Nielsen BioSciences is aiming to change this paradigm. The San Diego-based company develops and manufactures skin test antigens to detect hypersensitivity against viral and fungal infections. These antigens play a key role in the diagnosis of diseases ranging from Valley Fever to HIV. Founded by Dr. Stewart Nielsen in 2013 and driven by his decades of antigen expertise, the strategy today evolves around Candin, a purified Candida albicans antigen. The company recently published the results of their Phase 2 clinical study and is currently conducting a Phase III clinical trial in the U.S. and Japan to evaluate Candin’s efficacy and safety in treating common warts. Nielsen takes a patient-centric view to their product strategy. Customer feedback is direct and constant. The company sells its products via wholesalers, but also directly to physician offices. This puts the team into near daily contact with customers. “Dermatologists are aware of immunotherapy as a treatment approach but are currently not considering this therapy class due to lack of standardized treatments, lack of placebo-controlled studies, and consequent lack of regulatory approval and reimbursement options” says Christoph Wulf, who is heading Nielsen’s commercial efforts. “We are aiming to change this: We hear a clear unmet need from Dermatologists and patients alike. Treatment cycles are lengthy and can be frustrating. We hope that we can drive change and provide a treatment option that lessens the burden.” The clinical focus on Dermatology has been a pivotal driver for growth at Nielsen and put the 12-year old company on a rapid growth trajectory. The company started their first Phase III clinical trial in 2023. The trial is the only multicenter, randomized, double-blind, placebo-controlled Phase III for the treatment of verruca vulgaris. After successful completion, the company plans to file for approval with the U.S. FDA and Japan's PMDA, potentially making Candin the first FDA-approved antiviral immunotherapy for common warts. Candin is currently not approved for the treatment of warts. Nielsen sees a global benefit of its drug. The company entered a strategic collaboration with Japan’s Maruho Ltd. for Candin. Maruho is a trusted leader within Dermatology in Japan and is planning to commercialize Candin in Japan after approval..

CellTrans has achieved what no other company has: FDA approval for the first-ever allogeneic islet cell therapy— Lantidra—marking a watershed moment in the treatment of diabetes. While most therapies manage the symptoms of type 1 diabetes, CellTrans is tackling the root cause by restoring the body’s ability to produce insulin naturally. Lantidra is created using donor-derived pancreatic islet cells that are isolated and processed under stringent FDA-compliant conditions. These cells are then infused into the patient’s liver via the hepatic portal vein. Once delivered, they begin functioning like native islet cells—monitoring blood glucose levels and releasing insulin in real time, effectively replicating the body’s own metabolic response. “With Lantidra, our goal is to help people with type 1 diabetes and severe hypoglycemia reclaim their body’s ability to produce insulin, potentially freeing them from the burden of daily injections,” says José Oberholzer, founder, president and CMO. The fact that CellTrans achieved this as a self-funded startup makes the story even more exceptional. With no outside capital and a lean, tightly knit team, it successfully navigated the regulatory and scientific gauntlet, including Chemistry, Manufacturing and Controls (CMC) strategy, clinical application development, regulatory interactions, Biologics License Application (BLA) submission and FDA approval. This level of end-toend execution is rare, even among large, well-funded biotech companies. Firsthand experience of building and navigating the entire development lifecycle now drives CellTrans’s work beyond its products. Through its contract research division, it helps other innovators bring first-in-class cell and biomaterial-based therapies to market. Its services cover the full spectrum: from early-stage proof-of-concept to IND-enabling studies, with deep expertise in in vitro and preclinical in vivo models, cell functionality and biomaterial integration for regenerative and therapeutic applications. Unlike traditional CROs with siloed departments and slow handoffs, CellTrans runs as a unified, agile team. The same scientists who help design your studies stay involved through execution, ensuring continuity, speed and quality. This structure reduces miscommunication, accelerates iteration and helps generate cleaner, more decision-ready data. At the core of this model is adaptability. CellTrans understands that no two clients face the same set of challenges. Whether the hurdle is budget constraints, tight timelines or complex technical demands, the team tailors its approach to meet the reality of each program. “Our journey made us resourceful,” says James McGarrigle, COO. “We’ve lived every part of the development lifecycle—viability, functionality, immune compatibility and tight budgets. That experience lets us de-risk our clients’ programs before problems even surface.”.

