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Genomics’ Proprietary Statistical Analysis Tools and Integrated Multi-Phenotype Database to be used to Support Research and Development at Vertex Pharmaceuticals, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 1: Next Generation Sequencing (NGS)

Genomics’ Proprietary Statistical Analysis Tools and Integrated Multi-Phenotype Database to be used to Support Research and Development at Vertex Pharmaceuticals

Reporter: Aviva Lev-Ari, PhD, RN

 

 

Press release

04 January 2016

Genomics and Vertex Collaborate to Identify Target Therapeutic Pathways

 

Genomics’ Proprietary Statistical Analysis Tools and Integrated Multi-Phenotype Database to be used to Support Research and Development at Vertex Pharmaceuticals

 

Oxford, UK, 04 January 2016: Genomics plc (“Genomics”), a leading analysis company developing algorithms, data resources, and software solutions to uncover the relationships between genetic variation and human disease, today announced that Vertex Pharmaceuticals will use Genomics’ integrated database and state-of-the-art analysis tools to inform its drug research and development.  These tools aim to provide confidence in the rationale for targeting Vertex’s pathways of interest for the treatment of certain diseases and to identify potential safety concerns and repositioning opportunities.

 

Genomics has developed a unique analytical platform for genome analysis and interpretation. The platform combines proprietary algorithms and software with the Company’s integrated genome-phenome database and analytical expertise to learn about human biology.  Genomics has several existing partnerships with large pharmaceutical companies, and in clinical genomics is a Platform Partner for Genomics England, the company undertaking the 100,000 Genomes Project in the UK.

 

John Colenutt, CEO, Genomics plc, said: “Pharmaceutical and biotech companies are increasingly using human genetic data in research to increase the chance of success in drug development.  We are excited that Vertex has chosen to use Genomics’ proprietary technology, integrated database and tools to support them in this aim.”

 

Paul de Bakker, Ph.D., Head of Computational Genomics for Vertex said: “Vertex is focused on advancing research programs where disease mechanisms are validated by human biology.  Our collaboration with Genomics is aimed at obtaining insights into the genetic underpinnings of specific targets and diseases to help predict which potential medicines may have success moving from discovery research toward patients.”

 

ENDS

 

Photo: John Colenutt, CEO, Genomics plc. For a high resolution image please contact lorna.cuddon@zymecommunications.com

 

For further information please contact:

 

Zyme Communications

Lorna Cuddon

Tel: +44 (0)7811996942

Email: lorna.cuddon@zymecommunications.com

 

About Genomics plc http://www.genomicsplc.com/

Genomics was founded by four leading Oxford academics, including Professor Peter Donnelly, Director of The Wellcome Trust Centre for Human Genetics, and Professor Gil McVean, Director of The Big Data Institute. The Company has developed a unique platform for genomic sequence data analysis and interpretation which combines world-leading expertise in statistical analysis and data mining with a unique integrated database linking genotypes and phenotypes. Genomics England, the company running the UK project to undertake whole genome sequencing of 100,000 patients in the National Health Service, has appointed Genomics plc as a Platform Partner and has also awarded the Company three SBRI grants. Genomics plc is also working with four major pharmaceutical companies to bring the benefits of genomic analysis to their drug development processes. The Company is supported by major investors, including IP Group, Invesco Perpetual, Woodford Investment Management and Lansdowne Partners.

SOURCE

From: Lorna Cuddon <lorna.cuddon@zymecommunications.com>

Reply-To: <lorna.cuddon@zymecommunications.com>

Date: Monday, January 4, 2016 at 4:11 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Genomics and Vertex Collaborate to Identify Target Therapeutic Pathways

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Top Seven big Pharma in Thomson Reuters 2015 Top 100 Global Innovators

Reporter: Aviva Lev-Ari, PhD, RN

 

NAME COUNTRY PREVIOUS WINNER PREVIOUS WINNER PREVIOUS WINNER
Abbott USA

2014

2013
Bayer GERMANY

2011

Boehringer

Ingelheim

GERMANY
Brinstol-Myers Squibb USA

2011

J&J USA

2014

2013

Novartis Switzerland

2014

Roche Switzerland

2014

2013

2012, 2011

SOURCE

http://images.info.science.thomsonreuters.biz/Web/ThomsonReutersScience/%7Beb621c66-e238-4994-b1b5-9f5f9f897a75%7D_Thomson_Reuters_Top100_Global_Innovators_final.pdf

Introducing the Thomson Reuters 2015 Top 100 Global Innovators Organization Country Industry Previous Winners

New in 2015:

Top Bay Area Innovators For the first time, Thomson Reuters analysts studied Silicon Valley, known as the technology and innovation corridor in the US, to see which companies are leading there. Following a methodology similar to that of the Top 100 Global Innovators, except for the Volume criteria, all companies headquartered or with a major subsidiary in that region were investigated. The Top Bay Area Innovators list can be found on page 19. There are 11 companies that overlap with the Top 100 Global Innovators; meaning 31 percent of the leading US innovators and 11 percent of the world’s top innovators are located in the Bay Area.

Absentees:

The United Kingdom is absent from the list yet again this year. Innovation incentives introduced in the UK, such as Patent Box legislation, do not have enough legacy yet to have had an impact. Additionally, the UK spends much less on R&D as a percentage of Gross Domestic Product (GERD) than the Top 100 Global Innovator countries do. The UK’s GERDis 1.63 percent, whereas, for example, Japan’s is 3.47 percent.5 The region’s underuse of its patent system and lack of significant commercialization keep the UK from making the list once again.

China is also absent from the 2015 list. It joined the innovation-leader ranks in 2014, for the first time, via Huawei, however wasn’t able to replicate that performance to join again in 2015. A big factor contributing to China’s shortcoming is the fact that most of its innovation is domestic and therefore is not realized outside of its borders. In fact, only about six percent of China’s innovation activity is protected, and commercialized, outside of China. In order for China to see more organizations join this prestigious group, it will need to think more internationally and look to bring its inventions to market around the world. There are 27 companies that dropped from the prior year (see Table 1 on page 12), including AT&T, IBM, Siemens and Xerox. While these companies are still innovating at noteworthy levels, their respective scores across all of the metrics did not advance them to the Top 100. It’s expected that we will see them again in the future.

Patent Reform

There’s been some influential intellectual property legislation that is shaping how companies innovate, where they seek protection and when. Some of these initiatives include the America Invents Act and the Patent Trial & Appeal Board; the European unitary patent and unified patent court; the UK’s Patent Box legislation; and impactful court rulings, such as Alice 101 in the US. The landscape is ripe with reform as patent offices and filers grapple with how best to implement these changes given their goals and needs. Despite these changes, one thing remains certain: the patent system is vital to protecting innovation and to the economic wellbeing of organizations, nations and our world. OECD statistics confirm that nations with higher GDPs have similarly high patent filing rates (aka strong patent infrastructures), whereas the converse holds equally true. One way for developing nations to propel their economies forward is to invest in innovation and building a reliable intellectual property infrastructure.

Methodology

The Thomson Reuters Top 100 Global Innovator methodology analyzes patent and citation data across four main criteria:

  • volume,
  • success,
  • globalization and
  • influence

using Thomson Reuters solutions including Derwent World Patents Index (DWPI), Thomson Innovation and Derwent Patent Citations Index (PCI).

Volume

Volume is the first criteria. An organization must have at least 100 unique inventions protected by a granted patent over the most recent five year period to advance for further analysis. A unique invention is defined as one instance of a published application or granted patent for an idea for which protection is sought. In DWPI, these are called “basic” patents. DWPI provides access to 50 patentissuing authorities. Subsequent filings for the same invention are recorded as equivalents and collated into patent families which, for this analysis, were not included. Once an organization passes the volume stage gate, it is measured across the next three criteria: success, globalization and influence.

