Feb Instream Data Cleaning

Enhancing Data Quality: Instream Data Cleaning

Join our Director of Clinical Operations, Marwa Noaman, and our Chief Medical Officer, Vijay Reddy, M.D., Ph.D, as they explore the game-changing practice of instream data cleaning. Noaman, a seasoned industry professional, emphasizes real-time data cleaning’s impact on crucial milestones, while Dr. Reddy highlights its role in driving safety and efficacy in clinical trials. This transformative technique empowers informed choices, enhances patient outcomes, and accelerates life-changing treatments’ development.

Marwa Noaman – Director of Clinical Operations, D2V Clinical 

Hello, everyone! My name is Marwa Noaman and I am the Clinical Operations Director here at D2V Clinical. 

As we all know, accurate data is crucial for driving innovation and advancing novel therapies. Today, we will explore how instream data cleaning is revolutionizing the way we ensure data quality, and our process for using this technique here at D2V Clinical. 

The process of instream data cleaning is to clean data and identify issues in as close to real time as possible over the entire course of the study. Performing statistical review is a critical step in the process. Data should quickly be analysis ready for multiple data cuts, such as data monitoring committee (DMC) meetings, dose escalation decisions, regulatory objectives, and database lock at the study completion. 

The instream data cleaning strategy involves collaboration with the entire study team to ensure statistical reviews are focused on cross CRF (Case Report Form) page, and cross data source reviews. For example, medical history and pre-treatment AEs (Adverse Events) will be reviewed together to check if the comorbidity of the enrolled population meets protocol assumptions. Correlation between safety endpoints and comorbidity will be examined if a potential trend is observed.  

Now that we have explored the power of instream data cleaning and its implementation at D2V Clinical, I will hand the floor over to our Chief Medical Officer, Dr. Vijay Reddy. 


Vijay Reddy, M.D., Ph.D. – Chief Medical Officer, D2V Clinical 

Hi, I am Dr. Vijay Reddy, the Chief Medical Officer at D2V Clinical. I oversee the implementation of instream data cleaning to ensure that our early-phase clinical research trials meet accurate and reliable data. Here is how we utilize these results from a medical perspective. 

Instream data cleaning supports the following 5 areas and more: 

  • Data-driven Decision Making 
  • Real-time Monitoring 
  • Enhancing Protocol Adherence 
  • Improved Patient Care 
  • Accelerating Research Insights 

The best examples that were already alluded to are for efficacy and safety from a clinical perspective. The overall response rate (ORR) is a critical key endpoint for clinical trials, particularly as measured for efficacy. Instream data cleaning supports this through accurate documenting and verification of the RECIST criteria for efficacy measurement.

In addition, safety with CTCAE criteria documentation is critical, and instream cleaning supports that while enhancing data quality of both clinical and lab parameters.

Instream data cleaning is revolutionizing early-phase clinical trials, empowering researchers to make data-driven decisions. To learn more about D2V Clinical’s innovative instream data cleaning solutions, contact us today at d2vclinical.com. 

Marwa Noaman

Marwa has more than 16 years of experience in the pharmaceutical industry, with success in leading global teams and implementing new innovative strategies. Over the past two decades, she has built long-lasting client relationships and successfully managed and overseen trials from start-up to trial publishing. Marwa focuses on patient care and obtaining quality data, while consistently demonstrating the flexibility needed to support clinical trials.

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Vijay has more than 25 years of clinical practice and biotechnology pharmaceutical industry experience in hematology, oncology and immuno-oncology. His background includes medical affairs leadership, clinical leadership of Phase I first-in-human trials for solid tumors, and the publication of more than 50 original research publications in high-impact peer reviewed journals.

