Novo Nordisk: Journey to an R-based FDA Submission

Shifting to An Open-Source Backbone Within Clinical Trials with Roche and Genentech

schedule

Wednesday, January 11, 12:00pm - 1:00pm (EST)

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24h

  • (GMT-11:00)Pacific, Midway
  • (GMT-11:00)Pacific, Niue
  • (GMT-11:00)Pacific, Pago Pago
  • (GMT-10:00)Pacific, Honolulu
  • (GMT-10:00)Pacific, Rarotonga
  • (GMT-10:00)Pacific, Tahiti
  • (GMT-09:30)Pacific, Marquesas
  • (GMT-09:00)America, Adak
  • (GMT-09:00)Pacific, Gambier
  • (GMT-08:00)America, Anchorage
  • (GMT-08:00)America, Juneau
  • (GMT-08:00)America, Metlakatla
  • (GMT-08:00)America, Nome
  • (GMT-08:00)America, Sitka
  • (GMT-08:00)America, Yakutat
  • (GMT-08:00)Pacific, Pitcairn
  • (GMT-07:00)America, Creston
  • (GMT-07:00)America, Dawson
  • (GMT-07:00)America, Dawson Creek
  • (GMT-07:00)America, Fort Nelson
  • (GMT-07:00)America, Hermosillo
  • (GMT-07:00)America, Los Angeles
  • (GMT-07:00)America, Mazatlan
  • (GMT-07:00)America, Phoenix
  • (GMT-07:00)America, Tijuana
  • (GMT-07:00)America, Vancouver
  • (GMT-07:00)America, Whitehorse
  • (GMT-06:00)America, Bahia Banderas
  • (GMT-06:00)America, Belize
  • (GMT-06:00)America, Boise
  • (GMT-06:00)America, Cambridge Bay
  • (GMT-06:00)America, Chihuahua
  • (GMT-06:00)America, Ciudad Juarez
  • (GMT-06:00)America, Costa Rica
  • (GMT-06:00)America, Denver
  • (GMT-06:00)America, Edmonton
  • (GMT-06:00)America, El Salvador
  • (GMT-06:00)America, Guatemala
  • (GMT-06:00)America, Inuvik
  • (GMT-06:00)America, Managua
  • (GMT-06:00)America, Merida
  • (GMT-06:00)America, Mexico City
  • (GMT-06:00)America, Monterrey
  • (GMT-06:00)America, Regina
  • (GMT-06:00)America, Swift Current
  • (GMT-06:00)America, Tegucigalpa
  • (GMT-06:00)Pacific, Easter
  • (GMT-06:00)Pacific, Galapagos
  • (GMT-05:00)America, Atikokan
  • (GMT-05:00)America, Bogota
  • (GMT-05:00)America, Cancun
  • (GMT-05:00)America, Cayman
  • (GMT-05:00)America, Chicago
  • (GMT-05:00)America, Eirunepe
  • (GMT-05:00)America, Guayaquil
  • (GMT-05:00)America, Indiana, Knox
  • (GMT-05:00)America, Indiana, Tell City
  • (GMT-05:00)America, Jamaica
  • (GMT-05:00)America, Lima
  • (GMT-05:00)America, Matamoros
  • (GMT-05:00)America, Menominee
  • (GMT-05:00)America, North Dakota, Beulah
  • (GMT-05:00)America, North Dakota, Center
  • (GMT-05:00)America, North Dakota, New Salem
  • (GMT-05:00)America, Ojinaga
  • (GMT-05:00)America, Panama
  • (GMT-05:00)America, Rankin Inlet
  • (GMT-05:00)America, Resolute
  • (GMT-05:00)America, Rio Branco
  • (GMT-05:00)America, Winnipeg
  • (GMT-04:00)America, Anguilla
  • (GMT-04:00)America, Antigua
  • (GMT-04:00)America, Aruba
  • (GMT-04:00)America, Asuncion
  • (GMT-04:00)America, Barbados
