Genentech 2002 Annual Report the Acceleration of Scientific Knowledge Over Time Has Been Profound— and It Is Ceaseless
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Fully Human Domain Antibody Therapeutics: the Best of Both Worlds
Drug Discovery Fully Human Domain Antibody Therapeutics: The Best of Both Worlds By combining the therapeutic benefits of small molecule drugs with those of fully human antibodies, Domain Antibodies are expected to have strong therapeutic and commercial potential. By Robert Connelly at Domantis Robert Connelly is Chief Executive Officer of Domantis. He has over 22 years’ commercial experience of the life science sector, including that gained in the fields of diagnostics, drug discovery technologies and antibody therapeutics. Prior to joining Domantis, he was CEO of Veritas Pharmaceuticals (Los Angeles, USA), an in vivo imaging start-up company. He spent over five years with IGEN International, latterly as Senior Vice President and General Manager, Life Sciences, where he took part in the company’s IPO and financing rounds, raising $130 million. The first 11 years of his career were spent at Abbott Laboratories in sales, marketing and management positions. Domain Antibodies (dAbs) are the smallest functional variable regions of either the heavy (VH) or light (VL) binding units of antibodies. At Domantis, we are chains of human antibodies. Domantis scientists applying our proprietary know-how in dAbs to deliver have used the variable domains sequences of human human therapies that address large, unmet medical antibodies to create a series of large and highly needs in areas such as inflammation, cancer and functional libraries of fully human dAbs, with each autoimmune diseases. Three and a half years after library comprising at least 1010 different dAbs. The opening our laboratories, we have a dozen proprietary dAbs selected from these libraries are both specific therapeutic programmes underway, and an additional for their biological target and are well folded and eight therapeutic programmes with partners. -
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. -
Power List 2018
APRIL 2018 # 40 Editorial Upfront In My View Sitting Down With Stop and look at how far Preparing for the EU’s new What can algae teach us Sophie Kornowski-Bonnet, the industry has come data protection regulation about medicine design? Roche Partnering 09 10 – 11 20 – 21 50 – 51 100 Power List 2018 www.themedicinemaker.com Continuous Growth Fibra-Cel® disks—3-D growth matrix for perfusion and continuous processes Suspend your disbelief: > Less susceptible to shear forces, The three-dimensional Fibra-Cel matrix clogging, and fouling entraps anchorage dependent and > Ideal for secreted product and vaccine suspension cells—for optimized growth production conditions and increased yields. > Suitable for GMP production > For use in autoclavable, sterilize-in- place or BioBLU® Single-Use Vessels www.eppendorf.com/Fibra-Cel Fibra-Cel® is a registered trademark owned by Imerys Minerals California, Inc., USA and licensed to Eppendorf, Inc., USA. Eppendorf®, the Eppendorf Brand Design and BioBLU® are registered trademarks of Eppendorf AG, Germany. All rights reserved, including graphics and images. Copyright © 2018 by Eppendorf AG. tmm_epp_ad_210x266_2018_04.indd 1 28.03.18 13:34 Online this Month The Power List The 2018 Power List, starting on page 24 of this issue, features 100 of the most inspirational professionals involved in A Scientist Walks into a Bar... format to the public”. Generally, drug development. The list was compiled it involves scientists speaking on a based on reader nominations and And gives a presentation as part variety of topics, from medicine, to feedback from a judging panel – but any of Pint of Science, a global science neuroscience, to robotics and more, in list will always be subjective. -
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. -