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Reaching Your Milestones: D2V Clinical's 2024 Mission

DURHAM, NC – As 2024 begins, D2V Clinical stands firmly committed to our core ethos: ‘Your Milestone. Our Mission.’ This guiding principle is the driving force behind our strategic expansions and enhancements in key areas. We’re broadening our therapeutic focus to encompass diverse medical fields, strengthening our network of clinical trial sites, embracing digital innovation in our trials, and intensifying our focus on patient safety and experience. These initiatives reflect our steadfast dedication to our partners and the pursuit of significant advancements in clinical research and therapeutic development.

Expanding Our Therapeutic Focus

This year marks a significant expansion in our therapeutic focus areas. With deep expertise in Ophthalmology, Metabolic Diseases, Cardiology, Women’s Healthcare, Autoimmune Diseases, Dermatology, and more, we are broadening our scope to include even more diverse medical fields. This expansion is fueled by our commitment to bring innovative treatments to a wider patient audience.

Enhancing Our Established Site Network

In 2024, D2V Clinical will continue to enhance our robust network of clinical trial sites. Our goal is to further enrich the diversity and reach of our network by connecting with additional patient populations. Building on our strong foundation, this expansion is geared towards refining patient enrollment processes and broadening data collection.

Enhancing Digital Integration in Clinical Trials

This year, D2V Clinical is committed to enhancing digital integration in clinical trials. The focus is on incorporating digital health tools, such as mobile health applications and telehealth services, to improve patient engagement and data collection efficiency. This digital shift is aimed at making clinical trials more accessible, allowing for broader participation and real-time monitoring, which can lead to faster, more accurate results.

Enhancing Patient Safety and Experience

In 2024, D2V Clinical reaffirms its commitment to patient safety and improving the patient journey in clinical trials. Our focus is on ensuring participant well-being, with vigilant monitoring for adverse effects, transparent communication, and strict adherence to informed consent practices. By prioritizing the patient experience, we aim to conduct ethical trials that are not only responsible but also empowering for participants.

2024 at D2V Clinical is about more than just achieving goals; it’s about setting new standards in the world of clinical research. As we embark on this journey, we are excited to partner with you in reaching your milestones, making each step forward a part of our collective mission. 

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Connect with D2V Clinical at ASH 2023


Stop by booth #3446 at ASH 2023 to meet the D2V Clinical team and discover how we can help you achieve milestones in your early-phase hematology program. Backed by leadership with 20+ years of drug development and senior FDA review experience, our agile approach eliminates surprise risk while ensuring meticulous data collection and insightful analysis. Connect with our experts to learn more about our commitment to expediting drug signal detection and hematology program advancement.

Ready to take the next step in your clinical research journey? Schedule a meeting with our experts at ASH 2023 to explore how our specialized expertise can help you advance your early-phase hematology program. 

65th ASH Annual Meeting & Exposition

Date: 9-11 December 2023 

Location: San Diego Convention Center, San Diego, CA  

Booth #: 3446 

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Project Optimus: Challenge vs. Opportunity

Join our Chief Medical Officer, Vijay Reddy, M.D., Ph.D., as he shares a perspective on Project Optimus, an FDA initiative revolutionizing oncology treatment development. Explore the shift from “more is better” dosing to optimized doses, maximizing efficacy, safety, and tolerability through pharmacokinetic and pharmacodynamic data. Learn more below on how prioritizing dose optimization in early phases can accelerate your drug development program and help you reach regulatory approval.

Hi, I’m Dr. Vijay Reddy, the Chief Medical Officer of D2V Clinical. 

Today, let’s explore Project Optimus, initiated by the FDA (Food and Drug Administration), which is a transformative effort to expedite the development and approval of innovative oncology treatments. 

As cited by the Oncology Center of Excellence (OCE) at the FDA, scientific progress has led to the development of entirely new classes of targeted drugs with different properties than traditional cytotoxic chemotherapies. Due to these advanced therapies, many patients, including those with advanced cancer, are living longer. Patients also want to live well, and their expectations are to receive more tolerable and efficacious drugs. 

However, not every targeted drug that enters a phase I clinical trial receives marketing approval, and poor dose optimization may be one reason for this. Historically, dose selection for oncology drugs was often based on a “more is better” paradigm. This is because, traditionally, drugs have been tested on an MTD (maximum tolerated dose) approach.  