  • (GMT-04:00)America, Blanc-Sablon
  • (GMT-04:00)America, Boa Vista
  • (GMT-04:00)America, Campo Grande
  • (GMT-04:00)America, Caracas
  • (GMT-04:00)America, Cuiaba
  • (GMT-04:00)America, Curacao
  • (GMT-04:00)America, Detroit
  • (GMT-04:00)America, Dominica
  • (GMT-04:00)America, Grand Turk
  • (GMT-04:00)America, Grenada
  • (GMT-04:00)America, Guadeloupe
  • (GMT-04:00)America, Guyana
  • (GMT-04:00)America, Havana
  • (GMT-04:00)America, Indiana, Indianapolis
  • (GMT-04:00)America, Indiana, Marengo
  • (GMT-04:00)America, Indiana, Petersburg
  • (GMT-04:00)America, Indiana, Vevay
  • (GMT-04:00)America, Indiana, Vincennes
  • (GMT-04:00)America, Indiana, Winamac
  • (GMT-04:00)America, Iqaluit
  • (GMT-04:00)America, Kentucky, Louisville
  • (GMT-04:00)America, Kentucky, Monticello
  • (GMT-04:00)America, Kralendijk
  • (GMT-04:00)America, La Paz
  • (GMT-04:00)America, Lower Princes
  • (GMT-04:00)America, Manaus
  • (GMT-04:00)America, Marigot
  • (GMT-04:00)America, Martinique
  • (GMT-04:00)America, Montserrat
  • (GMT-04:00)America, Nassau
  • (GMT-04:00)America, New York
  • (GMT-04:00)America, Port of Spain
  • (GMT-04:00)America, Port-au-Prince
  • (GMT-04:00)America, Porto Velho
  • (GMT-04:00)America, Puerto Rico
  • (GMT-04:00)America, Santiago
  • (GMT-04:00)America, Santo Domingo
  • (GMT-04:00)America, St Barthelemy
  • (GMT-04:00)America, St Kitts
  • (GMT-04:00)America, St Lucia
  • (GMT-04:00)America, St Thomas
  • (GMT-04:00)America, St Vincent
  • (GMT-04:00)America, Toronto
  • (GMT-04:00)America, Tortola
  • (GMT-03:00)America, Araguaina
  • (GMT-03:00)America, Argentina, Buenos Aires
  • (GMT-03:00)America, Argentina, Catamarca
  • (GMT-03:00)America, Argentina, Cordoba
  • (GMT-03:00)America, Argentina, Jujuy
  • (GMT-03:00)America, Argentina, La Rioja
  • (GMT-03:00)America, Argentina, Mendoza
  • (GMT-03:00)America, Argentina, Rio Gallegos
  • (GMT-03:00)America, Argentina, Salta
  • (GMT-03:00)America, Argentina, San Juan
  • (GMT-03:00)America, Argentina, San Luis
  • (GMT-03:00)America, Argentina, Tucuman
  • (GMT-03:00)America, Argentina, Ushuaia
  • (GMT-03:00)America, Bahia
  • (GMT-03:00)America, Belem
  • (GMT-03:00)America, Cayenne
  • (GMT-03:00)America, Fortaleza
  • (GMT-03:00)America, Glace Bay
  • (GMT-03:00)America, Goose Bay
  • (GMT-03:00)America, Halifax
  • (GMT-03:00)America, Maceio
  • (GMT-03:00)America, Moncton
  • (GMT-03:00)America, Montevideo
  • (GMT-03:00)America, Paramaribo
  • (GMT-03:00)America, Punta Arenas
  • (GMT-03:00)America, Recife
  • (GMT-03:00)America, Santarem
  • (GMT-03:00)America, Sao Paulo
  • (GMT-03:00)America, Thule
  • (GMT-03:00)Antarctica, Palmer
  • (GMT-03:00)Antarctica, Rothera
  • (GMT-03:00)Atlantic, Bermuda
