Author Archives: Kat

On miners and bots – the future of the Medical Affairs Department

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On miners and bots – the future of the Medical Affairs Department
It’s 2025 and I would like you to join me in welcoming the new colleagues to the Medical Affairs Department:
A data scientist, an AI bot and a digital capabilities specialist. Who are they and how could they enhance the work a Medical Affairs team does? Let’s take a look back where things started, where we are now and where we are headed.

From the initial compound screen through to regulatory approval, reimbursement and commercial supply, drug development involves scientists in operational and medical functions to run the studies and operations. The Medical Affairs team uses the data generated by Research and Development to communicate and get insights from HCPs, payors and often, although indirectly, patients. The insights they are receiving contributes to the mission to bring a new drug to patients, improve an existing therapy or expand an indication. Along this long journey, the Medical Affairs team often provides education internally and externally, ensures scientific accuracy of promotional activities and facilitates opportunities to collaborate with academic centres and key HCPs to identify further data gaps or get insights on the therapeutic landscape.

Nowadays the Medical Affairs function has evolved from the “MSL trademark” established in 1980 that was described as an educational service to initiate studies and develop workshops around drug related medical topics to now being a strategic partner connecting internal and external stakeholders.

Over 40 years have gone by from the first trademark to today and the Medical Affairs role has changed and expanded into a multi-facetted role. At the same time, the speed of data generation and the way of communication has also changed. The digital revolution has led to digital record keeping and digital communication. The first mobile phone came out as a brick in the 70s, computers/laptops with internet have become an everyday item, social networking which started in the early 2000s is now part of everyday communication and smart phone are now part of everyday life. At the same time data generation by scientific research was accelerated at speed. The PCR (polymerase chain reaction) for example was invented in 1985 and formed the basis for assays like deep sequencing, generating huge amounts of big data that can no longer be analysed by one person. In the wake of this are in-coming: your new colleagues the digital capabilities specialist, the AI bot and the data scientist.

We all experienced how the global pandemic fast forwarded digital engagement initiatives and might forever change the way Medical Affairs communicates. Digital capability experts quickly became a new set of stakeholders that needed to be engaged to organise webinars, virtual advisory boards or work on an application that helps to ensure the Quality Use of Medicines (QUM).

Artificial intelligence (AI) is the science of machine learning algorithms, artificial neural networks that have the capability to learn to abstract outputs based on their inputs. An example is IBM Watson, a cloud-based machine learning service that can be trained to deploy AI powered applications. Another impressive example is the use of AI to analyse biopsy images and it has already been shown to outperform the specialists in recognising abnormal cell growth.

The data scientist role has developed due to the large amounts of data generated by scientific research or by companies collecting insights from their respective fields. These specialised scientists mine, collect and analyse large amounts of data from databases, RWD (Real-World Data) evidence or disease registries.

These new Medical Affairs functions will work in close collaboration with the traditional Medical Affairs colleagues. Companies who start engaging data scientists and AI to obtain and analyse data will be able to move faster by gaining insights from large amounts of medical and scientific data sources to drive research and development and increase commercial value. An experienced Medical Affairs team who employs a data scientist could add value to medical innovation and research by linking this information to clinical outcomes. They could work in close collaboration with medical specialists to identify needs for digital capabilities such as remote patient monitoring for drug adherence and to detect potential side effects much earlier. Insights could be gained from internal databases or Real-World data sources to identify open questions, to feed into medical strategy, identify educational needs or open research questions to further drug development. Real- World data mining, performed by data scientists can support discussions around health technology assessments (HTA) with payors, to the extent that AI could identify complex biological patterns in large datasets from clinical trials to identify responders and non-responders to a therapy.

While some of this might sound very abstract and far away, if I had a data scientist at hand, I would have asked them to research and analyse the history of the Medical Affairs function and then used an AI bot to come up with an algorithm to determine future solutions. It would provide all the relevant info within minutes and helped write this blog. In all seriousness it’s probably time to start familiarising ourselves with these new functions and embracing their capabilities and the opportunities they provide to a Medical Affairs function.

The role of radiopharmaceuticals in the diagnosis and treatment of cancer


Clinical Development Team

Radiopharmaceuticals are radioisotopes that have been bound to biological molecules to target specific cells, organs or tissues. These relatively new drugs are being increasingly used for both the diagnosis and treatment of a number of diseases including: prostate cancer, renal cancer and glioblastoma. These medicines may allow for better diagnosis and more effective therapies.
At the virtual 2020 AusBiotech + Invest conference, a panel of leading industry experts discussed the current and future trends in the drug development of radiopharmaceuticals and how these may improve the quality of life of cancer patients.