The mission of Project Optimus is to ensure that doses of oncology drugs are optimized to maximize efficacy as well as safety and tolerability. One could say this is a “less is more” approach, emphasizing the need for better dose selection for oncology drugs. Therefore, a focus on dose optimization is an essential component of oncology drug development and is necessary to realize the promise of targeted therapies.  

The key principles to identify an optimized dose now include a paradigm shift from an MTD approach to the selection of several doses based on pharmacokinetic (PK) and pharmacodynamic (PD) data, as well as preliminary information regarding activity, safety, and tolerability.  

The doses can be evaluated more thoroughly, preferably early in development with randomized evaluations of multiple doses, to obtain a more comprehensive assessment of dose-response and exposure-response relationships for efficacy, safety, and tolerability. These evaluations will, in turn, inform the dose or doses for a registration trial and eventual drug approval. As mentioned by the FDA, focusing on dose optimization starting early in clinical development rather than in the post-marketing setting will allow more efficient identification of an optimal dose. 

In conclusion, the success of Project Optimus hinges on fostering collaboration and knowledge sharing among researchers, sponsors, and regulatory bodies. As clinical research professionals, embracing Project Optimus offers immense potential for accelerated drug development, patient-centered trials, and transformative breakthroughs in cancer therapies. 

If you would like to learn more about Project Optimus and how it may impact your drug development program, contact us at d2vclinical.com to connect with our experts. 

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Vijay has more than 25 years of clinical practice and biotechnology pharmaceutical industry experience in hematology, oncology and immuno-oncology. His background includes medical affairs leadership, clinical leadership of Phase I first-in-human trials for solid tumors, and the publication of more than 50 original research publications in high-impact peer reviewed journals.


Friends of Cancer Research: The ASCO Post – How to Get the Dose Right. Available at https://friendsofcancerresearch.org/news/the-asco-post-how-to-get-the-dose-right/ 

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Unlocking Insights: Strategic Positioning of the PK Package

Join D2V Clinical’s Chief Development Officer, Jill Loftiss MHS, as she shares valuable insights on strategically positioning PK packages within NDAs. With 22+ years of drug development experience, Jill provides expert guidance on leveraging the timing of your PK package to enhance the likelihood of successful submissions.

Hi, I’m Jill Loftiss, and I work for D2V Clinical, a CRO handling early-phase oncology and hematology programs. Today let’s talk about the positioning of our pharmacokinetic (PK) package within our New Drug Application (NDA).

There is a lot of difference between oncology and non-oncology programs. Often, with non-oncology programs, we can start with healthy volunteer studies where we establish a full pharmacokinetic/pharmacodynamic (PK/PD) and safety analysis upfront in our first-time-in-human (FTIH) trial before we move to populations of special interest. With oncology trials, we establish the safety of where we want to begin our dosing based on our animal trials in our pre-clinical package, and we move directly into patients.

With our FTIH, we will do an initial PK draw to see if the dosing is at the levels we expect it to be at. We’ll save the full comprehensive package until proof of concept is shown because that will reduce unnecessary risk and prevent premature investments. The full PK package for oncology studies can include drug-drug interaction studies and studies of patient special populations with patients with dysfunctional kidneys or livers. We can also go into food effects with high-fat and low-fat meals. We may also do a definitive QT study, depending on what the pre-clinical work showed.

If you have any questions about how to build your PK package or where you should start with your dosing, please feel free to contact D2V Clinical today.

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Jill brings more than 22 years of experience as an R&D Clinical Operations Leader in pharma, managing clinical operations specialists and clinical scientists. Over those two decades, Jill built a flexible, scalable outsource model with leading CROs to meet internal project demands and led teams to multiple successful BLAs, NDAs, and sNDAs in oncology. She specializes in patient-centric, quality-focused and innovative approaches to accelerate drug development.

