Whether you work at a small tech startup or a large, established manufacturer, there is an implicit understanding that business success can be easily quantified. Whether you are a CEO or a sales representative, the common wisdom is that there are identifiable numbers that can objectively determine if you are a success or a failure. In a world full of endless layers of nuance and opinion, tangible metrics of business performance are irresistibly attractive. However, there are serious limitations to taking such a binary approach to measuring success. This black and white approach to measuring business success is actually counterproductive, particularly if the goal is to achieve transformative performance improvement.
Read More →Interview with Victoria Yeager, Head of Contracts and Compliance, Genentech
We were honored to have Victoria Yeager, Head of Global Pharma Procurement Contracts & Compliance at Genentech, join us as a key speaker at the 2017 American Pharma Outsourcing Summit where she discussed “To Outsource or Not to Outsource? Developing Your Ideal Contract Support Model.” We sat down with Victoria at the summit to gather her insights on the current and future state of the pharma outsourcing industry. Watch the full video interview above or read a partial transcript below. What do the next 5 years in the outsourcing space look like? The next five years in the outsourcing space, in my opinions, looks like more outsourcing. I think if we go back to the (Peter) Drucker Quote – to paraphrase – “do what you do best and outsource the rest.” I think that’s going be even more and more important and the reason is, in the pharma industry, things are changing so fast we have to be agile, and so allowing companies to focus on what they do best and their partners to focus on what they do best will allow everything to operate much more smoothly and agilely, which I think is really important.
Read More →In the Global Life Sciences Market, What You Don’t Know CAN Hurt You
The global life sciences market is witnessing an unprecedented pace of change across pharmaceuticals, medical devices, and biologics. It’s the new normal as trends like big data, the Internet of Things, increasing supply chain complexity and the advance of biosimilars create new opportunities – and challenges – for life sciences companies. As regulators around the globe scramble to stay abreast of these trends, they are making important and often major updates to directives. Quite often these directives are not coordinated between markets, creating a patchwork compliance landscape to be navigated. If you are involved in your company’s quality, regulatory surveillance, compliance, or knowledge management efforts, the following questions are for you: Do you have frequent (i.e. at least monthly) conversations with the regulators in the markets where you manufacture AND sell? Does your company have the expertise to predict and interpret regulatory directives? Do you have reliable methods of disseminating information on the impact of regulatory directives to your clinical operations teams? How does your organization remain aware of and respond to GxP actions, import alerts, or other market actions against other companies in your industry?
Read More →Benchmarks and Best Practices for Next-Generation QMS
In a recent study conducted for Pilgrim, quality and compliance professionals from the top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies were surveyed on the “state of the state” of the business, regulatory, and technology landscape of their current quality management systems (QMS). This research provides fresh insights into the state of quality and compliance management in the Life Sciences industry, as well as quantitative data which demonstrates that many Life Sciences companies are preparing for or embracing Next-Generation Quality Management practices.
Read More →GDP for APIs New Regulations
The Shift to Monitoring BioPharma Product Quality Throughout Their Lifecycle For years, pharmaceutical manufacturers have talked about the last mile. With mail order pharmacies, direct to pharmacy/patient channels, and things like orphan drug clinical trials, the last mile can be complex yet largely unregulated. The other end of the pharmaceutical supply chain, the inbound supply of ingredients, has received more solid guidance from regulators. In 2000, major markets including the EU and US supported the ICH Q7 initiative by publishing their own guidelines specifically for GMP for APIs. Although GMP guides have included some elements on storage and distribution, the only GDP focused guide was the WHO Guide on GTDP for Pharmaceutical Starting Materials until recently.
Read More →Choosing the Right Writer for Your Documentation Project
Pharmaceutical technical writers are a broad collection of technical people including engineers, biologics, chemists, microbiologists, and even a few liberal arts majors. Nearly all writers share a passion for accuracy, completeness, robustness, compliance, and clarity. But what pharmaceutical companies need from their writers differs across projects, products, departments, and maturity. Some companies need document processors to manage redlines and facilitate approvals. Other companies need an expert to identify and address compliance or procedural gaps. Some companies need writers to compile, analyze, and summarize data for reports. And others need authors who can leverage data to tell a story, inform and instruct readers, or present a scientific perspective for a submission. Matching writer skills to project objectives is an important first step. Why?
Read More →Case Study: How Lundbeck uses ELPRO cold chain monitoring solutions to streamline processes
Project Partner Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with psychiatric and neurological disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at disease areas such as depression, schizophrenia, Parkinson’s disease and Alzheimer’s disease. Project As a large R&D organization with clinical sites around the world, Lundbeck needed a cold chain monitoring solution that streamlined end to end processes communicating temperature data that would ensure successful clinical trial progression and cost-effectiveness. In addition, it was their priority to meet new GDP requirements to demonstrate control during transport by collecting data and having an auditable database.
Read More →Pharma Supply Chains: Transitioning to the Modern World of Data Monitoring and Analysis
In the world of pharmaceutical supply chains, where cost reduction is king and a growing number of products are temperature-controlled – collecting, communicating and analyzing temperature and logistics data is critical to success. If data is the foundation of business intelligence, why are Pharma companies still using old practices for data analysis – reviewing data by hand, doing manual entries and archaic reporting methods? All of these outdated practices and long processes create human error and surging hidden costs. Today, all of the important temperature data and automation tools are at the industry’s fingertips, so why not use them?
Read More →Biopharma M&A Outlook for 2018
Biopharma M&A activity has already been big news in 2018. On January 22, it was reported that Celgene had bought the 90% of Juno Therapeutics it did not already own for $9 billion, just weeks after they announced the purchase of cancer startup Impact Biomedicines. This news fits within a few broader trends we are seeing in the biopharma industry and sets the tone for this year, in which we expect to see a lot more M&A activity in the industry. Tax reform in the United States, particularly a lower levy on US companies’ overseas cash, means we will see companies repatriating these funds and likely spending them on M&A activity. This M&A activity will lead to consolidation in increasingly-crowded categories, such as cancer therapy, and there will be a continued focus on young or early-stage development companies.
Read More →Addressing the Challenges Facing the Biomanufacturing Industry in the Next Five Years
Last year, at the American Biomanufacturing Summit, we sat down with some thought leaders from MedImmune, AstraZeneca, Pfizer, Takeda, Celgene, and Portola Pharmaceutical and asked them: “What do the Next Five Years Look Like in the Biomanufacturing Industry?” Most agreed that it will be an exciting time with new product modalities improving patient care, but that these new product modalities will give rise to new challenges in capacity and raw material sourcing, as well as talent recruitment and management. We asked them to go further and tell us what key challenges organizations need to overcome to be successful in this period of unprecedented change.
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