  • (GMT-03:00)Atlantic, Stanley
  • (GMT-02:30)America, St Johns
  • (GMT-02:00)America, Miquelon
  • (GMT-02:00)America, Noronha
  • (GMT-02:00)Atlantic, South Georgia
  • (GMT-01:00)America, Nuuk
  • (GMT-01:00)America, Scoresbysund
  • (GMT-01:00)Atlantic, Cape Verde
  • (GMT+00:00)Africa, Abidjan
  • (GMT+00:00)Africa, Accra
  • (GMT+00:00)Africa, Bamako
  • (GMT+00:00)Africa, Banjul
  • (GMT+00:00)Africa, Bissau
  • (GMT+00:00)Africa, Conakry
  • (GMT+00:00)Africa, Dakar
  • (GMT+00:00)Africa, Freetown
  • (GMT+00:00)Africa, Lome
  • (GMT+00:00)Africa, Monrovia
  • (GMT+00:00)Africa, Nouakchott
  • (GMT+00:00)Africa, Ouagadougou
  • (GMT+00:00)Africa, Sao Tome
  • (GMT+00:00)America, Danmarkshavn
  • (GMT+00:00)Atlantic, Azores
  • (GMT+00:00)Atlantic, Reykjavik
  • (GMT+00:00)Atlantic, St Helena
  • (GMT+00:00)UTC
  • (GMT+01:00)Africa, Algiers
  • (GMT+01:00)Africa, Bangui
  • (GMT+01:00)Africa, Brazzaville
  • (GMT+01:00)Africa, Casablanca
  • (GMT+01:00)Africa, Douala
  • (GMT+01:00)Africa, El Aaiun
  • (GMT+01:00)Africa, Kinshasa
  • (GMT+01:00)Africa, Lagos
  • (GMT+01:00)Africa, Libreville
  • (GMT+01:00)Africa, Luanda
  • (GMT+01:00)Africa, Malabo
  • (GMT+01:00)Africa, Ndjamena
  • (GMT+01:00)Africa, Niamey
  • (GMT+01:00)Africa, Porto-Novo
  • (GMT+01:00)Africa, Tunis
  • (GMT+01:00)Atlantic, Canary
  • (GMT+01:00)Atlantic, Faroe
  • (GMT+01:00)Atlantic, Madeira
  • (GMT+01:00)Europe, Dublin
  • (GMT+01:00)Europe, Guernsey
  • (GMT+01:00)Europe, Isle of Man
  • (GMT+01:00)Europe, Jersey
  • (GMT+01:00)Europe, Lisbon
  • (GMT+01:00)Europe, London
  • (GMT+02:00)Africa, Blantyre
  • (GMT+02:00)Africa, Bujumbura
  • (GMT+02:00)Africa, Cairo
  • (GMT+02:00)Africa, Ceuta
  • (GMT+02:00)Africa, Gaborone
  • (GMT+02:00)Africa, Harare
  • (GMT+02:00)Africa, Johannesburg
  • (GMT+02:00)Africa, Juba
  • (GMT+02:00)Africa, Khartoum
  • (GMT+02:00)Africa, Kigali
  • (GMT+02:00)Africa, Lubumbashi
  • (GMT+02:00)Africa, Lusaka
  • (GMT+02:00)Africa, Maputo
  • (GMT+02:00)Africa, Maseru
  • (GMT+02:00)Africa, Mbabane
  • (GMT+02:00)Africa, Tripoli
  • (GMT+02:00)Africa, Windhoek
  • (GMT+02:00)Antarctica, Troll
  • (GMT+02:00)Arctic, Longyearbyen
  • (GMT+02:00)Europe, Amsterdam
  • (GMT+02:00)Europe, Andorra
  • (GMT+02:00)Europe, Belgrade
  • (GMT+02:00)Europe, Berlin
  • (GMT+02:00)Europe, Bratislava
  • (GMT+02:00)Europe, Brussels
  • (GMT+02:00)Europe, Budapest
  • (GMT+02:00)Europe, Busingen
  • (GMT+02:00)Europe, Copenhagen
  • (GMT+02:00)Europe, Gibraltar
  • (GMT+02:00)Europe, Kaliningrad
  • (GMT+02:00)Europe, Ljubljana
  • (GMT+02:00)Europe, Luxembourg
  • (GMT+02:00)Europe, Madrid
  • (GMT+02:00)Europe, Malta
  • (GMT+02:00)Europe, Monaco
  • (GMT+02:00)Europe, Oslo
  • (GMT+02:00)Europe, Paris
  • (GMT+02:00)Europe, Podgorica
