Tag Archives: Pharmaceuticals

Amplify Analytics: De-risking Analytical Development for Pharmaceuticals

What a difference 10 weeks can make! Back on March 31st, Malvern Panalytical and Concept Life Sciences announced our partnership – just as lockdown was starting in the UK – but already it feels like a different era!

Back then, delivering webinars from spare rooms whilst trying to minimize background noise and keep children occupied was a novel challenge, but now it’s part of daily life for most of us.

The feedback received from customers of both organizations has been hugely supportive, and we already have a significant number of joint projects in motion which are delivering value to our clients globally.

Hot on the heels of the initial announcement, which was centred around the provision of analytical services to complement the portfolio of physicochemical characterization solutions from Malvern Panalytical, we are delighted to be presenting a further web seminar on June 25th, in which we will reveal the latest developments in our partnership – newly-christened ‘Amplify Analytics’.

Amplify Analytics provides services which are specifically aimed at clients in the small molecule drug development and generics space and provides solutions for the challenges of low rates of return on investment, late stage pipeline failures, regulatory hurdles and resourcing issues within pharmaceutical development companies.

We provide an agile and collaborative team with extensive expertise and knowledge to precisely complement your in-house capability and consistently deliver on your project milestones.

Amplify Analytics increases the likelihood of product success, from candidate screening through to formulation and subsequent manufacturing, by implementing the developability classification system (DCS) and manufacturing classification system (MCS), informed by decisions based on robust analytical data, and providing absolute confidence in the process.

Join us on June 25th to find out how Amplify Analytics can de-risk and accelerate your small molecule development projects.

Spotlight Interview with Miki Goetsch, Director of Regional Expansion at Inceptua

A conversation with Miki Goetsch, Director of Regional Expansion at Inceptua

Miki Goetsch is a Director at Inceptua Group, responsible for rapidly growing regions, such as Asia’s developing clinical trial market. Miki is also a board member for Inceptua’s Japan office in Kobe.

Miki has extensive experience working with Japanese, American, and European companies, particularly with consulting on how to benefit most efficiently from the opportunities of collaboration between East and West. During her time at Inceptua, Miki has been responsible for ensuring the success and setup of the Japan, China, and UK offices, as well as leading the Operations team in the Clinical Trial Services department. Her main focus is to strategically implement what is best for clients in terms of their needs from EU/US to Asia. Miki is fluent in Japanese and English.

Miki is reachable for questions and consultation on China and broader Asia expansion at miki.goetsch@inceptua.com

BRW: What do you hope the audience will learn from this webinar?

China has become the world’s second-largest pharmaceutical market, which comes with enormous opportunities, but the landscape is complex. Our webinar will help the audience understand the challenges they may face when undertaking a clinical trial project in China. We will discuss how finding a reliable partner who can provide strategic consulting, support with sourcing, and ensure high-quality standards and service in the region is key to making the most out of the opportunities in China.

BRW: What discussions do you look forward to having with the audience?

Companies hoping to launch clinical trial projects in China are often daunted by risks to supply chain integrity, and the inevitable challenge of cost control in an unknown market. We look forward to addressing any specific queries audience members may have on these issues and exploring some of the solutions Inceptua can offer.

BRW: What do you enjoy most about your role?

I greatly enjoy working with our specialized team in China to explore new business opportunities. My colleague and co-host, Viktor Sandstedt, has in-depth knowledge of the local market and knows how to support domestic and international clients in finding the best solutions for operating in China. In addition, our COO, Kay-Christian Karstadt, is an expert in the Asian Pharmaceutical industry, specialising in the optimization of global clinical supply chains.

I am a Japanese native speaker, but the rest of our team in China is fluent in Mandarin, including Viktor and Kay. I really enjoy working as part of an international team who are engaged with the local culture in China and can help guide our clients through cultural and communication challenges of operating there.

BRW: How did you get into the industry?

I joined Inceptua four years ago. I’ve always had strategic roles in aligning the needs and priorities of East and West, usually between Japan and the US or EU. Since joining Inceptua, I’ve been involved in setting up the Japan, China, and UK branches and have held global roles in Administration and Operations. As we are adapting to current market trends, we now have a specialized team that can support clients wishing to expand their activity in Asia. Inceptua has a long history of doing business in China, and we have an office in Shanghai. I love that Inceptua is really answering to our clients’ needs and proving to be a flexible, strategic, and successful partner in the growing Chinese market.

