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 of CMC processes, is the gauntlet sponsor companies must run to succeed in 2024. 

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 development and service-provider management, it’s a good time to take the pulse of this middle component of creating new options for patients.

• CDMOs More Willing To Please
• The Initial Contract With A CDMO
• Two Tips For Your Outsourcing Consideration
• CDMO Selection: One Size Doesn’t Fit All
• What Could Possibly Go Wrong?
• Backup Plans: At The Same Contract Developer Or Elsewhere?
• Scope-Of-Work Strategies When Contracting With CDMOs
• FTEs, Fees-For-Service, Or Time-And-Materials?
• Don’t Fear CDMO Or Facility Change

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.

• Workforce Challenges Key To Outsourcing
• Managing Multiple Partners – And Materials – From Around The Globe
• The Outsourcing Context Has Changed. Have You?
• Accelerated Approval Pressures Starting Materials
• Quality Agreements, Inspections, And PQS
• Today’s Quality And Regulatory Workforce Challenges
• The Wrong Way For Your CDMO To Upgrade Facilities
• The Nature Of Quality Management Needs To Change
• File First In Europe, Then The U.S.?
• How To Connect Quality And Regulatory “At The Hip”
• The Fundamental Outsourcing Question All Sponsors Face

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 experiences. Learn how to avoid and overcome CDMO challenges and successfully meet your supply chain needs.

• AI Defines “Supply Chain”
• A Supply-Chain Experience Applicable To All Therapies
• An Early-Phase, Raw-Material, Clinical Manufacturing Case Study
• A Happy And Unhappy Supply Chain Experience
• Surviving A Viral-Vector Supply-Chain Challenge For A Commercial Product
• Know Your Supply Chain Analytics!
• Leave The Starting Materials To Your CDMO
• Global Supply Chains: How Do You Decide Where To Outsource?
• Continuous, Continuous-Manufacturing

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.

• Opening Thoughts On Selecting Your CDMO
• Top 3 Factors For Working Successfully With CDMOs
• Looking for An External Partner Starts With An Internal Investigation
• Transactional Or Relational? Both Can Work Out With Your CDMO
• Our All-Star Panel All Start With A Key Point On CDMO Selection
• Understanding Must Haves And Nice To Haves
• Make Your RFP Work For You
• The Final Decision: Who Selects The Winning CDMO?
• CDMO Pricing For Viral Vectors And Cell & Gene Services
• Subjective And Quantitative Analysis Of Your External Partner
• Just Ask The Question!
• Your CDMO As Consultant
• CDMOs Will Tell You Anything. What Are You Telling Them?

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.

• When Consultants Work Out, And When They Don’t
• Consultants For A Global Industry
• Make Sure It’s The RIGHT Consultant
• Consulting Agencies: Getting What You Pay For
• Interviewing Consultants And “Free” Advice
• What Value Do Your Consultants Bring To CDMOs?
• Consultants Should Take The Right Gig
• Good Consultants Aren’t One-Sided Advocates
• I’ve Worked For Gift Cards: A Roundtable On Consultant Contracts
• Expertise For Technology, Capacity, And Equipment
• Consultants Are A Part Of Our Biopharma History
• Conduits Of Industry Intel

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 October 2022, Outsourced Pharma Live's panelists discussed the identified macro and micro trends impacting deal-making at CDMOs. Exclusive data from BioPlan Associates was also presented. Learn what to be on the lookout for as well as how to prepare and take advantage of (another) "life cycle" in our industry – this time in the cell & gene therapy space.

• The Economy Will Force Capacity Openings
• Whole Lot Of CDMO Expansion Going On
• The Other Side Of “The Capacity Tunnel”
• Pfizer’s Gene Therapy Background In Three Minutes
• The Analytical Services Outsourcing Bottleneck
• Your CDMO’s Location Impacts Worker Availability
• Build Vs. Buy: A Pfizer Professional Weighs In
• Keep Cell and Gene Partnerships On Shore?
• In-House Or Outsource? There’s Also A Third Option
• How You Can Help Your CDMO Help You?
• Keeping CDMOs On The Same Page And Responsive
• Outsourcing Challenges In The CGT Space In 2023

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 the model; regulators are renaming it “continuous processing,” and attempting to push it along. With enabling technology, regulatory developments, and commercial products, it’s an ideal time to check out the latest On-Demand webinar from Outsourced Pharma Live, where our panel of experts take measure of continuous processing and its growing adoption across the modality spectrum.

• Biologics Gaining On Continuous Manufacturing
• Starts And Stops, ICHQ 13 And Continuous Manufacturing
• It Could’ve Been Done 20 Years Earlier: Slow Implementation of Continuous Manufacturing
• How Do You Get Started On The Continuous Manufacturing Path?
• That’s Not The FDA We Encounter Today
• Are There CDMOs Ready For Your Continuous Processing Needs?
• USP Looking To Help Bend The Continuous Manufacturing Arc
• What’s The Cost Of Poor Quality? A Question For The Adoption Of CM
• Single Use And Continuous Manufacturing

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 that can help you no matter your position within the outsourcing development and supply chain at your organization.

