Newsletter | May 2, 2025

05.02.25 -- Tariffs Rising, But R&D Licensing From China Keeps Climbing

SPONSOR

Webinar: Utilizing a Stepwise Approach for Nitrosamine Risk Mitigation

Mandatory nitrosamine testing has driven stricter standards for drug development. Join Cambrex's Todd Sprouse as he shares a stepwise, product-specific approach to detect, quantify, and control nitrosamine impurities efficiently. Key topics include risk evaluation, formation feasibility, analytical method development, and mitigation through targeted testing of materials. Click here to learn more.

FEATURED EDITORIAL

Tariffs Won't Stop Drug-Candidate Licensing From China Biotechs

According to Global Data, the total deal value of U.S. licensing of innovator drug candidates from Chinese biopharma companies has surged since 2020. This is an area way upstream of the current tariff focus on manufacturing. But how this R&D trend and those tariffs play out will  impact your U.S.-based CDMOs.

A Practical Guide To Defining Priority Data In MES

Manufacturing execution systems (MES) play a crucial role in pharma/biotech, but MES platforms face the challenge of identifying the critical data that should be prioritized for supporting effective operations.

INDUSTRY INSIGHTS

Continuous Manufacturing: An Evolving Technology For Drug Manufacturing

Explore the exciting developments in continuous manufacturing and learn how leveraging this innovative technology can help improve manufacturing processes and discover new clinical candidates.

Optimized Processes: A Guide To Lyophilization Cycle Development

Review the essential phases of the lyophilization cycle — freezing, primary drying, and secondary drying — and critical success factors to achieve optimal product quality and stability.

From Crisis To Confidence: Ensuring Smooth Regulatory Submissions

Consider some of the major challenges medical writing submission specialists face today and what strategies can overcome them, consistently setting the stage for success.

Identify And Mitigate Absorption Risks With PBPK Modeling

See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

Nasal Inhalation Delivery – An Introduction Guide

Unlock the potential of nasal inhalation for delivering active pharmaceutical ingredients by exploring the benefits of both liquid and dry powder formulations as companies drive innovation in the field.

Integrating Early Development With Clinical Supply

In the era of seamless development, reducing time to the clinic and getting rapid approval is key. An integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes.

Crucial Steps In Pharmaceutical Formulation Development

Learn how formulation development drives every phase of early drug development, ensuring precise dosing, stability, and safety while providing critical data for regulatory submissions.

SPONSOR

Discover how CDMOs can help you achieve and maintain CMC compliance throughout the drug development lifecycle. Outsourced Pharma Live will explore how to leverage CDMO expertise in process optimization, documentation, and regulatory submissions. Learn practical strategies to align your CMC goals with CDMO capabilities to accelerate development and ensure successful drug launches. Registration is free thanks to the support of Curia.

SOLUTIONS

Continuous Flow Processing: A Sustainable Manufacturing Solution

Optimize your manufacturing processes and enhance sustainability, while meeting regulatory requirements and minimizing environmental impact.

Stability Testing – Onsite Preclinical Services Supporting Product Development

The results gleaned from our stability studies guide the development of robust drug formulations and packaging, aid in regulatory submissions, and lay the groundwork for successful commercialization.

Solid Form Services

We have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program.

Pharmaceutical Outsourcing

Discover how Adare's innovative technologies, global reach, and commitment to quality and patient centricity can deliver exceptional solutions for your oral solid dose needs.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

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

Connect With Outsourced Pharma: