Why we need Medical Affairs 3.0 24 Jul 2023
New biotechs and small pharma companies find it hard to take their products from discovery to market because of a lack of capital and early-stage expertise. Dr Malcolm Barratt-Johnson, PharmaMedic Consultancy’s Managing Director, says the traditional routes do not work and offers a plan to help innovators move their products forward.
Twelve years ago, when he was working with the Medicines and Healthcare products Regulatory Agency (MHRA) on clinical trials, Dr Malcolm Barratt-Johnson realised that nascent biotechs and small pharma companies were struggling to start on the path to commercialising their discoveries. This was because they could not afford to follow the classic route to market of paying large contract research organisations to assist them through the process – nor did they have the funds or capacity to set up the alternative, namely in-house teams of experts.
The traditional way that pharma companies work is to employ functions like medical affairs, regulatory, pharmacovigilance, marketing and HR directly, but this is expensive and does not flex with the varying requirements of a fledgling business as it grows.
Malcolm realised that important research was languishing when it could be helped along the regulatory and financing pathway to, ultimately, benefit patients. A new model was required, and his solution was a virtual, external group of experts who could provide the flexibility and affordability that new biotechs required. To meet this need he established PharmaMedic Consultancy (PMC).
Today, this need remains as urgent as it did then, and perhaps more so, given current constraints on Government spending and the unprecedented number of scientific advances being made. In addition, many of these developments are technologically complex and following the traditional ways means that the expertise is not available to support their commericalisation.
Now, as in the past, these startups require three things; good advice from an early stage that they can afford, expert guidance along the regulatory route, plus access to seed funding.
As the consultancy has matured, Malcolm has realised that an important aspect of the Team’s work is the provision of medics who can bridge the knowledge gap between the academics and prospective investors. The medics understand the science behind the biotechs’ discoveries and can translate this into an explanation of the commercial prospects for these assets. Their input can help the investors understand the likely benefits of the products or patents and, hence, the likely returns on their investments. This clarity can mean the difference between securing funding or not, so it is crucial to have the right expert available at the right time.
Enabling new biotechs and small pharma companies by providing expert input at an early stage is what Malcolm terms “Medical Affairs 3.0”. The medics cannot be boxed off separately within a company any longer. All the business functions need to work together from the outset, with input from top level medics included in business planning. Scientists, pharmacists and academics must collaborate to help formulate the business plan. This means that the external consultants must be conversant with a range of specialist knowledge areas.
Lack of expertise
One issue to be addressed is a lack of expertise – both in the UK and trans-globally. The sheer volume of small biotechs coming out of universities is huge and there are not enough medical advisers to assist them under the old method. Those from the Golden Triangle of London, Oxford and Cambridge alone probably total hundreds.
Another aspect to take into consideration is the volume of niche products being developed, with genomics enabling greater personalisation of treatments. This means that there are a lot more companies chasing a smaller number of patients, which again underlines the fact that these biotechs do not have the upfront capital to employ large medical teams.
Many do not know how to take their research and patents to the next level, but it is important that they are helped to realise their potential in the real world. This is where the virtual consultancy model is vital.
As Malcolm notes, “Today there are more companies, more products with greater patient specificity, promising greater outputs and better cure rates. However, at the same time, there is a lack of funding, a lack of expertise and a lack of people to carry out the work needed. The only solution is to revise the business model, bringing together different people – primarily from medical – to fill that gap. This is not easy, but it is essential to persevere to provide a “Chamber of Professionals” who can come together to provide outputs. We cannot carry on with the previous 2.0 mindset.”
Furthermore, regulators like the MHRA cannot afford the time, commitment, or people to advise startups like they did in the past. This is another reason to bring medical consultants together to meet this need. In addition, better training is necessary to ensure the next generation can step up and support this new model into the future.
Do you think Dr Barratt-Johnson has the right solution?
What is your answer to help biotechs and small pharma companies in the current climate? PMC welcomes your views. Please contact us via email@example.com or T: +44 (0) 208 168 1668.