These products are typically made up of three key parts including the ‘delivery vehicle’ (a targeting moiety – a small molecule or macromolecule such as an antibody), a proprietary linker and the ‘payload’ (a radioactive isotope). The delivery vehicle can bind to specific cancer cell transmembrane proteins (e.g PMSA in prostate cancer) where the radioactive isotope can be delivered and achieve the desired imaging or therapeutic effect. These novel agents are administered systemically and unlike older, conventional therapies (e.g radiation therapy, chemotherapy, surgery) can deliver precise, targeted radiation treatment to the cancer, (including small, distant metastases) which may not have been possible with other therapies.

Radiopharmaceuticals are referred to as Molecularly Targeted Radiation (MTR) products. The development of MTR products typically occurs in ‘theranostic’ pairs where generally the development of an imaging asset leads to the development of the paired therapeutic asset for a disease. Clinicians can utilize this mode of treatment to ‘’See it, Treat it’’, meaning that diagnostic isotopes (e.g 68Ga, 89ZR) enable accurate PET imaging of the cancer while therapeutic isotopes (e.g 177Lu, 131I) enable precise radiation therapy to be delivered directly to the cancer cells. An advantage of this approach is that radiopharmaceutical dosing can be tailored to the individual patient and clinicians are able to readily evaluate patient response to treatment.

Interestingly, the design of radiopharmaceuticals is somewhat like a ‘meccano’ set. That is, the three key elements can be disassembled and reconfigured to make a different style of related drug which can be used for a multitude of different applications. For example, the radioactive isotope of a traditional product may be substituted for an alpha emitter which is able to deliver a different type of high energy radiation with less penetration therefore making it effective for more disseminated hematological cancers (e.g Multiple Myeloma).

These products are not hoping to replace the current standard of care for cancer treatments. Instead, MTR products should be used as a synergistic, additive to current treatments. In prostate cancer, radiopharmaceuticals are being used in combination with androgen deprivation therapies and chemotherapy while in renal cell carcinoma they are being combined with immuno-oncology products such as checkpoint inhibitors to improve response rate, survival rates and most importantly patient quality of life.

A Vision for Bio-Tech Beyond COVID-19

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Clinical Development Team 

A  revealing final session of the “AusBiotech and Invest 2020” conference addressed the opportunities and risks for the Australian Biotechnology sector. A discussion between diverse industry experts painted an optimistic future for the industry as recent government policy movements have provided a golden opportunity for Australian Biotech to showcase its value. It was unanimously agreed that a key barrier for the success of the industry centred on the collective agreement on how to measure industry value.

Most recently, it was anticipated that a $1.8 billion reduction in investment was upon the industry, instead there was a $2 billion investment handed out through tax incentives; a backflip that surprised many industry leaders. The continued support reaffirms the government’s goals to be a global leader in medical research and has thus abolished investor uncertainty in the future of the industry. It now falls to industry to seize the opportunity and demonstrate the output of this government investment.

One of the initial challenges outlined by the panel was the need for the industry to have a universal agreement on shared goals. Currently, individual biotech companies’ goals vary greatly from one another, this was established to be a disadvantage. From an agreement on common goals, mechanisms of quantification could be developed which will display the achievement in these shared outcomes. Metrics could then be adopted in the industry’s narrative to convey causality between investment and output to substantiate to policymakers the value in developing Australia’s Biotechnology sector.

Quantifying value is dependant on a robust definition of commercial success, a standard that Australia’s industry is yet to decide upon. Should this definition be developed on the grounds of the amount of capital raised by a venture? One of the panel members argued that capital only enables a company to be successful but is not useful as a metric for success. Does academic output demonstrate the potential for commercial translation and success? Or potentially the political environment for a company to flourish perhaps even comparison of company performance in a global context should be the primary mechanism for defining success?

Following the discussion on the industry needing to agree on definitions and goals, Australian biotech’s access to the market was discussed. It was established that Australia is disadvantaged due to its geographical isolation and time zone from value chains. “In Boston, you’ve got your academic researcher, your laboratory, your investor and your pharmaceutical company all in one location” it was explained by one of the panel members, thus Australia could to better in ensuring the proximity to key development infrastructure. The isolation could be a hindrance in establishing new relationships and completing the commercialisation chain – this will be particularly present in the current environment when international travel is not possible. It was speculated it may be necessary to have permanent staff in other countries to develop these cross-national relationships with a personal element.

