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In the discovery and investigation of novel biomarkers, tissue immunohistochemistry (IHC) studies are critical, but how do you translate the
technology into the clinical laboratory for patient testing once a biomarker target has been identified?


Tissue IHC: Translating Technology into Patient Testing After Biomarker Target is ID

March 23rd 2022 at 11 am EST | The use of tissue IHC in the development of novel biomarkers and clinical applications. 

Tissue IHC: from R&D to Clinical Lab Testing

Do you know how AI can inform clinical development planning and drive competitive advantage? In this webinar, learn how AI can be used to simulate clinical development pathways, from pre-clinical all the way to post launch, helping to inform clinical development planning to optimize speed, cost and value.

https://www.pharmexec.com/pe_w/successful-clinical-development

As clinical trials increase in complexity and the race to market intensifies, AI/ML methodologies can provide insights that support the probability of technical, regulatory and even commercial success. Predictive modeling, generative AI and other techniques can be layered to help sponsors objectively assess their assets, design better trials and develop strategies to increase speed and value, while reducing costs. This webinar provides an overview of the many ways AI/ML can be applied throughout R&D to guide sponsors in their decision making.



Discover how AI can predict the success of clinical trials in terms of efficacy, regulatory approval, operational feasibility, reimbursement attainment and product uptake.


Understand how AI can help with indication selection and sequencing for an asset, as well as trial parallelization and sequencing, to optimize the value of clinical development plans from a cost, time to market and value perspective.


Explore how AI-powered scenario planning can identify both design and planning risks so sponsors can correct course early on.



 is focused on transforming life sciences with Applied AI. As the VP for Machine Learning, Raja is determined to change healthcare with the power of AI. He believes that imagination is the biggest barrier and motivates his team to create new narratives that fully leverage AI's potential to reshape the industry from R&D through to commercialization. Raja brings together a diverse set of technical and strategic capabilities, including Machine Learning, Deep Learning, Generative AI, Product Development, Life Sciences Expertise and Business Consulting Skills. His team combines data science, domain expertise and consulting skills to create "superhero" change makers who drive impactful change by applying AI to life sciences and healthcare decisions. Raja is a trusted advisor to global life sciences companies, public sector clients, as well as international organizations.



Webinar Date/Time: Wednesday, September 25th, 2024 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST    

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Using AI to drive successful clinical development planning

In an interview with Nico Saraceno at DPHARM 2024, Pellegrino highlights current challenges she is seeing in patient recruitment and the use of technology to identify patients. 

DPHARM2024: AutoCruitment CEO Jill Pellegrino Discusses Patient Recruitment

ACT: You hosted a session on how to “Unlock the Power of the Patient for Better Patient Recruitment Outcomes.” What was the premise of the presentation?

 It was talking about a company, AutoCruitment, which focuses on bringing patient recruitment solutions. There's really two primary points I was trying to make in that. One is that to really substantially change the way that clinical trials are enrolled, and to increase the patient number of people that get access to trials, you really have to develop solutions that focus on a very large part of the population that doesn't get the opportunity to participate in trials when you're working through sites alone. We find that only 10% of the patients that are eligible for trials actually get the opportunity to participate in one with the relationships they have with sites. Our recruitment focuses on that other 90% in developing strategies to access that population. That was the first primary point, but the second point is that you have to have in place the right services to qualify those patients to help support the sites and the patients to make sure that they are translating into randomized patients. We talked a lot about the services and the ways that we accomplish that.

ACT: In your experience, what are the most common patient recruitment challenges that you’ve encountered?

 Access to patients is absolutely one of them, but even when you get access to those patients, qualifying them is really, really critical, because the protocols usually have very narrow inclusion/exclusion criteria. A lot of times that inclusion/exclusion criteria can't be validated unless you have a relationship with that patient or have access to their medical history, so depending on the requirements and the complexity of the protocol, sometimes it can be difficult to find patients that are qualified and appropriate for the clinical trial. That's one of the challenges. The other challenge is that you do rely on the clinical trial sites to make a recruitment campaign successful and clinical trial sites are working on a lot of trials right now, and sometimes they're understaffed and they don't have all the resources they need, so you need to be able to have support for those sites to be able to work with the additional patients so that they can capture more patients in their practice, see those patients, and then put them into trials.

ACT: Could you describe what EMR Capture & Intelligence technology is exactly, and how it can help identify and qualify patients?

 Yes, that was EMR Capture & Intelligence, and that's one of the services that we have to help better qualify patients for complex protocols. Patient recruitment companies a lot of the time rely on self-reported data from patients in order to see if they're eligible to refer them to trial sites, so we're not relying purely on self-reported data. We have a new service, EMR Capture & Intelligence, which allows us to get the consent from the patients directly to review their medical records. It's all automated in our technology, where we can collect their medical records very easily for them, and then we have AI-powered technology that reviews those records and organizes that data and assesses it to see if they're eligible for the protocols. We find that is really effective in some of those harder conditions and more complex protocols to be able to find some of those harder to find patients.

ACT: What other sessions or topics at DPharm have piqued your interest?

