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The Drug Repurposing Ecosystem: Intellectual Property Incentives
Halabi: The Drug Repurposing Ecosystem: Intellectual Property Incentives, The Drug Repurposing Ecosystem: Intellectual Property Incentives, Market Exclusivity, and the Future of "New" Medicines Sam F. Halabil 20 YALE J. L. & TECH. 1 (2018) The pharmaceutical industry is in a state of fundamental transition.New drug approvals have slowed, patents on blockbuster drugs are expiring, and costs associated with developing new drugs are escalating and yielding fewer viable drug candidates. As a result, pharmaceutical firms have turned to a number of alternative strategies for growth. One of these strategies is "drug rep urposing"-findingnew ways to deploy approved drugs or abandoned clinical candidates in new disease areas. Despite the efficiency advantages of repurposing drugs, there is broad agreement that there is insufficient repurposing activity because of numerous intellectual property protection and market failures. This Article examines the system that surrounds drug repurposing, including serendipitous discovery, the application of "big data" methods to prioritize promising repurposing candidates, the unorthodoxly regulated off-label prescription practices of providers, and related prohibitions on pharmaceutical firms' off-label marketing. The Article argues that there is a complex ecosystem in place and that additional or disruptive IP Fulbright Canada Research Chair in Health Law, Policy, and Ethics, University of Ottawa and Associate Professor, University of Missouri School of Law.; J.D. Harvard; M.Phil. The University of Oxford (St. Antony's College); B.A., B.S. Kansas State University. The author is grateful for comments and helpful suggestions given at faculty workshops at Arizona State University's Sandra Day O'Connor School of Law, Boston University's biolP Faculty Workshop, and Seton Hall University School of Law, as well as the American Society of Law, Medicine, and Ethics' Annual Health Law Professors Conference. -
WO 2016/106159 Al 30 June 2016 (30.06.2016) W P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2016/106159 Al 30 June 2016 (30.06.2016) W P O P C T (51) International Patent Classification: (74) Agents: BALICKY, Eric, M. et al; Hamilton, Brook, C07K 16/28 (2006.01) Smith & Reynolds, P.C., 530 Virginia Rd, P.O. Box 9133, Concord, MA 01742-9133 (US). (21) International Application Number: PCT/US20 15/066954 (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (22) Date: International Filing AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, 19 December 2015 (19. 12.2015) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, (25) Filing Language: English DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (26) Publication Language: English KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (30) Priority Data: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, 62/095,675 22 December 2014 (22. 12.2014) US PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 62/220,199 17 September 2015 (17.09.2015) US SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 62/25 1,082 4 November 2015 (04. 11.2015) US TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. -
Vallenar Bay Article – Ketchikan Daily News
Mariners get 1st win Mom organizes Houghtaling safety • Seattle takes it to Texas, committee, See page 7 Page 16 48 º/39 º Weather, page 3 $K1.00 ETCHIKAN WEDNESDAY, APRIL 6, 2016 T WDITTER.COAM/KDNI NEWLS Y N WWW.KEETCHIWKANDAILYNSEWS.COM 16 PAGES Gravina Prince of Wales tells whale tales Local pot road plan panel out to bid returning By MATT ARMSTRONG Daily News Staff Writer By NICK BOWMAN The State of Alaska put a Gravina Is - Daily News Staff Writer land road project out to bid on Thurs - A clash between state marijuana day. law and federal control of air and The state’s Department of Natural water transportation is resurrecting Resources issued an invitation to bid Ketchikan’s Marijuana Advisory Com - on construction of new roads and re - mittee. construction of existing roads as part of The committee of local leaders from the Division of Forestry’s proposed Val - the Ketchikan Gateway Borough As - lenar Bay Timber Sale. sembly, Ketchikan and Saxman city The bid is “for the construction of 8.4 councils and the Ketchikan School miles of linear graded road and associ - Board guided marijuana policy on the ated drainage structures, supply and in - island in 2015, but has been dormant stall of culverts and modular bridges as for months after approving a set of necessary, reconstruction of approxi - final recommendations. mately 1.1 miles of existing forest road However, the committee will meet and associated drainage structures.” again to discuss whether local policy According to the bid invitation, the should change as a result of federal state-funded road project has an esti - control of air and water travel. -
(12) Patent Application Publication (10) Pub. No.: US 2016/0319019 A1 Amirina Et Al
US 201603.19019A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0319019 A1 Amirina et al. (43) Pub. Date: Nov. 3, 2016 (54) ANTI-PD-1 ANTIBODIES (22) Filed: May 11, 2016 (71) Applicant: Enumeral Biomedical Holdings, Inc., Related U.S. Application Data Cambridge, MA (US) (62) Division of application No. 14/975,769, filed on Dec. 19, 2015. (72) Inventors: Najmia Amirina, Cambridge, MA (60) Provisional application No. 62/095.675, filed on Dec. (US); Hareesh Chamarthi, Allston, 22, 2014, provisional application No. 62/220,199, MA (US); Maria Isabel Chiu, Newton filed on Sep. 17, 2015, provisional application No. Centre, MA (US); Daniel Doty, 62/251,082, filed on Nov. 4, 2015, provisional appli Arlington, MA (US); Bin Feng, cation No. 62/261,118, filed on Nov. 30, 2015. Newton, MA (US); Aleksander Jonca, Publication Classification Boston, MA (US); Thomas McQuade, Cambridge, MA (US); Anhco Nguyen, (51) Int. Cl. Needham, MA (US); Sheila C07K 6/28 (2006.01) Ranganath, Arlington, MA (US); Hans (52) U.S. Cl. Albert Felix Scheuplein, Arlington, CPC ..... C07K 16/2803 (2013.01); C07K 231 7/567 MA (US); Vikki A. Spaulding, Acton, (2013.01); C07K 23.17/34 (2013.01); A61 K MA (US); Lei Wang, Braintree, MA 2039/507 (2013.01) (US); Jennifer Watkins-Yoon, Brighton, MA (US) (57) ABSTRACT Antibodies that bind to programmed cell death protein 1 (PD-1), compositions comprising Such antibodies, and (21) Appl. No.:y x- - - 15/152,1929 methods of making and using Such antibodies are disclosed. Patent Application Publication Nov. 3, 2016 Sheet 3 of 27 US 2016/0319019 A1 s's is 5 w c. -
Classnotes: Fall 2019 Written by Kmerusi
DREW CLASSNOTES The College of Liberal Arts Ronald Vander Schaaf C’56, T’59 One of the most fit men in our class has September I went to Sloss Furnace, a defunct 56 [email protected] got to be Roy Haynes. He entered a 5K race steel mill, to see the dedication of a plaque Prunella (Read) Williams, Harold in Wooster, Ohio, and finished it! He finished that honors two men, Tom Redmond and “Hal” Quigley and Barbara (Young) Quigley third of the six men who were in the age-70- Jake McKenzie, who were lynched on Sloss visited Flora (Robinson) Hullstrung in and-over group. For that he received a $10 property in 1890 and 1897. In a “small August this past summer. All are doing well. gift certificate. Ruth (Schubert) Haynes world” moment, the man next to me and The late Bob Hullstrung’s cousin Garrett didn’t enter the race, but she is enjoying the I began the normal kind of conversation visited Flora for four days as well. Garrett new storage areas added to their kitchen. between two strangers. When it got around lives on Maui, Hawaii. Lynn (Swader) Monk Mary (Henck) Sharp modestly reported to children, he mentioned that his daughter Fedor is planning to move to a smaller that she and Richard have visited all 50 went to a small college in New Jersey. It facility. In the process of getting ready for states and seven continents. In August, they turned out to be Drew! And she was there! the move, she discovered her file of past went on a two-week truck tour of Russia. -
