DEIB and the Freedom to Recruit the Best

June 28, 2022

Jessica Moffitt, Associate Recruiter, Talent Acquisition As an Associate Recruiter in Talent Acquisition, Jessica Moffitt understands how valuable the DEI&B program is to her work – day-in and day-out – and to Worldwide’s People, Strategy and Culture (PSC) program overall. Speaking personally, Jessicia says: “I have struggled to thrive in typical corporate positions that promote conformity at the expense of the individual. However, for the first time in my career I can show up at Worldwide as my best self and best employee instead of the best version of a cookie-cutter ideal. I feel secure and valued within my team as a person first and foremost because we are viewed as individuals with dynamic strengths.” As a recruiter, Jessica has been saddened to learn what some people go through to get a job – especially at organizations that have little or no commitment to DEIB initiatives. “I’ve heard about recruiters who suggested that a man with an ‘effeminate’ voice, for example, I might want to alter his voice for a phone interview. Or people with ‘ethnic’ names on a LinkedIn profile being encouraged to use names like William or Katherine on their resumes to conceal their identity.” With a solid DEIB program behind her, Jessica feels free to recruit the best possible candidates for Worldwide and to free them of...

Read More

Mapping the Way for Transgender Inclusion in Clinical Trials

June 16, 2022

In today’s world, diversity and inclusion in clinical trials is a hot topic. Lately, the focus has been on increasing racial and ethnic minority inclusion in clinical trials to make the data more representative for them, but we are missing a large piece of the inclusion puzzle. While FDA has released several guidance documents on diversity and inclusion, the LGBTQIA+ community has been largely overlooked, specifically the transgender community. Why is this topic so important? There are currently 1.6 million people in the United States who identify as trangender1. In a recent survey, 44% of US adults say they know someone who is transgender2. So, chances are, if you’re reading this, you know of someone who fits within this growing group of people whose gender does not match the gender they were assigned at birth.   When it comes to clinical trial recruitment, how do we include, for example, transwomen (women who were assigned male sex at birth and have transitioned to female)? Recently, we were enrolling patients for a clinical trial for a genetic disorder only affecting males. During this process, a transgender woman reached out asking if she could participate while transitioning — which she should have been able to do. However, since the protocol specifically stated that only males could be enrolled, we were unable to permit...

Read More

Can We Rebuild Trust with Blockchain?

June 15, 2022

By: Aman Khera, VP, Global Head of Regulatory Strategy The industry moved at 1,000-miles-per-hour to implement digital solutions during the pandemic. Now, it’s time to pull back a little. We need to create a framework around the use of digital technologies in clinical research.   Regulatory agencies must lead the way with clear direction. At the same time, they must also work together with industry to ensure that the path we follow gives patients the data transparency and ownership they so urgently crave. We must move forward thoughtfully, with the same rigor expected in clinical trials. While great digital tools exist to open data access and make studies more convenient, restoring patient trust requires more than merely transitioning from paper-based forms and processes (e.g., consent forms) to digital ones. Although certainly beneficial, I’d argue such tools don’t represent real innovation. Real innovation entails viewing digital technologies through the eyes of the patient, setting frameworks that break down silos in ways that ultimately offer transparency and put patients in control. Others have also noticed “… a growing emphasis on the ethical, responsible and transparent use of AI and data science.” But as one author notes, “In order for the promise of digital health to be realized, companies will need to ensure their patients’ data is safe, secure and error-free.” That’s where...

