Alcami aims to be “Connected at Every Level,” and our compliance and quality team members work every day to help us deliver that vision. Like all cGMP companies in the CDMO industry, we host many external and internal audits every year. Our risk-based approach promotes the internal review of activities across all systems, processes and facilities, while concurrently managing a high volume of external audits, which can range from paper assessments to full-scale mock pre-approval inspections. Alcami’s corporate regulatory and compliance team works in concert with site-based quality, compliance and leadership teams to support these audits and maintain a constant state of inspection readiness. Operational resource talent pools are leveraged across the Alcami network to tackle opportunities and potential concerns with a holistic approach.
Joseph Payne
Vice President, Regulatory Affairs & Compliance, Alcami
RxGen is a preclinical contract research organization with global reach that offers specialized nonhuman primate models in ophthalmic, CNS and other prevalent disease conditions, with broad experience in small molecule, biologics and gene therapy candidate evaluation. RxGen partners to achieve the development objectives of sponsors in North America, Europe and Asia and complies with international animal research, regulatory and shipping guidelines, and all of those that apply within respective regions.
RxGen’s commitment to efficiently conducting resource-intensive research with the objective of improving the lives of patients is inherently a heavily social activity, built on positive relationships maintained at a local level within immediate communication and execution time frames. This includes the physical communities in which RxGen directly works and our emulating the qualities of local-level connectivity in our engagement with clients at distant sites, allowing RxGen to act as an extension of their labs. Our mission is to drive substantial gains in R&D productivity in serving the diverse needs of the biomedical research community globally. Critical to that capability is bringing immediate, first-hand know-how to demands that are specific to a given project and location –– an expertise we have achieved through working long and effectively within local and global compliance standard and managing the logistical dependencies associated with multi-site science.
Matthew Lawrence
Chief Executive Officer and Chief Scientific Officer of RxGen
Isofol is currently advancing lead developmental candidate arfolitixorin in a global phase III clinical study in patients with metastatic colorectal cancer treated in the first line. With trial sites in the United States, Canada and Europe, we have to be keenly aware of maintaining global compliance throughout the process of designing and executing the trial. We have worked closely with regulatory agencies, as well as top oncology experts from each of these regions, to ensure that we have accounted for as many potential concerns as possible, including regulatory differences and variances in existing standard of care to make sure that this process is as smooth as possible. We also have regular dialogue with individual trial sites in local regions to ensure that all their trial planning, enrollment and execution needs are met.
Anders Rabbe
Chief Executive Officer of Isofol Medical
Catalent provides customized regulatory services for customers utilizing our contract development and manufacturing services. Compliance is interwoven into the regulatory support we provide. Whether Catalent authors applicable sections of a customer’s dossier or supports its generation, the customer provides us the applicable sections of the dossier for review and comment prior to submission, ensuring that the regulatory documentation accurately reflects the development history, Catalent’s manufacturing process and applicable Health Authority requirements. Regulatory affairs specialists also review proposed changes to assess which products are affected and the type of regulatory reporting that will be required for the change, prior to it being implemented.
We have regulatory affairs experts in various regions to help evaluate the impact of any regulatory changes for the jurisdiction in which a product is registered. Our CDMO regulatory affairs organization stays current with regulatory requirements through the experience of supporting numerous customers. Additionally, we have a dedicated regulatory intelligence team, which shares information throughout Catalent, so we can transform the information into actionable plans to mitigate risk. It is to our advantage to be well informed so we can identify opportunities and optimize product development to deliver successful outcomes for customers and the patients we all serve.
Veda K. Walcott
Vice President, Global Regulatory Affairs & Compliance, Catalent
As the world of pharmaceuticals rapidly advances, it is more important than ever to manage both local services and global compliance. We are developing a corrective eye drop for presbyopia, also known as age-related farsightedness, which affects more than 1.8 billion people globally. Our goal is to bring a convenient and on-demand solution to these people in our local community and other regions of the world.
We have designed a strategic path forward to navigate the local and global regulatory and compliance landscape. More than 115 million people in the United States are affected by presbyopia and that number will increase to over 130 million in the next 10 years. We want to bring a pharmaceutical solution to these people and that’s why it’s incredibly important for us to understand the U.S. market and regulatory path. After successfully completing phase IIa studies locally in Israel, we started testing our product candidate in a phase IIb clinical study across several states in the United States.
Elad Kedar
Chief Executive Officer of Orasis Pharmaceuticals
