosensitization 738 EPIDEMIOLOGY, ETIOLOGY, DIAGNOSIS Pacific Pharmaceuticals 709 AND PROGNOSIS RSR-13 738 CHEMOTHERAPY 710 Chemosensitization 738 WORLDWIDE EPIDEMIOLOGY OF Approved Drugs for CNS Cancer PRIMARY CNS TUMORS 670 Indications 710 Artificial oxygen carriers 738 USA Epidemiology 670 Carmustine and lomustine 710 Chemoprotection 739 Gender 670 Gliadel 710 Dexrazoxane 739 Race 670 Commercial Drugs in Clinical Trials NOVEL APPROACHES TO PREVENT/ Age 670 for CNS Cancer Indications 712 TREAT METASTASES 739 EPIDEMIOLOGY OF SECONDARY Chemotherapy Delivery Options 712 Matrix Metalloproteinase (MMP) CNS TUMORS 670 Intra-arterial chemotherapy 712 Inhibitors 739 EPIDEMIOLOGY OF METASTATIC Intrathecal chemotherapy 712 Bryostatin-1 739 CNS CANCER 672 DepoCyt 717 Marimastat 745 Neoplastic Meningitis 672 HEMATOPOIETIC SUPPORT/BONE MARROW Inhibition of Angiogenesis 746 ETIOLOGY OF PRIMARY TUMORS TRANSPLANTATION 718 Carboxyamide triaxole (CAI) 746 OF THE CNS 673 CURRENT TREATMENT BY TUMOR TYPE 723 MAb 81C6 746 Hereditary/Familial Factors 673 Primary Malignant CNS Cancer 723 Thalidomide 746 Environmental Factors 674 Pediatric Tumors 723 TNP-470 746 Other Factors 674 Metastatic Brain Tumors and Cancer Vascular endothelial growth factor MOLECULAR GENETICS AND MOLECULAR Metastisized to the Brain 724 (VEGF) 746 BIOLOGY OF PRIMARY BRAIN TUMORS 675 MANAGEMENT OF TREATMENT-RELATED Selective Targeting of Tumor Gene Factors 675 AND OTHER COMPLICATIONS 724 Vasculature 747 Chromosomal/gene abnormalities 675 Hearing Loss 724 Exploiting Other Mechanisms 747 Gene amplification 680 Peritumoral Brain Edema 724 Brain-enriched hyaluronan-binding Growth Factors 681 Shunts 725 protein (BEHAB) 747 DIAGNOSIS 681 Steroids 725 Glioma-specific Chloride Channel 747 Neuroimaging 682 Human corticotropin-releasing IMMUNOTHERAPY/VACCINES 747 Stereotactic Techniques for Tissue factor (hCRF) 725 Antigen-specific Cellular Sampling 683 Seizures 725 Immunotherapy 747 COPYRIGHT © 1998 NEW MEDICINE, INC. 949. 830. 0448. FUTURE ONCOLOGY VOLUME 3, NUMBER 1-12 INDEX MAY 1998 Activated Cytotoxic T Cells 747 Combination Therapies 620 Genetically-modified Tumor Cells 748 MEETING COVERAGE HEPATOCELLULAR CARCINOMA 621 Granulocyte-macrophage colony- ASCUS PATIENT MANAGEMENT Multimodality Therapy 621 stimulating factor (GM-CSF) 748 IN CERVICAL CANCER SCREENING Liver transplantation combined Immune Response 748 with neoadjuvant and adjuvant FROM THE 45TH ANNUAL CLINICAL MEETING chemotherapy 621 Anti-hCG Vaccines 748 OF THE AMERICAN COLLEGE OF OBSTETRICIANS Intra-arterial Lipodol-iodine 131 621 Administration of Growth AND GYNECOLOGISTS Factors/Cytokines 748 LAS VEGAS, NV, APRIL 28-30, 1997 PANCREATIC CANCER 621 PNU-214565 621 “SUICIDE” GENE THERAPY 749 SCREENING AND DIAGNOSIS OF Adenoviral Vector-mediated Transfer 749 CERVICAL CANCER 562 COLORECTAL CANCER 622 IntroGene 749 ROLE OF HUMAN PAPILLOMAVIRUS Monotherapy 622 University of Pennsylvania 749 IN CERVICAL CANCER 562 AG-337 622 Parvoviral Vector-mediated Transfer 749 Digene’s Hybrid Capture HPV Raltitrexed 622 DNA Assay 564 Avigen 749 Irinotecan 622 DIAGNOSTIC TRIAGE USING HPV Retroviral Vector-mediated Transfer 750 Capecitabine 622 SCREENING 564 Combination Regimens 623 Chiron 750 5-FU Administration Options 623 Genetic Therapy/Novartis 750 NEW DEVELOPMENTS IN THE Multimodality Therapy 623 MONOCLONAL ANTIBODIES 750 TREATMENT Chemoradiation 623 Lexigen Pharmaceuticals 750 OF GYNECOLOGIC CANCERS CARCINOID SYNDROME 623 Techniclone 751 FROM THE 21ST CONGRESS OF THE EUROPEAN Octreotide Acetate LAR 623 NOVEL POTENTIAL TREATMENTS DRIVEN SOCIETY OF MEDICAL ONCOLOGY IENNA USTRIA OVEMBER BY NEW GENE DISCOVERIES 751 V , A , N 1-5, 1996 NEW APPROACHES FOR THE DELIVERY OF THERAPEUTICS TO INVASIVE CERVICAL CANCER 565 TREATMENT OF HEAD AND NECK THE RAIN Metastatic Cervical Cancer 565 B 752 CANCER Electroporation for Delivery HIV-related invasive cervical of Genes 752 cancer 565 FROM THE 33RD ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY Combination Regimens in Invasive Crossing the Blood-Brain Barrier DENVER, CO, MAY 17-20, 1997 (BBB) 752 Cervical Cancer 565 MULTIMODALITY THERAPY 641 Cereport 752 BEMP regimen 565 3 Taxanes 641 SP2000 Biotransport 752 Docetaxel 641 DEMYSTIFYING THE ROLE OF Paclitaxel 641 PROSTATE CANCER — PART II CYTOKINES IN TUMOR IMMUNOBIOLOGY
