DCAT® Women Leaders in Pharma Interview Series: Dr. Joanne Santomauro
As published in DCAT®
As published in DCAT®
Sometimes, we are lucky enough to get a reminder of the tangible impact we make right here at home. Ancillare is proud to celebrate one of those stories from our employee, Jessica.
At age 15, Jessica suffered serious injuries when she was hit by a drunk driver while riding her bike. Her doctors did not immediately realize that she had injured her back. Jessica eventually discovered she had suffered permanent nerve damage, and her pain persisted through adulthood. She explored all options for treatment, only stopping short of opioids to avoid potential addiction.
After decades with no relief, Jessica connected with a renowned neurologist at Delaware Valley Pain & Spine Institute. Dr. Bromberg told her about a device called the Saluda Closed Loop Spinal Cord Stimulator that works by sensing and responding to the patient’s neurological activity. This new therapy, which was developed by an Australian medical device company, was not yet available in the U.S. — but recruitment had just begun for clinical trials in the United States.
Excited to seize the opportunity, Jessica agreed to have the simulator attached to her spine and noticed dramatic relief. She then underwent surgery to have the device implanted, becoming the first American to do so.
Jessica says the device has had a life-changing impact for her and has since stopped all other medications.
Just like each and every Ancillare employee, Jessica contributes to our mission of relieving Sponsor’s Clinical Trial Ancillary Supply Chain (CTASC™) pain points that slow down advancements in medicine. Now, her participation in a clinical trial has given her relief from physical pain that she has endured most of her life.
Our work to make clinical trials run more smoothly helps our partners create hope for patients every day, all over the world — be it through symptom relief, COVID-19 immunization, or the chance to live longer. No matter how small our tasks may seem, we are making a difference.
The COVID-19 pandemic disrupted the global clinical supply chain. The sudden demand for ancillary supplies for clinical trials like needles, syringes, caps, IV lines, and thermometers put tremendous strain on Sponsors, who were up against the clock to develop safe and effective treatments.
Traditional procurement models could not meet the urgent need for these supplies. The same products needed to conduct vaccine trials were directed to healthcare systems and governments first, leading to unprecedented shortages.
Ancillare’s background of industry-wide innovation made the organization uniquely prepared to address these challenges. And in the post-pandemic environment, with no end in sight to recalls, shortages, and other supply chain interruptions, the CTASC approach offers the best path forward to mitigate risk and avoid costly delays.
Many years prior to the pandemic, Ancillare’s founders applied decades of supply chain expertise to develop the Clinical Trial Ancillary Supply Chain (CTASC™) model. CTASC treats sourcing and managing ancillary supplies for clinical trials as its own discipline, creating detailed protocols to meet any type of supply chain challenge, and going beyond the confines of individual trials to develop program-wide strategies.
Many of Ancillare’s responses to crisis conditions will remain permanent CTASC offerings. For example, during a COVID-19 vaccine trial, Ancillare’s Innovation Team created and delivered customized kits that were equipped with all supplies required for a single patient’s visit. As a result, direct-to-patient kitting will be made available to all Sponsors as a quality assurance measure.
Dedicated CTASC management has always offered a clear advantage to Sponsors by deriving real-time solutions from long-term data. The COVID-19 crisis put this approach to the test during a period of unusually high demand — and also proved its long-term value for Sponsors.
In addition to working directly with Sponsors, Ancillare partners with Contract Research Organizations to alleviate pressure at any stage of the CTASC cycle. A centralized, strategic procurement option gives CROs a more reliable option for supply and equipment sourcing.
We believe that a well-planned Clinical Trial Ancillary Supply Chain is essential to on-time, on-budget trials. Whether for a single upcoming project, or your entire clinical development program, our experts are always happy to discuss strategies tailored to your team’s needs. Schedule a fifteen-minute consultation today.
Ancillare’s CEO, Dr. Joanne Santomauro, discusses how the organization overcame supply chain challenges in the height of the COVID-19 pandemic to source ancillary supplies for clinical trials.
As published in WorldPharma Clinical Trials Insight
Dry eye syndrome is a common condition around the globe. There are at least three million people diagnosed each year in the United States. It often occurs as a result of decreased tear production with age.
The symptoms of dry eye are extensive and diverse within the adult population. Common complaints from patients may include burning, itchiness, foreign body sensation, excessive watering, redness, and light sensitivity. When a patient presents with a dry eye, the optometrist may notice changes on the front surface of the eye in the tear film, swollen eyelids, and debris buildup on the eyelashes. In these patients, vision may be reduced and can often improve temporarily with repeated blinking.
Other common causes include refractive surgery, which can create less tear production, as well as the use of medications, such as antihistamines, antidepressants, diuretics, and beta blockers, which reduce mucus production. Links have been drawn to excessive screen use, on a computer or cellphone, as people tend to blink less while using their device. Systemic change in hormones deriving from pregnancy and menopause as well as changes in environmental conditions, such as increased wind and low humidity, are all common causes of dry eye syndrome.
