With a truly patient-focussed approach we offer a best-in-class Early Access Program service that ensures patient, healthcare professional, and client needs are met through passionate and tailored program delivery.
Sourcing commercial drug products for clinical trials can be a complex process and is often one of the last considerations during study design. Our experienced Global Sourcing Team is uniquely positioned to support you through the commercial drug sourcing process with their deep understanding of clinical trials and commercial drug markets.
Here, you will find a collection of case studies, fact sheets, articles, and media giving you insight into how we can support you.
Whether or not an Early Access Program requires a formal treatment protocol will be dependent on regulatory expectations that differ per region. This complexity increases when real‑world data is intended to be collected and analysed. Establishing these requirements early is essential for effectively planning medical writing activities for global EAP submissions.
In this podcast, Maya Zlatanova sits down with Naomi Litchfield, Director of Patient Advocacy at Bionical Emas, to explore the life‑changing impact of Early Access Programs (EAPs). Naomi shares how her personal journey, after her sister survived four rare cancers thanks to an early access medicine, fuels her passion for expanding access to investigational treatments. Together, they break down what EAPs are (also known as Expanded Access or Compassionate Use), who is eligible, and why these programs matter for patients who have exhausted all other treatment options. Naomi explains the key differences between clinical trials and EAPs, why EAPs cannot be promoted, and why requests must come unsolicited from healthcare professionals. She also highlights the potential for data collection through EAPs to support real world understanding of investigational treatments.
Technology is evolving at an unprecedented pace, and artificial intelligence (AI) is at the forefront of this transformation. Bionical Emas is excited about the opportunities AI presents to enhance the service it delivers to patients, healthcare professionals, and clients. Integrating advanced technology is allowing Bionical Emas to focus its energies on providing an even greater human element, accelerating its mission to bring life-changing medicines to patients around the world. For further information please email info@bionicalemas.com
In this episode, we are joined by leading expert Giovanni Baranello, a professor of paediatric neuromuscular disorders at Great Ormond Street Hospital Institute of Child Health, London. In his fast-paced role he manages competing clinical priorities involving the diagnosis and clinical management of children with different neuromuscular conditions. Professor Baranello gives his unique perspective and insight into Real World Data collection from Early Access Programs.
In this episode, we hear from two people who have lived experiences in advocating for their ethnicity, race, gender, and communities. They discuss their personal journeys and what led them to advocate for others to improve equality and diversity in today's clinical development landscape. Our host, Naomi Litchfield - Director of Patient Advocacy at Bionical Emas, speaks to Dr Sondra Butterworth, psychologist and founder of RareQOL, and Alfred Samuels, author, patient advocate and prostate cancer survivor. They discuss everything from accessibility and language barriers to mental health and the value of community, demonstrating the importance of how the patient voice can contribute to true equality and diversity.
Navigating Real-World Data Collection From Early Access Programs in the UK: An Underutilized Opportunity
Applying a Decision-Making Framework for Expanded Access to Duchenne Muscular Dystrophy
This episode of The Patient Voice explores the myriad of ways in which patients’ personal experiences, perspectives, and preferences can provide an informed voice for access to medicines.
Lung cancer is the leading cause of cancer deaths worldwide, claiming more lives yearly than colon, breast, and liver cancers combined.
Expanded Access offers a potential pathway to investigational treatment for patients who are ineligible to participate in clinical trials and have exhausted all available treatment options. The Johnson & Johnson Guide provides patients, their caregivers, and their physicians with much-needed clarity around their options at a moment when the power of information cannot be underestimated. Bionical Emas is proud to have collaborated on this first-of-its-kind Guide.
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