Grant Playter

Stuart Malcolm, head of Standards, Efficiency, and Automation at Veramed, spoke with Grant Playter, associate editor, on-site at the REV4 data conference in New York City. Stuart spoke at length on the intersection of statistical programming and clinical trials and how the industry plans to leverage data, automation, visualization, and artificial intelligence technologies going forward.

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Stuart Malcolm, head of Standards, Efficiency, and Automation at Veramed, speaks on how advancing technologies are shaping clinical trials.

How Breakthrough Technologies are Shaping Clinical Trials with Stuart Malcolm

Parexel, a clinical research organization (CRO), and Partex, a biopharmaceutical company that has developed a digital pharma platform, announced a preferred strategic alliance on Aug. 15, 2023. According to a company press release, the goal of the alliance is to leverage artificial intelligence (AI)-powered solutions to accelerate drug discovery and development. According to a company press release, Parexel’s experience in Phase I to IV clinical development and Partex’s big data and AI capabilities are expected to complement one another in this endeavor.

Under the agreement, clinical trial execution through Partex will be managed by Parexel as the company’s preferred CRO partner. The parties will collaborate on improving clinical trial execution through the Partex-validated AI platform, which is designed to add to and expand Parexel’s existing AI tools and capabilities. According to the release, the companies ultimately hope to further advance drug developers’ ability to understand the probability of clinical success of assets within their portfolio, as well as recommend other disease indications for which their assets may be clinically viable.

"One of the biggest and most complex challenges in drug development is anticipating the investigational therapies that will be safe and effective treatment options,” said Jamie Macdonald, CEO, Parexel, in the release. “Our innovative alliance with Partex helps to address this challenge by bringing to the forefront those assets with the strongest probability of clinical success, in turn enabling customers to focus their time and resources where it is most beneficial to patients.”

"By combining Partex's … AI capabilities with Parexel's renowned clinical research expertise, we aim to accelerate the delivery of safe and effective therapies to patients worldwide, ultimately transforming the biopharmaceutical landscape,” said Gunjan Bhardwaj, CEO, Partex, in the release. “We eagerly anticipate the unveiling of new value-generating approaches and groundbreaking innovations resulting from this collaboration.”

Articles

The collaboration between Parexel and Partex is designed to leverage artificial intelligence-powered solutions to accelerate drug discovery and development.

Parexel and Partex Enter AI Alliance

Pfizer announced that FDA has granted accelerated approval to its multiple myeloma treatment, Elrexfio (elranatamab-bcmm), on Aug. 14, 2023. The treatment is approved for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-cluster of differentiation 38 monoclonal antibody. According to a company press release, approval was based on a Phase II trial (MagnetisMM-3), and continued approval is contingent upon verification of clinical benefit in a confirmatory trial.

Elranatamab-bcmm is a subcutaneously delivered B-cell maturation antigen (BCMA)-cluster of differentiation three (CD3)-directed bispecific antibody immunotherapy. The treatment is designed to bind to BCMA on myeloma cells and CD3 on T-cells, bringing them together and activating the T-cells to kill myeloma cells.

According to the press release, data from the Phase II study showed meaningful responses among heavily pretreated RRM patients who received elranatamab-bcmm as their first BCMA-directed therapy. Among patients who received four or more lines of therapy prior to elranatamab-bcmm, overall response rate was 58%, with 82% maintaining the response for at least nine months.

“[Elranatamab-bcmm] reflects our ongoing commitment to developing scientific breakthroughs that meaningfully improve outcomes for people with cancer. Discovered at Pfizer, we advanced this therapy from a first-in-patient trial to approval in less than five years, because we know that time is life for people living with multiple myeloma,” said Angela Hwang, chief commercial officer and president, Global Biopharmaceuticals Business, Pfizer, in the release. “With significant responses in a patient population with highly refractory disease, we believe [elranatamab-bcmm] is poised to potentially become the new standard of care for multiple myeloma, as we plan to build upon this indication with continued development across the … MagnetisMM program.”

“Most multiple myeloma patients will experience relapse or resistance of their disease to treatment, often facing increased symptom burden and lowering their chance of surviving longer with each attempted line of therapy,” said Ajay Nooka, director of the Multiple Myeloma Program at Winship Cancer Institute of Emory University and MagnetisMM clinical trial investigator, in the release. “By offering durable clinical response with an established safety profile and the convenience of subcutaneous administration, [elranatamab-bcmm] provides a much-needed new option for heavily pre-treated multiple myeloma patients who are struggling with relapsed myeloma.”

