FDA Approves Yale Medical Cannabis Human Trials

Ganjapreneur | November 12, 2019

The Food and Drug Administration has granted approval to the Yale School of Medicine and CT Pharma for human drug trials to study the efficacy of cannabis-based medicines, according to a Connecticut Public Radio report. The study will be the first with FDA approval to test cannabis on human subjects. Yale University School of Medicine’s Dr. Rajita Sinha, the lead researcher for the clinical trial, said the studies will attempt to figure out how medical cannabis works, who it works for, what symptoms can be alleviated, dosages, and whether there is “a need for refinement.” Michael Fedele, board chair of the Portland, Connecticut-based CT Pharma, told CPR that he hopes the study will result in the first FDA-approved cannabis-based medicine to be manufactured in the U.S. According to the FDA, the agency “is aware that there is considerable interest in the use of marijuana to attempt to treat a number of medical conditions” and does support “research into the medical use of marijuana and its constituents through cooperation with other federal agencies involved in marijuana research.”

Spotlight

Interestingly, the above quote by Benjamin Franklin epitomizes in many respects the significant daily challenges faced by biopharmaceutical companies – to lengthen and improve the quality of life, while always facing the mortality of patients against increasingly challenging diseases, and at the same time engaged in pursuing this noble endeavor in a prudent economic fashion. This white paper goes outside the traditional boundaries of biopharmaceutical commercial analytics to explore a topic noted in the second part of Benjamin Franklin’s quote – taxes. In particular, this white paper will explore the application of econometric analysis of biopharmaceutical transfer pricing, a direct result of differentials in cross-country corporate income tax rates. Given disparities in the US corporate income tax rate relative to other developed countries with major biopharmaceutical operations, this is a white paper that deserves your attention, and will guarantee not to “tax” you (pun intended).

Spotlight

Interestingly, the above quote by Benjamin Franklin epitomizes in many respects the significant daily challenges faced by biopharmaceutical companies – to lengthen and improve the quality of life, while always facing the mortality of patients against increasingly challenging diseases, and at the same time engaged in pursuing this noble endeavor in a prudent economic fashion. This white paper goes outside the traditional boundaries of biopharmaceutical commercial analytics to explore a topic noted in the second part of Benjamin Franklin’s quote – taxes. In particular, this white paper will explore the application of econometric analysis of biopharmaceutical transfer pricing, a direct result of differentials in cross-country corporate income tax rates. Given disparities in the US corporate income tax rate relative to other developed countries with major biopharmaceutical operations, this is a white paper that deserves your attention, and will guarantee not to “tax” you (pun intended).

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PHARMA TECH

Medable and CVS Health Announce Collaboration to Expand Clinical Trial Access

Medable Inc. and CVS Health | February 08, 2022

Medable Inc. and CVS Health announced a collaboration to expand clinical trial access and engagement for patients at select MinuteClinic™ locations via Medable’s clinical trials software platform. CVS Health Clinical Trial Services™ will manage the relationship. The collaboration combines Medable’s software platform with CVS Health’s community reach and experienced MinuteClinic providers to effectively deliver clinical trials in a way that improves patient access, engagement and retention to advance research effectiveness. Despite the importance of clinical trials, less than four percent of Americans participate in clinical studies. Additionally, 30 percent of participants drop out before study completion, and 80 percent of studies do not meet enrollment deadlines. While industry efforts are making progress in closing the gap in African-American clinical trial participation, Asian, Hispanic and Latino groups also continue to be significantly and consistently underrepresented. “Our mission is to bring effective therapies to all patients, regardless of where they live, their social status or race. This collaboration intends to bridge research and science into communities with local access and experience that builds greater trust in health and medicine. Practical applications of Medable technology with the reach and experience of CVS Health gives us an opportunity to harness this time of change and respond differently to unmet needs in local communities.” Sans Thakur, chief growth officer at Medable “This dynamic collaboration with Medable will help us intensify our efforts to drive meaningful awareness and access to a broader population, in particular those with mounting chronic illnesses and the vulnerable populations who today are underrepresented in clinical research. Those populations often have limited access to health care, and therefore a greater chance of poor health and lower life expectancy. Over 40% of the vulnerable population in the U.S. lives within five miles of a CVS Pharmacy location, so we have a chance to engage them,” said Tony Clapsis, General Manager and Senior Vice President of CVS Health Clinical Trial Services. “Coupling Medable’s software platform and experience with CVS Health’s national reach, analytics, and established clinical trial and care delivery teams and services will further enrich and accelerate our ability to make a difference in the lives of patients and support an improved clinical research process.” CVS Health’s unwavering commitment to diversity and inclusion fits well in this partnership. A diverse CVS Health workforce can also contribute to improving culturally inclusive care delivery and clinical trial services. Since May 2021, CVS Health Clinical Trial Services (CTS) has been working with key stakeholders in the biopharmaceutical industry and across the clinical trial ecosystem to design and deliver innovative approaches to research and real-world evidence generation. CTS was instrumental to help engage patients and facilitate trials for investigational COVID-19 vaccines and treatments. As part of this collaboration, CVS Health will continue to offer: Precision patient recruitment: Study population readiness that leverages advanced analytics, national reach and local community connections to drive awareness and engagement in clinical research for faster and more comprehensive trial recruitment, especially in hard-to-reach populations. Clinical trial delivery: Innovative, decentralized options for the delivery of Phase III/IV clinical trials and real-world evidence studies at designated MinuteClinic locations, in home through its Coram home health services team, and virtually. Real-world evidence generation: Retrospective and prospective studies that measure the impact of novel devices and therapeutics in real-world settings. Where applicable, CVS Health will employ Medable’s clinical trial software platform to enhance patient access, engagement and retention while capturing required endpoint data and other information both onsite and remotely. Medable is a leader in the evolving digital and hybrid clinical trial landscape. Technology has played a vital role in extending trial engagement beyond the clinic, allowing patients and clinicians to communicate regularly and enroll participants online, review documentation, sign consent forms and report health status remotely via mobile applications and medical devices. Medable has deployed its software-as-a-service platform via more than 150 decentralized and hybrid clinical trials in 60 countries, serving 1M+ patients and research participants globally. Medable customers have achieved impressive results with decentralized and hybrid trials – including 200% faster enrollment, 90% retention rates and 50% cost reductions. About CVS Health CVS Health is the leading health solutions company, delivering care like no one else can. We reach more people and improve the health of communities across America through our local presence, digital channels and approximately 300,000 dedicated colleagues – including more than 40,000 physicians, pharmacists, nurses and nurse practitioners. Wherever and whenever people need us, we help them with their health – whether that's managing chronic diseases, staying compliant with their medications, or accessing affordable health and wellness services in the most convenient ways. We help people navigate the health care system – and their personal health care – by improving access, lowering costs, and being a trusted partner for every meaningful moment of health. And we do it all with heart, each and every day. About Medable Medable is on a mission to get effective therapies to patients faster by transforming clinical drug development with disruptive technologies. The company’s digital platform streamlines design, recruitment, retention and data quality for decentralized trials, replacing siloed systems with integrated digital tools, data and interfaces to accelerate trial execution. Medable connects patients, sites and clinical trial teams to improve patient access, experience and outcomes. Medable is a privately held, venture-backed company headquartered in Palo Alto, California.