Success

The success metric covers the ratio of inventions described in published applications (those patents which are filed and publicly published by the patent office but not yet granted) to inventions protected with granted patents over the most recent five years. Not all patent applications pass through the examination process and are granted.

Globalization

Globalization has to do with the value an organization places on an invention by protecting it across the major world markets. The premise being that inventions protected in all four of the Thomson Reuters Quadrilateral Patent Index authorities: the Chinese Patent Office, the European Patent Office, the Japanese Patent Office and the United States Patent & Trademark Office, are deemed to be of significant value to the organization. A ratio is created of the inventions protected across the Quadrilateral Patent Index authorities versus the total volume for that period. Influence Finally,

Influence

influence is the downstream impact of an invention, measured by how often it is cited by other organizations. Via the Derwent Patent Citation Index, citations to an organization’s patents are counted over the most recent five years, excluding self citations. Scores for each of these areas are tallied and combined to produce the Top 100 Global Innovator list.

Top 100 Global Innovator list

3M Company USA Chemical 2011, 2012, 2013, 2014

Abbott Laboratories USA Pharmaceutical 2013, 2014

Advanced Micro Devices USA Semiconductor & Electronic Components 2011, 2012, 2013, 2014

Air Products USA Chemical 2013

Aisin Seiki Japan Automotive 2014

Alcatel-Lucent France Telecommunication & Equipment 2011, 2012, 2013, 2014

Alstom France Electrical Power

Amazon USA Media Internet Search & Navigation Systems

Analog Devices USA Semiconductor & Electronic Components 2011, 2012, 2013

Apple USA Telecommunication & Equipment 2011, 2012, 2013, 2014

Arkema France Chemical 2011, 2012, 2013, 2014

Avago Technologies (previously LSI) USA Semiconductor & Electronic Components 2011,2012, 2013, 2014

BASF Germany Chemical 2011, 2014

Bayer Germany Pharmaceutical 2011

Becton Dickinson USA Medical Devices

Blackberry Canada Telecommunication & Equipment 2013, 2014

Boehringer Ingelheim Germany Pharmaceutical

Boeing USA Aerospace 2011, 2012, 2013, 2014

Bridgestone Japan Automotive

Bristol-Myers Squibb USA Pharmaceutical 2011

Canon Japan Imaging 2011, 2012, 2013, 2014

Casio Computer Japan Computer Hardware 2014

Chevron USA Oil & Gas 2011, 2012, 2013

CNRS, The French National Center for Scientific Research France Scientific Research 2011, 2012, 2013, 2014

CEA–The French Alternative Energies and Atomic Energy Commission France Scientific Research 2011, 2012, 2013, 2014

Daikin Industries Japan Industrial 2011, 2014

Dow Chemical Company USA Chemical 2011, 2012, 2013, 2014

DuPont USA Chemical 2011, 2012, 2013, 2014

Emerson Electric USA Electrical Products 2012, 2013, 2014

Ericsson Sweden Telecommunication & Equipment 2011, 2012, 2013, 2014

Exxon Mobil USA Oil & Gas 2011, 2012, 2013

Fraunhofer Germany Scientific Research 2013, 2014

Freescale Semiconductor USA Semiconductor & Electronic Components 2013, 2014

Fujifilm Japan Imaging 2012, 2013, 2014

Fujitsu Japan Computer Hardware 2011, 2012, 2013, 2014

Furukawa Electric Japan Electrical Products 2014

General Electric USA Consumer Products 2011, 2012, 2013, 2014

Google (now Alphabet Inc.) USA Media Internet Search & Navigation Systems 2012, 2013, 2014

Hitachi Japan Computer Hardware 2011, 2012, 2013, 2014

Honda Motor Japan Automotive 2011, 2012, 2013, 2014

Honeywell International USA Electrical Products 2011, 2012, 2013, 2014

Idemitsu Kosan Japan Oil & Gas

IFP Energies Nouvelles France Scientific Research 2011, 2012, 2013, 2014

Intel USA Semiconductor & Electronic Components 2011, 2012, 2013, 2014

InterDigital USA Telecommunication & Equipment

Japan Science and Technology Agency (JST) Japan Scientific Research

Johnson & Johnson USA Pharmaceutical 2013, 2014

Johnson Controls USA Automotive

JTEKT Japan Automotive Kawasaki Heavy Industries Japan Industrial

Kobe Steel Japan Primary Metals 2014

Komatsu Japan Industrial 2014

Kyocera Japan Electrical Products 2014

LG Electronics S Korea Consumer Products 2011, 2012, 2013, 2014

Lockheed Martin USA Transportation Equipment 2012, 2013, 2014

LSIS S Korea Electrical Power 2011, 2012, 2013, 2014

Makita Corporation Japan Machinery

Marvell USA Semiconductor & Electronic Components 2012, 2013, 2014

MediaTek Taiwan Semiconductor & Electronic Components 2014

Medtronic USA Medical Devices 2014

Micron USA Semiconductor & Electronic Components 2012, 2013, 2014

Microsoft USA Computer Software 2011, 2012, 2013, 2014

Mitsubishi Electric Japan Electrical Products 2011, 2012, 2013, 2014

Mitsubishi Heavy Industries Japan Machinery 2012, 2013, 2014

Mitsui Chemicals Japan Chemical NEC Japan Computer Hardware 2011, 2012, 2013, 2014

Nike USA Consumer Products 2012, 2013, 2014

Nippon Steel & Sumitomo Metal Japan Primary Metals 2012, 2013, 2014

Nissan Motor Japan Automotive 2013, 2014

Nitto Denko Japan Chemical 2011, 2012, 2013, 2014

Novartis Switzerland Pharmaceutical 2014 2015

NTT Japan Telecommunication & Equipment 2011, 2012, 2013, 2014

Olympus Japan Healthcare Products 2011, 2012, 2013, 2014

Oracle USA Computer Software 2013, 2014

Panasonic Japan Consumer Products 2011, 2012, 2013, 2014

Philips Netherlands Electrical Products 2011, 2013, 2014

Qualcomm USA Semiconductor & Electronic Components 2011, 2012, 2013, 2014

Roche Switzerland Pharmaceutical 2011,2012,2013, 2014

Safran France Transportation Equipment 2013, 2014

Saint-Gobain France Industrial 2011, 2012, 2013, 2014

Samsung Electronics S Korea Semiconductor & Electronic Components 2011, 2012, 2013, 2014

Seagate USA Computer Hardware 2012, 2013, 2014

Seiko Epson Japan Imaging 2011, 2012, 2013, 2014

Shin-Etsu Chemical Japan Chemical 2011, 2012, 2013, 2014

Showa Denko Japan Chemical

Solvay Belgium Chemical 2012

Sony Japan Consumer Products 2011, 2012, 2013, 2014

Sumitomo Electric Japan Industrial 2011, 2013, 2014

Symantec USA Computer Software 2011, 2012, 2013, 2014

TE Connectivity Switzerland Semiconductor & Electronic Components 2011, 2012, 2013, 2014

Thales France Transportation Equipment 2012, 2013

Toray Japan Chemical

Toshiba Japan Computer Hardware 2011, 2012, 2013, 2014

Toyota Motor Japan Automotive 2011, 2012, 2013, 2014

Valeo France Automotive 2012, 2013

Xilinx USA Semiconductor & Electronic Components 2012, 2013, 2014

Yamaha Japan Consumer Products 2011, 2014

Yamaha Motor Japan Automotive

Yaskawa Electric Japan Industrial

Yazaki Japan Automotive

 

SOURCE

http://images.info.science.thomsonreuters.biz/Web/ThomsonReutersScience/%7Beb621c66-e238-4994-b1b5-9f5f9f897a75%7D_Thomson_Reuters_Top100_Global_Innovators_final.pdf

 

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FDA Drug Approvals in 2014: Drug Indication, Approval Date, Pharma, Agent Type and Drug Name

Curator: Stephen J Williams, PhD

Summary of 2014 FDA Approvals

Small Molecules versus Biologics

Below is a summary of the 2014 FDA Approvals with respect to their classification as small molecule or biologic. Data is taken from the FDA website https://www.centerwatch.com/drug-information/fda-approved-drugs/year/2014

In molecular biology and pharmacology, a small molecule is a low molecular weight (<900 daltons) organic compound that may help regulate a biological process, with a size on the order of 10−9 m. Most drugs are small molecules.

