EDITORS' DESK

  • Are CMOs Sufficiently Serving Biotechs?
    Are CMOs Sufficiently Serving Biotechs?

    Louis Demers of Xoma knows what he wants in contract development and manufacturing organizations. For example, they should be networked with other service providers, and in mission-critical alignment. Can he get what he wants? Can any outsourcing leader at a biotech today? CMO consolidation may make it more difficult.

Is Pharma’s New HR “Majority” Good For Hiring?

What impact is a growing class of front-line hiring professionals in the human resources departments of the biotechnology, pharmaceutical, and contract services industries having on the employment of drug development outsourcing professionals? Is this a part of a societal shift?

Pharma Copycats In CMO Acquisition Strategy

It used to be Pharma swept up emerging companies and their new technologies. Now CMOs do so as well. With Pharma, the technologies might end up on the shelf; not so with CMOs. But what about those emerging companies themselves? "If there are two guys thinking about doing a startup, they should do it,” we’re told.

Pharma’s Potemkin Village On The River Of Outsourcing

Grigory Potemkin was governor of war-ravaged New Russia in 1787. He’s said to have deployed a shiny “mobile village” along the Dnieper River to impress Catherine II (and the world) as she inspected the region from her barge. Were we, too, in the year 2016, deploying polished porticoes to hide a dimmer reality, at our Outsourced Pharma conferences?

Pfizer Sets Example For CMOs In M&A Strategy

“Big CMOs” acquire smaller contract development and manufacturing organizations in the same way as Big Pharma has historically acquired biotechs and smaller drug developers. This allegory resurfaced with Pfizer’s recent asset acquisition of Bind Therapeutics. What better modern-day model for CMOs to emulate? And we’ve just seen the cases of Catalent’s gobbling up Pharmatek, and Piramal lassoing Ash Stevens …

More From Chief Editor Louis Garguilo

GUEST CONTRIBUTORS

  • Genentech’s Ocrevus: Pioneering The Progressive MS Therapy Landscape
    Genentech’s Ocrevus: Pioneering The Progressive MS Therapy Landscape

    The last 12 months have brought about sought-after breakthroughs in the treatment of underserved progressive multiple sclerosis (MS) patients, and a landmark approval for one new therapy — Genentech’s Ocrevus (ocrelizumab) — may come in December. In Part 1 of this two-part article, we will explore the landscape that Ocrevus will enter and the factors that will influence its uptake in progressive MS.

  • Do You Make These 8 Big Mistakes In Your Deviation Investigations?
    Do You Make These 8 Big Mistakes In Your Deviation Investigations?

    Deviation investigations are one of the most important quality activities in any GMP (good manufacturing practice) organization. They are also perennially near the top of the list of most frequently cited issues in observations, warning letters, and consent decrees from the U.S. Food and Drug Administration (FDA) and other regulatory authorities.

  • Trump And The FDA: What to Expect (And What’s At Stake)
    Trump And The FDA: What to Expect (And What’s At Stake)

    Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.

  • Serialization Data – Who Needs It And Why?
    Serialization Data – Who Needs It And Why?

    As pharmaceutical manufacturers continue to implement serialization capabilities, there is often a failure to recognize key stakeholders within the organization who will require access to serial number data. For some organizational roles, access to serialization data will be needed on a routine basis to perform on-going activities, while for other roles the need may be required as part of an unplanned event, such as a recall, product complaint, or inquiry. To date, the majority of attention for defining requirements and qualifying solutions has resided with the serialization program/project team and has been concentrated on the data exchange between manufacturer and contract manufacturer enterprise systems and between enterprise systems and packaging site/line systems.

More From Guest Contributors

PHARMA OUTSOURCING WHITE PAPERS

  • 3 Decisions That Impact Shipping High-Value Active Packaging Containers

    It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of blockbuster drug from South East Asia destined for Russia. In France, the roads are closed for days due to a monster snowstorm, with your irreplaceable shipment of investigational drugs stopped somewhere en route between Paris and the clinical trial site. Will all be lost, or can informed choices made before the shipment departs ensure product safety despite unforeseen circumstances?

  • Corporate Culture: A Competitive Advantage

    CEOs increased awareness of corporate culture’s role can be traced to a series of studies over more than two decades. Among the first and most important was the comprehensive, critical analysis of more than 200 companies
    that was conducted by Harvard Business School professors John P. Kotter, Ph.D., and James L. Heskett, Ph.D. Their landmark study determined that corporate culture is a strong predictor of financial performance.

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

  • Conducting An Independent Analysis Of Drug Development Practices
    Conducting An Independent Analysis Of Drug Development Practices

    Industry research shows that about 90% of all drugs in clinical development will be rejected by the FDA or will fail to reach the final stages of regulatory review for other reasons. Given the FDA’s stringent rules and standards for review of drugs, this failure rate is not completely surprising. But while we tend to associate a development program’s failure with dangerous adverse events or underwhelming efficacy data, analysis of the true risks associated with clinical research yields some surprising conclusions.    

  • A Growing Number Of Pharmas Are Thinking Outside The Box
    A Growing Number Of Pharmas Are Thinking Outside The Box

    Everyone knows the mantra – reduce, reuse, recycle – but reusing temperature-sensitive packaging has not been the normal practice in the pharmaceutical/life science sectors. However, changes are afoot.

  •  Principles of Technology Transfer
    Principles of Technology Transfer

    In the context of contract drug development and manufacturing, transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacturing sites.” It is the systematic procedure that is followed to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible party.

  • Quality Assessment – Quality Metrics That Truly Matter
    Quality Assessment – Quality Metrics That Truly Matter

    What elements comprise a “quality” quality assessment in the pharmaceutical industry? Which metrics matter the most? Evaluating the quality or operational excellence across a contract pharmaceutical manufacturing organization is one of the most critical aspects of vetting prospective contract manufacturing partners.

  • 5 ADC Manufacturing Challenges You Need To Know
    5 ADC Manufacturing Challenges You Need To Know

    The unique targeting capabilities and promising clinical trial results of antibody-drug conjugates (ADCs) have made them an exciting and promising treatment in the fight against cancer. According to recent analysis, experts anticipate the ADC market to be worth $10 billion annually by 2025. However, despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Below are five key areas where pharmaceutical manufacturers may face the biggest uphill battles.

More Industry Insights

OUTSOURCING EVENTS

The Future Of Outsourcing In Clinical Research – Preparing For A Changing Global Landscape December 7, 2016
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Update to ICH GCP E6 (R2) – Changes and Implementation December 12, 2016
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response December 13, 2016
10:30am-12pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Identification of Medicinal Products (IDMP) – Building a Compliance-Driven Pilot Program December 13, 2016
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Laboratory Data Integrity: Current Expectations for OOS Result Investigations December 14, 2016
10:30am-12pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
More Industry Events