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Applied Clinical Trials September 2023

Jim Kremidas, former executive director, Association of Clinical Research Professionals, shares his experiences as a patient in clinical trials.

Perspective and Hope From the ‘Other Side’

Senior leaders gather to share insights on the increased investment in real-world data to boost the quality and efficiency of drug development.

Executive Roundtable: The Rise of RWD in Clinical Research

Lokavant announced that it has received an $8 million strategic investment from Mitsui & Co. to expand its AI-optimized platform across the Asia-Pacific region. As part of the investment, the company intends to open a new regional headquarters in Tokyo. According to a company press release, the investment is the result of a yearlong effort between the two companies, with Mitsui pledging to provide operational support, including business development, staffing, and product localization to expand Lokavant’s range in the region.

“Lokavant’s platform has driven significant value to pharmaceutical sponsors and CROs on global clinical trials, and with exceptional validation of the platform in Japan, it is a natural next step to launch Lokavant Asia,” said Rohit Nambisan, CEO, co-founder, Lokavant. “With a distinguished track record in international business and a rapidly growing reputation in life sciences innovation, Mitsui & Co is the ideal strategic partner for the creation of Lokavant AsiaPac.”

: Lokavant Announces $8M Strategic Investment from Mitsui & Co. to Expand AI and Predictive Clinical Trial Intelligence into Asia-Pacific. 

October 3, 2023. Accessed October 3, 2023. https://www.businesswire.com/news/home/20231003076721/en/Lokavant-Announces-8M-Strategic-Investment-from-Mitsui-Co.-to-Expand-AI-and-Predictive-Clinical-Trial-Intelligence-into-Asia-Pacific

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Company intends to expand AI and predictive clinical trial intelligence throughout the Asia-Pacific region. 

Lokavant Receives $8M Investment from Mitsui & Co. 

Image Credit: © Andrey - stock.adobe.com

Signant Health has announced the launch of Signant Biotech—an integrated clinical research approach leveraging software and services tailored to the unique needs of small- to mid-sized biopharmaceutical organizations.

Signant Biotech is anchored by a unified technology platform consisting of fully integrated EDC, eCOA, eConsent, RTSM, and telemedicine solutions. Delivered in conjunction with Signant's scientific and regulatory expertise, the technology platform and accompanying services enable customers to scale from local to multinational studies.

Studies using the unified platform can be implemented in typically four to six weeks. Sponsors and contract research organizations (CROs) can also elect to deliver studies using a self-service model. Either approach is enabled by a configurable designer tool that allows non-technical staff to build studies without software coding. The designer leverages a library of pre-built forms and edit checks which further accelerates study builds.

"We know that small- to mid-sized biopharma sponsors have unique needs," said Graciela Racaro, chief operating officer of Signant in a press. "They want to work with a partner who can balance flexibility and standards to get them to their readouts as quickly and efficiently as possible. They also want to leverage a partner's experience and lessons learned from similar trial designs and global launches."

"We appreciate that our smaller customers in the biotech segment are in a challenging funding environment, where money comes less easily and at more expense," said Roger Smith, chief executive officer of Signant Health in a press release. "We are pleased to support this segment of customers with technology and services that allow them to focus their precious time and resources on advancing their clinical assets, and not having to make trade-offs between scale, capability, accountability, and value."

Signant Health Launches Signant Biotech to Accelerate and Streamline Clinical Development for Emerging Biopharmaceutical Organizations

New clinical research approach aims to accelerate and streamline clinical development for emerging biopharm organizations.

Signant Health Launches Signant Biotech

Image Credit: © Sergey Nivens - stock.adobe.com

Veeva Systems has announced that LEO Pharma is using Veeva Vault Safety to optimize its safety operations. With this foundation, the company can incorporate affiliates into safety workflows, boost operational efficiencies, ensure compliance, and unify its global pharmacovigilance data on one platform.

“LEO Pharma is deeply committed to the safety of patients using its products,” said Pilar Carrero, vice president of global safety at LEO Pharma in a press release. “With Veeva Vault Safety, we now have real-time visibility into adverse events and data transparency for affiliates that helps us work even better together.”