From the FDA Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include:
• vaccines
• blood and blood products for transfusion and/or manufacturing into other products
• allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots)
• human cells and tissues used for transplantation (for example, tendons, ligaments and bone)
• gene therapies
• cellular therapies
• tests to screen potential blood donors for infectious agents such as HIV

CONCLUSIONS:

As shown there were 106 small molecules approved and 59 biologics approved in 2014.

  • Sales figures were or their anticipated market size as well as cost/benefit analysis.   This was mentioned as a very important requirement in drug development by JNJ. The pharmacy benefit managers, insurers and the pharma companies said they were talked early in the drug development process using cost/benefit analysis as a criteria of go/ no go decision point.
  • The insurers are very cost conscious as well as the PBMs. There are some classes that had mainly biologics and this was not oncology. In addition inflammation had lots more small molecule. The breakdown seems to be more meaningful than the totals and there are many reformulations and double indications.
Cardiology/Vascular Diseases (2 small molecules)
Drug Indication Pharma drug type Drug Name Approval Date
For the treatment of severe hypertriglyceridemia AstraZeneca small molecule Epanova (omega-3-carboxylic acids) May-14
For the reduction of thrombotic cardiovascular events Merck small molecule Zontivity (vorapaxar); May-14
Dermatology 7 small molecules 2 biologics
For the treatment of acute bacterial skin and skin structure infections Durata Therapeutics synthetic small molecule Dalvance (dalbavancin); May-14
For the treatment of onychomycosis of the toenails Valeant Pharmaceuticals synthetic small molecule Jublia (efinaconazole) 10% topical gel Jun-14
For the treatment of onychomycosis of the toenails Anacor synthetic small molecule Kerydin (tavaborole) Jul-14
For the treatment of unresectable or metastatic melanoma Merck biologic Keytruda (pembrolizumab) Sep-14
For the treatment of unresectable or metastatic melanoma Bristol-Myers Squibb biologic Opdivo (nivolumab) Dec-14
For the treatment of acute bacterial skin and skin structure infections The Medicines Company semisynthetic small molecule Orbactiv (oritavancin) Aug-14
For the treatment of moderate to severe plaque psoriasis Celgene small molecule Otezla (apremilast) Sep-14
For the treatment of acute bacterial skin and skin structure infections Cubist Pharmaceuticals small molecule Sivextro (tedizolid phosphate) Jun-14
For the treatment of inflammatory lesions of rosacea Galderma Labs semisynthetic small molecule Soolantra (ivermectin) cream, 1% Dec-14
Endocrinology 6 small molecules 4 biologics
For the treatment of diabetes mellitus Mannkind biologic Afrezza (insulin human) Inhalation Powder Jun-14
For the treatment of hypogonadism Endo Pharmaceuticals small molecule Aveed (testosterone undecanoate) injection Mar-14
For the treatment of type II diabetes Bristol-Myers Squibb small molecule Farxiga (dapagliflozin) Jan-14
For the treatment of type II diabetes Boehringer Ingelheim small molecule Jardiance (empagliflozin) Aug-14
For the treatment of deficiency or absence of endogenous testosterone Trimel Pharmaceuticals small molecule Natesto, (testosterone) nasal gel May-14
For the treatment of acromegaly Novartis biologic Signifor LAR (pasireotide) Dec-14
For the treatment of type II diabetes mellitus GlaxoSmithKline biologic Tanzeum (albiglutide) Apr-14
To improve glycemic control in type II diabetics Eli Lilly biologic Trulicity (dulaglutide) Sep-14
For males with a deficiency or absence of endogenous testosterone Upsher-Smith synthetic small molecule Vogelxo (testosterone) gel Jun-14
For glycemic control in adults with type II diabetes AstraZeneca small molecule Xigduo XR (dapagliflozin + metformin hydrochloride) Oct-14
Family Medicine 21 small molecules 11 biologics
For the treatment of diabetes mellitus Mannkind biologic Afrezza (insulin human) Inhalation Powder; Jun-14
For the treatment of hemophilia B Biogen Idec biologic Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] Mar-14
For the treatment of asthma, GlaxoSmithKline small molecule Arnuity Ellipta (fluticasone furoate inhalation powder) Aug-14
For the treatment of hypogonadism Endo Pharmaceuticals small molecule Aveed (testosterone undecanoate) injection; Mar-14
For the treatment of insomnia Merck small molecule Belsomra (suvorexant) Aug-14
For the maintenance treatment of opioid dependence BioDelivery Sciences small molecule Bunavail (buprenorphine and naloxone) Jun-14
For chronic weight management Takeda Pharmaceuticals U.S.A small molecule Contrave (naltrexone HCl and bupropion HCl) Sep-14
For the treatment of acute bacterial skin and skin structure infections Durata Therapeutics semisynthetic small molecule Dalvance (dalbavancin) May-14
For the management of mild, moderate or severe pain Hospira small molecule Dyloject (diclofenac sodium) Injection Dec-14
For the treatment of adults with ulcerative colitis and Crohn’s disease Millenium Pharmaceuticals biologic Entyvio (vedolizumab) May-14
For the treatment of type II diabetes Bristol-Myers Squibb small molecule Farxiga (dapagliflozin) Jan-14
For the treatment of grass pollen-induced allergic rhinitis Merck biologic Grastek (Timothy Grass Pollen Allergen Extract) Apr-14
For the treatment of type II diabetes Boehringer Ingelheim small molecule Jardiance (empagliflozin) Aug-14
For the treatment of onychomycosis of the toenails Anacor small molecule Kerydin (tavaborole) Jul-14
For the treatment of bacterial vaginosis Actavis, Inc semisynthetic small molecule Metronidazole 1.3% Vaginal Gel Apr-14
For the treatment of congenital or acquired generalized lipodystrophy Bristol-Myers Squibb biologic Myalept (metreleptin for injection) Feb-14
For the treatment of deficiency or absence of endogenous testosterone Trimel Pharmaceuticals semisynthetic small molecule Natesto, (testosterone) nasal gel; May-14
For the treatment of neurogenic orthostatic hypotension Chelsea Therapeutics synthetic small molecule Northera (droxidopa) Feb-14
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) Apr-14
For the treatment of adults with active psoriatic arthritis Celgene small molecule Otezla (apremilast) Mar-14
For the treatment of moderate to severe plaque psoriasis Celgene small molecule Otezla (apremilast) Sep-14
For the treatment of relapsing multiple sclerosis Biogen Idec biologic Plegridy (peginterferon beta-1a) Aug-14
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome Upsher-Smith Laboratories small molecule Qudexy XR (topiramate) Mar-14
For the treatment of short ragweed pollen-induced allergic rhinitis Merck biologic Ragwitek (Short Ragweed Pollen Allergen Extract) Apr-14
For the treatment of acute uncomplicated influenza in adults Biocryst small molecule Rapivab (peramivir injection) Dec-14
For chronic weight management Novo Nordisk biologic Saxenda (liraglutide [rDNA origin] injection) Dec-14
For the treatment of type II diabetes mellitus GlaxoSmithKline biologic Tanzeum (albiglutide) Apr-14
For the management of severe chronic pain Purdue Pharma small molecule Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets Jul-14
For the treatment of acute pain Iroko Pharmaceuticals small molecule Tivorbex (indomethacin) Feb-14