Developing a Novel Concept Regenerative Treatment for DPN: Engensis (VM202) Phase 3 Results and Future Plans
Developing a Novel Concept Regenerative Treatment for DPN: Engensis (VM202) Phase 3 Results and Future Plans Seung Shin Yu Disclosure Disclaimer This presentation has been prepared by Helixmith Co., Ltd. (“Company”) solely for your information and for your use and may not be taken away, distributed, reproduced, or redistributed or passed on, directly or indirectly, to any other person (whether within or outside your organization or firm) or published in whole or in part, for any purpose by recipients directly or indirectly to any other person. By accessing this presentation, you are agreeing to be bound by the trailing restrictions and to maintain absolute confidentiality regarding the information disclosed in these materials. Forward-Looking Statements This presentation may contain statements that constitute forward-looking statements. Forward-looking statements can generally by identified by the use of language such as “may”, “will”, “expect”, “estimate”, “anticipate”, “plan”, “intend”, “believe”, “potential”, “anticipate” and “continue” or the negative thereof or similar variations. These forward-looking statements are based on the current beliefs, expectations and assumptions of the Company’s management about the Company’s business, planned acquisitions, future plans, anticipated events and other future conditions. In addition, the forward- looking statements are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and result of clinical trials; difficulties or delays of regulatory filings and approvals; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development, and commercialization activities, and others, all of which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. -
( 12 ) United States Patent
US010738128B2 (12 ) United States Patent ( 10 ) Patent No.: US 10,738,128 B2 Chappel et al. (45 ) Date of Patent : Aug. 11, 2020 ( 54 ) ANTIBODIES THAT BIND CD39 AND USES 5,571,698 A 11/1996 Ladner et al . THEREOF 5,580,717 A 12/1996 Dower et al . 5,624,821 A 4/1997 Winter et al . 5,648,260 A 7/1997 Winter et al. (71 ) Applicant: Surface Oncology , Inc., Cambridge, 5,658,727 A 8/1997 Barbas et al . MA (US ) 5,698,426 A 12/1997 Huse 5,733,743 A 3/1998 Johnson et al. (72 ) Inventors : Scott Chappel, Milton , MA (US ) ; 5,750,753 A 5/1998 Kimae et al. 5,780,225 A 7/1998 Wigler et al. Andrew Lake , Westwood , MA (US ) ; 5,821,047 A 10/1998 Garrard et al . Michael Warren , North Chelmsford , 5,858,358 A 1/1999 June et al. MA (US ) ; Austin Dulak , Reading , MA 5,883,223 A 3/1999 Gray (US ) ; Erik Devereaux, Hanover , MA 5,969,108 A 10/1999 McCafferty et al. (US ) ; Pamela M. Holland , Belmont, 6,001,329 A 12/1999 Buchsbaum et al. 6,005,079 A 12/1999 Casterman et al . MA (US ) ; Tauqeer Zaidi, Sharon , MA 6,194,551 B1 2/2001 Idusogie et al . (US ) ; Matthew Rausch , Cambridge , 6,300,064 B1 10/2001 Knappik et al . MA (US ) ; Bianka Prinz , Lebanon , NH 6,352,694 B1 3/2002 June et al . ( US ) ; Nels P. Nielson , Lebanon , NH 6,534,055 B1 3/2003 June et al . -
Analytics for Accelerating Biomedical Innovation Kien Wei Siah
Analytics for Accelerating Biomedical Innovation by Kien Wei Siah B.Eng., National University of Singapore (2015) S.M., Massachusetts Institute of Technology (2017) Submitted to the Department of Electrical Engineering and Computer Science in partial fulfillment of the requirements for the degree of Doctor of Philosophy in Electrical Engineering and Computer Science at the MASSACHUSETTS INSTITUTE OF TECHNOLOGY February 2021 ○c Massachusetts Institute of Technology 2021. All rights reserved. Author.............................................................. Department of Electrical Engineering and Computer Science December 17, 2020 Certified by. Andrew W. Lo Charles E. and Susan T. Harris Professor, Sloan School of Management Thesis Supervisor Accepted by . Leslie A. Kolodziejski Professor of Electrical Engineering and Computer Science Chair, Department Committee