09:00
Welcome
Opening of the conference.
Tentative programme · v2
Programme
Two intensive days bringing together regulatory experts, clinical leads, industry executives and business-development specialists.
Day 1 · Training
Wednesday, 16 September 202609:35
Introduction to VAMs / 505(b)(2)
Setting the scene: definition and market trends in the US and Europe.
Ana GavaldáAnnion
10:05
Portfolio of VAM / 505(b)(2)
Understanding the concept of VAM value: a balance between market opportunities and specific challenges.
Ana Caterina PintoBluepharma
10:50
Regulatory & clinical requirements — US
A review of the main regulatory characteristics of the 505(b)(2) pathway and how to overcome the challenges.
Angela Drew(tbc)Cathy(tbc)
11:30
Coffee break
12:15
Regulatory & clinical requirements — EU
A review of the main regulatory characteristics of the European hybrid pathway and how to overcome the challenges.
Granzer(tbc)Adalvo(tbc)
12:35
Non-clinical requirements
Bridging strategy and check-listing review.
Nicolay FerrariArendiBio Solutions
13:00
Patent challenges
Protecting innovation beyond the molecule: IP strategies for added-value medicines.
Toni SantamariaAdalvoIrene CasalprimAdalvo
▸ Read abstract
As the pharmaceutical industry increasingly focuses on added-value medicines, intellectual property plays a key role in supporting differentiation and commercial sustainability. This session will provide practical insights from an in-house pharmaceutical perspective and will discuss different options to build IP strategies around reformulations, repurposing, new indications, and new fixed-dose combinations in Europe and the United States.
The presentation will address patent-drafting strategies, freedom-to-operate considerations and litigation risks, as well as the interaction between patents and regulatory exclusivities related to VAM products.
14:00
Lunch break & networking
14:30
Business strategy to succeed with the development
Strategic enablement of 505(b)(2) development: a business-development perspective.
Rosanne d'AlessioValdiano
▸ Read abstract
Within the 505(b)(2) development landscape, business development plays a critical but often underappreciated role — not in asset origination, but in enabling sponsors to navigate complexity, align stakeholders, and execute a coherent development strategy.
Emphasis will be placed on BD's role in helping sponsors navigate procurement decisions, engage appropriate vendors and collaborators, and align nonclinical, clinical and regulatory strategies to support efficient development and a successful regulatory submission.
The session will also underscore how early scientific and nonclinical insights inform business decisions, reduce execution risk and strengthen interactions with regulatory agencies.
15:00
Market access — Europe
Title pending.
James BurtProductLife
15:30
Legislative status in Europe
Policies for improving VAMs.
Medicines for Europe(tbc)
16:00
Coffee break
17:00
Market access — US
De-mystifying U.S. managed care for 505(b)(2) developers: why early market-access strategy determines commercial success.
Will BainbridgePremier(tbc)
17:00
Round table · Market access
Dealing with the differences between country pricing & reimbursement.
James BurtProductLifeHans PlatteeuwNeuraxpharm
17:30
Day recap
Questions & answers — closing of the first day.
From 17:30
Networking event
Evening networking — venue to be confirmed.
Day 2 · Industry experience
Thursday, 17 September 202608:00
Welcome to Day 2
Ana GavaldáAnnion
08:00
Value proposition
Tips to understand the value of a development — commercial strategy, gaps and mindset.
Ana GavaldáAnnion
08:50
Technologies that can add value
A Second Life: How Solid-Form Engineering Gives Old Drugs New Purpose
Victor PerezSolitek▸ Read abstract
Value-Added Medicines are often framed as commercial or regulatory strategies — tools for lifecycle management. But many of the most meaningful VAM stories were not born in a boardroom. They were born in a crystallisation vessel.
A drug that is already approved, already prescribed and already working can still fall short for the patient who takes it. Its absorption may depend on specific dietary constraints. Its tablet may need a cold chain. These are not pharmacological limitations — they are physical ones, rooted in how the molecule is arranged in the solid state.
This session walks through four cases — posaconazole, rotigotine's transdermal patch, ritonavir / Kaletra, and Entresto, the first commercial drug-drug cocrystal — each illustrating a different situation.
Nanomedicine Development: A Robust Strategy for Targeted Delivery and Controlled Release
Alba Córdoba Insensé, PhDNanomolHumanized biological drugs
Kai TittmannUniversityLyophilised tablets
Paolo RaddaniZibletsRepurposing of drugs
Hans PlatteeuwGalenicap
Morning
Coffee break
Morning
Round table · Portfolio selection of VAMs / 505(b)(2)
Ana Caterina Pinto (lead)BluepharmaGosha (ODT)(tbc)Marta Huguet(tbc)Dina Ferreira(tbc)
Morning
Business development
Country pricing & reimbursement — dealing with the differences across markets.
Neuraxpharm(tbc)
Morning
Bridging EMA and FDA
A two-way road to global approval for 505(b)(2) and value-added medicines.
Carlos RodriguezPolpharma
▸ Read abstract
The presentation will explore the key differences between product-evaluation pathways in Europe and the US, highlighting the strategic aspects that shape successful Value-Added Medicines and 505(b)(2) projects.
It will address how to build a robust business case — including partnerships, project scope, fees, distribution models and market assumptions — while focusing on what truly creates value for potential partners.
Morning
Round table · Business
Midday
Lunch break & networking
Afternoon
The industry experience
Innovating beyond generics: 25 years of Bluepharma's patient-centric journey.
Ana Caterina PintoBluepharma
Afternoon
Round table · Licensing VAMs
Rosanne d'Alessio (lead)ValdianoCarlos RodriguezPolpharmaNeuraxpharm(tbc)
End of day
Closing remarks
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