Investor Presentation March 19, 2019
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Symbols Alexian Brothers Health System Index to Nov P
Volume 19, Index December 2014 Symbols Alexian Brothers Health System Index to Nov p. 2 Health Care M&A News 1-800-CONTACTS Feb p. 18 A&L Goodbody Apr p. 16, July p. 16 All Care Home Health, LLC Feb p. 17 Each company and orga- A Allergan Inc. Feb p. 10, May p. 1, nization discussed in Health May p. 19, Jun p. 15, July p. 3, Care M&A News, from Janu- Abbott Labs July p. 3, Aug p. 17, July p. 10, Sept p. 16, Oct p. 3, ary through December 2014, Dec p. 4 Nov p. 1, Dec p. 4, Dec p. 16, is listed alphabetically here. AbbVie Inc. July p. 3, July p. 16, Dec p. 19 References are typically to Aug p. 9, Oct p. 2, Oct p. 16, Allscripts Feb p. 2, Apr p. 10 the first occurrence of the Nov p. 19, Dec p. 2 AllSpire Health Partners Nov p. 2 company’s or organiza- ABL, Inc. Aug p. 18 All Staffing Services Jan p. 17 tion’s name in the pertinent Acadia Healthcare Company Feb p. 16, Almost Family, Inc. Apr p. 16 issue; further discussion July p. 17, Oct p. 17, Nov p. 17 ALN Medical Management, LLC may follow later in the text Accelera Innovations, Inc. Jan p. 17 Accelrys, Inc. Jan p. 15 Feb p. 8 but is not indicated here. AccessClosure, Inc. May p. 15 Alta Partners Jun p. 16 Achillion Pharmaceuticals July p. 17 Altos Solutions, Inc. Jun p. 15 References are sorted by Actavis (Foshan) Pharmaceuticals Co. -
Preclinical Development & IND Filing: Nuts, Bolts, Best Practices
“Preclinical Development & IND Filing: Nuts, Bolts, Best Practices and Regulatory Aspects.” Speakers: Amit Kalgutkar (Pfizer), Chandra Prakash (Agios), Sanjeev Thohan (Novartis), Li- Chun Wang (Takeda), Wei Yin (Biogen) Organizers: Sanjeev Thohan and Chandra Prakash Date: 6/29/2017 Time: 8:30 am – 5.00 pm Location: Boston/Cambridge Area: Marriott Kendall Square, 50 Broadway, Cambridge MA 02142 Fees: $175 - Regular (before June 1st, 2017), $225 - Regular (after June 1st, 2017); $125 - Unemployed & Academic; $2000 - Major Sponsorship; $475 - Vendor Show Registration: www.PBSS.org Workshop Description: An investigational new drug application (IND) is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives, expectations and processes of assembling an IND is a key to not only successful filing, but also a promising clinical development path forward. Often there are cases where too many of our “nice-to-have” studies crowd the package at the expense of critical study needs/issues. This can lead to significant delays in clinical developments with back-and-forth of Q&A sessions both internally and with regulatory agencies. As we have seen, the regulatory landscape is changing as rapidly as the industry innovates into new therapeutic modalities. Therefore, it is critical to keep up to date on regulatory requirements and the industry’s best practices in different aspects of the IND: non- clinical safety, PK, CMC, and clinical plans. In this workshop, our speakers who bring years of experience with multiple successful IND filings, will discuss systematically the preclinical studies required for small molecule IND’s as well as the nuts and bolts of putting together a high–quality IND package. -
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 -
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, -
Healthcare & Life Sciences Group
HEALTHCARE & LIFE SCIENCES GROUP 2 1 Healthcare and life sciences clients have long turned to S&C for help succeeding in today’s rapidly changing business environment. Large and mid-size, public and private, throughout their lifecycles, these companies rely on our multi-disciplinary, global team to address their most complex legal and business challenges and reach their strategic goals. Sector expertise: We offer unrivaled OUR CLIENTS GET… knowledge of the healthcare and life sciences industries, our clients’ businesses and the sector-specific competitive pressures bearing down on them. Sullivan & Cromwell’s Healthcare and Life Sciences Group has negotiated complex transactions and resolved high-stakes disputes for almost three decades. Today, it possesses an unparalleled grasp of these sectors and a practical understanding of the commercial realities underlying them. We position our clients to succeed through it all. The Firm represents international clients in the following healthcare sectors: Pharmaceuticals and Life Sciences Medtech