Supplier management in pharmaceutical manufacturing requires strict risk-based management in due to recent GMP globalization.  In particular, proper selection and management of overseas suppliers are indispensable factors in preventing product recalls and market shortages. Based on the revision of the GMP Ministerial Ordinance that came into effect last year, we will explain the points to keep in mind when selecting and managing API suppliers.

【Language：English/ Japanese】

API sourcing and supply chains have been key areas of focus about two years, with the pandemic raising questions of where APIs should be manufactured. As the global demand for quality and increasingly novel APIs continues to grow, what does the future look like?This panel discussion brings together leading market experts to discuss the lay of the land:

-Market Outlook for APIs
-Key driving factors & challenges in the global API market
-Emerging product trends & market opportunities
-Impact of COVID-19 on the global API industry
-What does 2022 hold for the API Market?

* This session was originally broadcast  on as part of the CPhI Worldwide 2021 content programme.

For drug discovery through open innovation, a pharma-company (Pharma) seeks an innovative drug seed coming from a bio-venture (BV), and BV desire to collaborate with a Pharma as Exit strategy like IPO/M&A.  Corporate strategy (Capital policy, IP & License) and issues/countermeasures for BV will be raised, and better alliance with Pharma will be encouraged.  

【Language：English/ Japanese】

More so than any other core function of the biopharma industry, clinical trials have been buffeted by the prevailing winds of the pandemic. From the turbulent waves of infection causing overstretched healthcare facilities, inaccessible sites and patient availability through to the relative plain sailing of mammoth Phase III vaccine trials, COVID-19 has permanently changed the nature of clinical research. This introductory session explores the negative and positive aspects that the clinical trial ecosystem has either endured or capitalized upon, and attempts to answer the question as to whether we have emerged from the storm in a stronger position than before. The presentation will touch upon topics such as disruption to ongoing and planned trials, patient engagement in clinical research, digital and technology acceleration, and sponsor strategies and dynamics.

The importance of manufacturing biologics is increasing since the post-Covid 19 eras. In this presentation, we will introduce the activities of the MAB organization toward therapeutic antibody and gene-therapy vector manufacturing.

In general, boryl groups in arylboronic acid derivatives have to be installed right before their coupling reactions because of their instability under various reaction conditions. We have developed novel syntheses of aryl boronic acid derivatives through functional group transformation in the presence of boryl groups. In this seminar, these synthetic methods with the handling of the boronic acid derivatives will be introduced.

Oligonucleotides have attracted attention as new drug-modalities in recent years and a scalable synthesis and purification method are key for a stable supply of oligonucleotide APIs. Ajinomoto conducts (1) the production of oligonucleotides in our original liquid-phase method (2) the development of process for siRNA (3) large scale purification etc. These topics are introduced in this session.

Open innovation has much importance in pharmaceutical industry. For process chemistry, open innovation is indispensable to achieve superior research results through the technology not owned in-house. In my lecture, I would like to present the domestic and international situation of open innovation and to discuss the future direction of open innovation.

Pharmaceutical supply chains are spread across the world, and purchasers / outsourcers have to manage their suppliers. GMP auditing is an important measure for such management, but it is not easy to establish trustful relationship with the suppliers through appropriate evaluation of GMP operations at the third-party site. In this presentation, topics on audits for overseas manufacturing sites, including communication issues, will be discussed.

Achieving regulation of endogenous gene expression in the central nervous system (CNS) with antisense oligonucleotides (ASOs) administered systemically would facilitate the development of ASO-based therapies for neurological diseases. We demonstrate that DNA/RNA heteroduplex oligonucleotides (HDOs) conjugated to cholesterol or α-tocopherol at the 5' end of the RNA strand reach the CNS after subcutaneous or intravenous administration in mice and rats. The HDOs distribute throughout the brain, spinal cord and peripheral tissues and suppress the expression of four target genes by up to 90% in the CNS, whereas single-stranded ASOs conjugated to cholesterol have limited activity. Gene knockdown was observed in major CNS cell types and was greatest in neurons and microglial cells. Side effects, such as thrombocytopenia and focal brain necrosis, were limited by using subcutaneous delivery or by dividing intravenous injections. By crossing the blood-brain barrier more effectively, cholesterol-conjugated HDOs may overcome the limited efficacy of ASOs targeting the CNS without requiring intrathecal administration.