BRW: Where is your favourite place in the world and why?

Tough question – I must say that there is a special place in my heart for Japan and Texas as both are my home, but I’ve always loved travelling and encountering new countries and cultures. I’ve had the great pleasure to have been to more than 50 countries and can confidently say that there is a uniqueness in nature, culture, architecture, cuisine, and people everywhere, in which that uniqueness connects us all. If I have to choose right now, I think I live in my favourite place in the world which is Berlin, Germany. I view it as a microcosm of the world, with many unique people and cultures colliding, coexisting, and collaborating, and it’s a great feeling living in a city where uniqueness is valued.

Join Miki Goetsch on the webinar entitled ‘Navigating Sourcing in China’ by Inceptua on 3PM London/10AM New York

Register Here!

Joanna Taylor, Senior Manager | EMEIA Advisory – EY

A conversation with Joanna Taylor – Senior Manager | EMEIA Advisory at EY

Joanna Taylor is a member of EY’s European, Middle East, India and Africa (EMEIA) Advisory team with over a decade of experience in the Life Sciences industry, working globally across the R&D and Commercial functions.

She has implemented regulatory information management, document management systems, clinical data warehouse, clinical reference library, master data management and product lifecycle management systems and enjoys working with Business and IT stakeholders to help organizations to overcome the challenges of harnessing new and emerging technologies and create real business value.

Joanna has a BSc (Hons) in Mathematics and an MSc in Management and combines her professional experience with PhD research into the benefits and challenges of social networking for those involved in the treatment and management of non-communicable diseases. She is a published researcher, presents at conferences and is a lecturer on the Business of eHealth and Public Health Informatics.

What do you hope the audience will learn from this webinar?

I hope that the audience will be as energized and motivated as we are about the future of regulatory in Life Sciences and how digital technologies such as cloud based solutions from Veeva, robotics and artificial intelligence can achieve real business value to the industry. The technologies already exist and it is often the business change required for this type of transformation that poses the biggest hurdle.  We plan to discuss approaches to enabling business change during the webinar and hope that participants will learn something new about how they can achieve the success they are striving for.

What discussions do you look forward to having with the audience?

Building a better working world is our purpose at EY. I’m looking forward to hearing about the experiences of participants in digitally transforming their regulatory functions, where they have had the most difficulties, how they have addressed these and the potential they see for the future. Sharing these insights, experiences and “war wounds” amongst this community is where we learn from each other and convert theory into practice.

What do you enjoy most about your role?

The variety of interesting people that I work within the industry and how different companies are responding to the regulatory pressures and technology trends that they are faced with. I am a practical person and seeing tangible change in the industry, that ultimately have positive implications for patients, is why I get up in the morning.

How did you get into the industry?

After becoming a consultant, I had my first experience working in the industry during the implementation of a clinical trial management system. I was hooked and the rest is history.

Join Joanna Taylor on 15th February for a webinar entitled Digital Transformation in Regulatory at 3PM CET/2PM GMT.

Dr. Adam Elhofy – Chief Science Officer at Essential Pharmaceuticals, LLC

Adam ElhofyDr. Adam Elhofy is the Chief Science Officer at Essential Pharmaceuticals, LLC. Dr. Elhofy developed the core technology for the Ess line of products and aided in creating patents around novel uses of materials. He has over 14 years of scientific research experience in the areas of immunology, neuroscience, and oncology. He was funded by both the National Institutes of Health and the Multiple Sclerosis society as an investigator at Northwestern University Medical School.

His doctoral research won him the award of the Top 5 trainee scientists by the American Association of Immunologists. Dr. Elhofy has 14 scientific publications in peer reviewed journals. He has played a variety of roles with start-up biotech companies ranging from Principal Investigator to Director of Corporate Development.

Tell us a little about Cell-Ess and how it fills a need in the industry for bio-processing?

For Process Development Scientists and Manufacturers, Cell-Ess is a media supplement and feed that is added to CHO cell media platforms to provide an additional increase in productivity while improving protein quality.  Cell-Ess is unique in that it can be added across different clones, media schemes and cell backbones to improve titer, even in previously optimized systems.  Further, Cell-Ess increases per cell productivity, which reduces issues downstream during purification since it does not increase biomass.  Finally, Cell-Ess not only improves titer, but it also improves glycosylation, which means that one does not have to sacrifice titer for quality.

What do you hope the audience will learn from attending this webinar?