Health Insurers Healthcare Services 2 Legal expertise: Clients come to us An integrated, global team: for the high-quality counsel and hands-on We’re a core group of dedicated healthcare representation we offer across multiple advisers across our 13 offices on four legal specialties, to successfully execute continents with a strong track record of their most important deals and resolve the sector’s most significant transactions critical disputes. We can execute any type and litigation matters, supported by all of transaction in any economic climate or the resources of an integrated, global firm. geographic region. Our experience in this We’re grateful to our clients for trusting sector includes: us with their future, and we’ll continue to help them position themselves for growth M&A and success in this exciting and ever- Corporate finance changing industry. -
Ipo Virtual Annual Meeting Sept
PATENTS | TRADEMARKS | COPYRIGHTS TRADE SECRETS | INDUSTRIAL DESIGNS IPO VIRTUAL ANNUAL MEETING SEPT. 21-24, 2020 IPO.ORG/AM2020 KEYNOTE SPEAKERS 30+ EDUCATION POPPY CRUM SESSIONS PhD, Chief Scientist, Dolby Laboratories ANTÓNIO CAMPINOS President, European Patent Office IP EXPO #IPOAM20 ANDREI IANCU Under Secretary of Commerce for Intellectual Property and Director United States Patent and Trademark Office KASUTANI NETWORKING TOSHIHIDE Commissioner, Japan Patent Office CONNECT ENGAGE LEARN IPO VIRTUAL ANNUAL MEETING | SEPT. 21-24, 2020 TABLE OF CONTENTS ANNUAL MEETING STANDING IP COMMITTEES 4 COMMITTEE BUSINESS MEETINGS 5 PROGRAM AT-A-GLANCE 6 GENERAL SESSIONS 8 WORKSHOPS 11 PATENT SESSIONS 12 TRADEMARK/COPYRIGHT SESSIONS 17 INDUSTRIAL DESIGNS SESSIONS 20 OPERATIONS SESSIONS 21 SPONSORS 22 VIRTUAL IP EXPO 23 NETWORKING 24 REGISTRATION AND MEETING POLICIES 27 REGISTRATION FORM 28 IPO VIRTUAL ANNUAL MEETING | SEPT. 21-24, 2020 ANNUAL MEETING We are looking forward to bringing our members together in a new and innovative way this year for the 2020 Virtual Annual PROGRAM COMMITTEE Meeting on a secure and engaging virtual platform. The IPO Annual Meeting offers a mix of educational programs LEADERSHIP: featuring leaders in the IP industry, committee meetings, networking opportunities, exhibits, and more. This must-attend CHAIR: event brings together IP professionals from around the world Steve Caltrider, Eli Lilly and Co. to discuss strategies, trends, and best practices. More than VICE CHAIR FOR PATENTS: 30 education sessions will be offered on patents, trademarks, Scott Barker, Micron Technology, Inc. copyrights, industrial designs, and – new this year – operations. In addition to the sessions planned by IPO’s Program VICE CHAIR FOR TRADEMARKS: Committee, several sessions are being organized by IPO’s Colette Durst, 3M Innovative Properties Co. -
The Year of Investment, Innovation and Implementation
2017 the year of investment, innovation and implementation 2017 annual report healthcare businesswomen’s association table of contents LETTER FROM CHAIR 1 INVESTMENT 2017 BY THE NUMBERS 2 MEMBERSHIP 2 CHAPTER BREAKDOWN 2 40 YEARS OF MILESTONES 2 MEMBER/VOLUNTEER SURVEY RESULTS 3 FINANCIALS 4 INNOVATION AND IMPLEMENTATION 2017 FLAGSHIP EVENTS 7 WOMAN OF THE YEAR 8 LUMINARIES 10 RISING STARS 11 ANNUAL CONFERENCE 13 ACE AWARDS 14 THE GENDER PARITY COLLABORATIVE CLICK HERE HBA “NOW” THE NEW OPERATING MODEL CLICK HERE IN APPRECIATION—WE COULDN’T DO IT WITHOUT YOU 2017 CORPORATE PARTNERS 15 2017 SPONSORS 16 2017 MEDIA PARTNERS 17 HBA ADVISORY BOARD 18 HBA BOARD OF DIRECTORS 19 LETTER FROM CEO LAURIE COOKE 20 HBA 2017 II annual report letter from the chair In my long career as a healthcare executive, I have seen firsthand the benefits of diversity in leadership time and again. From gender to ethnicity to age and other factors, the best engagement and the most powerful results always arise when there is a diversity of perspectives in the room. This is why I joined the HBA board. This year marks the 40th anniversary of the organization’s founding. And though I am a relatively new member, I quickly became a believer in the HBA’s rich history and deep commitment to both the advancement of women individually, and to the achievement of gender parity in healthcare overall. This is also why I am proud of the HBA’s aggressive—but achievable—strategic plan to move the needle on gender parity through partnership by 2020. -
ANNUAL and SUSTAINABILITY REPORT 2017 Forward-Looking Statements This Report Includes Forward-Looking State- Ments