Recently, GMP violations and illegal manufacturing have been reported one after another. In order to prevent these incidents, it is necessary to establish a legal compliance system and ensure consistency between the approval items and the actual manufacturing process by appropriate change control.  In this lecture, I will explain the points of concrete response to the revised GMP Ministerial Ordinance and the revised Pharmaceutical and Medical Devices Law, focusing on how to proceed with appropriate change control.

In the new corona countermeasures, large subsidies will be granted for the production of ordinary biopharmaceuticals and other products during normal times, and for the production of new coronavirus vaccines during contingencies.　The lecture will explain considerations in designing multi-purpose facilities such as CDMOs, considerations for facilities and equipment design related to formulation facilities, and trends in equipment design considering the impact of coronas on the supply chain.
 

We will introduce the latest technologies of Ajinomoto's proprietary microbial secretory peptide/　protein produ ction technologies, which are particularly suitable for antibody-related pharmaceuticals.

Recently, automation and labor saving have become a major theme in various stages of experiments. Bravo, a proven general-purpose automated pipetting system, is capable of not only dispensing general liquids but also automating various sample processing from small molecules to large biological molecules. In this presentation, we will introduce the solution of sample processing with Bravo, including actual examples.

Multidimensional LC (MS) such as 2D-LC is increasingly used for analysis of oligonucleotides, peptides, antibody, ADC, and adeno-associated virus (AAV). It has expanded from research and development to in-process control and QA/QC. We will deliver application examples of multidimensional LC, and in the second half, we will touch on the analysis of mRNA and lipid nanoparticles.

During showing the drastic growth of biotheapeutic market in the world, the new technologies of chromatography media have been developed for the downstream processing. In this seminar, we would like to introduce you some applications using the Bio-Rad's Mixed Mode chromatography media for the purification development and/or commercial process of biologics.

*This seminar is cancelled due to the speaker's unforeseen circumstances.

In this lecture I explain about risk management concerned to assurance of manufacturing process and testing process in biopharmaceutical product included some actual examples. Much of overt and potential risk exsit to produce biopharmaceutical product in manufacture process and testing process compared to small molecule compound. I make recommendation adopting method of quality risk management(QRM) （ICH Q9）and minimizing risk to solve those risk.

AGC Biologics is a global CDMO that manufactures a wide range of modalities, from biopharmaceuticals using mammalian cells and microorganisms to gene and cell therapy products. This seminar will introduce the globally integrated End to End CDMO service at AGC Biologics, explaining our newly acquired Cell and Gene therapy facilities in the United States and Europe.

For a wide range of protein drug characterization and QA/QC analyses, it is necessary to select an analytical instrument that considers the analytical purpose. In this seminar, we will introduce our latest commercial Multi-Attribute Method (MAM) workflow: Thermo Scientific™ MAM 2.0 which replaces many of the time-consuming methods typically required for the characterization and QC of therapeutic proteins by peptide mapping-based analysis. In addition, we will cover released glycan analysis with ion chromatography which is possible to analyze N-glycans and O-Glycans in a label-free form and resolve glycans according to charge, size, composition, isomers and linkages.

The improvement of modified nucleic acid technology and the progress of DDS technology have accelerated the development of therapeutic drugs mainly for various intractable and rare diseases, and highly effective nucleic acid drug candidates are being developed one after another.
In this seminar, we will introduce a compact automated oligo synthesizer suitable for process development and small-scale manufacturing in nucleic acid drug manufacturing, and the nucleic acid drug manufacturing solution provided by Cytiva.

【Language：English/ Japanese】

Continuous manufacturing provides a solution for uncertainty in capacity as drug candidates progress through clinical development to commercial supply. We present a case study describing the production of a monoclonal antibody using a single-use flowpath, 500 L scale process in a non-GMP pilot facility, which is a forerunner to the construction of a continuous GMP manufacturing facility. Using our proprietary ApolloXTM high-biomass ‘perfusion ready’ cell line, combined with a commercially available single-use bioreactor operated in perfusion mode and our proprietary SymphonXTM liquid handling systems, which are used for point-of-use buffer dilution and multiple chromatography steps in a connected, intensified downstream process, we were able to process ~1 kg mAb/day.

