In my role at AstraZeneca, I oversee the clinical development of the Early Oncology portfolio.

I lead a global cross-functional team of more than 160 people, comprised of physicians, scientists, and clinical operations experts dedicated to advancing in the clinical stage our extensive pipeline of immuno-oncology, tumor drivers and resistance, DNA damage response and antibody drug conjugates compounds.

The key to our approach is our focus on innovative clinical trial designs, from first time in human to Phase 2, grounded on the most cutting-edge science. We are aiming at reinventing conventional early clinical development, by employing adaptive designs, using biomarker-rich multidrug platforms, targeting early disease or integrating innovative translational approaches.

Everyday, I’m inspired by our colleagues and research partners who are passionate about pushing the boundaries of science. Together, we are driven by improving the efficiency and speed at which we develop and deliver the next generation of oncology therapies, in order to shift the paradigm in the lives of people affected by cancer.

I’ve led development programmes exploring compounds in numerous solid tumours, including breast cancer and thoracic cancer. Prior to joining AstraZeneca, my most recent roles included positions at Bristol Myers Squibb and Novartis where I led multifunctional teams for immuno-oncology, antibodies and small-molecule inhibitor programmes.

Board-certified in medical oncology, I earned my medical degree at Lille II University in Lille, France and have authored more than 40 cancer studies.

I have earned multiple awards during my career, including several Vision Awards, and President Awards at Novartis.
 

As a medical oncologist with 20 years of experience in cancer research, I am passionate about serving patients as they navigate their treatment journey. Optimizing clinical development to offer better and faster treatment solutions to cancer patients is what drives me

Caroline Germa Vice President, Head Clinical Development, Early Portfolio, Oncology R&D

CURRENT ROLE

Vice-President, Head Clinical Development, Early Portfolio, Oncology R&D

2018-2019

Vice President, Development team lead, NKTR-214, Bristol-Myers Squibb (in collaboration with Nektar Therapeutics)

2014-2018

Vice president, Senior Global Clinical Program Head lead role for ribociclib (selective cyclin-dependent kinase inhibitor) clinical development programme and successful submissions; then for canakinumab (IL1 beta inhibitor) clinical development programme at Novartis

2011-2014

Senior Global Clinical Leader responsible for the multiple phase 1 to 3 of the PI3K inhibitor BKM120 then BYL719 (alpelisib) at Novartis

 Featured publications

Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer.

Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J. Ann Oncol. 2019 Aug 13;29(7):1541-1547

Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial.

Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz SA, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, Liu MC, Carlson G, Hughes G, Diaz-Padilla I, Germa C, Hirawat S, Lu YS. Lancet Oncol. 2018 Jul 24;19(7):904-915

Discovery and development of novel therapies in advanced breast cancer: rapid development of ribociclib.

Germa, C & Miller, M & Mukhopadhyay, P & Hewes, B & Caponigro, G & J Scherer, S & Hirawat, S. Ann Oncol. 2017 Aug 1;28(8):2021-2024

 

Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer.

Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, André F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016 Nov 3;375(18):1738-1748

PI3K inhibitors as new cancer therapeutics: implications for clinical trial design.

Massacesi C, di Tomaso E, Urban P, Germa C, Quadt C, Trandafir L, Aimone P, Fretault N, Dharan B, Tavorath R, Hirawat S. Onco Targets Ther. 2016 Jan 7;9:203-10

Overcoming Phosphatidylinositol 3-Kinase (PI3K) Activation in Breast Cancer: Emerging PI3K Inhibitors.

Massacesi, M, di Tomaso E, Urban P, Germa C, Fretault N, Bharani-Dharan B, Tavorath R, Quadt C, Coughlin C, and Hirawat S. J Oncopathol. 2015 Apr;3(1): 27–39