There are many barriers to Australian companies accessing global markets and this story has not been successfully conveyed to the government to ease this pressure. Although, it was also argued that it was a shame that the Australian industry was encouraged to concentrate commercial efforts overseas when it would be beneficial to Australia to keep it within national borders. It was suggested to overcome this – preferential regulatory pathways could be established with the Therapeutic Goods Administration (TGA) to incentivise Australian companies to begin on local soil before extending out globally. The Medical Research Future Fund is a mechanism in which the government aims to provide long term funding for Australian health and medical research and there was a discussion on the potential for politicisation of this program. It was countered that more effort in establishing value and metrics would facilitate the public’s trust in this program.

The overall message that was conveyed from this discussion is that a narrative needs to be constructed by Australian Biotech; one that incorporates metrics universally decided to measure the success of the industry. This narrative then needs to be conveyed to policymakers with emphasis on how barriers can be removed to further enable Australian Biotech to flourish. If this can be achieved, the future of Australian Biotech is all but secured.

The role of digital health in clinical trials

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The role of digital health in clinical trials

Rose-Marie Pennisi – Pharmaceutical Manager

Digital tools and technologies are transforming the way clinical trials are being conducted and creating better engagement with more empowered trial participants and better collaboration between trial sites, clinicians, vendors and sponsors. Not only can these new innovative electronic tools and platforms improve site selection, patient recruitment, retention, monitoring and collection of trial data they can also reduce costs. 

At this year’s virtual AusBiotech + Invest 2020 conference, a panel of leading industry experts discussed how the adoption of digital health technologies introduces a range of significant benefits and advances to clinical trial programs for the life science industry.

Fundamental changes are happening and with virtual trials now possible, making them much more patient-centric. Technology can now keep patients from dropping out of trials since they no longer need to keep going to the trial site.

COVID-19 has accelerated adoption of digital platforms and technologies and the use of simple technology such as Zoom, has enabled clinical trials to continue during the COVID-19 pandemic when in the past without this technology these trials would have been put on hold and patients would have to wait. Zoom has allowed sites to get support digitally, supporting both the clinical team and patients. Simple technology such as this opens up new opportunities.

Digital platforms are enabling online meetings for ethics committees, electronic submissions, electronic signatures and are having quite a profound impact on how trials are designed and the type of data that can be generated. Use of digital technologies enables KOLs and investigators opportunities to provide input into meetings they might otherwise not be able to attend and engage with all stakeholders. Better tools are available for trial planning, design and forecasting phases using activity-based costing for more accurate and efficient costing and digital whiteboards to facilitate brainstorming across geographic areas.

With greater technology comes a greater level of patient engagement and age should be no barrier with participation. For the technology to be effective patients need to be able to readily interact with their devices and engagement should be made easier and more fun. Patient-centric platforms including e-consent platforms can now include animations and videos and user manuals available in multiple languages having the potential for better patient engagement, troubleshooting and reduction in trial costs.

Innovative technologies are empowering patients to look for information, be engaged in their condition and be more proactive. They are also able to gather more accurate real-time data using digital biomarkers, novel digital endpoints and telehealth. We’ve come a long way since handwritten diaries.

Automatic data logging provides a better understanding of how a patient interacts with and uses their device and can collect many more data points. This has the potential to generate real-world evidence in a post-market situation.

Simply pushing technology won’t work and there are many considerations when adopting it. It needs to be seamless, embraced by and enjoyed by a range of users and suit the workflow. Other factors to consider are compliance and regulatory considerations around data security, cybersecurity, data privacy, sharing of data and audit trails. Also critical is compatibility and integration with other systems e.g. hospitals, medical records.

These innovative digital platforms and technologies have revolutionised the way we conduct clinical trials and opportunities and possibilities that a few years ago we couldn’t even imagine.

If you’re interested in incorporating digital tools and technologies into your clinical trials, contact My Medical Department to find out how we can help.

The Real World Evidence Revolution – What’s the hype all about?

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Rose-Marie Pennisi – Pharmaceutical Manager

With the costs of new product development now estimated to be around $1.4 billion USD, Real World Evidence (RWE) is more important than ever with companies looking for ways to do more with less. RWE) is emerging as invaluable in the clinical evidence landscape and transforming the way we collect clinical data. The evolution of the healthcare landscape is driving the need for change and we need to think differently about evidence approaches.

