Flexible and engaging, tutorial access over six or nine months, and with the option to complement the learning with mentoring and a Certificate of Completion.

Enimera RegsPlus Learner Leader Modules in Regulatory Affairs

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“… It took:

a.    40 years to get 50 million radios on earth.

b.    14 years to get 50 million TVs.

c.    1 year to get 50 million Facebook accounts.

d.    4 months for 50 million WeChat accounts.”

Fascinating.

Relevant to organisational vision and strategy, yes.

Relevant to commercially-oriented functions, yes.

Relevant to scientifically-oriented functions within the therapeutics and wellness sectors?  Absolutely.

Functions like Regulatory Affairs, Medical Affairs, Clinical Research and others are often described by their organisational counterparts as being slow, overly conservative and resistant to changing organisational priorities.

So let’s get a little scientific (or somewhat mathematical) about agility…

• Agility ⇒ being quick and nimble, adjusting to changing priorities without ‘drag’
• Agility ⇏ disregard for compliance
• Agility + other team attributes = effective business partnering.

So I challenge you to hold up your agility mirror in the context of your team’s performance.

THREE QUESTIONS TO ASK YOURSELF WHEN HOLDING UP THE AGILITY MIRROR

• How is your function often described by others?
• What are your top three operational bottleneck or ‘drag’ areas?
• What is your team’s collective agility profile?

[1] May 2019, The Digital Director – Are you ready? Nicole Donegan, COO, Women on Boards

Could your team benefit from productivity lift? In addition to traditional Regulatory consulting services, Mary offers team operational effectiveness checks and support.

Contact Mary for a complimentary Team Effectiveness Check.

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And “challenges” isn’t code for ‘a little tricky’ – it is estimated that only 9.6% of medicines in Phase I clinical trials actual progress to US FDA approval[1]. And a 2009 review article estimated that only about one in a thousand synthesised compounds actually progresses to clinical development[2].  Whilst statistics may vary amongst publications, the challenges of drug development are quite well known. A little daunting?  Perhaps.

But certainly there are successes, and two research programs entering the development phase are Cancer Therapeutics (CTX’s) chromatin modifying enzyme programs, which received a significant financial injection from biopharmaceutical giant Pfizer as part of a collaboration and license agreement worth up to $670M.

Cancer Therapeutics CRC (CTx) CEO, Brett Carter, shared this information with me in achieving the successful deal with Pfizer…

“For early stage, novel science it is not uncommon for deals to take over 12 months from the initial interaction to the signing of the agreement, and this was certainly the case in our deal with Pfizer. The deal process itself – diligence, agreeing deal structure and terms, gaining approvals and negotiating contracts – often takes 6 months or more and this only commences once there has been a thorough courting on the science and a commitment from the partner to enter into negotiations.”

Brett is keen to emphasise the importance of networks and relationships in building your brand with a potential partner organisation, remembering that a potential partner is likely also considering many drug development options. He suggested that, conferences, for example, are a great way to meet people with a shared interest.

So the Cancer Therapeutics CRC (CTx) story is one about good science that is amenable to drug discovery / drug development, good relationships, and, according to Brett, a good measure of “perseverance and tenacity”.

To medical researchers, Brett has this advice…

“Firstly, consider the application of your research. What is the best factor in the biology to target and what type of intervention would be most suitable for modulating that target? Finally, good fundamental biology is essential, however it is very rare that it alone is adequate to get partners on the hook. If researchers can demonstrate pharmacological modulation of a target which recapitulates genetic experiments, then the chances of getting partners to engage are far higher.”

In essence, commercialisation aspirations are best entwined with a futurist outlook of today’s medical research, enabling downstream considerations to be considered early on.

Here are a few more tips….

THREE QUESTIONS TO CONSIDER TO HELP YOU COMMERCIALISE YOUR RESEARCH

–      Are you thinking “beyond the Nature paper”? (Brett’s quote)

–     What are the key relationships to start building, or to nurture, now?

What is the potential unmet clinical application of your research?

[1] Clinical Development Success Rates 2006-2015, BIO Industry Analysis, June 2016

[2] Tamini and Ellis, 2009. Drug Development: From Concept to marketing! Clinical Practice, 113:p123-131

In addition to Regulatory and Related Consultung Services, Mary offers industry-readiness programs for people looking to enter the pharma, biopharma, biotech, med tech and wellness organisations. Contact Mary for a complimentary industry-readiness check or discussion on how this program may be applied to your organisation.

The post Isn’t my research enough? – Success amongst the learnings appeared first on Enimera RegsPlus.

What I would like to do in this article is help you navigate some of the important stakeholders (of course, there are others) to be aware of.