Read More

5 Things You Need to Know from Our Recent Gene Therapy Webinar

At the end of May, we hosted a webinar titled “Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapies” to provide a quick update on the latest advancements and ongoing in development of these advanced therapeutics. In case you missed it, you can watch the full webinar, here, or check out the top five things you missed: 1. Clinical holds are becoming more common, especially in gene therapy programs. There’s been a sharp increase in clinical holds over the past few years, largely because of advancing gene therapy programs and the safety concerns they present. Around 40% of clinical holds are for gene therapy programs. We’re noticing that around half of clinical holds are for oncology programs. Most holds are being lifted, especially for oncology and hematology, but neurology holds are seeming to stick around longer1. Consulting with regulatory experts and experts in toxicology, manufacturing, etc., can help you prepare your study and documentation to comply with agencies. Early engagement and discussions can help you prevent the risk of a clinical hold. To discuss your study and how to reduce the chances of receiving a clinical hold, talk with us.  2. Sites are struggling to activate — even now.  The pandemic has had a lasting impact on the ability of sites to participate in trials, particularly...

Read More

“This [clinical] trial has given our family hope”: A story of cancer survivorship

June 7, 2022

In her own words, a daughter shares how a career in cancer research helped support her mother’s courageous battle with late-stage ovarian cancer. By Cathy Purvis, MBA; Site Activation Manager, Oncology and Rare Disease, Worldwide Clinical Trials I landed in oncology thanks to the luck of the draw. This area happened to be where I was assigned when first starting in Site Activation. I quickly became intrigued by the complex nature of the study/site processes and did whatever I could to meet and beat targets, despite the additional oversight that often accompanies oncology trials. I also enjoyed building relationships with both the sites and sponsors, as I mainly was working with small biotech companies on Phase I escalation/expansion trials. In January 2020, my mom had not been feeling well and decided to go to the doctor before attending my twin nieces’ first birthday party, thinking her symptoms, including a rash on her abdomen, might be shingles and didn’t want to expose them. Well, it wasn’t shingles – it was late-stage ovarian cancer. She quickly got in to see an oncologist and on a treatment plan. After several rounds of platinum chemo, plus a surgery, she was considered cancer free. However, her three-month scan showed the cancer was back and even more aggressive than before, and she was indicated as platinum-resistant....

Read More

A Parent’s Story: Supporting Families Through Palliative Care

May 31, 2022

By: Kerri Padgett, Courageous Parents Network This year, I will celebrate the life of my son, Kai, for the 10th time since his passing from hypothalamic optic glioma at the age of two. I feel immense gratitude for the support we received during his cancer journey, but there are also moments when I wish I’d had more support. I know there are many families out there needing more, too. I am sharing our story during Brain Cancer Awareness month to offer opportunities to consider an improved experience for families facing one of the hardest things life can bring. Kai received a formal brain tumor diagnosis at eight months of age, after I spent months working to convince doctors that he was regressing at a concerning rate and something was wrong. During this time, we saw over a dozen pediatricians, neurologists, and ophthalmologists trained to find the most probable cause of his symptoms. This practice makes sense in theory, but for Kai, this meant our journey to diagnosis was long, as the “most likely answer” never quite fit. The diagnosis was equal parts devastation and relief – relief after months of trying to figure out what was wrong, and devastation to know Kai had cancer. But, it was the first step towards helping my baby feel better. Though I faced many...

Read More

The Current State of Advanced Therapeutics

May 20, 2022

The past few years we’ve had exciting opportunities to work on more cell and gene therapy programs for our sponsors. The industry is just at the tip of the iceberg for exploring the potential of these therapies in revolutionizing how we treat disease, and as the approvals start to trickle in, the pipeline only grows. (For a full look at the cell and gene therapy landscape, check out our webinar titled: “Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapy.”) Right now, the pipeline is booming—since 2012, there has been a 10x increase in gene therapy development, up from nearly 200 to more than 2,000 today, according to the American Society of Cell + Gene Therapy. Most of the pipeline is for anticancer therapies and therapies for rare cancers1. Since these therapies go beyond symptom management to address the cause of the disease, the treatment potential surpasses what most previous treatments could offer to patients. Even the most devastating of rare diseases could be offered the possibility of treatment in the next few decades. Most treatments currently in development are in the early stages, with around 70% still in preclinical and only 1.4% (26) currently in Phase III of their program1. Though some of the disparity can be attributed to the difficulty of advanced therapeutic development,...

Read More