  • (GMT+02:00)Europe, Prague
  • (GMT+02:00)Europe, Rome
  • (GMT+02:00)Europe, San Marino
  • (GMT+02:00)Europe, Sarajevo
  • (GMT+02:00)Europe, Skopje
  • (GMT+02:00)Europe, Stockholm
  • (GMT+02:00)Europe, Tirane
  • (GMT+02:00)Europe, Vaduz
  • (GMT+02:00)Europe, Vatican
  • (GMT+02:00)Europe, Vienna
  • (GMT+02:00)Europe, Warsaw
  • (GMT+02:00)Europe, Zagreb
  • (GMT+02:00)Europe, Zurich
  • (GMT+03:00)Africa, Addis Ababa
  • (GMT+03:00)Africa, Asmara
  • (GMT+03:00)Africa, Dar es Salaam
  • (GMT+03:00)Africa, Djibouti
  • (GMT+03:00)Africa, Kampala
  • (GMT+03:00)Africa, Mogadishu
  • (GMT+03:00)Africa, Nairobi
  • (GMT+03:00)Antarctica, Syowa
  • (GMT+03:00)Asia, Aden
  • (GMT+03:00)Asia, Amman
  • (GMT+03:00)Asia, Baghdad
  • (GMT+03:00)Asia, Bahrain
  • (GMT+03:00)Asia, Beirut
  • (GMT+03:00)Asia, Damascus
  • (GMT+03:00)Asia, Famagusta
  • (GMT+03:00)Asia, Gaza
  • (GMT+03:00)Asia, Hebron
  • (GMT+03:00)Asia, Jerusalem
  • (GMT+03:00)Asia, Kuwait
  • (GMT+03:00)Asia, Nicosia
  • (GMT+03:00)Asia, Qatar
  • (GMT+03:00)Asia, Riyadh
  • (GMT+03:00)Europe, Athens
  • (GMT+03:00)Europe, Bucharest
  • (GMT+03:00)Europe, Chisinau
  • (GMT+03:00)Europe, Helsinki
  • (GMT+03:00)Europe, Istanbul
  • (GMT+03:00)Europe, Kirov
  • (GMT+03:00)Europe, Kyiv
  • (GMT+03:00)Europe, Mariehamn
  • (GMT+03:00)Europe, Minsk
  • (GMT+03:00)Europe, Moscow
  • (GMT+03:00)Europe, Riga
  • (GMT+03:00)Europe, Simferopol
  • (GMT+03:00)Europe, Sofia
  • (GMT+03:00)Europe, Tallinn
  • (GMT+03:00)Europe, Vilnius
  • (GMT+03:00)Europe, Volgograd
  • (GMT+03:00)Indian, Antananarivo
  • (GMT+03:00)Indian, Comoro
  • (GMT+03:00)Indian, Mayotte
  • (GMT+03:30)Asia, Tehran
  • (GMT+04:00)Asia, Baku
  • (GMT+04:00)Asia, Dubai
  • (GMT+04:00)Asia, Muscat
  • (GMT+04:00)Asia, Tbilisi
  • (GMT+04:00)Asia, Yerevan
  • (GMT+04:00)Europe, Astrakhan
  • (GMT+04:00)Europe, Samara
  • (GMT+04:00)Europe, Saratov
  • (GMT+04:00)Europe, Ulyanovsk
  • (GMT+04:00)Indian, Mahe
  • (GMT+04:00)Indian, Mauritius
  • (GMT+04:00)Indian, Reunion
  • (GMT+04:30)Asia, Kabul
  • (GMT+05:00)Antarctica, Mawson
  • (GMT+05:00)Antarctica, Vostok
  • (GMT+05:00)Asia, Aqtau
  • (GMT+05:00)Asia, Aqtobe
  • (GMT+05:00)Asia, Ashgabat
  • (GMT+05:00)Asia, Atyrau
  • (GMT+05:00)Asia, Dushanbe
  • (GMT+05:00)Asia, Karachi
  • (GMT+05:00)Asia, Oral
  • (GMT+05:00)Asia, Qyzylorda
  • (GMT+05:00)Asia, Samarkand
  • (GMT+05:00)Asia, Tashkent
  • (GMT+05:00)Asia, Yekaterinburg
  • (GMT+05:00)Indian, Kerguelen
  • (GMT+05:00)Indian, Maldives
  • (GMT+05:30)Asia, Colombo
  • (GMT+05:30)Asia, Kolkata
  • (GMT+05:45)Asia, Kathmandu
  • (GMT+06:00)Asia, Almaty
  • (GMT+06:00)Asia, Bishkek
  • (GMT+06:00)Asia, Dhaka
  • (GMT+06:00)Asia, Omsk
  • (GMT+06:00)Asia, Qostanay
  • (GMT+06:00)Asia, Thimphu
