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commercial eyes recruiting: research analyst

Apply you research and analysis skills to build a commercial career in the Healthcare industry.

 

The Role…

As the Market Insight Research Analyst you will be responsible for undertaking technical research and data analysis to support the delivery of key insights to Commercial Eyes clients. You will also assist with the development of research hypotheses and research tools and frameworks for analysing and presenting data. As a key contributor to the team you will assist in writing high quality reports and developing presentations for clients.

To be successful in this role, you will ideally possess…..

  • a degree in a life science discipline, business or marketing
  • strong research and analytical skills
  • an understanding of the Australian healthcare market
  • experience in compilation of research reports, data analysis and presentations
  • excellent written and interpersonal communication skills
  • a high attention to detail
  • a continuous improvement mindset
  • strong problem-solving capability
  • excellent collaboration and teamworking skills. 

 

The rewards…..

At Commercial Eyes we work with and support the industry’s best.

  • Propel your professional development through a breadth of experience
  • Be assured of interesting & meaningful work that challenges and demands your best
  • Gain exposure to leading healthcare companies
  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives
  • This is a full-time position; however flexible work arrangements may be negotiated.

 

At Commercial Eyes we believe in doing what is right.

  • Be part of an inclusive and diverse working environment
  • Join a company that is generous to the community

 

Please note: to apply for this role you must be a permanent resident or citizen of Australia. Commercial Eyes does not accept applications from recruitment agencies.

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

 

To apply, please submit your CV and cover letter to [email protected]

Please note Commercial Eyes does not accept applications from recruitment agencies.

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IWD as HR Manager at Commercial Eyes.

I have a science degree, and I remember being a minority in the lecture theatre during my degree, I was a maths and science teacher and I remember being a minority in the staff room and having to battle the concept that girls aren’t as good at maths and science as boys. Now I am surrounded by women working in science, women leading their business units, and there is no question that girls are great at science and business.

International Women’s Day (March 8) is a global day celebrating the social, economic, cultural and political achievements of women. The day also marks a call to action for accelerating gender parity. I am the HR Manager at Commercial Eyes, and I want to take the opportunity to celebrate the super smart, super successful, women that lead the business and that I get to work with.

The IWD 2019 theme is “Gender Balance”. At Commercial Eyes we work in the Life Sciences Sector, In the report by AusBiotech ‘Australia’s Life Sciences Sector Snapshot 2017’, they found that on average, women represent 50 per cent of the workforce across the entire sector; however female representation decreases as seniority levels increase’. Commercial Eyes is bucking this trend. Instead of female representation dropping as seniority levels increase, at Commercial Eyes it increases! 85% of our management team are women.

I see two key factors that I think have contributed to the strong representation of women in the Commercial Eyes management team.

When Andrew Carter, Managing Director of Commercial Eyes started the business in 2001, he worked with a talent pool of women looking for flexibility that was not at the time readily available in the industry. Incredibly talented women who wanted to balance work and family. – Flexible work practices were essential to Commercial Eyes’ early success and have gone on to become one of the companies’ core values. Today 37% of the CEPL employees work part time or casual, and many more access flexible work practices including altered core hours, and working remotely, to enable them to manage work and life.

They say, ‘success begets success’, at Commercial Eyes the question of women in leadership – is not one that needs to be pondered, because it is happening every day. Having so many women in key business leadership roles, provides role modelling and mentors for others. It’s easier to climb the mountain when you see that someone else has done it. The great thing is that as a consulting firm the female members of our management team engage with people across the sector every day, providing role modelling and inspiration beyond our doors.

It is a pleasure to be working in this environment with such great women.

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International Women’s Day Celebrations

International Women’s Day (March 8) is a global day celebrating the social, economic, cultural and political achievements of women. The day also marks a call to action for accelerating gender parity.

On IWD we celebrated our amazing woman and we considered the role gender imbalance plays in Domestic Violence, and thought about what we can each do for #BalanceforBetter.

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Commercial Eyes Recruiting: Regulatory Services Associate / Consultant

Regulatory Services Associate

Experience it all! Pharma, Med Device, Industry leading companies, broad range of therapeutic areas…

 

The role…

Operating within the Regulatory Services Business Unit this role will involve providing Regulatory Affairs and Quality consulting services to the clients of Commercial Eyes, from routine regulatory submissions to major submissions, such as Category One (1) Applications and New Medicine Applications.

