Welcome to Outsourced Pharma Live – An online interactive forum to discuss the most important topics and trends impacting drug development and manufacturing outsourcing, and working with CDMOs.
Throughout the year, our Chief Editor, Louis Garguilo, brings together industry experts to discuss how sponsor companies can tackle some of today's biggest challenges in managing your CDMOs. Our audience gets to ask and have answered their questions during the presentation. Each Outsourced Pharma Live session is archived, and can be accessed at any time by registered site users.
SELECTING & MANAGING CDMOS FOR NOVEL THERAPIES
Selecting & Managing CDMOs For Novel Therapies
Outsourced Pharma Live welcomes Verve Therapeutics' Praveen Prasanna, Ph.D., GenSight Biologics' Scott Jeffers, and University of Minnesota's Vaibhav Patel to explore the critical considerations and best practices for selecting and managi...
EMERGING MODELS FOR OUTSOURCING DEVELOPMENT AND MANUFACTURING
Emerging Models for Outsourcing Development and Manufacturing
What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships?
HOW CAN CMC KEEP UP WITH THE RUSH TO THE CLINIC?
How Can CMC Keep Up With The Rush To The Clinic?
In an effort to support fast-track clinical programs and the otherwise rush to the clinic, CMC (chemistry, manufacturing, and controls) professionals in early-stage biotechs find themselves behind the eight ball. Start-ups habitually overestimate their understanding of th...
A NEW AGE FOR SMALL MOLECULE DEVELOPMENT
A New Age For Small Molecule Development
Expedited regulatory pathways are being used more often, even as small molecule pipeline candidates grow in complexity, creating new risks for drug developers. The need for speed – from discovery to development to manufacturing at scale – while maintaining tight control o...
EFFECTIVELY OUTSOURCING DRUG DEVELOPMENT IN 2024
Effectively Outsourcing Drug Development in 2024
Has 2024 ushered in new trends, challenges, and opportunities for outsourcing drug and therapy development, and working with external partners? Our panel of development experts thinks so. From new platforms, modalities and technologies, to the fundamentals of process deve...
STRATEGIES FOR TODAY’S TOP QUALITY & REGULATORY OUTSOURCING CHALLENGES
Strategies For Today's Top Quality & Regulatory Outsourcing Challenges
Accelerated timelines and the rapidly growing outsourcing market are driving the need for robust quality and regulatory teams. Experts discuss this landscape and offer strategies to meet challenges.
MEET OUR HOSTS
Louis Garguilo is chief editor of Outsourced Pharma, and is considered a leading authority on the art and science of drug development and manufacturing outsourcing. His widely read editorials are written in an engaging and unique style that guide readers through the macro aspects and subtle nuances of outsourcing, and working with CDMOs.
Ben Comer is chief editor of Life Science Leader magazine. He has covered the biopharmaceutical, medtech and medical device industries for 15 years as a reporter and editor, and worked as a senior manager in PwC’s Health Research Institute.
CASE STUDIES FOR IMPROVING YOUR SUPPLY CHAIN RELIABILITY
Case Studies For Improving Your Supply Chain Reliability
Outsourced Pharma Live welcomed Pathways Pharma Consulting's Joseph Graskemper, Sonnet BioTherapeutics' Susan Dexter, Stoke Therapeutics' Tony Sampognaro, and CARGO Therapeutics' Adam Haskett to offer their drug development and manufacturing outsourcing ex...
WHICH CDMO IS BEST FOR YOU?
Which CDMO Is Best For You? -- A Debate on Selection, Service, Talent and Technology
Discover how to evaluate the technologies and skill sets best suited to your product’s modality as this panel of experts discuss best practices for selecting a CDMO.
CAUTION: OUTSOURCING WITHOUT CONSULTANTS COULD BE HAZARDOUS
Caution: Outsourcing Without Consultants Could Be Hazardous
Experts explore the role of consultants today as well as arising industry trends that influence your relationships with them. They touch on all modalities and share best practices.
WHAT'S DRIVING THE CELL & GENE THERAPY OUTSOURCING CAPACITY CYCLE?
What's Driving The Cell & Gene Therapy Outsourcing Capacity Cycle?
The feared, then realized capacity shortage in the cell & gene outsourcing space appears to be abating. But the market – and economy – remain in flux. We could be heading for overcapacity for some services, but remain constricted in others.
In Oc...
CONTINUOUS MANUFACTURING: “PROCESSING” A PROJECT NEAR YOU
Continuous Manufacturing: "Processing" A Project Near You
Companies like Novartis, Vertex and Lilly have proven its commercial success and/or built dedicated facilities for future products; CDMOs are aggressively marketing their technology, and recognizing a larger opportunity to differentiate; the biologics space is embracing t...
BIOPHARMA CEOS AND CDMOS: HOW INVOLVED SHOULD THEY BE?
Biopharma CEOs And CDMOs: How Involved Should They Be?
Should CEOs be wading in the outsourcing weeds – involved in not only the strategy, but day-to-day management and activities at CDMO partners? In March 2022, Outsourced Pharma Live hosted three experienced CEOs who shared their experience, outlook and advice th...
BEST PRACTICES FOR OUTSOURCING PROCESS DEVELOPMENT VIDEO SEGMENTS
Best Practices For Outsourcing Process Development
Perhaps no outsourcing service better determines your drug program’s ultimate success than process development. But “PD” covers a wide range of specific and timely needs. Particularly if you aren’t a process chemist, can you identify key components...
ADVANCED THERAPY CONUNDRUM: SHOULD YOU BUILD, OUTSOURCE OR GO HYBRID VIDEO SEGMENTS
Advanced Therapy Conundrum: Should You Build, Outsource Or Go Hybrid
Companies developing advanced therapies have to decide early on: Build capacity, and how much? Outsource, and how little? Mix and Match, and how effective? Fortunately, there are guiding principles and best practices for getting these individual assessments right.
ADVANCED THERAPY CONUNDRUM: SHOULD YOU BUILD, OUTSOURCE OR GO HYBRID
YOU'RE A VIRTUAL BIOTECH? THINK AGAIN.
You're A Virtual Biotech? Think Again.
If you claim you are a “virtual organization” fully utilizing an “outsourced model,” you may be headed for an identity crisis – one that’s beneficial.
WHAT COVID-19 VACCINES TEACH US ABOUT ALL TECH TRANSFERS
What COVID-19 Vaccines Teach Us About All Tech Transfers
Are there “lessons learned” and “best practices” from the COVID-19 vaccine efforts you can apply to tech transfers of your own projects — be they small molecule, biologics, or cell and gene therapies? View the On-Demand version of OP-Virtual ...
HOW TO HIRE A NEW GENERATION OF BIOPHARMA WORKERS FOR AN OUTSOURCING MODEL
How to Hire A New Generation Of Biopharma Workers For An Outsourcing Model
Are you productively filling the open positions in your organization? New recruiting strategies are needed to attract and keep the best of a new generation of biopharma worker. In today’s highly outsourced model, technical experience must be matched carefully with &...
