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The Development of Large-Scale De-Identified Biomedical Databases in the Age of Genomics—Principles and Challenges Fida K
Dankar et al. Human Genomics (2018) 12:19 https://doi.org/10.1186/s40246-018-0147-5 REVIEW Open Access The development of large-scale de-identified biomedical databases in the age of genomics—principles and challenges Fida K. Dankar1* , Andrey Ptitsyn2 and Samar K. Dankar3 Abstract Contemporary biomedical databases include a wide range of information types from various observational and instrumental sources. Among the most important features that unite biomedical databases across the field are high volume of information and high potential to cause damage through data corruption, loss of performance, and loss of patient privacy. Thus, issues of data governance and privacy protection are essential for the construction of data depositories for biomedical research and healthcare. In this paper, we discuss various challenges of data governance in the context of population genome projects. The various challenges along with best practices and current research efforts are discussed through the steps of data collection, storage, sharing, analysis, and knowledge dissemination. Keywords: Biomedical database, Data privacy, Data governance, Whole genome sequencing Background first, now increasingly shifting to whole exome and whole Overview genome sequencing [2, 3]). The project started by Decode Databases are both the result and the instrument of has generated one of the best resources for discovery in research. From the earliest times, assembling collections biomedical sciences and inspired development of multiple of samples and stories was essential for any research pro- populational and national genomics projects, also feeding ject. The results of research feeding back into the libraries into integrated databases. Genomics England [4], Human and collections create a positive feedback in the accumula- Longevity [5], All of US (formerly known as Precision tion of knowledge limited only by the technological plat- Medicine Initiative) [6], China’s Precision Medicine Initia- form for storage and retrieval of information. -
Fibrolase: Trials and Tribulations
Toxins 2010, 2, 793-808; doi:10.3390/toxins2040793 OPEN ACCESS toxins ISSN 2072-6651 www.mdpi.com/journal/toxins Review Fibrolase: Trials and Tribulations Francis S. Markland 1,2,* and Steve Swenson 1,2 1 Department of Biochemistry and Molecular Biology, Cancer Research Laboratory, Keck School of Medicine, University of Southern California, 1303 N. Mission Rd., Los Angeles, CA 90033, USA 2 USC/Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA; E-Mail: [email protected] * Author to whom correspondence should be addressed; E-Mail: [email protected]; Tel.: +1-(323) 224-7981; Fax: +1-(323) 224-7679. Received: 11 March 2010; in revised form: 31 March 2010 / Accepted: 19 April 2010 / Published: 20 April 2010 Abstract: Fibrolase is the fibrinolytic enzyme isolated from Agkistrodon contortrix contortrix (southern copperhead snake) venom. The enzyme was purified by a three-step HPLC procedure and was shown to be homogeneous by standard criteria including reverse phase HPLC, molecular sieve chromatography and SDS-PAGE. The purified enzyme is a zinc metalloproteinase containing one mole of zinc. It is composed of 203 amino acids with a blocked amino-terminus due to cyclization of the terminal Gln residue. Fibrolase shares a significant degree of homology with enzymes of the reprolysin sub-family of metalloproteinases including an active site homology of close to 100%; it is rapidly inhibited by chelating agents such as EDTA, and by alpha2-macroglobulin (). The enzyme is a direct-acting thrombolytic agent and does not rely on plasminogen for clot dissolution. Fibrolase rapidly cleaves the A()-chain of fibrinogen and the B()-chain at a slower rate; it has no activity on the -chain. -
Guidelines on CVD During Pregnancy (TF17) - Task Force Members and Additional Contributors
