Posts Tagged Events

Webinar: Digital Transformation in Pharma: Challenges and Enablers

Digital Transformation in Pharma: Challenges and Enablers

Webinar: Digital Transformation in Pharma: Challenges and Enablers

We are excited to invite you to our new webinar titled “Digital Transformation in Pharma: Challenges and Enablers”. In the last 10 years, the international and Italian managerial debate has focused heavily on the issue of corporate digitalisation. For pharma and healthcare professionals, the digital age brings new uncertainties.

Companies face a difficult choice:

  • Evolve with the new era by building a digital organisation
  • Risk becoming less competitive on the market as they fail to embrace the change

In this webinar we will discuss the challenges that pharmaceutical companies face on the road to digital success and how to overcome them.

Click here to learn more about the webinar and register your attendance

Who should attend?

CIOs, Clinical, Pharmacovigilance and R&D professionals looking for harnessing the power of new digital technologies

Date and time:

Wednesday, October the 21st, 2020, 4:00 PM – 5:00 PM CEST

The key learning outcomes will be:

  • What is digital maturity
  • Main challenges in embracing digital transformation in pharma industry
  • Enables of digital transformation

Speaker: Silvia Gabanti, Managing Director of Arithmos

Silvia has an impressive 15-year track record in the industry. She began her career in the CRO environment as pharmacovigilance and clinical research specialist. On her career record, she also has extensive experience with Oracle applications – as analyst she was working with pharmacovigilance and clinical systems like Oracle Clinical. Frequent speaker at the industry events, for the last two years before becoming Managing Director she held the position of Service Delivery Manager.

Leadership in the Workplace: Angela Weston

International Women's Day

Leadership in the Workplace: Angela Weston

International Women’s Day takes place on March 8th and is an important day in the calendar as it celebrates the social, economic cultural and political achievements of women.  It’s theme this year is “An equal world is an enabled world”. Women today are still striving to close the gap in the workplace, and many seek out networking opportunities by sharing life experiences, philosophies and making new connections.

We have taken the opportunity to talk to Angela Weston, Chief Commercial Officer, PM Holding. Angela has been an influential leader for over 20 years, working with multinational companies in the pharmaceutical, medical device and CRO environments. Angela has an impressive track record of implementing strategies to support global sales, marketing and proposal management.

Do you think there are any differences between how men and women lead?

Yes – I think it is clear in our approaches.  Women tend to be far more critical about their own abilities; instead of being proud of their achievements. There is always a need to strive for excellence and for a woman this can sometimes influence decision-making. Men can come across as more confident in certain situations and this can sometimes work to their advantage and sometime not

A real challenge that remains today is the lack of progress being made across many industries in women climbing the corporate ladder although the glass ceiling is beginning to crack. Women in board room positions fell in 2019, but I see a change afoot.

What are some patterns you’ve noticed over the years about how women develop and manage their careers?

Women have a natural ability to multi-task and prioritise with; family, career, managing social commitments and maintaining outside of work friends and interests. I may be biased, but I think women and multi-tasking are ahead of the curve in this respect. Example: I can run a Global pipeline call, have a glass of wine in hand and be ironing and all at the same time!

What are the biggest challenges you face in management and what keeps you pushing forward?

The biggest challenge is always people management – my role requires me to work cross functionally and with multiple stakeholders. It is important that the work environment is a fun, collaborative but productive one. I always go the extra mile to ensure my team are happy, motivated and well looked after – it’s a big and very important part of my day to day life.

I am always pushing myself and my teams, to exceed in all that they do, being a driven person doesn’t allow me much time to sit still for long – however this approach has always brought success and has allowed me to have choices throughout my career.

Who is one female entrepreneur who you personally admire and why?

Margaret Thatcher, the “Iron Lady” of British politics, she was not afraid to speak her mind and she was driven by her passion and beliefs – she went above and beyond to achieve her goals.

What advice do you have for the next generation of women leaders?