To improve glycemic control in type II diabetics Eli Lilly biologic Trulicity (dulaglutide) Sep-14
For the management of acute pain Mallinckrodt Pharmaceuticals small molecule Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release Mar-14
For the treatment of acute otitis externa Alcon small molecule Xtoro (finafloxacin otic suspension) 0.3%; Dec-14
For the treatment of complicated intra-abdominal and urinary tract infections Cubist Pharmaceuticals small molecule Zerbaxa (ceftolozane + tazobactam) Dec-14
Gastroenterology 3 small molecules 2 biologics
For the prevention of chemotherapy-induced nausea and vomiting, Helsinn small molecule Akynzeo (netupitant and palonosetron) Oct-14
For the treatment of gastric cancer Eli Lilly biologic Cyramza (ramucirumab); Apr-14
For the treatment of adults with ulcerative colitis and Crohn’s disease, Millenium Pharmaceuticals biologic Entyvio (vedolizumab) May-14
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain AstraZeneca small molecule Movantik (naloxegol) Sep-14
For the treatment of complicated intra-abdominal and urinary tract infections Cubist Pharmaceuticals small molecule Zerbaxa (ceftolozane + tazobactam) Dec-14
Genetic Disease 2 small molecule 2 biologic
For the treatment of hemophilia B Biogen Idec biologic Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Mar-14
For the treatment of certain adult patients with Gaucher disease type 1 Genzyme small molecule Cerdelga (eliglustat) Aug-14
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome Upsher-Smith Laboratories small molecule Qudexy XR (topiramate) Mar-14
For the treatment of Mucopolysaccharidosis type IVA BioMarin biologic Vimizim (elosulfase alfa) Feb-14
Healthy Volunteers 1 biologic
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) Apr-14
Hematology 4 small molecule 6 biologics
For the treatment of hemophilia B Biogen Idec biologic Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Mar-14
For the treatment of relapsed or refractory peripheral T-cell lymphoma Spectrum Pharmaceuticals small molecule Beleodaq (belinostat) Jul-14
For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia Amgen biologic Blincyto (blinatumomab) Dec-14
For the treatment of hemophillia A Biogen Idec biologic Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] ; Jun-14
For the treatment of chronic lymphocytic leukemia Pharmacyclics small molecule Imbruvica (ibrutinib) Feb-14
For the treatment of acquired hemophilia A Baxter biologic Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] Oct-14
For the treatment of hereditary angioedema Pharming Group biologic Ruconest (C1 esterase inhibitor [recombinant]) Jul-14
For the treatment of multicentric Castleman’s disease Janssen Biotech biologic Sylvant (siltuximab); Apr-14
For the reduction of thrombotic cardiovascular events Merck small molecule Zontivity (vorapaxar) May-14
For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma Gilead small molecule Zydelig (idelalisib) Jul-14
Immunology 3 small molecules 9 biologics
For the treatment of adults with ulcerative colitis and Crohn’s disease Millenium Pharmaceuticals biologic Entyvio (vedolizumab) May-14
For the treatment of grass pollen-induced allergic rhinitis Merck biologic Grastek (Timothy Grass Pollen Allergen Extract); Apr-14
For the treatment of Primary Immunodeficiency Baxter biologic HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Sep-14
For the treatment of chronic obstructive pulmonary disease GlaxoSmithKline small molecule Incruse Ellipta (umeclidinium inhalation powder); May-14
For the treatment of congenital or acquired generalized lipodystrophy Bristol-Myers Squibb biologic Myalept (metreleptin for injection) Feb-14
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) Apr-14
For the treatment of adults with active psoriatic arthritis Celgene small molecule Otezla (apremilast) Mar-14
For the treatment of moderate to severe plaque psoriasis Celgene small molecule Otezla (apremilast) Sep-14
For the treatment of relapsing multiple sclerosis Biogen Idec biologic Plegridy (peginterferon beta-1a) Aug-14
For the treatment of short ragweed pollen-induced allergic rhinitis Merck biologic Ragwitek (Short Ragweed Pollen Allergen Extract) Apr-14
For the treatment of multicentric Castleman’s disease Janssen Biotech biologic Sylvant (siltuximab) Apr-14
For the treatment of HIV-1 ViiV HealthCare biologic Triumeq (abacavir, dolutegravir, and lamivudine); Aug-14
Infections and Infectious Diseases 13 small molecules 0 biologics
For the treatment of acute bacterial skin and skin structure infections Durata Therapeutics semisynthetic small molecule Dalvance (dalbavancin) May-14
For the treatment of hepatitis C, Gilead small molecule Harvoni (ledipasvir and sofosbuvir) Oct-14
For the treatment of visceral, cutaneous and mucosal leishmaniasis Knight Therapeutics small molecule Impavido (miltefosine) Mar-14
For the treatment of onychomycosis of the toenails Valeant Pharmaceuticals small molecule Jublia (efinaconazole) 10% topical gel Jun-14
For the treatment of onychomycosis of the toenails Anacor small molecule Kerydin (tavaborole) Jul-14
For the treatment of bacterial vaginosis Actavis, Inc small molecule Metronidazole 1.3% Vaginal Gel Apr-14
For the treatment of acute bacterial skin and skin structure infections The Medicines Company semisynthetic small molecule Orbactiv (oritavancin) Aug-14
For the treatment of acute uncomplicated influenza in adults Biocryst small molecule Rapivab (peramivir injection) Dec-14
For the treatment of acute bacterial skin and skin structure infections Cubist Pharmaceuticals small molecule Sivextro (tedizolid phosphate) Jun-14
For the treatment of HIV-1 ViiV HealthCare small molecule Triumeq (abacavir, dolutegravir, and lamivudine) Aug-14
; For the treatment of genotype 1 chronic hepatitis C virus Abbvie small molecule Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets; Dec-14
For the treatment of acute otitis externa Alcon small molecule Xtoro (finafloxacin otic suspension) 0.3% Dec-14
For the treatment of complicated intra-abdominal and urinary tract infections Cubist Pharmaceuticals small molecule Zerbaxa (ceftolozane + tazobactam) Dec-14
Internal Medicine 1 small molecule
For the treatment of certain adult patients with Gaucher disease type 1, Genzyme small molecule Cerdelga (eliglustat); Aug-14
Musculoskeletal 2 small molecule 3 biologic
For the treatment of relapsing multiple sclerosis Genzyme biologic Lemtrada (alemtuzumab) Nov-14
For the treatment of adults with active psoriatic arthritis Celgene small molecule Otezla (apremilast) Mar-14
For the treatment of relapsing multiple sclerosis Biogen Idec biologic Plegridy (peginterferon beta-1a) Aug-14
For the management of severe chronic pain Purdue Pharma small molecule Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets Jul-14
For the treatment of Mucopolysaccharidosis type IVA BioMarin biologic Vimizim (elosulfase alfa) Feb-14
Nephrology 3 small molecule
For the treatment of hyperphosphatemia in patients with chronic kidney disease Keryx Biopharma small molecule Auryxia (Ferric citrate) Sep-14
For the treatment of hepatitis C Gilead small molecule Harvoni (ledipasvir and sofosbuvir) Oct-14
For the treatment of genotype 1 chronic hepatitis C virus Abbvie small molecule Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets Dec-14
Neurology 10 small molecules 2 biologics
For the treatment of insomnia Merck small molecule Belsomra (suvorexant) Aug-14
For the management of mild, moderate or severe pain Hospira small molecule Dyloject (diclofenac sodium) Injection Dec-14
For the treatment of non-24-hour sleep-wake disorder in the totally blind Vanda Pharmaceuticals small molecule Hetlioz (tasimelteon) Jan-14
For the treatment of relapsing multiple sclerosis Genzyme biologic Lemtrada (alemtuzumab) Nov-14
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain AstraZeneca small molecule Movantik (naloxegol) Sep-14
For the treatment of moderate to severe dementia of the Alzheimer’s type Forest Laboratories small molecule Namzaric (memantine hydrochloride extended-release + donepezil hydrochloride) Dec-14
For the treatment of neurogenic orthostatic hypotension Chelsea Therapeutics small molecule Northera (droxidopa) Feb-14
For the treatment of relapsing multiple sclerosis Biogen IDEC biologic Plegridy (peginterferon beta-1a) Aug-14
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome Upsher-Smith Laboratories small molecule Qudexy XR (topiramate) Mar-14
For the management of severe chronic pain Purdue Pharma small molecule Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets Jul-14
For the treatment of acute pain Iroko Pharmaceuticals small molecule Tivorbex (indomethacin) Feb-14
For the management of acute pain Mallinckrodt Pharmaceuticals small molecule Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release Mar-14
Nutrition and Weight Loss 2 small molecule 3 biologics
For chronic weight management Takeda Pharmaceuticals U.S.A small molecule Contrave (naltrexone HCl and bupropion HCl) Sep-14
For the treatment of type II diabetes Boehringer Ingelheim small molecule Jardiance (empagliflozin) Aug-14
For chronic weight management Novo Nordisk biologic Saxenda (liraglutide [rDNA origin] injection) Dec-14
For the treatment of type II diabetes mellitus GlaxoSmithKline biologic Tanzeum (albiglutide) Apr-14
To improve glycemic control in type II diabetics Eli Lilly biologic Trulicity (dulaglutide) Sep-14
Obstetrics/Gynecology (Women’s Health) 2 small molecule
For the treatment of previously treated BRCA mutated advanced ovarian cancer, AstraZeneca small molecule Lynparza (olaparib) Dec-14
For the treatment of bacterial vaginosis Actavis, Inc small molecule Metronidazole 1.3% Vaginal Gel Apr-14
Oncology 6 small molecules 4 biologics
For the prevention of chemotherapy-induced nausea and vomiting Helsinn small molecule Akynzeo (netupitant and palonosetron) Oct-14
For the treatment of relapsed or refractory peripheral T-cell lymphoma Spectrum Pharmaceuticals small molecule Beleodaq (belinostat) Jul-14
For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia Amgen biologic Blincyto (blinatumomab) Dec-14
For the treatment of gastric cancer Eli Lilly biologic Cyramza (ramucirumab) Apr-14
For the treatment of chronic lymphocytic leukemia Pharmacyclics small molecule Imbruvica (ibrutinib) Feb-14
For the treatment of unresectable or metastatic melanoma Merck biologic Keytruda (pembrolizumab) Sep-14
For the treatment of previously treated BRCA mutated advanced ovarian cancer AstraZeneca small molecule Lynparza (olaparib) Dec-14
For the treatment of unresectable or metastatic melanoma Bristol-Myers Squibb biologic Opdivo (nivolumab) Dec-15
For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma Gilead small molecule Zydelig (idelalisib) Jul-14
For the treatment of ALK+ metastatic non-small cell lung cancer Novartis small molecule Zykadia (ceritinib) Apr-14
Ophthalmology 2 small molecule 1 biologic
For the treatment of non-24-hour sleep-wake disorder in the totally blind Vanda Pharmaceuticals small molecule Hetlioz (tasimelteon) Jan-14
For use during eye surgery to prevent intraoperative miosis and reduce post-operative pain Omeros small molecule Omidria (phenylephrine and ketorolac injection) Jun-14
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) Apr-14
Orthopedics/Orthopedic Surgery 1 small molecule
For the treatment of adults with active psoriatic arthritis Celgene small molecule Otezla (apremilast) Mar-14
Otolaryngology (Ear, Nose, Throat) 1 small molecule 3 biologic
For the treatment of grass pollen-induced allergic rhinitis Merck biologic Grastek (Timothy Grass Pollen Allergen Extract) Apr-14
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) 14-Apr
For the treatment of short ragweed pollen-induced allergic rhinitis Merck biologic Ragwitek (Short Ragweed Pollen Allergen Extract) Apr-14
For the treatment of acute otitis externa Alcon small molecule Xtoro (finafloxacin otic suspension) 0.3% Dec-14
Pediatrics/Neonatology 2 small molecule 2 biologics
; For the treatment of hemophilia B Biogen Idec biologic Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] Mar-14
For the treatment of asthma GlaxoSmithKline small molecule Arnuity Ellipta (fluticasone furoate inhalation powder) Aug-14
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome Upsher-Smith Laboratories small molecule Qudexy XR (topiramate) Mar-14
For the treatment of Mucopolysaccharidosis type IVA BioMarin biologic Vimizim (elosulfase alfa) Feb-14
Pharmacology/Toxicology 3 small molecule 1 biologic
For the prevention of chemotherapy-induced nausea and vomiting Helsinn small molecule Akynzeo (netupitant and palonosetron) Oct-14
For the maintenance treatment of opioid dependence BioDelivery Sciences small molecule Bunavail (buprenorphine and naloxone) Jun-14
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain AstraZeneca small molecule Movantik (naloxegol) Sep-14
For the treatment of congenital or acquired generalized lipodystrophy Bristol-Myers Squibb biologic Myalept (metreleptin for injection) Feb-14
Psychiatry/Psychology 1 small molecule
For the maintenance treatment of opioid dependence BioDelivery Sciences small molecule Bunavail (buprenorphine and naloxone) Jun-14
Pulmonary/Respiratory Diseases 6 small molecule 3 biologic
For the treatment of asthma GlaxoSmithKline small molecule Arnuity Ellipta (fluticasone furoate inhalation powder) Aug-14
For the treatment of idiopathic pulmonary fibrosis InterMune small molecule Esbriet (pirfenidone) Oct-14
For the treatment of grass pollen-induced allergic rhinitis Merck biologic Grastek (Timothy Grass Pollen Allergen Extract) Apr-14
For the treatment of chronic obstructive pulmonary disease GlaxoSmithKline small molecule Incruse Ellipta (umeclidinium inhalation powder) May-14
For the treatment of idiopathic pulmonary fibrosis Boehringer Ingelheim small molecule Ofev (nintedanib) Oct-14
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) Apr-14
For the treatment of short ragweed pollen-induced allergic rhinitis Merck biologic Ragwitek (Short Ragweed Pollen Allergen Extract) Apr-14
For the treatment of chronic obstructive pulmonary disease Boehringer Ingelheim small molecule Striverdi Respimat (olodaterol) Jul-14
For the treatment of ALK+ metastatic non-small cell lung cancer Novartis small molecule Zykadia (ceritinib) Apr-14
Rheumatology 1 small molecule
For the treatment of adults with active psoriatic arthritis Celgene small molecule Otezla (apremilast) Mar-14
Sleep 1 small molecule
For the treatment of non-24-hour sleep-wake disorder in the totally blind Vanda Pharmaceuticals small molecule Hetlioz (tasimelteon) Jan-14
Urology 1 small molecule
For the treatment of complicated intra-abdominal and urinary tract infections Cubist Pharmaceuticals small molecule Zerbaxa (ceftolozane + tazobactam) Dec-14

 

SOURCE

https://www.centerwatch.com/drug-information/fda-approved-drugs/year/2014

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Hyper Innovations in Pharma 2015

Reporter : Gérard Henri Loiseau, ESQ

 

Bio Pharma 2015: Soaring to New Heights

Pharmaceutical Manufacturing, Steven E. Kuehn, Nov 10 2015

 

Growth Statistics

Bio Pharma is an “evolving accelerating science” (John J. Castellani, PhRMA).

R&D spending which was

$2 billion in 1980 is estimated

$51,6 billion in 2013,

it represents 1 in every 5 dollars spent on domestic R&D in the US.

90% is spent on Clinical Trials,

6199 Clinical Trials in 2013.

>$2.6 billion is the cost estimated to develop and bring a new drug on the market

In 2014 FDA approved 44 drugs, so a good year both for NCEs and NBEs, Forbes Magazine, Bernard Munos

 

Hyper Innovation

According to Mr. Munos the main players are

  • Novartis
  • J&J
  • GSK
  • AstraZeneca

Deloitte’s report “Advanced Biopharmaceutical Manufacturing: An Evolution, Underway” identifies several targets:

  • Continuous manufacturing
  • New process analytical tools
  • Single-use systems
  • Alternative downstream processing technique

Amgen vice president Jim Thomas points out:

  • A more competitive business environment
  • A more challenging reimbursement environment
  • A more conservative regulatory environment

There is a necessity for the highest quality manufacturing environments.

“Design the molecule. Design the Process. Design the plant,” is his credo, which generates its “transforming Biotechnology Manufacturing” initiative

  • Trends in analytical tools will support operational excellence
  • Bio therapeutics manufacturing will be centered on cell-based systems
  • A greater productivity within a smaller footprint will be allowed
  • Flexibility is the goal thanks to standardized processes across all stages

These are the keys to operational excellence.

 

Process Analytical Technology (PAT)

FDA’s perspective is that ”quality cannot be tested into products; it should be built-in or should be by design”

Deloitte estimates that PAT can promote fewer recalls and less scrap inventory.

 

Towards a continuous future?

A recognized potential for small molecule drugs, and some companies have developed this continuous technology.

Deloitte’s study says that FDA views continuous manufacturing as consistent with the FDA’s quality by design efforts.

How to define a batch in case of product recall is a true challenge, which means that new measurements methods are needed.

Continuous manufacturing opposed to efficient, well-planned and engineered facilities, which is the vision developed by Amgen and others innovative players.

SOURCE

http://www.pharmamanufacturing.com/articles/2015/bio-pharma-2015/

 

 

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Pharmacy International Conference

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

 

3rd Nirma Institute of Pharmacy International Conference
NIPiCON – 2016
January 21 – 23, 2016 ………….http://www.nipicon.org/.

Anthony Melvin Crasto   https://www.facebook.com/groups/worlddrugtracker/permalink/1170816792946389/

The pharmaceutical sciences is a dynamic and interdisciplinary field that combines a broad range of scientific disciplines that are critical to the discovery and development of new drugs and therapies. Over the years, pharmaceutical scientists have been instrumental in discovering and developing innovative drugs that save people’s lives and improve the quality of life.

NIPiCON was initiated in a year 2013 to offer a common platform for academicians, researchers, industrialists, clinical practitioners and young budding pharmacists to share their ideas and research work and finally emerge with new concepts, innovations and novel strategies for various challenges in the pharmaceutical field.

The 3 International Conference, NIPiCON 2016 aims to provide a knowledge sharing experience in the area of “Global Challenges in Drug Discovery, Development and Regulatory Affairs”.

Pharmaceutical innovation is a complex creative process that harnesses the application of knowledge and creativity for discovering, developing and bringing to clinical use, new medicinal products that extend or improve the lives of patients.A successful pharmaceutical R&D process is one that minimizes the time and cost needed to bring a compound from the scientific ‘idea’, through discovery and clinical development, to final regulatory approval and delivery to the patient. This conference will provide an open forum for the academicians, researchers, clinicians and professionals of pharmaceutical industry to enrich their knowledge in the area of drug discovery, development and its regulatory requirements.

The conference features plenary sessions which will be delivered by eminent national and international speakers from different disciplines of pharmaceutical field. In addition, there will be invited lectures and sessions delivered by distinguished and young researchers in their respective fields during parallel technical sessions. The conference willalso provide the opportunity to scientists and research scholars from various organizations to put forth their innovative ideas and research findings by means of deliberations, discussions and poster presentations.

 

NIPiCON was initiated in a year 2013 to offer a common platform for academicians, researchers, industrialists, clinical practitioners and young budding pharmacists to share their ideas and research work and finally emerge with new concepts, innovations and novel strategies for various challenges in the pharmaceutical field.

The 3 International Conference, NIPiCON 2016 aims to provide a knowledge sharing experience in the area of “Global Challenges in Drug Discovery, Development and Regulatory Affairs”.

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Future of the Pharmaceutical Industry in Japan and South Korea

Reporter: Gerard H Loiseau, ESQ

 

Japan and South Korea are both top-ten global pharmaceutical markets with governments determined to ensure domestic drug manufacturers capture as much of those markets as possible. The national agencies responsible for regulating these two pharmaceutical markets have been very active creating initiatives and incentives aiming to steer market growth while minimizing healthcare spending, though the approach and ultimate goals of these agencies differ greatly.

 

SOURCE

http://lsconnect.thomsonreuters.com/how-japan-and-south-korea-are-preparing-for-their-pharmaceutical-futures/

 

Other articles on the Pharmaceutical Industry in Japan published in this Open Access Online Scientific Journal include the following: 

Japan’s Ceramics and Glass Industries

 

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From Turing to Watson

Larry H Bernstein, MD, FCAP, Curator

LPBI

From Turing to Watson: The Long-Burning Hype of Machine Learning

Thomas Slowe, Founder & CEO, Nervve

http://www.rdmag.com/articles/2015/10/turing-watson-long-burning-hype-machine-learning?

http://www.rdmag.com/sites/rdmag.com/files/MachineLearning_Infographicx500.jpg

Each year, technology industry watchers anxiously await the release of Gartner’s Hype Cycle to see what’s rising, what’s falling and what’s completely fizzled when it comes to emerging technologies. Many observers specifically look for the “peak of inflated expectations” to see which technologies have hit their high point when it comes to media saturation, but still need several years before reaching their true potential. While there are many well-known categories on this year’s list, including 3-D printing, virtual reality and wearables, they’re joined by one that comes with a bit more mystery—machine learning.

For people in technology, the definition of machine learning is relatively simple. Machine learning is a form of artificial intelligence (AI) that provides computers with the ability to learn without being explicitly programmed. Machine learning focuses on the development of computer programs that can teach themselves to grow and change when exposed to new data.

However, if you ask someone on the street, you’re likely to get a blank stare. Some may be able to connect the dots to AI, or perhaps they can reference the technology’s most famous example to date, IBM Watson, thanks to its ability to defeat Jeopardy champions. In reality, machine learning plays a larger role in our everyday lives than people realize. From Siri and Cortana, to our Bluetooth car entertainment systems, to visual technology that can be trained to spot a specific piece of clothing on fuzzy surveillance video, these automated technologies many take for granted have been developed thanks to a machine’s ability to “learn” from prior interactions.

While it may seem machine learning has developed overnight thanks to huge investments and breakthroughs from major players in Silicon Valley, it has, in fact, gone through a long and meandering history over the past 80 plus years. It has morphed from the research focus of a few dozen engineers to the power behind some of today’s most widespread consumer technologies.

