OCE

IQVIA and Salesforce Expand Global Partnership to Accelerate the Development of Life Sciences Cloud

Retrieved on: 
Monday, April 8, 2024
Data Management, Biotechnology, Technology, Professional Services, Health, Health Technology, Other Science, Research, Data Analytics, Software, Science, Cloud, CRM, Organization, Partnership, OCE, SVP, Sale, AI, Patient safety, HCP, IQV, Fine chemical

IQVIA (NYSE:IQV), a leading global provider of data, analytics, technology and services to the life sciences industry, and Salesforce (NYSE:CRM), the #1 AI CRM, today announced an expanded global strategic partnership to accelerate the development of Salesforce’s Life Sciences Cloud, a next-generation customer engagement platform for the global life sciences industry.

Key Points: 
  • IQVIA (NYSE:IQV), a leading global provider of data, analytics, technology and services to the life sciences industry, and Salesforce (NYSE:CRM), the #1 AI CRM, today announced an expanded global strategic partnership to accelerate the development of Salesforce’s Life Sciences Cloud, a next-generation customer engagement platform for the global life sciences industry.
  • Building on the IQVIA Orchestrated Customer Engagement ( OCE ) platform, launched in 2017, the partnership will apply innovations from IQVIA OCE with Salesforce’s Life Sciences Cloud to provide customers with a new single, end-to-end engagement platform.
  • As part of the expanded partnership, IQVIA will license the OCE CRM related software to Salesforce, and the parties will collaborate to accelerate development of Life Sciences Cloud for customer engagement, expected to be available in 2025*.
  • “Our collaboration with IQVIA marks a pivotal moment for Salesforce Life Sciences Cloud innovation.

FDA Roundup: March 22, 2024

Retrieved on: 
Friday, March 22, 2024
Health, Capecitabine, PFAS, FCN, Dietary supplement, OCE, Risk, COVID-19, Patient, Warning, Tablet, Public, RNA, DNA, Animal, News, Plasma protein binding, Emergency Use Authorization, Human services, Role, System, SARS-CoV-2, Physical examination, Plasmodium vivax, Plasmodium falciparum, Highlight, Malaria, Heated tobacco product, CFR, Vaccination, Safety, DPD, Cosmetics, Growth, Vaccine, Plasmodium ovale, Marketing, Food, FDA, Multimedia, Ponatinib

On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.

Key Points: 
  • On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.
  • From launch of the Breakthrough Devices Program through December 31, 2023, in total, the FDA granted 933 Breakthrough Devices designations and authorized 95 Breakthrough Devices for marketing.
  • On Thursday, the FDA approved safety labeling changes for fluorouracil injection products.
  • These changes also enable the FDA to more effectively respond to new information on the safety and use of food contact substances.

Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority

Retrieved on: 
Friday, February 2, 2024
Orbis, HC, JAMA, TGA, HSA, European, Shirin David, Immunotherapy, Trial of the century, Nasopharyngeal carcinoma, NPC, PFS, Clutch (eggs), Cisplatin, Patient, Safety, ASCO, New Drug Application, American Medical Association, Shanda, Progression-free survival, FDA, Marketing, OCE, Dor, Food, Society, Health Canada, Risk, Journal, Death, Health care, NDA, HKEX, Pharmaceutical industry

This NDA was submitted through Project Orbis, an initiative of the US Food and Drug Administration (FDA)’s Oncology Center of Excellence (OCE).

Key Points: 
  • This NDA was submitted through Project Orbis, an initiative of the US Food and Drug Administration (FDA)’s Oncology Center of Excellence (OCE).
  • At present, eight regulatory agencies have joined Project Orbis, including the FDA, the Australia Therapeutic Goods Administration (“TGA”), HSA, Health Canada (HC), the U.K.
  • Previously, two NDAs for toripalimab for the treatment of NPC had been submitted to the TGA through Project Orbis and were successfully accepted.
  • Junshi Biosciences will explore accelerated marketing opportunities in countries and regions where it is applicable.

Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations, European Medicines Agency, Amsterdam, the Netherlands, from 1 February 2024, 15:30 (CET) to 1 February 2024, 17:00 (CET)

Retrieved on: 
Friday, January 19, 2024
Role, Patient, OCE, Accelerated approval (FDA), Melanoma, European Medicines Agency, EMA, Outline, Location, Multiple myeloma, Therapy, Acute leukemia, Pharmaceutical industry

The conversation will focus on the introduction of certain innovative therapeutic classes in the past two decades that have revolutionized the care for patients with chronic myeloid leukemia, multiple myeloma, and melanoma.

