Commercial Strategy Development
A small public biotech company previously focused on drug discovery and development sought Health Advances' help to develop a strategy to build a more fully integrated organization. We helped prepare a comprehensive plan that included a reprioritized product portfolio, a detailed in-licensing and out-licensing plan, an infrastructure plan, and pro-forma financials to guide our client's transition.
Biotech Transformation Strategy
Working directly with the new CEO, Health Advances led a planning process to lay out a multi-year plan for transforming the company from a platform company into a product company. The plan would completely change the vision and business model, and required an extensive examination of how that company might create a product portfolio and assemble the required organizational skills.
The client team sought a strategy that would dramatically enhance the momentum for the company. By reviewing the technology platform and portfolio, organizational strengths, and opportunities to apply those in new areas, we identified several new strategic directions for the company and developed detailed plans for building internal skills capabilities and driving business development activities.
M&A Strategy and Due Diligence
A Cambridge-based biotech company seeking to complete a major acquisition engaged Health Advances to conduct an extended acquisition-focused project. Over a period of months, and in parallel with due-diligence level review of several possible candidates, Health Advances advised the management team on the criteria that management should use for evaluating the attractiveness and strategic fit.
Drug Out-Licensing Support
Our client, a small public biotech company, engaged Health Advances to assist with the out-licensing of a protein therapeutic for use in wound healing. During our analysis we identified a second possible application, prepared a market analysis, and proposed development steps required to make this new indication a strong component of the licensing package offered to potential partners.
Novel Cardiopulmonary Bypass Oxygenator
Health Advances forecasted the revenues for an oxygenator that appears to reduce the peripheral damage caused by traditional cardiopulmonary bypass circuits during major cardiothoracic procedures. In addition to estimating future penetration of the market, the study forecasted the future procedure volumes in light of demographics and growth of interventional procedures. Health Advances interviewed cardiothoracic surgeons in the EU to assess the new product.
A Respiratory Support Device Strategy
Developed a commercialization strategy for the launch of a respiratory support device in spinal cord injury, ALS, and ICU settings. The strategy included consideration of US markets and prioritization of EU markets. The in-depth primary interview program targeted spinal cord specialists, rehabilitation physicians, intensive care doctors, ALS specialists, payers, executives, and advocacy groups in both the US and EU. Detailed secondary analysis included evaluation of market size, current practices, referral patterns, unmet needs, and costs and charges within each segment.
Percutaneous Coronary Intervention Trends
Assessed the trends in both percutaneous coronary interventions and vascular interventions given recent stent performance data and trends in the use of CT cardio imaging. Numerous dynamics such as reimbursement and technical imaging advancements were evaluated along with clinician feedback to estimate the future percutaneous intervention market.
Vascular Access Market Analysis
The team assessed key trends and the relative importance of various technical product features. The team interviewed US interventional radiologists, cath lab supervisors, materials managers, oncology infusion nurses and vascular access nurses to understand their roles in purchase and utilization decisions and future trends.
Novel Mechanical Thrombus Ablation Technology
Health Advances assessed and prioritized the opportunities for the device. For each potential target indication, Health Advances segmented and sized the relevant market and conducted secondary and primary research to understand the unmet needs, decision-making process and referral patterns in each area. The team also identified hurdles or opportunities for the novel device to be adopted in each area.
Life Science Tools Business Unit Strategy
The team worked with the Bio-discovery division of a large life sciences company to help set the division's strategy for the next 3-7 years. In addition to extensive secondary research, the team interviewed academic, CRO and industry researchers in the US, EU, China, and India across a range of disciplines including mass spec, flow cytometry, genomics, biomarker discovery, HTS, and HCS. The team identified target acquisition candidates and developed an execution strategy for building a business that would address major unmet needs from basic research to translational medicine.
Go-To Market Strategy
For an emerging core lab diagnostics player, the team analyzed the US hospital and reference lab markets to determine the appropriate customer segmentation and key marketing messages for commercialization of a novel hematology analyzer. Adoption potential across customer segments was evaluated through qualitative interviews and a quantitative survey with hematology lab directors and managers and interviews with hospital purchasing managers. Based on primary research feedback and an examination of other diagnostic product analogs, the team created a revenue forecast and profit and loss statement for the novel analyzer. The optimal instrument and per test price points were determined based on an examination of laboratory economics and an evaluation of the trade-offs between revenue, profits, and cash flow at various price points. Ultimately, the work was used to determine the client’s corporate and product strategies and facilitate an acquisition by a global IVD player.
Working with the executive team of a multi-billion dollar diagnostics and life sciences company, our team led a board-mandated review of the strategic positioning and business options for the company. In addition to a thorough assessment of internal strengths and weaknesses, we also examined the competitive environment, trends with customers, our clients’ position and the options for expanding the business internally and through acquisition. Areas of investigation included immunoassay, clinical chemistry, hematology, flow cytometry, molecular testing, and coagulation testing. This strategy was one of multiple projects across the company over several years, including new product launches, reinvigoration of older platform lines, voice of the customer program development, and diligence work.