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Modern Therapies: Inside Early-Phase ADC Development

Join our Chief Medical Officer, Vijay Reddy, M.D., Ph.D, as he explores the vital role of early-phase design in antibody drug conjugates (ADC) development. With a wealth of experience in drug development, Dr. Reddy’s career in ADCs began during his Ph.D. research, where he pioneered monoclonal antibodies targeting colorectal cancer cells. Now, he shares cutting-edge insights into designing successful ADC programs.

I’m Dr. Vijay Reddy, the Chief Medical Officer of D2V Clinical. I am licensed physician in the United States, and I’ve worked in the biopharmaceutical industry for many years.

My career in antibody drug conjugates (ADCs) began many years ago while doing my Ph.D. when I developed monoclonal antibodies that were conjugated with the chemotherapeutic drug Doxorubicin that targeted CEA expressing colorectal cancer cells.

Advances in ADC design and technology have rapidly increased the pace of approvals in recent years with over a dozen ADCs that have been approved and many more on the way. ADCs are designed to combine the benefits of targeted therapy and chemotherapy. The three components of ADCs to remember broadly are the vehicles which are the monoclonal antibodies that deliver what’s called a payload of chemotherapeutic drug to the cancer cells that have a target, which is a tumor- associated antigen.

Early-phase clinical research lays the foundation for the success of ADCs, and careful evaluation has to be given to the target identification, patient selection, safety, and dose optimization for efficacy. The best example to understand how critical the early-phase development is can be understood by the development of the first ADC that was approved, gemtuzumab ozogamicin or Myelotarg for acute myeloid leukemia.

While it was originally approved nearly 20 years ago, it was subsequently withdrawn voluntarily due to safety issues. However, after further dose optimization – with a lower dose and different scheduling, it was found that the benefit outweighed the risk, and the FDA approved it 17 years after its initial execrated approval. Therefore, early-phase clinical development is critical in understanding the target. For example, certain targets such as CD30 are ubiquitously expressed by cancer cells, in the case of Hodgkin’s Lymphoma here with Brentuximab.

In the case of HER2, ADCs targeting HER2, 15%-20% of breast cancer cells express this and can also be, however, effective in a so-called bystander effect where HER2 null-cells, which have no HER2 expression, can benefit. Therefore, understanding the payload and the target are critically important.

The recent ASCO conference demonstrated promising results for several ADCs that are being evaluated in clinical trials. Examples of these ADCs include targets such as B7H3 in metastatic castration resistant prostate cancer, HER3 in metastatic breast cancer, TROP-2, HER3, MET, CEACAM5, etc. in NSCL lung cancer.

In conclusion, ADCs are antibody drug conjugates that combine the benefits of antibodies and targeted therapy with chemotherapy, or such toxic agents. Early phase ADC clinical development is a dynamic process and is driven by dedicated professionals like you. If you’re working with an ADC development program and require expert guidance, we are here to help.

Contact D2V Clinical today to schedule a consultation and talk to our experts regarding your ADC development program.

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Vijay has more than 25 years of clinical practice and biotechnology pharmaceutical industry experience in hematology, oncology and immuno-oncology. His background includes medical affairs leadership, clinical leadership of Phase I first-in-human trials for solid tumors, and the publication of more than 50 original research publications in high-impact peer reviewed journals.

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D2V Clinical: Raising the Bar for Early-Phase Oncology

DURHAM, NC – Dose2Value Clinical (D2V Clinical) is a full-service global CRO addressing the challenges of early-phase oncology studies faced by biotech companies. Founded by seasoned veterans from the industry and the FDA, D2V Clinical focuses on asset value creation for sponsors. The company offers vast knowledge and insight to expedite program advancement and ultimately, to get better medicines to patients as efficiently as possible. Early-phase oncology studies require highly specialized expertise, and many smaller drug developers don’t have the needed resources on staff.

