November 2020

LifeBee is proud to announce Teresa Minero, elected and newly appointed, as a Director of the 2020-2022 ISPE International Board of Directors.

Teresa will contribute at global level to the association mission, vision and strategic priorities, to ensure that business operations are consistent with ISPE Policies, best practices and appropriate laws.

Teresa Minero says: “Being part of the International Board of Directions is a great honor and responsibility. I will continue to serve ISPE with the same energy and passion that I have devotes as a member for 25+ years, as a Chair of the Italian Affiliate, within the European Leadership Team and the Pharma 4.0™ Global Special Interest Group”.

LifeBee is one of the ISPE Partner ShowCase in ALL five virtual ISPE conferences planned through year-end:

•             ISPE Europe Annual Conference, 16-17 September

Teresa Minero - session leader for "Regulators' View on COVID-19"

•             ISPE Asia Pacific Pharma Manufacturing Conference, 21-23 September

•             ISPE Europe Biotechnology Conference, 7-8 October

•             ISPE Annual Meeting & Expo, 2-6 November

Teresa Minero - session leader and speaker session for "Digital Transformation to Pharma 4.0" - 6 November, 11:30AM - 13:00AM

•             ISPE Europe Pharma 4.0 Conference, 17-18 November

Teresa Minero - speaker in two sessions "ISPE Pharma 4.0: Fourt Survey: Is Quality and Regulations Impacted?" and "Whorkshop 4: How to Pitch, Shape, Estimate and Kick-Off a Pharma 4.0 Project" - 18 November, at 8:30AM and 10:30AM

Teresa Minero for ICF – Rivista dell’Industria Chimica e Farmaceutica – May 2020

The Digital Therapeutics Alliance (DTA) defines Digital Therapies (or DTx) as follows:

"They offer scientifically supported, therapeutic interventions to patients, who are then monitored by high-quality software programs to prevent, manage or treat a broad spectrum of behavioural, physical and mental conditions."

DTx are already part of current procedure and are applied in the treatment of an increasing number of diseases: Diabetes, respiratory problems, high blood pressure and more. Some DTx have been already approved by regulators (FDA, MHRA).

The main function of a DTx is to integrate into, or even substitute traditional therapy (Medicine). The peculiarity is that they can be clinically validated by rigorous clinical trials), be approved by regulators, be subject to a Health Technology Assessment (HTA) and therefore be subsequently prescriptible.

The active ingredient, so to say, is software that implements algorithms of varying complexity, integrating them with equipment / sensors (wearable, biometric or otherwise) and allowing information to be easily accessible on a smartphone, tablet or pc. Information then available to the patient and treating physician, with full regard to one’s privacy and security.

Such methods help to alter a patient’s lifestyle, improving the state of their condition. This would typically arise through use of external devices (meters of various clinical parameters, scales, surrounding air quality), intelligent and personalized processing of collected data, including indications for the patient and treating medical expert to follow.

An indication from LifeBee Experience

The Life Sciences world has a well-established culture of binding regulation and standards which serve as a benchmark for correct software lifecycle management when it has (directly or indirectly) a possible influence on the quality of the medicine or medical device. All systems must be validated and qualified according to strict procedures, and are now established in the industry and constantly inspected by regulators.

Valuable support for industry operators originates from ISPE GAMP guidelines® which provide the industry and its suppliers with methodologies and practice for the design, documentation, testing and maintenance of all such related software with a potential impact on the quality of medicines or medical devices, and ultimately on patient health.

DTx is software that in essence acts as medicine in curing humanity, with a substantial impact on a person’s health.