Life Science Research and Clinical Diagnostic Due Diligence Assessment
Our team worked with an investment group to assess the market outlook for a company with nucleic acid analysis products in both the life science research (LSR) and clinical diagnostics markets. Revenue projections were generated for the LSR business based on market sizing from secondary research, penetration rates from primary interviews, and adoption timelines from analog tool ramps. Revenue projections for the clinical diagnostic were based on market sizing from secondary research, penetration rates from a quantitative physician survey, and adoption timelines from analog tool ramps.
CMO/CDO Expansion Strategy
Our client, a contract manufacturing and design (CMO/CDO) organization for the in vitro diagnostics and device markets with a specialization in equipment rather than disposables, had been experiencing strong revenue growth and margins for several years. On the back of this, the client's parent company, requested a strategy to grow its business from $60MM to $120MM over the next 1-3 years. Our team was tasked with helping the client to determine the most appropriate strategy for accomplishing that goal. Through mediation of several brainstorming sessions with corporate executives and through detailed secondary research a variety of M&A approaches were suggested and potential target companies identified.
M&A Opportunity Prioritization
Our team was engaged to assist in the identification and prioritization of acquisition targets for a mid-sized diagnostics company. After working collaboratively to develop prioritization criteria on which to evaluate potential targets, a small subset of companies were recommended for further evaluation. The team engaged in extensive secondary research as well as primary research to develop detailed company profiles that provided our client with relevant target company details and a preliminary recommendations regarding acquisition strategy priorities.
Liquid Biopsy Opportunity Assessment
A leading genomic diagnostics company enlisted our team to prioritize oncology indications and use cases for a novel circulating, cell-free DNA “liquid biopsy” technology. Our team prioritized oncology use cases according to criteria including market opportunity, development burden, and strategic value. High potential use cases were further divided into near and long-term opportunities.
Budget Impact of Diagnostic
A global core lab diagnostics player engaged our team to develop an interactive budget impact model to demonstrate the economic impact of the implementation of a diagnostic cardiac marker to potential customers. Building from in-depth primary research, key secondary research was performed to populate the model which included deep reviews of clinical and economic literature for the diagnostic marker, clinical and cost effectiveness arguments for the diagnostic work-up, and the cost and reimbursement for the indication. This model was then tested in interviews with payers, laboratorians, and ER department heads to support its validity.
Corporate Strategy for a Molecular Technology
Working with the management team of a small public company, our team assessed the outlook for a novel approach to assessing genomic abnormalities and DNA replication and repair. A number of potential specific applications were assessed for the technology through interviews with a variety of stakeholders including clinicians, pathologists, and researchers. Detailed market sizing, revenues projections, and a full P&L were developed to assess the outlook for various product launch strategies. This work resulted in a switch in corporate strategy from primarily a diagnostics CLIA lab to a life science research product company.
Molecular Test System Economics
Our team developed a system economics model and payer strategy for a molecular diagnostics company developing novel prognostic and predictive tests for cancer. One such test helps physicians determine the optimal treatment strategy for patients with early stage breast cancer. The team developed a system economics model based on the unique aspects of the test’s value proposition which helped differentiate the test from others in the space. We incorporated the system economic justification into a broader payer strategy based on conversations with payers and an analysis of analog diagnostics.
Specialty National Diagnostic Laboratory Diligence
As part of a due diligence effort, our team assessed the outlook for a specialty national diagnostic testing laboratory. The analysis was accomplished through interviews with laboratory directors, physicians, and payers to understand the outlook for specific tests, drivers for selection of specific service providers, and factors that will change the competitive environment in the future. In addition, we conducted secondary research to understand the extent of baseline epidemiology-driven testing growth, the impact of a changing reimbursement landscape on customers ordering the tests, and the laboratory’s current and anticipated positions in the competitive landscape.
Business Plan for Social Robotics Engagement
Health Advances worked with the founding team of a company focused on combining social robotics, artificial intelligence, and adaptive programming to create a mobile device capable of truly personalized medicine. The team evaluated applications across the entire healthcare landscape to identify the best first pragmatic and self-financing product as well as the long-term roadmap of follow-on lucrative applications. Much of the work centered on picking applications where the company's IT capabilities brought unique value beyond typical mobile "apps."
Information Rich Patient Registry Database Development
Designed the strategy for and supervised the development of the largest disease-focused health data exchange in the world that integrates a clinical registry, biobank, clinical trial matching database and web-based patient portal. Leveraged data from an existing disease foundation and relationships with a major online community site to attract and build a leading clinical community with a novel privacy platform.
Comparative Effectiveness Marketing Strategy for Hospital Surveillance
Health Advances performed an extensive literature review to identify and document cost effectiveness data potentially attributable to hospital-based electronic surveillance and computer decision support systems. The HCIT tool was designed to help hospitals, especially pharmacies and infection control departments, to capture, analyze and flag data indicative of an infection outbreak, existence of resistant and susceptible pathogens and/or inappropriate antibiotic use. The findings were summarized to serve as the foundation for future prospective quantification of the cost effectiveness of antibiotic stewardship programs, clinical decision support programs and electronic surveillance enabled by implementation of a hospital-wide clinical intelligence platform.
