Dr Craig Rayner

CEO – d3 Medicine "Creative thinking must not be restricted by complexity and dogma"

Stranded Sea Turtles Could Help Australia Transform Locally Discovered Molecules into Global Medicines

10 Comments

How many of you had seen the articles Smart Country Sells Itself Short and Australia Blind to the Innovation Boom – Beattie published in the Sydney Morning Herald on 10th November?  Well, ironically, I was first made aware of these articles by three antipodean, but internationally stranded sea turtles!

The article titles themselves paint a view that is shared by many ‘international’ Australians who, having left for foreign shores at various stages of their careers, are faced with the desire of returning home; it hits a particularly raw nerve with those of us closely involved in the development and commercialisation of medicines.

The strengths of Australian science, discovery and optimisation of potential new drugs, are appreciated here at home, and also abroad. We celebrate our fair share of Nobel laureates and the discovery triumphs of brilliant scientists: Ian Frazer and his Queensland team’s cervical cancer vaccine discovery, the discovery of flu-fighting Relenza at CSIRO and Monash University; and world class research productivity from institutes like the Walter and Eliza Hall Institute of Medical Research that showcases Australia’s outstanding research focused medical fraternity.

So why is it that Australia sits 107th on the 2012 Global Innovation Index, behind Georgia, Malawi and Colombia?  As Peter Beattie highlighted, “Our basic research is world-class, our commercialisation is not”. Australia is viewed as a rich hunting ground for “early stage opportunities” for international medicine developers.  Real value capture in the life sciences space for Australia is lost when we sell our drugs too early in the development process. Rather, we should be managing risk and intelligently moving some of these early opportunities further along the development path. This requires “development and commercialisation” skills.

This process of “development and commercialisation” of a medicine, like rocket science, is extremely complex, expensive (>$1Bn), risky (<10% of drugs that eventually make it into humans reach the market), and it is definitely not an “individual” sport. It requires “teams” of dedicated, top minds tackling a problem from multiple perspectives in parallel. A typical core drug development team may have 10 or more highly qualified representatives (most with doctoral degrees, and many with multiple qualifications across disciplines)   from diverse functional areas, each supported by many others. Roles include medical development, clinical pharmacology, clinical safety, toxicology, pharmaceutical science, project management, operations, commercial, intellectual property, modelling and simulation, epidemiology, regulatory affairs, health economics as well as very smart project leadership. For a molecule to become a medicine, each of these elements must come together and be integrated successfully.  A seasoned “medicine developer” is someone who has not only deep technical knowledge, but importantly, an ability to integrate knowledge (and to ask for expert help as required) gained from substantial experience working within cross-functional development teams  solving development problems. The process of applying science in this way is not a discipline which is taught in Universities, but rather is a skill and art which is only learned by experience.

In contrast to US and Europe, this profile of a development professional is under-recognized, under-valued and under-resourced in Australia. A major reason is Australia’s lack of critical mass in this area, a fact which unfortunately drives abroad Australians seeking to pursue leading edge experiences in drug development and commercialisation. A seldom celebrated fact is many Australian’s do incredibly well in these environments. Some have established themselves internationally as leaders in their respective fields, making significant contributions to human health. In fact, the next time you open a medicine’s patient information leaflet, you should reflect that it is quite likely an Australian abroad had a hand in creating the product. Unfortunately, when after years away, such talented Australians ask themselves the question, “What opportunity could I return home too?”, the answer is generally silence.

Can we fix this? What really strikes me, is the chicken and egg problem that we have in Australia.

On one hand we bemoan the fact that we are not good at commercialising the discoveries from our brilliant scientists. I would argue, that an important driver is lack of critical mass in “development and commercialisation” experience in Australia. On the other hand, we actually have a bale (thanks Wikipedia) of sea turtles with critically relevant experience wanting to come home. China has recognised the value of its diaspora, encouraging the return home of internationally experienced scientsist: Australia should do the same.

