Pros

Parexel Recognized with Frost & Sullivan's 2023 North American Customer Value Leadership Award for Impactful Real-world Evidence Solutions Addressing Customer Needs

Retrieved on: 
Tuesday, December 19, 2023
RWD, Health, Health care, Research, Frost, SAN, Pros, Parexel, ChromeOS, RWE

SAN ANTONIO, Texas, Dec. 19, 2023 /PRNewswire/ -- Frost & Sullivan today recognized Parexel, one of the world's largest clinical research organizations (CROs), with the 2023 North American Customer Value Leadership Award following recent in-depth research of the Real-world Evidence (RWE) services industry. Parexel has more than 40 years of experience and 21,000+ dedicated professionals globally who successfully collaborate with biopharmaceutical leaders to design and conduct patient-focused clinical trials worldwide.

Key Points: 
  • SAN ANTONIO, Texas, Dec. 19, 2023 /PRNewswire/ -- Frost & Sullivan today recognized Parexel, one of the world's largest clinical research organizations (CROs) , with the 2023 North American Customer Value Leadership Award following recent in-depth research of the Real-world Evidence (RWE) services industry.
  • Parexel leverages its in-depth RWE knowledge to identify evidence gaps and formulate evidence-generation strategies.
  • "The rise in RWE incorporation into regulatory submissions combined with resource scarcity provides Parexel with a growth path for its RWE services.
  • Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.

Parexel Recognized with Frost & Sullivan's 2023 North American Customer Value Leadership Award for Impactful Real-world Evidence Solutions Addressing Customer Needs

Retrieved on: 
Tuesday, December 19, 2023
RWD, Health, Health care, Research, Frost, SAN, Pros, Parexel, ChromeOS, RWE

SAN ANTONIO, Texas, Dec. 19, 2023 /PRNewswire/ -- Frost & Sullivan today recognized Parexel, one of the world's largest clinical research organizations (CROs), with the 2023 North American Customer Value Leadership Award following recent in-depth research of the Real-world Evidence (RWE) services industry. Parexel has more than 40 years of experience and 21,000+ dedicated professionals globally who successfully collaborate with biopharmaceutical leaders to design and conduct patient-focused clinical trials worldwide.

Key Points: 
  • SAN ANTONIO, Texas, Dec. 19, 2023 /PRNewswire/ -- Frost & Sullivan today recognized Parexel, one of the world's largest clinical research organizations (CROs) , with the 2023 North American Customer Value Leadership Award following recent in-depth research of the Real-world Evidence (RWE) services industry.
  • Parexel leverages its in-depth RWE knowledge to identify evidence gaps and formulate evidence-generation strategies.
  • "The rise in RWE incorporation into regulatory submissions combined with resource scarcity provides Parexel with a growth path for its RWE services.
  • Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.

Geron Announces IMerge Phase 3 Presentations at ASH Highlighting Significant Durability of Transfusion Independence and Breadth of Effect Across MDS Subgroups with Imetelstat in Lower Risk MDS

Retrieved on: 
Monday, December 11, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Yale Cancer Center, Associate, International Prognostic Scoring System, Quality, IPSS, VAF, ASH, Acute myeloid leukemia, Cytopenia, Risk, Pros, Corporation, Yale school, Fatigue, Patient, Thrombocytopenia, Research, Periodic breathing, Imetelstat, Quality of life, Internal medicine, MDS, Neutropenia, MBBS, Yale School of Medicine, Bleeding, Survival, Pain, AML, Geron Corporation, Society, Iron overload, Mutation, RBC, Pharmaceutical industry, Dietary supplement, Lancet, Geron, SF3B1, Blood, Medicine, Hematology

The results showed that imetelstat consistently had higher RBC-TI response rates than placebo across these different risk subgroups.

Key Points: 
  • The results showed that imetelstat consistently had higher RBC-TI response rates than placebo across these different risk subgroups.
  • Overall, durable 24-week and 1-year RBC-TI responses were observed with imetelstat in all lower- and higher-risk subgroups.
  • This analysis suggests clinical benefit of imetelstat across different molecularly defined subgroups and independent of the underlying molecular mutation pattern.
  • This analysis indicates that achievement of RBC-TI was associated with improved survival, suggesting that transfusion dependence is a modifiable predictor of clinical outcomes in lower risk MDS.

Bristol Myers Squibb Presents New Data at ASH 2023 Demonstrating Clinical Benefit Across B-cell Malignancies with Breyanzi as a Second-Line Treatment in High-Risk Follicular Lymphoma and in Relapsed or Refractory Chronic Lymphocytic Leukemia

Retrieved on: 
Monday, December 11, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, City, ASH, CRS, Pros, Patient, Probability, Conference, Bristol Myers Squibb, Prognosis, ORR, Quality of life, Disclosure, Safety, Food, SLL, Jungian cognitive functions, DOR, Trial of the century, Blood, Lymphoma, Society, Bone marrow, Neuropsychological test, Haematopoietic system, BMY, Pain, Journal of Clinical Oncology, NYSE, BTK, MCL, Clinical trial, Fatigue, Follicular lymphoma, PRO, Chronic lymphocytic leukemia, BMS, NHL, CLL, HIV disease progression rates, Pharmaceutical industry, Veterinary medicine, Lisocabtagene maraleucel, Hematology

TRANSCEND FL is the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including FL.

