EDITORS' DESK

  • Continuous Much More Than Manufacturing
    Continuous Much More Than Manufacturing

    Bernhardt Trout of the Novartis-MIT Center for Continuous Manufacturing, and Salvatore Mascia of CONTINUUS Pharmaceuticals, Inc., reveal the “true benefits” of this disruptive innovation. It’s not all about enabling new forms of manufacture, but also the discovery and development of novel molecular entities, and all the processes by which we will bring new drugs to patients.

What Are New Board Members Saying About Outsourcing?

Leaders from Achaogen, Allergan, Genzyme, Pfizer and Shire have joined the Outsourced Pharma Advisory Board. Already, they've provided some bold analysis — and a few grams of guidance — on outsourcing drug development and manufacturing.

Chemical Development From Cotton Candy To Pharmaceuticals

Sriram Naganathan, Senior Director, Chemical Development, Dermira, wants to be know as the person who: Came, Learned, and Taught. “I believe," he says, “I ended up working at the two best places for me in the world to learn process chemistry, Pfizer and Roche.” Now he teaches Outsourced Pharma readers what you should know for drug development outsourcing.

Are You The Future of Pharmaceutical Development?

Pfizer's Bernie Huyghe and ADC Therapeutics' Michael Mulkerrin get bushwhacked with this question in a public forum. Their open replies will help each one of you to your own personal assessment. Be prepared for some soul searching.

Outsourcing 2017: Countries, Costs, And Some Concerns

"Topic one for me during 2016 was the rather sudden realization that CMOs will not be able to carry us forward in the near term …” says Darren Dasburg, VP BioVentures – Biologics, Medimmune/AstraZeneca. He and other Outsourced Pharma Editorial Board members provide useful insight for the New Year.

More From Chief Editor Louis Garguilo

GUEST CONTRIBUTORS

  • 5 Proven Steps To Successfully Select & Onboard Outsourced Logistics Partners
    5 Proven Steps To Successfully Select & Onboard Outsourced Logistics Partners

    In preceding articles in this series, we reviewed some of the challenges and remediation approaches for the storage and distribution of life science products, highlighting some of the specific risks related to storage, transportation, and material control across an extended chain of custody. This brings us to the final article, in which we will discuss best practices for selecting the partners that will be an extension of your staff for monitoring and control across an ever-changing global landscape.

  • The Role Of Human Performance Tools & Just Culture In Biopharma Operations
    The Role Of Human Performance Tools & Just Culture In Biopharma Operations

    The behavior of the people within an organization can be the least predictable part of the business. While the pharmaceutical and biotech industry has been successful in incorporating lean and Six Sigma principles to increase operational and system efficiency, there has been a lack of similar gain demonstrated when dealing with human behavior and human error.

  • U.S. DoD Opens Advanced Biologics Manufacturing Facility For Private, Public Use
    U.S. DoD Opens Advanced Biologics Manufacturing Facility For Private, Public Use

    The U.S. Department of Defense recently opened the Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) facility — the first dedicated advanced manufacturing facility capable of developing and making biological (and small-molecule) products to protect service members who may be exposed to biological weapons or natural threats. 

  • An Analysis Of FDA FY2016 Drug GMP Warning Letters
    An Analysis Of FDA FY2016 Drug GMP Warning Letters

    This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Monitoring publicly available enforcement actions and trends as part of a comprehensive GMP intelligence program is crucial, because FDA expects firms to monitor these actions and correct similar deficiencies at their site(s).

More From Guest Contributors

PHARMA OUTSOURCING WHITE PAPERS

  • 5 Ways MasterControl Ensures System Compliance With 21 CFR Part 11

    Under 21 CFR Part 11, FDA-regulated companies that choose to maintain electronic records to meet predicate rules are required to validate their electronic record-keeping systems.

  • User Testing ... Time Is Running Out It is now over two years since Directive 2004/27/EC introduced a change in the order of presentation of information in patient information leaflets (PILs) and the requirement that PILs should reflect the results of consultations with target patient groups. We have until July 2008 to comply with Article 59(3) and to complete user tests for all existing, as well as new products. Submitted by ICON
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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

  • What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?
    What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?

    When a company is looking at acquiring or in-licensing a pharmaceutical product, there are a few technical factors that should be carefully considered before the deal is completed. 

  • Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies
    Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies

    There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago. 

    More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.  

  • Shift From Central Lab To POC
    Shift From Central Lab To POC

    As new technologies work to change the market space, this article takes a look at the market forces that are helping and hindering the shift to zero wait time for patient test results. Comprehensive analysis of both test settings allows for better understanding of the diagnostic landscape as it exists today, offering insight to both product and process innovations for your next generation product.

  • The Direct-To-Patient Model: Your Top 10 Q&A

    In clinical trials, a direct-to-patient model allows for drug therapies to be delivered and administered in the patient’s home and/or biological samples to be taken and uplifted from the patient’s home. Depending on the complexity of the trial protocols, patients may take medicines themselves, or rely on a homecare nurse or caregiver for clinical support. Because the direct-to-patient model allows the patient to participate in the clinical trial from home, it reduces the need for them to travel to the investigator site, increasing the likelihood they will agree to participate and decreasing the possibility that they will drop out of the study.

  • NEW DOCUMENT

    Manufacturing of biopharmaceuticals is a large commitment to the public health and helps save the lives of millions of people. The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.

     

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OUTSOURCING EVENTS

cGMP Compliance - Understanding The Top Drug Enforcement Trends January 24, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Introductory Rate
The Investigational New Drug (IND) Submission - Tips to Win the First Time January 25, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template January 30, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Lyophilization - An Introduction to the Scientific Principles February 13, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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