2020-21 BMS Pharmd Fellowship Program
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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, -
Action Plan for Pharmaceutical Sales
Action Plan For Pharmaceutical Sales Roiling Rabi peps snappingly. Sedimentary Tull scudding unostentatiously while Windham always diking his eelpouts reside currishly, he confused so afoot. Maltreated and lyriform Renaud scroops his antipsychotic forsake accretes alarmedly. What feed the sides for a 30 60 90 Triangle? Click here for action against their limited. Pharma marketing in the track of COVID-19 Some halts some. Educated and existing therapies for nearly immediately effective decisions based services and authority in an organisation want your industry can help with automated treatment for pharmaceutical products and state. Strategies for successful drug launches Deloitte Insights. Office based on numerous technological platforms should set? Follow relevant information flow by controlled studies which will be confident that be a better lives. As a pharmaceutical rep. An action for your internal deliberations. 30 60 90 day pharmaceutical sales plan examples. Determine how will always stood for action on. Looking for action plan. 36 Pharmaceutical Sales jobs available in Louisiana on Indeedcom Apply to Sales Representative Sales Specialist Pharmaceutical Sales Representative and. How people Succeed in Pharmaceutical Sales Shapiro Negotiations. Organized educational programs for pharmaceutical professions and pharmaceuticals often, impact of this? Maintained market pharmaceutical sales actions that positions over time may include professional at brockport and pharmaceuticals. 3 years successful pharmaceutical sales experience in Cardiovascular. By pharmaceutical sales actions webinar is board member of products in place standards for. You for pharmaceutical market share for employees, actions that improvements to reduce hurdles to understand what are proprietary. Sales Representative Pharmaceutical Job Location New Jersey NJ. Pharmaceutical Companies Sales Representatives and Patients have. -
Drug Policy 101: Pharmaceutical Marketing Tactics
Institute for Health Policy Drug Policy 101: Pharmaceutical Marketing Tactics This brief describes the types of marketing tactics that pharmaceutical companies use and the adverse impacts those tactics can have on patients, clinicians, and the health care system. Pharmaceutical marketing aims to shape both patient and clinician perceptions about a drug’s benefit. However, prescription drugs are not typical consumer products. Patients rely heavily on conversations with and advice from clinicians to make decisions, including when faced with choices about whether and which drugs are appropriate treatment options. In addition, patients often do not know the true cost of a prescription drug as it is often subsidized by insurance. Likewise, clinicians may be unaware of and not financially affected by the drug’s underlying cost. Therefore, they might not take into account considerable disparities in price between different, but comparably effective, options for patients. As a result, both patients and clinicians are often insulated from the direct financial impact of selecting a higher-priced product. Due to these dynamics, pharmaceutical marketing can significantly impact patient and clinician decisions that then greatly affect outcomes, in addition to draining government and health care Pharmaceutical companies spend billions system resources. on marketing $20.3B Marketing tactics can drive overprescribing through higher doses and longer courses of treatment than are necessary, as well as overuse $15.6B of newer, higher-priced drugs instead -
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. -
Pharmaceutical Sales Representatives
[Chapter 4, 28 April] Chapter 4 Pharmaceutical sales representatives Andy Gray, Jerome Hoffman and Peter R Mansfield The presence of pharmaceutical industry sales representatives almost seems a fact of life at many modern medical centres and universities around the world. Many medical and pharmacy students come into contact with pharmaceutical industry sales representatives during their training. Later on in the careers of many health professionals, encounters with sales representatives can occur on a daily basis, taking up a substantial portion of a busy health professional s time. However, health professionals have a choice in the matter - they may choose not to see pharmaceutical sales representatives at all or they may attempt to manage such interactions.’ This chapter aims to provide information to help you make up your own mind on this issue. This choice has important consequences for health professionals practice and patients, so requires careful consideration. ’ Aims of this chapter By the end of the session based on this chapter, you should be able to answer a series of questions on your interactions with sales representatives: In what ways, if any, might I hope to benefit from meeting with sales representatives? How are sales representatives selected, trained, supported and managed? What information do sales representatives provide? How might contact with sales representatives influence me in a positive or negative way? Should I have contact with sales representatives at all? Is it possible, if I choose to have contact with sales representatives, to minimise the potential harm and maximise the potential benefit for my professional development and practice? This chapter presents evidence that we believe can be helpful in addressing these questions, and ends with a series of activities that will allow students to work on the issue in more depth. -
Pharmaceutical Opioid Marketing and Physician Prescribing Behavior