  • Reach for the stars – dream big, you can do anything you want to when you put your mind to it.
  • Have a can-do attitude.
  • Invest time and effort to learn, don’t be afraid to step outside your comfort zone.

What are you most passionate about?

Health, wealth and happiness.

The health and wellbeing of family, friends and colleagues is very important to me. I also have tremendous passion for business and relish new challenges and contributing to the Healthcare Industry gives me a good feeling.

What are your personal values?

Integrity – this has helped me throughout my career, I believe it’s important to be honest and transparent even if the message you sometimes communicate is sometimes a difficult one.

What is your favourite film, website and brand?

  • Top Gun
  • Amazon
  • Channel

Thank you for taking the time to talk to us today.

 

Breaking Down The Silos: First Step Towards Fruitful Collaboration

Breaking Down the Silos Regulatory Day

Breaking Down the Silos Regulatory Day

Breaking Down The Silos: First Step Towards Fruitful Collaboration

On the 10th of October the top industry professionals gathered in Madrid, Spain, for Regulatory Day, an immersive workshop organized by Arithmos in collaboration with its partners Oracle Health Sciences and Asphalion.

The event, entitled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” brought together the best regulatory, QA, clinical, and pharmacovigilance specialists to discuss how they can collaborate to make the product development journey through post-marketing as efficient as possible both in EMA and FDA regulatory environments.

The Regulatory Day agenda was divided into three sessions, each of them dedicated to a different aspect of product development:

Session #1 Comparison of EMA and FDA Regulatory Landscape in Clinical Trials

  • Introduction to FDA and EU Regulatory Activities for Drug Development and Clinical Trials – Lidia Canovas (Asphalion) and Bruce Thompson (Reguliance);
  • Integrated Summaries: Strategies for Meeting Regulatory Challenges Faced by Sponsors – Marta Zanus (CROS NT);
  • Pre-Marketing Safety Reporting & Signal Detection – Una Kessi (Oracle Health Sciences);

Session #2 Post-Market Regulatory

  • Comparison of US vs EU Regulations, Procedures, Requirements, Practical Examples and Submission Format – Lidia Canovas (Asphalion) and Bruce Thompson (Reguliance);
  • Surveillance and Safety Obligations after Approval – Una Kessi (Oracle Health Sciences);
  • Post-authorisation Studies in the EU: PASS and PAES – Stefania De Santis (seQure);

Session #3 Impact of Technology on Regulatory and Vice Versa

  • The (R)evolution of Technology in the Pharmaceutical Sector – Marcos Fernàndez Gómez (Asphalion);
  • Digital Transformation in Clinical Trials: eClinical Selection and the Regulatory Impact – Silvia Gabanti (Arithmos);
  • How AI and Cloud are Impacting Multivigilance – Michael Braun-Boghos (Oracle Health Sciences);
Breaking down the silos - Regulatory Day

Silvia Gabanti, Arithmos Managing Director, at Regulatory Day

Roundtable discussions

The final part of Regulatory Day engaged the event guests in the roundtable discussions on where the market is moving and invited them to share their own experience in breaking down the silos between departments in their companies.

  • Roundtable #1: Regulatory Challenges in the Industry: EU vs FDA, Brexit, and IDMP
  • Roundtable #2: Breaking Down the Silos between Regulatory Affairs, Safety, and Clinical R&D

Breaking Down the Silos: Complexities and Benefits

The information flow between various departments involved in medicinal product development is not always straightforward, especially when it comes to large companies. Due to the structural obstacles and lack of time caused by pressing deadlines regulatory, clinical, and safety professionals might not fully comprehend the work done by other departments.

Collaboration and continuous information exchange between different professionals that work either in EMA or FDA environment favour the acceleration of product development and increase efficiency. Regulatory Day gave participants a sneak peek into the work of their colleagues and challenges they face, inviting them to explore new ways of collaboration.

Interested in other Arithmos events?

PM Holding Appoints Angela Weston as Chief Commercial Officer

Angela Weston Chief Commercial Officer

PM Holding Appoints Angela Weston as Chief Commercial Officer

Angela Weston Chief Commercial Officer Verona, Italy (11 September 2019) – PM Holding, a group of diverse service providers in the life sciences industry, announces the appointment of Angela Weston as Chief Commercial Officer to manage business development operations across the entire group.

