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endpoint Company Profile

10:10 EDT 21st June 2018 | BioPortfolio

Endpoint provides clients with high-quality, authoritative advice on the clinical development of medicines. Endpoint's clients include multinational pharmaceutical companies, emerging biomedical ventures, biotechnology investment firms, contract research organizations, regulatory agencies and national health services.
Endpoint was started in London by Kenneth Klein, MD, a Harvard-trained physician who is board-certified in both internal medicine and gastroenterology. After a career in academic medicine Dr. Klein worked for 15 years in the pharmaceutical industry, holding various management positions with companies in the United States and Europe. He has helped bring major products from Phase I through regulatory approval and marketing. For example, for four years he was Global Project Leader for the anti-migraine drug zolmitriptan, now marketed as Zomig. In this position he led all aspects of the drug's worldwide development. This included primary responsibility for the design and implementation of the clinical trial program and coordination of the basic science, manufacturing, regulatory and commercial strategies.

Contact

Email: kbk@PrimaryEndpoint.com


News Articles [245 Associated News Articles listed on BioPortfolio]

ICON Enhances Endpoint Adjudication Services

Will leverage AG Mednet's comprehensive electronic endpoint adjudication system

Proving HPV vaccines really prevent cancer

In the clinical trials for HPV vaccines cervical cancer was not a primary endpoint. An endpoint in a clinical trial is a disease or a symptom of interest. I want to explain why cancer was not an endpo...

Eli Lilly's Cyramza meets primary endpoint in phase 3 liver cancer trial

Eli Lilly’ liver cancer treatment Cyramza (ramucirumab) has met its primary endpoint of overall survival (OS) and the secondary endpoint of progression-free survival (PFS) in the phase 3 Reach-2 stu...

Surrogate Endpoint, Safety Questions May Be Too Much For Waylivra To Overcome At US FDA Panel

Akcea Therapeutics' familial chylomicronemia syndrome drug will be faced with questions about its surrogate endpoint and a thrombocytopenia safety signal.   

Lilly’s Cyramza Meets Overall Survival Endpoint in Late-Stage Study in Patients with Hepatocellular Carcinoma

INDIANAPOLIS, April 4, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced top-line results from its Phase 3 REACH-2 study of CYRAMZA® (ramucirumab) as a single agent in ...

Innovation Pharmaceuticals Brilacidin Meets Key Secondary Endpoint in Phase 2 Trial, Delays Onset of Severe Oral Mucositis (SOM); Latest Results Further Support Topline Data Showing Trial Met Primary Endpoint of Reducing Incidence of SOM

BEVERLY, Mass., Jan. 03, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today presented additional secondary en...

Use of PK as an endpoint for clinical switching studies

FDA is ‘sensitive to changes in immunogenicity and/or exposure that may arise as a result of alternating or switching’. PK can be used as a surrogate endpoint to detect the impact of clinically im...

BerGenBio meets first efficacy endpoint in Phase II trial of BGB324

BerGenBio has met the initial efficacy endpoint in its Phase II trial of BGB324 (bemcentinib) selective AXL inhibitor in combination...Read More... The post BerGenBio meets first efficacy endpoint in ...

Drugs and Medications [38 Associated Drugs and Medications listed on BioPortfolio]

Perindopril erbumine [Aurobindo Pharma Limited]

These highlights do not include all the information needed to use perindopril erbumine safely and effectively. See full prescribing information for perindopril erbumine tablets.Perindopril Erbumine Ta...

Losartan potassium [Qualitest Pharmaceuticals]

LOSARTAN POTASSIUM TABLETS USP R only

Losartan potassium [Endo Pharmaceuticals Inc. DBA Endo Generic Products]

Losartan Potassium Tablets USP R only

Leflunomide [NorthStar RxLLC]

Leflunomide Tablets USP

Renagel [Genzyme Corporation]

These highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel. Renagel (sevelamer hydrochloride) Tablet for Oral use In...

PubMed Articles [100 Associated PubMed Articles listed on BioPortfolio]

Statistical considerations in the choice of endpoint for drug use disorder trials.

To date, the US Food and Drug Administration (FDA) requires drug use disorder trials developing new medications to use abstinence, a clinically meaningful endpoint, as the primary outcome. Although ab...

The "F" in SAFE: Reliability of assessing clean faces for trachoma control in the field.

Although facial cleanliness is part of the SAFE strategy for trachoma there is controversy over the reliability of measuring a clean face. A child's face with no ocular and nasal discharge is clean an...

Excellence has no endpoint.

The Average Hazard Ratio - A Good Effect Measure for Time-to-event Endpoints when the Proportional Hazard Assumption is Violated?

In many clinical trial applications, the endpoint of interest corresponds to a time-to-event endpoint. In this case, group differences are usually expressed by the hazard ratio. Group differences are ...

Development of reaching during mid-childhood from a Developmental Systems perspective.

Inspired by the Developmental Systems perspective, we studied the development of reaching during mid-childhood (5-10 years of age) not just at the performance level (i.e., endpoint movements), as comm...

Clinical Trials [1061 Associated Clinical Trials listed on BioPortfolio]

A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)

This is a multi-center, prospective, international, randomized (1:1), open-label study with two parallel groups. This phase III study is planned to investigate the efficacy and safety of d...

Repeatability and Reproducibility of Skin Test Endpoint Titration

This study will examine the within-tester repeatability and between-tester reproducibility of skin test endpoint titrations performed in those with allergic sensitivities.

Risk Accessment Model for Ischemic Stroke Endpoint Events

The present study aims to develope a risk accessment model of ischemic stroke endpoint events combining multi-dimensional TCM indicators with modern medicine indicators. The proposed study...

The WEB®-IT China Clinical Study

This trial is a prospective, multicenter, single-arm Objective Performance Criteria controlled confirmatory study. It is for evaluating safety and effectiveness of the WEB Aneurysm Emboliz...

To Compare the Efficacy of the Addition of Methotrexate (MTX) to Current Standard Acute Graft-versus-host Disease (GVHD) First-line Treatment With Corticosteroids

Phase III randomized double-blinded trial designed to compare the efficacy of the addition of MTX to current standard acute GVHD first-line treatment with corticosteroids. The protocol wil...

Companies [26 Associated Companies listed on BioPortfolio]

EndPoint Technologies

EndPoint Technologies is dedicated to providing comprehensive technology and business consulting services to life science organizations. Specializing in Medical Affairs in pharmac...

Endpoint Research

Endpoint Research is a full service Clinical Research Organization founded in 1990. We provide Phase I/II to IV clinical development services to pharmaceutical, biotechnology and medical device compan...

IGEL

IGEL delivers powerful unified endpoint management (UEM) software that is revolutionary in its simplicity and purpose-built for the enterprise. The company’s world-leading pr...

Valentis

Valentis is a biotechnology company that was engaged in the development of innovative products for peripheral arterial disease (PAD), a large and unsatisfied market. On July 11, 2006 Valentis announce...

endpoint

Endpoint provides clients with high-quality, authoritative advice on the clinical development of medicines. Endpoint's clients include multinational pharmaceutical companies, emerging biomedical ventu...

More Information about "endpoint" on BioPortfolio

We have published hundreds of endpoint news stories on BioPortfolio along with dozens of endpoint Clinical Trials and PubMed Articles about endpoint for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of endpoint Companies in our database. You can also find out about relevant endpoint Drugs and Medications on this site too.

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