 I would say an area that's always top of mind and top of interest for me is different strategies to be able to access patients, as I shared. We find that to be really effective in driving higher enrollment rates, you have to be able to reach that 90% of the population, so I find I'm really pleased to see so many companies that are working in this space now looking for creative solutions and ways to find patients, and that's always an area of great interest to me and AutoCruitment.

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The FDA issued draft guidance that provides recommendations for companies holding multi-regional clinical trials (MRCT) for cancer drugs.

 Trials such as these are important in determining the effect a drug or treatment has on a variety of populations, but they can also produce skewed results. According to a press release from FDA, MRCTs are including shrinking proportions of US citizens, which may make the results less effective for determining the impact on the US population.

As FDA is a US agency, its goal is to determine the safety and efficacy of drugs and treatments on the US population.

In a press release, FDA’s director of its Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in FDA’s Center for Drug Evaluation and Research Richard Pazdur, MD, said, “The FDA encourages sponsors to pursue multi-regional clinical trials, but stresses that such trials should be conducted within the appropriate context. It is important that data from multi-regional clinical trials are applicable to patients in the United States who may use the drug and our current standards of oncological care. The new draft guidance, when finalized, will not only support the agency's review of data generated from multi-regional clinical trials, but also help sponsors improve the generalizability and applicability of results from these trials to the U.S. population and to U.S. medical practice."

This is just the latest draft guidance issued by FDA. In July, the agency issued guidance related to companies responding to misinformation about clear and approved medical products.

In a press release issued at the time, FDA commissioner Robert M. Califf, MD, said, “Regulated industry plays a critical role in ensuring consumers have accurate information about medical products. We've updated our draft guidance to help further ensure industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation they are seeing. The growing spread of rumors about science and medicine continues to put patients and consumers at risk. We remain steadfast in our commitment to address this public health concern and continue to support and encourage all parties in the public health ecosystem to take an active role."

In June, the agency also issued guidance that provided pharma companies with diversity action plans for clinical trials.

“Participants in clinical trials should be representative of the patients who will use the medical products," Califf said in a press release issued at the time. "The agency's draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved."

Also, in April, FDA issued guidance aimed at ensuring the safety of LDTS.

"LDTs are being used more widely than ever before – for use in newborn screening, to help predict a person's risk of cancer, or aid in diagnosing heart disease and Alzheimer's. The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work," said Califf said. "The final rule announced today aims to provide crucial oversight of these tests to help ensure that important health care decisions are made based on test results that patients and health care providers can trust."

FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology. 

. September 16, 2024. https://www.prnewswire.com/news-releases/fda-issues-draft-guidance-on-conducting-multiregional-clinical-trials-in-oncology-302249082.html

FDA Updates Guidance to Further Empower Companies to Address the Spread of Misinformation. 

. July 8, 2024. Accessed September 16, 2024. https://www.prnewswire.com/news-releases/fda-updates-guidance-to-further-empower-companies-to-address-the-spread-of-misinformation-302190916.html

FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies. 

. June 26, 2024. Accessed September 16, 2024. https://www.prnewswire.com/news-releases/fda-guidance-provides-new-details-on-diversity-action-plans-required-for-certain-clinical-studies-302183322.html

FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests. 

. April 29, 2024. Accessed September 16, 2024. https://www.prnewswire.com/news-releases/fda-takes-action-aimed-at-helping-to-ensure-the-safety-and-effectiveness-of-laboratory-developed-tests-302130166.html

Multi-region clinical trials can provide for varied results, but may not paint a full picture for a specific population.

NOINDEX

NOFOLLOW

FDA Issues Draft Guidance on Multi-Regional Clinical Trials

One of the first presentations to kick off DPHARM 2024 (following the patient keynote) was hosted by Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, centered around “Examining Short and Long-Term ROI of DCT Deployments.”

Getz noted that ROI—or return on investment—is “an extremely important way that we [the industry] persuade and ultimately drive adoption,” in essence, it serves as a way to entice the adoption of an innovation.

His objectives heading into the presentation were to review the past research that measured the short and long term ROI of DCT (decentralized clinical trial) deployments; discuss the on-going techniques that organizations are employing in order to incorporate DCTs into their clinical trial planning and execution processes; and share results from the PACT Consortium, which is essentially a collective of 30 sponsors and contract research organizations who have shared metrics for benchmarking DCT use and impact.

Short-term vs. long-term quantitative ROI assessment

In a nutshell, Getz explained that short-term ROI, is arguably the most meaningful measure today. It's most commonly used for clinical trials during periods where the economy is more challenged—particularly in a softer economic environment—and could be represented by periods of high inflation. However, it’s limited by being narrowly focused, and the fact that it only measures point-based effects.

On the other hand, long-term ROI is utilized in the opposite climate: a robust financial environment, measured during program development.

eNPV modeling—short for expected net present value—is a long-term financial technique used to measure investment value, specifically pertaining to technical, operating, and regulatory risk. It’s run by many major pharma and mid-sized pharma companies, mapping out the outflows (all of the program development costs) and inflows (commercialization revenue).