The audience will learn how lipids may be a critical and overlooked player in protein formation, production, and quality, but have been a challenge to deliver to cells due to issues with solubility and stability.  In addition, they will learn how adding in lipids via a novel delivery mechanism will aid in increasing titer.  The talk will also demonstrate how potential improvements in Golgi function increase glycan pattern consistency and higher order glycosylation.

What do you find most challenging in this industry?

We hear many different challenges when we speak with biopharmaceutical companies.  Therefore, there are several hurdles we face when collaborating with them to address their challenges.  The first is trying to understand what the objectives are of the end users.  In some cases, the stated simple objective is not really the end goal, so trying to understand the unique goals of each group has been a challenge.  Sometimes there are added hurdles for companies when they aren’t able to share their most pressing issues and needs upfront.  The second part is the much bigger challenge of crafting a method to utilize Cell-Ess within the pre-defined parameters to reach the target.  Since every biopharmaceutical company has different (sometimes proprietary) practices, we strive to ensure that our recommendations are robust enough for every scenario.

What is the most rewarding aspect of your job?

The most rewarding aspect is helping solve problems collaboratively with potential users.  There are often small windows of opportunity to work with a new and innovative product.  The window may be small due to logistical and regulatory practices already in place, so finding the best way to use the right tool at the right time is rewarding.  Of course when our solution helps a biopharmaceutical company address their current issue, it is an added bonus.

Join Dr. Elhofy and Essential Pharmaceuticals in their upcoming webinar “Mechanisms to Increase Titer While Improving Glycosylation”.  Register now!

Sophie Bell BSc, Senior Technician – In-Vitro Toxicology – Wickham Laboratories Ltd.

Sophie Bell BSc (2)

Sophie Bell joined Wickham Laboratories in 2016 as a Technician in the In-Vitro Toxicology department. She was promoted to Senior Technician the same year and currently specialises in in-vitro Pyrogen testing and Cell Culture methods. 

She received her Bachelor’s degree in Biomedical Sciences from the University of Sheffield in 2015. 

 

Tell us a little about Wickham Laboratories, what does the company do?

Wickham Laboratories specialises in microbiology and toxicology testing for the global pharmaceutical and medical device industries.  We have over 50 years of experience in testing services and a broad range of technical expertise in identifying and providing solutions for our clients.  This long-standing experience in the industry means there is rarely a problem that we haven’t previously encountered and our clients rely on this expertise to ensure their regulatory compliance.

Why did you choose to hold this webinar?

We continuously strive to identify new technologies and services that are of benefit to the company, our clients and the industry. As part of this we recognise the need to implement in vitro testing methods where ever possible and have a strong commitment to reducing the need for animal testing.

Wickham Laboratories has a dedicated in vitro R&D department, of which I am part of, and our sole focus is on investigation into and implementation of non-animal alternative tests. We hope to showcase our extensive knowledge in both the technical and compliance aspects of implementing these alternatives.

What do you hope the audience will learn from attending this webinar?

My colleague will be running through the ongoing research into developing a potency bioassay replacement test and in my section of the webinar, I present a comparison of the three approved methods for pyrogen testing including limitations that should be considered.  While these specific instances may not be applicable for all of the audience, I hope that the audience will gain some further insight into the complicated process behind developing these alternative methods.

It’s important to understand that it’s not just a case of wanting to replace the animal test, but we also have to ensure through very thorough research that the new methods are at a minimum equivalent to (and ideally, better than) the existing methods, and often have to be considered in a product specific case by case basis.  This is because of the crucial focus on patient safety, which is at the heart of everything we do at Wickham Laboratories.

What was your inspiration to get into the industry?

After graduating from the University of Sheffield in Biomedical Sciences, where I gained experience in a research laboratory, I was looking to apply my knowledge and develop skills in an industry based setting. Moving into a company with the wealth of experience such as Wickham Laboratories, made perfect sense.

What is the most rewarding aspect of your job?

I would say the most rewarding aspect of my job is knowing that the work done here at Wickham Laboratories allows for utter assurance of product safety and, therefore, patient safety. In addition, being a part of the research into alternative methods is highly exciting, interesting and rewarding work.

Join Sophie Bell & Wickham Laboratories on 29th June for a webinar entitled ‘The Push for In-Vitro Alternatives in Toxicology’ at 3PM London/10AM New York.

 

Process Protection – What Does It Mean To You?

