Data collection opportunities within continued and early access programs can vary significantly by country, and within a country, there may be different regulatory pathways to pursue. Most non-clinical trial pathways for access require or allow safety data collection by the manufacturer; however, guidance on acceptable effectiveness or health outcomes data collection is limited. Many also eliminate the requirements for protocol, patient informed consent and ethics committee approval which are necessary elements for data collection, thus limiting the ability to collect data.
The existing guidelines that do address the possibility of data collection fail to be specific enough, leaving the door open for interpretation. It is also important to note that these programs which anticipate more robust data collection (e.g., United States Treatment Use Protocol, United Kingdom Early Access to Medicines Program, and France Early Access Program) also involve a more extensive approval process, including protocol and informed consent requirements.
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As the number of early access programs and the use of RWD to inform market access continue to grow, so will the benefits of collecting RWD in these programs.
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Register for this webinar to learn more about the challenges and benefits of collecting RWD in continued and early access programs along with opportunities to collect RWD that are scientifically robust, practical and ethical.
Speakers
Emily Speas, Director, Project Management, Access Solutions, Peri- and Post-Approval Interventional Studies, PPD clinical research business, Thermo Fisher Scientific
Emily Speas has worked in the CRO industry for 15 years in a variety of operational roles as a member of investigational site, sponsor and CRO teams. In the last eight years, Emily has focused on providing strategic support for early and continued access to medicines through non-clinical trial pathways, such as Expanded Access Programs (EAPs); Compassionate Use Programs (CUPs); and Named Patient Programs (NPPs), and rollover studies and open-label extension studies. Her design and management of global programs has spanned drugs, biologics and devices. Emily has also assisted sponsors in developing company charters and standard operating procedures related to individual sponsor’s philosophy on patient access to medicines.
In her current role as Director for Access Solutions, Emily oversees the project delivery of teams managing various types of access programs, supporting the development of strategy around complex regulatory and logistical issues to offer patients with life-threatening conditions access to needed medications.
Message Presenter
Pedro Barroso Inácio, Manager, Regulatory Affairs, PPD clinical research business, Thermo Fisher Scientific
Pedro Barroso Inácio has over 12 years of industry experience in Regulatory Affairs. He has held various roles in the business, including Regulatory Affairs Manager, where he focuses on accelerating the development of new medicines. His depth of experience managing regulatory affairs consists of all clinical trial phases, interventional studies without investigational medicinal products and non-clinical trial pathways for access to medicines with demonstrated expertise in real-world evidence. Pedro is a Subject Matter Expert in both post-approval non-interventional studies and non-clinical trial pathways for access to medicines across North and Latin America, Asia Pacific and Europe.
Pedro holds a master’s degree in pharmacy (PharmD) from the University of Lisbon in Portugal and a PhD from the University of Helsinki in Finland. He has also served as a Visiting Researcher at the University of Helsinki.
Message Presenter
Almudena Olid Gonzalez, Director, Value and Access Consulting, Evidera, part of PPD clinical research business, Thermo Fisher Scientific
Almudena Olid Gonzalez has extensive experience in market access, having led a range of different projects across a variety of disease areas, including infectious diseases, oncology, CNS conditions, diabetes, CKD, and rare diseases, among others, covering from small molecules to gene therapies, vaccines and medical devices.
Almudena spent much of her early consulting career leading access and pricing strategy projects, including price corridor setting and product value testing. In addition to her time in consulting, Almudena also spent time in the industry at Norgine BV, where she was a pricing manager and led the global pricing committee.
In recent years, her efforts have shifted to more evidence-focused projects, such as Integrated Scientific Advice, HTA policy consulting, and evidence generation planning, to optimize patient access to medicines by ensuring the evidence developed meets stakeholder needs and to support clients in their efforts to take novel therapies through innovative access pathways.
(Moderator) Grace Fattal, Director, Hematology Oncology, Project Delivery, CRG, PPD clinical research business, Thermo Fisher Scientific
Grace Fattal has over 19 years of clinical research experience within the pharmaceutical industry at the sponsor and CRO levels. Her experience includes global projects Phases I-IV and cross-organizational initiatives, including SOP/Policy/Guidelines revisions. She cultivated increasing positions of leadership, including Director, Compassionate Access/Expanded Access Program with Pfizer. Utilizing her leadership and strong analytical skills, Grace implements oversight for quality, compliance, risk assessments, contingency plans, continuous improvements, and resource allocations within her portfolio in project delivery. Prior to Grace’s pharmaceutical experience, she was a Critical Care Nurse, specializing in Cardiology and Intensive Care, acting as a mentor for new nurses. She has a Master’s Degree in Public Administration and a Bachelor of Science in Nursing.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following fields:
- Medical affairs
- Clinical development
- Market access/value and access
- Patient access
- Research and development
- Peri- and post-approval
- Regulatory
- Data management
- Patient advocacy groups
- Spans all TUs, but most relevant to: oncology/hematology, rare disease, infectious disease
What You Will Learn
Attendees will gain insights into:
- The impact of varying global regulations on data collection and the additional complexity of its operationalization
- The ways in which the regulatory and operational challenges may be mitigated and alternate approaches for data collection
- The value, utility and opportunity to expedite real-world data collection
Xtalks Partner
PPD
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, PPD’s capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, we serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, we apply cutting-edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.
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