Life Science Innovation: The Rise of the Kymanox Hyper-Virtual Model?

A newer and expanding model is changing the way people think about starting, growing, and investing in product start-up companies:

The rise of the hyper-virtual sponsor, backed by venture capital, and powered by Kymanox.

While we may be familiar with “Three Guys and a Molecule” start-up stories, the degree to which such companies can now remain hyper-virtual is a more recent innovation.? Several Kymanox clients have already benefited from this model for well over a decade and more companies are set to benefit in the future.?

The “hyper-virtual” approach effectively tackles two pivotal aspects that concern individuals with a stake in these enterprises and who are well-versed in the field:

• SPEED: This encompasses the acceleration from ideation to market (i.e., bench to patient), swift progression through developmental stages, and direct navigation to the next value inflection points.
• RISK: The approach focuses on adept management and reduction of risks associated with the business and technology translation.

(NOTE: If you are a Top 20 Biopharma and feel this couldn’t apply to you, please don’t tune out as there is something great for you at the end!)

Every facet of Kymanox has been meticulously crafted with intention and purpose.? It stands on a completely distinctive platform, specifically engineered to bolster translational modern medicine. ?The company name, taken from Greek, means IDEAL KNOWLEDGE TRANSFER? and implies service:

Kymanox doesn’t make products for patients, we help make those products better, faster, and more accessible.?

Now after two decades of growth and maturation, Kymanox is able to fully support a new class of companies that can be classified as “hyper-virtual.” These companies are the innovators and sponsors for biologics, drugs, medical devices, and combination products (e.g., a biologic in a device delivery system) and they don’t rely on internal team members to execute their vision; rather, they outsource everything but their (i) Vision, (ii) Decision Making, and (iii) Accountability.

You may have heard the term of a "virtual" biopharma company as those companies have existed for quite some time; traditional virtual companies partner with Contract Development and Manufacturing Organizations (CDMOs), Clinical Research Organizations (CROs), and several other third-party suppliers.? A typical virtual company will have 50 important suppliers that each require legal agreements, financial relationships, account management, and oversight. Managing these suppliers requires significant internal effort and numerous employees to do so.? While a hyper-virtual company ultimately requires the same development tasks to be accomplished, it adopts a different approach.? Instead of involving 50 or so more suppliers, it strategically engages as few as five and empowers key suppliers to perform strategic subcontracting.? By Kymanox’s definition, a hyper-virtual company has employees in the single digits (i.e., nine or fewer permanent payroll employees) and can often be quite successful with only three; in some extreme cases, n=1 is all it takes to move from a napkin sketch concept to product approval submission.

Overseeing 50 suppliers proves to be a daunting challenge for a burgeoning (drug) development company.? Two persistent forces are at always at play, sapping enterprise value:

• ONE: Technical personnel at or near the director level must invest time in managing the following elements, diverting their focus from advancing the product through development and commercialization:

o?? Confidentiality Agreements (CDAs, NDAs)

o?? Master Service Agreements (MSAs)

o?? Proposals and Change Orders

o?? Timesheets and Invoices

o?? Relationship Communication that Scales to N*(N-1)/2.

• TWO: Interactions between suppliers, requiring continuous coordination by the same higher-level company representatives, create a dynamic where Supplier A often blames Supplier B for schedule delays, needed rework, and cost overruns.? Managing all the various roles and responsibilities, including all the interdependencies, ultimately slows down the company.?

The following table helps illustrate the key differences between an ordinary virtual company and one that is HYPER-virtual:

A high-performing business demands its technical leaders to predominately focus on analyzing the current state of development and making critical decisions to propel development to commercial approval.? Simultaneously, these leaders must hold third-parties accountable for their contributions.? The primary hinderance to development often lies in the sluggishness of decision-making, rather than the speed of a specific task.? Decision-making, inclusive of final conclusions drawn from summarized data analyses, is crucial, and anything impeding the flow of data becomes a cause for schedule delays. Because the meter is always running at a (drug) development company, due primarily to employee payroll, extending the schedule translates to increased expenses and total cost – and a shorter runway.