 

To be successful in this role, you will ideally possess…

  • 2+/5+ yrs experience in Aust and NZ regulatory affairs.
  • Knowledge of TGA and Medsafe legislation, regulations, guidelines. 
  • Degree in science or a related discipline (post-grad advantageous)
  • High level written and oral communication skills.
  • Proven problem solving and project management skills.
  • Ability to deal with high level of confidentiality.
  • Previous consulting experience advantageous. 

The rewards…

At Commercial Eyes we work with and support the industry’s best.

  • Propel your professional development through a breadth of experience
  • Be assured of interesting & meaningful work that challenges, changes, and demands your best
  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives through health

 

At Commercial Eyes we believe in doing what is right.

  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment
  • Join a company that is generous to the community

 

Please note: to apply for this role you must be a permanent resident or citizen of Australia. Commercial Eyes does not accept applications from recruitment agencies.

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

To apply, please submit your CV and cover letter to [email protected].  If you want to know more information call Stephanie Gaylard, HR on 03 92510777.

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Commercial Eyes Recruiting: Medical Information Associate / Jr Associate

Accelerate your Med Info Career

 

The Role…

This role is a great opportunity to take your career to the next level, through exposure to medical information across a range of companies and products. Join a great team, providing Med Info services on behalf of a range of clients (pharma, OTC, devices, local & global) to enquirers including; healthcare professionals, consumers, and the client’s internal staff.

 

Duties…

  • Receive, assess and respond to medical information enquiries in a timely and compliant manner.
  • Assist in maintenance (creation, review and approval) of standard responses in the medical information database.
  • Respond to customer queries using various medical databases and research strategies, including performing literature reviews.
  • Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures and regulations.
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities.

To be successful in this role, you will ideally possess……….

  • Health Science degree (Pharm, BioMed, PharmSci, etc).
  • 1+ years’ experience in medical information.
  • Knowledge of the principles of medical information communication.
  • Ability to conduct basic literature searches using Pubmed or Embase.
  • Knowledge of prescription, medical device and/ or complementary medicines.
  • Knowledge of ANZ & key overseas regulations in medical information and drug safety reporting.
  • Highly developed verbal and written communication, organisational and problem-solving skills.

The rewards…

At Commercial Eyes we work with and support the industry’s best.

  • Propel your professional development through a breadth of experience
  • Be assured of interesting & meaningful work that challenges, changes, and demands your best
  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives through health

At Commercial Eyes we believe in doing what is right.

  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment
  • Join a company that is generous to the community

 

Please note: to apply for this role you must be a permanent resident or citizen of Australia. Commercial Eyes does not accept applications from recruitment agencies.

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

To apply, please submit your CV and cover letter to [email protected].  If you want to know more information call Stephanie Gaylard, HR on 61 3 92510777.

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Are you ready for the mandatory transition to eCTD for prescription medicines?

Mandatory Transition to eCTD

In October 2018 the TGA announced the long-awaited timelines for transition to eCTD. A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new biological entity, biosimilar and new combination medicine applications; with a proposed implementation by first quarter 2019. The timelines for Stage 2 (other Category 1 applications) and Stage 3 (variations and other types of applications) are 1 October 2019 and 1 July 2020, respectively.

The TGA consultation on the Transition to eCTD only for prescription medicines closes on 4 December 2018 and it is an opportunity to provide feedback on how the staged transition to eCTD will impact your organisation.

The transition to eCTD may seem daunting for companies who have not “taken the plunge”, and with valid reason, as it is not a simple project. Acquiring eCTD software will require considerable planning and resource before you are up and running. Some of the key steps to consider in planning your transition include defining your publishing requirements, investigating software solutions, selecting a vendor, procuring software, preparing IT systems, installing software and training.

Full or partial outsourcing of eCTD publishing is an alternative option which can support your transition to eCTD. Outsourcing can provide a cost and time effective solution for accessing eCTD software and publishing expertise. Partial outsourcing is also an option for increasing publishing capacity and access to local publishing resources in the same time zone can assist with meeting short deadlines.

 

To discuss how Commercial Eyes can assist you with all your eCTD outsourcing needs, contact our Regulatory Services team at [email protected]

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November 2018 PBAC Meeting Agenda

The November 2018 PBAC Meeting is scheduled to conclude today. Here, the Commercial Eyes Market Access team provides an analysis of the meeting agenda, including Sponsors with multiple submissions and the nature of requested listings by type.

 

 

The Commercial Eyes Market Access can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

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Patient programs for improved patient outcomes

In the digital age of present, patients have never been better equipped with the devices and technologies to take control of their own healthcare needs and outcomes. With the ease of online access to tools such as patient forums, advocacy groups and self-assessment sites to name a few, patients are well informed and able to play a strong role in the dialogue of their own health care matters. This has ultimately led to a feeling of empowerment among the patient community, as well as an expectation to be heard.1

This shift in perspective is leading pharmaceutical companies to focus on patient centric services and technology-based solutions. In a survey of over 200 patient services executives from the US and European industries (Accenture 2016), 85% of companies said they would be raising their investment towards a patient-centric approach over the next 18 months (Figure 1).2

Figure 1

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

 

In the same survey, 95% of respondents said they would be planning to invest in patient engagement technologies during the next 18 months (Figure 2), showing the industry trend towards alignment with the ever more technology-focused patient.

Figure 2

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

Of the top ten patient services cited by surveyed patients as ‘extremely valuable’ (Accenture 2016), those which received the highest patient value included:

  • Medication delivery/support (85%)
  • Benefit coverage and access support (79%)
  • Remote monitoring (79%)
  • Patient outreach, reminders, scheduling (79%)
  • Adherence program management (77%)

 

Based on these figures it is not surprising that Pharmaceutical companies are focusing more and more closely on patient programs as initiatives to improve access to, usage of and adherence to medicines. Spending on these solutions has increased by nearly threefold in recent years as companies strive to deliver improved patient outcomes.3

In response to the top two patient rated services above – medication and access support – pharmaceuticals companies are looking towards medicines access programs (MAPs) to allow for a deferred cost of, or cost-free or subsidised access to medicines which do not have the relevant funding in place. For example, free access to medicines for indications which are not included within a funded scheme, e.g. clinical trial, and usually involving life-threatening conditions (compassionate access programs) or free access to medicines which are TGA-approved, however have not yet reached government reimbursement via the Pharmaceutical Benefits Scheme (PBS) (patient access programs).4 These are examples of the types of patient programs we can expect to see continued industry growth and investment in.

How can we help?

At Commercial Eyes, we have expertise in the development of online and paper-based patient programs, including compassionate access programs, patient access programs, product familiarisation programs (PFPs), patient support programs (PSPs) which can also involve the use of nurse support. We have collaborated with centralised pharmacies to allow for supply management direct to patient and have worked on nominated pharmacy models alike. We are passionate and excited about the upward trend towards patient services and can provide advice, support, assistance and expert project management for programs tailored to our clients’ needs.

For more information on how we may be able to help you develop a successful compliant Patient Program please contact [email protected]

 

  1. Therapeutic Innovation & Regulatory Science 2017, Vol. 51(4) 460-467
  2. The patient is in pharma’s growing opportunity in patient services. 2016. Online access July 2018
  3. Patient Support Programs That Deliver Results. 2015. Online access July 2018
  4. Managing Medicines Access Programs. 2015. Online access July 2018

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PBAC Meeting Outcomes – July 2018

The July 2018 PBAC Meeting Outcomes were published on 17th August 2018. With 64 outcomes in total, the Commercial Eyes Market Access team provides an overview of PBAC decision making, including additional analysis conducted on biosimilar and oncology submissions.

 

PBAC Meeting Outcomes

 

The Commercial Eyes Market Access can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

 

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Public Submissions to the August 2018 PBAC Special Meeting – Part 2

In the second part of this two-part series (Read Part 1 about here) we bring you further insight into opinions from the public submissions to the August 2018 PBAC Special Meeting.

Opinions from the Public Submissions


28 public submissions were received regarding the PBAC considerations for PD-1 and PD-L1 checkpoint inhibitors for multiple cancer types.

 

Do you think that different evidentiary requirements are appropriate for rare cancers?

 

YES – 64%   NO – 4%

No answer provided – 14%
Not published – 14%
Other* – 4%

 

* ”There are no set evidentiary requirements for applications seeking PBS listing of a drug, other than that the available data be presented systematically, in an unbiased manner and present evidence of comparative efficacy, safety and cost-effectiveness…”

 

How do you think cost-effectiveness should be established in this case?

A number of submissions commented on managed entry agreements and evidence development. A shared funded access mechanism could be applied where, after commencement, fit-for-purpose data could be collected prospectively to confirm the biological rationale and effectiveness of the product.

Multiple submissions stressed the generation of real-world outcome data for populations with rare and less common cancers as critical.

Do you think it is possible for the PBAC to satisfy itself that treatment with a PD-1 or PD-L1 checkpoint inhibitor is cost-effective without an economic model that is specific to that kind of cancer? How?

A number of submissions commented on the difficulties and challenges of determining cost-effectiveness without an economic model, or assessment of multiple indications within a single economic funding model. In the absence of multi-tumour data, there is significant uncertainty, and a greater tolerance of uncertainty may be justified in situations of high unmet need.

Some submissions provided possible approaches to establishing cost-effectiveness across cancer types:

  • Develop a separate model for each cancer type included in the multi-tumour list and perform separate cost-effectiveness analyses to identify the tumour type(s) where the drug is cost-effective
  • Develop a single, comprehensive model to simultaneously inform cost-effectiveness in multiple cancer types with the possibility of clustering different but related tumours types (e.g. similar natural progression, treatment approach). This model could allow estimation of incremental cost-effectiveness ratios (ICERs) of individual tumour types based on the relative prevalence and utilisation of the proposed drug in each tumour type
  • In the absence of an economic model, establish scores of clinical value (e.g. ESMO Magnitude of Clinical Benefit Scale (MCBS), ASCO value framework) and link price to scoring systems
  • Follow-on indication pathway: resources are devoted at the start of the agreement to define the populations and clarify expectations of the evidence and cost-effectiveness. For follow-on indications in the 3-year risk-sharing deeds, cost-effectiveness is verified at the end of the agreement period and this could be accomplished using a multi-indication model using pre-agreed principles
  • Rare cancer pathway: a pay-for performance type approach to medicines access should ideally not require the construction of, or evaluation of, a traditional PBAC-level economic model. This approach, in this population, controls expenditure and maximises value for public money by ensuring funds are spent when response (as a measure of effectiveness) is confirmed


FDA – 3 submissions referenced the FDA’s decision to consider pan-tumour indications and the approval of Keytruda® (pembrolizumab).

MA OIT – 4 submissions referred to the Medicines Australia’s (MA) Oncology Industry Taskforce’s (OIT) preliminary research into innovative international models for subsidy consideration across multiple indications. This found that there are various initiatives underway in overseas health systems (Belgium, Denmark, Netherlands, Germany and Italy). As per Medicines Australia: “While many of these agreements would not fit within the Australian legislative requirements, there are elements (e.g. initial horizon scanning of upcoming indications) that could be quite useful locally.” For further information, please refer to the submission by Medicines Australia: http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/agenda/pdf/august-2018-special-meeting/submission-27-medicines-australia.pdf

Outcomes of the PBAC’s considerations will be published through the PBS website scheduled for 28 September 2018.

Abbreviations: PBAC = Pharmaceutical Benefits Advisory Committee; PD-1 = programmed cell death-1; PD-L1 = ligand of PD-1 receptor; ICER = Incremental Cost-Effectiveness Ratio; ESMO = European Society for Medical Oncology; MCBS = Magnitude of Clinical Benefit Scale; ASCO = American Society of Clinical Oncology; FDA = Food and Drug Administration; MA = Medicines Australia; OIT = Oncology Industry Taskforce

Source: Pharmaceutical Benefits Scheme

 

The Commercial Eyes Market Access team has extensive experience in pricing and reimbursement and can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

This article was written by Michelle Yassa, Market Access Consultant.

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