Pharmaceutical Posts

Quality within the BioPharma Industry Landscape

Quality within the BioPharma Industry Landscape

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company

The American Society for Quality, touted as the “Global Voice of Quality,” states that manufacturers in the pharmaceutical industry are always working to balance the demands of meeting global regulations and production costs, in an effort to produce the most innovative research and development while also producing safe, reliable prescription drugs. As a biopharmaceutical industry veteran, I know the challenge is real. In fact, when illustrating a graphic representation of the Biopharma industry’s information management landscape, as I see it, the depiction is quite dense and complex. (more…)

The Benefits of Supplier Management

The Benefits of Supplier Management

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Supply chain risks grow as an organization’s suppliers expand geographically and companies increase offshoring and outsourcing activities. The increasing sophistication in technology, and ever-increasing regulatory oversight, are additional factors in the increased supply chain risk. Resulting supply chain issues are impacting medical device and pharmaceutical manufacturers around the globe, costing billions of dollars in market devaluations, recalls, regulatory fines, and settlements. But supplier management is a viable tool in the arsenal to minimize the risk of those outcomes. (more…)

Imperatives for Next-Generation QMS – Key Takeaways from Last Week’s Webinar

Imperatives for Next-Generation QMS – Key Takeaways from Last Week’s Webinar

Roxane Napoli, Senior Marketing Manager, Pilgrim Quality Solutions

Is your quality system keeping up with regulatory changes, industry pressures, and the demands of global business? Most quality management software (QMS) solutions on the market today are struggling to meet the rapid pace of change in the Life Sciences industry. Last week, in conjunction with PwC, Pilgrim Quality Solutions presented a webinar on the next generation of QMS.
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The Supplier Qualification Framework – Assessment, Responsibility, and Control

The Supplier Qualification Framework – Assessment, Responsibility, and Control

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions

Last week, I had the opportunity to explore the Life Sciences Supplier Qualification and Control Framework along with Nicky Dodsworth of Premier Research, Dr. Benjamin del Tito of the Biologics Consulting Group, Peggy J. Barry of Synergy Consulting, and The Knowledge Group. In today’s post, we’ll review key takeaways from Pilgrim’s portion of the webinar. If you’d like to view the entire webinar, you can watch the on-demand version of Life Sciences Supplier and Contractor Qualification and Control Framework Explored here.
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Using Agile in a Regulated Environment

Using Agile in a Regulated Environment

Stanley Curtis, Chief Technology Officer & Senior Vice President of Software Engineering, Pilgrim Quality Solutions

Recently, I was reviewing a MOOC (Massively Open Online Course) that teaches how to use Agile methodology in the development of SaaS (Software as a Service) products. This is a great scenario for the Agile SDLC (Software Development Lifecycle) since SaaS solutions typically change on a frequent basis as new features are added, or defects are fixed and released on a defined and regular schedule that fit into one or more sprints that range in length from 1-4 weeks. As there are changes, the software is updated and pushed to production to meet new or changing market requirements. If you read the textbooks about Agile, what I just described fits the Agile narrative very closely.
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Pharmaceutical Quality in the Cloud – Key Takeaways from Last Week’s Webinar

Pharmaceutical Quality in the Cloud – Key Takeaways from Last Week’s Webinar

Bernard Jee, Product Manager, Pilgrim Quality Solutions

Last week, we hosted a webinar called “Make the Move – Why Pharmaceutical Quality is Better in the Cloud.” During the webinar, speakers from PwC, Concerto Cloud Solutions, and Cardinal Health shared their perspectives on the changing drivers in quality, compliance, and patient safety, and how many of those challenges are best met using cloud-based quality management tools. If you missed last week’s webinar, you can view the Make the Move to the Cloud On-Demand Webinar here.
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Make the Move – Why Pharmaceutical Quality is Better in the Cloud

Make the Move – Why Pharmaceutical Quality is Better in the Cloud

Larry Ferrere, Senior Vice President, Product Strategy & Chief Marketing Officer, Pilgrim Quality Solutions

It’s time to make the move to the cloud. Most businesses are taking advantage of cloud-based applications, private clouds, or cloud data storage on some level. In recent years, the cloud has surged in popularity, and many business are making the move. Early adapters and small businesses view the cloud as a way to reduce IT infrastructure and resource costs, and also as a way of gaining access to technologies that might normally be reserved for larger companies.

Today, businesses are realizing increased benefits from cloud-based technologies beyond just cost savings. For the Pharmaceutical industry, many of the challenges that quality and compliance teams currently face can be simplified by deploying a quality system in the cloud. Let’s take a look at how a cloud-based quality system can propel your compliance efforts to the next level.
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India Flexes Its Muscles against Big Pharma

India Flexes Its Muscles against Big Pharma

Mark Crawford

Outsourcing to India is one thing; getting patent protection is another. Big pharma is entrenched in several high-profile cases in the Indian court system, including:

  • Bayer’s challenge to a decision by the patent office that forces it to license its drug, Nexavar, to an Indian firm
  • The patent office revoked Roche’s patent for Valcyte, which the company is appealing
  • India rejected two patent applications by Gilead for its HIV drug Viread; the case is under appeal
  • In 2006 India refused to grant Novartis a patent for its leukemia drug Glivec—Novartis is now challenging that decision in court

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As Pharma Cuts Back, CROs Do More

As Pharma Cuts Back, CROs Do More

Mark Crawford

Reacting to market and regulatory forces, pharmaceutical science continues to adapt and survive.Years of downsizing and reduced R&D budgets, combined with the “patent cliff” that many large pharmaceutical companies are facing, have resulted in tens of thousands of layoffs, flooding the job market and creating aftershocks felt throughout the industry. Regulatory changes are also hitting hard. New FDA requirements, especially those focusing on long-term studies, have lengthened internal development timelines and increased costs. The overall effects of these changes are reduced drug applications and less innovation, with fewer products in the pipeline. (more…)