Develop a business case for a complimentary contract manufacturing organization (CMO) and biosimilar business for a multi-billion-dollar global pharmaceutical company.
- Customers, segments, market drivers
- Competitive position; SWOT analysis
- Market size and projections of market share
- Gap and partnering analysis
- Recommended strategies for gap remediation from gap analysis
- ROI, IRR and NPV models for a variety of scenarios and sensitivities
- Presentation for senior management team (CSO, CFO, and COO)
Client adopted recommendations and is now a top tier CMO and biosimilar organization.
Business Development: Licensing
Identify and implement a licensing and partnering strategy for a small drug delivery company.
- Identify licensing and co-development strategy
- Research market and identify licensing partners
- Negotiate licenses
- Licensing strategy that enabled development without dilution
- Facilitate closing of licensing deals to accomplish objectives.
Closed seven licensing deals with significant upfront payments and royalties. Company was able to develop their technology to commercialization without selling equity.
Strategic Market Analysis
Develop a strategic plan for a small, privately-funded biomanufacturing technology company
- Identify inflection points for a step-up in company valuation
- Run a supporting financial model identifying critical assumptions and risks
- Conduct detailed market and competitive analysis
- A market adoption model to achieve inflection points as rapidly as possible with minimal investment
- Presentation to the board
Company elected to pursue an alternative strategic approach from what was recommended. After two years of devaluation, new CEO adopted recommended approach. Inflection point was achieved within two more years and company was sold to the largest market player.
Commercial and Portfolio Analysis
Develop a combined vaccine and biosimilar strategy for a start-up drug company.
- Identify pipeline candidates
- Research a marketing and reimbursement strategy
- Support the development of an initial regulatory strategy
- Initiated discussions for the in-licensing of molecules
- Various financial models
- A manufacturing strategy
- A marketing and reimbursement strategy
A recommendation that the in-licensing models proposed along with the unique market and reimbursement dynamics made the business a higher risk than client originally anticipated. Client elected not to pursue the model further.
Interim Executive Management
Provided interim executive management for a mid-tier CMO with the mandate to increase the valuation and sell the company.
- Serve as Interim CFO and VP of Business Development
- Implement financial and sales and marketing systems
- Secure bridge debt
- Build a robust pipeline and close clients
- Support the Board, CEO and Investment Bank in:
- Crafting the offering memorandum
- Identifying and engaging potential buyers
- Supporting the valuation, due diligence, and negotiations
Increase value of company to support higher valuation and lead to acquisition.
Sale of the company within 18 months at 4X the client’s valuation prior to the engagement.
To educate the service offerings and go-to-market strategy for a new business area within a multi-billion -dollar pharmaceutical service and equipment supplier.
- Worked with client to create an interview script and target list of key industry leaders
- Established objective and subjective metrics for evaluating responses
- Scheduled and conducted detailed interviews. Conducted follow-ups where required
- Leveraged feedback and industry expertise to analyze results and draw conclusions
- Provided results in report and presentation formats
A detailed written report and presentation of the data, analysis and conclusions
Client made adjustments to the marketing approach and messaging associated with the offerings. The services are now integral/successful parts of the client’s global offerings.
Marketing and Business Plans
To help the founder and CEO of a start-up equipment supply company create an initial marketing and business plan to support financing and to provide an implementation roadmap.
- Prepared a Business Plan
- Developed a Marketing Plan
- Used limited customer feedback to define offering and messaging
- Helped established go-to-market strategy including identification of:
- Lead customers and key decision makers
- Outreach and communications strategy
- Tactical sales plan that uses internal and external resources
- Estimated pro-forma sales targets based on industry size, competitive options and demand
- Created Operating Plan
- HR plan with projected staffing requirements
- OEM Plan where company heavily uses contractors
- Internal manufacturing and logistics plan
- Leveraged information from the marketing and operating plans to develop pro-forma financial statements and plan for financing
- Supported Fund Raising by introducing the company to private investors, two of which provided seed funding.
A basic business plan and access to seed funding
Result: Client has implemented the plan and is one of two top providers in their niche market.
Provide program management support to a BARDA prime contractor who focuses on research, development and commercialization of vaccines.
- Provided senior level Program Management support to a Prime Contractor who is developing an biodefense vaccine.
- Managed Drug Product Production, Dose Defining Ph1b Clinical Study, Development, qualification, and/or validation of specialized clinical assays, Process Scale-up, and Project management
- Developed and/or monitored the project integrated master schedule, project budget, monthly EVMS reports, project action items, project risks, and project meetings.
- Hosted BARDA bi-weekly teleconferences, providing updates on developmental activities and on contractual issues. Coordinated development of agendas and minutes.
- Supported EVM report preparation and provided budget and schedule variance information as required.
- Actively involved in the management of multiple subcontractors, including the facilitation of telecons, including agendas and minutes, and the identification and tracking of subcontractor action items.
- Contributed to the preparation of the project monthly report, including updating the integrated master schedule on a monthly basis.
- Senior level strategic support.
- Leadership and expertise in all aspects of management of the project, including: project initiation, planning, execution, monitoring and control, and project close-out
The program was successfully managed and key program milestones have been met. LBG assisted in the development of proposals and negotiation of the award for optional work included in the prime contract.
Note: As a result of positive performance, LBG was subsequently awarded additional PM scope in the follow on programs.
Perform technical and COGs due diligence of biotechnology company – assist client in recommendation multimillion dollar investment decision
- Assembled team for technology review and proposed plan
- Site visits (3) by CMC, Quality and financial model team members in coordination with client team members
- Assess facility capabilities
- Quality systems
- Reviewed regulatory and quality framework for product type
- Report on technology readiness assessment and risks associated with plan
- Comparative cost models and COGs analysis
- Recommendation of likelihood of programmatic success, if funded
Client deliberating investment decision
To provide general business development support for a smaller business unit within a larger company. A multiplicity of potential partners and research pathways needed support to make sure all options were feasible and BD activities did not delay timelines.
- Multi-party MTAs
- Technology in-licensing
- GMP supply agreement
- Consulting agreements
- Option agreements.
Agreements completed or ready to proceed when the associated research and development pathway was selected.
An understanding of the team’s needs was obtained in a short amount of time, allowing agreements to progress as rapidly as possible.
Note: The client was extremely pleased with the rapid response and the ability to integrate into the team.