Meet EPL and Aclairo at the 38th Annual ACT in Booth #200 
Members of EPL, Inc. and Aclairo Pharmaceutical Development Group, Inc. will attend the 2017 38th Annual meeting of the American College of Toxicology held at the Palm Springs Convention Center – 277 N. Avenida Caballeros –Palm Springs, CA 92262.  Register for ACT

Join EPL at Our Hosted Program: “All About Peer Review and Pathology Working Groups”
When and Where: 12:00PM – 12:55PM, Wednesday, November 8, 2017; Mesquite G Room, Palm Springs Convention Center. A light lunch will be provided.

For those attending the 2017 ACT Annual Meeting, please join EPL for our Exhibitor-Hosted Program: “All About Peer Review and Pathology Working Groups.” Toxicologists and Study Directors will have an in-depth presentation on why a peer review may help the integrity of the entire study, approaches in designing a peer review evaluation, how consensus works, and when disagreements on interpretation happen, how to resolve these differences with a Pathology Working Group (PWG).

Aclairo Welcomes Ric Stanulis, PhD, DABT and Kenjie Amemiya, PhD, DABT
Aclairo Pharmaceutical Development Group, Inc. is very excited to welcome Ric Stanulis and Kenjie Amemiya as the newest members of our Consulting Team.
 
Ric Stanulis, PhD, DABT
Dr. Stanulis is a board certified toxicologist with approximately 20 years of experience in pharmaceutical drug development.  He has been the head of nonclinical safety assessment for three biotechnology companies (most recently Acorda Therapeutics), a project team toxicologist for a mid-size pharmaceutical company, and a CRO study director. Ric has lead multiple development programs across a spectrum from discovery/pre-IND through NDA/post-approval, for both small and large molecules.  He has been responsible for the design, oversight, and interpretation of studies for nonclinical development programs; addressing issues that arise in the development process; and writing nonclinical sections of regulatory documents, including regulatory agency correspondence.
 
Ric also has extensive experience with in-licensing evaluation of potential pipeline opportunities, as well as supporting the out-licensing of internal programs.  One of Ric’s strengths is understanding the unique perspective and needs of small biotech companies as they maneuver through the drug development process.

Kenjie Amemiya, PhD, DABT
Dr. Amemiya brings over 25 years of experience in the pharmaceutical industry as a drug development toxicologist in therapeutic areas including oncology, neurology, anti-psychotics, anti-infectives, cardiovascular, respiratory and inflammation. His experience includes research phase and development project team leadership, extensive experience in GLP compliance, and a specialized focus on reproductive toxicology and its application to patient safety. He has had the opportunity to be part of four market applications – two in oncology, an anti-infective and an orphan drug. Two of the more recent exciting experiences for Kenjie have been serving as a Clinical Drug Safety Scientist and as a member of the Roche Patient Drug Safety Committee, applying translational skills towards development of healthy volunteer/patient safety management. He also recently led a SEND cross-functional Genentech team to successful implementation of a validated submission management tool and business process.
 
Kenjie believes that the most challenging and exciting opportunities in drug development center around ever-increasing expectations to understanding drivers of toxicity, and evermore, the translation of non-clinical safety findings to healthy volunteer and patient safety management strategies. “Our focus should be on patient safety using all the tools we have in our safety arsenal – extensive application of target biology, in silico and screening tools and finally focused and decision-making animal studies. Having had the opportunity to live in the clinical safety arena after so many years in non-clinical has made me realize that more than ever, conversations between non-clinical and clinical safety scientists and sharing those learnings with health authorities will be the key to developing safer drugs.”

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