Bridging the Gap: How Plasma Services Group is Revolutionizing Access to Biospecimens and Data

We are delighted to have the opportunity, during the ADLM conference, to sit down with Nichelle Fernandez , the inspiring CEO who has led Plasma Services Group to new heights. In this insightful conversation, Nichelle will share her perspective on the company's journey from rare diseases to precision medicine, highlighting the groundbreaking research that is making a real difference in patient care. Additionally, she will discuss PSG's dedication to quality and collaboration, emphasizing how these principles are fostering advancements and shaping a brighter future for the healthcare sector.

Ms. Porto, can you elaborate on PSG's mission? How does this mission translate into real-world benefits for researchers and clinicians?

Nichelle Porto: At Plasma Services Group, our mission is rooted in a deep understanding of the critical role that high-quality biological materials and well-characterized patient cohorts play in advancing scientific discovery and improving healthcare outcomes. We understand the unique challenges faced by those working in the biomedical field. Our mission is to be a reliable partner, ensuring that professionals across procurement, EQA programs, R&D, manufacturing, and assay development have access to the highest quality biospecimens and data. This is crucial for maintaining regulatory compliance, driving innovation, and ultimately, improving patient care.?

We achieve this by meticulously controlling every step of our process, from donor recruitment and screening to sample collection, processing, and storage. This rigorous approach ensures the integrity and reliability of our biospecimens, a cornerstone for accurate and reproducible results in various applications.

We recognize that each project has unique needs, demanding a tailored approach that goes beyond simply providing samples. That's why we prioritize flexibility and collaboration, working closely with our partners to develop custom solutions that address their specific requirements. Our team of experts offers consultation and support throughout the entire research and development process, ensuring not only the highest quality biospecimens but also a commitment to integrity and transparency at every step.

You mentioned PSG's commitment to integrity and transparency. Could you share some specific examples of how this commitment has shaped your interactions with clients and partners?

Porto: At PSG, integrity and transparency are more than just words; they are the guiding principles that shape every interaction we have with our clients and partners. We believe that trust is the foundation of any successful collaboration, and we earn that trust by being open, honest, and upfront about our capabilities, limitations, and processes.

Here are a few examples of how our commitment to integrity and transparency translates into real-world actions:

Clear and Honest Communication: We maintain open lines of communication with our clients, providing regular updates on project progress, addressing any concerns promptly, and proactively communicating any potential challenges or delays. We believe in setting realistic expectations and avoiding overpromising, even if it means turning down a project that doesn't align with our capabilities or ethical standards.

Detailed Documentation: We meticulously document every step of our sample collection, processing, and storage procedures. This ensures traceability and transparency, allowing our clients to have full confidence in the quality and reliability of our biospecimens.

Rigorous Quality Control: We adhere to the highest quality standards, including IRB approval for sample collection, ISO certification, and FDA registration. We regularly audit our processes and undergo external quality assessments to ensure we consistently meet or exceed industry benchmarks.

Ethical Sourcing: We prioritize ethical considerations in all our operations. We obtain informed consent from all donors, protect their privacy, and compensate them fairly for their time and contribution. We also ensure that our sourcing practices are compliant with all applicable regulations and guidelines.

Openness to Feedback: We actively seek feedback from our clients and partners, and we use that feedback to continuously improve our processes and services. We believe that open dialogue and collaboration are key to building strong, lasting relationships.

Our commitment to integrity and transparency has not only earned us the trust of our clients and partners but has also fostered a positive reputation in the industry. We are proud of the work we do, and we are committed to upholding the highest ethical standards in everything we do.

PSG aims to address the industry's challenges in accessing quality samples and data. How has PSG's innovative approach helped to bridge this gap, and what impact have you seen on research and diagnostic accuracy?

Porto: At PSG, we recognize that the lack of access to high-quality samples and associated data is a major bottleneck in scientific research and diagnostic development and manufacturing. We've taken a multifaceted approach to address this challenge, combining innovative strategies with a deep commitment to quality and ethical practices.

Our approach focuses on several key areas:

Building a Diverse and Extensive Donor Network: We actively recruit and engage with donors who have a wide range of medical conditions, ensuring a diverse pool of samples that reflects the real-world patient population. This diversity is crucial for researchers developing and validating diagnostic tests that are accurate and reliable across different demographics.

Rigorous Donor Screening and Medical Data Collection: We go beyond basic demographic information, collecting comprehensive medical histories and clinical data from our donors. This rich dataset provides valuable context for researchers, allowing them to understand the underlying conditions and factors that may influence biomarker expression and disease progression.

State-of-the-Art Sample Collection and Processing: We employ cutting-edge technologies and adhere to stringent quality control measures to ensure the integrity and stability of our samples. This includes specialized collection protocols, optimized processing techniques, and carefully controlled storage conditions.

By bridging the gap in access to quality samples and data, PSG has made a significant impact on research and diagnostic accuracy. Researchers now have access to a wider range of well-characterized samples, allowing them to design more robust studies, validate their findings in diverse populations, and ultimately accelerate the development of new therapies and diagnostics.