Dissolution improvement of poorly water-soluble drugs　has been achieved by technical progress and functional excipient development. 
Starting from early-stage solid dispersion and micronization, amorphous solid dispersion and nanocrystal product have been developed and on market. In addition, formulation properties as well as dissolved states of drug at the absorption site can be evaluable due to the progress of physicochemical characterization technology, making it possible to develop more high quality product.

Lipid nanoparticles used in mRNA vaccines are essential for the delivery of mRNA. Targeting rare diseases, infectious diseases and cancers, more than 750 RNAs are under development worldwide. Micropore's system is a second-generation technology that uses a unique single-layer membrane emulsification that produces nanoparticles with low shear and low pressure.

There are multiple emerging needs in Biologics/Biotech drug market in global, also there are considerable progress at Japanese pharma industry in looking at new technology in this area.

Under this situation, Drug Delivery Device is now becoming a critical pillar for ensuring successful entry in this space. “Transforming Drug Delivery” – will address gaining a competitive edge with patient-centered design for customizable, user-friendly devices along with technology solutions that support local and global commercialization.

Phillips-Medisize is global leader in end-to-end from providing device design, development and manufacturing services, and will engage drug manufacturers in an interactive discussion on how to reach the market faster and expedite product development with proven technology accelerators for all types of infusion, injection and inhalation devices. 
We have a considerable experience of partnering with Pharma/Biotech companies for their injectable/biotech portfolio for global markets with FDA registered Reusable Electromechanical Autoinjector device with “Connected Health” platform.  

As pharma company’s true drug delivery partner, Phillips Medisize is presenting a comprehensive product/service solution for your entire drug delivery needs.

Despite the invaluable service that pharmaceutical products provide society, it still comes at a cost to the environment as a major emitter of environmental pollutants consequentially affecting human health. In this talk, I will present our study on the holistic assessment of monoclonal antibody (mAb), where we quantitatively computed the environmental impact from the production of mAb, and the health benefit they bring.

Organocatalysis has received considerable attention for being efficient and clean catalysts, because organocatalysts are less toxic than metal catalysts, as well as inexpensive, environmentally benign properties, and stable against moisture and oxygen. From a green chemistry perspective, the development of organocatalysis is a significant research subject for a sustainable society. The major focus in our research group is to study on the development of novel organocatalysts and the reactions achieved from using them. Recently, we designed and synthesized the diaminomethylenemalononitrile (DMM) organocatalysts and squaramide-sulfonamide organocatalysts. We demonstrated that they are effective for many valuable asymmetric reactions. In this seminar, I would like to present the following asymmetric reactions. (1) Asymmetric hydrophosphonylation; the DMM organocatalyst efficiently catalyzes the hydrophosphonylation of aldehydes, unactivated ketones to give the corresponding a-hydroxy phosphonates with high yields and excellent enantioselectivities. (2) Stereoselective synthesis of g, g-disubstituted g-butenolides; the squaramide-sulfonamide organocatalysts promoted the asymmetric direct vinylogous aldol reactions of furan-2(5H)-one and 5-substituted furan-2(3H)-one with aldehydes. In addition, asymmetric direct vinylogous conjugate addition of deconjugated butenolides to benzoyl acrylonitriles using the DMM organocatalysts resulted in the corresponding addition products with high to excellent enantioselectivites. The obtained products can be readily transformed to the bicyclic g-lactam derivatives.

The first step to document the reliable submission dossiers including CMC is “Zero defects”. Only minor defects can deteriorate the quality of the whole dossiers. The points to prepare global CMC sections will be introduced.

Real-time analysis facilitates process understanding and optimization and speeds up drug development and manufacturing. In the first half, we will introduce reaction monitoring by a brand-new Online HPLC. It reduces chemists’ burden. In the second half, we will introduce Mobile Handheld Raman for a wide range of containers, from glass vials to paper bags.

Brønsted base-catalyzed carbon–carbon bond-forming reactions under proton transfer conditions are a promising methodology for construction of fundamental structures of fine chemicals such as pharmaceuticals in atom economical manner. Here, I describe development of novel alkaline metal Brønsted base catalyst systems for carbon–carbon bond forming reactions of weakly acidic and less reactive materials which are difficult to use in typical Brønsted base catalyzed reactions.

