Role of Cardioprotective Medications in Patients with Reduced Global Longitudinal Strain Undergoing Autologous Hematopoietic Stem Cell Transplant to Prevent Post-Transplant Cardiac Morbidity

Background: Cardiotoxicity is one of the side effects of many antineoplastic treatments. Establishing a baseline cardiac function prior to initiating therapy is of paramount importance and may be the limiting factor to choose a certain antineoplastic treatment regimen. Echocardiographic strain techniques including Global Longitudinal Strain (GLS) measurements are sensitive for detecting preclinical cardiac dysfunction and is a predictor for future reduction in ejection fraction and long-term outcome. Autologous transplant is performed as a consolidation strategy for many hematological malignancies and patients who undergo transplant are treated with high doses of chemotherapy including alkylating agents, which can affect cardiac function along with the strain of pancytopenia. Literature that describes the effects of transplant on cardiac function in patients who have reduced Global Longitudinal Strain is scarce if any at all. Most of the data for low GLS in patients receiving cardiotoxic medications suggest poor long-term morbidity and mortality. Objective and design: We present a case series of 3 patients diagnosed with multiple myeloma undergoing an autologous stem cell transplant as part of their treatment with reduced global longitudinal strain on pre-transplant assessment. These patients were treated with cardioprotective medications (Beta Blockers and/or ACEi/ARBs) before and while undergoing conditioning chemotherapy and subsequently autologous stem cell transplant and were followed until day 100. Results: Follow up in the post-transplant period showed improvement of GLS with and none of these patients demonstrated any signs or symptoms of cardiovascular morbidity. Conclusion: Reduced GLS should therapy in patients undergoing ASCT and cardioprotective medications may have a role in reducing cardiac morbidity and mortality in these patients. Our patients displayed improved GLS in the post-transplant period suggesting the need for further research and streamlining the role of cardio-oncology and cardioprotective treatment in similar situations. Figure 1 Figure 1. Disclosures Raval: Abbvie Pharmaceuticals: Speakers Bureau; Adaptive Biotechnologies: Consultancy; ADCT Therapeutics: Consultancy, Speakers Bureau; Alexion Pharmaceuticals: Speakers Bureau; Amgen Biotechnology Company: Research Funding; Astellas Pharmaceuticals: Speakers Bureau; Astrazeneca Pharmaceuticals: Consultancy, Speakers Bureau; Beigene Pharmaceuticals: Speakers Bureau; Bristol Meyers Squibb Pharmaceuticals: Consultancy; Epizyme Pharmaceuticals: Consultancy, Speakers Bureau; Genetech Biotechnology Company: Research Funding; GlaxoSmithKline Pharmaceuticals: Consultancy; Incyte Pharmaceuticals Corporation: Speakers Bureau; Jazz Pharmaceuticals: Consultancy; Karyopharm Therapeutics: Consultancy; Morphosys Biotech Company: Speakers Bureau; Sanofi Genzyme: Consultancy; Seagen Biotechnology Company: Research Funding; Takeda Pharmaceuticals: Consultancy, Speakers Bureau.

Partnership agreements for regenerative medicines: a database analysis and implications for future innovation

Aim: Partnerships have been leveraged to advance the regenerative medicines (RMs) development. This study analyzed the evolution of partnership landscape for regenerative medicines (RMs). Methods: Partnership agreements publicly announced from January 2014 – June 2020 were described. Results: 1169 partnership agreements with total amount of US$63,496 million were identified. Most agreements concerned RMs that were for oncology (25.3%), in the discovery or preclinical phase (66.9%) and gene-based products (45.3%). The most common partnership type is collaborative agreements without licensing. The partnerships between ‘Biotechnology company and not-for-profit organizations’ represented the largest number (n = 416; 35.6%). ‘Big Pharma’ preferred collaboration and licensing agreements with a higher amount. Conclusion: Collaborations between highly specialized players with complementary expertise promote the successful translation of scientific discovery to RMs.

The Outcomes of Scientific Debates Should Be Published: The Arivale Story

There is an ongoing scientific debate regarding the merits and shortcomings of P4 Medicine (predictive, preventive, personalized, and participatory) and O4 Medicine (overtesting, overdiagnosis, overtreatment, and overcharging). P4 Medicine promises to revolutionize scientific wellness through longitudinal big data collection, denoted as “dense phenotyping,” which could uncover early, actionable signs of disease, thus allowing earlier interventions and possible disease reversal. On the other hand, O4 Medicine draws attention to the potential side effects of P4 Medicine: overtesting, overdiagnosis, overtreatment, and overcharging fees. Preliminary data from the P4 Medicine concept have been recently published. A novel biotechnology company, Arivale, provided customers with services based on P4 Medicine principles; however it could not sustain its operations and closed its doors in April 2019. In this report, we provide our own insights as to why Arivale failed. While we do not discount that in the future, improved testing strategies may provide a path to better health, we suggest that until the evidence is provided, selling of such products to the public, especially through the “direct to consumer” approach, should be discouraged. We hope that our analysis will provide useful information for the burgeoning fields of personalized medicine, preventive medicine, and direct to consumer health testing.

Inside Industry

The following topics are under this section: Providing New Insights to Fighting COVID-19 with AI-Powered Remote Monitoring Platform Agreement Signed for Production of Anti-VISTA Antibody for Cancer Clinical Trial Exploring the Cancer Genomic Landscape of the Japanese Population First Center of Excellence in Singapore to Advance Imaging Mass Cytometry RMAT Designation Granted by FDA using CAR-T Cell Therapy for CD-30 Positive Classical Hodgkin Lymphoma Expanding Investment for COVID-19 Vaccine Development Singapore-based Biotechnology Company Launches Integrated Agri-Food Pilot Facility

Old In Vitro Antimicrobial Breakpoints Are Misleading Stewardship Efforts, Delaying Adoption of Innovative Therapies, and Harming Patients

The current antimicrobial market and old (pre-2000) in vitro antimicrobial susceptibility test interpretative criteria (STIC) are not working properly. Malfunctioning susceptibility breakpoints and antimicrobial markets have serious implications for both patients (ie, from a safety and efficacy perspective) and antibiotic-focused pharmaceutical and biotechnology company economic viability. Poorly functioning STIC fail both patients and clinicians since they do not discriminate between likely effective and ineffective antimicrobial regimens. Poor economic viability fails patients and clinicians as it decreases the industry’s ability to develop antimicrobial agents that clinicians and patients urgently require now and in the future. Herein, we review how STIC for older antimicrobial agents were determined and how their correction can impact the perceived utility of old relative to new antimicrobial agents. Moreover, we describe the data and analysis needs to systematically reevaluate older STIC values. We call for professional infectious diseases societies, government agencies, and other consensus bodies interested in the appropriate use of antimicrobial agents to join an effort to systematically evaluate and, where warranted, correct STIC for all relevant antimicrobial agents. This effort will amplify the effects of other measures designed to increase appropriate antimicrobial use (ie, good antimicrobial stewardship), development, and regulation.

Accessing Continuous Glucose Monitoring (CGM) Sensors in France and the US

Blood sugar monitoring is at the heart of every type one diabetic’s treatment. Because patients need make 500,000 decisions over a lifetime on average, reliability on monitoring devices is vital. Thus, the development of Continuous Glucose Monitoring (CGM) systems came as a revolution, as patients need not prick their fingers anymore and now have access to previously unavailable blood sugar trends. This note uses Abbott’s FreeStyle Libre (FSL) as a CGM case study comparing the patenting strategies, regulatory and pricing obstacles this biotechnology company had to face to market its product in both France and the United States.