At the recent ARCS Virtual Summit 2020, a daily feature of the program was exploring different perspectives on RWE. The presentations focused on why RWE is now more important than ever, the Australian landscape and various stakeholder perspectives, the long-lasting impact that COVID-19 has had on RWE and its impact on clinical care, registration and market access applications.

Some of the major trends that are impacting this landscape are today’s significant costs of development, the growth in rare and orphan drugs coming to market (in 2018, these were 58% of FDA approved medicines), advances in personalised and precision medicine where target populations are very small numbers (in 2018, these were 46% of FDA approved medicines) and accelerated approval pathways for innovative medicines.

These trends are resulting in fewer products coming to market with traditional data packages, fewer blockbusters coming to market with common approaches and huge target populations, smaller and more dispersed patient numbers for rare diseases and precision medicines and products coming to market with lighter clinical evidence. These present great clinical challenges and RWE is part of the solution in developing these innovative and smaller population medicines and evolving healthcare.

While randomised controlled trials (RCTs) remain the gold standard, real world evidence (RWE) comes in many forms and has the flexibility to address a broad range of research questions across the life cycle. It’s not about lowering the bar with RWE. It is about having an ethically and practically driven approach that is scientifically robust. By combining RWE and RCTs, we can get the best of both worlds and create higher standards using both. Collection of RWE creates a holistic evidence package that can address limitations and uncertainties and overcome challenges of RCTs by filling data gaps and unmet needs.

With all it offers, RWE does present some challenges which can limit its utility to varying degrees. Key barriers can include the quality of the data collected, lack of standardised processes and methodologies, access to data being challenging due to separate and fragmented sources, governance, privacy issues and lack of experience.

Relative to major developed markets, Australia is earlier in the RWE journey. While the Australian ecosystem contains a breadth and depth of high-quality data, it is somewhat fragmented due to being available in separate sources. These sources include MBS and PBS data in federal systems, hospital data in state systems, claims databases, registries, mobile and digital devices, and commercially owned data sets (e.g., retail pharmacy data), private providers with electronic medical records (EMR) registry-based datasets, academic and research sectors.

So what is Real World Data?

RWD can be generated in early development, pre-launch and in-market phases, and can come from cost-effective sources such as survey questionnaires for healthcare professionals and patients, chart reviews, database studies using retrospective analysis and EMR, prospective, eCRFs and PROs from non-interventional study (NIS) and pragmatic RCTs and use of single arm trial designs as pivotal evidence.

RWE has an immense potential to transform the healthcare landscape and engaging stakeholders in government, regulators, payers, HCPs, policy makers, HTA, patients, patient organisations, industry, academics, researchers, data custodians and HRECs will be key to this integration into regulatory and market access applications to support regulatory decision making, accelerate innovation and enable access to innovative medicines and ultimately drive improvements in clinical care.

There is a realisation that these opportunities will require significant work and collaboration across the healthcare sector, between industry, government and other stakeholders.

One of the speakers used the analogy of Netflix. Netflix is not a one size fits all approach and has revolutionised and personalised TV entertainment. So too will innovative, specialised and personalised medicines require customised, cost-effective, out of the box approaches to development.

Innovative Medicines require Innovative Approaches

My Medical Department was delighted to host a booth at this year’s AusBiotech Exhibition in Brisbane (31st October – 2nd November).

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As Australia’s premier life science conference, AusBiotech brings together all levels of industry to establish and develop client relationships, network with like-minded service providers and build awareness of their unique customer value proposition within the international life sciences community.

At this year’s event, My Medical Department had the privilege to connect with many remarkable Australian and international biotech leaders. Panel discussions and key themes covered such topics as: regulation, clinical trials, new markets, business development, emerging technologies and research translational strategies.

We found our interactions to be extremely gratifying and we would like to thank all exhibitors and delegates that we encountered for taking the time to stop by and discuss possible collaborations, introduce their services or even just have a chat.

We look forward to connecting and working with you in the future!

Contact My Medical Department, your independent medical consultancy, for Pharmaceutical and Medical expertise, anytime, anywhere.

Is your product a medicine, device, cosmetic or food? Know how to tell.


Many products make claims about their health effects. This does not necessarily mean that they are therapeutic goods. However, the desire to extract more health benefits from our cosmetics and foods has made it hard to tell and raises the question: what is my product?

