Ascierto 2020-12-30
Public Declaration of Interests and Confidentiality Undertaking of European Medicines Agency (EMA), Scientific Committee members and experts
Public declaration of interests
I, Paolo Antonio Ascierto Organisation/Company: National National Cancer Institute - G.Pascale FoundationCancer Institute - G.Pascale Foundation Country: Italy do hereby declare on my honour that, to the best of my knowledge, the only direct or indirect interests I have in the pharmaceutical industry are those listed below:
2.1 Employment
No interest declared
2.2 Consultancy
Period Company Products Therapeutic Indication 02/2012-(current) Bristol Myers Squibb ipilimumab, nivolumab advanced melanoma
08/2014-(current) Roche-Genentech vemurafenib, cobimetinib, advanced melanoma and vismodegib advanced basal cell carcinoma
12/2014-(current) Merck Sharp & Dohme pembrolizumab advanced melanoma
03/2012-(current) Novartis dabrafenib, trametinib advanced melanoma
08/2014-11/2016 Amgen T-VEC advanced melanoma
11/2015-(current) Array Biopharma encorafenib, binimetinib advanced melanoma
11/2015-(current) Pierre Fabre encorafenib, binimetinib advanced melanoma
06/2016-(current) Merck Serono avelumab Merkel Cell Carcinoma
06/2017-02/2018 Incyte epacadostat advanced melanoma
09/2016-(current) Astra Zeneca durvalumab NSCLC
10/2017-11/2017 Medimmune durvalumab all solid tumors
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09/2017-09/2017 NewLink Genetics indoximod advanced melanoma
09/2017-09/2017 Genmab Hx-AXL-ADC advanced melanoma
12/2017-01/2018 Syndax entinostat advanced melanoma
05/2018-(current) SunPharma sonidegib Locally advanced and metastatic basal cell carcinoma
05/2018-(current) Sanofy cemiplimab Locally advanced and metastatic squamous cell carcinoma
06/2018-(current) Idera tilsotolimod advanced melanoma
06/2018-(current) Ultimovacs UV1 vaccine advanced melanoma and NSCLC
12/2018-(current) Sandoz ipilimumab biosimilar Melanoma and NSCLC
12/2018-(current) Immunocore IMCgp100 Metastatic uveal melanoma
2.3 Strategic advisory role
Period Company Products Therapeutic Indication 12/2014-(current) Bristol Myers Squibb ipilimumab, nivolumab, melanoma relatlimab, BMS-986205, NKTR214
11/2016-(current) Roche-Genentech vemurafenib, cobimetinib, advanced melanoma atezolizumab
01/2017-(current) Novartis dabrafenib, trametinib, advanced melanoma spartalizumab
03/2013-(current) Array Biopharma encorafenib, binimetinib advanced melanoma
2.4 Financial interests
Company Financial Interest BMS honoraria Roche-Genentech honoraria MSD Honoraria and travel support Novartis Honoraria PrimeVax Stocks Pierre Fabre Honoraria Incyte Honoraria AstraZeneca Honoraria ARRAY Honoraria
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AMGEN Honoraria SANOFI Honoraria Merck Serono Honoraria
2.5 Principal investigator Period Company Products Therapeutic Indication
05/2009-(current) Glaxo Smith Kline NY-ESO1 Vaccination advanced melanoma
05/2011-(current) Roche-Genentech vemurafenib, cobimetinib, advanced melanoma ATEZOLIZUMAB
02/2014-(current) MSD PEG-Intron, pembrolizumab advanced melanoma
02/2016-(current) BMS ipilimumab, nivolumab, advanced melanoma AND relatlimab, BMS-986218, TUMOR SOLID BMS-986253, BMS- 986205, MS-986179
02/2016-(current) Array Biopharma encorafenib, binimetinib advanced melanoma
03/2012-(current) NOVARTIS LAG525, PDR001, INC280, ADVANCED MELANOMA ACZ885, DABRAFENID AND TRAMETINIB
01/2019-(current) INCYTE Epacadostat, INCMGA ADVANCED MELANOMA, 0012-201 ADVANCED MERKEL CELL CARCINOMA
01/2019-(current) Nektar Therapeutics NKTR214 advanced melanoma e tumor solid
01/2019-(current) 4SC AG 4SC-202 advanced melanoma
01/2019-(current) IDERA PHARMACEUTICALS IMO-2125 advanced melanoma
2.6 Investigator
Period Company Products Therapeutic Indication
02/2014-(current) BMS ipilimumab, nivolumab melanoma, TNBC, gastric, pancreatic, SCLC, bladder
01/2013-(current) MSD pembrolizumab melanoma, other solid tumor
08/2011-(current) Roche-Genentech vemurafenib, cobimetinib, Advanced melanoma, vismodegib, atezolizumab advanced BCC, solid tumors
05/2009-02/2015 GSK Mage-A3, Prame, melanoma dabrafenib, trametinib
04/2013-02/2015 Novartis encorafenib, binimetinib, advanced melanoma ribociclib,
07/2013-(current) Medimmune durvalumab melanoma, NSCLC, CRC, TNBC, endometrial
12/2014-(current) Merck Serono avelumab advanced merkel cell carcinoma
03/2015-(current) Novartis ribociclib, dabrafenib, advanced melanoma trametinib, LAG525, PDR001, INC280, ACZ885,
