PRTODAY / NewswireToday Free press release distribution service network

Written by / Agency / Source: Ippolito Media Arts (IMA)

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

Pinnacle 21 CEO Max Kanevsky Named to PharmaVOICE 100 - Pinnacle 21 announced today that its president & CEO, Max Kanevsky, has been named to the prestigious PharmaVOICE 100 list of the most innovative and influential people in the life-sciences industry - Pinnacle21.net
Pinnacle 21 CEO Max Kanevsky Named to PharmaVOICE 100

 

NewswireToday - /newswire/ - Blue Bell, PA, United States, 2015/08/04 - Pinnacle 21 announced today that its president & CEO, Max Kanevsky, has been named to the prestigious PharmaVOICE 100 list of the most innovative and influential people in the life-sciences industry - Pinnacle21.net.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Industry leader celebrated for his role in evolving the new-drug development and approval process

Pinnacle 21, a technology consultancy that specializes in optimizing the new-drug development and approval process, announced today that its president and CEO, Max Kanevsky, has been named to the PharmaVOICE 100: an annual list of the 100 most innovative and influential people in the life-sciences industry.

“When we first started, back in 2008, our pie-in-the-sky hope was to flip the industry on its head,” said Mr. Kanevsky. “We still have a long way to go, I think. But maybe this award means that we’re on our way. I’m grateful and humbled to be selected.”

The Clinical Data Interchange Standards Consortium (CDISC), a non-profit organization, was formed in 1997 to collaborate on the development of global standards that could be leveraged to streamline medical research and drug review. This was in reaction to the FDA’s concern that a lack of standard clinical data had led to great inconsistencies from one submission to the next, which led to procedural time drains. The goal was to achieve a standard for clinical data that would be used throughout the life-sciences industry. But, once CDISC began to define these standards, neither they nor the FDA had the means of helping the industry implement them.

But then, in 2008, Mr. Kanevsky created an open source, freely available toolkit that enabled the implementation of CDISC standards, which revolutionized the way the life-sciences industry exchanges clinical data. This was done through a project called OpenCDISC, which, for years, offered technologies and education to help statistical programmers and data managers with the implementation process. In 2011, Max and his partners founded Pinnacle 21 as a commercial extension of OpenCDISC, to generate the resources necessary to keep pace with an industry that was struggling to adapt to ongoing change.

In 2014, the FDA mandated that, starting in December 2016, all new drug applications must be submitted electronically and in accordance with CDISC standards. Some life-sciences companies are already CDISC compliant; but most are far away. The clock is now ticking, and the risks couldn’t be higher. The FDA is threatening to refuse to file (RTF) submissions that don’t meet the new standard. But, Mr. Kanevsky and his colleagues at Pinnacle 21 believe there is time enough.

“It’s mostly a matter of adjusting your mind-set,” Mr. Kanevsky said. “It’s natural to resist change, of course. But now, the industry has no choice. The FDA has thrown down the gauntlet. But, if you embrace the change, if you’re willing to adjust your process, you’ll see that it’s a good thing. All the inefficiencies will fall away, and important new drugs will get approval faster. It’s a matter of evolution now. Those who adapt are going to survive and thrive.”

The PharmaVoice 100 is a special feature that’s compiled once yearly, and is published in the July/August edition of PharmaVOICE magazine. According to the publisher, the professionals selected for the PharmaVOICE 100 Class of 2015 are those who “set industry trends, [because] their passion and conviction create opportunities out of obstacles. They are innovative and have the ability to think outside-the-box. They develop breakthrough strategies, products, and services. They are known for pioneering new paths and lifting their companies to new heights.”

To read the full list of 2015 PharmaVOICE 100 profiles, read the July/August 2015 edition of PharmaVOICE.

About Pinnacle 21

Pinnacle 21 (pinnacle21.net) is life-sciences technology consultancy dedicated to one thing: maximizing the speed and efficiency of the new-drug development and submission process. With singular technologies and unmatched expertise with CDISC and FDA compliance, clinical data quality, and FDA submission readiness, we help new drugs earn FDA approval faster extending their Revenue Earning Period (REP) and maximizing their profitability. In 2008, our founders created OpenCDISC Validator, the most widely used open-source software in the biopharmaceutical industry; and, since 2011, we’ve supported the FDA with enterprise software that screens electronic submission data for standards compliance and data quality.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: Ippolito Media Arts (IMA)

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 

 
  Your Banner Ad showing on ALL
Pharma/BioTech/Nutrition articles,
CATCH Visitors via Your Competitors Announcements!


Pinnacle 21 CEO Max Kanevsky Named to PharmaVOICE 100

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

|
Publisher Contact: Greg Ippolito - Ima314.com 
215-421-3034 liz[.]ima314.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Ippolito Media Arts (IMA) securities in any jurisdiction including any other companies listed or named in this release.

Pharma/BioTech/Nutrition via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From Ippolito Media Arts (IMA) / Company Profile


Read Pharma/BioTech/Nutrition Most Recent Related Newswires:

BD Announces Adoption of Windows 10 ‘Internet of Things’ for the Pyxis™ ES System
Greenphire Named to Deloitte 2016 Technology Fast 500™
Genentech Showcases New Clinical Data Across a Variety of Blood Diseases at American Society of Hematology 2016 Annual Meeting
BD Collaborates with JDRF to Focus on Extended Wear Innovations for Insulin Infusion Delivery
BD Launches First Syringe Designed for Use with Humulin® R U-500 Insulin
MDxHealth Announces Unique CPT Code Awarded for ConfirmMDx from the American Medical Association
BD MAX™ Vaginal Panel Receives FDA Market Authorization to Detect Most Common Causes of Vaginal Infections
Greenphire Receives EU-US Privacy Shield Certification
The 2016 Georges Mathé Prize Recognizes Research on the Immunological Determinants of the Response to Breast Cancer Treatment
MDxHealth Announces Agreement with HIFU CLINIC Prostate Cancer Center for Distribution of SelectMDx in Poland
First Patient in Malaysia Receives TheraSphere™ Radioembolisation Therapy
FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) Prefilled Syringe
BTG and Mirada Medical Announce CE Mark Certification for Simplicit90Y Dosimetry Software in Europe
FDA Grants Priority Review to Genentech’s Lucentis® (Ranibizumab Injection) Supplemental Biologics License Application
Genentech’s TECENTRIQ® (Atezolizumab) Shows Significant Survival Advantage Compared to Chemotherapy

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  Triggr & Bloom

Visit  JobsWare.com





 
  ©2016 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)