Navigating these intricacies is the D2V Clinical leadership team, whose roster of distinguished industry veterans includes co-founder and CEO Amanda Fu (formerly of MedImmune), co-founder and President Walt Cao (former FDA senior pharmacology reviewer), Chief Medical Officer Vijay Reddy (formerly of MedImmune), and Chief Development Officer Jill Loftiss (formerly of MedImmune).

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“D2V Clinical is here to bring value to our partners and is on a mission to solve the unmet business needs of biotech companies,” Fu said. “Our team has decades of experience in the areas most critical to development success.”

“One of our first priorities when helping a client in Phase I is to help them find the right dose with the right patient. With the appropriate science-based study design, we can limit the number of patients exposed to a dose that is not safe and effective and we can see the desired signals earlier,” Cao said. “We are committed to excellence in early-phase studies because avoidable errors can cause major issues down the line.”

“The ‘value’ in our name captures our dedication to creating value for our clients and for the patients who will ultimately be taking these treatments for cancer and rare diseases,” Loftiss said. Regulatory approval rests on good insights and evidence, not guesswork. The D2V Clinical team members have been sponsors, CRO executives and regulators. We have been accountable for hitting milestones and know what it takes to help our clients succeed.”

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Insights from a Former FDA Reviewer on the Latest FDA Draft Guidance Regarding Dosage Optimization in Oncologic Clinical Development


DURHAM, N.C. (May 16, 2023) – The U.S. Food and Drug Administration (FDA) and the National Cancer Institute collaborate on the Oncology Center of Excellence (OCE) Project Optimus, which aims to optimize oncology drug development through innovative trial designs, validated biomarkers, and consensus on clinical endpoints. The new draft guidance for industry issued by the FDA in January 2023, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” is a part of this effort. Within this guidance, the FDA explores the historical pattern of Phase I trial design reflecting a need to find the maximum tolerated dose (MTD) while overlooking opportunities to optimize dosage. While this approach effectively identified the optimal dosage for cytotoxic chemotherapy drugs, modern targeted oncology therapies often require a revised strategy.

“It is imperative to find the right dose with the right patient at the right time,” said President of D2V Clinical and former senior FDA reviewer Walt Cao. “Identifying the optimal dose during the early phases of oncology clinical trials is crucial in finding the balance between acceptable toxicity and clinically meaningful response. Due to the long-term nature of targeted therapies versus the specified time frame in which non-targeted therapies are administered, targeted therapies should be assessed in a way that allows us to identify the highest level of efficacy associated with toxicity levels that will not render the therapies unviable for continued use in the long term.”

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Identifying the optimal dosage of a drug is crucial for both patients and drug approval processes. It ensures that patients receive the maximum clinical benefit of the drug while minimizing potential side effects. Moreover, during the New Drug Application (NDA) or Biologic License Application (BLA) review process, the clinical benefits of a drug must outweigh the risks for it to be approved. Therefore, the dose optimization strategy must be carefully planned and executed during Phase I studies to ensure that the drug meets the necessary efficacy and safety criteria for approval by regulatory agencies such as the FDA. As drug development becomes increasingly complex, optimizing the dosage of a drug remains critical in achieving successful clinical outcomes and obtaining regulatory approval.

“One of our first priorities when helping a client in Phase I is to help them find the right dose with the right patient. We can limit the number of patients exposed to the inefficacious dose, and in the meantime, the design can answer the scientific question for dose selection with fewer patients,” said Cao. “We are committed to excellence in early-phase studies because of avoidable errors, which cause issues down the line. The science-based protocol design will fundamentally help the sponsor reach the goal of Phase I & II with fewer patients and see the efficacy signal earlier.”

As a former senior reviewer at the FDA, our regulatory expert, Cao, has extensive experience evaluating dose optimization strategies for drug approval. Cao understands the intricacies and complexities of the regulatory landscape and can provide valuable insights on optimizing your drug development process to meet the necessary efficacy and safety standards. If you want to learn more about the importance of dose optimization for regulatory approval and patient benefit, contact us today.