Newsletter | May 6, 2026

05.06.26 -- FDA Letters Made Public Are Creating New Risks

SPONSOR

CPhI North America 2026: CDMO Partnerships With Mikart

For organizations navigating supply chain risk, cost pressures, and the complexity of modern therapies, choosing the right CDMO partner is increasingly strategic, not just tactical. At this year’s CPhI, many conversations will center on how sponsors can align with manufacturing partners who combine technical aptitude, regulatory credibility, and the flexibility needed to scale oral solid and liquid programs. Learn more.

INDUSTRY INSIGHTS

Insourcing And Outsourcing: Meeting Drug Development Timelines, Budgets

Article | By Carolyn Garrett, Eurofins

How do biopharma companies solve the common challenge of increasing output while decreasing headcount? Explore three options: temporary staffing, outsourcing, and insourcing.

Developing Scalable, Global Solutions For Cell & Gene Manufacturing

Article | Novartis Contract Manufacturing

Cell and gene therapies offer transformative potential for treating complex diseases, but their manufacturing and global delivery face significant challenges.

Stick-Pack Benefits For Pharmaceuticals And Nutraceuticals

Article | Ropack Pharma Solutions

Find out the key advantages of stick-pack formats for pharmaceuticals and nutraceuticals, from enhanced product safety and cost-efficiency to improved compliance and marketability.

FEATURED EDITORIAL

FDA Letters Made Public Are Creating New Risks

By Louis Garguilo, chief editor, Outsourced Pharma

There is a pharma-backed citizen petition challenging the FDA over its new practice of publicly releasing redacted Complete Response Letters (CRLs). It could potentially end in a lawsuit. Chief Editor Louis Garguilo provides early analysis of what is at stake.

Overcoming 3 Key Challenges Of Working With CDMOs For Radiopharmaceuticals

By David Hertlein, Pinnaql

Radiopharmaceuticals have a level of operational complexity that challenges traditional outsourcing models. Address these three critical challenges early and intentionally.

INDUSTRY INSIGHTS CONTINUED

Solving Bioavailability Challenges In bRo5 Drugs

Case Study | Catalent

Leverage mechanistic, material-sparing formulation strategies to enhance bioavailability and accelerate development of challenging bRo5 small molecules, even with limited resources.

Small Molecule Oral Delivery For Rare Diseases: Complexities As A CDMO

Article | By Rachel Timberlake, Bend Bioscience

Developing therapies for rare diseases faces hurdles like high costs, small patient populations, and complex small-batch manufacturing. CDMOs offer crucial support, expertise, and flexibility.

Using Synthesis And Route Design Technology To Approach API Complexity

Article | By Dr. Ryan Littich and Dr. Juergen Swienty-Busch, Lonza

Applying computer-aided synthesis design technology and route scouting in the early stages of development can aid you in designing an efficient and cost-effective path to API manufacturing.

SOLUTIONS

Small‑Molecule Drug Substance Manufacturing At Scale

SK pharmteco

Innovative Formulations And Higher Drug Loads Across The Life-Cycle

Nanoform

Speed, Precision, Impact: The CRO Revolutionizing Bioanalysis

Dash Bio

Pharmaceutical Formulation Development

Altasciences

Scalable Solutions For High Potent OSD Manufacturing

Recipharm AB

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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