Lallemand Health Solutions (LHS) is pioneer in probiotics for 80 years through expertise and continuing R&D work to supply the best Probiotic strains and products. Thanks to STAR® 3-level protection technology, Lallemand Health Solutions ensures the optimal delivery of live probiotics in the gut. STAR® can be applied to any custom blends of Rosell, Lafti and Harmonium strains formulated in capsules, and LHS also possesses strong expertise in the selection, development, production, and formulations (specialized, customized blends for customers) that support human health and well-being.
Pharmaceutical Standardization Divsion
Nation Institute of Food and Drug Safety Evaluation (NIFDSS)
Ministry of Food and Drug Safety
Partnership is now getting the most important strategy to drive innovation for business success. According to Thomson Reuters (IP&Science) research, over 60% of late-stage pipeline value is generated externally.
In 2015, we have the busiest year of deal-making worldwide, which indicates the proactive partnership by many types of players in pharmaceutical industry. This partnership has been more emphasized due to the more complicated challenges – patent cliff and payer pricing/regulatory pressure. About 50 Billion USD in pharmaceutical industry revenue has been estimated to come off patent in 2014. Governments and other payers are instituting price control and increasing their use of generics and biosimilars. Even with the recent advance in biomedical technology, the successful drug-development companies need to adopt this new wave of technology though creative partnership.
The talk will look at how various players in pharmaceutical industry strive on building strategic partnership to drive the next generation of therapeutics by overcoming current challenges.
Accelerating the development and delivery of innovative and biosimilar antibodies to patients enhances quality of care and quality of life. Shortening development times also helps biotech companies efficiently deploy capital while providing their investors with a faster return on investment. This presentation outlines specific areas where KBI significantly reduces development timelines to enable faster progression into and through clinical trials for therapeutic antibodies.
Brian is responsible for IMS Health operations in Greater China, Singapore, Malaysia, Indonesia, Thailand, the Philippines, Vietnam, Pakistan and Burma.
Since joining IMS Health in 2008, Brian has served in key leadership positions within the organization that include general manager of Greater China and senior principal, IMS Consulting Group.
Prior to joining IMS Health, Brian held management roles of increasing responsibility at Pfizer and Amylin Pharmaceuticals focused on portfolio planning, new product marketing, R&D strategy and business development.
Brian holds a Ph.D. in Pharmaceutical Chemistry from the Ohio State University and an M.B.A. from the University of Chicago.
Therapeutic protein development requires some physical analyses because a protein has each conformation in various formulations.
We will here present some applications of physical analyses, such as viscosity, thermal stability, size distribution, chemical spectroscopy and sub-visible particle (SVP) detection with Malvern products.
We also trace them on the development work flow for biopharmaceuticals in order to show total solution
GMP Compliance by Inspection is prerequisite for marketing authorization of a pharmaceutical product in Japan. GMP compliance inspection or investigations must be done not only at the time of marketing authorization application but also after marketing authorization is provided, periodical ones must be given to drug manufacturing sites. Since the establishment of PMDA in 2004, PMDA’s Office of Manufacturing/Quality and Compliance have conducted GMP compliance inspections to domestic as well as overseas manufacturing sites. Comprehensively PMDA confirmed methods and practices of quality and production control of APIs and drug products and it has contributed to supply of better quality products.
My lecture will present on PMDA’s inspection approaches, uncompliant GMP inspection cases, and the necessity for cooperation between overseas API manufacturers and MAHs in Japan
The 17th Edition of Japanese Pharmacopoeia has been published in March and enforced in April 2016. The English version will be available in September.
In the coming lecture I will explain the main revised parts of the 17th edition, such as comprehensive administration of residual solvents and public comments invitation in the PMDA’s English version website and trials for disclosure of the column information.
Regarding the latest information on the master files, I will talk about the requirement for attachment materials of the application dossier of generic prescription drugs which shall be in principle in CTD format according to the notification published in March 2016.
The goal of « Medicines for Europe » (formerly EGA) is to improve health by ensuring better access to treatment for patients in Europe and beyond. As Market Access Director, the objective of Maarten’s team is to shape in the EU a dynamic and sustainable market situation that enables fast and fair pricing and reimbursement for generic, biosimilar and value-added medicines.
Maarten joined « Medicines for Europe » in 2011 as Medical Affairs Manager with responsibilities in the areas of fighting Falsified Medicines and Pharmacovigilance. In his life before the association, he worked in the pharmaceutical industry providing pharmacovigilance consultancy and in the medical device industry liaising with Key Opinion Leaders. He combined these roles while working weekends in a community pharmacy.
Maarten is a pharmacist by education and holds an MBA from “Solvay Brussels School of Economics and Management” and “École des Ponts Business School”.
Mrs. Marieke van Dalen works for Aspen Oss B.V., a company located in the Netherlands, producing a wide variety of APIs. She is also a Board Member of APIC (Active Pharmaceutical Ingredients Committee), which is the Technical European Industry Association for API producers, based in Brussels.