This model, Getz added, “looks at multiple scenarios, some where a drug will fail, others where it will succeed, and the expected net present value is the average for all of the outcomes in the model.”

And according to Tufts CSDD studies, a Phase III program’s probability of achieving approval is 56%, with with an average overall direct clinical phase cost of $285 million. For additional perspective, Cortellis, Adis Insight data revealed that it takes an average of 10 years for a company to achieve peak sales, which, at the point, could potentially reach a mean of $1.8 billion.

As alluded to above, this collective provides actual DCT use and performance outcomes data from recent clinical trials. It was launched summer 2023, receiving funding from both the Regan-Udall Foundation and Medable.

In the first year alone, members have established governance, define consensus definitions so that they are all on the same page in terms gathering and measure the same qualities, including data on the demographic representation of patients enrolled in the studies that needed to be gathered properly.

For year two, the goals revolve around scaling the data set and conducting much more granular analysis.

Getz K. ROI Keynote: Examining Short and Long-Term ROI of DCT Deployments. September 17, 2024. DPHARM 2024. Philadelphia.

Session reveals how organizations can implement DCTs into their clinical trial planning and execution processes.

DPHARM 2024: Analyzing DCT Deployments

The evolving regulatory landscape in clinical research was an important topic covered at the 2024 Veeva R&D and Quality Summit. As the complexity of trials grow, regulatory agencies are enforcing greater oversight to ensure they remain compliant. At the Summit, 

 caught up with Dee DeOliveira, senior director, global regulatory operations, Cerevel (now part of AbbVie) to discuss the current regulatory landscape as well as her own experience with managing regulatory operations.

ACT: Could you tell us a little about Cerevel and your role?

 First of all, Cerevel was very recently acquired by AbbVie. I now work for AbbVie. Cerevel was a small pharmaceutical company established in 2019 seeking to transform lives of patients with neuroscience diseases.

At Cerevel, I was head of global regulatory operations. I was hired in early 2020 to establish the regulatory operations function. I built and provided oversight of the team that manages regulatory submission logistics, including publishing and we also administered all regulatory systems such as Veeva Vault RIM.

ACT: At Cerevel, you’ve built the regulatory operations function from the ground up. What was your vision for regulatory operations and the strategy to make it a reality?

 Given Cerevel was a small company, my vision was to create a full service global regulatory operations function that was fit for purpose. In a startup environment, you have individuals wearing many hats and things happening quickly. This required regulatory operations to be a nimble, focused function at Cerevel. Our key to on-time quality submissions was early engagement, frequent touchpoints, having a focus on quality by building QC steps along the way, and aiming to optimize logistics to allow submission teams to focus on the science.

The regulatory operations team consisted of internal individuals and an external publishing vendor. There is a lot of ways to do this, but at Cerevel the vendor was used strategically to optimize budget spend and allow us to get submissions out the door as quickly as possible. To do that we did submission/content plan management and document-level publishing in-house while utilizing the external vendor predominantly for the eCTD submission build.

ACT: Cerevel enabled site, product, and clinical study data to flow between the clinical and regulatory vaults. What are the benefits of establishing this connection between clinical and regulatory?

 Cerevel was early adopters of Veeva’s Regulatory to Clinical Connector, which allows both documents and data to be transferred between the regulatory and clinical vaults.

An industry pain point is the redundant work that is required due to the overlap of documents within the eTMF and RIM systems. You also have more than one person making duplicate uploads or entering identical information which could led to misalignment. The biggest benefit is we didn’t have people doing the same thing twice, this eliminated redundancy, ensured consistency, and maintained a single source of truth.

 is focused on regulatory, so this question will help our readers. As clinical trial complexity grows, regulatory agencies require more data and proof products are effective. We want to tap into your robust experience in regulatory operations. What advice would you give to companies looking to remain compliant while executing complex clinical trials?

 As clinical trials become more complex, a well-structured defined submission process is key. However, it’s crucial to strike the right balance, you still want to be able to do things efficiently and quickly. In my opinion, a centralized approach to managing CTAs can be extremely helpful. For example, having a dedicated regulatory operations resource who can guide the team through the process and ensure compliance can be a game changer. For example, for EU CTR, training was crucial to getting everyone on the same page cross functionally, and regulatory operations was involved to not only to provide CTIS portal administration but also the guardrails to ensure compliance with proper document handoffs and approvals.

ACT: Looking ahead, where do you see regulatory operations advancing over the next five years?

As we move forward, I anticipate regulatory operations will continue to evolve towards a more technical and strategic role. Rather than administrative, the regulatory operations professionals should be seen as technical experts, data governors, and systems and process builders.

Technology will play a crucial role in this transformation. Automation can help streamline processes, reduce manual tasks, and improve efficiency. For example, I see the potential to delegate repetitive tasks to AI and focus on more strategic work that requires human expertise.

Additionally, data governance will become more important as we move away from document summaries towards data driven submissions.

DeOliveira, senior director, global regulatory operations, Cerevel (now part of AbbVie) highlights her experience in regulatory operations and how to address increased oversight from regulators. 

2024 Veeva R&D and Quality Summit: Q&A with Dee DeOliveira

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