The legendary bassist Carol Kaye, also proved it is not only a man’s world…. She is an American musician, who is one of the most prolific recorded bass guitarists in rock and pop music, playing on an estimated 10,000 recordings in a career spanning over 50 years. Enjoy the beauty of gender equality… https://youtu.be/QEH-wfo7nPo

Last year, Elizabeth Holmes, founder of Silicon Valley startup Theranos, was charged with nine counts of wire fraud and two counts of conspiracy to commit wire fraud, and she faces 20 years in jail if convicted. Why? For claiming that her company could run medical tests using a single drop of blood.

The public was misled by Holmes and former Theranos president Ramesh Balwani through a massive lack of transparency. The company did not have peer-reviewed evidence proving the safety and effectiveness of its blood-testing machine, and questions went unanswered about the integrity of Holmes and Theranos, leading to the company’s eventual demise. Although many lessons can be learned from Theranos’ failure, the one that stands out the most is this: Transparency is essential throughout the entire product development life cycle.

Transparency is critical for all industries these days, but especially for the life sciences sector. When it comes to innovative services and products from emerging life sciences companies, transparency can be pivotal to preventing fraud and wasted investments. It can help keep investors informed and up-to-date, improve product development processes and quite literally save people’s lives.

Below are five ways to achieve and maintain continual transparency in a fast-growing life sciences company:

1. Keep investors informed. Since your investors are financially backing your company and its products, they have every right to full transparency of products being created. They should be communicated with regularly and made aware of the development steps taken, any changes made to processes, and notable failures and successes throughout the entire product development life cycle.

That said, venture capital interest can be difficult to snag these days, especially for life sciences startups. Consider other funding sources available, such as angel investors, private placement, incubators, entrepreneurial competitions, crowdfunding as well as city, state and county resources. Above all, remember that no investment pitch—no matter the investor source receiving it—will succeed without a specific clinical date, clear unmet and demonstrable cost savings over existing solutions/treatments, and a commitment to peer-reviewed research and transparency.

2. Digitize all assets and processes. As technology advances and market demands intensify, systems that rely on inefficient, insecure, and costly paper-based and hybrid processes are falling short. By digitizing all assets and processes, life sciences companies can remain competitive and avoid a Theranos-esque debacle by making information more readily available to company stakeholders. Additionally, digital systems can help strengthen data integrity, which provides the assurance of accuracy. When first initiating a digitization project, it’s important to begin by analyzing all existing systems, processes, tasks, and assets, including those already leveraging digitization.

Also during digitization projects, keep in mind that any data being generated throughout R&D and manufacturing, supply chain and patient aftercare processes will need to be collected, stored, sifted, and mined for meaning. For many life sciences companies, this calls for strengthening master data management architectures and strategies (especially since IoT data can unleash even more process data). For instance, when a life sciences organization adds data analytics capabilities to its products or processes, usability can be radically improved without a dramatic increase to the price point. Furthermore, when combined with IP connectivity, such data is easy to collaborate on and transfer, regardless of a users’ location, whether it’s a doctor accessing the information through an app or a pharmacist receiving automatic shelf-stocking notifications.

3. Pass audits and inspections with flying colors. Audits and inspections tend to make employees stressed and unsure of exactly what could happen. “What if I don’t know the answer?” “What if I can’t provide what they are asking for?” Instead of allowing employee stress in an unproductive manner, remember that an auditor’s goal is to confirm that the trial is run in a way that ensures the safety of subjects, protects their rights, and generates reliable data, while an inspector has a similar goal with respect to the assessment of trial conduct. Transparency can help ensure that trials are run at the level of quality regulators and inspectors expect, and also empower employees to provide auditors and inspectors with the information they require, in the format they’re expecting, and precisely when they ask for it.

4. Encourage collaboration across the entire organization. Ultimately, everyone in a life sciences company needs to be on the same page and be able to effectively collaborate. The right digital solutions can connect employees and any company stakeholders, providing virtual collaboration environments while also avoiding the dangers of information silos. When data is siloed and various business units within a company are unable to share information with one another, errors ensue, work processes slow down, and employee frustration is inevitable. Make sure everyone in the company—from sales and marketing teams, to quality assurance and compliance units, to C-suite executives—is aware of who has access to what data, and ensure that all business units can share, connect, and collaborate to promote a truly transparent culture.