Vault Safety is helping LEO Pharma improve oversight of case intake, processing, submission, and distribution while simplifying safety workflows and eliminating data reconciliation with affiliates and partners. By standardizing drug development on Veeva Development Cloud, LEO Pharma can better connect safety to other crucial business areas like clinical, regulatory, and quality.

“Now, all parties have visibility into case data, ownership, and status, facilitating improved collaboration and sharing of learnings,” said John Lawrie, vice president of Vault Safety at Veeva in a press release. “Veeva is happy to partner with LEO Pharma to make its safety operations simpler and more effective.”

Vault Safety is a safety case management system that enables adverse event intake, processing, and submission for clinical and marketed products. It is part of Veeva Development Cloud.

LEO Pharma Connects Affiliates with Veeva Vault Safety to Transform Safety Operations. 

Company can now incorporate affiliates into safety workflows, boost operational efficiencies, ensure compliance, and unify its global pharmacovigilance data on one platform.

LEO Pharma Connects Affiliates with Veeva Vault Safety

Michael Pourdehnad, MD, senior vice president, head of early clinical development, Hematology/Oncology & cell therapy at Bristol Myers Squibb discusses the work his team is doing at the site-level with potential oncology, hematology, and cardiovascular therapies. He also explores the area of targeted protein degradation and its evolution as well as his passion for bringing therapies to patients and how it shaped his career path.


Michael Pourdehnad, MD, is senior vice president, head of early clinical development, hematology/oncology & cell therapy at Bristol Myers Squibb. He leads a team focused on developing cancer treatments to combat hard-to-treat diseases. Michael oversees early clinical development programs for a diverse range of treatment modalities such as cell therapy, protein degraders, T-cell engagers, monoclonal antibodies, and small molecules. Michael is also currently a clinical assistant professor of hematology and oncology with UCSF Medical Center.

 bring you the latest commercial insights to master the science of success. Podcast episodes examine current trends, key conferences, and critical topics in the bio/pharmaceutical industry.

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While clinical research in rare diseases has many unique operational challenges, there is plenty of work being done to advance it and bring effective therapies to patients. 

Advancing Rare Disease Research and the Development of Targeted Therapies

Emmes has announced that Peter Ronco has been named CEO, effective immediately.

Ronco succeeds Christine Dingivan, who will serve as a senior advisor to Executive Chairman Sastry Chilukuri and Emmes’ board of directors.

“Emmes has a 45-year legacy of scientific innovation and advancing public health. Peter’s leadership and operational expertise in the life sciences sector will be invaluable in our next phase of growth. I am excited to welcome Peter to the Emmes team,” said Kyle Peterson, managing director at New Mountain Capital and member of the board of the directors of Emmes, in a press release. “We are grateful for Christine’s leadership through an important chapter of growth and diversification after taking over from the original founders. She is a remarkable physician-entrepreneur and industry leader and will continue to support Peter, Sastry, and the board going forward.”

“Peter is a seasoned and innovative life sciences leader. He brings deep experience in running global operations with frontline use of technology and data science, which will propel our company forward,” added Chilukuri in a press release.

Ronco is a global pharmaceutical executive with experience in a number of R&D leadership positions over more than two decades. He most recently served as senior vice president, global development at Johnson & Johnson, responsible for the design and delivery of a drug development portfolio of more than 500 active clinical studies across all therapeutic areas and phases of development. He has also held senior roles with Bristol Myers Squibb, Accenture, and Pfizer.

“I am thrilled to be joining a company with an outstanding scientific track record and extensive credibility in clinical research,” said Ronco in a press release. “Emmes has a storied history, addressing some of the most complex health issues of our time. We look forward to an exciting future together as we partner with patients, clinical sites, government agencies, and biopharmaceutical companies to advance the next phases of scientific innovation and change the trajectory of health care.

“I believe that advances in decentralized clinical trials, data science, and generative AI offer huge potential to make clinical research even faster and more patient-focused. Embracing and accelerating the uptake of these approaches will allow us to have a greater impact on global health and biopharma innovation in the discovery and development of new medicines.”

Ronco is a graduate of Nottingham University in the UK and will be based out of Emmes’ Rockville, Maryland, headquarters.

Emmes Appoints Peter Ronco as Chief Executive Officer. 

Ronco is a global pharmaceutical executive with experience in a number of R&D leadership positions over more than two decades.