Key Points: 
  • TRANSCEND FL is the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including FL.
  • Additionally, the company presented long-term data from the TRANSCEND CLL 004 study evaluating Breyanzi in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) with 24-month follow-up ( Oral Presentation #330 ).
  • Bristol Myers Squibb (BMS) has the broadest ongoing cell therapy development program in CD19-positive malignancies with Breyanzi, which also includes trials investigating its use in patients with relapsed/refractory mantle cell lymphoma (MCL).
  • In the TRANSCEND FL clinical trial, 130 patients with relapsed or refractory follicular lymphoma (FL) were enrolled and treated with Breyanzi in the second-line and third-line plus settings.

EMA and European Organisation for Research and Treatment of Cancer (EORTC) workshop: How can patient-reported outcomes (PRO) and health-related quality of life (HRQoL) data inform regulatory decisions?, European Medicines Agency, Amsterdam, the Nethe[...]

Retrieved on: 
Monday, December 18, 2023
Location, EORTC, European Medicines Agency, Treatment, Pros, Quality of life (healthcare), EMA, Patient, Research, PRO, Facilitation, HRQOL, Industry, Medical device, Cancer

Date

Key Points: 
  • Date
    - Thursday, 29 February 2024
    Location
    - European Medicines Agency, Amsterdam, the Netherlands
    Event summary
    The European Medicines Agency (EMA) and the European Organisation for Research and Treatment of Cancer (EORTC) are jointly organising a workshop on how patient-reported outcomes (PRO) as well as health-related quality of life (HRQoL) data can inform regulatory decisions (please see the draft agenda attached).
  • This workshop will bring together international experts from academia, learned societies, patients, regulatory agencies, health technology assessment bodies, and industry.
  • The aims of the workshop are to:
    - Understand the current global landscape on the use of PROs and HRQOL for evaluation of anti-cancer treatments across different stakeholder groups.
  • - Understand the use of validated PRO questionnaires to measure core HRQOL outcomes and disease-related symptoms; and PRO Item Libraries in the development of trial-specific/treatment-specific item lists.

Analysis Group Researchers Evaluated Long-Term Patient Experience with Dupilumab Using Groundbreaking Method for Generating Real-World Data

Retrieved on: 
Tuesday, December 12, 2023
Regeneron Pharmaceuticals, JAMA Dermatology, Analysis Group, Atopic dermatitis, LEAP, Physician, Gold, Pros, Clinical trial, Yale school, RWD, Sinusitis, Harvard Medical School, Polyp (medicine), Yale School of Medicine, Area studies, JAMA, Nursing, Pharmaceutical industry, Sanofi, Dermatology, Patient

The study, published in the journal Dermatology and Therapy , extends the one-year results of the previously published RELIEVE-AD study in JAMA Dermatology , which was based on a groundbreaking method for generating real-world data (RWD).

Key Points: 
  • The study, published in the journal Dermatology and Therapy , extends the one-year results of the previously published RELIEVE-AD study in JAMA Dermatology , which was based on a groundbreaking method for generating real-world data (RWD).
  • This approach provides a true baseline against which to compare longitudinal data over time.
  • "Generating real-world data is particularly challenging for conditions like atopic dermatitis that require long-term therapy extending beyond the initial study period.
  • "Leveraging manufacturers' programs, such as patient support programs, has proven to be a breakthrough solution for generating early and long-term high-quality RWD."

Powered by MRP Announces Attendance at the Medical Aesthetics Professionals Meeting December 14th-16th

Retrieved on: 
Thursday, November 30, 2023
Pros, LYFE Kitchen, MRP, Medicine, Trust, Elective surgery, GPO, Booth, MAP, Cons, Venetian, Physician, Education, Power

PARK CITY, Utah, Nov. 30, 2023 /PRNewswire/ -- Today, globally recognized aesthetics device company Powered by MRP announced their attendance at the Medical Aesthetics Professionals (MAP) meeting at The Venetian in Las Vegas on December 14th-16th at Booth 338.

Key Points: 
  • PARK CITY, Utah, Nov. 30, 2023 /PRNewswire/ -- Today, globally recognized aesthetics device company Powered by MRP announced their attendance at the Medical Aesthetics Professionals (MAP) meeting at The Venetian in Las Vegas on December 14th-16th at Booth 338.
  • The MAP meeting is a conference specially designed for those looking to start or enhance an aesthetics clinic or add aesthetics to an existing practice.
  • MAP partners with leading experts in the field who hold extensive experience in opening and operating aesthetics businesses.
  • "We are excited to participate in the MAP meeting and contribute to the collective advancement in medical aesthetics," said Scott Carson, Founder and CEO of Powered by MRP.