We are proud of the role we play in advancing scientific discovery and improving patient care. By providing researchers and clinicians with the tools they need to succeed, we are contributing to a brighter future for healthcare.

What sets PSG apart from other providers of biological materials??

Porto: PSG stands out from other providers of biological materials in several key ways:

1. Unparalleled Technical Expertise: Our team possesses deep scientific and medical knowledge, allowing us to understand the nuances of various diseases and the specific requirements of different research applications. This expertise ensures that we collect and process samples in a way that maximizes their utility and value for our clients.
2. Unwavering Commitment to Quality: We maintain rigorous quality standards throughout our entire process, from donor recruitment and screening to sample collection, processing, and storage. We adhere to strict ethical guidelines and comply with all relevant regulations, ensuring the integrity and reliability of our biospecimens.
3. Personalized Attention and Customer-Centric Approach: We prioritize building strong relationships with our clients, taking the time to understand their unique needs and challenges. We offer customized solutions and go above and beyond to ensure their satisfaction, even if it means investing extra time and resources.
4. Proactive Problem Solving: We don't just react to client requests; we proactively anticipate their needs and identify potential roadblocks. This proactive approach allows us to provide seamless service and deliver solutions before problems arise.
5. Flexibility and Adaptability: We understand that research is dynamic and ever-evolving. We are flexible and adaptable, able to pivot quickly to accommodate changes in project scope or unexpected challenges.

Specific Examples of PSG's Impact:

• Rare Disease Research: We have helped researchers working on rare diseases access critical samples that were previously unavailable, enabling them to make significant strides in understanding these conditions and developing potential treatments.
• Diagnostic Test Development: Our high-quality samples and associated clinical data have been instrumental in the development and validation of new diagnostic tests for a variety of diseases, including autoimmune disorders, infectious diseases, and coagulation disorders.
• Clinical Trial Support: We have provided crucial biospecimens and patient data to support clinical trials, helping to accelerate the development of new therapies and improve patient outcomes.?
• CRO / testing capabilities

Our clients consistently praise our technical expertise, responsiveness, and commitment to quality. They value our personalized approach and our willingness to go the extra mile to ensure their success. We believe that these qualities are what truly set PSG apart in the industry.

How does PSG's proactive approach and dedication to understanding client needs differentiate you from competitors in the market?

Porto: At PSG, we don't simply wait for client requests; we actively anticipate their needs and go above and beyond to ensure their success. Our proactive approach sets us apart from competitors in several key ways:

1. Deep Understanding of Client Needs: We invest significant time and effort into understanding our clients' research goals, project timelines, and specific challenges. This allows us to tailor our services to their unique requirements, providing customized solutions that address their specific needs.
2. Anticipating Challenges and Providing Solutions: We don't just react to problems as they arise; we proactively identify potential roadblocks and develop solutions before they impact our clients' projects. This forward-thinking approach minimizes delays, reduces costs, and ensures a smoother research process.
3. Open and Transparent Communication: We maintain open lines of communication with our clients, providing regular updates on project progress and proactively addressing any concerns or questions they may have. This transparency fosters trust and ensures that our clients are always informed and engaged.
4. Collaboration and Partnership: We view our clients as partners, not just customers. We work collaboratively with them throughout the entire process, from project conception to completion. This collaborative approach ensures that our solutions are aligned with their goals and that they achieve the best possible outcomes.
5. Going the Extra Mile: We are committed to providing exceptional service and exceeding expectations. We are always willing to go the extra mile to help our clients succeed, whether it's sourcing a rare sample, providing additional clinical data, or offering expert consultation.

Our proactive approach and dedication to understanding client needs are deeply ingrained in our company culture. We believe that this customer-centric focus is what truly differentiates us from our competitors. By building strong relationships with our clients and actively supporting their research endeavors, we are not just providing biological materials, we are empowering scientific discovery and ultimately, improving patient care.

Could you share some testimonials from clients who have benefited from PSG's services? How has PSG helped them overcome challenges and achieve their goals?

Porto: We're incredibly proud of the numerous success stories we've helped our clients create. Here are a few testimonials that highlight the impact of our work:

"You are all so thoughtful and strategic in the way you partner with us."

"Your meticulous attention to detail is why we're eager to collaborate on our next project, and we should start that conversation soon."

"We've faced significant issues with materials from other sources, and we're committed to working with you as much as possible. How can we help you make that happen?"

These testimonials illustrate how PSG's services have made a tangible difference for our clients. We are constantly inspired by the groundbreaking research and innovative products our clients are developing, and we are honored to be a part of their success.

What specific products, services, or innovations will PSG be showcasing at ADLM?

Porto: At ADLM, PSG will be showcasing a comprehensive suite of products, services, and innovations designed to address the evolving needs of researchers and clinicians in the field of diagnostics and therapeutics development:

1. Sourcing Bulk Plasma: We understand the critical role that high-quality bulk plasma plays in advancing research and development, and we are dedicated to providing a reliable and efficient sourcing solution. PSG is proud to offer a comprehensive solution for that.

• Disease-State Donor Network: Leveraging our extensive disease-state donor network to procure bulk materials tailored to our customers' unique needs.
• Rare Materials: Sourcing high-value, rare bulk material through established recruitment processes and long-standing clinical and sourcing relationships.
• Vertical Integration: Offering seamless vertical integration capabilities, from initial assay testing to final manufacturing, to optimize our customers' workflows.
• Global Reach: Serving over 50 bulk plasma clients across the globe, demonstrating our commitment to meeting the diverse demands of the international market.

1. Expanded Biobank Portfolio: We're excited to unveil our significantly expanded biobank portfolio, featuring a diverse range of disease states and patient cohorts, including those mentioned earlier (APS, DFS70, Lupus, RA, Myeloma, Lyme Disease, and Systemic Sclerosis). These biobanks offer researchers access to high-quality, well-characterized samples and associated clinical data, accelerating the development of innovative diagnostics and therapies.
2. Custom Collection Services: We'll be highlighting our ability to provide custom sample collection services tailored to the specific needs of individual research projects or clinical trials. Our experienced team can design and execute collection protocols that meet the most stringent quality standards, ensuring the reliability and validity of research findings.
3. Partnering Opportunities: We'll be actively seeking to forge new partnerships with research institutions, pharmaceutical companies, and diagnostic developers. We believe that collaboration is key to driving innovation and accelerating the translation of research discoveries into real-world solutions.

We invite all ADLM attendees to visit our booth to learn more about our comprehensive suite of products and services. We are confident that our innovative solutions and unwavering commitment to quality will make a lasting impression and contribute to the advancement of scientific research and improved patient care."

How can attendees at ADLM connect with PSG to learn more about your company and explore potential collaborations?

Porto: We're eager to connect with ADLM attendees who are interested in learning more about PSG and exploring potential collaborations. There are several ways to engage with us during the conference:

• Visit Our Booth: Our team will be stationed at Booth #5232 throughout the conference. Stop by to chat with our experts, learn about our latest offerings, and discuss your specific research or clinical needs.?
• Schedule a Meeting: If you'd like to have a more in-depth conversation, we encourage you to schedule a meeting with us in advance. You can do so through the ADLM Meeting app or by contacting us directly through our website or email: [email protected]

We're happy to set aside time to discuss your specific research needs and explore potential collaborations.

• Connect on Social Media: Follow us on X/Twitter or LinkedIn for updates throughout the conference, including behind-the-scenes glimpses, and opportunities to engage with our team virtually.
• Contact Us After the Conference: If you're unable to connect with us during ADLM, don't hesitate to reach out to us after the conference. We're always happy to answer?

We believe that ADLM is an excellent opportunity to build new relationships and foster collaboration in the field of diagnostics and therapeutics development. We look forward to meeting you there and learning how we can support your research and clinical goals.

What message do you want to convey to ADLM attendees about PSG's commitment to quality, innovation, and customer service?

Porto: At ADLM 2024, we want to leave attendees with a clear and lasting impression of PSG as a trusted partner who is deeply committed to advancing scientific research and improving patient care. Our message revolves around three core pillars:

1. Unwavering Commitment to Quality:

Quality isn't just a buzzword for us; it's the foundation upon which PSG is built. From the moment we engage with a donor to the delivery of our biospecimens, we adhere to the most rigorous quality standards in the industry. We hold ourselves accountable to these standards through meticulous documentation, regular audits, and external quality assessments.

Our commitment to quality isn't just about meeting regulations; it's about ensuring that every researcher who uses our samples can trust the integrity and reliability of their data. This ultimately leads to more robust scientific discoveries and, most importantly, better outcomes for patients.

2. Relentless Pursuit of Innovation:

We believe that innovation is the key to unlocking new possibilities in research and diagnostics. We are constantly seeking new and better ways to serve our clients, whether it's through expanding our biobank offerings, developing cutting-edge data management tools, or tailoring our services to meet the unique needs of each project.

Our dedication to innovation is evident in our diverse portfolio of biobanks, including our newly launched collections for rare and understudied diseases. We are constantly pushing the boundaries of what's possible, and we invite researchers to partner with us to explore new frontiers in scientific discovery.

3. Unmatched Customer Service:

At PSG, our clients are more than just customers; they are partners in our shared mission to advance science and improve healthcare. We pride ourselves on our personalized approach, taking the time to understand each client's unique needs and challenges. We believe in open communication, proactive problem-solving, and going the extra mile to ensure their success.

We are committed to building long-lasting relationships with our clients, based on trust, collaboration, and mutual respect. We understand that their success is our success, and we are dedicated to providing the highest level of support at every step of their research journey.

Our message at ADLM is simple: PSG is your trusted partner in scientific discovery. We provide the highest quality biospecimens, innovative solutions, and unmatched customer service to empower your research and drive meaningful advancements in healthcare.