Schedule 14A
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Boston University Journal of Science & Technology
4 B.U. J. SCI. & TECH. L. 1 January 23, 1997 Boston University Journal of Science & Technology Law Symposium Financing the Biotech Industry: Can the Risks Be Reduced? Ronald Cass, Joshua Lerner, Farah H. Champsi, Stanley C. Erck, Jonathan R. Beckwith, Leslie E. Davis, Henri A. Termeer Table of Contents Speeches..........................................................................................................................[1] Dean Ronald Cass.............................................................................................[1] Joshua Lerner....................................................................................................[2] Farah Champsi..................................................................................................[8] Stanley Erck.....................................................................................................[18] Jonathan Beckwith.........................................................................................[24] Leslie Davis......................................................................................................[37] Henri Termeer.................................................................................................[47] Question and Answer Session..................................................................................[60] Financing the Biotech Industry: Can the Risks Be Reduced?† Jonathan R. Beckwith, Farah H. Champsi, Leslie E. Davis,* Stanley C. Erck, Joshua Lerner, Henri A. Termeer Dean Ronald Cass: 1. The biotechnology -
AVEO PHARMACEUTICALS, INC. (Name of Registrant As Specified in Its Charter)
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant x 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)) x Definitive Proxy Statement ¨ Definitive Additional Materials ¨ Soliciting Material Pursuant to §240.14a-12 AVEO PHARMACEUTICALS, 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): x 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. -
Proqr Therapeutics N.V
ANNUAL REPORT 2017 Meaningful progress - Excited about the future PAGE I PAGE II ANNUAL MAGAZINE 2017 ANNUAL MAGAZINE 2017 our courage to do things differently University of Colorado and during his ACCOMPLISHMENTS – and challenge the status quo. career has earned a global reputation A QUICK GLANCE We can and will make a meaningful for translating cutting-edge science impact – changing the lives of into transformational new therapies Eluforsen (formely known as QR-010) for CF patients. Be it in a small way – for rare diseases including cystic fibro- • Completed second trial for eluforsen by improving one’s quality of life. sis, pulmonary fibrosis, pulmonary • Announced positive data from Or in a big way – by stopping artery hypertension, severe immuno- Phase 1b safety and tolerability study a disease or by curing patients. logic, and inflammatory diseases. • Received FDA Fast Track designation and Orphan Drug Designation (ODD) CREATING MEANINGFUL IMPACT At ProQR, we do it all in the interest Dave is excited to be part of ProQR’s in US and Europe of patients. We’re driven, deter- management team: “ProQR has • Granted two key patents mined, excited to make this differ- a patient-centric culture committed ence. Today, tomorrow and more to transforming lives. Applying our QR-110 for LCA 10 days to come, until we get it right. RNA editing platform to precision • IND clearance from FDA and IN THE INTEREST medicine in hereditary forms of commenced Phase 1/2 safety and Building ProQR blindness, dystrophic epidermolysis efficacy trial In 2017, we made important strides bullosa, cystic fibrosis and other • First patient in trial dosed in late 2017 in ProQR’s growth. -
Orphan Drug Letters
November 18, 2010 Kent Lieginger Senior Vice President, Managed Care and Customer Operations Genentech 1 DNA Way South San Franciso, CA 94080 Dear Dr. Lieginger: We are writing on behalf of a broad coalition of hospitals participating in the federal 340B drug discount program. We have been advised that Genentech has begun to withhold 340B pricing for orphan drugs purchased by a subset of our membership, primarily children’s and rural hospitals. We are aware that, under the Health Care and Education Reconciliation Act (HCERA), Congress established a statutory exclusion with respect to orphan drugs purchased by hospitals specifically added by the Patient Protection and Affordable Care Act (PPACA) to the 340B program under the Public Health Service Act, including freestanding cancer hospitals, children’s hospitals, sole community rural referral centers, and critical access hospitals. 