PassPort Technologies is rewriting the narrative of drug delivery by blending precision engineering with pharmaceutical innovation to offer an elegant alternative to injections. In a landscape where convenience, compliance, and patient experience are increasingly paramount, PassPort introduces an innovative, more human-centered approach. “Our needle-free system provides patient benefits, good compliance, and superior effectiveness to current injectables,” says Hirotoshi Adachi, COO. It begins with the PassPort device, a compact and intuitive tool that creates microscopic pores in the skin painlessly and in milliseconds. These pores reach the viable epidermis without causing pain or discomfort. Once formed, a pre-aligned dry drug patch is applied over the pores. Interstitial fluid naturally rises through the micropores, dissolving the drug on contact. The dissolved compound then flows back through the same channels, entering the systemic circulation. Early trials confirm not only a rapid onset but also strong and consistent bioavailability. This delivery mechanism is highly adaptable. The system can be fine-tuned to match a broad spectrum of drug profiles, from small molecules, peptides, proteins, oligonucleotides, and even mRNA-lipid nanoparticles. Developers control the number and size of pores and tailor the dry formulation to suit either rapid or sustained release needs. Real-time sensors ensure that each application creates the precise micropore pattern required for uniform absorption. This level of control unlocks opportunities for therapies previously limited by oral bioavailability issues or the drawbacks of injections and infusions. “The platform is designed around patients and providers, not protocols. We adjust shape, feedback, and experience to fit real lives,” says Uros Kascak, head of engineering. Clinical applications illustrate the platform’s promise. For acute conditions like severe migraines, the PassPort patch achieved rapid systemic absorption, much faster than oral tablets, on par with injections in the US Phase 1 study, but without the need for a needle. In another study, a novel peptide for early-stage Alzheimer’s Disease, delivered through PassPort, reached cerebrospinal fluid with 20 to 40 times the availability of intravenous methods. Not only did the drug cross the blood-brain barrier, but it also demonstrated evidence of mitochondrial activation in brain cells, a crucial factor for effective neurodegenerative treatments. Phase 1 study will be starting in 2025 in Japan..

Before synthetic biology captured headlines, CST Technologies was already reshaping the diagnostics landscape. For over four decades, the company has specialized in developing synthetic serum and urine matrices—delivering contamination-free, scalable, and highly stable solutions that have become the backbone of some of the industry’s most trusted diagnostic controls. By replacing inconsistent biological materials with engineered precision, CST Technologies helped set new benchmarks long before the world caught on. The company’s impact on in vitro diagnostic (IVD) manufacturing has been profound. With products that eliminate lot-to-lot variation and cold-chain dependencies, CST offers a rare combination of consistency, reliability, and peace of mind. Its unwavering commitment to quality has earned CST a reputation as a silent standard-bearer for laboratories and manufacturers worldwide. CST’s journey began in the early 1980s when the diagnostics industry heavily relied on human and bovine serum albumin (HSA and BSA) to produce controls and standards. Though common, these biologics presented serious challenges: unpredictable batch variability, sensitivity to temperature fluctuations, and heightened safety risks amid the AIDS and hepatitis epidemics. During this turbulent period, CST’s late co-founder, Dr. Anand Akerkar, recognized the urgent need for a safer and more dependable alternative. A Ph.D. chemist with a passion for solving real-world problems, Dr. Akerkar pioneered the development of synthetic matrices designed to replace HSA and BSA. His groundbreaking work culminated in creating CST’s flagship innovations—SERASUB, URISUB, and LOSOURISUB. These synthetic solutions did more than eliminate the risks associated with biological materials; they revolutionized diagnostic manufacturing. Offering room-temperature stability and eliminating batch inconsistencies, CST’s matrices became a critical advancement that continues supporting global healthcare infrastructure today. Products Designed for Precision CST’s pioneering synthetic matrices—SERASUB, URISUB, and LOSO-URISUB—brought a new level of control to an environment once at the mercy of biological variability. SERASUB, a synthetic serum substitute, provides a stable, contamination-free platform for spiked reagents. Whether calibrating cholesterol levels or hormone assays, manufacturers can trust SERASUB to deliver accuracy without the guesswork of biological samples..

ExecuSearch of Chicago’s story is irrefutable proof that the American dream is still alive and vibrant as ever. What Kara and Simon McCune started in their two-bedroom apartment has now grown into a nation-spanning recruitment firm. Their story is about ambition, grit and the relentless pursuit of opportunity. Simon started in the pharmaceutical industry, climbing up to a leadership position in sales, where he discovered his love for identifying talent. Subsequently, he joined a recruiting firm to learn the business. After gaining enough knowledge, he founded ExecuSearch of Chicago with owner, Kara, to solve recruitment challenges in the pharmaceutical industry. Initially focusing on sales, the company has expanded to provide recruiting solutions to other functional areas, including: clinical development, medical affairs, market access, research & development, marketing, and operations across the healthcare industry. Few can match the firm’s advantage, built on Simon’s deep expertise. Affiliated with the industry in one form or another for over three decades has imparted a level of knowledge and connections that are hard to replicate. Expanding on that expertise and network, the team actively participates in conferences and career fairs to connect with new talent. The experience and access to a vast pool of talent enable them to select the best candidate for the role while providing a faster solution. “We've filled roles that sat vacant for over a year in just 15 to 30 days thanks to our expertise and industry connections,” says Simon. “Ultimately, what we do affects patient outcomes. By placing the right individuals with our clients, we help them build teams that develop and distribute therapies that improve the lives of patients.” ExecuSearch of Chicago accomplishes this through partnerships with clients and candidates, acting as a bridge between them. This gives the firm insights to determine the best match and compatibility for both parties, even if that’s not apparent on paper. This is the primary reason the firm places such emphasis on maintaining good relations with its candidate pool. Many of these connections have lasted for years, built on trust and positive past experiences. As a result, even when not actively seeking new opportunities, candidates continue to engage with the firm, eager to hear more about potential roles. These passive candidates often represent the industry's top performers, ensuring the highest level of performance and patient care..