Experimental Pathology Laboratories, Inc. (EPL), Aclairo Pharmaceutical Development Group, Inc. (Alcairo), and Dr. Ada H.C. Kung with Expedient Solutions International (ESI) announce a new strategic alliance to enhance Preclinical Pathology and Regulatory Consulting Services to the Greater China pharmaceutical and biotechnology industry. This alliance is targeted to expand and enhance EPL, Aclairo, and ESI’s capabilities and offerings in the rapidly expanding Greater China pharmaceutical and biotechnology sector.
The initial focus of this strategic alliance will be to provide pathology peer reviews, pathology training, and review of Investigational New Drug (IND) applications being submitted to the US FDA.
First Annual Meeting on Regulatory Affairs and Drug Development: Current Thinking and Challenges
The three alliance groups, in association with the Shanghai Institute of Materia Medica, will be presenting an upcoming Workshop in China and Taiwan – the First Annual Meeting on Regulatory Affairs and Drug Development: Current Thinking and Challenges. The Workshop will be presented in two locations and will take place on April 21, 2017 in Shanghai, China, and on April 24, 2017 in Taipei, Taiwan.
Drs. Tacey White (Aclairo), Peter Mann (EPL) and Ada Kung (ESI) will make presentations at the Workshop. The presentations will include a range of topics including: An overview of the US FDA, preclinical regulatory expectations in the US, the role of pathology in preclinical and clinical development, peer review of histopathology evaluations, translational medicine, and the China FDA’s perspectives on preclinical drug development.
EPL, Aclairo, and ESI are very excited to announce this strategic alliance and they believe that this partnership will bolster Preclinical Pathology and Regulatory Consulting Services in Asia.
Founded in 1971, EPL is a private, employee-owned US company that is recognized internationally for its ability to meet the needs of the scientific community and the challenges of preclinical safety testing with high quality, on-time histopathology services. Valued for its objectivity and responsiveness, EPL has become industry’s and government’s premier source for expert toxicologic pathology evaluation and consultation.
EPL services are by design more highly focused than the typical complex, full-service Contract Research Organizations (CROs). Consequently, we are able to offer a unique combination of responsive, personal attention and wide breadth of expertise. Our resources include over 100 highly trained and experienced anatomic veterinary pathologists, histotechnologists, technical personnel and dedicated quality assurance staff. These experts are supported by outstanding information technology systems and state-of-the-art laboratories.
Regardless of the location, scope or time-sensitive needs of a study, EPL offers the benefits of a classic “scale without mass” approach – delivering the highest level of scientific quality in the most cost-effective manner.
Aclairo, a wholly owned subsidiary of EPL, is committed to delivering independent and objective nonclinical and regulatory advice to the pharmaceutical industry. Aclairo’s full time staff offers decades of experience as industry scientists and strategists; US FDA supervisors and reviewers; and operations specialists to integrate and solve the complexities in pharmaceutical, device, and gene therapy development. Aclairo implements a deep experience-based approach to provide strategic, scientific regulatory services, and operations support.
Aclairo consultants are experts in US FDA regulations and guidelines and provide insight into current regulatory interpretation at the US FDA. Aclairo consultants are well-versed in a broad range of pharmaceutical development areas resulting in an ability to customize services to suit each client’s individual needs. Aclairo specializes in product development programs and strategies, data interpretation, gap analysis, and design and implementation of nonclinical and early phase clinical studies. In addition, Aclairo consultants are experienced in supporting the gamut of regulatory document preparations including final study reports, investigator brochures, expert reports and US FDA response documents.
Aclairo’s experience as US FDA supervisors, reviewers, and industry strategists has forged a unique comprehension of the product-specific complexities of pharmaceutical development. The Aclairo advantage is the experience-based approach to providing strategic, scientific and regulatory services. This has proven to be the greatest asset in focusing and streamlining clients’ development efforts, reducing both time and costs.
ESI was formed by Dr. Ada H.C. Kung in 2008. Dr. Kung is a career Pharmacologist (animal efficacy modeling and DMPK) and Toxicologist, and is certified by the American Board of Toxicology. In addition, she has in-depth experience in drug development with small molecules, vaccines, peptides and protein therapeutics. Dr. Kung has extensive expertise in regulatory and quality systems and serves as a liaison between pharmaceutical and biotechnology companies with the US FDA. She has specialized in Investigational New Drug (IND) and New Drug Application (NDA) submissions to US FDA as well as China SFDA. Dr. Kung was responsible in successfully submitting two of the first IND’s to US FDA using data generated from China labs. Dr. Kung has a rare combination of China and US drug development expertise.
From 2010 till 2012, Dr. Kung served as senior vice president for Taigen, a pharmaceutical company in Taiwan. During her tenure with Taigen, Dr. Kung was responsible for preclinical drug development activities with company products including anti-infective, chemo-sensitizer, and anti-viral products. Dr. Kung was involved in the regulatory submissions to US FDA and China SFDA.
Dr. Kung was also the co-founder of Bridge Pharmaceuticals (now Pharmaron). She assumed the role of General Manager of the Beijing lab in early 2006. As the GM for the laboratory, she was instrumental in establishing from ground-up one of the first bilingual (English and Chinese) Western standard GLP (Good Laboratory Practices) compliant and AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) accredited state-of-the-art preclinical testing facilities in Beijing, China. During her tenure with Bridge Laboratories (2004- 2008) she also served in the US as Chief Technical Officer (CTO) and Senior Vice President of Operations and Product Development of Bridge Laboratories, Gaithersburg, Maryland, USA. In this role she served as a consultant for clients with their regulatory, drug development and DMPK/toxicology programs.
Prior to the position at Bridge Laboratories, Dr. Kung held a variety of top management positions in the pharmaceutical industry, most recently as Vice President, Product Development and Project Management at Gryphon Therapeutics and as Director, Product Development and Project Management at SRI International.
Dr. Kung has authored a book entitled: Therapeutic Proteins: Pharmacokinetics and Pharmacodynamics as well as author of numerous peer-reviewed papers. She was Invited speaker at many international industry conferences. Dr. Kung received her Ph.D. from the Ohio State University.