In the beginning
While AT&T Bell Labs’ development of the electronic speech synthesizer in 1936 may have been the first major breakthrough for machine learning, the more well-known achievement from this early era was the Turing Test in 1950. Alan Turing introduced the test in a paper he opened with the simple words “I propose to consider the question, ‘Can machines think?’” By proving that humans couldn’t always differentiate between a real person and a machine in basic textual conversations, Turing laid the groundwork for societal acceptance of the concept that machines can learn.

Major advancements in early machine learning weren’t limited to solely voice and text recognition. From the Rosenblatt Preceptron in 1957, to Larry Roberts Computer Visions dissertation in 1963, image also played a major role in molding future research within the artificial intelligence community.

Relatable examples
So when did machine learning truly evolve into a real-world technology? A few major breakthroughs occurred in the 1970s that made the concept much more relatable. In 1976, a license plate recognition system was invented in the U.K. at the Police Scientific Development Branch. While license plate software didn’t become more widely used until a couple of decades later, this type of computer vision technology was the basis for the more high-tech versions used by law enforcement and intelligence agencies today.

Machine learning and robotics collided when the Stanford Cart successfully crossed a chair-filled room without human intervention in 1979. The process took more than five hours, thanks to many pauses so the cart could process what it was seeing and plan a new route. While Google’s self-driving cars certainly don’t take that long to navigate the streets of San Francisco or Austin, machine learning technology brings us closer than ever before to realizing technology that was previously only imagined in movies.

The modern era
The past two decades of AI and machine learning have seen the technology grow. The power of neural networks was initially appreciated in mid-1980s, but computers were too weak to tap the value at a practical level. Geoffrey Hinton revived interest in neural networks in 2006 under the name of “Deep Learning” when he demonstrated a system that learned to classify handwritten digits with high accuracy. Even more impressive was the system’s ability to generate novel handwritten examples that it hadn’t been shown before.

IBM's Watson computer system, powered by IBM POWER7, competes against Jeopardy!'s two most successful and celebrated contestants: Ken Jennings and Brad Rutter. Image: IBM Newsroom
IBM’s Watson computer system, powered by IBM POWER7, competes against Jeopardy!’s two most successful and celebrated contestants: Ken Jennings and Brad Rutter. Image: IBM Newsroom

This work started a wave of major Silicon Valley investment in the technology that now powers many of the consumer-focused technology we see today. From virtual assistants like Siri and Cortana, to virtual online chat agents and even to our GPS systems, machine learning-based technology influences almost every aspect of our daily interactions.However, one legacy company has made an outstanding and lasting impact when it comes to how the public perceives the topic of machine technology—IBM. From Deep Blue’s defeat of world chess champion Garry Kasparov in 1997, to Watson’s take down of legendary Ken Jennings on Jeopardy in 2011, one could argue IBM has done more to raise public awareness of a machine’s ability to learn than any other company. Watson’s achievements were particularly impressive, because it wasn’t just about its deep knowledge of questions and answers, but the ability to use natural language processing to understand Alex Trebek’s questions and signal its answer more quickly than humans.

The future
As we look into the future of machine learning, some may have visions of machine overlords eventually taking over the world. However, we believe we’re still several decades away from contemplating this scenario. What we can choose to focus on instead is where the technology will generate value in the next five to 10 years.

While entirely autonomous machines are unfeasible in the near future, “person-in-the-loop” approaches have shown enormous value. From digital services like learning how to beat video games, to physical world applications (like visually identifying possible infrastructure failures and helping doctors perform complicated surgeries), the societal possibilities for machine learning are endless. And when in doubt just ask Siri!

• CONFERENCE AGENDA ANNOUNCED:

The highly-anticipated educational tracks for the 2015 R&D 100 Awards & Technology Conference feature 28 sessions, plus keynote speakers Dean Kamen and Oak Ridge National Laboratory Director Thom Mason.  Learn more.

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Cancer Biology and Genomics for Disease Diagnosis (Vol. I) Now Available for Amazon Kindle

Cancer Biology and Genomics for Disease Diagnosis (Vol. I) Now Available for Amazon Kindle

Reporter: Stephen J Williams, PhD

Article ID #179: Cancer Biology and Genomics for Disease Diagnosis (Vol. I) Now Available for Amazon Kindle. Published on 8/14/2015

WordCloud Image Produced by Adam Tubman

Leaders in Pharmaceutical Business Intelligence would like to announce the First volume of their BioMedical E-Book Series C: e-Books on Cancer & Oncology

Volume One: Cancer Biology and Genomics for Disease Diagnosis

CancerandOncologyseriesCcoverwhich is now available on Amazon Kindle at                          http://www.amazon.com/dp/B013RVYR2K.

This e-Book is a comprehensive review of recent Original Research on Cancer & Genomics including related opportunities for Targeted Therapy written by Experts, Authors, Writers. This ebook highlights some of the recent trends and discoveries in cancer research and cancer treatment, with particular attention how new technological and informatics advancements have ushered in paradigm shifts in how we think about, diagnose, and treat cancer. The results of Original Research are gaining value added for the e-Reader by the Methodology of Curation. The e-Book’s articles have been published on the Open Access Online Scientific Journal, since April 2012.  All new articles on this subject, will continue to be incorporated, as published with periodical updates.

We invite e-Readers to write an Article Reviews on Amazon for this e-Book on Amazon. All forthcoming BioMed e-Book Titles can be viewed at:

http://pharmaceuticalintelligence.com/biomed-e-books/

Leaders in Pharmaceutical Business Intelligence, launched in April 2012 an Open Access Online Scientific Journal is a scientific, medical and business multi expert authoring environment in several domains of  life sciences, pharmaceutical, healthcare & medicine industries. The venture operates as an online scientific intellectual exchange at their website http://pharmaceuticalintelligence.com and for curation and reporting on frontiers in biomedical, biological sciences, healthcare economics, pharmacology, pharmaceuticals & medicine. In addition the venture publishes a Medical E-book Series available on Amazon’s Kindle platform.

Analyzing and sharing the vast and rapidly expanding volume of scientific knowledge has never been so crucial to innovation in the medical field. WE are addressing need of overcoming this scientific information overload by:

  • delivering curation and summary interpretations of latest findings and innovations
  • on an open-access, Web 2.0 platform with future goals of providing primarily concept-driven search in the near future
  • providing a social platform for scientists and clinicians to enter into discussion using social media
  • compiling recent discoveries and issues in yearly-updated Medical E-book Series on Amazon’s mobile Kindle platform

This curation offers better organization and visibility to the critical information useful for the next innovations in academic, clinical, and industrial research by providing these hybrid networks.

Table of Contents for Cancer Biology and Genomics for Disease Diagnosis

Preface

Introduction  The evolution of cancer therapy and cancer research: How we got here?