Building on our strengths Building ANNUAL AND SUSTAINABILITY REPORT 2017 Forward-looking statements This report includes forward-looking state- ments. Actual results may differ from those stated. Internal factors such as the successful management of research programmes and intellectual property rights may affect future results. There are also external conditions such as the economic climate, political changes and competing research programmes that may affect Sobi’s results. Sobi™ is an international biotechnology company dedicated to rare diseases. Our mission is to transform the lives of people with rare diseases by providing inno vative therapies in our focus areas.” Guido Oelkers, CEO CONTENTS Contents This is Sobi .......................................................................4 The year in brief ..........................................................6 INTERVIEW Interview with the CEO and Chairman ......................8 CEO and Chairman Strategy .....................................................................10 8 Sobi operates throughout the entire value chain, from early research, over to clinical development and into the commercial market. Business areas ...............................................................16 “We can add significant value to our partnerships by leveraging all Haemophilia ..............................................................16 our com petencies, making us the partner of choice for a range of Specialty Care ...........................................................22 companies -
Bristol Myers
United States Court of Appeals for the Federal Circuit ______________________ BRISTOL-MYERS SQUIBB COMPANY, Plaintiff-Appellant, v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellee. ______________________ 2013-1306 ______________________ Appeal from the United States District Court for the District of Delaware in No. 10-CV-0805, Magistrate Judge Christopher J. Burke. ______________________ Decided: June 12, 2014 ______________________ WILLIAM F. LEE, Wilmer Cutler Pickering Hale and Dorr LLP, of Boston, Massachusetts, argued for plaintiff- appellant. With him on the brief were LAUREN B. FLETCHER and ANDREW J. DANFORD; AMY K. WIGMORE and THOMAS G. SAUNDERS, of Washington, DC. Of counsel on the brief were PAUL BERGHOFF, ALISON J. BALDWIN, and JOSHUA R. RICH, McDonnell Boehnen Hulbert & Berghoff LLP, of Chicago, Illinois. GEORGE C. LOMBARDI, Winston & Strawn LLP, of Chi- cago, Illinois, argued for defendant-appellee. With him on the brief were LYNN MACDONALD ULRICH, IVAN M. 2 BRISTOL-MYERS SQUIBB COMPANY v. TEVA PHARMACEUTICALS USA, INC. POULLAOS, JULIA MANO JOHNSON, and WILLIAM P. FERRANTI. ______________________ ∗ Before PROST, Chief Judge, PLAGER and CHEN, Circuit Judges. CHEN, Circuit Judge. This patent infringement case concerns a drug for the treatment of hepatitis B. After a four-day bench trial, the United States District Court for the District of Delaware found claim 8 of U.S. Patent No. 5,206,244 (’244 patent) invalid as obvious. We affirm the district court’s invalidi- ty judgment for the reasons that follow. I. Appellant Bristol-Myers Squibb Co. (BMS) owns the ’244 patent. Claim 8 of the ’244 patent is directed to a nucleoside analog composed of two regions: a carbocyclic ring and a guanine base. -
Stamford Therapeutics Consortium Consortiapedia.Fastercures.Org
Stamford Therapeutics Consortium consortiapedia.fastercures.org Stamford Therapeutics Consortium consortiapedia.fastercures.org/consortia/stamford-therapeutics-consortium/ Research Areas At a Glance Status: Active Consortium Tool Development Year Launched: 1994 Clinical Trial Initiating Organization: Dr. Paul Dalgin Data-Sharing Enabler Initiator Type: Industry Location: North America DevelopmentProduct Drugs Abstract Stamford Therapeutics Consortium (STC) is a privately owned and operated clinical research site specializing in phase II, III, and IV clinical trials for the pharmaceutical and biotechnology industries. STC has a strong working relationship with a cardiology group, a large multispecialty medical practice, and a team of physicians who serve as sub-investigators for many of its clinical trials. STC maintains a significant presence in research for the treatment of osteoarthritis and rheumatoid arthritis, while continuing to expand its research into new therapeutic