on Graduate Students 2 Analytics for Accelerating Biomedical Innovation by Kien Wei Siah Submitted to the Department of Electrical Engineering and Computer Science on December 17, 2020, in partial fulfillment of the requirements for the degree of Doctor of Philosophy in Electrical Engineering and Computer Science Abstract Despite the many breakthroughs in biomedical research and the increasing demand for new drugs to treat unmet medical needs, the productivity of research and development in the pharmaceutical industry has been steadily declining for the past two decades and is at its lowest level today. Traditional sources of financing in biopharma are no longer compatible nor aligned with the new realities of biomedical innovation, a process which has become more challenging, complex, expensive, time-consuming, and risky in the past twenty years. This has led to an outflow of capital from the biopharma industry, creating an ever-widening gap in funding between early-stage basic biomedical research and late-stage clinical development, where many promising academic discoveries fail not because of bad science but due to financial reasons. -
Small-Cap Research [email protected]
November 11, 2015 Grant Zeng, CFA 312-265-9466 Small-Cap Research [email protected] scr.zacks.com 10 S. Riverside Plaza, Chicago, IL 60606 Enumeral Biomedical Holdings, Inc. (ENUM-OTC) OUTLOOK ENUM: Phase I study planned in 2016 for PD-1 program, Great progress has been Enumeral has identified multiple PD-1 antibodies that that appear to bind to the PD-1 inhibitory checkpoint made in pipeline advancement----Buy protein in a manner different from that of currently marketed anti-PD-1 antibodies. The company plans to initiate Phase I study with its PD-1 program. Current Recommendation Buy Prior Recommendation N/A Enumeral recently signed an agreement with Merck. The Date of Last Change 09/29/2014 collaboration includes use of Enumeral's human approach to interrogating the tumor microenvironment in colorectal Current Price (11/11/15) $0.24 cancer tissues obtained directly from patients in order to identify functional cellular responses to immuno-oncology $2.00 Target Price therapies being developed by Merck. We believe the shares are attractively valued. SUMMARY DATA 52-Week High $1.25 Risk Level High 52-Week Low $0.27 Type of Stock Small-Cap Growth One-Year Return (%) -73.00 Industry Med-Drugs Beta -0.29 Average Daily Volume (sh) 41,320 ZACKS ESTIMATES Shares Outstanding (mil) 52 Market Capitalization ($mil) $14 Revenue (in millions of $) Short Interest Ratio (days) N/A Q1 Q2 Q3 Q4 Year Institutional Ownership (%) N/A Insider Ownership (%) N/A (Mar) (Jun) (Sep) (Dec) (Dec) 2014 $0.05 A $0.00 A $0.07 A $0.04 A $0.16 A Annual Cash Dividend $0.00 2015 $0.27 A $0.38 A $0.48 A $0.49 E $1.63 E Dividend Yield (%) 0.00 2016 $1.50 E 2017 $5.00 E 5-Yr. -
Immuno-Oncology
IT SAR* Targeted with a mAb Alternatively spliced extradomain-B of fibronectin Philogen (Fibromun/L19-TNF) •• TNFα *Soft Tissue Sarcoma Clinical stage codes M MEL Toxic to tumor neovasculature and activates the endothelium; highly toxic if used systemically Preclinical/Discovery OTC Over-the-Counter Not targeted with a mAb Boehringer Ingelheim (Beromun; isolated limb perfusion) M SAR • Phase 1 NDA New Drug Application Beromun Limited to use in isolated limb perfusion •• Phase 2 BLA Biologics License Application ••• Phase 3 MAA Marketing Authorization Application (Europe's NDA) Long-acting SC Merck (Sylatron/peginterferon α-2b) M MEL Class has M Marketed D Dormant/discontinued Less frequent injections Ñ february 2017 known G Generic Failed survival IB FKD Therapies Oy (Instiladrin/rAdIFN w/ Syn3) •• UCC RCT Randomized Controlled Trial CP Compounding Pharmacy benefit Interferon-α (IFNα) Genetically modified non-replicating virus to the tumor Adenovirus expressing IFNα2b IST Investigator-Sponsored Trial PD(L)1 immuno-oncology 21 22 M NHL PDUFA PDUFA POC: Unknown • Enhances T-cell and DC response via a poorly-characterized MoA M MEL • Associated with dose-limiting AEs, including influenza-like symptoms (fatigue, fever, headache and muscle SC/IM/IC Merck (Intron-A/interferon α-2b) M CLL ANDA Abbreviated New Drug Application POC: Validated aches), nausea, dizziness, anorexia, depression and leukopenia Merck (SC Intron-A/interferon α-2b + IV Keytruda/pembrolizumab) MEL FAILED OL Off-label POC: Failed IFNα2b Roche (IV Tecentriq/atezolizumab -