5. Get your clinical trials under control. With an ever-growing collection of data, activities and relationships that can change from day to day, it’s crucial to maintain indivisible connections between clinical operations and clinical quality. Because clinical trials are so data- and documentation-intensive, manual, paper-based processes are simply not effective. Digital systems can create efficient, consistent, and well-managed clinical processes that lead to successful trials. By digitizing, automating, and connecting all documents, the right tools can help orchestrate the management of site protocols, SOPs, and reporting across sites to accelerate trials while improving alignment.

A lack of transparency in clinical research has serious implications not only for patients, but also for providers, stakeholders, investors, and more. Failure to publish trial results is an ethical violation and withholding findings after individuals have participated in trials is a violation of a researcher’s responsibility to those participants. Most importantly, a lack of clinical trial transparency can leave patients and their providers with an incomplete picture of a treatment’s benefits and risks. The inefficiencies caused by a lack of transparency can also lead to unnecessary health system spending on ineffective or even harmful therapies.

While horrifying to witness it unfold, the Theranos saga is an outlier among ethical companies. In fact, many tech and life sciences companies have best practices already in place that other startups can and should learn from. For example, by prioritizing digitization, transparency, and collaboration, and regularly interacting with and getting feedback from customers, vendors, peer reviews, partners, and other third parties, life sciences companies have an opportunity to accelerate their products’ time to market, all while ensuring safety and continual compliance. The key is remembering that companies that play by the rules and prioritize transparency only stand to benefit and, ultimately, win!

Contributed Commentary by Matt Lowe

Aligning with the industry requirements has always been a priority for organizations. En route, they are heavily relying on revolutions that can help them stay ahead of the competition. One such revolution is Industry 4.0 – an amalgamation of pathbreaking technologies like industrial internet of things (IIoT), big data, artificial intelligence (AI), etc. The industry 4.0 has automated and optimized companies’ business processes and business models.

As industries across the world reaping the benefits of Industry 4.0 and its technologies, the pharma industry has taken a nimble step towards embracing and adopting the change commonly referred as Pharma 4.0. The move is aimed at digital transformation of two most important areas of pharma, namely, product development and regulatory operations.

Regulatory Operations: The data collected during research, clinical trials, product development, and post-market surveillance often remains disparate. When put together, without a right means to analyze the entire data from various perspectives, the results can either be inconclusive or be ambiguous. There, Pharma 4.0 comes into picture with big data analytics that implement algorithms to sum up clusters of data and to analyze it in less time.

Pharma manufacturers are willing to simplify their manufacturing processes and streamline regulatory operations. But do all the technologies of Industry 4.0 suit the needs of the pharma industry? Apparently not. Only a few of them, as listed below, fit the required criteria.

1. Big data
2. Smart factory
3. Internet of Things (IoT) and cloud computing
4. Artificial intelligence (AI)
5. 3D Printing

Pharma 4.0: functionalities in focus

Pharma 4.0 is here to help the medicinal product manufacturers to evolve and become more efficient and at the same time to reduce the costs. But in what way? Which parts of regulatory operations can they be applied to?

1. Drug research and development

Pharma companies rely heavily on innovation, and research for drug development. Companies are turning towards new revolutionary digital capabilities to reduce the time spent on R&D and boost their productivity. In such scenarios, AI-powered dashboards can help companies to keep track of the latest updates from the health authorities and comply accordingly.

As is well known, in the early stages of drug development,clinical data from public repositories is collected to analyze the history of proposed drugs’ ingredients. With machine language and deep neural networks, the advanced extensions of AI, such data can be utilized to derive insights on possible effectiveness/risk/benefits of a new compound. They allow manufacturers to enhance the nature of the human study and their decision-making while optimizing their workflow. In a way, stakeholders can identify the patterns and nature of patients to develop more customer-centric products and can bank upon less chances of failure and increase the cost efficiency.

