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Conducting Early Phase Oncology Studies - Successfully Moving Through to Proof of Concept


Date: Monday, November 6, 2017

Time: 10am EST / 3pm GMT (UK) / 4pm CET (EU-Central)

Duration: 60 minutes

Featured Speakers:

This one-hour webinar will focus on considerations for small, young biotech when selecting a Clinical Research Organisation (CRO) to take their molecule through to proof of concept:

  • Trial design: the choice of target tumour and challenges to recruitment such as competing studies, rarity of the tumours, practical considerations regarding ‘all comer’ studies, dose escalation (3+3 vs other designs)/ expansion, & biomarkers
  • Protocol development: creation of clear unambiguous protocols, ‘sense-checking’ with subject matter experts / KOL's (and patients)
  • Site feasibility and selection: feasibility, considerations for specific countries, building on relationships with specific centres and existing key investigative sites
  • Budgeting and trial set-up: open and transparent budgets, finding efficiencies, developing synergies in a joint approach to deliver on key milestones and objectives
  • Conduct of the trial: including safety reviews/DSMB
  • Project and data management: how to ease fast review of data, and patient profiles

Keywords: Oncology, Proof of Concept, Early Phase Trials


Shankar Balaratnam, Associate Medical Director, Simbec-Orion Group

Shankar Balaratnam has been the Medical Director of Orion Clinical Services since October 2016. He has over 9 years of clinical experience in pharmaceutical medicine, covering clinical development, medical affairs and pharmacovigilance and has obtained his Certificate of Specialist Training in Pharmaceutical Medicine from the Faculty of Medicine, Royal College of Physicians, London.

His previous experience includes acting as the Medical Assessor, Pharmacovigilance and Risk Management Group for MHRA. he has also held medical advisory positions in oncology for Celgene UK, GSK and Roche UK.

He has a keen interest in oncology and rare and orphan indications and has acted as Medical Monitor for numerous research-related projects, including clinical trials and compassionate use programs. He is responsible for input into development strategies, medical monitoring, and oversees pharmacovigilance and safety for challenging studies and therapeutic areas.

Fabrice Chartier, PhD, Chief Operating Officer, Simbec-Orion Group

Fabrice was appointed COO of Simbec-Orion upon completion of the merger of Simbec Research and Orion Clinical Services in June 2014.

In 1998, Fabrice and Dr Alan Irvine, founded Orion Clinical Services Ltd, an international CRO operating internationally and specialised in Rare and Orphan diseases, oncology and other indications with high medical need. In 1994, Fabrice founded for Fournier Laboratories, a medium-size French pharmaceutical company, their UK International Clinical Development Unit, specialised in Gene Therapy and Immunotherapy. Previously, he was one of the directors of an international CRO based in Paris.


C-level and senior professionals from Biotechnology companies involved in Oncology research and drug development


Orion Clinical is the full-service clinical development division of Simbec-Orion Group.

Founded 20 years ago as a full service CRO we have expanded, through consistent delivery of studies in complex areas. Our operations are based in the United Kingdom, France, USA, Germany and Italy. We have operational staff across mainland Europe (Western, Eastern & Central) and throughout North America.

With over 20 years of experience in the delivery and conduct of oncology clinical trials, including rare & orphan and paediatric studies, we use our skills elegantly to design, execute and deliver our clients' clinical development needs.

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