Steve Brozak Interview with the Life Sciences Report 5-27-15
As Cancer Immunotherapy Turns 125, WBB Securities' Steve Brozak Ponders What Investors Can Expect from Biotech Next The Life Sciences Report www.TheLifeSciencesReport.com 05/27/2015 Steve Brozak sees a bubble getting larger, and he is anticipating the time COMPANIES MENTIONED when biotech stocks pull back to take a breather, like all high-flying markets Bellicum Pharmaceuticals Inc. ultimately do. While investors may own innovative companies with highly bluebird bio Inc. disruptive technologies, Brozak insists on careful diligence to find names with the potential for explosive growth and avoid the disappearing acts. In this Celldex Therapeutics Inc. interview with The Life Sciences Report, Brozak, president and managing Juno Therapeutics partner at WBB Securities, showcases six names with strong Kite Pharma immunotherapeutic platforms that he believes have extraordinary potential to Navidea Biopharmaceuticals Inc. reward investors many times over. Source: George S. Mack of The Life Sciences Report The Life Sciences Report: Steve, I know that you believe we're in a biotech Streetwise Reports LLC bubble right now. The NYSE.Arca Biotechnology Index (BTK) is up 33% over the 101 Second St., Suite 110 past year, and 132% over the past two years. The NASDAQ Biotechnology Index Petaluma, CA 94952 (NBI) is up 57% and 99% during those corresponding periods. Biotech has Tel.: (707) 981-8107 performed quite well. Why do you think we're headed for trouble? Fax: (707) 981-8998 [email protected] Steve Brozak: The problem I have with looking at these new therapeutic modalities as investments is that they don't lend themselves to general biotech stock and index THE ENERGY REPORT buying. -
Financial Times and Thomson Reuters Name Steve Brozak As a 2013 Starmine "Top Stock Picker"
Financial Times and Thomson Reuters name Steve Brozak as a 2013 StarMine "Top Stock Picker" WBB's Steve Brozak named "Top Stock Picker" in Pharmaceuticals For Immediate Release August 22, 2013 SAN DIEGO, CA – The Financial Times and Thomson Reuters have named Steve Brozak, president of WBB Securities as a 2013 StarMine "top stock picker" among Pharmaceutical Analysts. With this award, Brozak has achieved top-ranking recognition in all healthcare fields including Biotechnology, Medical Devices, and Pharmaceuticals over the last four years by the Thomson Reuters Awards for Excellence or The Wall Street Journal Best on the Street Survey. Each year, the StarMine Analyst Awards recognize analysts who have shown exemplary performance either as stock pickers or as earnings estimators during the prior year. The 2013 stock picking awards for the United States are based on the 2012 calendar-year performance of recommendations. Only analyst performance on companies that are based in the United States are included in the awards calculations. WBB Securities is often quoted in news media and has contributed opinion articles on a wide range of healthcare and economic issues. Steve Brozak is a guest contributor to Forbes.com, ABCNews.com and Bloomberg.com, frequently publishing opinion articles in those publications. About WBB Securities WBB Securities is a leading investment management, investment banking, and equity research firm. Established in 2001 and headquartered in San Diego, California, WBB Securities is a registered independent broker dealer and investment advisor with proprietary trading desks that have market-making capabilities. WBB Securities has built a nationwide team of respected senior investment and research professionals with a network of branches throughout the US serving institutional and high net worth clients.