Digital enablement

Improving the sponsor, patient, and provider experience

The digital transformation known as Pharma 4.0 is revolutionizing process optimization and decision-making within the pharmaceutical industry—at every level and across the clinical development lifecycle and supply chain. At the same time, decentralized clinical trials are now taking a leading role in clinical research. While the approach is not new, the pandemic has increased the incentive for using decentralized trials for future drug development.

We are responding with digital innovations that push the limits of efficiency, agility, and quality for our customers as we adopt networked systems, data analytics, and advanced automation. Customers will see an improved experience at every step. Activities are streamlined, from routine daily status checks or placing orders, to executing a global decentralized clinical trial or manufacturing a full product line. 

77%

Digital tools such as mobile technologies, mobile HCPs, and mobile phones are used in 77% of current decentralized trials1

60-70%

Sixty to 70% of molecules in clinical development have high permeability but poor solubility; predictive modeling can help


Digital enablement solutions and capabilities 

From day-to-day order management and batch tracking to monthly forecasting, our digital mysupply Platform provides timely visibility and real-time collaboration tools to enable more efficient ways of working. mysupply can help you mitigate risk and keep you informed of production status by highlighting where and when your attention is most needed. 

 
  • Simple order management: Skip the email and log on to the platform to submit new orders and track existing ones. 
  • Process transparency: Check the status of your batches throughout the process, including change requests, analytical results, quality deviations, and shipping.
  • Automated forecasting: Avoid the manual forecasting and reviewing process by relying on a templated and digital forecast system.
  • Streamlined digital experience: Stop digging through emails and files for information. mysupply offers one place to review everything you need.   

 

The platform gives you the ability to view current order status and batches linked to those orders, as well as risks associated with batches and orders. It also allows users to input change requests. Use it to identify delays and proactively address critical alerts and traceability of products.

What’s more, the mysupply Platform provides near real-time data sharing to enhance transparency, build trust, and encourage collaboration among stakeholders. 

Forecasts

Automated forecast entry and upload with status tracking to monitor progress. 

Orders

Dynamic order submission and tracking capabilities detailing order to batch connection. 

Batch tracker

Improved visibility int obatch tracking/status for specific orders.                    

Dashboard

Up to date, transparent data for collaborative business reviews and daily performance management. 

Helpful resources 

Did you know?

  • Remote, virtual, or decentralized trials more than doubled from 2015 to 20192
  • 9 out of 10 survey respondents expect COVID-19 to catalyze adoption of deccentralized trial strategies

 

Decentralized clinical trials eliminate the need for a patient to visit an investigator site to receive treatment. These trials were on the rise for years before COVID-19, but their success in keeping drug development programs on course during the pandemic won these studies a new leading role in mainstream clinical development and commercialization going forward.

Sponsors are turning to an integrated supply chain solution known as direct-to-patient services to execute decentralized trial strategies. Direct-to-patient services allow patients to participate in clinical trials from their homes by providing them with study drugs and care where they live, using telemedicine and mobile or local healthcare providers. 

    The direct-to-patient category includes:

    Fully decentralized studies, often called virtual or site-less trials. These studies bring the clinical trial to a patient’s home using a central, often virtual, coordinating facility. More than 75% of current decentralized trials use mobile technologies.1 These trials may also harness telehealth, in-home devices, sensors, and wearables, as well as digital therapeutics. The use of artificial intelligence (AI) and machine learning (ML) is also becoming more routine to facilitate diagnoses, patient stratification, and evidence generation.

    Hybrid trials incorporate some virtual elements into a site-based study. These studies often access a combination of mobile clinics and patient-reported outcomes.