List of Section 13F Securities
List of Section 13F Securities 1st Quarter FY 2004 Copyright (c) 2004 American Bankers Association. CUSIP Numbers and descriptions are used with permission by Standard & Poors CUSIP Service Bureau, a division of The McGraw-Hill Companies, Inc. All rights reserved. No redistribution without permission from Standard & Poors CUSIP Service Bureau. Standard & Poors CUSIP Service Bureau does not guarantee the accuracy or completeness of the CUSIP Numbers and standard descriptions included herein and neither the American Bankers Association nor Standard & Poor's CUSIP Service Bureau shall be responsible for any errors, omissions or damages arising out of the use of such information. U.S. Securities and Exchange Commission OFFICIAL LIST OF SECTION 13(f) SECURITIES USER INFORMATION SHEET General This list of “Section 13(f) securities” as defined by Rule 13f-1(c) [17 CFR 240.13f-1(c)] is made available to the public pursuant to Section13 (f) (3) of the Securities Exchange Act of 1934 [15 USC 78m(f) (3)]. It is made available for use in the preparation of reports filed with the Securities and Exhange Commission pursuant to Rule 13f-1 [17 CFR 240.13f-1] under Section 13(f) of the Securities Exchange Act of 1934. An updated list is published on a quarterly basis. This list is current as of March 15, 2004, and may be relied on by institutional investment managers filing Form 13F reports for the calendar quarter ending March 31, 2004. Institutional investment managers should report holdings--number of shares and fair market value--as of the last day of the calendar quarter as required by Section 13(f)(1) and Rule 13f-1 thereunder. -
Companies in Attendance
COMPANIES IN ATTENDANCE Abbott Diabetes Care Archbow Consulting LLC Business One Technologies Abbott Laboratories ARKRAY USA BusinessOneTech AbbVie Armory Hill Advocates, LLC CastiaRX ACADIA Artia Solutions Catalyst Acaria Health Asembia Celgene Accredo Assertio Therapeutics Celltrion Acer Therapeutics AssistRx Center for Creative Leadership Acorda Therapeutics Astellas Pharma US Inc. Cigna Actelion AstraZeneca Cigna Specialty Pharmacy AdhereTech Athenex Oncology Circassia Advantage Point Solutions Avanir Coeus Consulting Group Aerie Pharmaceuticals Avella Coherus Biosciences AGIOS AveXis Collaborative Associates LLC Aimmune Theraputics Bank of America Collegium Akcea Therapeutics Bausch Health Corsica Life Sciences Akebia Therapeutics Bayer U.S. CoverMyMeds Alder BioPharmaceuticals Becton Dickinson Creehan & Company, Inc., an Inovalon Company Alexion Biofrontera CSL Behring Alkermes Biogen Curant Health Allergan Biohaven CVS Health Almirall BioMarin D2 Consulting Alnylam BioMatrix Specialty Pharmacy Daiichi Sankyo Amarin BioPlus Specialty Pharmacy DBV Technologies Amber Pharmacy Bioventus Deloitte Consulting LLP AmerisourceBergen Blue Cross Blue Shield Association Dendreon Amgen Blue Fin Group Dermira Amicus Therapeutics bluebird bio Dexcom Amneal Boehringer Ingelheim Diplomat Pharmacy Anthem Boston Biomedical Dova Applied Policy Bowler and Company Decision Resources Group Aquestive Therapeutics Braeburn Eisai Arbor Pharmaceuticals Bristol-Myers Squibb 1 electroCore Indivior Merz Pharmaceuticals EMD Serono Inside Rx Milliman Encore Dermatology, -
News Release
NEWS RELEASE Media: Nikki Levy (650) 225-1729 Investor: Susan Morris (650) 225-6523 Biogen Idec Contacts: Media: Amy Brockelman (617) 914-6524 Investor: Eric Hoffman (617) 679-2812 GENENTECH AND BIOGEN IDEC ANNOUNCE POSITIVE RESULTS FROM A PHASE II TRIAL OF RITUXAN IN RELAPSING-REMITTING MULTIPLE SCLEROSIS SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass. – August 28, 2006 – Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) announced today that a Phase II study of Rituxan® (Rituximab) for relapsing-remitting multiple sclerosis (RRMS) met its primary endpoint. The study of 104 patients showed a statistically significant