This is where Kymanox steps into the equation and disrupts what is possible. Kymanox is structured like a robust mid-cap biopharma organization; the only difference is that we don't have our own product or manufacturing facility. Our products are our clients’ products, and our facilities belong to our clients or CDMOs. Kymanox has nearly every imaginable function within its own walls, including a versatile CGxP laboratory and a fully operational electronic Quality Management System (eQMS) to support the Kymanox Hyper-Virtual Model?. Furthermore, our well-organized groups have engineered overlap to ensure group-to-group connectivity, resilience, and reliability. While there are some functions that Kymanox does not perform, it is a very small list (e.g., we don’t name your drug, price your drug, or write new manufacturing PLC code).? When Kymanox needs to access additional capabilities, specialized expertise, and bandwidth, we have proven partners inside our Kymanox Preferred Partner Network (KPPN) that we can seamlessly activate or, if required, make the high-level executive connections to facilitate an expedient business agreement.? Kymanox can significantly reduce the number of suppliers so that hyper-virtual companies are only left to manage five key supplier relationships, such as:

1. Legal and Finance
2. Kymanox (e.g., can replace up to 90% of traditional individual suppliers and with few-to-none subcontracting arrangements)
3. CDMO (laboratory and manufacturing)
4. CRO (non-clinical and clinical studies)
5. Other (e.g., human resources, specialty lab)

With the Kymanox Hyper-Virtual Model?, the small, capable team at the sponsor company can concentrate on their core strengths and essential tasks: refining the vision, swiftly assessing summarized data analyses, and making prompt decisions.??

While Kymanox operates with considerable complexity, holding us accountable for the myriad of workstreams under our scope is straightforward for clients. ?The organizational chart at Kymanox is function-based, yet our approach involves assembling and communicating through teams.? These teams are frequently associated with specific client projects, but they are also formed to cover specialty practice areas, action-oriented subcommittees, and various levels of leadership and business management.? Although it may seem intricate, a typical Kymanox employee is often a member of seven or more teams simultaneously. For instance:

1. Department (e.g., Process Engineering)
2. Client Project X (e.g., IND-enabling a novel biologic in a novel autoinjector)
3. Client Project Y (e.g., technology transfer for a late-stage nanoparticle drug)
4. Client Project Z (e.g., new CGMP facility start-up)
5. Leadership Team (e.g., Functional Leadership Team)
6. Task Force (e.g., Artificial Intelligence)
7. Sub-Committee (e.g., Kymanox Annual Meeting)

What distinguishes the Kymanox team as robust, influential, and distinctive is not just the brilliance of our individuals, but rather the seamless interconnection among our smart and hardworking team members.? At the core of it all is a strong company culture; “being part of an extraordinary team” is why most employees are highly satisfied with their employment and career at Kymanox.? What makes a human brain powerful, and even an AI tool powerful, is simply the number of connections; the more connections, the greater the power.? Kymanox leverages this interconnectedness to navigate efficiently and successfully through thousands of unique workstreams that accompany the journey from early development to post-market.? For a given client program, hundreds of our global employees may touch the development and commercialization of a given product over multiple years.? Furthermore, Kymanox is built based on the concept of talent stacking T-shaped professionals; ‘T-’ people are relatively scarce and possess three things that mesh perfectly into supporting a hyper-virtual approach:

• Broad interests, including genuine curiosity on a variety of matters.? This is the horizontal part of the ‘T’.
• High academic achievement (i.e., smart).? This is what holds the horizontal and vertical parts of the ‘T’ together.?
• Disciplined learning approach, strong work ethic, and willingness to dive deep into a given topic when necessary and to quickly get up to speed with the resident experts.? This is the vertical part of the ‘T’.