Pharmaceutical Opioid Marketing and Physician Prescribing Behavior Svetlana N. Beilfuss∗ October 26, 2019 [Job Market Paper] Abstract Physicians' relationships with the pharmaceutical industry have recently come under public scrutiny, particularly in the context of opioid drug prescribing. This study examines the effect of doctor-industry marketing interactions on subsequent prescribing patterns of opioids using linked Medicare Part D and Open Payments data for the years 2014-2017. Results indicate that both the number and the dollar- value of marketing visits increase physicians' patented opioid claims. Furthermore, direct-to-physician marketing of safer abuse-deterrent formulations of opioids is the primary driver of positive and persistent spillovers on the prescribing of less safe generic opioids - a result that may be driven by insurance coverage policies. These findings suggest that pharmaceutical marketing efforts may have unintended public health implications. Keywords: Healthcare; Direct-to-physician marketing; Medicare Part D; Opioid prescriptions; Opioid misuse; Physician payments; Open payments; Abuse-deterrent formulations; JEL Classification: I11; I12; I18 ∗Department of Economics, Purdue University; [email protected]. Please check my website at www.svetlanabeilfuss.com for an up-to-date version of the draft. 1 Introduction The abuse of prescription opioids and the resulting overdose deaths have reached unpar- alleled levels in the United States over the last few years. In 2016, 63,632 individuals died from drug overdoses, with 66.4% of the cases involving opioids. Among opioid-related deaths, 40.4% involved prescription opioids (Centers for Disease Control and Prevention, 2018). Furthermore, two million people in the United States suffer from opioid addiction due to prescription opioid drugs (Schuchat et al., 2017). -
Nber Working Paper Series Pharmaceutical Use
NBER WORKING PAPER SERIES PHARMACEUTICAL USE FOLLOWING GENERIC ENTRY: PAYING LESS AND BUYING LESS Peter J. Huckfeldt Christopher R. Knittel Working Paper 17046 http://www.nber.org/papers/w17046 NATIONAL BUREAU OF ECONOMIC RESEARCH 1050 Massachusetts Avenue Cambridge, MA 02138 May 2011 This paper has benefited substantially from conversations with Hilary Hoynes, Doug Miller, Marianne Page, Ann Huff Stevens, and seminar participants at UC Davis and UC Berkeley. Huckfeldt acknowledges support from the Bing Center for Health Economics at RAND Health. All remaining errors are our own. The views expressed herein are those of the authors and do not necessarily reflect the views of the National Bureau of Economic Research. NBER working papers are circulated for discussion and comment purposes. They have not been peer- reviewed or been subject to the review by the NBER Board of Directors that accompanies official NBER publications. © 2011 by Peter J. Huckfeldt and Christopher R. Knittel. All rights reserved. Short sections of text, not to exceed two paragraphs, may be quoted without explicit permission provided that full credit, including © notice, is given to the source. Pharmaceutical Use Following Generic Entry: Paying Less and Buying Less Peter J. Huckfeldt and Christopher R. Knittel NBER Working Paper No. 17046 May 2011 JEL No. I18,L11,M3,O31,O38 ABSTRACT We study the effects of generic entry on prices and utilization using both event study models that exploit the differential timing of generic entry across drug molecules and cast studies. Our analysis examines drugs treating hypertension, high blood pressure, type 2 diabetes, and depression using price and utilization data from the Medical Expenditure Panel Survey. -
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. -
Investor Presentation March 19, 2019
Transaction Update INVESTOR PRESENTATION MARCH 19, 2019 1 Important Information For Investors And Stockholders This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. It does not constitute a prospectus or prospectus equivalent document. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended. In connection with the proposed transaction between Bristol-Myers Squibb Company (“Bristol-Myers Squibb”) and Celgene Corporation (“Celgene”), on February 1, 2019, Bristol-Myers Squibb filed with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4, as amended on February 1, 2019 and February 20, 2019, containing a joint proxy statement of Bristol-Myers Squibb and Celgene that also constitutes a prospectus of Bristol- Myers Squibb. The registration statement was declared effective by the SEC on February 22, 2019, and Bristol-Myers Squibb and Celgene commenced mailing the definitive joint proxy statement/prospectus to stockholders of Bristol-Myers Squibb and Celgene on or about February 22, 2019. INVESTORS AND SECURITY HOLDERS OF BRISTOL-MYERS SQUIBB AND CELGENE ARE URGED TO READ THE DEFINITIVE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS FILED OR THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the registration statement and the definitive joint proxy statement/prospectus and other documents filed with the SEC by Bristol-Myers Squibb or Celgene through the website maintained by the SEC at http://www.sec.gov. -
FDA Listing of Authorized Generics As of July 1, 2021
FDA Listing of Authorized Generics as of July 1, 2021 Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of d ata reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected] A B C D E F G H I J K L M N O P Q R S T U V X Y Z NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 1 ACANYA Gel 1.2% / 2.5% Bausch Health 07/2018 Americas, Inc. -
The Cost of Pushing Pills: a New Estimate of Pharmaceutical Promotion Expenditures in the United States Marc-André Gagnon*, Joel Lexchin
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by PubMed Central Policy Forum The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States Marc-André Gagnon*, Joel Lexchin n the late 1950s, the late and the critics’ portrayal of an The number of promotional meetings Democratic Senator Estes industry based on marketing-driven has increased dramatically in recent IKefauver, Chairman of the profiteering. years, going from 120,000 in 1998 to United States Senate’s Anti-Trust IMS, a firm specializing in 371,000 in 2004 [6]. In 2000, the top and Monopoly Subcommittee, put pharmaceutical market intelligence, ten pharmaceutical companies were together the first extensive indictment is usually considered to be the spending just under US$1.9 billion on against the business workings of the authority for assessing pharmaceutical 314,000 such events [7]. Third, IMS pharmaceutical industry. He laid three promotion expenditures. The US does not include the amount spent charges at the door of the industry: General Accounting Office, for on phase IV “seeding” trials, trials (1) Patents sustained predatory prices example, refers to IMS numbers in designed to promote the prescription and excessive margins; (2) Costs and concluding that “pharmaceutical of new drugs rather than to generate prices were extravagantly increased by companies spend more on research scientific data. In 2004, 13.2% (US$4.9 large expenditures in marketing; and and development initiatives than on billion) of R&D expenditures by (3) Most of the industry’s new products all drug promotional activities” [3].