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inSeption Group’s Executive Vice President, is elected Chair-Elect of the Council on Professional Registration for the Society of Quality Assurance
inSeption Group is thrilled to announce that Dawn Niccum has been designated as Chair-Elect of the Council on Professional Registration (CPR) for the Society of Quality Assurance (SQA) for the 2024 term.
“I am honored to have been elected to this position by my peers. In this role, I hope to continue to give back to SQA as it has been instrumental in supporting me in my career.”
As Chair-Elect of the CPR, Dawn will be responsible for overseeing the activities surrounding the Professional Registry credentials of Registered Quality Assurance Professionals in Good Clinical Practice (RQAP-GCP) and Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP), which are recognized standards of experience and knowledge in the industry. Her leadership will undoubtedly inspire others to uphold the highest standards of quality assurance, ensuring the delivery of safe and effective treatments to patients worldwide.
At inSeption Group, Dawn has been instrumental in elevating the company’s reputation and performance in quality assurance and full-service clinical outsourcing.
According to Managing Partner Joe Arcangelo, “Dawn’s expertise has brought significant value to the inSeption Group. Not only have her contributions helped ensure inSeption’s services consistently exceed industry standards and regulatory requirements, but her deep knowledge and experience has empowered inSeption to bring innovative solutions to our industry.”
Joe further added, “We are proud of her recent election as Chair-Elect. I am certain she will be an important catalyst for increased awareness and membership by fostering collaboration, knowledge sharing, and continuous improvement, contributing to the advancement of quality assurance practices.”
About Dawn Niccum
With over 30 years of Clinical Operations, Clinical Systems, and Quality Assurance pharmaceutical experience, Dawn provides clients with a unique perspective of efficiency, speed, and compliance. She is an experienced leader in clinical compliance and auditing, inspection readiness activities, SOP development, computer system validation, quality document management, training, and safety. Her extensive experience and strength in establishing quality structures and streamlined approaches to reduce risk remains a tremendous asset in inSeption’s ability to deliver outstanding quality, best practices, efficient systems, and cost savings to our sponsors. Additionally, Dawn is recognized for her expertise in implementing TMFs across settings and systems, is a member of the CDISC TMF Reference Model Group Steering Committee and Chair of the Education Committee, is an active member of the Society of Quality Assurance and has presented as a Subject Matter Expert at numerous conferences.
About inSeption Group
inSeption Group is a full-service, global outsourcing company built on a foundational culture of exceptional service and quality. Specializing in complex trials within the oncology, rare disease, and neurodegenerative space, inSeption stands apart from traditional outsourcing options by its ability to attract and retain a subset of highly experienced and committed professionals. inSeption Group delivers quality as promised, efficiently and affordably, so that life-changing therapies can reach the patients and families who need them.
Every submission matters for kids like Loie
If you ever need a reminder of who your hard work helps, let it be Loie.
Loie Hammond seemed like a typical toddler. She loved playing with dogs of all sizes, being outside, listening to books, making up names for her dolls, and chasing around her big brother Owen. But soon, certain behaviors began sparking questions about her development, and eventually her family was given a tragic answer.
Loie was two years old when she was diagnosed with metachromatic leukodystrophy (MLD), a rare and fatal genetic disease. Children with MLD typically exhibit normal development in their early years, but as the disease progresses, they lose the ability to walk, talk, and interact with the world around them. Like many rare diseases, treatment options were limited to symptomatic support, and most kids don’t survive their first decade. Loie didn’t live to her 4th birthday. But, thanks in part to the work done right here at inSeption, the outcome may be different for other families.
Finding purpose in the pain
Loie’s parents, Matt and Lauren, were determined to keep fighting on behalf of their daughter, and they worked closely with another MLD family to establish the Leukodystrophy Center of Excellence at the Children’s Hospital of Philadelphia in 2015—the first of its kind in the US and now the leading leukodystrophy center in the world.
inSeption Group became a part of Loie’s legacy through our work with Orchard Therapeutics. Over the course of 2+ years, the inSeption/Orchard team prepped the BLA submission for OLT-200, a gene therapy treatment for MLD. They dedicated their time, talents, and energy, tackling many challenges and complexities along the way. Matt Hammond was a consistent presence during the process, sharing Loie’s story, encouraging the team, and helping us all to remember that what we’re doing matters to other MLD families across the world.