2. Clinical research

With a large number of resources involved in clinical research and trials, manufacturers should work upon developing statistical analyses plans and protocols. Apart from this, there are several documents which demand ample amount of time for analysis. With the help of AI-based tool integration, all these processes can be streamlined and expedited with minimal errors. AI-powered tools help researchers to go through research documents and extract necessary data with utmost accuracy within the time required. They can help in analyzing clinical information in real-time to ensure compliance while compiling, validating and submitting clinical trial data.

3. Manufacturing

Health authorities across the world are emphasizing on implementing continuous manufacturing process by applying concepts of smart factory which make the process more connected, flexible, smart and precise. With the continuous process, manufacturers would not have a need to stop the manufacturing process in between for evaluation. This reduces the overall downtime of the process and also the human errors. This shift is helpful for manufacturers who are catering to the need of personalized medicines.

Pharma 4.0 assists manufacturers to minimize consumer risk and increase process optimization by statistically analyzing data with the help of big data. The insights drawn from the data can help manufacturers make necessary changes to the manufacturing process to achieve the desired level of product quality. It helps them to follow the manufacturing best practices.

4. Quality management

The Pharma 4.0 technologies have the capability of transforming each and every function of the value chain. They allow manufacturers to rely solely on results obtained from the real-time data. Digitization will help manufacturers to ensure better quality and compliance while reducing human errors. For example, for publishing and submissions, companies have become paperless and are relying heavily on electronic records and electronic dossier submissions. With Pharma 4.0 technologies, they are assured of data integrity is maintained across the life cycle.

Challenges in adoption

Though the revolution of Pharma 4.0 is set to create limitless opportunities, there are challenges for companies to overcome.

1. Unclear regulations for new-age technologies

Pharma 4.0 seems relevant and advantageous for both manufacturers and data reviewers, but there is still a vacuum in terms of regulating these technologies. While some health authorities are taking quick measures to establish the standards, others are waiting for regulated markets’ reflections.

2. Lack of skill set

Pharma 4.0 requires an extensive technical skill set to carry out operations efficiently. The workforce to be deployed should possess knowledge with respect to Regulatory aspects and the technological improvements as well. As a radical improvement in the knowledge is necessary to sustain the revolution, organizations are required to build teams that are dynamic to adopt the technological transformations.

3. Data integration

One of the main concerns for pharmaceutical companies is maintaining data integrity. While many companies have started using technologies for electronic conversions and paperless submissions, some are lagging behind with the legacy technologies integrated. Without the electronic version of data sets, collating and migrating data on to virtual platforms will become a challenge for companies, which in turn will lead to difficulty in comprehensive data access and assessment.

Conclusion

The pharma industry is on the verge of a radical change. Across clinical trials, manufacturing processes, technology integrations, and ever-evolving regulations, the industry is in need of complete transformation.

By adopting new-age technologies, companies can streamline their processes, increase productivity, accelerate their regulatory processes and reach the global markets in an expedited, cost-effective, and compliant way. But the regulation question prevails. How regulated are these technologies? While some of the global health authorities are taking considerable measures to regulate Pharma 4.0 technologies, a few are still considering their viability. Sooner or later, however, they will be the future of the pharmaceutical

De volgende open training sessie is onze 3-daagse Contaminatie Controle Training. Deze zal in Darwin wetenschapspark te Niel doorgaan. Wederom in samenwerking met Co-Valent. Onze opleidingen binnen onze Q-Academy zijn “gratis” beschikbaar via Co-valent: Co-valent biedt GRATIS opleidingen aan voor ondernemingen die behoren tot de life science sector – paritair comité 116 (arbeiders) of 207 (bedienden).

Hierbij een overzicht en de nodige links om u in te schrijven:

Quality is nonnegotiable in the medical field…

When dealing with medical problems, the medical device should not add to these problems. Medical device manufacturing requires the highest quality—and industry takes no chances with this. Regulations are de rigueur. The need for quality of a bone screw should be obvious, and the same goes for any medical device.

While medical devices in years past may have meant items like stethoscopes or blood pressure cuffs—and these haven’t gone away—a number of innovations in the medical industry such as stents and pacemakers require extremely high levels of quality.