reduction in the total number of gadolinium enhancing T1 lesions observed on serial MRI scans of the brain at weeks 12, 16, 20 and 24 in the Rituxan-treated group compared to placebo. Genentech and Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting. “These initial results exceeded our expectations,” said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. “Showing a significant benefit at 24 weeks in this small Phase II trial supports our hypothesis that selective B-cell targeted therapy may play an important role in the treatment of MS.” - more - - 2 - “Biogen Idec is committed to offering multiple options for people living with MS, a devastating disease. We are very encouraged by these data and look forward to learning more about the potential of Rituxan as a therapy to treat MS,” said Alfred Sandrock, M.D., Ph.D., senior vice president, neurology research and development, Biogen Idec. -
A Balanced Trade Context for HIV Patent Pool
iMedPub Journals 2011 TRANSLATIONAL BIOMEDICINE Vol. 2 No. 1:3 This article is available from: http://www.transbiomedicine.com doi: 10:3823/420 A Balanced Trade Context for HIV Patent Pool Daniele Dionisio, M.D. Member, European Parliament Working Group on Innovation, Access to Medicines and Poverty- Related Diseases. Reference Advisor for “Drugs for the developing countries”, SIMIT (Italian Abstract Society for Infectious and Tropical Diseases). Former Director, Infectious Disease Division, Pistoia city Hospital (Italy). Background: Reluctance of the multinational pharmaceutical companies to join the Medicines Patent Pool plan for HIV drugs (antiretrovirals-ARVs) might undermine E-mail: [email protected] its desirable objective of scaling up long-term, extended access to novel, affordable and appropriate ARV formulations in resource-limited settings. Methods: This paper makes an analysis of conflicting issues and calls for a trade context facilitating a reverse of multinational drug manufacturers’ reluctance to join patent pool. To this aim, partnerships between multinational companies are urged first to make cutting edge brand fixed-dose combination (FDC) ARVs promptly avail- able, and secondly, to allow patent pool agreements to be negotiated immediately afterwards. This context rejects clauses that exclude middle-income countries from sharing in the patent pool. Expected results: The suggested trade context can help speed up the partici- pation of originator pharmaceutical companies in the Medicines Patent Pool, while allowing them to maintain competitiveness, take advantage of incoming joint ven- ture opportunities and circumvent the need for additional incentives. This context potentially tackles in an appropriate way the directions of evolution in emerging markets, while bringing benefits to resource-limited populations, multinational drug corporations and manufacturers from middle-income countries. -
The Path Less Costly
COMMENtaRY CASE STUDY The path less costly Brady Huggett When faced with a competitive threat, two companies took diametrically opposite approaches. Both were ultimately successful, but Genzyme’s decision proved to be the cleaner and cheaper option. s the world’s leader in developing enzyme-replacement drugs, and Novartis of Basel. Houston-based Tanox was founded in 1986 to AGenzyme has always understood the importance of first to market. In focus on anti-IgE antibodies and by 1989 was looking for a clinical 1991, the company obtained approval for Ceredase (alglucerase injection), development partner; it sent samples of its candidate to both Genentech an enzyme replacement therapy for lysosomal storage disease (LSD) type and Ciba Geigy (the company that would later become Novartis). 