Health IT M&A Entrance Strategy
Health Advances assisted a medium-sized medical device company in calibrating its M&A and organic growth strategy in light of the growing IT market and healthcare reform. Direct expansion into adjacent IT markets as well as necessary connectivity challenges were reviewed and prioritized based on research with industry experts, hospital stakeholders, and end-users. Ultimately Health Advances reviewed a number of potential expansion paths with senior management and the board of directors.
Health IT Due Diligence
Health Advances has performed multiple due diligence products for strategic buyers looking at Health IT expansion opportunities. One example project evaluated the opportunity for a best of breed hospital workflow optimization tool for a medium sized software and medical device company. The analysis focused on a validation of need, market segmentation, and strategic growth opportunities
Health Advances worked closely with the senior management team to identify new sources of growth. We evaluated new test offerings, new report formats, and new pricing models for existing customers. Likewise, we identified new prospective customers for existing tests and offerings. Finally we considered offering new services that would reduce the client’s dependence on reimbursement policies.
Hospitals’ central pharmacies have gradually outsourced admixes and certain compounding to local and regional pharmacies. When a competitive pharmacy was closed by the Federal government due to deaths from contaminated admixes, Health Advances helped our client reevaluate its offering and determine whether to invest and greatly expand its product offering to include prefilled syringes in configurations not offered by traditional biopharma manufacturers.
Outsourced Component Manufacturing
An investor client asked Health Advances to evaluate the growth prospects of a contract manufacturer known for its expertise in an unusual manufacturing technique. Existing customers’ end markets were stagnant, so the technology would need to be deployed successfully to other medical devices in order to meet the company’s growth forecasts. Health Advances interviewed design engineers, procurement executives, and supply chain experts to evaluate whether the manufacturing technology could be deployed and the circumstances under which executives would try the new approach.
Potential Acquirer Identification and Business Development Calls
A large healthcare investment firm was considering debt and/or royalty financing agreements with a target company in drug delivery. As part of its diligence of this target, the firm’s royalty team asked Health Advances to assist by identifying and then conducting a series of discussions with companies that may consider entering into a future deal with the target. After debriefing the royalty team, Health Advances targeted a list of 15 prospective partner companies and senior level business development executives. Leveraging Health Advances’ senior level contacts, calls were made directly to decision-makers within these companies to test potential interest level in, and the valuation criteria for, future acquisition of the target company.
Preparing Portfolio Company for Sale
Health Advances initially supported the private equity investment in an emerging core lab diagnostics company. About 3 years later, the investor and company management team enlisted Health Advances to help refine the company’s strategy and ultimately position it for sale. The team analyzed the US hospital and reference lab markets to determine the appropriate customer segmentation and key marketing messages for commercialization of a novel hematology analyzer. Adoption potential across customer segments was evaluated through qualitative interviews and a quantitative survey with hematology lab directors and managers and interviews with hospital purchasing managers. Based on primary research feedback and an examination of other diagnostic product analogs, the team created a revenue forecast and profit and loss statement for the novel analyzer. The optimal instrument and per test price points were determined based on an examination of laboratory economics and an evaluation of the trade-offs between revenue, profits, and cash flow at various price points. This plan and financial forecast was presented by Health Advances to prospective buyers during the sales process which resulted in a very attractive sale price.
Hospital-Based Software Company Diligence
Health Advances evaluated the opportunity for a strategic acquisition of a small start-up software company offering a best-of-breed software system designed to assist hospitals in addressing meaningful use criteria. The core business and growth opportunities were tested with key decision makers within the hospital (CEOs, CFOs, CIOs) as well as the end-users (physicians and nurses) to forecast the market potential with a particular focus on EMR segmentation.
Corporate “White Space” Strategy and Growth Opportunity Identification
Health Advances helped a major international healthcare company define strategic objectives and high priority projects for an executive-level initiative focused on corporate growth. Health Advances conducted a broad scan of the entire health care industry to identify areas of strategic fit and high potential and screened ideas to recommend ten growth areas. The senior management team subsequently gained Board buy-in and is now methodically pursuing acquisitions in these specific areas. As a result of this exercise, the corporate business development function no longer gets distracted by opportunities it receives “over the transom” that do not fit the 10 chosen areas.
Global Biosimilar Acquisition & Strategy Support
Health Advances supported a major biopharma deal by conducting a comprehensive, short-turnaround global diligence on the opportunity for a biosimilar portfolio. The team evaluated clinical and payer strategies to accelerate adoption of the biosimilars in each market and vetted the client’s internal forecast for the assets. Detailed market by market analyses were provided, as were high level strategic recommendations to the client team. The deal was ultimately consummated.