PM Holding consists of specialized service providers in the drug and device development sector including:

  • CROS NT (global, expert biometrics CRO);
  • Arithmos (technology solution provider and system integrator);
  • seQure Life Sciences (niche provider of vigilance, quality assurance and regulatory services).

Angela brings a wealth of experience in business development, marketing and product management roles at a global level for multinational companies in the pharmaceutical, medical device and CRO environments. She started her career in Nursing moving into sales with B.Braun and Boston Scientific, she later moved into the CRO sector with Premier Research Group, Aptiv Solutions (ICON plc) and Inventiv Health (Syneos Health). Angela has an impressive track record of implementing strategies to support global sales, marketing and proposal management with a thorough understanding of our industry and client needs.

The decision to hire a CCO comes at time when the PM Holding group of companies are expanding globally and offering more comprehensive services to the market especially in the area of digital health.

Paolo Morelli, CEO and Owner of PM Holding, said, “we are at a crucial, yet exciting, phase in PM Holding where we are developing new solutions to meet market demands in data science, digital health and overall oversight and quality in clinical trials. It’s a collaborative effort, and I am confident that Angela’s experience and industry knowledge will help us identify our key markets, positioning and message. Her success in implementing successful business development and marketing infrastructure and strategies to enable company growth speaks for itself”.

Angela commented, “for the past several years I have supported companies to develop value generation strategies, and therefore I see PM Holding as a great opportunity and fit for me. The companies under the PMH brand have huge potential both individually and collectively to offer impeccable quality services and innovative solutions to our clients in the global marketplace and I am excited to be part of this growth phase”.

Angela is based in Europe.

ACDM: New Era of Data Management

ACDM New Era in Data Management

ACDM Data Management

ACDM: New Era of Data Management

The annual event of the Association for Clinical Data Management (ACDM) took place last month in Amsterdam. ACDM represents professionals working in clinical data management: from data collection and database builds to technology solutions for data capture. For 30 years, ACDM has been at the forefront of change in all aspects of data management.

This year, just as last year, Arithmos had the pleasure to participate in ACDM as an exhibitor and was present through the whole event that lasted two days. What did we take away from this insightful event?

About ACDM Annual Meeting 2019

Staying updated on industry developments is a priority for us. Arithmos is very active in data management, as it provides consultancy to Life Sciences companies and has developed its own EDC system Symphony. We recognize that with emerging new technologies and regulatory changes like GDPR, it is particularly important to stay informed and compliant.

Attending industry events like ACDM is a great occasion to catch up with the colleagues and discuss just how this field is evolving.

Here are just a couple of facts about ACDM:

  • Total amount of participating companies: 90;
  • Number of exhibitors: 15;
  • Number of sponsors: 5;
  • Number of presenters: 21;
  • Growth of the audience since 2018: +15%.

The outstanding fact about ACDM 2019 was its focus on digital transformation. The agenda featured many topics related to this fascinating, yet still developing trend of digital transformation, such as mobile sensors in clinical trials and artificial intelligence. It marks a new era in data management – how are new technologies impacting the field of data management, transforming the ways we looked at it before and demanding the reorganization of existing processes.

We all remember years ago when the great debate was paper or electronic CRF, pointing out the pros and cons of each. The field has now reached a new great debate, and that is how to integrate disruptive technologies such as wearables and mobile sensors into the existing data management collection and analysis processes with which we are already familiar.

We were particularly eager to learn how companies are managing vendor oversight when it comes to data management, which disruptive technologies companies are applying to data collection and how GDPR has had an impact on data management processes and EDC systems.

ACDM Data Management

ACDM Annual Award

This year Arithmos, together with its sister company CROS NT, was honored to be shortlisted as a finalist for an ACDM excellence award. The Annual Award was established in order to highlight the achievements in data management among ACDM members.

