Cross-Speaker Emotion Transfer for Low-Resource Text-to-Speech Using Non-Parallel Voice Conversion with Pitch-Shift Data Augmentation

Data augmentation via voice conversion (VC) has been successfully applied to low-resource expressive text-to-speech (TTS) when only neutral data for the target speaker are available. Although the quality of VC is crucial for this approach, it is challenging to learn a stable VC model because the amount of data is limited in low-resource scenarios, and highly expressive speech has large acoustic variety. To address this issue, we propose a novel data augmentation method that combines pitch-shifting and VC techniques. Because pitch-shift data augmentation enables the coverage of a variety of pitch dynamics, it greatly stabilizes training for both VC and TTS models, even when only 1,000 utterances of the target speaker's neutral data are available. Subjective test results showed that a FastSpeech 2-based emotional TTS system with the proposed method improved naturalness and emotional similarity compared with conventional methods.Comment: Submitted to Interspeech 202

Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval

For drugs that are intended to fill unmet medical needs, such as the treatment of rare diseases or a subtype of cancer, it can take a long time to conduct confirmatory clinical trials due to limited patient availability. Delayed access to these drugs increases the risk of mortality of patients with these diseases. To address this issue, the Ministry of Health, Labour, and Welfare of Japan has decided to implement the Conditional Early Approval System with issuing the Ministry Notification in 2017. Drugs eligible for conditional early approval are those that are indicated for the treatment of a serious disease, have proven safety and efficacy, and cannot be examined easily by confirmatory clinical trials. When the benefit of immediate availability outweighs the risk of having less comprehensive data with which to confirm the clinical benefit of a product in the premarketing phase, products can be approved under the Conditional Early Approval System, accompanied by postmarketing regulatory requirements to manage postmarketing risks and, if needed, conduct postmarketing confirmatory clinical studies. Overview of the pre‐approval and post‐approval regulatory considerations will promote to more efficiently develop pharmaceutical products that fill unmet medical needs, leading to the prompt delivery of safe and effective drugs to patients who often have few therapeutic options available. As of March 2020, four drugs had been approved under the Conditional Early Approval System. In this review, we describe the premarketing and postmarketing requirements of these drugs and discuss the regulatory landscape around the Conditional Early Approval System