Archives: Speakers

Dr Antonini received her M.D. from the University of Rome “La Sapienza” Magna Cum Laude, with Top Honors in all examinations. She has a PhD in Clinical Pharmacology. In more than 30 years of experience in Pharma Industry Dr Antonini has played a key role in many successful programs of drug development, capitalizing on her scientific leadership and on-the-job experience in the designing, implementation and interpretation of clinical trials. Among Dr Antonini’ accomplishments are a substantial contribution to the clinical development of a number of products in the cardiovascular (including but not limited to biomarkers and medical devices), internal medicine, metabolism, respiratory, oncology, immunology and neuroscience area. Dr Antonini has established valuable relationships and collaborations with many key scientific leaders in a number of therapeutic areas and this allowed her to build an innovative, strong partnership with Italian and International Academia in the field of Clinical Research.  As a peer interlocutor of Academy members Dr Antonini has been invited to be Lecturer in various Universities, has authored several peer-reviewed articles and has been invited as speaker in International events in the areas of Pharmaceutical Medicine, Methodology of clinical trials and Pharmacology.

Philibert is currently Head of the Vaccines patient Office for GSK Vaccines in Belgium. He is coordinating  patient insights gathering for clinical and medical projects, and internal awareness on the impact of diseases and vaccination.  He has been working in the Pharma industry for the past  15 years in the US, Canada, France and Belgium, in a variety of roles, such as Auditing, Key Account Management, Ethics and Compliance, and now Patient Office.

Michael is responsible for a team of 11 people and the overall delivery of the conducted studies. The group runs several studies in different indications with a clear focus on rare diseases. In 2016 AOP Orphan received approval for one new product (RAPIBLOC®). In 2019 AOP received the marketing authorization for their first biological (BESREMi®), after completing a series of clinical studies and successfully passing a series of EMA inspections under Michael’s responsibility.

Before joining AOP Orphan Michael has been operations manager for Haemophilia at Baxter.
Michael has many years of experience as a project manager and learned the job in clinical research from scratch starting as CRA at Amgen.
Michael received his Ph. D in biochemistry from the University of Vienna.

Experienced Innovation & Learning Specialist with a long history of working in the pharmaceuticals industry (20+ years) representing both pharma and CRO. Consistently rated as high performer, skilled in digital product development, learning & development and drug development.

Hasse is currently holding the position of Director of External Clinical Project Management at LEO
Pharma, a Danish mid-size pharma company focusing on dermatology. He has almost 20 years of
experience in the pharmaceutical industry and has for the past 12 years worked in different position
focusing on externalization and outsourcing in both research and development.
In his current position, Hasse is working to establish an alternative operating model for outsourcing
clinical trials at LEO Pharma and is furthermore responsible for the Clinical Trial Supply and
Partnership Management groups within Global Clinical Operations.

Susan Carino, MBA, MS, PMP, RAC is a Principal Consultant with Integrated Project Management Company, Inc., (IPM) headquartered in Chicago, IL with offices in Boston, Los Angeles, Minneapolis, New Jersey, Saint Louis, and San Francisco. She has 25 years of industry experience in R&D across multiple therapeutic areas and specializes in project/program/portfolio management and regulatory submissions. She is a founding member of IPM’s Center of Excellence for Quality and Regulatory Affairs. Her career includes roles leading diverse cross-functional program teams engaged in complex product development, clinical trial conduct, regulatory submissions, product launches, and post-approval regulatory commitments to ensure quality and regulatory compliance. Projects she has led include the development and launch of new pharmaceuticals, biologics, medical devices, and in vitro diagnostic tests. Susan is a certified Project Management Professional (PMP) with the Project Management Institute (PMI) and is also certified in Regulatory Affairs (RAC) currently serving as the San Francisco Bay Area Chair for the Regulatory Affairs Professionals Society (RAPS). Susan is a UC Berkeley Extension Advisory Board Member for the Clinical Research Conduct and Management Certificate Program. She is also a course developer and instructor. Susan holds a Bachelor of Arts (BA) in Chemistry from Oberlin College, a Master of Science (MS) from the University of Wisconsin at Madison,

Starting in the Clinical Research area 30 years ago as a study coordinator I have worked my way to being senior director of clinical operations of AM-Pharma through roles in clinical Pharmacology, different CNS areas in midsize Pharma. CNS, Leukemia and now Acute Kidney Injury in Biotech companies. The Biotech has really stolen my heart and sole because of the creativity you have to use in these small companies and the close cooperation with every department. Regulatory Inspections are not a threat but I actually have to say I like them. Partially because I like to be challenged but also because I believe you can constantly work towards a good outcome. There are always findings but they are also a recipe for improvement.

Tanja holds a PhD in Neurosciences from the University of Montreal. She then moved to Paris to persue her research on metalloproteases as drug targets in academia before joining Pharmaleads in 2006 as Head of Biochemistry, characterizing metalloprotease and inhibitor activity in vitro and in vivo, through the design of specific assays. Her work was essential in selecting Pharmaleads’ drug candidates, Dual development in the treatment of severe pain.

In 2014, Tanja was appointed Head of Clinical Operations overseeing all operational aspects of the DENKIs clinical trials and was names Director of Clinical Development in 2017.

Pharma & biotech professional with 16 years’ experience in clinical trial set-up, monitoring, management and in program leadership. My work experience to date includes a number of indications including oncology, paediatric rare diseases, cardiovascular disease, CNS and rheumatology across all phases in small, medium and large biotechnology and pharmaceutical companies. I am experienced in vendor, budget and matrix project team management and possess a sound understanding of the drug development process gained both professionally and academically.