Arithmos together with CROS NT presented its observational study project being carried out with a large pharma player. It involves hemophiliac patients and redefines the way we look at data collection and management in the era of digital transformation.

Data is being collected via ePRO as well as a FitBit wearable device with the aim of analyzing the impact of physical activity on these hemophiliac patients for at least 10 hours per day for the duration of the study. Using an innovative eClinical platform both the ePRO and FitBit data are automatically transferred into the eCRF (Symphony EDC – a product of Arithmos) making it easy for the Investigator to analyze the data.

Impact and Benefits:

  • The project is successfully applying “disruptive technologies” (IoT) to implement more efficient data collection and management processes;
  • The inclusion of wearables creates better patient engagement and retention in providing a non-invasive and interactive collection tool;
  • Guaranteed data privacy and security as Arithmos is an ISO 27001:2014 certified company.

Do you want to know more about the digital solution we presented at ACDM 2019? Learn more about Symphony EDC,  a proprietary Software as a Service Electronic Data Capture solution with a GDPR compliant database, which was originally designed by an investigator and further developed by Arithmos.

Request your free non-binding demo by sending us a request through the website

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Arithmos appoints Silvia Gabanti as new Managing Director

Silvia Gabanti Managing Director

Arithmos appoints Silvia Gabanti as new Managing Director

Verona, Italy (3/04/19)

Silvia Gabanti Managing DirectorArithmos, an Information Technology company specialized in technology solutions for the Life Sciences sector, has named Silvia Gabanti as its new Managing Director. Silvia was promoted from her role of Service Delivery Manager that she held for the last two years.

Silvia Gabanti joined Arithmos as IT Manager in 2010 during the company’s startup and growth phase. As Life Science Applications Manager and Project Manager, she led key research and development projects such as Symphony EDC and Argus Blueprint.

Silvia began her career in the CRO environment where she developed experience in applications for pharmacovigilance and clinical trials. On her career record, she also has experience as an Oracle application analyst particularly with pharmacovigilance and clinical systems like Oracle Clinical. With an impressive 15-year track record in the industry, Silvia exhibits developed skills in managing operations with both in-house and remote teams, providing clear guidance and leadership.

Building on her Service Delivery and clinical IT management experience, Silvia will join forces with the Arithmos team to scale the business on a European level and bring Arithmos to the forefront of technology expansion in Life Sciences.

Paolo Morelli, CEO of Arithmos, said: “We are excited to welcome Silvia Gabanti in the position of Managing Director. Her knowledge of the market and expertise in innovation and across the product field are of undeniable value for the future of Arithmos. In addition to her industry knowledge, she knows Arithmos as a company and has seen it grow and certainly knows its potential”.

Arithmos is part of PM Holding, a group of companies operating in the Life Sciences sector and providing a complete platform of products and services for end-to-end drug and device development.

Interested in more Arithmos updates?

Summary: conference “Artificial Intelligence and Clinical Research” (Milan) | What is the industry saying?

Artificial Intelligence in Clinical trials Milan

Summary: conference “Artificial Intelligence and Clinical Research” (Milan) | What is the industry saying?

Artificial Intelligence (AI) is a hot topic in the world of clinical trials, with researchers, academics and industry experts examining how it can “change the rules of the game”. Arithmos strives to be at the forefront of digital transformation in life sciences, so on the 18th of September we were present at the conference “Artificial Intelligence and Clinical Research” (Intelligenza artificiale e ricerca clinica) to get the latest updates from the industry. It took place at Politecnico di Milano, the largest technical university in Italy and looked at analyzing the possibility of simplifying the clinical research process with Artificial Intelligence.