  • (GMT+06:00)Asia, Urumqi
  • (GMT+06:00)Indian, Chagos
  • (GMT+06:30)Asia, Yangon
  • (GMT+06:30)Indian, Cocos
  • (GMT+07:00)Antarctica, Davis
  • (GMT+07:00)Asia, Bangkok
  • (GMT+07:00)Asia, Barnaul
  • (GMT+07:00)Asia, Ho Chi Minh
  • (GMT+07:00)Asia, Hovd
  • (GMT+07:00)Asia, Jakarta
  • (GMT+07:00)Asia, Krasnoyarsk
  • (GMT+07:00)Asia, Novokuznetsk
  • (GMT+07:00)Asia, Novosibirsk
  • (GMT+07:00)Asia, Phnom Penh
  • (GMT+07:00)Asia, Pontianak
  • (GMT+07:00)Asia, Tomsk
  • (GMT+07:00)Asia, Vientiane
  • (GMT+07:00)Indian, Christmas
  • (GMT+08:00)Antarctica, Casey
  • (GMT+08:00)Asia, Brunei
  • (GMT+08:00)Asia, Choibalsan
  • (GMT+08:00)Asia, Hong Kong
  • (GMT+08:00)Asia, Irkutsk
  • (GMT+08:00)Asia, Kuala Lumpur
  • (GMT+08:00)Asia, Kuching
  • (GMT+08:00)Asia, Macau
  • (GMT+08:00)Asia, Makassar
  • (GMT+08:00)Asia, Manila
  • (GMT+08:00)Asia, Shanghai
  • (GMT+08:00)Asia, Singapore
  • (GMT+08:00)Asia, Taipei
  • (GMT+08:00)Asia, Ulaanbaatar
  • (GMT+08:00)Australia, Perth
  • (GMT+08:45)Australia, Eucla
  • (GMT+09:00)Asia, Chita
  • (GMT+09:00)Asia, Dili
  • (GMT+09:00)Asia, Jayapura
  • (GMT+09:00)Asia, Khandyga
  • (GMT+09:00)Asia, Pyongyang
  • (GMT+09:00)Asia, Seoul
  • (GMT+09:00)Asia, Tokyo
  • (GMT+09:00)Asia, Yakutsk
  • (GMT+09:00)Pacific, Palau
  • (GMT+09:30)Australia, Adelaide
  • (GMT+09:30)Australia, Broken Hill
  • (GMT+09:30)Australia, Darwin
  • (GMT+10:00)Antarctica, DumontDUrville
  • (GMT+10:00)Antarctica, Macquarie
  • (GMT+10:00)Asia, Ust-Nera
  • (GMT+10:00)Asia, Vladivostok
  • (GMT+10:00)Australia, Brisbane
  • (GMT+10:00)Australia, Hobart
  • (GMT+10:00)Australia, Lindeman
  • (GMT+10:00)Australia, Melbourne
  • (GMT+10:00)Australia, Sydney
  • (GMT+10:00)Pacific, Chuuk
  • (GMT+10:00)Pacific, Guam
  • (GMT+10:00)Pacific, Port Moresby
  • (GMT+10:00)Pacific, Saipan
  • (GMT+10:30)Australia, Lord Howe
  • (GMT+11:00)Asia, Magadan
  • (GMT+11:00)Asia, Sakhalin
  • (GMT+11:00)Asia, Srednekolymsk
  • (GMT+11:00)Pacific, Bougainville
  • (GMT+11:00)Pacific, Efate
  • (GMT+11:00)Pacific, Guadalcanal
  • (GMT+11:00)Pacific, Kosrae
  • (GMT+11:00)Pacific, Norfolk
  • (GMT+11:00)Pacific, Noumea
  • (GMT+11:00)Pacific, Pohnpei
  • (GMT+12:00)Antarctica, McMurdo
  • (GMT+12:00)Asia, Anadyr
  • (GMT+12:00)Asia, Kamchatka
  • (GMT+12:00)Pacific, Auckland
  • (GMT+12:00)Pacific, Fiji
  • (GMT+12:00)Pacific, Funafuti
  • (GMT+12:00)Pacific, Kwajalein
  • (GMT+12:00)Pacific, Majuro
  • (GMT+12:00)Pacific, Nauru
  • (GMT+12:00)Pacific, Tarawa
  • (GMT+12:00)Pacific, Wake
  • (GMT+12:00)Pacific, Wallis
  • (GMT+12:45)Pacific, Chatham
  • (GMT+13:00)Pacific, Apia
  • (GMT+13:00)Pacific, Fakaofo
  • (GMT+13:00)Pacific, Kanton
  • (GMT+13:00)Pacific, Tongatapu
  • (GMT+14:00)Pacific, Kiritimati

