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thoughtspot_Adrian Wallace
THOUGHTSPOT

4 Steps To Ensure Clinical Trial Compliance

When performing research studies, clinical trial compliance plays a vital part in ensuring the safety and effectiveness of the research. It means adhering to ethical and regulatory requirements established by governing bodies that guarantee the well-being of study participants and the legitimacy of study results. Sponsors, investigators, and study sites could face considerable legal and…
April 26, 2023

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VIEWPOINTS_Paul K Owens_2023
VIEWPOINTS

Paul K Owens, VP of Global Brand Development, Insulins & Glucagon at Eli Lilly & Company Shares Insights from the US FDA Approval of Lyumjev

Shots: Paul talked about the approval of the Lyumjev Injection for the improvement of glycemic control in children and adolescents with diabetes. He also shared various details about Lyumjev Paul further discussed the study design and the key findings from the registrational PRONTO-Peds study The interview also talks about Lilly’s Diabetes Solution Center which helps eligible…
April 20, 2023

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VIEWPOINTS_Scott Stout_2023
VIEWPOINTS

Scott Stout, CEO of MedVector his Views on the Misunderstood FDA’s Guidance on DCTs at 2023 J.P. Morgan Healthcare Conferences

Shots:  Scott gave a brief about the MedVector and shared his personal experience from his treatment of arthritis by participating in the clinical trial  He also elaborated on how MedVector clarified the misunderstanding on FDA’s guidance on DCTs by the clinical research industry at the 41st Annual J.P. Morgan Health Care Conference 2023  The interview…
March 30, 2023

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Disease of the Month: AIDS
INSIGHTS+

Disease of the Month: AIDS

“Putting Ourselves to the Test: Achieving Equity to End HIV”  -Theme of the year 2022  Introduction: HIV/AIDS is one of the top 10 cause of mortality. It is a chronic, epidemic disease caused by human immunodeficiency virus (HIV), a virus that infect WBC’s CD4 T-cell of the immune system. HIV, a type of retrovirus that isn't…
December 20, 2022

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Viewpoints_Dr. Volker Knappertz
VIEWPOINTS

Dr. Volker Knappertz, EVP R&D, Aurinia Shares Insights on LUPKYNIS MAA from EMA

Shots: Volker spoke about the granting of marketing authorization by EC to treat adults with active lupus nephritis.The approval was based on the results of the P-III AURORA study  Volker also talked about the collaboration between Aurinia and Otsuka Pharmaceutical for the development and commercialization of LUPKYNIS The interview gives an understanding of how Aurinia…
December 7, 2022

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Viewpoints_Patrick Mooney
VIEWPOINTS

Patrick Mooney, CEO at SpyGlass Pharma, Shares Insights from the 3-Month Data of its Innovative Drug Delivery Platform for Chronic Eye Conditions

Shots: Patrick spoke about the 3-month data from the First-in-Human glaucoma treatment trial of Spyglass’ innovative  drug delivery platform that helps in lowering intraocular pressure in patients with glaucoma or ocular hypertension Patrick also talked about the study design and key findings from the First-in-Human glaucoma treatment trial The interview gives an understanding of Spyglass’…
November 29, 2022

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Viewpoints_Natalie Shiff
VIEWPOINTS

Natalie Shiff, Associate Medical Director, Janssen Rheumatology Shares Insights from the FDA Approval of Stelara to Treat Pediatric Patients with Active Psoriatic Arthritis

Shots: Natalie spoke about the study design and key findings from the P-III study evaluating Stelara for the treatment of pediatric patients with active psoriatic arthritis She also spoke about the patient support program that is executed by Janssen to support patients to get Stelara  The interview gives an understanding of how Janssen is advancing…
October 31, 2022

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Viewpoints_Alex Zimmerman_Alexander Lin
VIEWPOINTS

Alex Zimmerman and Alexander Lin Share Insights on the FDA Breakthrough Device Designation Received for Non-Invasive Virtual Biopsy Technology

Shots: Alex Zimmerman talked about virtual biopsy technology using standard MRI scanners. The technology will allow doctors to understand brain imaging via chemical indicators more extensively Alexander Lin spoke about the data on which the BDD was granted by the FDA and the usage of Magnetic Resonance Spectroscopy (MRS) by this software BrainSpec is a…
October 10, 2022

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Viewpoints_Erika Ross
VIEWPOINTS

Erika Ross, Director of Clinical & Applied Research at Abbott Shares Insights on FDA Breakthrough Device Designation to Explore its DBS System to Treat Treatment-Resistant Depression

Shots:  Erika spoke about the FDA Breakthrough Device Designation received by Abbott to investigate its deep brain stimulation (DBS) system to treat treatment-resistant depression (TRD) Erika also talked about how NeuroSphere Virtual Clinic is compatible with the  deep brain stimulation (DBS) system  The interview gives an understanding of Abbott’s vision to bring life-changing technologies in…
October 5, 2022

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PharmaShots Interview In Conversation with Cidara’s CEO, Dr.Jeff Stein, Where he Shares Insights on the IND acceptance by the FDA to Treat Influenza
VIEWPOINTS

PharmaShots Interview: In Conversation with Cidara’s CEO, Dr.Jeff Stein, Where he Shares Insights on the IND acceptance by the FDA to Treat Influenza

Shots: Jeff spoke about IND acceptance by the US FDA for its lead flu drug-Fc conjugate immunotherapy for the prevention and treatment of Influenza He also discussed Cidara’s collaboration with Janssen Pharmaceuticals to develop and commercialize Cidara’s DFCs The interview also emphasizes Cidara’s Cloudbreak platform to develop immunotherapeutic antivirals and treatment options for influenza Smriti:…
June 6, 2022

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