Elena Chiariello

For Onco-haematology and Oncology products (main: Kyprolis (RRMM), Blincyto (ALL), Nplate (ITP), Bekemv (PNH), Vectibix (mCRC) and Hematology and Oncology Pipeline, including Bemarituzumab (GC) and Sotorasib (NSCLC and GC)

Med Com activities:

• Non-promotional material: approval/ local adaptation /creation of product / disease medical-scientific tools. Active participation to GMCLT (Global Medical Core Lead Team ) meetings for discussion on new educational materials release.
• Local Products Medical Communication Plans definition
• Promotional material: partners with commercial in planning, contents input and reviews
• Disease and Product training for Sale Representative and MSLs
• Internal Scientific update on main publications for Sales Reps
• Medical Booth setup at National Congresses (e.g. SIE, AIOM) and collaboration with EU Med Com colleague for preparation of AMGEN symposium and Booth at the International EMN Congress in Italy.
• Single point of contact for some cross product initiatives: Global educational website (Medical Meeting Point), BiTE Communication Campaign and internal reference for specific projects, e.g. Editorial Projects, taking part to CAT meetings (Contract Advice Team), or Compassionate Use Management Internal Process.
• Process and system trainings for Medical Colleagues: Compassionate Use Process, Veeva VOLT, etc

Med Info activities:

• Responding to complex Medical information requests by literature searches and interacting with the external Vendor (from May 2022, while before with an Internal Graduate)
• Directly processing the Expanded Access Compassionate Use requests in the Med Info system (BioConnect)
• From June 2023, monitoring the Vendor cross-product Activities and participating to regular meetings
• Provides country metrics and interpretation

For Oncology Products: 2009 -2010, Vectibix (mCRC) and Onco Pipeline; 2011, XGEVA (Bone Mets-SRE) ; 2013 -2015, Oncology Pipeline Products: Blinatumomab (ALL and NHL), T-VEC (Melanoma), Rilotumumab –AMG 103 and AMG 337 (Gastric Cancer), Trebananib-AMG 386 (Ovarian Cancer) and from September 2014 also for Neulasta (NF prevention) and Nplate (ITP).

Main activities:

• Scientific advisor for Investigator Sponsored Trials (protocol discussion, budget discussion, internal approvals, etc)
• Advisory Board organization and management
• Medical Marketing activities in collaboration with Product Manager (promotional material, support in symposia and lecture and other scientific events, etc)
• Networking with KOLs/OLs
• Medical Scientific Liaison training, product up-dating, supporting and educational material preparation
• Sale Representative training and supporting
• Scientific Support to Access and HE Department
• Medical Product Budget management
• Supervision of feasibility of Amgen Sponsored Trials and study documents
• Preparation of the Value Dossier for price discussion with Health Authority (up-dated label)
• Italian Medical Plan of Action preparation

For Onco-hematology products: Glivec (CML, Chronic Myeloid Leukemia) and Tasigna (CML)

Main activities:

• Scientific advisor for Investigator Initiated Trials and Phase IV Novartis sponsored studies (protocol preparation, budget discussion, internal approvals and up-date, Investigator Meeting, etc)
• Compassionate Use approval responsible
• Medical Marketing activities in collaboration with Brand Manager: in particular preparation of Tasigna product launch (promotional material, internal training, internal and external launch events, etc)
• Relationships with KOLs (onco-haematologists)
• Collaboration in scientific symposia preparation and other external events
• Medial Scientific Liaison training and supporting
• Sale Representative training and supporting

For Products: Zevalin (non Hodgkin Follicular Lymphoma); Mab Campath (B-CLL); Fludara (B-CLL)

• Local Study Coordinator of international clinical trials and Investigator’s Sponsored Studies in oncology (chemotherapy, hormone therapy and target therapy in breast cancer, colon-rectum cancer, glioblastoma indications) and Study Manager of an Observational Local Study on Quality of Life in B-CLL patients.
• Main Activities: Centre selection and initiation, authorization’s requests preparation, investigational drug management, CRAs coordination, Investigator’s Meetings organization, collaboration in protocol and CRF finalization (for local studies)
• Clinical Monitor for an international, phase III clinical trial in oncology (anti-angiogenesis target therapy in colon-rectum cancer). ( 2003-2004)

• Monitoring and management of multinational, phase III, clinical trials with lipid lowering drugs
• Local clinical trials’ management
• Drug Safety activity (July 2001-January 2003)

• Organization and monitoring clinical trials in antibiotic therapy field (macrolides, fluoroquinolones, penicillins)
• Training course for sale representatives
• Management of a project on a genetic therapy of tumours (R&D projects)

• Research on molecular analysis of human malignant gliomas and positional cloning of new tumour suppressor genes on 10q

• Research on identification of lung tumour susceptibility and resistance genetic loci in mouse model.