1 However, we are deeply concerned with Genentech’s broad interpretation of the orphan drug exclusion, which Genentech has stated extends to all drugs that have been designated “orphan” by the FDA, regardless of the intended use of the drugs. We believe that, absent guidance from the Health Resources and Services Administration (HRSA) regarding the scope of the orphan drug exclusion, it is premature to withhold 340B pricing on orphan drugs. Accordingly, we request that Genentech resume its sale of orphan drugs to hospitals identified in PPACA at 340B prices until directed otherwise by HRSA. We understand that several manufacturers have decided to delay implementation until they receive further guidance from the government and ask that you follow their lead. Our concerns regarding your company’s interpretation are two-fold. -
Ultragenyx Announces Emil D. Kakkis, M.D., Ph.D. As Recipient of BIO’S 2019 Henri A
Ultragenyx Announces Emil D. Kakkis, M.D., Ph.D. as Recipient of BIO’s 2019 Henri A. Termeer Biotechnology Visionary Award May 29, 2019 NOVATO, Calif., May 29, 2019 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, today announced that the Biotechnology Innovation Organization (BIO) has awarded this year’s Henri A. Termeer Biotechnology Visionary Award to Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer, President and founder of Ultragenyx. The award, which will be presented to Dr. Kakkis on June 5 during the BIO 2019 International Convention keynote session, recognizes Dr. Kakkis’ transformative work to accelerate research and development of novel treatments for rare diseases. “Henri Termeer was a pioneer who worked relentlessly to do what many thought was impossible and bring therapies to patients with rare diseases,” said Dr. Kakkis. “I am deeply honored to receive this award from BIO.” “Dr. Kakkis’ innovative work has pushed the boundaries of our knowledge in rare diseases and through his efforts our industry better prioritizes treatments for rare and ultra-rare diseases and understands the unique needs of clinical trials in this category,” said Jim Greenwood, President and CEO of BIO. “His contributions to the study of rare diseases have been monumental for patients and families, and we’re looking forward to presenting him with this well-deserved honor at BIO 2019.” Over the last 25 years, Dr. Kakkis has spearheaded the development of many rare disease treatments, including an enzyme replacement therapy for the rare and debilitating disorder, mucopolysaccharidosis type I (MPS I), which was approved by the FDA in 2003. -
Biotechnology Summit: Putting a Human Face on Biotechnology
17Rla S. HRG. 106-677 BIOTECHNOLOGY SUMMIT: PUTTING A HUMAN FACE ON BIOTECHNOLOGY HEARING before the JOINT ECONOMIC COMMITTEE CONGRESS OF THE UNITED STATES ONE HUNDRED SIXTH CONGRESS FIRST SESSION September 29, 1999 PRINTED FOR THE USE OF THE JOINT ECONOMIC COMMITFEE U.S. GOVERNMENT PRINTING OFFICE WASHINGTON: 2000 CC 62-990 FOR SALE BY THE U.S. GOVERNMENT PRINTING OFFICE SUPERNTENDENTOF DOCUMEN CONGRESSIONALSALESOFFICEWASHINGTON, D.C20402 JOINT ECONOMIC COMMITTEE [Created pursuant to Sec. 5(a) of Public Law 304, 79th Congress] SENATE HOUSE OF REPRESENTATIVES CONNIE MACK, Florida, Chairman JIM SAXTON, New Jersey, Vice Chairman WILLIAM V. ROTH, JR., Delaware MARK SANFORD, South Carolina ROBERT F. BENNETT, Utah JOHN DOOLITTLE, California ROD GRAMS, Minnesota TOM CAMPBELL, California SAM BROWNBACK, Kansas JOSEPH R. PITTS, Pennsylvania JEFF SESSIONS, Alabama PAUL RYAN, Wisconsin CHARLES S. ROBB, Virginia PETE STARK, California PAUL S. SARBANES, Maryland CAROLYN B. MALONEY, New York EDWARD M. KENNEDY, Massachusetts DAVID MINGE, Minnesota JEFF BINGAMAN, New Mexico MELVIN L. WATT, North Carolina SHELLEY S. HYMES, Executive Director JAMES D. GWARTNEY, Chief Economist HOWARD ROSEN, Minority Staff Director (ii) CONTENTS OPENING STATEMENTS OF MEMBERS Senator Connie Mack, Chairman ........ ..................... I Representative Pete Stark, Ranking Minority Member ..... ...... 4 Senator Bill Frist . ......................................... 6 Senator Edward M. Kennedy ............................... 31 Senator Robert F. Bennett .. .............................. 33 Representative David Minge ................................ 36 Senator Jeff Sessions .............. ....................... 39 WITNESSES PANELI Statement of Carolyn Boyer-Fortier, Breast Cancer Survivor. ...... 8 Statement of Dr. Steven Shak, Staff Scientist and Senior Director of Medical Affairs, Genentech ........................... 11 Statement of Joan London, Rheumatoid Arthritis Patient .... ..... 13 Statement of Dr. Robert Bunning, Director of the Arthritis Program at National Rehabilitation Hospital. -
How Scientist/Founders Lead Successful