Excipient Information Package (EIP) published by IPEC Federation can be used as a document to provide detail information on the quality of excipients. In this seminar, excipient manufacturers can recognize how to create EIP and pharmaceutical companies can recognize about EIP, so that a preparation/inquiry of a simple and detail explanatory document can be understood.

The real cause of the unstable supply of generic medicines whose settlement seems not near is not because of distribution problems but of quality regulations under PMD Act. While many manufacturers and MAHs are struggling to comply the regulations but unsuccessfully and are forced “Blind Compliance”, the calls for the revision or review of the Regulations are almost non-existent. The Japanese Quality Regulations have many ambiguities and shortcomings, and I would like to discuss those issues including those of local governments and to explore the tips for the improvement.

【Language: English】

A brief introduction to the open access publication service at Dove Medical Press (DMP) & publishing trends in Asia. The presentation first looks at the background and some key facts about DMP. It also demonstrates the journey of a manuscript submitted to DMP and various institutional membership programs that DMP offers and the benefits of these programs.

The presentation then discusses publishing trends in Asia such as diversity in scholarly publishing. It also touches briefly on striving for sustainability in open access publishing in the future.

Maintaining a healthy lifestyle is essential in leading a happy life. However, it is difficult to know exactly how healthy we are and get information catered to us to keep us healthy. In this seminar, we will discuss the key points of how digital health can help people lead healthier and more fulfilling lives, and how digital health can contribute to business development.

【Language: English/ Japanese】

1. Greeting
Speaker: Commerce Department of U.S. EMBASSY

2. Healthcare in a Post-COVID World, the connection to mental health = healthy body, using exercise and nutrition as medicine, and what that  means for healthcare in a post-covid world.
Speaker：Prime Movement Healthcare

3. Revolutionizing Diagnosis and Treatment of Glaucoma
Speaker: Smartlens, Inc.

4. Reduce Cost, Time and Complexity of Clinical Trials with At-home Testing
Speaker：iFirst Medical Technologies

5. Health & Longevity Innovations for Japan
Speaker： Cardiospire/Nozomi MedAlliance

6. iSWAB: The innovative sample collection device
Speaker： Mawi DNA Technologies LLC.

A real digital transformation strategy gives an organization a competitive edge. It’s a strategy that is foundational, iterative, and comprehensive enough to produce digital technologies that are sustainable and maximally valuable to the business. 

Yet many science-based business outcomes today are constrained by tools that don’t fit the way scientists think and work, limiting innovation. To capture the full value of a digital investment, scientists must be empowered with both the appropriate skills and tools to allow them to focus on their research.

This presentation will demonstrate how Enthought has addressed these challenges in a real world case study from the pharmaceutical industry. The case study will show how digital technologies such as automation, AI, and ML can be used to transform scientific workflows and result in new insights that advance discoveries and accelerate time to market.

Enthought powers digital transformation for science. Our technology and deep scientific expertise enable faster discovery and continuous innovation. We build your digitally enabled workforce and arm them with analytics-ready scientific data to be catalysts of value creation in science and business. 

As remote work becomes more common, sales offices are being eliminated, especially at major pharmaceutical companies, and face-to-face contact with medical institutions is being restricted. In this environment, more and more pharmaceutical companies are rethinking their traditional promotional activities. In this presentation, we will explain how to increase the productivity of promotional activities in the non-contact era, along with examples.

The combination of digital and AI enables the development of "anytime," "anywhere," and "anyone" medicine, and could serve as the foundation for next-generation medicine, including precision medicine. This presentation will review the most recent advances in AI and medical AI, and explain the AI and platform requirements for building next-generation medical systems.

HCPs already use well over 20 different channels. We will cover the keys to omni-channel success, including platform needs, change management, agile marketing, data curation, and decision support.

The spread of Covid-19 has led to rapid digitalization in the pharmaceutical industry. With the advancement of hybrid work, new uses of video communication are becoming widespread in R&D, production, and sales departments. In this seminar, we will introduce "hints" for digitalization, including new use-cases and approaches of Zoom in the pharmaceutical industry.