With patient care at the forefront, it is critical to assess the economics of both outsourcing models and ensure the one you select provides the most efficient path to commercialization. This was the purpose of a recent study by the Tufts Center for the Study of Drug Development (CSDD), which compared cycle times and development economics between multi- and single-source CDMO models.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the most effective treatment for patients with high risk and relapsed hematologic malignancies. When donor T cells recognize the host as foreign, they induce an immune response against the host and may cause life-threatening graft-versus-host disease (GvHD), a major complication of allo-HSCT.
Flow cytometry is an important tool for the diagnosis and classification of leukemia. While many leukocyte markers have been identified and are used to determine the exact subtypes of leukemia a patient may have, high-dimensional multicolor analysis has been limited by instrument capabilities. This has often resulted in splitting a valuable limited sample into multiple independent tests to fully define the patient’s phenotype.
Does the human body have the capability to heal itself? The idea of immunotherapy, harnessing the body’s own immune system to eradicate disease, has moved from the realm of possibility to something much more tangible. Interestingly, this promising therapy is not a new concept and has actually existed for more than 125 years, originating when William Coley, MD introduced the notion that the immune system could be useful in the treatment of cancer. He had observed that bone and soft tissue sarcoma patients experienced remission as a result of a concurrent bacterial infection and began to treat patients with heat-killed streptococcal organisms that he called Coley toxins. The toxins he administered to patients resulted in a 50% near-complete remission rate (Institute for Clinical Immuno-Oncology 2015).
Liquid biopsy is a noninvasive method used for the diagnosis and monitoring of disease states, including cancer. Instead of physically taking a biopsy of the affected tissue, cell-free DNA (cfDNA), circulating tumor DNA (ctDNA, a subset of cfDNA present only in tumors), or cancer cells in suspension (also known as circulating tumor cells, CTCs) are collected from blood or other fluids.
MolecularMD is a preferred provider of molecular diagnostic products and services to pharmaceutical and biotechnology drug developers. Our capabilities range from specialty molecular testing performed in our centralized CLIA-certified and CAP-accredited laboratories to development of FDA-approved companion diagnostics.
FDA Commissioner Scott Gottlieb has taken the wheel at an exciting time, when insights from genomics are starting to come to fruition and promising new therapies based on new technologies are being developed. This article explores some of the policy changes happening now in the regulatory rare disease space — and shifts we expect to see in the future — as the FDA’s leadership team implements these changes at the agency.
Pharmaceutical companies face many challenges: developing life-changing products that meet the needs of patients, physicians, and payers; adhering to regulatory standards; and managing health technology and payer scrutiny, all while trying to satisfy investors. As drug prices seem to be continually rising, many health plans are shifting more of the cost-sharing burden to patients. As a result, the patient is becoming more of a “consumer” in the traditional sense.
IDN characteristics can include shared clinical guidelines, a common technology platform, and the ability to jointly negotiate with payers on contracts that may involve financial risk for quality and patient outcomes. Simply put, IDNs are healthcare ecosystems unto themselves.
The increasing complexity of bioprocess engineering has driven a shift toward cell biology and away from process engineering. Cell types have become more diverse, the science more complex, and genetic modifications more common, all while products are becoming more targeted and cost effective. What should we expect to see from industry and academia to keep the field moving forward?
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