• Outsourcing When It’s Me, Myself And I
• After Time-Line Decisions, CEO Leaves Outsourcing To CMC Team
• Intersection Of Device And Pharma: A CEO’s Opening Gambit
• Biopharma CEO Provides Contact Points For CDMO Onboarding
• Your Next CEO Must Have Outsourcing Experience
• Training To Become An Outsourcing Executive
• What Experience/Position Should Your CMC Professional Have?
• When Working With CDMOs, What If YOUR CEO Is A Pain In The Neck?
• CDMOs Less In “Sell Mode” Post-Pandemic
• Should Your Company Be Involved In Politics?
• CDMO M&A Can Work Out Nicely For Biotechs (Or Not)
• How Can You Help Your CEO When It Comes To Outsourcing?

BEST PRACTICES FOR OUTSOURCING PROCESS DEVELOPMENT

• 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 for working with CDMOs on this crucial step?

• First Thoughts On PD With CDMOs
• QA Ratio To PD Personnel
• Perfect The Enemy Of Good Enough?
• Contracts, Contracts, Contracts … And Project Timing
• Do You Even Need Any Process Development?
• Should Your CDMO Manage Raw Materials?
• Do You Have A Back-Integrated Supply Chain?
• The Final Word On Process Development Outsourcing

ADVANCED THERAPY CONUNDRUM: SHOULD YOU BUILD, OUTSOURCE OR GO HYBRID

• 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.

• A “Perfect” Storm For Advanced Manufacturing Strategy
• Insourcing Or Outsourcing: Not So Different Strategies?
• Outsourcing Vs. Knowledge Retention At Advanced Therapy Biopharma
• Can You NOT Outsource?
• What’s The Business/Financial Case For Building Capacity?
• Is It Difficult To Manage A Hybrid Outsourcing Model?
• Analytical Support At CDMOs For Advanced Therapy Products: Does It Exist?

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.

• “Leakage” In Drug Development And Manufacturing Outsourcing
• The 90-10 Financial Aspiration For Outsourcing Services
• Outsourcing Contracts To Incentivize CDMOs
• The Balance Of Power Between Virtual Biotech And Big CDMOs

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 from our discussion on November 4, 2020 on what we’ve learned thus far, and how to “transfer” that knowledge to your projects.

• Tech Transfer’s Best Practice: Receive The Requisite Analytical Support Services
• A Robust Data Management Program Is Key To Any Tech Transfer
• Think Sequential: Vaccine Company CEO Says We Can All Get To Market Quicker
• What CDMO Has The Right Facilities For Your Drug Program?
• Quality Vs. Cost: What COVID-19 Vaccines Teach Us About All Tech Transfer

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 “people skills,” and the right attitudes. Not to mention currently you have to do this in the middle of the COVID-19 pandemic. Some good news? We assembled a panel of experienced HR and external supply chain professionals, and the founder of three Centers for Biopharma Education and Training (CBET), to offer you their best practices, and answer your questions.

• How Do CDMOs Hire New Workers – For Your Projects?
• When HR For A Biopharma Dialogues With HR For A CDMO
• Universities Can Help You Recruit and Train Biopharma Workers
• A Biopharma SVP and His VP of HR Discuss Hiring New Workers
• Have Biotechs Changed So Much It Now Impacts Who We Hire?

A NEW DECADE OF OUTSOURCING: WHAT CAN WE EXPECT?

• A New Decade Of Outsourcing: What Can We Expect?

  Will the "Twenty-Twenties" be as exciting as they sound for our industry? For certain, nobody saw a coronavirus outbreak put outsourcing in such a public light. Outsourced Pharma hosted a live, virtual discussion in June 2020 focusing on four key areas: continuous manufacturing; cell and gene therapy influences; new sponsor-CDMO service models; and "Supply Chain 4.0."

• A New Decade Of Outsourcing: What Can We Expect? - Advice from Jana Spes, Head of Pharmaceutical Development & Manufacturing Sciences, Ironwood Pharmaceutical
• A New Decade Of Outsourcing: What Can We Expect? - Advice from Shawn Eisenberg, Executive Director, Manufacturing & Supply Chain, ImmunoGen
• Continuous Manufacturing - What's The Holdup?

MANAGING YOUR CDMOS - ADVICE FROM PROFESSIONALS WHO HAVE BEEN ON BOTH SIDES OF OUTSOURCING

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• Managing Your CDMOs: Advice From Professionals Who Have Been On Both Sides Of Outsourcing

  At our second OP-Virtual, Outsourced Pharma Chief Editor Louis Garguilo invited professionals who have had careers at both CDMOs and biotechs to give us advice, and some best practices, regarding what they’ve learned having been on both sides of the outsourcing equation. Here are excerpts from the opening comments of our speakers.

• Managing Your CDMOs - Advice from Lisa Wyman of Acceleron Pharma
• Managing Your CDMOs - Advice from Ken Baker of Sage Therapeutics
• Managing Your CDMOs - Advice from Charlie Montgomery of Skyhawk Therapeutics
• Managing Your CDMOs - Advice From Bernhard Paul Of Carinth Consulting
• Managing Your CDMOs - Advice from Steve Collier of Sage Therapeutics