Fierce Virtual Series: JPM Week 2021

A global network of community pharmacists enhancing the recruitment, dispensing and patient counseling, driving significant time and cost savings while making clinical trials a viable healthcare option for Everyone, Everywhere. 

The TD2/VieCure partnership offers enhanced clinical decision making and accelerated therapeutic development processes to community oncology practice with incomparable outcomes. TD2 is a precision medicine therapeutic development company with an enabled early development community oncology practice research network. The VieCure platform is a next generation oncology clinical decision-support system that combines an A.I. clinical inference engine, clinical pathways and an integrated EMR to support personalized treatment planning. The Partnership offers access to real-time, de-identified patient data to assist with site selection, feasibility, and patient identification as well as improved protocol design. Together, the combined capabilities create the foundation for a precision medicine program in the oncology community setting that delivers early responses to clinical trial targets leading to accelerated approvals of a range of therapeutics and patient access to life-saving therapies.

In 2020, the life sciences sector mobilized at unprecedented speed to tackle the most significant health crisis facing humanity in a century. Researchers, industry and regulators collaborated to harness innovative science with some creative deal structures to develop treatments and vaccines in record time, clinicians adopted new approaches to consult and treat patients, greater sums of money, from both public and private sources, have been invested to finance these efforts. Clarivate’s Sarah Hardison and Mike Ward will discuss what lessons can be learnt that could accelerate the development of treatments for other major diseases and improve patient care.

As more emerging pharma and biotech companies launch new drugs, a significant part of the battle is ensuring patient and provider education, accessibility, and engagement. A short timeline, a small budget, and the need to build analytical capabilities from the ground up creates a unique challenge. Dynamic market conditions and potential fast track approval by the FDA further add to the need for speed and agility. Early availability of advanced analytics is essential to reduce market risk and make the right decisions quickly.

Advancements in AI and cloud technologies have made it possible for pre-revenue companies with cost and resource constraints to be equipped with advanced analytics that were previously only available to big pharma organizations. There are many moving parts during the commercialization process and building a unified data-driven strategy is essential. Accessibility of unified data and analytics can provide a step change in an organization’s efforts to mitigate risks, lower costs and increase the likelihood of the product’s commercial success.

This discussion will provide real-world examples of using advanced analytics to solve the challenges faced during fast track drug launches. In addition, we will illustrate how efficiently advanced analytics can be deployed and managed with fewer resources.

The successful outcomes delivered by cell and gene therapies coupled with emergence of modalities across nucleic acid therapeutics and microbiomes pose the next challenge for innovators to make these new modalities available at scale. Faster adoption of emerging cutting-edge development and manufacturing technologies will be vital to success and broad accessibility for patients. In this talk, we review and present key areas of technology innovation that have the potential to reshape how these advanced therapeutics are manufactured at scale.

In trying to bring therapeutics and vaccines to market more efficiently, many manufacturers need to deal with legacy equipment.  Do you have “islands of automation” consisting of a variety of equipment and skids without an overarching supervisory system? As the need for speed and agility is greatly increasing, biopharma production facilities need some way to better visualize batch processing across various equipment and systems.

Orchestration can help achieve centralized recipe management, real-time visibility across the entire process, and batch reporting. This enables faster updates to existing facilities, and ramping up production of new biopharma products.

There can be no mention in today’s clinical trial world without considering decentralised capabilities. The continued digitization of trials combined with the COVID-19 pandemic have thrust trials into new and unexplored pathways. Now, with several companies heralding the promise of real-time data, the industry may be about to take a sharp right turn. Join our speakers as they discuss key real-time data and decentralised trial principles from the patient journey and measures that matter to clinical research as a care option.

In the light of the COVID 19 pandemic, a comprehensive understanding of COVID 19 and the underlying core molecular mechanisms which control and determine the individual host response is urgently warranted.

To this end, an evidence-based, holistic, precision-medicine approach is required. Molecular Health established an integrated disease-modeling processes — augmented by state-of-the-art data capture, curation, and analysis — to map the totality of fundamental mechanisms involved in COVID 19. Using our Dataome platform, we built a comprehensive COVID 19 disease model that links key molecular players of COVID 19 pathophysiology to disease symptoms, severe manifestations and outcome, or severity-associated risk factors. Our model revealed that the multitude of seemingly disparate clinical phenotypes can largely be linked to the pleiotropic activity of a few core molecular players and mechanisms involved in the host response, thereby offering an in toto approach to decoding the disease. Within six weeks, we generated a current, inclusive atlas of COVID 19 pathogenesis, with potentially significant implications on the development of diagnostic and therapeutic strategies. This project demonstrates the utility of our Dataome platform in decoding complex diseases.