Guidelines on CVD during Pregnancy (TF17) - Task Force Members and Additional Contributors Expert Relationship Type of relationship with industry Financial declaration with Industry Blomstrom-Lundqvist Yes A - Direct Personal payment: Speaker fees, Honoraria, Consultancy, Advisory Board fees, Investigator, Committee Member, etc. Carina - Medtronic : Pacemaker B - Payment to your Institution: Speaker fees, Honoraria, Consultancy, Advisory Board fees, Investigator, Committee Member, etc. - Atricure : AF ablation Borghi Claudio Yes A - Direct Personal payment: Speaker fees, Honoraria, Consultancy, Advisory Board fees, Investigator, Committee Member, etc. - Menarini International : ACE-inhibitors - Boheringer Ingelheim : Antihypertensive drugs - Recordati International : Antihypertensive drugs - Novartis : Antihypertensive, Heart Failure D - Research funding (departmental or institutional). - Barilla Food Company : Lactotripeptides Cifkova Renata Yes A - Direct Personal payment: Speaker fees, Honoraria, Consultancy, Advisory Board fees, Investigator, Committee Member, etc. - Boehringer-Ingelheim : cardiovascular - Daiichi Sankyo : cardiovascular - MSD-SP, Boehringer Ingelheim, Bayer : cardiovascular B - Payment to your Institution: Speaker fees, Honoraria, Consultancy, Advisory Board fees, Investigator, Committee Member, etc. - Daiichi Sankyo : cardiovascular - Novartis : cardiovascular D - Research funding (departmental or institutional). - Krka Czech Republic : cardiovascular - Servier Czech Republic : cardiovascular Ferreira J Rafael No -
Health Industry Business Communications Council
Health Industry Business Communications Council Registered Labelers: Accredited Auto-ID Labeling Standards Argentina New MedTek Devices Pty Ltd Oxavita SRL Norseld Pty Ltd. Novadien Healthcare Pty Ltd The following companies Odontit S.A. (and/or their subsidiaries/ PAMPAMED S.R.L. Numedico Technologies Pty Ltd divisions) have applied PATEJIM SRL Opto Global Pty. Ltd. for a Labeler Identification Orthocell Limited Code (LIC) assignment with Austria Prolotus Technologies Pty Ltd HIBCC*. By doing so, they afreeze GmbH Red Milawa Pty Ltd dba Magic Mobility have demonstrated their AMI GmbH SDI Limited commitment to patient safety Bender Medsystems GmbH Signostics Ltd. and logistical efficiency for BHS Technologies GmbH Sirtex Medical Pty Ltd their customers, the industry Metasys Medizintechnik GmbH Smith & Nephew Surgical Pty. Ltd. and the public at large. PAA Laboratories GmbH Staminalift International Limited Safersonic Medizinprodukte Handels The Pipette Company Pty. Ltd. Any organization that is GmbH Thermo Electron Corporation interested in using the HIBC W & H Dentalwerk Burmoos GmbH Vush Pty Ltd uniform labeling system may apply for the assignment of VUSH STIMULATION Australia one or more LICs. William A Cook Australia Pty. Ltd. Adv. Surgical Design & Manufacture, Ltd. Last updated 9-21-2021 AirPhysio Pty Ltd Belgium Annalise-AI Pty Ltd 3M Europe Apollo Medical Imaging Technology Pty Advanced Medical Diagnostics SA/NV Ltd Analis SA/NV Benra Pty Ltd dba Gelflex Laboratories Baxter World Trade Bioclone Australia Pty. Ltd. Bio-Rad RSL Candelis, Inc. Bio-Rad Lab Inc Clinical Diag. Group DePuy Australia Pty. Ltd. Biosource Europe SA For more information, please dorsaVi Ltd Cilag NV contact the HIBCC office at: EC Certification Service GmbH Coris Bioconcept Fink Engineering Pty Ltd Fuji Hunt Photographic Chemicals NV 2525 E. -
OSI Pharmaceuticals and AVEO Pharmaceuticals Expand Oncology Discovery and Translational Research Collaboration