areas. Year after year STC's list of specialties grows to accommodate a growing demand and new innovations in healthcare. With over 15 years of clinical trials operations, STC has conducted more than 350 national and multi-national clinical trials. Mission The company’s sole mission is to conduct the highest quality clinical trials so that new, safe, and effective medications can be developed, researched, and approved for a variety of indications and diseases. Stamford Therapeutics Consortium - consortiapedia.fastercures.org Page 1/4 Stamford Therapeutics Consortium consortiapedia.fastercures.org Consortium History The site was launched in 1994 and has contributed to clinical trials research ever since. Structure & Governance The consortium is governed by their president, medical director, founder, and clinical research coordinators. Patent Engagement STC actively recruits patients from all over Fairfield County, CT and Westchester County, NY. -
Bristol-Myers Squibb Company [email protected]
UNITED STATES SECURITIES A ND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 DIVISION OF CORPORATION FINANCE March 1, 2019 Lisa A. Atkins Bristol-Myers Squibb Company [email protected] Re: Bristol-Myers Squibb Company Incoming letter dated December 21, 2018 Dear Ms. Atkins: This letter is in response to your correspondence dated December 21, 2018 concerning the shareholder proposal (the “Proposal”) submitted to Bristol-Myers Squibb Company (the “Company”) by People for the Ethical Treatment of Animals (the “Proponent”) for inclusion in the Company’s proxy materials for its upcoming annual meeting of security holders. We also have received correspondence from the Proponent dated January 3, 2019. Copies of all of the correspondence on which this response is based will be made available on our website at http://www.sec.gov/divisions/corpfin/ cf-noaction/14a-8.shtml. For your reference, a brief discussion of the Division’s informal procedures regarding shareholder proposals is also available at the same website address. Sincerely, M. Hughes Bates Special Counsel Enclosure cc: Jared Goodman PETA Foundation [email protected] March 1, 2019 Response of the Office of Chief Counsel Division of Corporation Finance Re: Bristol-Myers Squibb Company Incoming letter dated December 21, 2018 The Proposal asks the board to implement a policy that it will not fund, conduct or commission use of the “Forced Swim Test.” There appears to be some basis for your view that the Company may exclude the Proposal under rule 14a-8(i)(7), as relating to the Company’s ordinary business operations. In our view, the Proposal micromanages the Company by seeking to impose specific methods for implementing complex policies. -
Guidelines with Regard to the Composition, Calculation and Management of the Index
INDEX METHODOLOGY Solactive Pharma Breakthrough Value Index Version 2.1 dated September 03, 2020 Contents Important Information 1. Index specifications 1.1 Short Name and ISIN 1.2 Initial Value 1.3 Distribution 1.4 Prices and Calculation Frequency 1.5 Weighting 1.6 Index Committee 1.7 Publication 1.8 Historical Data 1.9 Licensing 2. Composition of the Index 2.1 Selection of the Index Components 2.2 Ordinary Adjustment 2.3 Extraordinary Adjustment 3. Calculation of the Index 3.1 Index Formula 3.2 Accuracy 3.3 Adjustments 3.4 Dividends and other Distributions 3.5 Corporate Actions 3.6 Correction Policy 3.7 Market Disruption 3.8 Consequences of an Extraordinary Event 4. Definitions 5. Appendix 5.1 Contact Details 5.2 Calculation of the Index – Change in Calculation Method 2 Important Information This document (“Index Methodology Document”) contains the underlying principles and regulations regarding the structure and the operating of the Solactive Pharma Breakthrough Value Index. Solactive AG shall make every effort to implement regulations. Solactive AG does not offer any explicit or tacit guarantee or assurance, neither pertaining to the results from the use of the Index nor the Index value at any certain point in time nor in any other respect. The Index is merely calculated and published by Solactive AG and it strives to the best of its ability to ensure the correctness of the calculation. There is no obligation for Solactive AG – irrespective of possible obligations to issuers – to advise third parties, including investors and/or financial intermediaries, of any errors in the Index.