Part I. Historical Perspective of Cancer Demographics, Etiology, and Progress in Research

Chapter 1:  The Occurrence of Cancer in World Populations

Chapter 2.  Rapid Scientific Advances Changes Our View on How Cancer Forms

Chapter 3:  A Genetic Basis and Genetic Complexity of Cancer Emerge

Chapter 4: How Epigenetic and Metabolic Factors Affect Tumor Growth

Chapter 5: Advances in Breast and Gastrointestinal Cancer Research Supports Hope for Cure

Part II. Advent of Translational Medicine, “omics”, and Personalized Medicine Ushers in New Paradigms in Cancer Treatment and Advances in Drug Development

Chapter 6:  Treatment Strategies

Chapter 7:  Personalized Medicine and Targeted Therapy

Part III.Translational Medicine, Genomics, and New Technologies Converge to Improve Early Detection

Chapter 8:  Diagnosis                                     

Chapter 9:  Detection

Chapter 10:  Biomarkers

Chapter 11:  Imaging In Cancer

Chapter 12: Nanotechnology Imparts New Advances in Cancer Treatment, Detection, &  Imaging                                 

Epilogue by Larry H. Bernstein, MD, FACP: Envisioning New Insights in Cancer Translational Biology

 

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Drug Discovery & Structural Biology: A Massively Multitask Networks Architecture – Collaboration between Stanford and Google

Reporter: Aviva Lev-Ari, PhD, RN

Massively Multitask Networks for Drug Discovery

Bharath Ramsundar*,†, ◦ RBHARATH@STANFORD.EDU

Steven Kearnes*,† KEARNES@STANFORD.EDU

Patrick Riley◦ PFR@GOOGLE.COM

Dale Webster◦ DRW@GOOGLE.COM

David Konerding◦ DEK@GOOGLE.COM

Vijay Pande† PANDE@STANFORD.EDU

( *Equal contribution, †Stanford University, ◦Google Inc.)

Abstract

Massively multitask neural architectures provide a learning framework for drug discovery that synthesizes information from many distinct biological sources. To train these architectures at scale, we gather large amounts of data from public sources to create a dataset of nearly 40 million measurements across more than 200 biological targets. We investigate several aspects of the multitask framework by performing a series of empirical studies and obtain some interesting results:

(1) massively multitask networks obtain predictive accuracies significantly better than single-task methods,

(2) the predictive power of multitask networks improves as additional tasks and data are added,

(3) the total amount of data and the total number of tasks both contribute significantly to multitask improvement, and

(4) multitask networks afford limited transferability to tasks not in the training set.

Our results underscore the need for greater data sharing and further algorithmic innovation to accelerate the drug discovery process

SOURCE

http://arxiv.org/pdf/1502.02072v1.pdf

Large-Scale Machine Learning for Drug Discovery

Posted: Monday, March 02, 2015

Discovering new treatments for human diseases is an immensely complicated challenge; Even after extensive research to develop a biological understanding of a disease, an effective therapeutic that can improve the quality of life must still be found. This process often takes years of research, requiring the creation and testing of millions of drug-like compounds in an effort to find a just a few viable drug treatment candidates. These high-throughput screens are often automated in sophisticated labs and are expensive to perform.

Recently, deep learning with neural networks has been applied in virtual drug screening1,2,3, which attempts to replace or augment the high-throughput screening process with the use of computational methods in order to improve its speed and success rate.4 Traditionally, virtual drug screening has used only the experimental data from the particular disease being studied. However, as the volume of experimental drug screening data across many diseases continues to grow, several research groups have demonstrated that data from multiple diseases can be leveraged with multitask neural networks to improve the virtual screening effectiveness.

In collaboration with the Pande Lab at Stanford University, we’ve released a paper titled “Massively Multitask Networks for Drug Discovery“, investigating how data from a variety of sources can be used to improve the accuracy of determining which chemical compounds would be effective drug treatments for a variety of diseases. In particular, we carefully quantified how the amount and diversity of screening data from a variety of diseases with very different biological processes can be used to improve the virtual drug screening predictions.

Using our large-scale neural network training system, we trained at a scale 18x larger than previous work with a total of 37.8M data points across more than 200 distinct biological processes. Because of our large scale, we were able to carefully probe the sensitivity of these models to a variety of changes in model structure and input data. In the paper, we examine not just the performance of the model but why it performs well and what we can expect for similar models in the future. The data in the paper represents more than 50M total CPU hours.

SOURCE
http://googleresearch.blogspot.com/2015/03/large-scale-machine-learning-for-drug.html

Google, Stanford say big data is key to deep learning for drug discovery

The researches explain the Premise of their methodology:

The efficacy of multitask learning is directly related to the availability of relevant data. Hence, obtaining greater amounts of data is of critical importance for improving the state of the art. Major pharmaceutical companies possess vast private stores of experimental measurements; our work provides a strong argument that increased data sharing could result in benefits for all.

More data will maximize the benefits achievable using current architectures, but in order for algorithmic progress to occur, it must be possible to judge the performance of proposed models against previous work. It is disappointing to note that all published applications of deep learning to virtual screening (that we are aware of) use distinct datasets that are not directly comparable. It remains to future research to establish standard datasets and performance metrics for this field.

. . .

Although deep learning offers interesting possibilities for virtual screening, the full drug discovery process remains immensely complicated. Can deep learning—coupled with large amounts of experimental data—trigger a revolution in this field? Considering the transformational effect that these methods have had on other fields, we are optimistic about the future.

SOURCE

https://gigaom.com/2015/03/02/google-stanford-say-big-data-is-key-to-deep-learning-for-drug-discovery/?utm_content=bufferb1e92&utm_medium=social&utm_source=linkedin.com&utm_campaign=buffer

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Re-Creation of the Big Pharma Model via Transformational Deals for Accelerating Innovations: Licensing vs In-house inventions

Reporter: Aviva Lev-Ari, PhD, RN

SOURCE

Teva-Allergan Buy Likely Heralds More Big Deals Teva’s acquisition of Allergan’s generic-drugs unit for $40.5 billion is likely to trigger more deal-making in the already-frenzied health-care sector. Bernstein analyst Ronny Gal said investors had highlighted

  • AbbVie,
  • Amgen,
  • Pfizer and
  • Biogen as potential transaction partners.

“Allergan clearly spells interest in using this case for acquisitions,” he said. (denise.roland@wsj.com; @deniseroland)

SOURCE

Market Talk is a stream of real-time news and market analysis that is available on Dow Jones Newswires.

Allegan

“We will have the potential to add scale in existing therapeutic areas, expand into new therapeutic areas and geographies and evaluate strategic transformational deals as we continue to build on our position as the most dynamic branded growth pharma company,” Allergan CEO Brent Saunders said.

In a sign of its continuing ambition, Allergan announced a deal on Sunday, saying it will pay $560 million upfront for Naurex Inc. and its antidepressant-drug candidate.

SOURCE

http://www.wsj.com/articles/teva-to-buy-allergan-generics-for-40-5-billion-1437988044

Allergan: Pharma’s Biggest Dealmaker Is On The Hunt Again

by Matthew Herper Forbes Staff – My favorite Write @Forbes on Pharma and HealthCare

For investors in the generic business, this may be a bit of a warning that stock prices are getting too heady. Saunders (I spoke to him between meetings this morning, as he went on just an hour of sleep) says he expects Teva stock to rise over the long-term, and thinks that the deal for Allergan will improve as that happens. But he also agrees that he’s getting an amazing multiple, and says that two factors led him to the “bittersweet” decision to sell: the great price, and the fact that consolidation among drug purchasers (CVS, Walgreens) and insurers (Aetna buying Humana, Anthem buying Cigna) led Saunders and Bisarro to realize that they had to either bulk up or get out. And they didn’t want to bulk up. Investors in Mylan Pharmaceuticals, which spurned Teva’s advances: Beware.

Saunders is obviously game. One thing that distinguishes him from Valeant billionaire Michael Pearson, the drug industry’s other great consolidator, is that Saunders comes to this from a different place. A decade ago, it looked like he was being groomed by Hassan to potentially take over Schering-Plough before that company ran into problems and got bought by Merck. Unlike Pearson, he’s not looking so much to dismantle the big pharma model as to re-create it.

SOURCE

http://www.forbes.com/sites/matthewherper/2015/07/27/allergan-pharmas-biggest-dealmaker-is-on-the-hunt-again/?utm_medium=email&utm_campaign=Daily%20Digest%20Send%20Control%202015-07-27&utm_source=Sailthru&utm_term=Daily%20Digest%20Horizon%20Control

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