About PPBIZ
Pharmaceutical Innovation
to Japan and from Japan
PointPath.Biz, K. K. (PPBIZ) is a pharmaceutical R&D consulting firm founded in 2008. The company name, PointPath, refers to our motto: Pointing the way (Path) to success.
We work with major Japanese pharmaceutical companies, mid-sized pharmaceutical companies, biotech ventures, and start-ups, as well as overseas pharmaceutical companies and biotech ventures. We provide a variety of services necessary for the research and development of pharmaceuticals and medical devices for each company, from basic development support services to tailor-made services for new approaches at times.
PPBIZ Strengths
- Many of our staff have experience in pharmaceutical R&D overseas, and have knowledge and a high level of experience in the development of pharmaceuticals, particularly in Europe and the U.S.
- Access to the latest overseas information through alliances with consultants and regulatory groups in Europe and the U.S.
- Ability to verify the potential and marketability of drug development in countries and regions other than Japan through collaboration with overseas consultants
- Compose international project teams including overseas consultants to lead international development
- Negotiate directly with service providers in Japan and overseas, select contractors, and manage after outsourcing
- Able to directly prepare submission documents CTD for overseas
- Able to assess the quality of clinical trial data
- Able to conduct manufacturing quality control and QA inspections
PPBIZ Members
PPBIZ members have many years of experience in research and development at domestic and international pharmaceutical companies. We have accumulated experience in a variety of specialized areas. Those areas of expertise include synthetic chemistry, bioinformatics, biochemistry, pharmacology, toxicology, clinical pharmacology, clinical sciences, clinical development, regulatory affairs, and intellectual property rights. Many have been involved in international development projects and have experience in development in the U.S., Europe, and Japan. In addition, PPBIZ has recently added members with expertise in pharmaceutical sales and marketing, new company start-ups, business development, accounting and finance, and regenerative medicine and cellular medicine.
PPBIZ has assembled the dedicated team necessary to accomplish the work required by our clients and provide support activities tailored to your needs.
Message from the Representative
Yutaka Waki, President and CEO, PointPath.Biz, K.K.
In May 2008, PointPath.Biz, K. K. (PPBIZ) was launched as a start-up company providing consulting services for pharmaceutical research and development. At that time, there were few consulting firms in Japan that were engaged in pharmaceutical-related outsourcing, which is a common and widely used practice in Europe and the United States, and the business model of consulting firms specializing in pharmaceutical R&D was not yet available in Japan. Many Japanese pharmaceutical companies were going through a difficult period due to the ice age of employment that lasted for more than 10 years from 1993, which made it difficult for companies to secure human resources, and the extreme decrease in hiring new employees reduced opportunities to develop human resources through in-house training and to learn experience in various fields within the company. I was sent to the U.S. as an expatriate for six years from 1998, where I worked with European and U.S. pharmaceutical companies. I learned firsthand about the differences in the way they approach their work and the differences in the way they think, including culture and customs, between Japan and the U.S. I also learned how to efficiently utilize highly specialized consultants and their networks, and how to work with a sense of speed. I also strongly felt that there is a need in Japan for a company that provides consulting services related to pharmaceuticals on a global scale.
As consultants, we work as a team to provide tailor-made support to meet the needs of the moment, both in general pharmaceutical R&D work and in new challenges in new fields, working together to solve problems and support the creation of new products.
We will continue to take on new challenges in the future.
We are also looking forward to the participation of experts with expertise and experience who are willing to take on challenges together with us.
Let us all support the pharmaceutical industry in Japan and the ventures that are about to take off in the world.
Brief Personal History
After obtaining his veterinary license, he joined Kyowa Hakko Kogyo (now Kyowa Kirin), where he was engaged in pharmaceutical research and development. After leading the acquisition of approval for drugs for hypertension and angina pectoris in Japan, he established a drug development organization from scratch as vice president of the U.S. subsidiary, building a system to promote clinical trials independently. As the hub of a development organization spanning Japan, the U.S., and Europe, he promoted global collaboration. He was also involved in many joint development projects with pharmaceutical companies around the world. He then joined Shogoo Pharma, a venture company, as a development director. He also served as COO of Brightpath Bio, a university-launched biotech company, where he helped to file an IND in the U.S. and contribute to the company's IPO. In addition, he has cross-sectional experience in cutting-edge areas such as supporting the establishment of biosimilar JVs among pharmaceutical companies, developing regenerative medicine using iPS cells, and developing ADCs (antibody-drug conjugates) in the US. Currently, he leads PointPath.Biz, a consulting company he established himself as a group of professionals specializing in overseas expansion of biotech companies, and supports a wide range of global development in the U.S., including antibody and cellular drugs, from biotechs to major pharmaceutical companies.