Prior to this accelerated approval, elranatamab-bcmm received breakthrough therapy and orphan drug designations from FDA. The FDA review was conducted under Project Orbis, a framework for concurrent submission and review of oncology drugs among international partners to potentially expedite approvals; five countries (Switzerland, Brazil, Canada, Australia, and Singapore) are currently participating. The Japanese Ministry of Health, Labour and Welfare is currently evaluating a new drug application for elranatamab-bcmm, and the European Medicines Agency is evaluating a marketing authorization under the Priority Medicines scheme.

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

FDA Grants Accelerated Approval to Pfizer’s Multiple Myeloma Treatment

Gilead Sciences and Tentarix Biotherapeutics, a biopharmaceutical company focused on targeted, multifunctional, conditional therapies, announced three multi-year collaborations on Aug. 15, 2023. The collaborations will use Tentarix’s Tentacles platform to discover and develop multifunctional, conditional protein therapeutics for oncology and inflammatory diseases. According to a company press release, these molecules will have the potential to conditionally target immune cells related to disease pathways without activating other immune cells that may create adverse events.

Tentarix will receive upfront payments and an equity investment from Gilead totaling $66 million across all three collaborations. Additionally, Gilead has the option to acquire up to three select Tentarix subsidiaries containing the programs developed under the collaborations for $80 million per subsidiary, placing the total value of the deal at approximately $306 million.

“At Gilead, a key area of our research strategy is addressing immune dysregulation in oncology and inflammatory diseases,” said Flavius Martin, executive vice-president, Research, Gilead Sciences, in the release. “This early-stage collaboration with Tentarix will be highly synergistic to our ongoing efforts, building upon our growing strength in protein therapeutics, and may provide access to next-generation, multi-specific biologics.”

“This collaboration is part of our strategy to join forces with innovators, like Gilead, who can help us rapidly advance new medicines to the clinic,” said Paul Grayson, president and CEO, Tentarix Biotherapeutics, in the release. “Our technology has great promise and collaborating with Gilead to build out this pipeline helps broaden the development of multi-functional, antibody-based therapeutics, providing an excellent mechanism to validate our science with the ultimate goal of bringing these potential medicines to patients faster.”

Gilead and Tentarix established three multi-year collaborations to discover and develop multi-functional, conditional protein therapeutics for oncology and inflammatory diseases. 

Gilead and Tentarix Strike Three Cancer And Inflammation Partnership Deals

CPHI, a pharmaceutical conference covering everything in the pharma spectrum from ingredients to packaging, announced on August 15, 2023 that it would be returning to Milan, Italy in 2024. The global pharma exhibition will be hosted at the Fiera Milano from October 8-10, 2024.

According to a press release from Informa, the event organizers, the 2024 event is expected to see record attendance due to a large number of international visitors and a rapid increase in attendees from major Asian pharma hubs. The event was previously held at this location for CPHI 2022.

“We are delighted to be returning to Fiera Milano, as Italy and the Lombardy region are widely known as one of the key pharma manufacturing centers in Europe,” said Adam Anderson, executive vice-president, Pharma, at Informa. “There are very few global locations with such a depth and breadth of local and regional talent. We expect a large international attendance and will marry this with local and regional manufacturing insights. I am excited to bring CPHI … back together with the industry in Milan.”

“Fiera Milano is the ideal venue for a global event like CPHI, which is an important tenet of this industry and central to the world economy, with the Lombardy region being a leading producer of pharmaceuticals,” said Roberto Foresti, deputy general manager of Fiera Milano, in the release. “What makes Milan so attractive is that the city has world-class infrastructure and is well connected to European, Asian, and North American countries. It’s why Fiera Milano continues to attract massive international events.”

CPHI 2024 will return to the Fiera Milano in Milan, Italy.

CPHI to Return to Milan in 2024

Caroline Phares, global head of Health and Life Sciences at Domino Data Lab, speaks with Grant Playter, associate editor, on integrating data processes into pharma operations. Topics of discussion include trusted research environments, the proper balance between data accessibility and privacy, how pharma will use artificial intelligence in the future, and more.

For more from Caroline, we encourage you to read her piece on interoperability difficulties stemming from the skills gap within statistical programming organizations. The piece can be read in full 

Caroline Phares, global head of Health and Life Sciences at Domino Data Lab, speaks on integrating data processes into pharma operations.