Key Points: 
  • The conversation will focus on the introduction of certain innovative therapeutic classes in the past two decades that have revolutionized the care for patients with chronic myeloid leukemia, multiple myeloma, and melanoma.
  • The discussion will provide an overview of regulatory programs that expedite access to patients, including FDA’s Breakthrough therapy designation and Accelerated Approval; and EMA’s Prime and Conditional Approval.
  • The panel of patients, investigators and regulators aims to highlight successes from development to approval.
  • We’ll specifically outline:
    - Patient experiences with new innovative therapeutic classes;
    - Investigator approaches in development;
    - Role of regulatory collaboration and programs to expedite development and approval of novel, safe, and effective therapeutics.

Syapse and FDA Extend Collaboration to Advance the Use of Real-World Data (RWD) and Inform Regulatory Science in Oncology

Retrieved on: 
Tuesday, December 5, 2023
RWD, COVID-19, OCE, Fear, Research, Lung cancer, MD, SAN, Cancer, Patient, LHN, Safety, RWE

SAN FRANCISCO, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Syapse®, a leading real-world evidence company dedicated to extinguishing the fear and burden of serious diseases by advancing real-world care, and the FDA Oncology Center of Excellence (OCE) renewed a four-year agreement to collaboratively develop and implement specific research projects to advance the use of real-world data (RWD) and explore the potential strengths and limitations of using real-world evidence (RWE) to inform regulatory objectives.

Key Points: 
  • SAN FRANCISCO, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Syapse®, a leading real-world evidence company dedicated to extinguishing the fear and burden of serious diseases by advancing real-world care, and the FDA Oncology Center of Excellence (OCE) renewed a four-year agreement to collaboratively develop and implement specific research projects to advance the use of real-world data (RWD) and explore the potential strengths and limitations of using real-world evidence (RWE) to inform regulatory objectives.
  • This collaboration specifically aims to evaluate RWD study designs and analytic methods, and to develop clinically meaningful research questions regarding care, treatment, and outcomes of patients with cancer.
  • “Our early work with the FDA Oncology Center of Excellence evaluated safety and health disparities through the lens of RWD,” said Thomas Brown, MD, Chief Medical Officer at Syapse.
  • “Specifically, we analyzed real-world immune-checkpoint inhibitor-related pneumonitis in lung cancer and were one of the first to respond to assess the impact of Covid-19 on cancer patients during the pandemic.

Junshi Biosciences Announces New Chemical Entity Application for Toripalimab Accepted by Australia’s TGA

Retrieved on: 
Saturday, December 2, 2023
Orbis, Marketing, Clutch (eggs), NPC, JAMA, Nasopharyngeal carcinoma, Risk, Ministry, OCE, ASCO, Shanda, Radiation, HSA, FDA, Dor, New chemical entity, European, Progression-free survival, Society, Cisplatin, NCE, MHRA, Cancer, Head, Death, American Medical Association, Health Canada, HC, World Health Organization, Primary tumor, Patient, Therapeutic Goods Administration, Safety, PFS, Journal, TGA, Pharmaceutical industry

Additionally, the TGA has also granted an orphan drug designation to toripalimab for the treatment of NPC.

Key Points: 
  • Additionally, the TGA has also granted an orphan drug designation to toripalimab for the treatment of NPC.
  • At present, seven other regulatory agencies have joined Project Orbis, including the TGA, Singapore Health Sciences Authority (HSA), Health Canada (HC), MHRA, etc.
  • Toripalimab for the treatment of NPC meets these application requirements and is the first domestic oncology drug to be included in Project Orbis.
  • Junshi Biosciences will explore the possibility of fast marketing in these countries and regions where the pathway is applicable.

FDA Oncology Center of Excellence: Programs & Projects That Impact Drug Development, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Tuesday, November 21, 2023
Drug development, Research, Assistant director, OCE, FDA, Pharmaceutical industry, Nursing

TORONTO, Nov. 21, 2023 /PRNewswire-PRWeb/ -- Since 2017, the FDA's Oncology Center of Excellence (OCE) has created more than 300 research and educational outreach projects and programs focused on advancing the design, analysis, and regulations surrounding oncology drug development. As development continues to rapidly evolve, these projects and programs are intended to promote more effective and safer products, more accessible and efficient trials, and better patient outcomes.

Key Points: 
  • In this free webinar, learn about the FDA Oncology Center of Excellence's special projects and programs.
  • Attendees will gain insights into the growing requirements for diversity, equity and inclusion among oncology clinical research.
  • In this webinar, Worldwide Clinical Trials' clinical research methodology and oncology strategy experts will present the OCE's most imperative initiatives.
  • Attendees of this webinar will gain an understanding of multiple evolving projects at the OCE and how they impact your oncology program.

