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Moderna Appoints Oncology Leader Dr. Stephen Kelsey As President of Onkaido
Moderna Appoints Oncology Leader Dr. Stephen Kelsey as President of Onkaido Former Genentech executive to lead Moderna’s first venture company, focused exclusively in novel biology for oncology drug development CAMBRIDGE, Mass., July 1, 2014— Moderna Therapeutics, the pioneer in developing messenger RNA (mRNA) TherapeuticsTM, a revolutionary treatment modality to enable the in vivo production of therapeutic proteins, announced today that Stephen Kelsey, M.D., will become president of Onkaido Therapeutics, Moderna’s oncology drug development company, effective July 21. Launched in January of this year, Onkaido is Moderna’s first venture company, focused exclusively on developing and commercializing mRNA-based oncology treatments. “As we continue to grow Moderna and perfect our mRNA Therapeutics platform, we are also focused on building a transformational oncology company that will benefit patients and society. This requires hiring the best oncology talent to lead Onkaido,” said Stéphane Bancel, president and founding chief executive officer, Moderna. “Steve brings a wealth of experience in oncology drug development to his new role. His knowledge and leadership, combined with the team of Onkaido scientists and Moderna’s innovative mRNA technology, will help speed a new class of cancer drugs to patients around the world.” Dr. Kelsey has extensive pharmaceutical industry experience in oncology. After 16 years as an academic clinician, he started his industry career at Sugen, and later was vice president of hematology/oncology at Genentech. While at Genentech, Dr. Kelsey played a significant role in the development of key products Perjeta®, Kadcyla® and Erivedge®, as well as other molecules in the company’s oncology portfolio. He left Genentech in 2009 to run Geron’s oncology division, where he served for four years as executive vice president, research and development, and chief medical officer helping to develop therapeutics and vaccines to fight cancer. -
Telaprevir (Incivek)
© Hepatitis C Online PDF created September 25, 2021, 4:19 pm Telaprevir (Incivek) Discontinued. This treatment has been discontinued. Table of Contents Telaprevir Incivek Summary Drug Summary Adverse Effects Class and Mechanism Manufacturer for United States FDA Status Indications Dosing Clinical Use Cost and Medication Access Resistance Key Drug Interactions Full Prescribing Information Figures Drug Summary Although telaprevir was a promising direct-acting antiviral agent that had impact in the hepatitis C treatment field during 2011 to 2013, it was subsequently replaced by newer direct-acting antiviral agents that were more effective, better tolerated, and more convenient. Based on the dwindling role of telaprevir after newer direct-acting antiviral agents were approved, Vertex pharmaceuticals discontinued the sales and distribution of telaprevir in the United States in October 2014. Telaprevir does have some current importance since persons who previously failed a telaprevir-based regimen may have developed resistant associated variants, which could potentially impact subsequent therapy. Adverse Effects The most significant adverse effects reported in the main registration trials and in post-marketing experience were rash, anorectal complaints, and anemia. When comparing triple therapy of telaprevir, peginterferon, and ribavirin with dual therapy of peginterferon and ribavirin alone significant differences were noted with rash (56% versus 34%), anemia (36% versus 17%), and anorectal complaints that include anorectal discomfort, anal pruritus, and hemorrhoids (29% versus 7%). In most cases, the rash that develops is eczematous or maculopapular in character and mild to moderate in severity; the rash is typically manageable with good skin care and topical emollients or corticosteroids. In some instances, however, telaprevir has caused serious skin Page 1/5 rashes, including Steven's Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN). -
J. SCOTT MCBRIDE PARTNER ━ 54 West Hubbard Street, Chicago, IL 60654 | 312.494.4436 | [email protected]