OSI Pharmaceuticals and AVEO Pharmaceuticals Expand Oncology Discovery and Translational Research Collaboration July 21, 2009 9:24 PM ET MELVILLE, NY and CAMBRIDGE, Mass., July 21, 2009 – OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) and AVEO Pharmaceuticals, Inc. today announced that they have expanded the drug discovery and translational research collaboration announced in October of 2007. The alliance is anchored around developing molecular targeted therapies to target the underlying mechanisms of epithelial-mesenchymal transition (EMT) in cancer and to develop proprietary datasets of associated patient selection biomarkers to support OSI’s targeted medicine pipeline. EMT is a process of emerging significance in tumor development and disease progression and the focal point of OSI’s proprietary oncology research efforts. The companies are expanding their efforts to validate cancer targets and to deploy key elements of AVEO’s proprietary translational research platform in support of OSI’s clinical development programs. Under the terms of the expanded discovery and research agreement, OSI will pay AVEO a total of $20 million at closing, $5 million of which is an upfront cash payment and $15 million of which is the purchase of additional equity in AVEO. OSI will also provide AVEO research funding over the next two years to support the collaboration, and the potential to achieve additional royalties and milestones. In return, OSI will immediately receive rights beyond the original collaboration including rights to additional EMT targets (including up to 4 antibody targets) and increased access to AVEO technology (i.e. tumor models, archives and biomarkers). OSI is also acquiring non-exclusive access to AVEO’s proprietary bioinformatics platform. -
'Iceland Inc.'?: on the Ethics of Commercial Population Genomics
University of Pennsylvania ScholarlyCommons Center for Bioethics Papers Center for Bioethics March 2004 'Iceland Inc.'?: On the ethics of commercial population genomics Jon F. Merz University of Pennsylvania, [email protected] Glenn E. McGee University of Pennsylvania Pamela Sankar University of Pennsylvania Follow this and additional works at: https://repository.upenn.edu/bioethics_papers Recommended Citation Merz, J. F., McGee, G. E., & Sankar, P. (2004). 'Iceland Inc.'?: On the ethics of commercial population genomics. Retrieved from https://repository.upenn.edu/bioethics_papers/52 Postprint version. Published in Social Science and Medicine, Volume 58, Issue 6, March 2004, pages 1201-1209. Publisher URL: http://dx.doi.org/10.1016/S0277-9536(03)00256-9 This paper is posted at ScholarlyCommons. https://repository.upenn.edu/bioethics_papers/52 For more information, please contact [email protected]. 'Iceland Inc.'?: On the ethics of commercial population genomics Abstract A detailed analysis of the Icelandic commercial population-wide genomics database project of deCODE Genetics was performed for the purpose of providing ethics insights into public/private efforts to develop genetic databases. This analysis examines the moral differences between the general case of governmental collection of medical data for public health purposes and the centralized collection planned in Iceland. Both the process of developing the database and its design vary in significant ways from typical government data collection and analysis activities. Because of these differences, the database may serve the interests of deCODE more than it serves the interests of the public, undermining the claim that presumed consent for this data collection and its proprietary use is ethical. -
IPR2016-01284 Patent 6,900,221 B1 ______
[email protected] Paper No. 49 571.272.7822 Filed: January 8, 2018 UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS HOLDINGS INC., AND APOTEX HOLDINGS, INC., Petitioner, v. OSI PHARMACEUTICALS LLC, Patent Owner. ____________________ Case IPR2016-01284 Patent 6,900,221 B1 ____________ Before LORA M. GREEN, RAMA G. ELLURU, and ZHENYU YANG, Administrative Patent Judges. GREEN, Administrative Patent Judge. FINAL WRITTEN DECISION Determining That Claims 44‒46 and 53 Are Shown to Be Unpatentable 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 IPR2016-01284 Patent 6,900,221 B1 I. INTRODUCTION Apotex Inc., Apotex Corp., Apotex Pharmaceuticals Holdings Inc., and Apotex Holdings, Inc., (“Apotex” or “Petitioner”) filed a Petition requesting an inter partes review of claims 44–47 and 53 of U.S. Patent