SOURCE: Ora Clinical

Ora Clinical

March 15, 2011 08:30 ET

Ora Introduces Larry Amdahl as New Director of Clinical Operations for Dry Eye

ANDOVER, MA--(Marketwire - March 15, 2011) - Ora, Inc. announced today that Larry Amdahl joined its team as the Director of Clinical Operations for Dry Eye. In his new role, Larry will be responsible for overseeing both the tactical execution of clinical programs and the planning and process evolution of Ora's Dry Eye Operations group.

Ora's Dry Eye department, led by George Ousler, Vice President, is currently working with several of the world's leading dry eye pioneers to develop the next generation of dry eye treatments. Over the past 13 years, Ora has evaluated over ten thousand patients across 150 dry eye trials, looking at 25 investigational drugs including hormonal therapies, secretagogues, mucomimetics, anti-evaporatives, anti-inflammatories and nutritional supplements.

Dry Eye Syndrome is a difficult disease to study due to environmental confounds, as well as the disease's multiple underlying etiologies and sub-groups. Ora has developed its Dry Eye System as a multi-point approach to address these dry eye drug development challenges. Ora's Controlled Adverse Environment (CAE) (SM) and Hybrid Environmental models have become widely recognized as the standard for conducting ophthalmic pharmaceutical studies for dry eye treatments.

Ora's Dry Eye department consists of a dedicated team of 25 professionals, including both ophthalmologists and research PhDs with significant experience in studying Dry Eye Syndrome. Ora's track record of clinical trial success is based upon vetted endpoints and scales, the ability to tailor a clinical program to the unique mechanism of action to the drug being studied, and a dedicated statistical team to provide complete biometrics support. Ora maintains a vast dry eye subject database, characterized by deficiency and severity, across dedicated dry eye research centers in North America, Europe, and Japan.

"We are pleased to welcome Larry Amdahl to the Ora team as the Director of Clinical Operations for Dry Eye," said Stuart B. Abelson, President and Chief Executive Officer of Ora, Inc. "Larry has deep knowledge of the pharmaceutical business, worldwide drug development and the regulatory process. As a senior Clinical Research management professional with a proven track record of successfully leading teams in conducting Phase I-IV clinical trials in the pharmaceutical and biotechnology industries, Larry will be a terrific addition to our team. With multiple dry eye programs advancing into Phase III this year, we are entering an exciting time with significant increases in both activity and operational complexity and I am confident that Larry's focused leadership of this critical growth area will ensure we continue to meet client expectations."

Prior to joining Ora, Larry was most recently Director of Clinical Affairs for Dow Pharmaceutical Sciences. During his career, Larry has developed the understanding and expertise to integrate product target objectives, implement regulatory strategy, oversee clinical advisor input and study logistics into effective clinical programs and protocols, and deliver timely, relevant and reliable trial data to advance the development of investigational products. In addition to his work at Dow, Larry has also held Director roles at Dynavax Technologies Corporation and in the Ophthalmic Division of Santen Incorporated, after beginning his career at in the Ophthalmic Division of Allergan.

About Ora
Ora, Inc. ( is the world's leading independent ophthalmic product development firm, with 32 product approvals during its 30-year history. Ora helps clients garner FDA approvals by providing strategic clinical-regulatory guidance and complete turnkey clinical-regulatory services. Ora's technology-based, concept-to-market services and solutions accelerate development timelines and improve the scientific quality of clinical research along every step of the development pathway.

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