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    On January 11th, 2023, data science leaders at Roche & Genentech will be joining us to present the organization's shift to an open-source backbone within clinical trials. This shift is the culmination of years of preparation and innovation both within the organization and across the entire pharmaceutical industry. 

    You can join the presentation on YouTube Live on the day of the event: https://www.youtube.com/watch?v=nqJsLSLd39A

    There's no need to register. Just add the event to your calendar.

    Presentation Details

    Topic: Moving to a fully open-source clinical reporting workflow as the default for clinical trials at Roche

    Problem: When pharmaceutical companies wish to get a new drug approved, they must produce hundreds of tables, plots, and listings to provide the evidence for regulators to assess. Traditionally these were produced using a proprietary language with internally developed tools, and the lifecycle of tools could be measured in decades.
     
    In 2023 Roche is moving to a new open-source backbone, with packages co-developed with other companies and a new focus on a continually evolving set of tools that are owned and contributed to by the users. 
     
    Over 1,000 statisticians and statistical programmers at Roche need to embrace this transition and adapt to a new set of R/Python tools to deploy our new data science focussed workflows. 
     
    Solution: Roche approached preparing for the go-live of end-to-end open source trials in a three-pronged strategy: 
     
    1) Build a culture that embraces lifelong learning and self-improvement, allowing our data scientists to take on new skills and languages as the industry evolves
    2) Build a plan to ensure study teams are closely supported, with a tight feedback loop between tool developers and the users
    3) Co-create tools by focusing on collaborations like the pharmaverse to pool our efforts and accelerate the development of tools across pharma companies.

    Add to Calendar 2023/01/11 12:00:00 2023/01/11 13:00:00 America/New_York Shifting to An Open-Source Backbone Within Clinical Trials with Roche and Genentech On January 11th, 2023, data science leaders at Roche & Genentech will be joining us to present the organization's shift to an open-source backbone within clinical trials. This shift is the culmination of years of preparation and innovation both within the organization and across the entire pharmaceutical industry. 

    You can join the presentation on YouTube Live on the day of the event: https://www.youtube.com/watch?v=nqJsLSLd39A

    There's no need to register. Just add the event to your calendar.

    Presentation Details

    Topic: Moving to a fully open-source clinical reporting workflow as the default for clinical trials at Roche

    Problem: When pharmaceutical companies wish to get a new drug approved, they must produce hundreds of tables, plots, and listings to provide the evidence for regulators to assess. Traditionally these were produced using a proprietary language with internally developed tools, and the lifecycle of tools could be measured in decades.
     
    In 2023 Roche is moving to a new open-source backbone, with packages co-developed with other companies and a new focus on a continually evolving set of tools that are owned and contributed to by the users. 
     
    Over 1,000 statisticians and statistical programmers at Roche need to embrace this transition and adapt to a new set of R/Python tools to deploy our new data science focussed workflows. 
     
    Solution: Roche approached preparing for the go-live of end-to-end open source trials in a three-pronged strategy: 
     
    1) Build a culture that embraces lifelong learning and self-improvement, allowing our data scientists to take on new skills and languages as the industry evolves
    2) Build a plan to ensure study teams are...

    ---
    Event details:
    https://www.addevent.com/event/ek15723352



    https://www.youtube.com/watch?v=nqJsLSLd39A false MM/DD/YYYY 30 OPAQUE aKHNCcebtzjkzVhQGmnG134315
    location_on

    https://www.youtube.com/watch?v=nqJsLSLd39A

    person

    Robert Bethell, robert@rstudio.com