J. SCOTT MCBRIDE PARTNER ━ 54 West Hubbard Street, Chicago, IL 60654 | 312.494.4436 | [email protected] EDUCATION & HONORS The University of Chicago Law School, 2002, J.D., with High Honors Order of the Coif 1st Place, Hinton Moot Court The University of Chicago Law Review Northwestern University, 1994, M.S. Ed., Earned Illinois Secondary Teaching Certificate for Chemistry, Physics and German Dartmouth College, 1992, A.B., summa cum laude, High Honors in Chemistry Phi Beta Kappa Rufus Choate Scholar German Academic Exchange Service Scholarship Chandler T. White Chemistry Research Prize CLERKSHIPS Honorable Richard D. Cudahy, United States Court of Appeals for the Seventh Circuit, 2002-2003 ADMISSIONS Illinois INTELLECTUAL PROPERTY LITIGATION ViiV Healthcare v. Gilead Sciences (D. Del.) Lead trial counsel for Gilead in patent infringement case related to Gilead's Biktarvy® HIV treatment. Case pending. www.bartlit-beck.com CHICAGO 312.494.4400 DENVER 303.592.3100 J. SCOTT MCBRIDE Adverio Pharma GmbH v. Alembic Pharmaceuticals, Ltd. et al. (D. Del.) Lead trial counsel for Adverio and Bayer in Hatch-Waxman litigation relating to Bayer's Adempas® (riociguat) treatment for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. Gilead Sciences v. Mylan Pharmaceuticals (D. Del.) Lead trial counsel for Gilead in Hatch-Waxman litigation relating to Gilead's Tybost® (cobicistat) product. Case settled favorably. UroPep v. Eli Lilly (E.D. Tex.) Lead trial counsel (with my partners John Hughes) for UroPep in patent infringement action related to Lilly's Cialis product. Trial verdict for UroPep with damages of $20 million; affirmed on appeal. Regents of the Univ. -
Print Layout 1
TECHNICAL PROGRAM Monday, March 19 5:00 – 8:00 pm Welcome Reception Tuesday, March 20 8:00 – 10:00 Session 1: Setting the Conference Context and Drivers Chair: Geoff Slaff (Amgen) Roger Perlmutter (Amgen) Conquering the Innovation Deficit in Drug Discovery Helen Winkle (CDER, FDA) Regulatory Modernization 10:00 – 10:30 Break Vendor and poster review 10:30 – 12:30 Session 2: Rapid Cell Line Development and Improved Expression System Development Chairs: Timothy Charlebois (Wyeth) and John Joly (Genentech) Amy Shen (Genentech) Stable Antibody Production Cell-Line Development with an Improved Selection Process and Accelerated Timeline Mark Leonard (Wyeth) High-Performing Cell-Line Development within a Rapid and Integrated Platform Process Control Pranhitha Reddy (Amgen) Applying Quality-by-Design to Cell Line Development Lin Zhang (Pfizer) Development of a Fully-Integrated Automated System for High-Throughput Screening and Selection of Single Cells Expressing Monoclonal Antibodies 12:30 – 2:00 Lunch Vendor and poster review 2:00 – 4:30 Session 3: High-Throughput Bulk Process Development Chairs: Brian Kelley (Wyeth) and Jorg Thommes (Biogen Idec) Colette Ranucci (Merck) Development of a Multi-Well Plate System for High-Throughput Process Development Min Zhang (SAFC Biosciences) CHO Media Library – an Efficient Platform for Rapid Development and Optimization of Cell Culture Media Supporting High Production of Pharmaceutical Proteins in Chinese Hamster Ovary Cells Nigel Titchener-Hooker The Use of Ultra-Scale-Down Approaches to Enable Rapid Investigation -
Genentech Tocilizumab Letter of Authority June 24 2021
June 24, 2021 Hoffmann-La Roche, Ltd. C/O Genentech, Inc. Attention: Dhushy Thambipillai Regulatory Project Management 1 DNA Way, Bldg 45-1 South San Francisco, CA 94080 RE: Emergency Use Authorization 099 Dear Ms. Thambipillai: This letter is in response to Genentech, Inc.’s (Genentech) request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of Actemra1 (tocilizumab) for the treatment of coronavirus disease 2019 (COVID-19) in certain hospitalized patients, as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes coronavirus disease 2019 (COVID-19).2 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 3 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section. Actemra is a recombinant humanized monoclonal antibody that selectively binds to both soluble and membrane-bound human IL-6 receptors (sIL-6R and mIL-6R) and subsequently inhibits IL- 6-mediated signaling through these receptors. -