Emmes Appoints Peter Ronco as Chief Executive Officer

Paige Bingham, CEO, Meeting Protocol Worldwide

, Paige Bingham, CEO of Meeting Protocol Worldwide shares her background in meeting planning and how it translated into addressing logistical challenges in rare disease clinical trials. Bingham also discusses the creation and work of Scout Clinical, a clinical trial patient travel and reimbursement company.

 How did you become interested in rare disease clinical trials?

My professional background is in clinical investigators’ meeting planning. One of our primary service offerings is the organization of clinical study kick-off meetings in which doctors and nurses from each clinical trial site may be trained on how to appropriately facilitate a clinical trial. This includes clinical trial protocol, such as administration of therapeutic candidates and compliance considerations. In coordinating these meetings, we became aware of the tremendous need for innovation within rare disease clinical trials and the incredible complexities of patient and caregiver travel.

ACT: You have been with Meeting Protocol Worldwide since 1999. Could you take our audience through your time there?

I joined Meeting Protocol Worldwide in 1999 to establish our London office and to extend our global presence. After five years in London expanding our meeting planning business to European clients, I returned to Dallas as Chief Operating Officer, at which point I started focusing on how we may adapt our meeting services to be as effective as possible for our clients. Our company became more involved in meeting agenda design, taking a consultative approach that extended past only organizing the logistics of booking flights and hotels and ordering meals. We helped our clients design their meetings to be as effective as possible.

As the clinical trial industry evolved, more compliance measures were established around the interactions between pharmaceutical companies and investigators. I helped oversee our regulatory department, making sure that we were complying with our clients’ guidelines as well as different countries’ rules and regulations around HCP reporting. As the company grew, my focus remained on understanding the industry from global and clients’ perspectives, the best places to conduct these meetings, and what the regulations and rules are.

ACT: During your time as COO, you played a major role in the creation of Scout Clinical. Could you tell our audience a bit about Scout Clinical and the process of how it was created?

For the last 28 years, Meeting Protocol Worldwide has organized investigators’ meetings in which we have moved hundreds of thousands of people on a global scale. Our clients are global clinical research organizations and clinical trial sponsors conducting their studies across multiple countries and continents. These organizations need a vendor that can work with them across all facets of clinical trial meeting planning, and it is this need that ultimately led to the creation of Scout Clinical.

Several years ago, during an annual sales meeting that we organize for one of our large CRO partners, our contact pulled me aside at a coffee break and asked if we had ever considered expanding our services into patient travel. At that point, we were operating on six continents and in over 100 countries, managing travel and reimbursements on a global scale. Through our investigators’ meeting experience, we understood the clinical trial industry, the timelines and terminology, and the importance of sites and patients to the success of a study.

We explored this request, and this ultimately led to the creation of Scout Clinical in 2016. Our team members’ skill set matched with the commitment and care needed to help make a difference for patients and their families through streamlining clinical trial transportation and payments.

ACT: What are some of the challenges associated with coordinating patient involvement in rare disease clinical trials, such as transportation and reimbursement?

There isn’t a one-size-fits-all solution for rare disease clinical trial transportation on a global scale. Many factors need to be considered, such as age, levels of mobility, socioeconomic status, and location.

From a logistics perspective, there are limited sites and treatment facilities that may accommodate rare disease clinical trials which leads to transportation and accessibility concerns. Many of the participants in rare disease clinical trials are children, and this requires transportation to clinical trial sites not just for the patient, but for their family members and caregivers as well. The use of wheelchairs and oxygen tanks also pose a challenge as many vehicles and methods of transportation do not accommodate medical equipment.

Movement between countries and continents can also pose unexpected challenges due to the legal ramifications of international travel. We work with patients with rare diseases from a variety of countries, and moving patients to clinical trial sites outside of their home country may require involvement of governments to approve the travel request.

In some cases, we will consult with national and international agencies for clarification on what parts of travel and reimbursement we are allowed to facilitate as a third-party clinical trial services vendor. This includes inquiring about our ability to book flights and pay for transportation for the patient and their family, as well as purchasing meals. Our team also works to provide patients and their families with the necessary legal paperwork to allow for international travel and clinical trial participation.

ACT: What are some solutions that can address these challenges?