HOW SCIENTIST/FOUNDERS LEAD SUCCESSFUL BIOPHARMACEUTICAL ORGANIZATIONS: A STUDY OF THREE COMPANIES Lynn Johnson Langer A DISSERTATION Submitted to the Ph.D. in Leadership & Change Program of Antioch University in partial fulfillment of the requirements for the degree of Doctor of Philosophy May, 2008 This is to certify that the dissertation entitled: HOW SCIENTIST/FOUNDERS LEAD SUCCESSFUL BIOPHARMACEUTICAL ORGANIZATIONS: A STUDY OF THREE COMPANIES prepared by Lynn Johnson Langer is approved in partial fulfillment of the requirements for the degree of Doctor of Philosophy in Leadership & Change. Approved by: ______________________________________________________________________ Alan E. Guskin, Ph.D., Chair date ______________________________________________________________________ Jon Wergin, Ph.D., Committee Member date ______________________________________________________________________ Mitch Kusy, Ph.D., Committee Member date ______________________________________________________________________ Alice Sapienza, DBA, External Reader date Copyright 2008 Lynn Johnson Langer All rights reserved Acknowledgements I arrive at this place in my journey to becoming a scholar supported in love and friendship by so many people. I must thank first and foremost my husband, Eric Langer, who has supported me in many ways, but particularly with my education. I thank my daughter, Julia Annemarie, my study partner. We shout across the hall to each other, complaining and laughing about all the work. I thank her for her support and the opportunity to be a role model. She never once complained about the plays and events I missed because I was away at a residency. I thank my son, Adam and his wife, Megan who through their lives, remind me to follow my dreams. I thank my son, Benjamin, who shows me that through hard work, we can accomplish great things. -
Conference Day One Thursday, April 23Rd 2015 – Main Conference Room
Conference Day One Thursday, April 23rd 2015 – Main Conference Room 8.55 Chairperson’s Opening Remarks Hans Schikan, Former Chief Executive Officer, Prosensa 9.00 Keynote: Data driving diagnostics - Clinically relevant information from ordinary photos, and an algorithm to aid in diagnoses of rare diseases Christoffer Nellaker, Research Fellow, Medical Research Foundation’s Functional Genomics Unit, Oxford University 9.30 Keynote: Is the market sustainable? Henri Termeer, Former Chairman, President and CEO, Genzyme (on video) 10.00 Speed Networking & Networking coffee break 11.00 Good medicine is good business: Transforming lives and meeting unmet needs Stephanie Okey, Senior Vice President and Head of North America, Genetic Diseases and US General Manager, Genzyme 11.20 The Great Debate: “The Price is Too Damn High!”…or is it? FOR: The orphan population is so small the rest of the population can more than cover the cost Ram Selvaraju, Managing Director, Equity Research – Healthcare, MLV & Co. AGAINST: First there was rare, now there’s ultra-rare. And it seems every other disease is rare and every other drug orphan. WE won’t be able to afford it – period. Ed Pazalla, VP, National Medical Director for Pharmacy Policy and Strategy, Aetna 12.00 Networking Lunch 1:00 Lunch session: Pediatric vouchers to expedite rare disease treatments in children Gayatri Rao, Director, Office of Orphan Product Development, FDA 1.30 2 x 40-minute roundtables with a 10 minute break in-between. Please sign up in the exhibition hall lounge. 1: How does miscommunication -
Influence | Intuition
invivo.pharmaintelligence.informa.com MAY 2019 Invol. 37 ❚ no. 05 Vivopharma intelligence ❚ informa LEADERSHIPInnovation | Influence | Intuition Biotech CEOs: Can Scientist Founders Beyond The Watershed: Gene Therapy The Eye Travels Wide: ProQR’s Bid Remain In Charge? Investment And Promise For Leadership In Genetics Of Sight PAGE LEFT BLANK INTENTIONALLY invivo.pharmaintelligence.informa.com STRATEGIC INSIGHTS FOR LIFE SCIENCES DECISION-MAKERS CONTENTS ❚ In Vivo Pharma intelligence | May 2019 THE LEADERSHIP ISSUE 10 16 22 Biotech CEOs: Can Scientist- Beyond The Watershed: Rentschler Biopharma: Founders Remain In Charge? Gene Therapy Investment Growing And Innovating As MELANIE SENIOR And Promise A CDMO Business Founder-CEOs do not typically remain at JO SHORTHOUSE LUCIE ELLIS the helm as biotechs mature. Exceptions Janet Lambert, CEO of the Alliance for Frank Mathias, CEO of Rentschler to that rule are multiplying, though, Regenerative Medicine, recently spoke to Biopharma, a contract development especially in Europe as companies aim In Vivo about the tremendous levels of and manufacturing organization, talks directly for Nasdaq. investment the cell and gene therapy to In Vivo about the company’s new industries are attracting, as well as corporate strategy and why he allowed 18 26 reasons why Europe excels at incubating months to prepare that plan for delivery. advanced product development. TISSIUM CEO’s Vision Is To Make 36 The Tissue Recon Label Stick 30 ASHLEY YEO Leading In Product Develop- The Eye Travels Wide: ment Means Planning -
