EDITORS' DESK

  • Debate On Project Management In Biopharma Gets Heated
    Debate On Project Management In Biopharma Gets Heated

    Forget presidential elections. We’ve got the debate we were looking for. The one on the professionalism of project management in the biopharma industry. It includes a reader’s comments that start with: “I call BS on this article.” The prosecuting paragraphs are copied below for careful dissecting. Vitriol can be valuable.

Biomanufacturing As Seen From A North Carolina Campus

Gary Gilleskie graduated with a Ph.D. in chemical engineering, went to work at a CMO, and became senior director for downstream manufacturing and process development. Now he’s back on campus to ensure part of his history isn't repeated: obtaining that first job in biomanufacturing without a solid background in the industry.

Still Spouting on Sovaldi? That’s A Misdiagnosis, Doc

In a recent LA Times Op-Ed, Dr. Daniel J. Stone, internal medicine and geriatric medicine specialist in Los Angeles, lashes out at the pharmaceutical industry, and the company that appears to have cured his patient of hepatitis. He raises some interesting points, and  give him credit for laying out his argument. Unfortunately, that argument includes a misdiagnosis of the ailment.

Silicon Valley, Meet BioPharma And Its CMOs (Please)

The information technology titans of Silicon Valley (and beyond) should meet up with the BioPharma industry and its subterranean contract development and manufacturing organizations (CMOs). We believe this could alter the topology of drug development and manufacturing. Here’s why, and an offer to assist in the primo incontro.

Pfizer Transitions In Risk Managing Clinical API Supply

Thomas Niemeyer leads a team for Pfizer that sources clinical API development and supply from Phase I through regulatory approval. That puts him in a transition zone when it comes to supplier risk management.

More From Chief Editor Louis Garguilo

GUEST CONTRIBUTORS

  • Are You Prepared For The EU’s Falsified Medicines Directive?
    Are You Prepared For The EU’s Falsified Medicines Directive?

    Given the complexities involved and time required for assessment and decision-making activities, it is imperative to start working toward meeting the EU’s Falsified Medicines Directive (FMD) standards immediately, leveraging previous efforts for compliance with other market regulations.

  • How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem
    How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem

    This article demonstrates two methods using the success-run theorem, which uses the confidence level (how sure we are) and reliability value (valid, consistent results) to determine appropriate statistically valid sample sizes for process validation.

  • The 5 Basic Tenets Of Data Integrity — And How Failures Occur
    The 5 Basic Tenets Of Data Integrity — And How Failures Occur

    It amazes me that, with all the data integrity issues highlighted in regulatory agency inspections over the last several years, very few people I talk with today are familiar with the court case that set the legal precedent for data integrity standards.  To me, this is one of the reasons why we see so many data integrity issues — those who forget the past are condemned to repeat it.

  • Brexit’s Impact On The Global Pharmaceutical Industry: Future Access To The EU Common Market
    Brexit’s Impact On The Global Pharmaceutical Industry: Future Access To The EU Common Market

    On June 23, 2016, the voters of the United Kingdom voted to leave the European Union in an advisory referendum colloquially referred to as the “Brexit” (British exit) vote. The aftermath of the vote has been chaotic — from financial troubles that have seen the British economy and currency plummet, to political bedlam that has led to a number of political casualties, including the Prime Minister and his heir apparent. While analysts, journalists, and the public all discuss the impact of Brexit on the UK and the path forward, few realize the implications that the vote will have on healthcare, and the pharmaceutical industry in particular.

More From Guest Contributors

PHARMA OUTSOURCING WHITE PAPERS

  • Using A Risk-Based Approach To Plan Your Solid Oral Dosage Scale-Up

    Using a risk-based approach for planning the timeline and strategy for your drug’s development and scale-up can help you avoid very costly delays. Yet, in the race to bring a drug to market, assessing risk can often be overlooked. Each case is going to be different; however, by creating a comprehensive plan for risk management (applying ICH Q9 as a basis), you can lower the overall level of risk from beginning to end. This not only puts you in the best possible position to avoid questions from the FDA at the time of submission but it also results in a more efficient development process and a higher-quality product.  

  • How Broadening The Analysis Of Compound Factors Allows For Predictive Solubility Solutions

    The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.

More Pharma Outsourcing White Papers

ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.

Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.

With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.

The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Louis Garguilo Articles

INDUSTRY INSIGHTS

  • Advancing Safety and Efficacy Studies with Novel Surgical Applications
    Advancing Safety and Efficacy Studies with Novel Surgical Applications

    Novel therapeutics such as gene and cell therapies, nanoparticles, and combination products requiring targeted delivery,  novel treatments for wound healing, cardiovascular disease, and bone regeneration,  and new medical device technologies call for innovative surgical procedures in preclinical trials to determine safety and efficacy.

  • How Are Analytical Methods Exchanged In A Technology Transfer?
    How Are Analytical Methods Exchanged In A Technology Transfer?

    As the principal means of assuring chemical identity and purity, instrumental analysis is the lifeblood of pharmaceutical development and manufacturing. In addition to standard instrumental methods, molecules may undergo enzymatic or cell-based assays to demonstrate some critical quality. Products often become “married” to analytical methods, and transferring this panel of tests during a technology transfer requires care.

  • In-Licensing Pharmaceutical Products: Due Diligence Can Help You Perform a Technology Transfer Successfully
    In-Licensing Pharmaceutical Products: Due Diligence Can Help You Perform a Technology Transfer Successfully

    When you are looking at acquiring or in-licensing a pharmaceutical product, there are numerous technical factors that you should carefully consider, including the manufacturing and packaging process itself as well as quality control, quality assurance, regulatory affairs and logistics. Approach a new product with due diligence and a detailed checklist to ensure you leave no stone unturned.

  • The Right Biomanufacturing Partner Can Improve Flexibility And Mitigate Risks From Forecasting
    The Right Biomanufacturing Partner Can Improve Flexibility And Mitigate Risks From Forecasting

    While forecasts can never be 100% accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible. To reduce the impact of inaccurate forecasting over the life cycle of a product, companies need to focus on those variables that they have the most control over.

  • In-Licensing Pharmaceutical Products: Get Technology Transfer Right
    In-Licensing Pharmaceutical Products: Get Technology Transfer Right

    When you are looking at acquiring or in-licensing a pharmaceutical product, there are numerous technical factors that you should carefully consider, including the manufacturing and packaging process itself as well as quality control, quality assurance, regulatory affairs and logistics. Approach a new product with due diligence and a detailed checklist to ensure you leave no stone unturned.

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OUTSOURCING EVENTS

Competency-Based Training in a GMP Environment – Results Based on Roles and Responsibilities July 26, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Building a Quality Risk Management Program and Leveraging Technology for RBM July 27, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Best Practices in CMC Dossier Preparation – Facing Tough Challenges July 28, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Price:  $199 - Includes Bonus Handouts!
Preparing for - and Surviving - a FDA Medical Device Inspection July 28, 2016
1pm-2:30pm EDT, Online Training
Root Cause Analysis for GCP – A Risk Action Plan Guide August 2, 2016
1pm-3pm EDT, Online Training
Price:  $349 - Includes Bonus Handouts!
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