Faculty Disclosure
Faculty Disclosure In accordance with the ACCME Standards for Commercial Support, course directors, planning committees, faculty and all others in control of the educational content of the CME activity must disclose all relevant financial relationships with any commercial interest that they or their spouse/partner may have had within the past 12 months. If an individual refuses to disclose relevant financial relationships, they will be disqualified from being a part of the planning and implementation of this CME activity. Owners and/or employees of a commercial interest with business lines or products relating to the content of the CME activity will not be permitted to participate in the planning or execution of any accredited activity. Nature of Relevant Financial Relationship Last Name Commercial Interest What Was Received For What Role AbbVie, Allergan/ Tobira Therapeutics Inc, Gilead Research Grant Research Balart Sciences Inc, Pfizer, Salix Pharmaceuticals AbbVie, Merck Honorarium Advisory Board Bau None N/A N/A Benz None N/A N/A AbbVie, Arbutus Biopharma, Dieterich Gilead Sciences, Inc., Bristol- Research Grant Consultant Myers Squibb, Merck Bayer HealthCare Pharmaceuticals, Gilead Sciences Honorarium Speaking, Consultant Inc. Bristol-Myers Squibb, Gilead Speaking, Advisory Sciences, Inc, Salix Honorarium Frenette Board Pharmaceuticals, Inc, Merck Intercept Pharmaceuticals Honorarium Advisor Conatus Pharmaceuticals Inc Honorarium Consulting Principle Investigator, Research Grant, Han Gilead Sciences, -
1976 3M Medical Solutions Division 2019 Electrocore, Inc. 2019 Optinose 1985 Abbott Laboratories, Inc
CURRENT SUSTAINING MEMBER COMPANIES MEMBER FOR OVER: 10 Years 25 Years 50 Years Member Since (alphabetical order) 1976 3M Medical Solutions Division 2019 electroCore, Inc. 2019 Optinose 1985 Abbott Laboratories, Inc. 2010 Endo Pharmaceuticals 2018 Organogenesis 2013 AbbVie Inc. 2017 Exelixis 2004 Otsuka America Pharmaceutical, Inc. 2021 Adaptive Biotechnologies 2016 Express Scripts Federal Pharmacy 2018 Pacira BioSciences, Inc. 2017 ACADIA Pharmaceuticals, Inc. 2010 Federal Practitioner 2018 Paratek Pharmaceuticals 2020 AcelRx Pharmaceuticals, Inc. 2018 Foundation Medicine, Inc. 1990 Pfizer Pharmaceuticals 2020 Acorda Therapeutics 2021 Frontier Technology Inc. (FTI) 2017 Pharmacyclics, LLC 2019 Aimmune 2020 Fresenius Medical Care North America 2020 RedHill BioPharma 2003 Alcon Laboratories, Inc. 1989 Genentech Inc. 2019 Red One Medical 2019 Alexion Pharmaceuticals, Inc. 2006 Gilead Sciences 2020 Regeneron 2017 Alkermes, Inc. 1983 GLAXOSMITHKLINE 2009 Regenesis Biomedical, Inc. 2019 Alnylam Pharmaceuticals 2013 Golden State Medical Supply, Inc. 2011 Remund Group, LLC 2019 Altarum Institute 2020 GRAIL 2018 Rigel Pharmaceuticals 2020 Amarin Corporation 2019 Greenwich Biosciences 2000 Sanofi 1994 AmerisourceBergen 2013 Gulf Coast Pharmaceuticals Plus, LLC 2020 Seattle Genetics 1992 Amgen 2008 Heritage Health Solutions, Inc. 2004 Siemens Medical Solutions 2020 Amneal Pharmaceutical 2017 Hill-Rom Company 2019 SK Life Science, Inc. 2019 Aptive Resources LLC 2020 Immunomedics 2002 Smith & Nephew, Inc. 2020 The Arbinger Institute 2019 ImmunoVation, LLC 2019 Sobi Inc. 2011 Arbor Pharmaceuticals, LLC 2019 Incyte Corporation 2013 Stryker Orthopaedics 2010 Argentum Medical, LLC 2019 Indivior 2018 Sun Pharmaceutical 2019 ASM Research, LLC 2015 Intercept Pharmaceuticals 1999 Sunovion Pharmaceuticals, Inc. 1986 Astellas Pharma US, Inc. 2019 Ipsen Biopharmaceuticals, Inc. 2016 Taiho Oncology, Inc. 1995 AstraZeneca 2018 IT Cadre 2015 Takeda Oncology 2020 Baudax Bio, Inc. -
COVID-19 Pharmacotherapy MATTHEW F