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    Immuno-Oncology Drug Development Workshop Hyatt Regency Washington on Capitol Hill Columbia A&B Ballroom Washington, DC October 13 - 14, 2016 Workshop Co-Chairs Maitreyee Hazarika, MD, Medical Officer, Division of Oncology Products 2, Office of Hematology Oncology Products, Center for Drug Evaluation and Research, FDA Dr. Hazarika is a Senior Medical Officer in the Melanoma and Sarcoma Team in the Division of Oncology Products 2 (DOP2) of the Office of Hematology and Oncology Products (OHOP) in the Center for Drug Evaluation and Research (CDER) of the United States Food and Drug Administration (FDA). As a regulatory reviewer, she has reviewed new molecular entities for marketing approvals in solid tumors and hematological malignancies, which have included immunotherapies, targeted kinase inhibitors, immunomodulators and folate analog metabolic inhibitors. She has presented FDA review findings as a speaker at oncology drug advisory committee meetings and has authored manuscripts presenting summaries on FDA drug approvals. In addition to the regulatory experience at FDA, she has experience in global clinical drug development while an Associate Medical Director, Clinical Development at Celgene International and also provided consulting services as a subject matter expert in oncology and on regulatory and clinical aspects of pharmaceutical drug development while a Principal Consultant at Parexel Consulting. Dr. Hazarika received her MBBS and MD degrees in India and completed her internship and residency in Internal Medicine and fellowship in Medical Oncology and Hematology at the New York University School of Medicine. As a fellow, she co-authored a book chapter while active in clinical research in ovarian cancer. Marc Theoret, MD, Lead Medical Officer, Division of Oncology Products 2, Office of Hematology Oncology Products, Center for Drug Evaluation and Research, FDA Dr.
  • Lishing Group Group Nature Publishing

    Lishing Group Group Nature Publishing

    PEOPLE Paul L. Berns (left) has been appointed Allos Therapeutics’ NitroMed (Lexington, MA, USA) has (Westminster, CO, USA) president, CEO and member of the board announced that Argeris (Jerry) Karabelas, of directors. He brings close to 15 years of pharmaceutical industry currently chairman of the board of directors, experience to Allos, holding senior management positions at Abbott has been appointed interim CEO, succeed- Laboratories, BASF Pharmaceuticals and Bristol-Myers Squibb. Mr. ing Michael Loberg, who resigned from his Berns was most recently president, CEO and a member of the board position as president, CEO and director of of directors of Bone Care International. With Mr. Berns’ appointment, NitroMed. In addition, Kenneth Bate, formerly Michael E. Hart has resigned his positions as president, CEO and CFO of Millennium Pharmaceuticals, has been CFO, and David C. Clark, the company’s controller and treasurer, has named chief operating officer and CFO, follow- been appointed to serve as interim CFO until a permanent replacement is found. ing the departure of Lawrence Bloch as CFO and chief business officer. Morphotek (Exton, PA, USA) has announced Privately held NascaCell IP (Munich) has was most recently head of clinical operations the appointment of Robert Radie as chief announced the appointment of cofounder at Vical. business officer and the promotion of Luigi http://www.nature.com/naturebiotechnology Michael Blind to the position of CEO. Dr. Grasso to senior vice president of R&D. Mr. Blind was previously responsible for research VLST Corp. (Seattle, WA, USA) has announced Radie was most recently senior vice president and development activities at NascaCell.