Guy Matthews, market development manager at Parker domnick hunter, explores what process protection means for biopharmaceutical manufacturers… and examines how supply chains can be made more robust.

Imagine the scenario. Your new blockbuster drug is making a significant difference to the lives of patients. But then your supply chain fails, taking the product out of circulation. The consequences for patient health – plus the damage to your reputation as a biopharmaceutical manufacturer – would be catastrophic, even before you consider the economic impact. Given the investment that has been put into the development of a production process – in both time and resources – it’s vital that the process can be implemented in a way that is as repeatable and predictable as possible, and that the risk of contamination, process failure or production shutdown is minimized.

As a biopharmaceutical manufacturer, you may have employed elements of quality by design (QbD) to established limits of operation, taking into account critical quality attributes (CQAs) but is process protection built into your operations? And what does it mean?

Protecting your process from contamination

Contamination is one of the most obvious ways in which a process can be compromised. The presence of a biological contaminate for example a mycoplasma, virus or bacteria can result in a reduced yield or the complete loss of a batch.

However, there are a number of ways in which contamination can be combated, including the use of:

• Mycoplasma retentive filters when processing mammalian cell culture media
• Bioburden reduction filters at key stages of the process
• Fully enclosed processing, making use of single-use technology
• Viral risk mitigation treatments such as HTST (high temperature short time)

System failure protection

Mitigating against the risk of production system failure and the resulting unplanned downtime also forms an important part of process protection, resulting in a secure supply chain.

You would not run a car without having it serviced regularly and biopharmaceutical manufacturers should also have a service support plan in place for identified pieces of critical equipment. This will ensure the system is running in an optimal state.

Also essential – though sometimes overlooked – is the importance of quick access to critical components. The additional investment in critical spares (whether they are components or fully assembled systems ready to be brought into play at a moment’s notice) would normally be at a significantly less cost than that incurred by an unplanned plant shutdown due to component failure and the inability to replace it. Linked to this is the need to ensure access to source codes for automated equipment. Such systems would ideally run on an industrial platform rather than a vendor’s bespoke solution, allowing support from more than one source.

The purchaser/vendor relationship

As a biopharmaceutical manufacturer, the relationship you have with your vendor can also shape your ability to protect your processes and guarantee operational continuity. Having a supply agreement with the appropriate service level agreement in place is a good starting point, as is ensuring that the vendor has a comprehensive disaster recovery plan, which could include (but not be limited to) the flexibility to offer manufacturing at dual sites.

But consider this. If your plant is made from stainless steel and a SIP cycle fails, it can be repeated – albeit with consequences for lead times. The use of single-use systems in bioprocessing changes the landscape: no process can be put into operation unless you have available to you the assemblies that make up that process. Put simply there is no product if there is no process.

In this environment ensuring that the supply chain is robust is critical and the relationship between the purchaser and vendor should go beyond placing orders and waiting for deliveries.
Having a two-way conversation and treating the relationship as a partnership, rather than simply viewing the vendor as a commodity supplier, can have significant benefits for process protection.

As a biopharmaceutical manufacturer, sharing information with a vendor on your manufacturing forecasts, for instance, can help the vendor to predict demand for stock, and plan production of key components, part-finished assemblies or indeed, finished systems around this forecast. This will enable the end user to access stock at the appropriate time rather than risking the consequences of a long turnaround time for delivery.

You may also consider holding stock in line with your own production forecasts and putting in place a contingency against product or process failure. Standardization can help here. If common parts are used in more than one process then the need for a contingency can be reduced.

In addition, a closer vendor/purchaser relationship will help to prevent any issues surrounding unrealistic expectations around delivery times, and support the development of a more holistic approach to the supply chain by all parties ensuring the supply of life saving products.

Contributed by Guy Matthews,  Market Development Manager at Parker Domnick Hunter

Join Parker Domnick Hunter on 13th June for their webinar entitled ‘Protect The Process; Protect the Patient‘ for more information on Process Protection.

Register Here

Keith Howells – Senior Vice President of Development, OmniComm Systems

Data Collection, Clinical Trials and Healthcare:

A Conversation With Keith Howells, Senior Vice President-Development for OmniComm Systems

Keith HowellsMr. Howells has almost 25 years of experience in building and implementing applications that support clinical research. As head of development for OmniComm Systems, he is responsible for the TrialMaster product for Electronic Data Capture, and the TrialOne product for Phase I clinic automation. 