No. 6,900,221 B1 (Ex. 1001, “the ’221 patent”). Paper 3 (“Pet.”). OSI Pharmaceuticals LLC1 (“OSI” or “Patent Owner”) filed a Preliminary Response to the Petition.2 Paper 7 (“Prelim. Resp.”). We determined that the information presented in the Petition and the Preliminary Response demonstrated that there was a reasonable likelihood that Petitioner would prevail in challenging claims 44–47 and 53 as unpatentable under 35 U.S.C. § 103(a). Pursuant to 35 U.S.C. § 314, we instituted trial on January 9, 2017, as to all of the challenged claims of the ’221 patent. Paper 8 (“Institution Decision” or “Dec. Inst.”). On February 8, 2017, the parties filed a Joint Motion to Limit Petition Under 37 C.F.R. -
Amgen 2008 Annual Report and Financial Summary Pioneering Science Delivers Vital Medicines
Amgen 2008 Annual Report and Financial Summary Pioneering science delivers vital medicines About Amgen Products Amgen discovers, develops, manufactures Aranesp® (darbepoetin alfa) and delivers innovative human therapeutics. ® A biotechnology pioneer since 1980, Amgen Enbrel (etanercept) was one of the fi rst companies to realize ® the new science’s promise by bringing EPOGEN (Epoetin alfa) safe and effective medicines from the lab Neulasta® (pegfi lgrastim) to the manufacturing plant to patients. NEUPOGEN® (Filgrastim) Amgen therapeutics have changed the practice of medicine, helping millions of Nplate® (romiplostim) people around the world in the fi ght against ® cancer, kidney disease, rheumatoid Sensipar (cinacalcet) arthritis and other serious illnesses, and so Vectibix® (panitumumab) far, more than 15 million patients worldwide have been treated with Amgen products. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. 0405 06 07 08 0405 06 07 08 0405 06 07 08 0405 06 07 08 Total revenues “Adjusted” earnings Cash fl ow from “Adjusted” research and ($ in millions) per share (EPS)* operations development (R&D) expenses* (Diluted) ($ in millions) ($ in millions) 2008 $15,003 2008 $4.55 2008 $5,988 2008 $2,910 2007 14,771 2007 4.29 2007 5,401 2007 3,064 2006 14,268 2006 3.90 2006 5,389 2006 3,191 2005 12,430 2005 3.20 2005 4,911 2005 2,302 2004 10,550 2004 2.40 2004 3,697 2004 1,996 * “ Adjusted” EPS and “adjusted” R&D expenses are non-GAAP fi nancial measures. See page 8 for reconciliations of these non-GAAP fi nancial measures to U.S. -
Biobanks for Europe
KI-NA-25-302-EN-C This expert group report on the ethical and regulatory challenges of international biobank research has been authored by an interdisciplinary group with experts from science, law, governance and ethics. Biobanks for Biobank research is rapidly evolving, and in close interaction with developments in informatics and genomics. The size and breath of the collections of biological samples and associated data that can be Europe assembled has increased exponentially. This opens up a vast range of new options for research and diagnosis, but at the same time also holds an important challenge for the governance of these activities. In this report, the expert group makes speci c recommendations for good A Challenge for Governance governance of Biobanks Research and Innovation policy Research and Innovation ed205134cover_BAT.indd 1-3 11/06/12 09:14 How to obtain EU publications Free publications: • via EU Bookshop (http://bookshop.europa.eu); • at the European Union’s representations or delegations. You can obtain their contact details on the Internet (http://ec.europa.eu) or by sending a fax to +352 2929-42758. Priced publications: • via EU Bookshop (http://bookshop.europa.eu). Priced subscriptions (e.g. annual series of the O cial Journal of the European Union and reports of cases before the Court of Justice of the European Union): • via one of the sales agents of the Publications O ce of the European Union (http://publications.europa.eu/others/agents/index_en.htm). EUROPEAN COMMISSION Directorate-General for Research and Innovation Directorate B — European Research Area Unit B6 — Ethics and gender Contact: Lino PAULA European Commission B-1049 Brussels E-mail: [email protected] ed205134cover_BAT.indd 4-6 11/06/12 09:14 EUROPEAN COMMISSION Biobanks for Europe A challenge for governance Report of the Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research Chair: Herbert Gottweis Rapporteur: Jane Kaye Members: Fabrizia Bignami, Emmanuelle Rial-Sebbag, Roberto Lattanzi, Milan Macek Jr. -
