10:00 am
Registration & Light Breakfast
10:25 am
Chair’s Opening Remarks
Empowering the Patient & Developing the Value for Patient Groups in an Orphan or Competitive Drug Market to Increase Uptake
10:30 am Understanding The Different Types of Engagements That Can Be Developed with Patient Advocacy Groups to Best Inform Launch Strategy
Synopsis
- How to leverage patient advocacy groups without overstepping internal stakeholders
- Understanding the mechanisms on how to engage with patient advocacy groups
- Balancing patient support programs with patient advocacy education and initiatives
11:00 am Understanding The Importance of Patient Liaison and How We Can Support Patients When Embarking on Uptake of a New Therapeutic
Synopsis
- How to assure patients whilst not being an extension of health care provision
- How best to support patients with the uptake of treatment and maintain regular monitoring without burdening the patient
- How to best collect information from patient and how to comply with policy
- How to best assess you patient, create individualised patient centric plans & encourage them to be their own self-advocate
11:30 am
Morning Break & Speed Networking
Innovating Internal Education of Commercialization to Allow for a Smoother Commercialization & Regulation Strategy
12:00 pm Preparing for a Shift in the Company Strategy from Early-Stage Commercialization to Late-Stage Commercialization
Synopsis
- How to develop understanding and educate the internal business on the shift between early to late-stage commercialization
- Understand the shift in prorates from early to late-stage commercialisation and how individual functions may change
- Addressing new regulatory hurdles, post-approval obligations, and real-world evidence requirements
12:30 pm Mastermind: Demystifying the Adaptations to Policy when Regarding Rare Disease to Ensure a Smoother Approvable Commercial Strategy
Synopsis
- Understanding how orphan drug designations, accelerated pathways, and regulatory incentives impact commercialization strategy
- Keeping pace with shifting global regulations to ensure compliance and optimize market access for rare disease treatments
- Effectively aligning regulatory strategy with pricing, reimbursement, and patient access considerations
1:00 pm
Lunch & Networking
Fuelling A Successful Go-to-Market Strategy by Redefining a Standard of Care Versus Creating an Orphan Drug Treatment & Progressing External Disease Education to Enable Maximum Commercial Success
2:00 pm Evaluating The Market Shaping That Needs to Be Carried Out in a Disease Area with Therapeutics Already Available
Synopsis
- Assessing unmet needs & differentiation strategies identifying gaps in current treatments to position a new therapy effectively
- Engaging payers & HTAs early addressing pricing, reimbursement, and value demonstration challenges in an already competitive market
- Overcoming physician prescribing habits developing strategies to shift physician behaviour when an established standard of care exists
2:30 pm Comparing The Education Needs of the Market in a Commercial Launch of an Orphan Drug with a Launch in a Competitive Space
Synopsis
- Engaging KOLs & patient advocacy groups leveraging external voices to shape perceptions and drive adoption in both launch scenarios
- Tailoring messaging for competitive markets vs first-to-market therapies differentiating education strategies based on existing treatment landscapes
3:00 pm How Best to Profile an Asset to Make Informed Decisions in the Beginning of a Commercial Strategy
Synopsis
- Defining the target patient population utilizing epidemiology data and real-world evidence to refine market size and potential
- Aligning clinical development with commercial objectives ensuring trial endpoints support regulatory approval and payer negotiations
- Prioritizing key geographies and markets identifying regions with the highest unmet need, fastest regulatory pathways, and most favourable reimbursement environments to maximize commercial success
3:30 pm
Afternoon Break & Networking
Engaging All Stakeholders & Unleashing Better Co-Creation When Working Across Multifunctional Commercial Teams
4:30 pm Ensuring Patient Voice Is the Influential Driver in Commercial Strategy
Synopsis
- Integrating patient-reported outcomes into value proposition demonstrating the realworld impact of treatment on quality of life
- Delving into the integration of patient report outcomes from the clinic and how to integrate this into this to benefit the asset long term
- Methods of collecting patient data and how this can influence are asset development
- Uncovering best practice on complying with FDA guidance on patient engagement
5:00 pm Analysing The Commercial Team & And How to Build Out Strategy That Combines Multiple Cross Functional Roles
Synopsis
- Defining key roles & responsibilities in rare disease commercialization structuring teams for maximum efficiency in a niche market
- Breaking down silos between clinical, medical, and commercial teams encouraging data-sharing and collaboration from development to launch
- Leveraging competitive intelligence & market insights ensuring all functions are aligned with market trends and emerging competitor strategies