OhmConnect Energy Boasts Impressive Savings and Protects Grid During Summer Heatwaves

Retrieved on: 
Tuesday, November 7, 2023
Public utilities commission, OCE, Commission, Risk, Public Utilities Commission of Ohio, Renewable energy, Electric power

HOUSTON, Nov. 7, 2023 /PRNewswire/ -- OhmConnect Energy (OCE), a first-of-its kind energy provider integrating residential demand response in all of its offerings, made significant strides in demonstrating the value of its offering as a critical tool in the transition to a renewable energy future. As temperatures soared and power consumption broke records across the state, OCE's community of energy-savers responded to calls to reduce their usage, taking strain off the grid while also reducing their utility bills.

Key Points: 
  • OCE utilizes demand response (DR) during peak times and rewards its customers for saving energy.
  • OCE dispatched nearly 40 energy-saving events, throughout the month of August, giving its customers more chances to save money, while playing their part in stabilizing the grid.
  • During the summer heatwaves, OCE customers collectively delivered 65MWh in energy savings to the grid by consistently reducing peak load by 5% during energy savings events.
  • They both highlight the potential for demand response to not only meet, but surpass, our expectations for energy savings, underscoring the significant strides we can make in advancing the evolution of our electric grid."

IQVIA to Provide Sanofi Its Orchestrated Customer Engagement (OCE) Platform in Africa & Middle East

Retrieved on: 
Monday, October 23, 2023
Health, Technology, Software, General Health, Research, Science, OCE, Intelligence, NYSE, Health care, IQV, Consumer Healthcare Products Association, HCP, Senior, Salesforce, CRM, IQVIA, Pharmaceutical industry, Management, Sanofi

IQVIA™ (NYSE:IQV), a leading global provider of advanced analytics, technology solutions and clinical research services to the pharmaceutical and broader life sciences industry, today announced that Sanofi will use the IQVIA OCE platform in select countries across Africa and the Middle East.

Key Points: 
  • IQVIA™ (NYSE:IQV), a leading global provider of advanced analytics, technology solutions and clinical research services to the pharmaceutical and broader life sciences industry, today announced that Sanofi will use the IQVIA OCE platform in select countries across Africa and the Middle East.
  • IQVIA OCE is a next-generation life sciences commercial platform that connects all customer-facing functions to deliver more personalized and optimized customer experiences.
  • “Sanofi Consumer Healthcare has been using IQVIA in many markets to support our HCP engagement.
  • “IQVIA has a longstanding relationship with Sanofi, and we are delighted to provide our OCE platform for their advanced customer engagement needs,” said Peter Lane, Senior Vice President and General Manager, Africa, Middle East and South Asia, IQVIA.

THE LAWFARE PROJECT FILES OFFICE OF CONGRESSIONAL ETHICS COMPLAINT AGAINST REP. RASHIDA TLAIB (D-MI)

Retrieved on: 
Monday, October 23, 2023
OCE, LP, Hamas, Complaint, Social media, Publishing, United States House Committee on Ethics, Office of Congressional Ethics, White House, Congress, Arab world, IDF, Representative, Lawfare Project, Islamic Jihad, Islamic Jihad Movement in Palestine, House, PIJ, United Nations Security Council, House Committee, Ethics

NEW YORK, Oct. 23, 2023 /PRNewswire/ -- On Thursday, October 19, 2023, The Lawfare Project's (LP) filed an official ethics complaint against Rep. Rashida Tlaib (D-MI) with the Office of Congressional Ethics (OCE). The complaint, linked here, asserts that Tlaib directly violated Rule 1 of the U.S. House of Representatives' Code of Official Conduct by publishing a statement on her X (formerly Twitter) account that falsely and recklessly accuses the Israeli Defense Forces (IDF) of being responsible for the recent deadly attack on a hospital in Gaza.

Key Points: 
  • World's Leading Pro Bono Jewish Legal Group Asserts Representative Violated U.S. House of Representatives Code of Official Conduct
    NEW YORK, Oct. 23, 2023 /PRNewswire/ -- On Thursday, October 19, 2023, The Lawfare Project 's (LP) filed an official ethics complaint against Rep. Rashida Tlaib (D-MI) with the Office of Congressional Ethics (OCE).
  • LP's complaint calls upon the OCE to immediately launch an investigation into Tlaib and to refer the matter to the House Committee on Ethics.
  • "Instead, she spoke at a pro-Hamas rally where she doubled down on the lie and has refused to retract it.
  • LP is urging individuals to contact their local congressional representatives in the House and demand that Congress launch an investigation into Rep. Tlaib.