On September 18, 2023, Orchard received the incredible news that the FDA accepted the BLA filing of OLT-200 under Priority Review, with an approval goal of March 18, 2024. This milestone marked the culmination of countless hours of hard work for inSeption—and the countdown to hope for hundreds of families living with MLD.
Never forget the difference you make
Every day in every way, you are not just showing up for the clients. You’re showing up for families like the Hammonds who are facing a devastating diagnosis and may be sitting down with their doctors at this very moment to hear their options. The inSeption team poured their hearts into the Orchard submission, and we know you all share that same level of passion for the sponsors you support. With each trial, program, and submission, we have the incredible privilege of bringing new solutions to their table.
Loie’s time came before a treatment did, but her light will live on in the future we’re building together.
Thank you for all you do and all you give. It matters.
Learn more about the CHOP Leukodystrophy Center of Excellence
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Danielle Starke has long known that she wanted to be a part of the cancer treatment landscape. What she didn’t know was that she would also venture into an entirely different kind of landscape—one that included lakes, cabins, and a whole lot of Wisconsin sunshine.
As a Clinical Manager, Danielle has seen firsthand how research can improve the lives of patients. But she knew the impact of cancer reached far beyond what she could influence at an investigation site.
“I wanted to understand and be a part of not only treatment for cancer, but also the social and quality of life implications it can cause.”
A one-of-a-kind camp community
Eight years ago, Danielle learned about Camp One Step, an organization that provides free year-round camp experiences for kids with cancer and their families. In many ways, their Summer Camp isn’t that different from any other camp. Kids can play games, swim and fish in the lake, dance, do crafts, sing around the campfire, and open themselves up to new experiences. Many of the campers are actively going through treatment or live with other physical, mental, or social challenges, so a full medical team of volunteer healthcare professionals are always on site.
Since its inception 45 years ago, Camp One Step has expanded to offer 10 in-person camp experiences, including Ski Camp, Adventure Camp, and a Dude Ranch, as well as a mental health and wellbeing program and virtual opportunities for kids who are unable to travel.
Growing up and giving back
Danielle co-leads the Seabees, a leadership and personal growth program for former campers 20 years and older who have limitations due to their disease, treatment, or other factors. Eager to stay involved, the Seabees provide important aid to counselors and act as role models for younger campers. Danielle spends a week with them at Summer Camp, but their bond doesn’t stop there. The Seabees host special events, plan fundraisers, volunteer at various charity events, and stay connected through parties and bimonthly Zoom sessions throughout the year.
“The Seabees find a sense of purpose in the work they do, and they get to keep feeling—and creating—the magic of camp while they’re doing it,”
A full-circle perspective
Danielle is no stranger to the hope that exists in the cancer community, and the importance of connection and support. During her years at Camp One Step, she has watched kids come out of their shells the longer they spend time with other people who truly see them, understand them, and celebrate them.
“It makes me appreciate every bit of life that we take for granted—and that makes me continue to work hard in my day job. When I have a camper’s face in mind, it’s all the reason I need to keep fighting for a cure.”
Camp One Step – By the Numbers
About Camp One Step
A pediatric cancer diagnosis turns a child’s life upside down, and suddenly nothing feels normal for a child or their family. Hospital visits, ongoing treatments, financial challenges, and time away from school, sports, and friends becomes the new norm. Fear, anxiety, isolation, and loss of identity can create social and emotional scars, as children often begin to feel more like a cancer patient than a person.
Camp One Step exists to help heal these invisible scars that no one can see by offering free in-person and CONNECTED digital camp programs serving kids with cancer, survivors, and their families. Through 10 in-person camps as well as our CONNECTED digital programs, children (ages birth – 19) and their families meet, bond, find understanding in shared experiences, and expand their network of support throughout the year. Inclusion, accessibility, connections and empowerment are core to their mission.