The event featured such speakers as:

  • Massimo Beccaria, Managing Director Alfa Technologies International;
  • Giuseppe Recchia, Vice President Medical Scientific, GSK;
  • Matteo Matteucci, Associate Professor of Politecnico di Milano (Robotics, Cognitive Robotics, and Machine Learning);
  • Roberto Fantino, Presidente NAT Style;
  • Enrico G. Caiani: Associate Professor of Politecnico di Milano, Chairman WG e-Cardiology European Society of Cardiology, Docente eHealth and Bioengineering;
  • Giorgio Manfredi, CEO Rumbletumbleweed, CEO Occambee, Founder Forever Identity Inc., Advisor ISMC;
  • Maurizio Viviani, CEO Strong Artificial Intelligence;
  • Ettore Murciano, VP Channel Sales and Alliances, Loop AI Labs Inc;
  • Eugenio Santoro, Responsabile del laboratorio di informatica medica, Istituto di Ricerche Farmacologiche Mario Negri – IRCCS;
  • Sergio Scaccabarozzi, Head of Country Clinical Operations-Italy, Roche.

All the speeches represented very interesting insights from various points of view – research center, private company or university. What were some key points we took home? We first look at how the industry is being setup to look for AI solutions:

Giuseppe Recchia, Vice President Medical Scientific, GSK:

  • The future of clinical research will be defined between 2018 and 2020;
  • The whole revolution in clinical trials is about searching for a solution for faster development of the cure;
  • Everything in clinical trials revolves around patients and gives birth to such notions as patient centricity and patient engagement. With time how the patient views himself has also changed:
    • Patient now does his own research, using his/her health data;
    • Patients now have their own input, for example, they are involved in medicine R&D;
    • Patient-expert is a new concept, formed only recently. Such patients have the experience of the illness and expertise. For example, they could have had training or understanding of the research dynamics and the regulatory basis.
  • The aim of modernizing Clinical Trials is getting us to the cure faster. Why is the process so lengthy now? There are several reasons: low enrollment rates, retention problems, adherence (patients do not take meds and says he/she does), quality, costs.
  • What are the steps in clinical trial modernization?
    • First step is developing patient centricity:
    • Second step is connecting to the patient. It is extremely important now, as siteless clinical trials are being developed because patient spend more time at home than at the research site.
    • Third step is modernization in the field of wearables;
    • Fourth step is taming big data;
    • Fifth and last step is applying AI in clinical trials;
  • Right now no pharma company applies these technologies at 100%, however, big steps are already being taken in this direction.

Enrico G. Caiani: Associate Professor of Politecnico di Milano, Chairman WG e-Cardiology European Society of Cardiology, Docente eHealth and Bioengineering:

  • Why does health care need AI? There are several main reasons:
    • For the quantity of data and its complexity: at the moment each person generated 1100 TRB during his/her lifetime;
    • For the sake of patient safety;
    • For achieving higher efficiency in terms of time;
  • AI is capable of changing the future of medicines in all its aspects from administrative to clinical;
  • The demand for AI in the scientific society grows every year: in 2013 at ESC Congress there were only 3 AI presentations and in 2018 – already 69;
  • What prevents AI from being adopted right away in clinical practice?
    • Pathology is always complex, so here having a big dataset is of ultimate importance. This enlarges costs and times for the medical data production. Moreover, since healthcare datasets are not usually shared, the possibility of using joint datasets is not available.
    • The clinical evidence is not sufficient since now there is a limited amount of evidence in research literature that can prove that AI is a superior technique.
    • This, in turn, triggers another barrier for AI adoption: lack of transparency on training, lack of information on timing and content of updates, lack of reports on performance and eventual fails;
    • Last, but not the least: the definition of ethical principles in AI is missing. In order to proceed with AI adoption, it should be clarified how AI can influence doctor-patient relations and decide who is responsible for errors caused by AI.