The complexities of patient travel cannot be addressed through technology alone. Ultimately, the solution is to have a team of dedicated human beings who can improvise and adapt to address issues as they arise. We are a service company that utilizes tech as a tool to help us provide services on a global scale. We are entrusted with providing not only efficient, but safe transportation for some of the most underserved and vulnerable patient populations.

Patient advocates are essential for effective clinical trial operations. At the backbone of our company are patient liaisons who speak a multitude of languages and provide assistance to the patient, their families, their caregivers, and clinical trial sites. We rotate our patient liaisons so team members are available around the clock, giving patients and our clients the opportunity to interface in real time with a person who can implement solutions immediately, and not just take a message and wait for someone to call them back.

Easy access to translation is also essential when considering clinical trials with a global scope. Aside from patient liaisons who are fluent in other languages, we utilize a technology for telephonic, immediate translation. If a site or patient calls us speaking a language we are not fluent in, we can contact a translator on the phone within two minutes.

Clinical trial transportation and payments must be considered from the onset while designing a study. Clinical trial planners should discuss what services the study needs based on the patient population, disease, and countries involved. Every country is different in terms of regulations and what transportation is available, so solutions may be adapted from country to country. Patients also have different cultural preferences, so clinical trial organizers must be cognizant of this on an individual basis when patients are transported outside of familiar areas.

ACT: What are some current or future projects you are excited about at Meeting Protocol Worldwide and/or Scout Clinical?

Our goal is to have the research sites be as involved or as uninvolved in the patient travel and payment process as they want to be. For sites that prefer a more hands-off approach, we facilitate all clinical trial transportation and payments once the client confirms that the patient is enrolled in the study.

We are focused on relieving the site burden and, most importantly, increasing patient retention, which is a major problem in the clinical trial industry. When a patient encounters a roadblock, we need to help them navigate around it and continue with the study. While we do not organize patient recruitment, we want to do everything in our power to help our partners keep patients in their trials. We continue to focus on the overall patient journey, and how we may act as a liaison for sites and patients as they navigate clinical trials.

Bingham discusses the logistical challenges associated with coordinating patient involvement in rare disease clinical trials.

Challenges in Rare Disease Clinical Trials: Q&A with Paige Bingham, CEO of Meeting Protocol Worldwide

FDA is taking steps to help further accelerate the development of novel drug and biological products for rare diseases. The agency is announcing the opportunity for a limited number of sponsors to participate in a pilot program allowing for more frequent communication with FDA staff to provide a mechanism for addressing clinical development issues.

Selected participants of the Support for Clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program will be able to obtain frequent advice and regular ad-hoc communication with FDA staff to address product-specific development issues, including, but not limited to, clinical study design, choice of control group and fine-tuning the choice of patient population.

The program will be open to sponsors of products currently in clinical trials under an active Investigational New Drug application (IND), regulated by the Center for Biologics Evaluation and Research (CBER) and/or the Center for Drug Evaluation and Research (CDER). Eligibility criteria for the pilot differs between CBER and CDER-regulated products.

In addition to having an active IND, eligible CBER-regulated products must be a gene or cellular therapy intended to address an unmet medical need as a treatment for a rare disease or serious condition, which is likely to lead to significant disability or death within the first decade of life. Under CDER's eligibility criteria, the product must be intended to treat rare neurodegenerative conditions, including those of rare genetic metabolic type.

FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

. (2023, September 29). Cision PR Newswire. 

Agency is announcing the opportunity for a limited number of sponsors to participate in a pilot program allowing for more frequent communication with FDA staff.

Graves Gilbert and Circuit Clinical broke the news that they will be collaborating to bring clinical trials to patients in South Central Kentucky. As part of the joint venture, the organizations intend to reduce the burden on patients who opt in for research participation. Localizing research participant care within Graves Gilbert's physician offices, Circuit Clinical supports the care provider team with embedded staff who have clinical trial experience and work side-by-side with the physicians in practice.

According to a company press release, the partnership was made possible through LabCorp. As the primary reference laboratory for Graves Gilbert, LabCorp will help identify clinical trials for which Graves Gilbert patients may be eligible, and the parties will work together to enroll patients into the trials quickly.