03/2015-(current) Array Biopharma encorafenib, binimetinib advanced melanoma
07/2016-(current) Novartis spartalizumab Melanoma, NSCLC, ATC
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02/2017-(current) Merck serono avelumab solid tumor
09/2016-(current) BMS nivolumab, relatlimab Gastric, Melanoma, NSCLC, HCC, RCC, SCCHN
12/2017-(current) BMS BMS986179 NSCLC, RCC, MELANOMA, HEAD AND NECK
12/2017-(current) REGENERON REGN2810 Advanced Basal Cell Carcinoma
12/2017-(current) BMS DARATUMUMAB TNBC, NSCLC, PAC
12/2017-(current) ROCHE RO6958688 SOLID TUMOR
12/2017-(current) JANSENN LUC1001 COLON, NSCLC, MELANOMA
04/2017-(current) Provectus Biopharmaceuticals PV10 MELANOMA
2.7 Grant / Funding to organisation /institution
Company Subject Matter Bristol Myers Squibb Istituto Nazionale Tumori Fondazione Pascale, Napoli, Italy Roche-Genentech Istituto Nazionale Tumori Fondazione Pascale, Napoli, Italy Array Biopharma Istituto Nazionale Tumori Fondazione Pascale, Napoli, Italy
2.8 Close family member interest
No interest declared
2.9 Repurposing of a medicinal product
No interest declared
2.10 Any other interests or facts I was in the Board of Cancer Development Drug Forum (CDDF) from 2017 to February 2019. I'm President of the Fondazione Melanoma Onlus, Napoli, Italy, since 2010. I'm President of the Campania Society of ImmunoTherapy of Cancer (SCITO), Italy, since 2014. I'm part of the Steering Committee of Society of Melanoma Research (SMR) since 2016 I'm member of Board of Directors for the Society of Immuno Therapy of Cancer (SITC) since 2017.
2.11 CAT member or alternate No interest declared
CONFIDENTIALITY UNDERTAKING
In view of the following definitions: "EMA Activities" encompass any meeting (including meeting preparation and follow-up, associated discussion or any
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DOI Form Version-number: 4 Ascierto 2020-12-30 5 other related activity) of the European Medicines Agency's Management Board, Committees, Working Parties, Expert Groups, or any other such meeting; work as an expert on assessments; work as an expert on guidance development. "Confidential Information" means all information, facts, data and any other matters of which I acquire knowledge, either directly or indirectly, as a result of my EMA Activities. "Confidential Documents" mean all drafts, preparatory information, documents and any other material, together with any information contained therein, to which I have access, either directly or indirectly, as a result of my participation in EMA Activities. Furthermore, any records or notes made by me relating to Confidential Information or Confidential Documents shall be treated as Confidential Documents. I understand that I may be invited to participate either directly or indirectly in certain EMA activities and hereby undertake:
• To treat all Confidential Information and Confidential Documents under conditions of strict confidentiality as long as the information or document has not been made public/is not in the public domain.
• Not to disclose (or authorise any other person to disclose) in any way to any third party any Confidential Information or Confidential Document.
• Not to use (or authorise any other person to use) any Confidential Information or Confidential Document other than for the purposes of my work in connection with EMA activities.
• To dispose of Confidential Documents as confidential material as soon as I have no further use for them.
• When expressing views to clearly indicate that the views are my own if acting in my own capacity or those of the EMA, Committee, Working Party, Expert Group or other group if acting on behalf that group.
• Not to disclose any commercially confidential information. This undertaking shall not be limited in time, but shall not apply to any document or information that I can reasonably prove was known to me before the date of this undertaking or which becomes public knowledge other than as a result of a breach of any of the above undertakings. I confirm the information declared on this form is accurate to the best of my knowledge and I acknowledge that my information will be stored electronically and published on the EMA website.
Full Name: Paolo Antonio Ascierto Date: 2020-12-30
For Definitions of activities etc, refer to Policy on Handling of competing interests / Electronic DOI template
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DOI Form Version-number: 4