Now is the time for Australia to be investing in our success beyond the mining boom.  I believe an important challenge for Australia, is determining how we can best access such “development and commercialisation” talent to support the existing strong discovery and innovation base our life sciences industry is reputed for.  However, retaining the talent will also require creating the right soft infrastructure for the sector. Bring our turtles home but make sure they have any environment in which they may thrive!

________________________________________________________________

Dr. Craig Rayner BPharm BPharmSc(Hons) PharmD MBA MAICD
Adjunct Associate Professor, Monash Institute of Pharmaceutical Sciences, Monash University
Director of Clinical Pharmacology, and previously Global Due Diligence Director at Roche

Personal Note: After many years abroad, I was extremely fortunate to be able to continue a global role in an International Pharmaceutical company working from my home in Melbourne with teams based in Europe, US and China. What amazes me, is that incredibly talented Australian’s are peppered throughout the international industry.  If we could gather them all up and bring them home, I am sure we could assemble a faculty that could rival any major Pharmaceutical company.

Author: Dr Craig Rayner

CEO of d3 Medicine LLC and Adjunct Associate Professor in Faculty of Pharmacy & Pharmaceutical Sciences at Monash University. Views are my own and not necessarily reflective of d3 Medicine or Monash University.

10 thoughts on “Stranded Sea Turtles Could Help Australia Transform Locally Discovered Molecules into Global Medicines

  1. Hi Craig, thank you for contributing to the Optimize Business Blog as a guest blogger. These are important issues for the future of scientific research, development and commercialisation in Australia. While the ‘brain-drain’ of many intellectual leaders is well documented and attempts have been made to address the issue, it will not be successful without the supporting infrastructure and environment to take innovations to a higher point in the value chain.

    If Australia is serious about becoming a smart economy, driven with research, innovation and technology, we need to make more than just symbolic gestures to address the issues. This will require re-examining the Australian funding model for academic research, which does not provide adequate weight to commercialisation.

    As Arnold responded below to your blog post (on the Optimize Business Blog), there needs to be a substantive move to “get the ball rolling.”

    “Arnold on December 1, 2012 at 9:08 am said:
    Could this only be a problem in the pharmaceutical industry ? Must be other sectors like technology where you have much of the same problem. If the sea turtles are ever to come home, there needs to be a dedicated, solutions oriented approach. The government should step in here, its probably the only entity that can solve the problem….or at least to build some initial momentum and incentives to get the ball rolling.”

    Andrew McIntosh CPA

  2. Hi Andrew and Arnold,

    I echo the commercialization sentiment expressed.

    On 28th Nov 2012, Senator Evans announced on behalf of the Australian government the “National Research Investment Plan.” http://www.innovation.gov.au/investmentplan

    Does this represent getting the ball rolling?

    The plan states a commitment to “deliver a strong, cohesive research fabric”. I sincerely hope this means there will be renewed focus on developing a stronger “research and commercialisation ecosystem” than what we have today in Australia. If so, then this provides hope that we may be able to attract back to Australia and also retain, more of the experience necessary to help the nation better captialise on our world-class science.

  3. Hot-from-press – mckeonreview.org.au and http://www.innovation.gov.au/investmentplan

    Will either of these reviews Improve Australia’s biotech ecosystem?

    I hope so.

    Is there enough recongnition that a key training ground for developing and commercializing medicines is the Biotech and Pharmaceutical industry? Some skills can only be obtained by “doing”.

    Encouraging cross sector collaboration is key. Breaking down silos between academia, clinical practice and industry and encouraging easier movement of professionals across the sectors.

    This works at a student and also senior practitioner level. One barrier to fluid movement across the industry and academic interface is the old “publish or perish” mentality. A greater awareness that “impact” and “creating value for society” is not only measured in terms of publications and grants.

    An excellent example is the Monash University and Gates Inhaled Oxytocin program.This collaboration brings in the best and brightest, irrespective of sector, to be focused on finding a solution to the critical issue of PPH.