• The NHMRC[1]  – National Health and Medical Research Council- perhaps you are most familiar with this stakeholder. Did you know that in addition to funding research projects, the NHMRC also provides evidence-based health advice to Australians?
• MTP Connect[2]. Established in 2015, MTPConnect’s remit is broadly to facilitate commercialisation in the medical technology and pharmaceutical sector. MTP Connect publishes reports and advocates for a more favourable commercialisation environment.
• NCRIS[3] – the National Collaborative Research Infrastructure Strategy (NCRIS) – The Australian government invests in research infrastructure to aid the development of medicines and medical technologies via Therapeutic Innovation Australia (TIA)[4]. TIA helps researchers from the public and private sectors to access specialised facilities and expertise necessary for therapeutic development. TIA can also assist in referring researchers to other NCRIS-funded capabilities such as ‘omics or imaging.
• Ausbiotech[5] – Member-based associations such as Ausbiotech connect members with relevant stakeholders and offer learning and networking opportunities, in addition advocating for the sector advocacy. Ausbiotech, in particular, represents organisations across the pipeline from research to commercialisation.
• Regulators – Regulators decide, based on scientific and medical principles, whether or not a medicine or medical technology can be marketed. Understanding concepts like GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice), manufacturing process and test method validation, risk-benefit considerations etc can help you appreciate some of the downstream considerations. Additionally, Regulators often publish valuable information such approvals and summaries of data assessments.  Which Regulator(s) to focus on depends on the ultimate market(s) of the commercialised product, and this may not be determined for some time. A good place to start is the Australian regulator, the Therapeutic Goods Administration (the TGA, for those in the know), which has a SME Assist service for small to medium enterprises, researchers and start-ups[6], and an option to subscribe to email updates[7].

Some additional tips…

THREE QUESTIONS TO CONSIDER

• What is your network like outside your immediate area of research?
• Who in your organisation is connected to a key stakeholder?
• What publically-available information can help you broaden your sector knowledge?

………

[1] https://nhmrc.gov.au/about-us

[2] https://www.mtpconnect.org.au/Category?Action=View&Category_id=86

[3] https://www.education.gov.au/national-collaborative-research-infrastructure-strategy-ncris

[4] https://www.therapeuticinnovation.com.au/

[5] https://www.ausbiotech.org/

[6] https://www.tga.gov.au/sme-assist

[7] https://www.tga.gov.au/sme-assist-email-list

………

In addition to Regulatory and Related Consultung Services, Mary offers industry-readiness programs for people looking to enter the pharma, biopharma, biotech, med tech and wellness organisations. Contact Mary for a complimentary industry-readiness check or discussion on how this program may be applied to your organisation. 

The post Isn’t my research enough? – Helpful resources appeared first on Enimera RegsPlus.

Let’s be clear – good research is absolutely fundamental to commercialisation, and there’s plenty of good research around. In Australia, we are top five globally in biotechnology[3] – and have been for three consecutive years – as measured by intellectual property, intensity, enterprise support, workforce/education, productivity, policy and stability.

Good research, however, is only one phase of the commercialisation journey.

If we work with the assumption that you have good research underpinning a potentially great new medicine or medical technology, why might your research not be enough?

Here are just a few reasons why…

• • Challenges in progressing to proof-of-concept or prototype
  • Complexities in scale up to commercial manufacture

• Toxicity studies reveal unacceptable risks
• Clinical trials reveal unacceptable efficacy and/or safety profiles
• The target population or medical condition is unclear
• The expected return on investment isn’t attractive to potential partner organisations

Translational research is a fairly risky proposition, with risk declining (but not completely removed) during the development phase.  Understanding downstream factors which must complement and align with your research can help you hold a rounded perspective to guide your research towards commercialisation success and great patient outcomes.

Here are a few more tips…

FIVE QUESTIONS TO HELP BRIDGE YOUR RESEARCH TO COMMERCIALISATION OUTCOMES

• What is your 30 second response to tell me about your research? Is it easily understood by a lay person and does it link to a healthcare outcome?
• Who are the key stakeholder groups outside my immediate area of research?
• How much research is enough to present a compelling basis for further development?
• How protected is my research (think Intellectual Property)?
• What sources can I consult to help me understand some of the potential downstream development challenges?

Upcoming related articles

• Isn’t my research enough? – Helpful resources
• Isn’t my research enough? – Success amongst the learnings

[1] https://www.mtpconnect.org.au/

[2] https://www.education.gov.au/national-collaborative-research-infrastructure-strategy-ncris

[3] 2018 Annual Report, AusBiotech

In addition to Regulatory and Related Consultung Services, Mary offers industry-readiness programs for people looking to enter the pharma, biopharma, biotech, med tech and wellness organisations. Contact Mary for a complimentary industry-readiness check or discussion on how this program may be applied to your organisation. 

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