"We look forward to continuing to serve our diverse communities by offering patients access to clinical trials and cutting-edge treatments all from the comfort of our offices, with the physicians they know and trust," said Chris Thorn, CEO, Graves Gilbert.

: Graves Gilbert, Circuit Clinical, and Labcorp Join Forces to Bring Clinical Trials to Patients across South Central Kentucky. 

September 27, 2023. Accessed September 28, 2023. https://www.prnewswire.com/news-releases/graves-gilbert-circuit-clinical-and-labcorp-join-forces-to-bring-clinical-trials-to-patients-across-south-central-kentucky-301940562.html

With support from LabCorp, partnership aims to bring trials to patients in south central Kentucky. 

Graves Gilbert, Circuit Clinical Launch Clinical Trial Collaboration 

Image Credit: Adobe Stock Images/Crystal light

In a company press release, Aitia announced a collaboration with the Pancreatic Cancer Action Network (PanCAN) focused on accelerating drug discovery and development. Through applying PanCAN's Spark health data platform, Atita intends to integrate de-identified human multi-omic data to create gemini digital twins, that will serve a wide range of applications, including the discovery of novel targets and biomarkers, simulation of drug candidates, identification of ideal patient subpopulations for clinical trials, and the determination of optimal drug combinations.

"Unraveling the complex genetic and molecular circuitry of Pancreatic Cancer is critical to the discovery of the next generation of drugs that can significantly increase the survival rate of patients," said Colin Hill, CEO, co-founder, Aitia. "We believe our Gemini Digital Twins, coupled with PanCAN's robust de-identified human multi-omic data, stand to increase efficacy in early research, ultimately leading to the discovery and development of breakthrough drugs. Collaborating with PanCAN is a pivotal milestone in our mission, as we envision reshaping the panorama of pancreatic cancer treatment by harnessing the potential of multi-omic patient data, Causal AI and Digital Twins".

: Aitia and Pancreatic Cancer Action Network Partner to Transform De-Identified Multi-Omic Patient Data into Digital Twins to Drive New Discoveries and Improve Patient Outcomes. 

September 27, 2023. Accessed September 28, 2023. https://www.prnewswire.com/news-releases/aitia-and-pancreatic-cancer-action-network-partner-to-transform-de-identified-multi-omic-patient-data-into-digital-twins-to-drive-new-discoveries-and-improve-patient-outcomes-301940556.html

Joint venture aims to drive new discoveries and improve patient outcomes. 

Aitia, Pancreatic Cancer Action Network Strike Drug Collaboration Deal

The Association of Diversity in Clinical Trials (AOD) has announced its newest partners, Accelerated Cure Project for Multiple Sclerosis and Arab Board for Clinical Research. This strategic collaboration aims to drive diversity and inclusion within the realm of clinical trials, addressing longstanding disparities in healthcare access.

AOD, an advocate for diversity and equity in clinical research, has forged these partnerships to expand its impact on underrepresented populations. Accelerated Cure Project for Multiple Sclerosis, a nonprofit organization dedicated to advancing multiple sclerosis (MS) research, shares AOD's commitment to equal access to treatments and therapies for all patients, regardless of their background. The Arab Board for Clinical Research, renowned for its advocacy work in the clinical research space, joins forces with AOD to enhance diversity in clinical trials on a global scale.

"Our partnership with the Accelerated Cure Project for Multiple Sclerosis and the Arab Board for Clinical Research is a vital step in addressing clinical trial disparities," stated Jeremy Mitchell, AOD's director of business development in a press release. "Together, we aim to improve healthcare outcomes for all by ensuring trials reflect our diverse communities."

This collaboration fosters knowledge sharing and strategies for diverse community engagement in clinical trials. AOD, Accelerated Cure Project for Multiple Sclerosis, and the Arab Board for Clinical Research unite for a more inclusive healthcare future.

Accelerated Cure Project for Multiple Sclerosis and Arab Board for Clinical Research Partner with the Association of Diversity in Clinical Trials.

 (2023, September 28). Cision PR Newswire. 

Strategic collaboration aims to drive diversity and inclusion within the realm of clinical trials.

Featured Content

Applied Clinical Trials September 2023

Perspective and Hope From the ‘Other Side’

Executive Roundtable: The Rise of RWD in Clinical Research