AILERON THERAPEUTICS, INC. (Name of Registrant As Specified in Its Charter)
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy Statement ☐ Definitive Additional Materials ☐ Soliciting Material Pursuant to §240.14a-12 AILERON THERAPEUTICS, INC. (Name of Registrant as Specified in Its Charter) (Name of Person(s) Filing Proxy Statement, if Other Than the Registrant) Payment of Filing Fee (Check the appropriate box): ☒ No fee required. ☐ Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. (1) Title of each class of securities to which transaction applies: (2) Aggregate number of securities to which transaction applies: (3) Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined): (4) Proposed maximum aggregate value of transaction: (5) Total fee paid: ☐ Fee paid previously with preliminary materials. ☐ Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. (1) Amount previously paid: (2) Form, Schedule or Registration Statement No.: (3) Filing Party: (4) Date Filed: Table of Contents AILERON THERAPEUTICS, INC. -
UNITED STATES SECURITIES and EXCHANGE COMMISSION Form
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 Form 10-K (Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ☒ 1934 For the fiscal year ended December 31, 2008 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ☐ OF 1934 Commission file number 000-12477 Amgen Inc. (Exact name of registrant as specified in its charter) Delaware 95-3540776 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) One Amgen Center Drive, 91320-1799 Thousand Oaks, California (Zip Code) (Address of principal executive offices) (805) 447-1000 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(g) of the Act: Common stock, $0.0001 par value; preferred share purchase rights (Title of class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. -
In the United States District Court for the District of Delaware
Case 1:15-cv-01063-UNA Document 1 Filed 11/17/15 Page 1 of 17 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE OSI PHARMACEUTICALS, LLC, PFIZER ) INC., and GENENTECH, INC., ) ) Plaintiffs, ) ) v. ) C.A. No. ) BRECKENRIDGE PHARMACEUTICAL, ) INC. and NATCO PHARMA LTD., ) ) Defendants. ) COMPLAINT FOR PATENT INFRINGEMENT Plaintiffs OSI Pharmaceuticals, LLC (“OSI”), Pfizer Inc. (“Pfizer”) and Genentech, Inc. (“Genentech”) (collectively, “Plaintiffs”), by their undersigned attorneys, bring this action against Defendant Breckenridge Pharmaceutical Inc., (“Breckenridge”), and Natco Pharma Ltd. (“Natco”) (collectively, “Breckenridge/Natco”) for patent infringement and allege as follows: NATURE OF THE ACTION 1. This is an action for patent infringement under the patent laws of the United States, Title 35 of the United States Code, the Federal Food, Drug, and Cosmetic Act, Title 21 of the United States Code, and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 et seq., arising from Breckenridge/Natco’s filing of an Abbreviated New Drug Application No. 208488 (“Breckenridge/Natco ANDA” or “ANDA No. 208488”) with the United States Food and Drug Administration (“FDA”) seeking approval to commercially market generic versions of TARCEVA® (“Breckenridge/Natco’s Proposed Generic Products”) prior to the expiration of certain patents that relate to that product, United States Reissued Patent No. RE 41,065 (“the RE ‘065 patent”), and United States Patent No. 6,900,221 (“the ‘221 patent”). Case 1:15-cv-01063-UNA Document 1 Filed 11/17/15 Page 2 of 17 PageID #: 2 THE PARTIES 2. Plaintiff OSI is a limited liability company organized and existing under the laws of the State of Delaware, with a principal place of business at 1 Astellas Way, Northbrook, IL 60062.