COVID-19 Pharmacotherapy MATTHEW F. DERAEDT, PHARM.D., B.C.P.S. ANMC EMERGENCY DEPARTMENT PHARMACIST LT, USPHS Disclosure •No conflicts of interest to disclose •Recommendations to follow primarily from Alaska Native Medical Center’s Policy and Procedures •Clinical questions regarding specific patients should be deferred to ANMC Infectious Disease Department •Rapidly evolving FDA EUA and approved indications Objectives •Understanding inclusion and exclusion criteria for COVID-19 pharmacotherapies •Mechanism of action (MOA), pharmacokinetics, and pharmacodynamics for various therapies •Monitoring parameters for pharmacotherapies •Regulatory requirements for emergency use authorization therapies Remdesivir (Veklury®) •Adenosine nucleotide analog prodrug that is metabolized intracellularly to a nucleoside monophosphate intermediate •The nucleoside monophosphate is phosphorylated to active compound nucleoside triphosphate metabolite •The remdesivir- triphosphate (RDV TP) competes with ATP for incorporation into nascent RNA chains by SARS-CoV-2 RNA Dependent RNA Polymerase (RdRp) •Inhibits RNA chain termination Adamsick ML, et al. JASN. 2020:31(7):1384 - 1386 Remdesivir [package insert]. Foster City, CA. Gilead Sciences Inc. 2020. Road To Approval •FDA released on Emergency Use Authorization (EUA) May 1, 2020 •FDA approval on October 22, 2020 for adult patients and pediatric patients 12 years of age or older weighing at least 88 lbs (40kg) for the treatment of hospitalized COVID-19 patients •No longer need to follow EUA requirements for the approved patient population •Three Clinical Trials 1. NIAID ACTT-1: Mild/moderate and Severe COVID-19 2. GS-US-540-5774: Moderate COVID-19 3. GS-US-540-5773: Severe COVID-19 Remdesivir [package insert]. Foster City, CA. Gilead Sciences Inc. 2020. Spinner CD, et al. -
ARK GENOMIC REVOLUTION MULTI SECTOR ETF (ARKG) HOLDINGS As of 09/27/2021
ARK GENOMIC REVOLUTION MULTI SECTOR ETF (ARKG) HOLDINGS As of 09/27/2021 Company Ticker CUSIP Shares Market Value($) Weight(%) 1 TELADOC HEALTH INC TDOC 87918A105 3,937,797 531,208,815.30 6.99 2 EXACT SCIENCES CORP EXAS 30063P105 3,971,013 381,296,668.26 5.01 3 PACIFIC BIOSCIENCES OF CALIF PACB 69404D108 13,696,148 350,347,465.84 4.61 4 VERTEX PHARMACEUTICALS INC VRTX 92532F100 1,722,281 316,228,014.41 4.16 5 FATE THERAPEUTICS INC FATE 31189P102 4,825,395 312,926,865.75 4.12 6 IONIS PHARMACEUTICALS INC IONS 462222100 8,572,965 310,341,333.00 4.08 7 REGENERON PHARMACEUTICALS REGN 75886F107 430,742 275,201,063.80 3.62 8 TWIST BIOSCIENCE CORP TWST 90184D100 2,237,350 250,829,308.50 3.30 9 TAKEDA PHARMACEUTIC-SP ADR TAK UN 874060205 13,592,076 229,570,163.64 3.02 10 ACCOLADE INC ACCD 00437E102 5,268,242 226,850,500.52 2.98 11 INTELLIA THERAPEUTICS INC NTLA 45826J105 1,508,421 224,965,907.94 2.96 12 VEEVA SYSTEMS INC-CLASS A VEEV 922475108 741,198 222,307,516.14 2.92 13 CAREDX INC CDNA 14167L103 3,433,475 220,978,451.00 2.91 14 CRISPR THERAPEUTICS AG CRSP H17182108 1,804,041 210,044,493.63 2.76 15 INCYTE CORP INCY 45337C102 2,893,385 199,643,565.00 2.63 16 INVITAE CORP NVTA 46185L103 6,059,066 182,135,523.96 2.40 17 ADAPTIVE BIOTECHNOLOGIES ADPT 00650F109 4,888,391 178,377,387.59 2.35 18 BEAM THERAPEUTICS INC BEAM 07373V105 1,849,698 175,110,909.66 2.30 19 SIGNIFY HEALTH INC -CLASS A SGFY 82671G100 8,107,683 160,937,507.55 2.12 20 UIPATH INC - CLASS A PATH 90364P105 2,955,628 155,761,595.60 2.05 21 CASTLE BIOSCIENCES INC CSTL 14843C105 2,130,211 -
Vertex Pharmaceuticals Global Medical Affairs Pharmd Fellowship Program 2020 Message from Global Medical Affairs Leadership
Vertex Pharmaceuticals Global Medical Affairs PharmD Fellowship Program 2020 Message from Global Medical Affairs Leadership Dear Candidates, Vertex Pharmaceuticals in collaboration with Northeastern University is privileged to host and expand the PharmD Fellowship Program. We are excited to work with our fellows as integral members of our team and facilitate in-depth exposure to a range of functional areas, offering them the critical opportunity to gain extensive experience in the biopharmaceutical industry. In addition to fostering each individual’s personal and professional growth, the program’s primary goal is to extend the visibility of valuable contributions that a Doctor of Pharmacy can bring to the pharmaceutical industry. At Vertex, our Global Medical Affairs fellows are highly encouraged to take on immersive projects, allowing them to work across departments with leaders in the industry. We advocate for them to partake in truly unique, impactful work that develops