Schedule 14A
QuickLinks -- Click here to rapidly navigate through this document 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 Filed by the Registrant ý Filed by a Party other than the Registrant o Check the appropriate box: o Preliminary Proxy Statement o Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ý Definitive Proxy Statement o Definitive Additional Materials o Soliciting Material under §240.14a-12 Verastem, 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): ý No fee required. o 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: o Fee paid previously with preliminary materials. o 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. -
Bio-IT World Conference & Expo
Featured Presentations by: Platinum Sponsors: Font: Optima Regular Colors: Dark Blue #003399 (CMYK 96, 69, 3, 0) Light Blue #6699CC (CMYK 62, 22, 3, 0) ENABlING TECHNOlOGy. Leveraging Data. TransformING mEDICINE. CONCURRENT TRACKS: KEYNOTE PRESENTATIONS BY: 1 IT Infrastructure — Hardware 2 IT Infrastructure — Software John Halamka, m.D., m.S., Gold Sponsors: CIO, Harvard Medical School 3 Bioinformatics and Next-Gen Data 4 Systems and Predictive Biology 5 Cheminformatics and ARTISTS IN DATA STORAGE Computer-Aided Modeling Christoph Westphal, m.D., Ph.D., eClinical Trials Technology CEO, Sirtris Pharmaceuticals; 6 Senior Vice President, Centre of 7 eHealth Solutions Excellence for External Drug Discovery, GlaxoSmithKline Deepak Singh, Ph.D., EVENT FEATURES: Business Development Manager, Access All Seven Tracks for One Price Amazon Web Services Network with 1,500+ Attendees Hear 100+ Technology and Scientific Presentations Bronze Sponsors: Attend Bio-IT World’s Best KEYNOTE PANEL: Practices Awards The Future of Personal Genomics Connect with Attendees Using CHI’s Intro-Net A special plenary panel discussion featuring: Participate in the Poster Competition James Heywood, Co-founder and Chairman, PatientsLikeMe See the Winners of the following Dan Vorhaus, J.D., M.A., Attorney, Robinson, Bradshaw & Hinson; 2010 Awards: Editor, Genomics Law Report Benjamin Franklin Dietrich Stephan, Ph.D., President & CEO, Ignite Institute Best of Show Kári Stefánsson, MD, Dr Med, Executive Chairman and President Best Practices of Research, deCODE genetics View Novel Technologies and Solutions in the Expansive Exhibit Hall Kevin Davies, Ph.D., Editor-in-Chief, Bio-IT World And Much More! And More... BIONETWORKS Corporate Support Sponsors Bio-ITWorldExpo.com Organized & Managed by: Official Publication: Cambridge Healthtech Institute 250 First Avenue, Suite 300, Needham, MA 02494 Phone: 781-972-5400 • Fax: 781-972-5425 • Toll-free in the U.S. -
Reactive Oxygen Species Insufficiency (ROSI) As the Basis for Disease Allowance and Coexistence
Reactive Oxygen Species Insufficiency (ROSI) as the Basis for Disease Allowance and Coexistence: Extraordinary Support for an Extraordinary Theory VOLUME I (One) BY PROF. HON. RANDOLPH M. HOWES, M.D., Ph.D. Orthomolecular Surgical Scientist and Biochemist Contents of volumes I through III: Volume I (One) Pages 1-530 of original: pp 501 Sections 1.0-1.9.0.4 Volume II (Two) Pages 531-1018 of original: pp 505 Sections 1.9.0.5-11.1.3 Volume III (Three) Pages 1019-1564 of original: pp 562 Sections 11.1.4-20.0.0 Unauthorized use of any of this material, without author permission, is prohibited by law. © 2008, Randolph M. Howes, M.D., Ph.D. Reactive Oxygen Species Insufficiency (ROSI) as the Basis for Disease Allowance and Coexistent: Extraordinary Support for an Extraordinary Theory Relationships between CANCER, ATHEROSCLEROSIS, DIABETES, OBESITY, HYPERTENSION, ARTHRITIS & CATARACTS (EMOD Insufficiency Syndrome of Howes) (EMODs) Electronically Modified Oxygen Derivatives THE HOWES SELECTIVE WORLD LIBRARY OF OXYGEN METABOLISM [The seventh in a series and a companion book to the following: #1. U.T.O.P.I.A. © 2004 Unified Theory of Oxygen Participation In Aerobiosis; #2. The Medical and Scientific Significance of Oxygen Free Radical Metabolism © 2005; #3. Hydrogen Peroxide Monograph 1: Scientific, Medical and Biochemical Overview & #4. Antioxidant Vitamins A, C, & E Monograph 2: Equivocal Scientific Studies, © 2006; #5. Cardiovascular Disease and Oxygen Free Radical Mythology, © 2006; #6. Diabetes and Oxygen Free Radical Sophistry, © 2006] A Selective World Literature Review Available at www.thepundit.com BY PROF. HON. RANDOLPH M. HOWES, M.D., Ph.D.