Eugenio Santoro, Responsabile del laboratorio di informatica medica, Istituto di Ricerche Farmacologiche Mario Negri – IRCCS:

  • What should be done in order to use AI in clinical research?
    • A structured approach should be implemented, as 80% of the data generated every day is not structured. Right now a huge amount of data is produced due to the use of smartphones, IoT and wearables, which has no formal system. The situation got escalated in the last 2 years – during which 90% of the world data was generated.
  • What is the potential of AI in healthcare?
    • Prevention and predictive models;
    • Early diagnosis;
    • Machine learning and chatbot;
    • Analyses of disease cause-effect, also called epidemiology 2.0. AI is employed here for finding possible logical connections between potential cause and effect;
    • Drug Discovery and clinical trials;
  • How can AI improve clinical research in particular:
    • Aggregation and synthesis of information: AI allows intuitive searches in the world biomedical research data including biomedical databases;
    • Recruiting for clinical trials: AI can analyze medical records and other unstructured documents to find the appropriate patients for clinical trials and can accelerate recruitment to complete the clinical trial faster.
    • Understanding the mechanism of disease: AI can analyzes databases, connecting published literature, experimental data, and clinical data and allows researchers to get insight into how the disease mechanism operates;
    • Repurposing existing drugs: AI can synthesize knowledge from multiple biomedical sources and find new indications for existing drugs;
    • Generate novel drug candidates: AI can generate novel drug candidates faster;
    • Optimize clinical trials: AI can analyze data of participants and reduce the dropout rates through personalized communication;
    • Publish data: AI can write a draft of a scientific manuscript based on provided data;
    • Sentiment analysis: AI can assist in the pharmacovigilance process by monitoring the adverse events and help with the study of public health, such as infection and drug abuse.

Workshop: Industry 4.0 and Life Sciences

Workshop Industry 4.0

Industry 4.0 Life Sciences

Workshop: Industry 4.0 and Life Sciences

This June, experts in the Life Sciences industry gathered in Milan to participate in a workshop on “Industry 4.0: The New Challenges for Project Planning and Oversight in the Life Sciences Industry”. The workshop was a result of joint efforts between our Arithmos team and LS Academy and was organized in order to peek into changes triggered by Industry 4.0.

Industry 4.0 is a recent concept that encompasses all the processes of automatizations and emerging cyber-physical systems in different industries. Life Science is among the areas most affected by these changes due to its willingness to adopt new technologies and its responsiveness to new trends. During our workshop, we covered different aspects of the Life Sciences industry that are affected by Industry 4.0.

Workshop agenda

We have invited a number of Key Opinion Leaders from the Pharma and Life Sciences fields to share their experience and ideas on Industry 4.0. Here are the topics they have covered during the workshop:

  • IoT and Big Data: advantages and opportunities of eHealth technologies in Life Sciences Sector.
  • New challenges for Human Resources in Industry 4.0: Management time planning research results and their structure.
  • Sponsor Oversight Management: Effective use of third party technology.
    • Speaker: Heike Schoen, Managing Director and Co-Founder at LUMIS International GmbH;
  • New model of Industry 4.0: Altea UP. Instruments and technologie for the pharma process governance.
  • Implementation strategy of ClinOps system: challenges and choices.
    • Speaker: Daniele Segagni, Group ICT Global Business Process and Application Specialist, Chiesi Group
  • How new technologies are changing patient relations: from the SEO era to IA and chatbot.
    • Speaker: Matteo Nicolosi, Web Content Developer at Istituto Clinico Humanitas;
  • How intelligent automation is reshaping the workforce landscape.
    • Speaker: Andrea Melison, Senior Manager Business Service at KPMG Italy.

Best quotes of the workshop

  • “Blending IoT, Big Data and AI in clinical trials processes can greatly improve the competitiveness of CROs and Pharma/Medical Companies, while at the same time lowering the costs of clinical research and facilitation the invention and validation of new medical products and services that will revolutionize healthcare in the years to come.” – Paolo Morelli
  • “Digital revolution has positive effect if it helps employers to compress time needed for standardized activities and relocate it to work activities that require non-standard approach.” – Roberto Bugatti
  • “Company should set adequate extended and shared IT Governance structure, which ensures that the company data is managed correctly.” – Pierluigi De Rosa
  • “Real-World Evidence could be used from R&D departments to support regulatory submissions for additional drug indications and to inform new drug development.” – Daniele Segagni”
  • “Robotic Process Automation and digital labor can be scaled much more quickly and cost effectively than traditional IT implementations.” – Andrea Melison

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