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PHARMACY MARKET

Thermo Fisher Scientific and AstraZeneca to Co-Develop NGS-based Companion Diagnostics

Thermo Fisher Scientific | September 03, 2021

Thermo Fisher Scientific's clinical sequencing business and AstraZeneca today announced they will co-develop next-generation sequencing (NGS)-based companion diagnostics (CDx) to support AstraZeneca's expanding portfolio of targeted therapies. The companies will collaborate under a multiyear, global agreement. "As the pipeline of targeted therapies expands, the availability of diagnostic tools that can interrogate multiple biomarkers simultaneously will ensure patients can be matched with the right therapies more rapidly – this is the promise of precision medicine," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Introduction of diagnostic tools early in the process of drug development can further facilitate the success of companion diagnostic development – and that's what we're doing with AstraZeneca." NGS-based companion diagnostics are increasingly used to match patients with new therapies for cancer and other diseases. More than 90 percent of AstraZeneca's clinical pipeline, across all main areas from oncology, cardiovascular and renal to metabolic and respiratory disease, are targeted precision medicine therapies. "Using the latest diagnostic science allows us to match the best treatment to the patient," said Ruth March, senior vice president, precision medicine and biosamples, AstraZeneca. "This collaboration with Thermo Fisher offers the technology, expertise and ability to decentralize CDx tests to local healthcare providers across our global markets, which will help us identify more patients around the world who may benefit from treatments and effective patient care." Thermo Fisher currently offers the only globally distributable NGS CDx solution approved and reimbursed by government and commercial insurers in more than 15 countries, including the U.S., multiple European nations, Japan, South Korea and the Middle East, and covering more than 550 million lives globally. To expand global access to a growing list of precision medicine therapies, in 2019 Thermo Fisher introduced the Ion Torrent Genexus System*, the first fully-integrated NGS platform featuring an automated specimen-to-report workflow that economically delivers results in a single day. The company's complete NGS workflow, powered by Ion AmpliSeq technology, includes multiple solutions for solid tumor biomarkers and liquid biopsy testing. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

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RESEARCH

Roivant Grows Computational Drug Discovery Engine with Acquisition of Silicon Therapeutics

Roivant Sciences | March 01, 2021

Silicon Therapeutics has assembled an exclusive industry-driving computational physics platform for the in silico design and optimization of small molecule drugs for testing disease targets. The platform incorporates custom strategies dependent on quantum mechanics, sub-atomic elements and measurable thermodynamics to beat basic bottlenecks in drug disclosure projects, for example, anticipating restricting energies and conformational conduct of molecules. Silicon Therapeutics' computational platform is controlled by a restrictive supercomputing group and custom equipment empowering exact all-molecule reenactments at organically important timescales. This computational platform is firmly incorporated with experimental laboratories equipped for biophysics, medical chemistry and biology to encourage the quick movement of drug applicants by expanding recreations with biophysical data. The organization has utilized these abilities to find numerous drug applicants. The procurement of Silicon Therapeutics supports and supplements Roivant's focused on protein debasement platform. That platform will be fueled by VantAI's high level AI models prepared on restrictive degrader-explicit experimental data and by Silicon Therapeutics' exclusive computational physics abilities, which help address a large number of the methodology explicit difficulties of degrader design and optimization. Coordinating Silicon Therapeutics and VantAI will empower Roivant to particularly catch the force of both computational physics and AI based ways to deal with drug design; for example, by joining exclusive computational physics reproductions as preparing data for VantAI's degrader-explicit profound learning models. "The combination of Silicon Therapeutics' integrated approach, platform and highly capable team with Roivant's technologies and commitment to transforming the pharmaceutical industry represents a new and exciting paradigm in drug discovery and development," said Roger Pomerantz, M.D., F.A.C.P., chairman of the board of directors of Silicon Therapeutics. About Roivant Sciences Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch Vants – nimble and focused biopharmaceutical and health technology companies.

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