Michela Gabaldo | Head Of Alliance Management
Fondazione Telethon

Michela Gabaldo, Head Of Alliance Management, Fondazione Telethon

Michela Gabaldo is Head, Alliance Management & Regulatory Affairs at Fondazione Telethon in Milan, Italy
where she joined in 2011.
As Head of Alliance Managment she was responsible for the execution of the first strategic Alliance of
Telethon/OSR with GSK managing gene therapy projects at different stage of development ranging from
preclinical, to clinical, to Registration & market access. With her capability to work in a matrix, she paved
the way for the very first ex-vivo gene therapy (Strimvelis) to move from clinical trial to market, ensuring
alignment and understanding between stakeholders from different areas and entities. Through her
collaborators she’s also responsible for the execution of the other strategic alliances established by
Telethon at both the internal Institutes (i.e., SR-TIGET and TIGEM).
Michela is also Head of Regulatory Affairs at Fondazione Telethon supporting internal Institutes through
the clinical development.
After graduation in Pharmaceutical Chemistry and Technology from the Padua University, she joined GSK in
2001 where she was involved in drug development working in Clinical Operations and CMC Regulatory
Affairs areas. She then granted a Master Degree in Regulatory Affairs and Market Access for NCE and
Biopharmaceutical products from Novara University in 2010. Winner of 2017 edition of TopRA Award in
the Future category, Michela offers up to date knowledge of the most recent regulation in ATMPs and is
frequently invited as speaker at international events on the subject.
She’s currently a member of the IRDIRC Scientific Committee.

Appearances:



15th May Pre-Conference Workshops and Summits Day @ 15:00

Clinical trial focus workshop: What needs to be done to get these experimental treatments to patients in the clinic?

· Centralized and decentralized models· Sourcing starting material: apheresis, tumor, bone marrow· From manufacture to back into local environment· Design of clinical trial

Conference Day 1: Thursday 16th May 2019 @ 12:10

Technology and Strategy Roundtables

25 senior level tables hosted by thought leaders on key challenges and opportunities in next-generation therapeutic development. Participants are invited to join the group discussions on a topic of importance to them.

· At each roundtable, the moderator will talk for 5 minutes to introduce the topic highlighting particular challenges specific to that area· The table will then move on to discussion for 25 minutes.· There will then be one rotation, giving participants the opportunity to have join two round tables in total

(2 x 30-minute rotations and max 15 PAX)

Table 3: Navigating the pathway to clinical success

Conference Day 1: Thursday 16th May 2019 @ 16:25

Panel discussion: Advanced Therapies Treatment Network: facilitating adoption, proof of adoption and how we get there, challenges and adoption

- What are your challenges?
last published: 14/May/19 13:35 GMT

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The World Advanced Therapies and Regenerative Medicine Congress and Exhibition is an international conference and exhibition featuring the latest in advanced therapies, bioengineering and surrounding technology. To attend the conference which features global leaders in the biopharma and regenerative medicine industries, there is a registration fee. The exhibition is free to visit.

Register your pass here.