Sword Bio
Five Recurring Deficiencies in Biologic Assay Submissions
Every biologic program passes through regulatory review, and the bioanalytical package is among the most scrutinized components of any submission. Agencies including the FDA and EMA consistently issue questions, information requests, and deficiency letters tied to assay validation, immunogenicity characterization, and data integrity. What follows is not a catalog of individual enforcement actions but a…
Validating Bioanalytical Assays Under ICH M10
A Practical Walkthrough for Biologics Sponsors For years, sponsors developing biologic therapeutics navigated a patchwork of regional expectations for bioanalytical method validation. A study designed to satisfy FDA bioanalytical method validation (BMV) guidance did not always map cleanly onto EMA expectations, and submissions intended for multiple regions often required duplicated or reconciled validation work. The…
From Biologics to Gene Therapy: A Conversation with Jim McNally
Overview Carolina Molecular recently sat down with Jim McNally of Sword Bio to discuss his path from the Gulf Coast of Mississippi into biotech and drug development, the evolution of CRO partnerships, and the increasing complexity of modern therapeutics. Throughout the conversation, Jim shares perspectives shaped by years of experience across academia, pharma, biotech, and…
How CRO Partnerships Accelerate Biologic Drug Development
How CRO Partnerships Accelerate Biologic Drug Development Biologic drug development is inherently complex. Unlike small molecules, biologics—monoclonal antibodies, fusion proteins, cytokines, gene therapies, and other advanced modalities—require highly specialized analytical characterization, immunogenicity assessment, and regulatory rigor. Internal teams at biotechnology companies often operate with lean headcount and limited infrastructure. As a result, strategic partnerships with…
Bioanalytical Challenges in Cell and Gene Therapy Products
Bioanalytical Challenges in Cell and Gene Therapy Products Cell and gene therapies (CGTs) represent one of the fastest-growing and most scientifically demanding areas of modern medicine. Unlike traditional small molecules or standard biologics, CGT products introduce living cells, viral vectors, nucleic acids, and genetically engineered constructs into patients. These therapies can produce durable, sometimes curative…
Sword Bio Appoints John Moriarity as Vice President, Business Development, East Coast
Sword Bio (“Sword”), a contract research organization that supports biotech and pharmaceutical companies with their bioanalytical needs for pre-clinical and clinical trials, announces the appointment of John Moriarity VP, Business Development, East Coast. John brings more than 20 years of biopharma experience to Sword Bio, with a career that began in the laboratory and evolved…
Sword Bio Appoints Michael Losauro as Vice President, Business Development, West Coast
Sword Bio (“Sword”), a contract research organization that supports biotech and pharmaceutical companies with their bioanalytical needs for pre-clinical and clinical trials, announces the appointment of Michael Losauro VP, Business Development West Coast. Mike joins Sword Bio with more than 20 years of experience driving commercial growth and building strategic partnerships across the biotech and…
Sword Bio Expands Space to Support Growth
Sword Bio today announced that it has expanded into additional space to accommodate the rapid growth the company has experienced over the past year. The team has nearly doubled in size, driven by exceptional market response to Sword Bio’s commitment to scientific expertise, personalized service, and industry-leading lead times. With the newly added space, Sword…
Advancing Biomarker Strategies in Rare Disease: Insights from Our Lunch & Learn
Last week, Sword Bio was proud to host a Lunch & Learn seminar in Cambridge, MA, where more than 20 professionals gathered to discuss one of the most pressing challenges in drug development: clinical biomarker strategy for rare diseases. We were honored to welcome Binodh DeSilva, Ph.D., Senior Vice President of Bioanalytical and Biomarker Development…
Lessons Learned: Analysis of Complete Response Letters from FDA
Byron Fitzgerald, Founder of ProGen Search analyzes complete response letters from the FDA. This report takes a deep dive into 202 complete response letters and where therapeutic deficiencies fall and what to consider as you plan, whether due to clinical efficacy concerns, manufacturing challenges, safety data gaps, or regulatory misalignment. Click here for the 202…