Ophthalmologic studies can vary greatly in supply and equipment needs, depending on the indication being studied. An ophthalmology CTASC looks at:
Ancillare offers specialized support for complex clinical supply chains. From consultative support such as the Ancillare Innovation Team, to technology resources such as the Ancillare Digital Communications Platform, we help Sponsors navigate the challenges of sourcing and managing ancillary supplies for clinical trials in ophthalmology and all therapeutic areas.
We manage ancillary supplies for clinical trials in ophthalmology through:
International Clinical Trials Day gives us the chance to honor the advancements in medicine brought forth by clinical trials. It is also a day to reflect on the enormous efforts that make clinical research possible.
Any given clinical trial involves dozens of roles with unique responsibilities — and it demands they are all met precisely. From clinical operations manager, to investigator, to patient, to biostatistician (to name just a few), each individual must be up to their respective task.
What can easily go unrecognized in the world of clinical research, however, is the lengths individuals and teams go to optimize trial operations.
Many trials today are conducted on a global scale. Even if the trial itself is not multinational, chances are an international CRO or other vendor is involved. Team members often communicate across different time zones, bending over backwards to ensure each part is in place. Success hinges on the ability of individuals to communicate, adapt to rapidly-shifting circumstances, and apply their expertise in innovative ways.
In short: the collaboration among clinical research professionals is the x-factor that keeps trials running smoothly.
At Ancillare, we see ourselves as a microcosm of this phenomenon. Ancillary supply chain is a world unto itself, with an ever-evolving regulatory environment, unique therapeutic area factors, and growing demands for cost and time efficiency. We developed the framework of Clinical Trial Ancillary Supply Chain (CTASC™) to meet all of these unique demands, creating a reliable and replicable system to serve Sponsors running global trials.
Of course, systems only work if you have the right people overseeing them. We depend on logistics experts, medical advisors, clinical development consultants, and many more specialists to address challenges and innovate on behalf of our Sponsors. That is why working with Ancillare is not just another vendor relationship — it is a strategic partnership.
This Clinical Trials Day, we are highlighting the individual areas of expertise that allows us to serve as much more than a supplier by taking you through each stage of the CTASC sequence.
1. Business Development
In our initial conversations with a prospective client, we do as much listening as possible. Then, we ask informed questions to further understand your pain points. That’s because, as a potential partner, we want to know how best we can support you, your teams, and the patients you serve. We recognize that each trial is unique. Therefore, individual CTASCs — and strategies for entire portfolios — must be designed with care and attention.
2. Innovation Team
A strong ancillary supply chain must be designed with an expert eye. Over time, we have expanded our team with Subject Matter Experts in a variety of fields so that we may best understand Sponsors’ unique needs, as well as other factors influencing clinical trial operations. Ancillare’s Innovation Team brings together specialists from all functional areas who work together to find the best solutions at the earliest stages of a trial so that any potential challenges are addressed immediately.
3. Clinical Operations
Clinical trials are highly complex, meaning Sponsors need a reliable resource who sees the big picture — particularly when it comes to compliance and efficiency. We do not only take an all-encompassing view of your current project; we look beyond the confines of individual trials to coordinate moving parts across your entire portfolio of studies. This also comes in the form of therapeutic area expertise, which can help ensure patient centricity and lend further insight to specific supply and equipment needs. Ancillare’s on-staff medical consultants and clinical operations professionals consult on all of these matters and more, and identify shared supply needs across portfolios with attention to the Sponsor’s bottom line.
4. Sourcing & Procurement
With decades of experience in supply chain management, our leadership has developed effective and innovative strategies that help our Sponsors get the most for their budget. We also pride ourselves on being a women-owned business and a Tier-1 supplier, helping clients achieve supplier diversity while offering the veritable benefits that come with those titles — because to us, they amount to much more than a box to check off. We are able to offer such creative solutions because of the variety of perspectives within our team. In a field as complex as clinical research, a forward-thinking mindset means better overall results for both you and the patients you serve.
5. Project Management
Ancillary supplies should not be an afterthought. We give full attention to every aspect your ongoing and upcoming CTASC needs, while moving as quickly and nimbly as needed. With a single point of contact, the little moving parts of your trial get the dedicated attention they deserve. This level of immersion is what enables us to help you meet or surpass critical milestones like site activation and first patient enrollment.
As the CTASC industry becomes more clearly defined, the value of strategic partnerships becomes more and more apparent. A consultative approach sets us apart from a traditional supplier or vendor that does not offer support beyond filling an immediate need.
On International Clinical Trials Day, we at Ancillare want to let you know that we see you. We know and appreciate the hard work that goes into managing your clinical trials. And we are proud to serve as your CTASC partner, helping your trials run as smoothly as possible so that you can continue developing treatments to improve and save lives for patients everywhere.