Prior experience includes 5 years as head of development for Medidata Solutions and 5 years as head of development for Oracle’s pharmaceutical application suite. Mr. Howells has a degree in physics from Oxford University, England.

Tell us a little about OmniComm; what does the company do?

OmniComm Systems, (OTCQX: OMCM), provides products and services that allow pharmaceutical and biotech companies to collect and manage clinical trials data. At first that sounds rather mundane – how hard can a data entry application be?

But in fact, the task is almost infinitely complicated and infinitely valuable. Whereas most web-based applications know in advance what data they wish to collect – Hertz.com knows you want to rent a car and Hotels.com knows you want a hotel room – we don’t know in advance what data is to be collected because every clinical trial is different.

Maybe the researchers are collecting blood pressure readings, maybe tumor measurements, maybe quality-of-life questionnaires, maybe all three. So we have to first supply a tool that allows customers to define their clinical trial; then we have to dynamically display the data-entry pages as if each had been lovingly crafted by hand. Those considerations, coupled with stringent regulatory requirements, make this a challenging and fascinating business.

In terms of the value, if we can save a month off the research time for a drug that becomes the next Humira, that month saved is literally worth a billion dollars. So we work hard to make sure our products are feature-rich and easy to use, and our service levels are highly responsive. There are a lot of vendors in this space, but we feel we have the right mix of robust capability and nimble responsiveness.

Why did you choose to hold this webinar?

It is remarkable how many different systems need the clinical data, whether for project management, payments to the investigative sites, safety reporting or data analysis. In today’s fast-paced world, you cannot afford a classical software development approach for each of these different data extract needs.

We’ve developed a number of generic approaches such that data may be extracted without programming, thereby providing a much more flexible and productive set of tools. We feel it is useful to share these techniques with interested members of the industry.

What do you hope the audience will learn from this webinar?

A number of the examples are based on our own technology, but we believe this webinar will provide value regardless of which data-collection system a company is actually using. We expect the audience to learn the generic mechanisms by which the raw data can be provided to the outside world, the kinds of re-formatting and manipulation that can be done on that raw data, and the standard mechanisms for extracting the data into other systems.

For example, safety reporting uses an international standard called E2B, and we’ll give a little insight into how that works and how the data is structured. It’ll be enough to educate some people and scare others!

What was your inspiration to get into the industry?

It was a total accident actually. When I was working for Oracle 30 years ago, the company split into servicing different vertical industries and there was no obvious choice for the pharmaceuticals vertical. So I bid for it. I had no idea what I was getting into, but the industry has proven uniquely fascinating, so I never left. It’s quite humbling to see the science and passion supporting the industry we serve, it’s an honor to be part of it, and obviously the mission brings a great sense of value. We’re not directly bringing life-saving products to market, but we’re helping the people who are.

What is the most rewarding aspect of your job?

We get to sit down at a computer screen and, out of thin air, create something that becomes a critical piece of other people’s lives. That’s pretty motivating.

Don’t miss the chance to join Keith and OmniComm in their upcoming webinar ‘Extracting Clinical Data for Reporting, Safety, SDTM & More’.

Mohammed Homman, CEO – Vironova AB, Sweden

by Mohammed Homman, CEO Vironova AB, SwedenMohammed Homman 800x673

Mohammed Homman is a dedicated entrepreneur with a degree in Biology from Uppsala University, Sweden and a Masters degree in Chemistry from the Karolinska Institute, Sweden. Mohammed developed ideas from his graduate research project in virology into the company, Vironova AB which he founded in 2005.

Image analysis software and a proprietary bench-top electron microscope system are at the heart of Vironova, that has now grown to 60 people and provides an instrument, software and expert consultancy solution.

Vironova was declared “one of the best start-ups of the year” in 2005, by the Swedish Government Agency for Innovation, VINNOVA. and Mohammed was honored with the Innovator of the Year award, by ALMI Stockholm.

Vironova AB has grown out of Mohammed’s passion for developing new ways to treat viral diseases and a need for objective viral and particle analysis. In a series of new companies, he has pursued various aspects of this goal.

Mohammed has continued to be recognized for his entrepreneurial and social skills, most recently in 2016 with the award from the King of Sweden of the “His Majesty Carl XVI Gustaf prize for remarkable entrepreneurial achievements”.

Tell us a little about Vironova, what does the company do?

