2024 CDMO Leadership Awards Issue

A great resource to help you find and evaluate the best CDMOs in the world. Included in this 2024 CDMO Leadership Awards issue are some insightful articles on development and manufacturing outsourcing.

What A Pharma Pro Teaches Biotechs About Outsourcing

They say biotech taught pharma how to outsource. So what’s someone who has spent 31 years working in Big Pharma know about outsourcing from the vantage point of smaller organizations?

A Professor's Practical Advice For AI And Outsourcing

It’s time to get real about artificial intelligence applied to our drug development and manufacturing outsourcing – practical supply-chain enhancements from AI-generated insights that can be implemented right now. A helpful source in this undertaking is Professor Tinglong Dai of Johns Hopkins University.

Women Impacting Outsourcing

More women are entering and making significant gains in our drug development and manufacturing outsourcing sector. Chief Editor Louis Garguilo highlights a few of these individuals, and takes account of the current environment for women who do enter our industry. From sponsors to service providers to concerned mothers, we are being enriched with the thoughts and activities of women in our industry today.

The "Outsourcing Master Class": 10 Modules For Success

Darren Dasburg, a long-tenured executive at GSK, Medimmune/AZ, well-regarded consultant, and currently Chief Business Officer, CRISPR Biotech, didn’t write the book on outsourcing. He did, though, design and teach the defining class on the subject. The “Outsourcing Master Class” is a capstone-case-review, team-based course sanctioned by the International Association of Outsourcing Professionals (IAOP). 

Cell Therapy Outsourcing: Current Thinking, Strategies And Trends

Outsourced Pharma Chief Editor Louis Garguilo brings readers this collection of editorials on the current thinking, strategies, and trends in the cell-therapy space regarding outsourcing, and working with external partners. These editorials are based on interviews with CEOs sharing their analysis and best practices as they play out currently in their companies, and within our global industry. Garguilo covers Europe from the perspective of Miguel Forte, CEO, Bone Therapeutics, a most respected entrepreneur (MD, and professor) in the cell-therapy industry there. In the U.S., 30-year industry veteran and current CEO of Triumvira Immunologics, Paul Lammers, details an intriguing relationship his biopharma has with CDMOs, and shares his view on aspects of autologous and allogeneic therapies.

Your Supply Chain On Inflation: An Outsourcing Analysis

Outsourced Pharma Chief Editor Louis Garguilo has been an ahead-of-the-curve chronicler of inflation in the development and manufacturing supply chain. Based on interviews with biopharma professionals – from CEOs to frontline workers and consultants – he’s kept readers informed of rising outsourcing challenges, including the price for materials and services at CDMOs, and hard-to-find capacity as supply chains remain strained. Now we’ve collected four of Garguilo’s editorials with outsourcing professionals to help you understand what they and the entire industry is experiencing, what you can expect in 2022, and some steps you might be able to take to mitigate these market forces.

CEOs And The Complexities Of Outsourcing

Decisions on the strategies and implementation of drug development and manufacturing outsourcing have never been so important to the overall health and direction of both emerging and established biopharma organizations. CEOs today need to take on a higher degree of leadership in making these decisions. To outsource or not, how much, where and when, have become existential questions of survival, and keys to success (or failure). Chief Editor Louis Garguilo looks into how the C-Suite can navigate the complexities involved.

Outsourcing In The Pursuit Of National And Global Goals

Outsourced Pharma Chief Editor Louis Garguilo wades into the noisy intersection of national and international politics, and our pharmaceutical industry, from the perspective of our main focus on drug development and manufacturing outsourcing. In this part one of a two-part collection of recent editorials, Garguilo leads readers through the external issues and developments impacting your outsourcing during the recent pursuit of COVID-19 vaccine production – and potentially well beyond.

A Critical Analysis Of Outsourcing In A Time Of Turmoil

What happens when your drug development and manufacturing outsourcing activities are impacted by an unusually tight and publicized nexus between national and international politics, and the pursuit of science in our pharmaceutical industry? In this second of two editorial collections, Chief Editor Louis Garguilo helps readers work through some answers, and look critically at how we’ve become front-page news. But be forewarned: “follow the science” may turn out to have a meaning quite different than what you expect.

Quality, Supply Chain Agility, Analytical Development: White Paper Analyses

Quality, Supply Chain Agility, Analytical Development: These are the subjects of three thought-provoking whitepapers on our biopharma industry, reviewed and analyzed for Outsourced Pharma readers by Chief Editor Louis Garguilo. Important in their own right, see how Garguilo pulls out the most salient points from the reports to help readers increase your understanding and efficacy of drug development and manufacturing outsourcing. Both retrospective and forward-looking at the same time, these whitepapers and analyses should be read by everyone in your organization interested in improving product quality, CDMO relationships, and all outsourcing outcomes.

Trending: New CDMO Models For Your Consideration (Part 1)

Something positive and of great importance also flowed through 2020: a handful of new and expanding business and service models at contract development and manufacturing organizations. CDMOs are changing, and providing drug sponsors – particularly virtual, and small to mid-sized organizations – with more, and it seems, improving options.

Trending: New CDMO Models For Your Consideration (Part 2)

Biopharma CDMOs. Best-In-Breed Collaborations. Nonprofit, University-Led Service Providers.

A “Dissertation” On The State Of Tech Transfer In Outsourcing

Don’t miss this opportunity to download this four-part “dissertation” on the physical and mental state of tech transfer in drug development and manufacturing outsourcing. It features a veteran CDMO professional who went “back to school” to study his trade, and reconsider how the biopharma industry performs tech transfers today; and a biopharma expert who played key roles in both the early successes of Amgen and Catalent – and advocates for the “elimination” of the tech-transfer practice altogether. Outsourced Pharma Chief Editor Louis Garguilo rolls this up into a thought-provoking e-book for readers at both biopharma and CDMOs. 

CDMO Selection: The Critical Art And Science Of Finding The Right Partners

CDMO search and evaluation are at the core of your drug development and manufacturing outsourcing. Select wisely, and projects and partnerships progress smoothly. Don’t, and time, money and frustrations can build up. In this ebook, Outsourced Pharma Chief Editor Louis Garguilo has chosen five editorials and sponsor articles on the art and science of “CDMO Selection.” 

COVID-19 And Your Supply Chains: Analysis And Advice From Outsourced Pharma

The coronavirus pandemic has tossed together your drug development and manufacturing supply chains with a worldwide health and health-care challenge, national security concerns, and international and domestic politics. Outsourced Pharma Chief Editor Louis Garguilo has covered this convergence from the very beginning of the outbreak. This collection of his editorials and podcast will help you to think through your outsourcing strategy in the face of the outbreak of COVID-19, and offers some keen analysis and best practices. He suggests biotech and pharma companies take this moment in time to deeply reconsider geographic and other supply-chain risks to enhance decisions for maintaining the most reliable source of drugs and vaccines, and to openly ask and answer difficult questions. Download the eBook now.

Expert Advice For All Facets Of Managing Your External CMC Partners

More outsourcing needs to translate to better outsourcing – improved efficiencies, productivity, speed, and CDMO relationships. Easier said than done. But no internal function at a biotech or pharma company can do more to accomplishing these improvements than the CMC (chemistry, manufacturing and controls) group.

Outsourcing Trends For Cell & Gene Therapy

The cell and gene therapy sector’s focus on outsourcing is a major area of on-going concern due to the shortage of suitable manufacturing facilities and qualified outsourcing staff.  This collection of articles weighs the economic benefits of outsourcing (i.e. productivity, efficiency, time-to-market, and quality gains) as well as best practices for selecting an outsourcing partner. Here you’ll find information about the current limitations associated with a complicated manufacturing process as well as existing and promising opportunities and developments needed to outsource most — if not all components — of the value chain.

Patents, Generics, And Innovative Drugs: New Ideas For Drug Development Within The U.S. Healthcare System

This collection includes suggestions for improving the business opportunities of the pharmaceutical industry and individual companies -- including those in the support and supply chain – as well as increase innovation in drug development, and ultimately improve patient outcomes.

Data Integrity In The Life Sciences

This eBook is a collection of articles from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.

Keeping Up With Continuous Manufacturing

The promise of continuous manufacturing seems almost limitless in its potential. But, what about the reality on the ground? Louis Garguilo, Chief Editor of Outsourced Pharma, looks at current continuous manufacturing initiatives underway and what’s slowing adoption.

The State Of Fill-Finish Services In Pharma

Outsourced Pharma’s Chief Editor, Louis Garguilo, takes a deep-dive into the current state of fill-finish services in the pharmaceutical outsourcing space. He talks to executives from both sponsor and CDMO companies and helps readers understand the current challenges in fill-finish, stakeholders’ role in improving outcomes, and potential future solutions.

Modeling Relationships With CDMOs

Partnerships between sponsor companies and contract manufacturers can take on endless variations. Louis Garguilo, Chief Editor of Outsourced Pharma explores several successful sponsor-CDMO relationships by talking to the participants involved.

Examining the Biopharma-CDMO Relationship with the Global Drug Industry

Are we dangerously reliant on outsourcing to China, and is this outsourcing without the good of U.S. patients in mind? Our drug development and manufacturing outsourcing industry can’t escape the ins-and-outs of geopolitical and global affairs. Learn more in this free collection of articles