Clario's Oncology Webinar Series Part 3 -- Integrating Objectively Measured Safety Endpoints and Patient-Reported Outcomes in Oncology Trials: A Scientific Approach

Retrieved on: 
Wednesday, November 22, 2023
Safety, Patient safety, Consultant, Science, Pros, Medicine, Part, FDA, CVI, QT interval, MD, EST, Doctor of Philosophy, Oncology, Knowledge, Outline, Circulation: Cardiovascular Imaging, Drug development, Blood pressure, Nursing, Medical imaging, Clario Tech, Cardiology

TORONTO, Nov. 22, 2023 /PRNewswire-PRWeb/ -- In the ever-evolving landscape of drug development within oncology, the importance of collecting high-quality data across multiple endpoints cannot be overstated. This data plays a pivotal role in determining the success of a drug. The integration of objective safety measurements with patient-reported outcomes is now essential in characterizing a drug's safety profile, influencing overall benefit-risk considerations. Through this webinar, Clario invites you to explore our comprehensive scientific approach to enhancing safety and tolerability assessments in oncology trials.

Key Points: 
  • In this free webinar, Part 3 of Clario's Oncology Webinar Series, learn about a scientific approach to enhancing safety and tolerability assessments in oncology trials.
  • The integration of objective safety measurements with patient-reported outcomes is now essential in characterizing a drug's safety profile, influencing overall benefit-risk considerations.
  • Through this webinar, Clario invites you to explore our comprehensive scientific approach to enhancing safety and tolerability assessments in oncology trials.
  • For more information, or to register for this event, visit Clario's Oncology Webinar Series .

Holistic Measures of Physical Functioning in Cancer: New Opportunities with Digital Health Technologies, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Monday, November 13, 2023
Development, Associate, Treatment, Assistant professor, Disease, Pros, Physical activity, Patient, Research, Colorado State University, Health, Digital, Cancer, Drug development, Medical imaging, Pharmaceutical industry, Genentech

TORONTO, Nov. 13, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar delving into the pivotal role of digital health technologies in capturing meaningful aspects of health in individuals living with cancer. Individuals living with cancer experience severely impacted health-related quality of life. Their ability to carry out activities of daily living is impaired by cancer and its treatments. There are various methods of understanding how a patient feels and functions in the disease and treatment. Patient-reported outcomes (PROs) can provide direct information on cancer-related symptoms and functioning and measure the benefit/risk of treatment in drug development.

Key Points: 
  • TORONTO, Nov. 13, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar delving into the pivotal role of digital health technologies in capturing meaningful aspects of health in individuals living with cancer.
  • Objective measures of real-world physical behavior have the potential to complement established PROs and provide additional insights into daily functioning.
  • Objective measures of real-world physical behavior have the potential to complement established PROs and provide additional insights into daily functioning.
  • Join this webinar as it will feature a panel of stakeholders from different perspectives (regulatory, pharma/industry, clinical and digital health) to discuss holistic measurement of physical function in cancer and opportunities for digital health technologies to provide value.

Global Healthy Living Foundation to Present Pioneering Patient-Centered Research at ACR Convergence 2023

Retrieved on: 
Thursday, November 9, 2023
Biometrics, Telemedicine, Virtual Medicine, Pharmaceutical, General Health, Health, Wearables, Mobile Technology, Technology, Other Health, Online, Rheumatism, American College, Hospital, Treatment, Face, Doctor of Philosophy, Medicine, Disease, Efficacy, COVID-19, Overalls, Culture, PRO, Pain, Medical Affairs Bureau, Gold, MPH, Impact, Additive effect, RA, American College of Rheumatology, Data management, Exercise, Patient, ACR, Plant, Rehabilitation, MD, Motivation, Mindfulness, Quality of life, Longitudinal study, Research, Osteoporosis, DSM-IV codes, Guideline, Rheumatoid arthritis, Role, TNF inhibitor, Pros, Conjoint analysis, Jaki, Poster, Ageing, WEAR, Pharmaceutical industry, Medical device, Medical imaging, Nursing, Dietary supplement, Diet, Rheumatology, Fatigue, Flare, Epidemiology, Arthritis

The Global Healthy Living Foundation and its digital, arthritis patient centered research registry, formerly ArthritisPower, will collaboratively present eight scientific abstracts and five patient perspective posters at the American College of Rheumatology Convergence 2023 (Philadelphia, PA, November 10-15, 2023).

Key Points: 
  • The Global Healthy Living Foundation and its digital, arthritis patient centered research registry, formerly ArthritisPower, will collaboratively present eight scientific abstracts and five patient perspective posters at the American College of Rheumatology Convergence 2023 (Philadelphia, PA, November 10-15, 2023).
  • Collectively, GHLF researchers will focus on innovative approaches to remote therapeutic monitoring, patient engagement, and personalized care in rheumatic and musculoskeletal diseases.
  • This study offers key insights on innovative disease tracking methods, including those that can happen outside traditional clinical settings, particularly for diseases like rheumatoid arthritis (RA).
  • GHLF anticipates engaging with fellow organizations and professionals at ACR Convergence to share their year-long accomplishments in rheumatic disease research.