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Proof of concept trials

PROOF OF CONCEPT TRIALS

proof of concept trials

ARENSIA delivers high degree of scientific and logistical expertise for Phase I/Ib/IIa and PROOF OF CONCEPT patient studies.

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PHASE I SPECIAL POPULATIONS

phase i special populations

ARENSIA offers exceptional fast recruitment rates for renal and hepatic impaired patients.

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REGULATORY PROCESS

regulatory process

ARENSIA has the know-how to successfully manage the regulatory process in various Eastern European countries.

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2016 In Review: Message from CEO and Co-Founder Claudia Hesselmann

HOME · NEWS · 2016 IN REVIEW: MESSAGE FROM CEO AND CO-FOUNDER CLAUDIA HESSELMANN

At ARENSIA, we are looking back on a very good business year, in which we were able to outdo ourselves with regard to outstanding patient enrolment rates in complex Phase 1, 2a, POC studies at our Phase 1 units in Eastern Europe. Studies involved sophisticated logistics, biomarker assessments (e.g. biopsy collection and imaging), intensive PK, hospitalization, in various indications and in populations.

We continue observing high interest from Sponsors in "integrated" protocol designs: First-in-Man in healthy volunteers performed at Phase 1 CROs in Western Europe or US + First-in-Patients performed at ARENSIA´s Phase 1 units in Eastern Europe. This approach has proven to be fast in terms of execution, as well as highly cost efficient.

Immunology, Oncology and Infectious Diseases remained the most striving areas in 2016:  ARENSIA units delivered record high recruitment rates in RA, OA, Psoriasis, UC, various cancers,  HCV, HBV patients, etc.

ARENSIA initiated a series of self-sponsored workshops dedicated to "Innovative Strategies to achieve first efficacy data / Proof of Concept in record time". Senior executives from pharma and biotech companies are invited to attend in highly interactive format moderated by industry experts. Next two workshops are scheduled for May 24th 2017 in San Francisco and Nov 9th 2017 in Boston. These events shall focus on case studies from Immunology, Oncology and Infectious Diseases. Please kindly get in touch with us if interested.

We take pleasure to update you below on how, in 2016, ARENSIA kept its promise of fast recruitment, quality and innovation, while increasing our capabilities to improve for our Sponsors.

Operational Highlights

  • Expansion of our client portfolio, with now 13 out of top 20 leading pharma companies worldwide being our Sponsors. In addition, we gained as clients 5 additional biotechs.
  • Increased collaboration with partner CROs to now 5 global players and 5 mid-size, which sub-contract to ARENSIA the portion of the early phase studies requiring patients. Thus, Sponsors who are bound by global outsourcing agreements can use ARENSIA´s niche expertise and unrivalled speed.
  • Increase by 25% of the number of on-going projects across all ARENSIA Phase 1 units.
  • Expansion of our operations to the US through the start-up of clinical operations in Monroe, Louisiana. We are collaborating with a private clinic dedicated to early patient studies. First project, Phase 2a in NASH patients, starts enrolment in early 2017.
  • Expansion of ARENSIA’s Phase I unit at the "Republican Clinical Hospital" in Chisinau, Moldova to 20 intensive monitoring beds, at state-of-the-art standards.
  • 23 Sponsor audits and 1 HA inspection (Romania) successfully passed.

Organisational and Administrative Highlights

  • Expansion of Headquarters and relocate into a new location inside the prestigious Düsseldorf Life Sciences Center.
  • Expansion of our representation in the US by opening a subsidiary in Boston, MA to enable a closer interaction with our North American clients.
  • Expansion of our central team by two new positions at ARENSIA HQ: full-time Compliance Officer and Director Clinical Operations, both were staffed with exceptionally experienced and capable ARENSIA staff.
  • Expansion of our Project Management and Admin center for Romania and relocate into downtown Bucharest, enabling shorter commutes to the Phase 1 units in the city.
  • Expansion of our teams in all locations to support the business growth, and also to fulfil increased administrative requirements from Sponsors and regulatory/legislative bodies.

We stay at your disposal for any questions and feasibilities and look forward to strengthen our collaboration in 2017.

We are grateful for all your support and fruitful interaction.

With kind regards,
Dr. Claudia Hesselmann
CEO and Co-Founder

04.01.2017