Category: General

De-risk Phase II/III Vital Commercial Investments by Customizing Support and Reducing Cost with an iCCO (Interim Chief Commercial Officer)

One of the biggest risks for Phase II/III pharmaceutical and biotech companies is hiring full time commercial staff before readout.  Of course, the company needs the expertise of an exceptional commercial leader, but that comes with the risk of having to fire and compensate that person if the Phase III readout is unfavorable.

The solution – An Interim Chief Commercial Officer.  The benefits of hiring an iCCO include:

• Adaptive commercial support
  • Appropriate amount of support needed to achieve company goals
  • Aligns with corporate Commercial/Regulatory scenarios.
• Create and defend a revenue forecast and commercial budget
• Facilitate alignment between the Executive Team and Board of Directors
• Reduced risk and cost to the company
• Significant cost savings compared to a full time CCO, oftentimes <50%

We recently worked with an emerging biotech company focused on discovering and developing products to treat cancer.  We provided full commercial support at the appropriate level during Phase III that aligned with an effective commercial launch.   We were able to establish the commercial priorities, medical affairs activities, headcount needs and costs of capital required to launch.  In addition, we established a three-year commercial budget and identified an excellent full time CCO who was ready to hire at PIII readout.  Using our adaptive “On/Off” model, the company was able to achieve their objectives at less than half the cost of a full time executive.

Using a team of experts, we provide the early commercial expertise needed for commercialization.  Our work inspires Executive team confidence encompassing a vast range of commercialization expertise including: 

• Leading the execution of all Commercial imperatives and CCO search until pivotal trial readout 
• Bridge commercialization roadmap 
• Commercial assessments & revenue forecasting  
• Commercial & medical affairs talent acquisition & onboarding
• Commercial strategy across geographies  

De-risk Phase II/III Commercial Investments by Leveraging an iCCO (Interim Chief Commercial Officer)

It is a familiar scenario.  Phase II/Phase III biotech companies hire a Chief Commercial Officer (CCO) to help guide product commercialization, yet it is a risky endeavor.  Recently, we worked with an orphan drug lung disease company located in Austin, TX.  They needed commercial expertise and execution guidance, but were reluctant to make the expensive investment in a Chief Commercial Officer in the early stages.

It is a conundrum for companies taking their products through the commercialization milestones.  They need the market expertise, but hesitate to make the investment.  If they hire a full-time commercial lead, they may have to turn around and let them go with a negative pivotal trial readout.  To mitigate this risk, they hired Bridge as an interim CCO.

The benefits were visible immediately.  They were able to execute commercial priorities by mapping the deliverables that were most important to their company.  In this case, we provided full commercial support at appropriate levels through Phase III readout.  This included a “commercialization roadmap”, commercial & medical affairs imperatives for the US and EU, creation of a four-year commercial budget, recommendations of five VPs of marketing at readout and alignment of the Executive Team and Board of Directors.

The company was able to save 50% over the cost of a full time Chief Commercial Officer without compromising on the deliverables or market expertise.  In addition, Bridge was able to provide crucial commercial support during a turbulent two-year period.  Most importantly, they did not need to terminate a full-time CCO, which would have had negative financial implications and a potential decrease in team morale.

iCCO (Interim Chief Commerical Officer) leadership enables all the benefits of a CCO without the risks.  In addition, your organization can build confidence with an “On/Off” adaptability not possible with a full time hire.  Bridge can jump in and out as the business dictates, delivering key commercial imperatives along the way.

If you would like to discuss the benefits of Bridge’s services, please contact us.

At Emerging Biotech’s, You Can Not Win If You Don’t Put the Money In (Early)

This year’s Biotech Showcase featured a seminar module entitled “Investing for Launch Success” and featured several Biotech commercialization experts. They reviewed data illustrating the correlation between late / too little commercialization spend with launch failure. This data is consistent with every emerging biotech industry metric including those from IQVIA, Symphony, Syneos and others.

Our internal metrics demonstrate that two thirds of Phase III companies have no commercial FTE on board and make no commercial investments pre-data readout.  This is consistent with the industry metrics above for lack of timely commercial investment.

The Psychology of Putting Off Commercialization

So, what are the drivers of the CEO/ Executive Team putting off Commercial investments and more importantly, what can be done to offset these delays?

There are several reasons CEO / Executive Team ignore the Commercial investment metrics but two rise above all others:

• Board reluctance for dilutive investment pre-Phase III data readout
• An Executive Team with no experience launching an FDA approved drug (e.g., “they don’t know what they don’t know”)

Remedies to De-Risk Commercialization

Board reluctance for dilutive financing before the Phase III readout is a real challenge and is compounded at times by early investors looking for an exit.  This may create a lack of alignment with the objectives of the Executive team looking to invest into a successful commercial launch.

Even with this conflict, there is a remedy which is stage-gated Commercial investments from late Phase II through data readout.

Our firm maps out the stage gates and then executes against them without an “at risk” Chief Commercial Officer (CCO).  We then utilize an efficient network of commercial partners with expertise in every dimension of a successful launch (e.g., Market Access, Pricing, Reimbursement, KOL Development, Publication Planning etc.) to meet your company needs.

Our model absorbs the risk of a pivotal trial failure and the need to terminate the Commercial Team.

For the Commercially inexperienced Executive team, the remedy is much more straightforward.

• Seek Commercial expertise ASAP and start asking questions.

Let’s schedule a time to talk about how your organization can benefit from a conversation about the timeliness of stage-gated drug Commercialization.  

Contact me at 415-307-0774 or russ@bridge1.net

Dear Biotech Colleagues,

While Bridge Consulting is in our 15th year of providing commercialization expertise to our emerging biotech company clients, our website has been down for a period of time but I am thrilled to state it is now back – completely revised and pin points the areas of commercial expertise we provide!

Here’s the URL: www.bridge1.net

We hope you like it and find it easy to navigate. We think it is pretty cool so have a look and let us know!

Russ

Russ Belden
President & CEO
Bridge Consulting LLC

Bridge Consulting In Brief
We provide commercial expertise to emerging biotech companies from Pre-clinical to Phase 3 readout.

Key Client Services

• interim Chief Commercial Officer (iCCO) leadership to Phase 3 companies
• Defensible Commercial Assessments & Differentiation that drive investor commitment and portfolio prioritization
• Market Access / Pricing & Reimbursement
• Clinical Decision Modeling for early stage clinical programs
• Commercial Learning Modules
• Biotech Commercialization Blog (see below)

About Russ Belden & Team
After 16 years in drug development, commercialization, market planning & forecasting at Genentech Inc., I founded Bridge Consulting and over the past 15 years we have worked with over 50 Preclinical through launch stage cancer, neuro, rare, gene therapy & specialty companies. I also serve as the Commercial Expert in the “California Life Science Institute (CLSI) Expert Network & FAST Programs,” (Please see the Expert Network page on the CLSI website).

We have an ongoing collaboration with Tessellon Inc., who are experts in epidemiology and forecasting across 80 countries and several other biotech drug developers and commercial specialists.

Biotech Blog
We will be routinely posting concise descriptions of biotech commercialization issues and how we think about them. We hope to inform a broad audience that creates an ongoing dialogue with interested executives at emerging biotech companies and investors. I look forward to engaging with you!