Depending on its use, it’s important to decide the intended purpose early. If you are not building the correct supporting evidence during development, you might find you need to modify your claims or re-do work to meet regulatory requirements. Here’s some general guidance on navigating through the regulations.

A therapeutic good is broadly defined as a product for use in humans in connection with;
• preventing, diagnosing, curing or alleviating a disease or injury
• influencing, inhibiting or modifying a physiological process
• testing a person for a disease
• preventing conception or testing for pregnancy
If your product has one or more of these intentions it is likely a medicine or device and will be regulated as a therapeutic good.

Sometimes it can be unclear as to whether a product is a complementary medicine or a food. To start, product presentation may help determine whether it is a food. For example, orange juice is a food. However, if vitamin C is extracted, concentrated and marketed in a tablet with claims that it may ‘relieve cold and flu symptoms’ it’s considered a therapeutic good. 

Foods may not make claims that are therapeutic in nature. They may not refer to the prevention, diagnosis, cure or alleviation of a condition. However, they can make nutrition content claims (e.g. good source of dietary fibre or source of vitamin C) and some health claims (e.g. enhances bone mineral density, reduces blood cholesterol, necessary for normal bone structure, contributes to regular laxation, contributes to heart health) if they meet specific conditions. 

In addition to foods, cosmetics may not make claims that are therapeutic in nature. They also are not to refer to the prevention, diagnosis, cure or alleviation of a condition. Even if a product is intended to be a cosmetic, it may be classified as a medicine depending on its ingredients, the route of administration and if therapeutic claims are made on its label, or in advertising.

At the end of the day it can be hard to make the call as to which regulations apply to your product. Regulations also vary from country to country if you intend launching your product globally. It’s wise to consult a regulatory expert for advice to ensure you’re aware of the requirements. 

Contact My Medical Department, your independent medical consultancy, for Pharmaceutical and Medical expertise, anytime, anywhere.

Digital Medical Information – Are you online?

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We live in a digital world. It has reshaped society and the way we interact so why hasn’t it re-shaped the pharmaceutical industry? Hiding behind the challenges of interacting digitally and treating it like an optional add-on, the pharmaceutical industry has fallen behind in a world that’s embraced a’ digital-first’ approach.

Communications of all types are increasingly intermediated through online platforms. Consumer hotlines and written responses are a thing of the past with customers becoming increasingly tech-savvy. Live chat does more than just allow customers another way to get in touch. It helps increase customer satisfaction by making consumers feel important.

92% customers feel satisfied when they use the live chat feature

42% of consumers say that they prefer live chat functions

Digital technologies have empowered consumers to seek information and interact in the way they choose, when they choose. 19 million people search health information websites like WebMD and twenty five percent of patients with chronic diseases visit support sites to interact with fellow suffers and discuss their condition. The medical community is digitalising too. 50% of doctors search Wikipedia for medical information. Peer-to-peer platforms are becoming increasingly popular and Twitter is emerging as a medium for specialists to swap news of latest developments. The internet is no longer a one-way interaction.

Live chat appeals to busy healthcare professionals and consumers particularly because of its accessibility and convenience. However, one of the biggest internal fears of digital adoption has been the level of perceived risk, particularly due to adverse event reporting requirements. Yet a 2014 study, funded by the FDA, examined 6.9 million Twitter posts and found that less than 0.1% resembled an ADR.

The pharmaceutical industry is an information intensive industry. A company-managed live chat can offer scientifically validated responses to ensure the correct use of therapeutics. Medical Information professionals have access to present, correct and valid information that they provide in response. Also, customer satisfaction has been known to increase due to the immediate and private nature of a live chat environment. It’s time to start interacting with your customer base. Don’t just have a voice, lend an ear.

Contact My Medical Department, your independent medical consultancy, for Pharmaceutical and Medical expertise, anytime, anywhere.

My Medical Department recently exhibited at the Drug Information Association (DIA) in Boston, June 24-28th.

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DIA brings together life sciences professionals from across all areas of expertise to engage with patients, industry, academic and clinical thought leaders and pharmaceutical industry stakeholders, providing an unrivalled platform to promote the benefits of conducting clinical research activities in Australia to a global audience. We engaged with global decision-makers and influencers in the biotechnology hub of 2018 that we would not otherwise have access to.

Our aspiration is to advance healthcare product development globally, for the advancement of human health.