EDITORS' DESK

  • Waldorf Departure Drama For DCAT?
    Waldorf Departure Drama For DCAT?

    I didn’t quite buy into the DCAT announcement regarding its departure from the Waldorf Astoria, the long-time central location for DCAT Week in New York City each spring. Call me cynical—a degree in public relations can do that – but I just couldn’t believe “checking out” of the Waldorf would be as easy as it sounded. I took this cynicism directly to Margaret Timony, Executive Director of the Drug, Chemical & Associated Technologies Association.

Biopharma Leadership Through Troubled Waters

At the turn of the 21st century, a rare, Houston-based biotech, busy pursuing the development of its own drugs and IP, discovers it has a sought-after talent for viral vector manufacturing. It decides to pursue contract manufacturing. This begins a tale of how devoted leadership in the midst of significant difficulties can provide a saving grace … and strengthen careers.

Leadership Lessons From Oil Patches To Biopharma Plants

From the oil patches of Wyoming to biomanufacturing in southern California, this is a tale of living your career, and the essence of leadership. “There’s a recurring theme of including people, taking calculated risks, learning about yourself, and being damn stubborn,” says David Enloe, President and CEO at Ajinomoto Althea, Inc. “Maybe not quite in that order.”

FLAG These Biopharma Outsourcing Beliefs

A few weeks away from Outsourced Pharma San Diego, we’re already into provocative discussion on outsourcing of drug development and manufacturing. Everything from the role of finance managers in CMOs; pharmacists in biopharma; Car-T and personalized medicine in development; the FDA in foreign lands; and project managers in situ. Frank Sorgi, Ph.D., President and CEO of FLAG Therapeutics, Inc., leads the charge.

Grunenthal’s Technology Model For The 21st Century

We’re entering our era of technology. It’s transferring preeminence from science to tech innovation. New players will enter; traditional biopharma will retool. Tech implementation of all hues will coalesce in the outsourcing model. Grünenthal of Aachen, Germany, is a leader in this new paradigm. Alexander Kraus, VP Product Development, Technical and Government Affairs, Grünenthal USA, Inc., explains how and why.

More From Chief Editor Louis Garguilo

GUEST CONTRIBUTORS

  • A Working Introduction To Six Sigma For Pharmaceutical Manufacturers
    A Working Introduction To Six Sigma For Pharmaceutical Manufacturers

    This is the first in a series of articles on Six Sigma that will introduce you to this methodical, rigorous approach to process excellence, and share the author's experiences using the technique in the pharmaceutical industry.

  • Data Integrity: Surveying The Current Regulatory Landscape
    Data Integrity: Surveying The Current Regulatory Landscape

    This review of recent regulatory actions related to data integrity first explores data integrity deficiencies cited in FDA warning letters issued between FY2013 and FY2015. Then, it moves to a review of the recently published FDA draft guidance on data integrity. Finally, it addresses the finalized version of the WHO guidance on the topic.

  • Can You Support Quality Metrics With Lobotomized Data?
    Can You Support Quality Metrics With Lobotomized Data?

    Life science companies are obsessed with collecting dumb data. We assemble it, retain it, and hoard it to support regulatory and legal requirements.

  • 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.

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.

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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 Does The FDA's Process Validation Guidance Simplify A Technology Transfer?
    How Does The FDA's Process Validation Guidance Simplify A Technology Transfer?

    The technology transfer of a process, whether it is from R&D to commercial manufacturing or from one manufacturing site to another, is a critical step in the life cycle of any drug product.

  • It’s Time To Go Electronic In The Lab – Infographic
    It’s Time To Go Electronic In The Lab – Infographic

    The paper-based lab versus the digital lab. The largest barrier to innovation for any lab is performing tasks manually and recording experiment data in paper lab notebooks. Easy-to-use digital applications can increase productivity while reducing wasted time and inefficiencies associated with searching for relevant experiment data.

  • Six Myths About Serialization
    Six Myths About Serialization

    The global countdown to serialization compliance is well underway. Early adopters, such as Turkey and Argentina, required serialization as early as 2010, and were followed by others such as India, China and Korea.  Over the next three years, many other major markets will require adherence to their own serialization requirements, including the United States and the European Union. Expect that by 2018, serialization mandates will govern most of world’s drug supply. Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.

  • 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.

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OUTSOURCING EVENTS

Analyzing and Understanding ISO 13485 Proposed Changes August 30, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Effective Clinical Investigator GCP Training - Getting It Right The First Time August 30, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Good Clinical Practices (GCP) Overview for Clinical Research Professionals - A Global Primer September 8, 2016
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Drug Development 101 – How A Drug Is Made September 13, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Update to ICH GCP E6 (R2) – Proposed Changes You Should Prepare For September 14, 2016
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
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