As the devices themselves continue to evolve, so do the regulations surrounding them. Ensuring compliance is never easy, but in the medical device field, it may have gotten a little simpler. Changing medical device manufacturing audits is a multi-year process, but it’s going on now. Medical device manufacturing is an increasingly complex field with one aspect—the audit program—now aiming to be less complicated.

The Medical Device Single Audit Program (MDSAP) is a new program that simplifies the audit process. According to the FDA, “The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.”

In other words, one audit can do more. The site goes on to explain that the program allows medical device manufacturers to be audited once for five different medical device markets: Australia, Brazil, Canada, Japan and the United States. Companies are now in the midst of this implementation. And it seems that the program has been well-received so far.

On the FDA site, there are testimonials from industry attesting to the benefits of the MDSAP: “With a Mission to improve the quality of life for patients, prevent progression of chronic diseases, and reduce overall healthcare system costs, ResMed is committed to driving innovation and efficiencies across all aspects of our business. The MDSAP program has allowed us to consolidate the global regulatory assessment process across multiple international locations, reducing internal costs while increasing the overall predictability of these efforts across our global footprint. By minimizing disruption to our business, we can focus on delivering the safest, most effective and technologically advanced products possible.”

Advanced products deserve more advanced audits. There are no shortcuts to good quality, but repeatedly proving your compliance to quality programs can take away from this mission. So how did this program come about? As discussed on the FDA site, the International Medical Device Regulators Forum (IMDRF) noted that a global approach to auditing and medical device manufacturing could improve their safety on an international level. Harmonizing the medical device manufacturing field could be a boon to industry as well as consumers. Making it easier to provide medical devices on a global scale, with fewer audits along the way, benefits manufacturers and the consumers they serve.

In other words, this program aims to make it easier for manufacturers to offer their devices to a worldwide market. As stated on the FDA site, the international partners participating in the MDSAP include: Therapeutic Goods Administration of Australia; Brazil’s Agência Nacional de Vigilância Sanitária; Health Canada; Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency; and The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers.

BSI, one of the auditing organizations that have worked with the new program, say that feedback about the program’s benefits has been “overwhelmingly positive.” According to the company, “A Single Audit by Auditing Organizations would:

• minimize medical device manufacturer disruptions due to multiple regulatory audits
• provide predictable audit schedules (agenda with opening and completion dates)
• benefit patient health and patient access with ease of entry to multiple markets
• leverage regulatory resources
• incorporate ISO 13485 assessment
• requirements, including Australia, Brazil, Canada, Japan and U.S.
• reduction in time and resource dealing with findings from multiple audits
• reduction in the cost of audits in comparison to independent audits
• improved transparencies in the industry.”

While outside forces do play a large role in the audit process, having good audit processes is something that you can control. Being prepared for the audits—no matter which program you are using—may come down to the right tools. One critical one is audit management software. In particular, being able to streamline audit tasks and centralize audit data is important. With the right tools, you can gain better visibility into audit performance as well as identify potential trends. Maintaining a strong record history becomes easier, as does maintaining compliance with FDA 21 CFR Part 11.

Manufacturing medical devices is an important mission, one that potentially benefits all of us. When your doctor suggests a new device, it’s comforting to know that the device was made to the highest standards. Fewer audits potentially means more time for innovative ideas. The next medical breakthrough could be just around the corner.

by Michelle Bangert

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

Volgende opleiding op maandag 2 december 2019; “GLP labo activiteiten binnen GMP life science productiebedrijven”. De sessie gaat door in het Darwin wetenschapspark te Niel. Deze opleiding binnen onze Q-Academy zijn “gratis” beschikbaar via Co-valent: Co-valent biedt GRATIS opleidingen aan voor ondernemingen die behoren tot de life science sector – paritair comité 116 (arbeiders) of 207 (bedienden).

Deze training is een aanvulling op de GMP/QMS-training en geeft meer achtergrond voor projectingenieurs en leidinggevende binnen GMP QC labo’s.  We bieden een regulatorische en praktische kader van het behandelen van stalen, uitvoeren en documenteren van QC testen en de daarbij behorende kwaliteitssystemen zoals validatie/kwalificatie, change control.  Daarnaast staan we ook stil bij transfers.

Schrijf je snel want de plaatsen zijn beperkt: https://www.co-valent.be/nl/details-formations