In brief, you could say that we pioneer methods for nanoparticle analysis to turn the invisible into meaningful data.

We make electron microscopy available to the pharmaceutical industry through desk-top, user-friendly instrumentation and expert services in a regulatory environment. This gives our customers control over processes and quality and access to objective data when developing products using biologicals and nano-particles.

Vironova is alone in providing a complete package of hardware, software, services and systems in this area.

How did you get to where you are now?  

I founded Vironova in 2005 out of my own passion for studying viruses and finding new ways to treat viral diseases.

It was very problematic to have to use a massive electron microscope, count particles manually for hours and not have an objective or reproducible way to collect data from the images.

To solve the problem, I contacted people of many different specializations: microscopists, programmers, experts in imaging and image analysis etc. Bit by bit we built a whole system with a desktop transmission electron microscope (MiniTEM), proprietary software, services and consultancy. No other company offers anything like this.

So that all started 10 years ago but the need to collect meaningful data from electron microscopy in drug development is only growing. Biological structures (like viruses or liposomes) are being used more and more in drug delivery or as vaccines etc.

Why did you choose to hold this webinar?

We engage wherever possible with our customers –it’s through these discussions that we learn how to best serve them.

Vironova is in the middle of a very exciting time. Our new MinTEM system is on the market and we’ve experienced a great interest for it as there is a need for new solutions for sub-visible particle characterization in the biopharmaceutical industry.

We have a lot of expertise that we can share with this community, and solutions we believe would be useful to them.

What is the best thing about your job?

That’s easy! The chance to do something significant towards improving new drug development, healthcare and to move the virus field towards new solutions for viral diseases. We’re working on many fronts and growing steadily. There’s always something going on at Vironova, so it’s an exciting place to be.

Join Vironova for their webinar on Gene Therapy Vectors. Register now!

Three Recommendations for Improving Clinical Assessment – Comprehend Systems

Multiple logins, one patient

Recently, a sponsor’s Chief Medical Monitor remarked to me that it requires six different logins for them to pull together a coherent view of patients in their studies. Unfortunately, this is only the tip of the iceberg.

With the rise of outsourcing and proliferation of data sources, it takes data management even longer to aggregate, clean, and validate data so it provides a useful picture of each study. Once this data is aggregated, it is often outdated. Even when it is accurate, it can be tough to sift through it to find specific sites or metrics that require additional attention from the medical team. When the team finally identifies patients that require additional investigation, the medical team typically runs into this six-logins problem. And once this patient data is compiled, it is often tough to create visualizations that help the medical team perform clinical assessment.

This problem is widespread. Over 85% of medical and data teams recently identified disparate data in multiple systems as the most significant barrier to medical review and clinical assessment.

How can we improve this medical review process?

Three recommendations for improving the clinical assessment process

We have worked with dozens of medical and data management teams to address this particular challenge. As a byproduct of these partnerships, we have identified three key recommendations for teams to overcome these challenges – and, in turn, create a more efficient and effective process for medical review and clinical assessment.

  1. Automate data aggregation

Increased outsourcing and digitization of clinical trials has created a wealth of data – and also a wealth of data sources. Although a huge opportunity, it has now become a significant challenge that typically requires a data manager to spend hours manually compiling data from this disparate sources across multiple vendors into a single, usable dataset. By the time manual aggregation is complete, the data is typically outdated. Automating this process will not only improve productivity, but provide real-time, up-to-date insights on each study.

Though perhaps the most obvious and impactful recommendation, it has yet to be widely adopted in the industry. In a survey performed earlier this year, over 90% of clinical operations teams report that they still have not automated this process, and the same respondents identified real-time data aggregation as the single most significant barrier to meeting milestones and keeping studies on track.

  1. Standardize and monitor the most critical KPIs

As MCC and Tufts CSDD recently reported, industry dynamics have placed a greater emphasis on standardizing and tracking key performance indicators (KPIs) across clinical research teams to identify best practices and diagnose areas for improvement. In fact, two-thirds of sponsors now use a standard set of KPIs to gauge study progress.

Standardizing KPIs is a critical step, but is only important to the extent that accurate data can provide insights on these KPIs and analytics can direct the team to focus on operational metrics that matter most for each study, site, or patient. These requirements suggest that data aggregation is necessary but insufficient. Once aggregated, it is critical to organize and analyze it so the research team can make decisions fully informed on progress against their standard KPIs.