To engage with the Kymanox Hyper-Virtual Model?, starting early in the formation of the company is ideal.? This may mean engaging at a time when the first non-founder money is being solicited for investment, or money is being raised beyond friends and family.? To evaluate and vet opportunities, Kymanox will often provide limited pro-bono support related to the regulatory roadmap, positioning for exclusivity, and key subjects in the pitch deck.? By far, the most common mistake that causes the largest schedule delays and cost overruns is misreading the regulatory pathway; this includes missing available options which can be quite complex or not well known in today’s current global regulatory landscape.? Kymanox can also provide a fractional leadership team to bolster or to even lead key areas; this includes tapping the esteemed Kymanox Executive Advisors (KEAs) who are well-known in the industry and have a track record for successful product commercialization.? Additionally, Kymanox can help with networking that is essential for fundraising, non-dilutive funding (e.g., grants, awards), and finding support outside of Kymanox’s areas (e.g., finance, legal).? Kymanox frequently remains in the wings until funding is secured, activating when financially feasible.? With proper teaming agreements in place, clients include Kymanox in their pitch deck and have budgetary estimates and binding Scopes of Work (SOWs) prepared in advance of funding to ensure both cost certainty and a swift initiation of activities.

Starting early with Kymanox is not always possible. Fortunately, starting based on “where you are” is also immensely beneficial.? In such instances, engaging Kymanox typically revolves around one of three different scenarios where Kymanox can help: ?

• Largest Problem (NOTE: Most reactive, e.g., negative FDA meeting)
• Highest Need (e.g., missing subject matter expertise or bandwidth)
• Improved Strategic Positioning (NOTE: Most proactive, e.g., addressing possible digital features that may utilize AI or connect the product, patient, provider, and/or payor)

Once engaged, and regardless of how narrow the initial scope may be, expanding Kymanox workstreams and connecting those within the Kymanox ecosystem is not only possible, but also the natural progression and a driver for Kymanox’s own growth.? The speed at which Kymanox’s scope and influence can expand is typically determined by the understanding and familiarity of the Kymanox model as a whole.?

Managing and reducing risk for the sponsor and their stakeholders is a key benefit of the Kymanox Hyper-Virtual Model?.? And these risks include risks related to Kymanox itself. ?If Kymanox is not performing in a specific area, sponsors could easily peel away individual workstreams as a corrective measure.? This ease of management is facilitated by how Kymanox organizes its work, both from an account management perspective (e.g., utilizing individual and separate Scopes of Work (SOWs)) and a program/project management perspective (e.g., employing individual project or sub-project charters with uniquely identified teams that are managed using the well-respected Kymanox Project Management Toolkit?).? Since INTEGRITY is one of the four core values at Kymanox, transparency into our operations is a defining hallmark and is often what drives client satisfaction and repeat business.? And unlike the latest popular AI tools, Kymanox does not work inside a black box; rather, we show all of our work, steps, and source references.? Kymanox’s culture is inherently proactive and communicative; we make a concerted effort to identify areas for improvement and address them with the client before any corrective action is required on their part. ?And by embracing the Kymanox Hyper-Virtual Model? now, you are not obligated to commit to it in the future. ?Instead, Kymanox will demonstrate its value at every step, earning the privilege to continue being the mission-critical partner it aspires to be.

Finally, the Kymanox Hyper-Virtual Model? extends beyond start-ups.? Top 20 Biopharma companies, when acquiring new entities, have successfully implemented and activated this model to manage the acquired companies or their key programs.? Also, some programs (e.g., assets, molecules) have been assigned to Kymanox to continue clinical development that would otherwise be impossible for the client due to the client's focus on their lead candidate and the client's limited internal bandwidth related to the necessary Subject Matter Experts (SMEs). And with this model, the vast majority of modern medicine programs can benefit given that Kymanox’s overall model leverages the intersection of the following:

• SECTORS:? Biotech (including Cell & Gene Therapy (C&GT)), Pharma, Device, and Combination Products
• DISCIPLINES:? Science, Engineering, Compliance (e.g., QA, RA), and Management (e.g., Program Management)
• TIMING:? Pre-Clinical, Development, Commercialization, and Post-Market

Thank you for your interest in the Kymanox Hyper-Virtual Model?. ?We are working tirelessly to lead the industry in this crucial area...

…because patients deserve better.?

By Stephen M. Perry, Founder and CEO, Kymanox