Benefits for sponsors 

  • Improved patient enrollment and participation
  • Shorter trial timelines
  • More diverse/representative patient populations
  • Reduced cost
  • Real-time data

Benefits for investigator sites 

  • Easier patient recruitment
  • No need to store study drugs and ancillaries during the duration of a study
  • Less administrative burden on site staff

Benefits for patients and caregivers 

  • Reduced time and travel burden, making easier to recruit and retain patients

Helpful resources 

Quadrant 2

Predicting solubility and bioavailability enhancement

Our proprietary computational modeling program, PatheonTM Quadrant 2TM, analyzes your compound’s specific molecular structure and chemical characteristics, in combination with your unique target product profile. The platform consists of exclusive algorithms that incorporate a variety of different computational methods including quantum mechanics, molecular dynamics, Quantitative Structure Activity Relationship (QSAR), ADMET, statistical analysis, and internally developed models.

Using your compound’s individualized data, Quadrant 2 predictive modeling: 

  • Predicts the most optimal solubility enhancement technology and excipient combination to meet your clinical and business objectives, at the earliest stages of development.
  • Eliminates solubility enhancement options that are unlikely to yield benefits for your program, dramatically reducing time and investment often wasted on trial-and-error experimentation.  

Quadrant 2 predictive modeling analyzes the molecular structure, as well as the physical and chemical characteristics of a compound based on the following information:

  • Active pharmaceutical ingredient (API) chemical structure
  • Physicochemical properties
  • Full-scale molecular modeling based on quantum and molecular dynamics simulations 
  • Exclusive excipient descriptor database developed by Patheon pharma services 

Our suite of predictive modeling tools also includes:

  • Accelerated stability testing (shelf life and component compatibility): Predictive accelerated stability studies allow the long-term stability characteristics of a drug substance or drug product to be characterized from extrapolation of results of short-term studies that measure, track, and quantify stability-indicating attributes, such as degradation, thermal properties, crystallinity, color, viscosity, and particle size.
  • Process development (material blending and compaction behavior): Offering advanced technologies such as compaction simulation, discrete element modeling (DEM), and computational fluid dynamics (CFD) for a wide range of applications, from material characterization and formulation development to process scale-up and tech transfer.
  • Predicting API physicochemical properties and pharmacokinetics: Use in silico models to investigate ADME-PK properties of new chemical entities is used to inform candidate selection, ADME characterization, and translation of exposure and effect.

Contact us to understand how our Engineered Solutions can enable you to make smart decisions and de-risk your product development.

 

Helpful resources 

Whitepaper

Quadrant 2 predictive platform for solubility and bioavailability enhancement 

Download
Fact Sheet

Engineered Solutions for oral solid dose product development

Download
White Paper

Advancing drug development using in silico modeling

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Pharma 4.0 is a new operating model for pharmaceutical factories and supply chains of the future, including new digitized and automated manufacturing approaches.

We are aligning across our network using processes that are more agile, collaborative and technology driven. The three primary ways we are doing that are as follows: Manufacturing technology and automation, including standardized processes and improved capacity; creating a digital shop floor and factory of the future; and implementing a digital toolbox and optimized processes to improve results.

Pharma 4.0 benefits to customers include: 

  • Faster decision making
  • Real-time control of operations and quality 
  • Global capacity expansion
  • Significant productivity improvements 
  • Data integrity and transparency
  • Seamless compliance
  • Reduced deviations
  • Time and money savings 

View references
1. Berlanga H, Shea K, Zweig L (2021) EU Clinical Trial Regulation 2022 – Impact on regulatory, labeling & QP. Thermo Fisher Scientific.
2. Lorck CA (2021) Annex VI to Clinical Trial Regulation 536/2014: risk assessment-based concept of an interim* solution on expiry date labelling of the immediate packaging of Investigational Medicinal Products (IMPs). European Federation of Pharmaceutical Industries and Associations.
3. TransCelerate Biopharma Inc. eLabels (website), n.d.
4. Wang B (2020) Pharma companies launch initiative to push for e-labeling. InsideHealthPolicy
5. https://www.pharmexec.com/view/e-labeling-change-underway