In a world where research team members face multiple priorities competing for their attention, advanced algorithms that monitor this data and notify the team when there are outliers or unexpected outcomes are even more critical to focusing on only the most important issues.

  1. Invest in graphical patient profiles

After implementing the first two recommendations, teams will have access to data across their sources, analytics on KPIs that show insights to adverse events and protocol compliance for each study, and monitors that notify specific members when a KPI requires their attention.

But when medical monitors need to perform a clinical assessment, they will still be forced to log into multiple systems to cobble together a clear picture of each patient. And once this data on each patient is aggregated, it is often tough to discern which are the most important data points for the particular patient in question.

To overcome this hurdle, teams should invest in graphical patient profiles that provide a clear picture of labs, adverse events, concomitant medications, and other critical inputs to clinical assessment for any given study. Visualizing this data will rapidly accelerate the process of performing clinical assessment and reduce the time it takes to begin drafting the clinical narrative.

The opportunity to benefit research teams and patients alike

Though implementing these three recommendations may seem like a chore, it is within reach for any clinical research team, regardless the size of their company. A new class of cloud software called Clinical Intelligence empowers teams to adopt each of these three recommendations in a matter of weeks.

Teams who follow these recommendations are experiencing productivity gains, cost savings, and, as a result, reduced cycle time for their studies. And, critically, the research teams are not the only ones to benefit. Patients who are participating in these trials are also finding that their issues are more quickly and readily addressed, resulting in a better patient experience.

By investing in Clinical Intelligence, clinical research teams automate data aggregation, standardize analysis of KPIs, and visualize patient profiles, thereby improving the clinical assessment process and patient experience at the same time.

Be sure to join Comprehend Systems in their upcoming webinar “Best Data Practices for Accelerating Medical Review” on 8th December. For more information and to register, click here.


About Comprehend Systems, Inc.

Comprehend offers a suite of Clinical Intelligence applications that enables ClinOps Execs, Data Managers and Medical Monitors to significantly improve the speed, safety and quality of a portfolio of clinical trials across teams, sites and CROs. Comprehend’s Clinical Intelligence Suite is particularly effective for centralized monitoring, risk monitoring, CRO oversight, and medical monitoring initiatives. Comprehend gives life sciences companies a new source of competitiveness and the confidence to deliver high quality clinical trial submissions at a new speed. Comprehend: the speed to quality results.

 

Contact

Comprehend Systems
(877) 201-3560

Ronak Savla, Pharm.D., Ph.D., Scientific Affairs Manager, Catalent Pharma Solutions

ronak-savlaRonak Savla is the Scientific Affairs Manager at Catalent Pharma Solutions and the Catalent Applied Drug Delivery Institute. He earned his Pharm.D. and Ph.D. from Rutgers University. His current research interests include the application of in silico models and simulations to aid in drug formulation design, integration of novel formulation technologies into the industry, and patient centric drug design. Dr. Savla is an author or co-author on over 35 publications including peer reviewed papers, articles, conference proceedings, and posters.

1. What was your inspiration to get into the industry?

I love the combination of the cutting edge science and the collaborative work environment. I have always been fascinated how taking a medicine can treat and cure diseases. Fundamentally, disease is a biological challenge. I became interested in pharmaceutics because it is an interdisciplinary field. We use chemistry backed a physics foundation to solve a biological problem Being in industry, I get to work with different teams and a variety of projects. There’s never a dull moment.     

2. What is your favourite part of presenting to a live audience?

I believe that in order to truly understand a concept, you have to be able to teach it to someone else. There are numerous ways to do this. However, there’s a certain excitement in presenting to a live audience. It’s not one-sided, you can gauge your performance in real time, adjust your approach, and interact with the audience.

3. What are you looking forward to explaining to the audience?

A couple years after insulin was discovered, scientists began trying to delivery by routes other than by injection. Almost a hundred years later, we only have a handful of successful examples of peptides delivered by non-invasive routes. I want the audience to understand that solving this challenge requires understanding the fundamentals of what we’re trying to accomplish, approaching the problem from multiple angles, and there isn’t a one-size-fits-all solution.

4. Where is your favourite place in the world and why?

New York City is my favorite place. It has a vibrant environment. There are always things to do and new places to explore. There are very few, if any, cities that compare to New York’s cultural diversity. 

Join Ronak in the Catalent webinar ‘Overcoming Barriers to Non-invasive Delivery of Macromolecules‘. Register now!