As described in the article “先駆け審査指定制度｜AnswersNews Plus (ten-navi.com)” released by AnswersNews on 15/03/2019, the SAKIGAKE designation system is a program that grants preferential treatment to innovative products such as pharmaceuticals, medical devices, regenerative medicine products, and in vitro diagnostic drugs that are applied for approval in Japan for the first time in the world. This system shortens the standard 12-month approval period to 6 months for designated products. To be designated as a target product, it is necessary to demonstrate the ground-breaking nature of the product, the severity of the targeted disease, extremely high efficacy, and an intention to develop and apply early in Japan. The SAKIGAKE designation system provides preferential measures such as advancing the approval review process, prioritizing review, consultation on development progress management, and extending re-examination periods. In addition, a “SAKIGAKE designation system addition” is added to the drug price of target products as a premium, which serves as an incentive for drug development.
In the article “薬価の基本｜AnswersNews Plus (ten-navi.com)” released by AnswersNews on 07/06/2018, they explain the “YAKKA” (drug price) system in Japan, the official price of prescription drugs used in medical care. The price of drugs that are covered by public medical insurance is determined by the government (the Minister of Health, Labor and Welfare), and pharmaceutical companies cannot freely determine the prices of drugs used in hospitals or clinics. The list that summarizes the official prices, known as the “YAKKA KIJUN” (price standard), plays the role of both a product catalog and a price list. Medical institutions and pharmacies bill patients for the cost of drugs prescribed or dispensed based on the official prices set by the price standard (Co-payment rate for a patient is basically 30%). A revision of the official prices called “YAKKA KAITEI” is conducted once every two years, usually in conjunction with the April revision of medical fee schedules.
Tim Dietlin Joins the Company as CEO
WASHINGTON, D.C. – The Validant Group, a leading international quality, compliance, and regulatory consulting firm, today announces that Tim Dietlin has joined the company in the role of Chief Executive Officer (CEO).
“Tim brings a unique skill set to his role as CEO of the Validant Group. His deep understanding of the life sciences industry, coupled with his business effectiveness and leadership advisory experience, allows Tim to build transformative teams that drive growth and attain long-term success,” said Alistair Macdonald, Chair of the Validant Group Board of Directors and Operating Partner, GHO Capital.
Tim Dietlin brings more than 25 years of leadership experience to his role as CEO of the Validant Group. Most recently, Tim served for eight years as the Global Managing Partner of the Healthcare and Life Sciences Practice at Heidrick & Struggles, a leading global executive search and management consulting firm. In this role, Tim led all aspects of the practice’s healthcare and life sciences business and specialized in providing leadership advisory services to a broad portfolio of clients, including established pharmaceutical companies, emerging high-growth biotechnology firms, and investor backed service and technology companies.
Tim’s extensive experience includes leadership roles at IBM, where he led the life sciences strategy and transformation consulting practice; INC Research, where he served as Senior Vice President of Global Consulting and Strategic Alliances; and Campbell Alliance, a life sciences management consulting firm, where Tim led the firm’s Research and Development and Medical Affairs consulting practices.
“The Validant Group has built a strong foundation as a leader in the life sciences industry. By uniting this already powerful partnership of companies, and capitalizing on our collective capabilities, we will unlock the full potential of our business,” said Tim Dietlin, Validant Group CEO. “Together, the Validant Group will deliver a full-service platform that provides unmatched regulatory clarity at every phase of the product life cycle. I look forward to cultivating and continuing to grow a united Validant Group that is stronger together and positioned for success.”
May 15, 2023
ABOUT THE VALIDANT GROUP
The Validant Group is a global, full-service life science consulting company focused on managing and resolving complex regulatory issues. The Validant Group is comprised of five companies offering collaborative consultancy services: