Friday, 14 August 2015 / Published in Knowledge

The Phases of a Clinical Trial

A clinical trial is a scientific study involving medicines, new treatments and new medical devices involving patient and non-patient human volunteers. They are necessary for collecting clinical data to demonstrate the safety and effectiveness of a new therapeutic, an existing therapeutic or a medical device.

Before commencing clinical trials on human subjects, extensive pre-clinical testing is performed on non-human subjects such as animals. This is necessary to determine whether the therapeutic has any merit as an investigational new drug and to obtain preliminary efficacy, toxicity, and pharmacokinetic information.

There are four different phases of clinical trials that a therapeutic can progress through during its development.

  • Phase I: Involves testing on healthy volunteers for dose ranging purposes. These clinical trials also identify preferred routes of administration – eg. tablet, injection, liquid, etc.
  • Phase II: This is the first stage that involves testing on patients to assess efficacy and safety. These clinical trials involve a smaller group of patients that are closely supervised.
  • Phase III: This involves testing on larger groups of patients. The purpose is to determine whether the therapeutic confers clinical benefit. A trial will only proceed onto Phase III, if Phase II demonstrated benefits that outweigh the risks. Potential side effects are also identified during this phase.
  • Phase IV: Gathers data for post-market surveillance. These trials are undertaken to further investigate the use of the medicine in a normal clinical setting and may involve comparisons with existing medicines.

Medical Devices

Medical devices are not classified via phase but involve similar concepts in demonstrating safety and efficacy. Pre-clinical testing may involve bench testing, biomaterial testing, immunogenicity and carcinogenicity testing. The new device may also be tested in animals. Initial clinical testing involve pilot studies on small groups of patients before commencing onto larger studies. Studies may also be performed to confirm the performance and safety of changes in design, materials or components of the device.

At Inner Maven we have assisted in the drafting of study protocols, determining ethical and regulatory requirements and in the general management of clinical studies in hospital, research institutions and independent laboratories.

Friday, 31 July 2015 / Published in Knowledge

Interdisciplinary research

Interdisciplinary research can be an essential driver for innovation in the medical device and pharmaceutical space. The opportunities are positive where collaboration between researchers or soon to be entrepreneurs can result in an idea that eventually leads to commercialisation.

Interdisplinary research involves bringing together inventors or researchers from separate disciplines. By drawing upon the unique expertise of each individual, the team creates new knowledge that would not be possible without collaboration. The Human Genome Project is a tremendous success story, where researchers from a variety of disciplines, such as: geneticists, biochemists, physicists and mathematicians, came together to decode the human genome. Although an understanding of human genetics was necessary, the staggering amounts of data analysed also required the expertise of computer scientists and mathematicians to manage the sensitive data. The data from the human genome project has resulted in the commercialisation of genetic diagnostic services, where patients are scanned for particular genes that are in indication of a higher risk of a particular disease.

The following may need to be considered when establishing an interdisciplinary team:

  • The additional time that may be required in developing a common language and framework to deliver a commercial output
  • How to set performance goals for an interdisciplinary team
  • Higher risk levels and cost
  • The funding of the project
  • Setting a realistic budget and promised deliverables
  • The roles of each individual within the collaboration
  • Potential IP ownership issues

At Inner Maven we have coached and managed collaborating researchers that started out in the research space, only to find that their separate ideas could come together to produce a commercial product. We have also assisted these teams in obtaining significant amounts of commercial funding.

Friday, 31 July 2015 / Published in Funding

Licensing Agreements – Payments

Licensing agreements are contractual arrangements that allow a licensee to use, manufacture or sell particular assets with permission from the contractual owner. Licensing has been integral for smaller medical device companies to gain access to resources, including specialist regulatory expertise or manufacturing and marketing capabilities. Compensation to the licensor can consist of a combination of the following:

Upfront Payment

Most licensors will want some form of lump sum payment at the commencement of the license.

Milestone payments

Milestone payments are made during significant events that occur as a result of Product Development and Marketing. As a product progresses further down the commercialisation pathway, the risks associated with bringing the product to market are lessened. For example, for the development of a medical device, this may involve successfully completing human clinical studies or achieving regulatory approval from the TGA/FDA. Once these milestones have been achieved, a payment may be made to the licensor.

Royalties

Royalties might be something you associate with musicians but are equally applicable to any form of licensing agreement. The payment represents a percentage of net sales derived from the use of an asset. You will need to decide in your agreement whether the rate will be fixed or has the ability to increase/decrease with net sales or changes in circumstance, e.g. third party competition, choice of territory, patent expiry, etc.

Loans

Licensing agreements involving loans are less common. This is where Company A may make available a loan of $X million to a start-up company. The potential credit available may have more attractive interest rates and payment terms compared to traditional financing methods.

Equity Agreement

Wherein instances like these, the financial terms within the agreement may enable the waiving of cash payments, in return for an equity stake in the company.

Inner Maven has experience negotiating terms of agreements to ensure the inventor is protected, and both parties are happy with the outcome. 

Tuesday, 23 June 2015 / Published in Market Strategies

Choosing the Best Path to Market

There are important things entrepreneurs need to consider before commercialisation. The fundamental question is whether your medical device is a sustaining technology or is it a disruptive one?

Sustaining Technology

A sustaining technology is one that relies on incremental improvements. For medical technology, this may be a diagnostic test that has improved sensitivity or accuracy to detect bladder cancer, or it may be a medical device that has improved functionality compared to currently available models. For sustaining technologies, it may be worth pursuing a licensing strategy, rather than competing directly with big competitors. This is where the owner of the intellectual property licenses the technology to another company to manufacture, market or distribute. Click for further information on licensing opportunities.

Disruptive Technology 

A disruptive technology is a game changer. It shakes up the industry, is groundbreaking and creates a completely new industry. Think of the introduction of the first smartphone, 3D printing, the first automobile, the first minimally invasive surgery, etc. In these instances, it is recommended that a medical device company pursue a start-up or spin-off strategy where raising capital in the early stages of commercialisation is pivotal. Pursuing a licensing strategy may not be suitable for disruptive game changes, particularly when the product may reduce the sales of a competing company’s existing product line. Click for further information on start-ups and spin-offs.

At Inner Maven, we can search the market for competing technologies and evaluate whether your product is sustaining or disruptive. Following this evaluation, we can then assist you to pursue the most appropriate market strategy.

Thursday, 28 May 2015 / Published in Intellectual Property

Challenges to Patentability in Biotechnology

Rapid advances in biotechnology have posed challenges for legislators and biotechnology companies as legal systems struggle to determine the patentability of biological matter. Key issues include the ownership of genes, the law of nature in diagnostic methods, GMOs and biopharmaceuticals.

Litigation that has reversed decades of US precedent is best demonstrated by the ‘Myriad’ case. Mutations in the BRCA1 and BRCA2 genes are well known in the medical community for being linked to increased risk of developing breast and ovarian cancer. The issue in this case, is whether the isolation of DNA is patent eligible. The US Supreme court invalidated previous claims that upheld the patent eligibility of the BRCA genes, by claiming that isolated DNA is a product of nature and therefore not patent eligible. The court later clarified that nucleic acids in which the order of the nucleotides has been altered do remain patentable. But the question remains how much of a ‘change’ is necessary or considered ‘significantly different’ for companies to retain their IP.

The question of ‘what is natural’ was also raised in the ‘Prometheus’ case. Diagnostic methods that apply a high level of generality to laws of nature were deemed patent ineligible. For instance, diagnostic methods that measure an increase in metabolite levels in a patient, is considered a naturally occurring phenomenon and too ‘general’. Any additional steps in the diagnostic process are considered well-understood and conventional activities that are routinely performed, e.g. administering the drug, determining metabolite levels, etc. Claims that cover application of the natural law or involve conventional steps are therefore not patent eligible. This raises the question for many diagnostic companies. Is the methodology in their diagnostic step sufficiently inventive and ‘significantly different’ from the natural law for them to retain the IP?

The US legal system is currently dealing with these challenges of ownership. An alternative strategy for inventors is to pursue narrower claims on items, items that are clearly novel and ‘significantly different’, e.g. a novel molecule, a new medical device, new formulations, etc. Further patent applications can then be filed if necessary, once the issue of patentability is more clear-cut.

Ownership of IP is pivotal in the commercialisation process. If you are looking to file a patent in the US that relates to genetic material, be wary of the challenges in patentability. Inner Maven can provide introductions to patent attorneys that can give consultation and advice on this matter and often work together with them through gaining IP protection. 

Thursday, 07 May 2015 / Published in Intellectual Property

The Basics of Confidentiality Agreements

A confidentiality agreement, also known as a non-disclosure agreement (NDA) is a legal contract between two parties. It restricts the sharing of confidential information outside of the parties involved. An NDA should be drafted and signed before commencing any discussion with third parties. This is particularly useful when discussing your medical device or idea with potential partners, licensees or investors. Protecting information that is not publicly available is important for commercialisation. Here are some essential elements of an NDA:

  • Choose a Two-Way agreement to prevent disclosure issues
  • Clarify the ‘field’ as clearly and narrowly as possible. The field will be your product of interest. Eg “BioCyst possesses information relating to CB3748, a novel antigen”
  • Specify information that you do not want to receive, eg. the structure of a molecule, specific design of a medical device, etc.
  • Clarify the permissible uses of any Confidential information and the purpose of using this information
  • The NDA should specify that the confidential information will be disclosed in writing, and that all confidential information be marked as ‘Confidential’. If confidential information is discussed orally, this should be summarized in writing within a specified time period.
  • All confidential information should be destroyed or returned after termination of contract.
  • Determine who is covered in the NDA. Will the information need to be discussed to external consultants or subsidiaries of the company? Clarify whether this information can be disclosed.
  • Specify the right to retain an archival copy to know what has been discussed.
  • Specify the exact date and time period where information can be disclosed and must be maintained as confidential.
  • There should be an exception clause, stating the definition of ‘not confidential’ e.g. if the information is already known to the receiving party

Inner Maven can help you draft various legal agreements. We have engaged in numerous discussions with potential licensees, investors and partners that have required the disclosure of confidential information. This is pivotal to protecting your IP and idea.

Thursday, 26 March 2015 / Published in Market Strategies

Building a Business Relationship

Finding a business partner is merely a small step in the commercialisation journey. From here on, the relationship needs to be managed to ensure it is a mutually beneficial one. Wasting time with mismatched partnerships is particularly harmful to those looking to commercialise medical devices or any technology device for that matter. It may significantly delay the development process, which in turn delays the regulatory process and the release date of the device. Consider the following points in managing a business relationship:

Agreements

Ensure the right agreements are in place before commencing any sort of transaction or discussion. You may want to hire a lawyer to draft one, however make sure you engage the right lawyer as some are more experienced in this than others. This may involve signing non-disclosure agreements to ensure company secrets or commercially sensitive information can be freely discussed between parties. You don’t want to be burned by the other party by not having the right agreement in place.

Clear expectations

Clearly communicate your expectations with the relationship. Again, this may be supported further by agreements depending on the type of relationship. For instance, you may require a distribution agreement for each district and distributor you are dealing with. License agreements, shareholder agreements, marketing agreements and various market entry agreements such as: joint ventures, partnerships, etc. are also common for medical devices. In the instance that the other party is not living up to the contractual agreement, it may be necessary to walk away or send warning notices. This is something a legal advisor will manage on your behalf.

Mutually beneficial

This is an obvious one, but both parties need to gain something for the relationship to be worth pursuing. Think of your weaknesses and how the partner can help. Think of their weaknesses and how you can help.

Communicate

The relationship should be a collaborative one where both parties communicate on a consistent basis, sharing issues and solving problems if necessary. Schedule monthly or weekly meetings as required to catch-up. Meet face to face to strengthen the relationship.

Give

Be willing to give and receive honest feedback. Business networks are increasingly important in the medical device industry. You never know which contacts both parties may have that may be useful to the other.

Seek Assistance

If you have no clue how to manage relationships such as joint ventures, partnerships, etc. – seek assistance.

Commercialisation consultants from Inner Maven can assist in finding and managing business relationships and can also refer you to the appropriate legal advisors.

Sunday, 15 March 2015 / Published in Knowledge

Factors for Biotechnology Success

For three years running, Australia has ranked in the top 5 in biotechnology in the world with 140 ASX- listed biotechnology companies with a market capitalisation of $50 billion (Ausbiotech, 2017). CSL remains the largest biotechnology company in Australia with Medical Technology and devices also surging forward. The big guns in this area include Cochlear and Respiri with their ear apparatus and breathing tracking devices. Biotechnology and Medical Devices certainly remain promising areas for commercialisation. But what are the critical factors for their success? Every company starts small, but with proper leadership to direct company management and translation of Research & Development into commercial products, your company can grow.

Amgen was a struggling company in the 1980s suffering in an era where biotechnology was a relatively unknown industry. Here are five critical success factors that contributed to Amgen’s success in translating drug development on a small scale to the mass market.

  1. Early Financing: M. Bowes was the founding shareholder of Amgen, hiring Winston Salsa, a UCLA scientist, to collaborate with him. Together they recruited a formidable scientific advisory board and raised $200,000 in venture capital. With this funding, Amgen recruited George Rathmann, the former chief of Abbott Laboratories, who then set out to raise large rounds of private equity funding. Early financing allowed Amgen to retain most of the marketing rights to Epogen and to survive the development and commercialisation process. It also meant that Amgen didn’t have to license away their rights to their best products.
  1. The Right People: Poor management can destroy a good company. With the right people, both with technical and commercial abilities, Amgen was able to raise the necessary funding to commence operation.
  1. Focused R&D: Amgen’s CEO insisted that the R&D strategy was to focus on a small number of high-potential projects. The strategic focus combined with effective R&D management allowed the company to successfully commercialise breakthroughs.
  1. Strategic Partnerships: Not every company or team is perfect. Amgen was able to recognize that it lacked manufacturing expertise. Establishing a joint venture with Kirin Brewery proved invaluable to both companies. Amgen was able to gain access to critical manufacturing technology, in exchange for some international marketing rights.
  1. First Entry: The early bird gets the worm indeed. Amgen invested heavily in marketing and manufacturing during the early days, positioning them as market leaders in an uncontested market for EPO based products.

From a little company in the LA, Amgen became one of the leaders in biotechnology.

At InnerMaven, we can help in the critical early stages to raise early financing and to provide commercial expertise.

Monday, 02 March 2015 / Published in Knowledge

Making a Pitch

By now, you would have heard of the show Shark Tank. This television series based on hopeful entrepreneurs, pitching their idea to a group of millionaire investors, is an inspiring watch. The panelists on the show are an impressive line: Naomi Simson, founder of Red Balloon, John McGrath of McGrath Partners Real Estate, Andrew Banks from the recruiter Morgan & Banks, Janine Allis founder of Boost Juice and Steve Baxter, IT entrepreneur. Funding is a big hurdle for successful commercialisation. Considering investors and venture capital firms are common sources of capital, presenting a good pitch is pivotal for communicating the benefits of your medical device and ultimately convincing an investor to take a risk on you. Consider these points when putting together a pitch:

Less is More

Keep your Powerpoint deck simple. Do not overload it with slides, then run out of time to speak through it all. Present your business in a manner that’s succinct and to the point. If an investor is interested, you can always provide additional information later.

Provide realistic projections

Base your projections on fact. Do not show the investor unrealistic projections, particularly when your company is at $0 revenue. You need to be able to justify your projections and assumptions. Refrain from saying unrealistic statements such as ‘we have no competition’ or overestimating the size of your market. Most investors are seeking a low-risk business that solves an existing problem. An experienced team, real world experience and cash flow are more enticing than an overblown forecast.

Do a Demo

If you can, demonstrate your medical device. A demo is worth a thousand words. But make sure it works well and looks good.

Research, Research, Research

Perform some due diligence before the meeting. Research the investor, his portfolio and his investment interests. There’s no point pitching a medical device to somebody that does not have an interest in the area.

Understand your Product & Business

An investor wants to know that you understand your product, your business and the market that you’re launching into. Be prepared for questions. A good entrepreneur should be able to explain how their medical device is differentiated from competitors, understand the risks of the business and be able to communicate a coherent business strategy in all aspects including marketing, customer acquisition, sales strategy, etc.

How will the investor’s funds be used?

Investors want to know the current stage of development of your technology. They want to know how their capital will be used and whether you have estimated realistic capital requirements.

At Inner Maven we have assisted clients in approaching potential investors, collating pitch decks and have successfully presented pitches to win millions in investor funds.

Wednesday, 25 February 2015 / Published in Market Strategies

Approaching Partners

Many start-up medical device companies face hurdles in lack of resources, expertise or capital. Many inventors choose to support the initial development phase of their technology with their personal resources, but soon find that they run out of time and money. The project may also be too early in the development phase to attract external investors or venture capital.  One solution is to find a commercial partner to support the commercialisation process. The two most common forms are to:

  1. License the technology: Find a company that may be interested in a co-development opportunity. They may be able evaluate the technology and provide the extra resources to speed up the development process.
  2. Partner with an OEM manufacturer: Risk share in the development and manufacturing of your medical device. An OEM manufacturer may have the expertise in the development and manufacturing of a particular niche technology. They may also have the ability to sell to other device companies with access to a particular target market.

The following are points to consider in increasing the likelihood of engaging a potential partner.

  • Don’t go straight to the big pharmaceutical companies. They are big for a reason and that also means that they are a lot fussier when choosing potential partners. Consider smaller medical device companies that are in a growth phase, that are looking to expand their portfolio.
  • Look at the current product offerings of the target partner. Is your product complementary to their current portfolio? Does your product fit in with the company’s vision?
  • Attend as many industry networking events as you can. Many medical device and biotechnology companies congregate at specific networking events, designed to bring together people of the same industry. You never know who you will meet that can connect you to the right target company.
  • Communicate. Communicate. Communicate. Once you have established a list of relevant target companies it is time to ask for an evaluation or potential partnership. Follow-up constantly, be responsive and continually update them on key milestones. Persistence is the key.
  • Engage a consulting firm like Inner Maven. The right consulting firm will already have the networks, relationships and knowledge to improve the quality of the partner you need and the timeframe to find them.

At Inner Maven we have successfully engaged multiple commercial partners for our clients during the early phases of development, which has resulted in the successful commercialisation of medical devices.