Alan Roberts Email & Phone Number | Currently retired and consulting. Experience: 30 plus years in the toxicology/safety assessment of oncology agents including: cytotoxics, targeted agents, biologics, and drug combinations. Experience with regulatory submissions in the United States, Europe and Japan; familiarity with international regulations and guidelines (FDA, EMEA, MHLW/JPMA, ICH). Selected Accomplishments: Responsibility for toxicology strategies and nonclinical dossiers of numerous regulatory filings: INDs’ (approx. 25) and NDAs/CTDs with several global regulatory approvals. Examples: - Eloxatin (oxaliplatin); in combination with infusional 5-fluorourocil/leucovorin for colon cancer; approved in the US, EU and Japan. - Elitek - (rasburicase) - recombinant urate oxidase enzyme for the management of plasma uric acid levels resulting from tumor lysis syndrome; approved in the US, EU and Japan. - Iniparib - PARP1 inhibitor developed for the treatment triple negative breast cancer. - Fedratinib - JAK2 inhibitor developed for the treatment of myeloproliferative neoplasms - Pemazyre (pemigatinib) - FGFR1/2/3 inhibitor for cholangiocarcinoma approved in the US and EU - Opzelura cream (ruxolitinib) - JAK1/JAK2 inhibitor for atopic dermatitis approved in the US Experience and familiarity with investigational and molecular toxicology approaches

Alan Roberts

Currently retired and consulting. Experience: 30 plus years in the toxicology/safety assessment of o...
Wilmington, Delaware, United States

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Alan Roberts’s Location Wilmington, Delaware, United States

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Alan Roberts’s Prior Industry Incyte | Sanofi Aventis

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VP Toxicology

2014-05-01 00:00:00 - 2022-04-01 00:00:00

Senior Director

2010-01-01 00:00:00 - 2014-05-01 00:00:00

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Alan Roberts is a Currently retired and consulting. Experience: 30 plus years in the toxicology/safety assessment of oncology agents including: cytotoxics, targeted agents, biologics, and drug combinations. Experience with regulatory submissions in the United States, Europe and Japan; familiarity with international regulations and guidelines (FDA, EMEA, MHLW/JPMA, ICH). Selected Accomplishments: Responsibility for toxicology strategies and nonclinical dossiers of numerous regulatory filings: INDs’ (approx. 25) and NDAs/CTDs with several global regulatory approvals. Examples: - Eloxatin (oxaliplatin); in combination with infusional 5-fluorourocil/leucovorin for colon cancer; approved in the US, EU and Japan. - Elitek - (rasburicase) - recombinant urate oxidase enzyme for the management of plasma uric acid levels resulting from tumor lysis syndrome; approved in the US, EU and Japan. - Iniparib - PARP1 inhibitor developed for the treatment triple negative breast cancer. - Fedratinib - JAK2 inhibitor developed for the treatment of myeloproliferative neoplasms - Pemazyre (pemigatinib) - FGFR1/2/3 inhibitor for cholangiocarcinoma approved in the US and EU - Opzelura cream (ruxolitinib) - JAK1/JAK2 inhibitor for atopic dermatitis approved in the US Experience and familiarity with investigational and molecular toxicology approaches