their skills, sparks curiosity, and drives the science. Vertex’s open and innovative culture allows the fellows to ask questions, challenge the status quo, and explore their interests across multiple expertise areas. As a pharmacist, I am extremely proud of the establishment of the Vertex PharmD Fellowship program in Global Medical Affairs and excited to welcome our future fellows. Vertex is an ideal place for fellows to start their professional career, and we are dedicated to the development of the next generation of pharmacist leaders in the biopharmaceutical industry. As Vertex continues to grow and evolve into a company in multiple disease areas, I am confident that our fellows will be an essential part of moving the needle to deliver on our commitment to patients. -
COVID-19 Therapies and Vaccine Landscape
editorial COVID-19 therapies and vaccine landscape Within a few weeks of the novel coronavirus genome sequence being published, numerous therapies and vaccines have entered clinical trials with a few showing great promise in alleviating symptoms and accelerating recovery. n late 2019, patients presenting with viral next-generation vaccine development can be pneumonia were reported in Wuhan, expedited by utilizing sequence information IChina, and a novel coronavirus was alone rather than relying on in vitro cultures quickly identified as the causative pathogen of live viruses. Nucleic acid-based vaccines that leads to severe acute respiratory that use this next-generation approach have syndrome (SARS-CoV-2) or COVID- been the frontrunners for COVID-19. One 19. The widely reported unpredictability such example is an mRNA vaccine (mRNA- of the disease means that some infected 1273 — encoding for the virus spike protein individuals are asymptomatic, some have used by viruses to latch onto human host mild flu-like symptoms, whereas other cells) developed by Moderna Therapeutics unfortunate individuals suffer from major and the National Institutes of Health has complications. The lower respiratory tract is already shown promising signs and is the main target for severe symptoms, where Credit: Andrey Deryabin/Alamy Stock Photo currently finalizing preparations for phase high virus shedding has been observed. The III clinical trials7. Another frontrunner body defends itself by an elevated immune in phase IIB/III clinical trials, ChAdOX1 response -
Pharma: Strategic Realignment for a 112/113 Better Future Prism / 2 / 2020
Pharma: Strategic realignment for a 112/113 better future Prism / 2 / 2020 Pharma: Strategic realignment for a better future ... and how the industry will be forced to overcome its hesitation to innovate in operations Ben van der Schaaf, Aurelien Guichard The life sciences sector faces significant impact from Amid the search for COVID-19 – and although the race for treatments and vaccines effective COVID-19 treatments and vaccines, is dominating the headlines, the effect on the industry will the pandemic will have not solely be positive. long-term side effects for the global pharmaceutical In the short term, some companies industry. As our article explains, companies are laying people off and reducing will need to focus on operations, whereas others are change in three areas reallocating resources to focus on (portfolio reprioritization, COVID-19, or even ramping up accelerated R&D and technology efforts in other areas. Stock-market transformation) if they performance has been as diverse are to position (Figure 1). themselves successfully for the future. Organizations need to consider major strategic questions now, to ensure their success in the longer term. The industry is clearly in the middle of the efforts to combat COVID-19: - More than 20 companies are trying to find a treatment with either new or approved drugs1. - More than 15 companies globally are mobilizing resources to develop new vaccines2. - Globally, by the end of May, more than 1,300 clinical trials related to COVID-19 were recruiting patients3. 1. Marketwatch.com, 6 May 2020 2. Drugtargetreview.com, 9 April 2020 3. clintrials.gov, 31 May 2020 Pharma: Strategic realignment for a 114/115 better future Prism / 2 / 2020 2.