    Creating a new medicine is never a slam dunk. We wish it was. This means academic investigators engaged in such programs, based on the old “publish or perish” mentality risk their publication records whilst pursuing these potentially life changing areas. Should they be trading off career versus impact to society?

    Extend this argument now to innovators who have left to academic environments to work on life changing medicines in biotech and Pharma.

    We need the Australian research ecosystem to encourage, not discourage cross-sector collaboration. I hope the outcome of the reviews above address this mind-set.

  4. Craig,
    You are on the money. All too often companies fail because they do not have access to a faculty of commercial and development skills that are required to plan then shepherd a product to the market. There has to be a better way to avail small companies of these skills and thereby increase capital efficiency and probabilities of technical and commercial success. Your thoughts on how to deliver this solution would be welcomed.

    Cheers Leigh
    VP Business Development Biota

    • Thanks Leigh for your posting.

      Always difficult to jump into solutions mode. I am sure there are multiple models that can be considered.

      An observation, though, which expert commentators like yourself make, is that Australian biotech companies themselves do not have the capital to go out and hire the various functional expertise I describe in my “sea turtles” blog. Even those who can afford to engage independent consultants, they are often let down on the “integration” of the advice. At the end of the day, the disparate opinions or puzzle pieces (often gathered from multiple “silos”) come in to the biotech, and when the puzzle is constructed, the pieces just don’t match. The resulting “development strategy” looks more like a Picaso than a Monet.

      So my point here, is that Australian biotech needs “affordable” access to “integrated” view from a team (or faculty as you put it) of “medicine developers”. A point I raised in my blog, was that there is enough “home sick” expatriate Australian talent to assemble such a faculty – if there was an infrastructure to support their return home. I am sure there are alternative approaches.

      Another key point, that I probably should have started with, is that, it also requires a commercial mindset. It requires value focused thinking. Each development activity needs to be conscious of the end in mind. It needs to address the “holy trinity” of key customers 1) patient 2) payor and 3) investors. Much more to be discussed on this topic – another blog for another time!

  5. Spot on!
    It’s not just the challenge of attracting talent back, but the challenge of attracting development programs back…phase 2 work is great, but phase 3 often pays the bills and that’s where a lot of the development expertise you refer to is gained. It needs to be a strategic and tactical partnership with governments and academia as well as Pharma before this talent drain becomes very difficult to reverse.

    Paul
    Executive Director – Global Pharma (USA)

  6. Thanks Paul for your posting.
    Another chicken and egg if I am not mistaken! Medicine Developers can only be grown by “doing”. As the bulk of phase 2 and 3 work occurs in Europe and the US, a requisite part of many an aspiring Medicine developer’s training program, requires a tour of duty in such places.

    Completely agree a strategic and tactical partnership at all levels is required to achieve this. However, it requires both a bottom-up (University, training) and also a top-down approach which should also include providing an environment that may support a faculty of experienced Medicine developers to be available to Australia.

    The Victorian Government deserves credit in my mind for a pilot program, where global quality project management experience is made available to its biotech community (www.medicinedevelopment.com). I wonder what kind of program could expand this type of initiative to inject the full complement of strategic and deep functional expertise that is required for any “Development team” to be successful?

  7. It’s great to read these comments. In particular also your comments on the need for a commercial mindset. There may be talent already in Australia which is currently untapped, as companies focus on skills versus behavior. The best scientists (based on publication rates) do not necessarily make the best project managers or commercial developers.

  8. Thanks Kerstin for your comments. I agree with you. Australia has incredible talent already. Our challenge however, is that the expertise is spread very thinly across the sector. Without the critical mass of a “faculty” (as Leigh farrell calls it) it really hampers the ability to provide an integrated strategy. ie. a plan can end up looking more like a Picaso rather than a Monet. Beginning with the end in mind and value focused develoment decisions are core attributes for successful development and commercialisation of medicines.

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