1 Gaucher. Three years later, its second-generation product, Cerezyme Genentech passed. Ciba Geigy, however, began working with Tanox (imiglucerase for injection), was also cleared for commercialization. The on anti-IgE antibodies for allergic diseases. lack of treatments for lysosomal storage diseases and effective patient out- Yet Genentech clearly had interest in the area, because it began its own reach and marketing meant that Genzyme could command soaring prices anti-IgE program a few years later—a move that prompted a misappro- for its orphan treatments. In 2000, the two drugs alone provided 66% of priation suit from Tanox. The companies fought in court for three years Genzyme’s entire product revenue. before Genentech, Tanox and Novartis reached a settlement and entered At this time, Novazyme Pharmaceuticals was a young company devel- a cross-licensing agreement for anti-IgE antibodies. -
Oral Presentation Disclosures
Oral Presentation Disclosures Adler, Lenard – Alcobra Pharma, APSARD/Pond Foundation, Major League Baseball, Major League Baseball Players Association, National Football League, New York University School of Medicine, Novartis Bioventures, Shire Pharmaceuticals, Sunovion, SUNY Upstate, Theravance, US Department of Veterans Affairs Cooperative Studies Program Anton, Raymond – Abbvie, Alkermes, Eli Lilly, Ethypharm, Lundbeck, Pfizer, Sunpharma Baker, Ross – Otsuka Pharmaceutical Development & Commercialization, Inc. Baldwin, David – Lundbeck Beaver, Jessica – Targacept, Inc. Bencherif, Merouane – Targacept, Inc. Bertolino, Alessandro – F. Hoffmann-La Roche, Ltd. Bradshaw, Mark – Euthymics Bioscience, Neurovance, Inc. Burdick, Katherine – Dainippon Sumitomo Pharma Bymaster, Frank – Euthymics Bioscience, Neurovance, Inc. Calabrese, Joseph – Sunovion, Teva (Cephalon) Cantillon, Marc – Forest, Kyowa, Lilly, Merck, Pfizer, Reviva Caroff, Stanley – Sunovion Chen, Yinzhong – Takeda Development Center Americas, Inc. Chengappa, Roy – Pfizer, Inc. Childress, Ann – Abbott Laboratories, Bristol Myer Squibb, GlaxoSmithKline, Ironshore, Janssen (Ortho-McNeil), Johnson & Johnson PRD, Lilly, Neos Therapeutics, Neurovance Inc., NextWave, Novartis, Noven, Otsuka, Pfizer, Rhodes, Sepracor, Shionogi, Shire, Somerset, Sunovion, Theravance Christine, Mazzucco – Janssen Cohen, Lee – Astra-Zeneca Pharmaceuticals, Bristol-Myers Squibb, Cephalon, Inc., GlaxoSmithKline, National Institute of Mental Health, National Institute on Aging, Noven Pharmaceuticals, Ortho-McNeil -
2019 Annual Meeting Education Committee All Relationships Are Considered Compensated
2019 Annual Meeting Education Committee All relationships are considered compensated. Relationships are self-held unless otherwise noted. I = Immediate Family Member, Inst = My Institution Patents, Royalties, Travel, Stock and Other Expert Name Employment Leadership Honoraria Consulting or Advisory Role Speakers' Bureau Research Funding Other Intellectual Accommodations, Other Ownership Interests Testimony Property Expenses Monica M. Abbvie (Inst), Agenus (Inst), Astellas Bertagnolli Pharma (Inst), AstraZeneca (Inst), Baxalta (Inst), Bayer Health (Inst), Breast Cancer Research Foundation (Inst), Bristol- Myers Squibb (Inst), Celgene (Inst), Complion (Inst), Eisai (Inst), Exelixis (Inst), Genentech (Inst), GHI Pharma (Inst), Gilead Sciences (Inst), GlaxoSmithKline (Inst), Incyte (Inst), Janssen (Inst), Jazz Pharmaceuticals (Inst), Leidos (Inst), Lexicon (Inst), Lilly (Inst), Matrex (Inst), Mayo Clinic (Inst), Merck (Inst), MGH (Inst), Millenium Pharamceuticals (Inst), Novartis (Inst), PCORI (Inst), Pfizer (Inst), Pharmacyclics (Inst), Robert Wood Johnson Foundation (Inst), Sagerock Advisors (Inst), Sanofi (Inst), Taiho Oncology (Inst), Takeda (Inst), Tesaro (Inst), Teva (Inst) Tatiana M. Prowell David R. Spigel AstraZeneca (Inst), Boehringer AstraZeneca (Inst), Boehringer Ingelheim (Inst), Bristol-Myers Ingelheim (Inst), Bristol-Myers Squibb Squibb (Inst), Celgene (Inst), (Inst), Celgene (Inst), Genentech/Roche Genentech/Roche (Inst), (Inst), Lilly (Inst), Merck (Inst), Novartis Novartis (Inst), Pfizer (Inst) (Inst), Pfizer (Inst), University