Technical Due Diligence & Risk Assessment

A.    Attractiveness of technology

B.     Developability / Manufacturability / scalability of the technology

C.     Identification of risk factors

                                                            1.      Facility risk for outsourced business models

                                                            2.      Technical / development hurdles

Support clients to develop and submit INDs with greater certainty of timing, expense and FDA acceptance

1. Provide document and planning framework for IND submission identifying contents and component activities

2. Provide benchmarking information regarding durations and costs of IND activities to construct budgets

3. Identify and analyze key regulatory and technical issues specific to the product and develop recommendations to address these issues

4. Develop strategy, plan and framework for document for pre-IND consultation with FDA

5. Participate with client in FDA consultations, if desired by client

6. identify sources of services to execute IND development and production activities; facilitate outsourcing, including framework for contractual terms, QA audits and technical and financial assessments

7. Draft pre-IND, IND and related documents

8. Provide IND Template (Table of Contents, guidance regarding composition of each section, useful references by analytical method and product type).

9. IND activity plan (component activities, durations and criteria)

10. Bench marking data (CMO and CRO pricing)

11. IND budget framework (based on IND activity plan)

12. Pre-IND document template

Support of management of all or part of product development efforts

A.   From turnkey management of product development (Virtual product development) for a chemical company with no Pharma & Device expertise and infrastructure to

B.    Management of specific parts of a development program e.g. managing the contract development of compound at a vendor to  coaching and enabling better management of the program by the sponsor team

C.  Helping set up practices and procedures for rapid development for both established and emerging companies

D.  Development of Target Product Profiles

Capital Project Planning & Implementation

1. Expert operational an engineering team members with experience designing and running many types of facilities

2. Enables the formal capture of key project parameters from a holistic perspective that all sides can understand and use.

3. Confirms the business case

4. Agrees scope of the project (Operational, Technical, Quality, ESH)

5. Finalises an outline of engineering concepts to enable engineers to efficiently apply their expertise

6. (Design Concepts, specific technologies etc)

7. Includes benchmarking of industry best practice

8. Defines project timing boundaries

9. Outlines project cost estimates ( high level)

CMC Specific Support

A.    Sourcing Vendor ID & Vendor auditing & management – enable use of US vendors,

B.     Route alternatives and registration strategy

C.   Dosage form strategy – strategy and execution of plans to re-purpose existing compounds

D.   Integration of CMC plans with clinical, safety and commercial plans to overcome problems, accelerate timelines

Quality  Support

1. Practical Quality Systems

2. Audits

3. Mock audits & GMP Readiness Gap Analysis and action plans

4. Practical, not Textbook cGMP Training & Implementation Support

Regulatory Support

1. Regulatory strategy from both practical, operational view and agency view

2. Advice on specific issues

3. Preparation for FDA meetings

 Support of  Maximizing Value of Assets for Out-license

1. Identification of potential risks, research programs to demonstrate mitigation potential

2. Targeted physician interviews to demonstrate

3. Valuation of compounds, portfolios, device technologies

4. Modeling of potential deal structure

Support of business strategy / business model development and action plans

1. Using experienced experts in their area of technology and focus

2. Leveraging our model to replicate an experienced functional team to work along side the client to

3. Develop or test an overall strategy

4. Estimate resource requirements and timelines

5. Develop and test realistic action plans

Design and implementation of critical functions for emerging companies to balance use of internal and external resources for optimal ROI.

1. Quality Systems

2. Analytical

3. Chemical Development

4. Pharmaceutics, Formulation Development

5. Toxicology

Operational Improvement

1. Assessment and optimization of key functions that can enable speed and efficiency

2. Practical Quality Systems

3. Practical Vendor management systems and approaches

4. Efficient analytical groups

5. Productivity Improvement Gap Analysis

6. Use of expert team to help clients identify opportunities for productivity improvement

7. Help internal teams understand what’s been accomplished elsewhere / best practices

Market Entry support

1. Refine offering and value proposition

2. Identify additional technical or market information needed to enhance potential for adoption

3. Develop high-impact confidential and non-confidential briefs and materials

4. Targeting and qualification of targets

5. Partner & channel strategy and approaches

6. Enabling meetings

Market sizing and assessment

1. Assembly of secondary research

2. Modeling of markets

3. Patent based market models

Valuation of Compounds and portfolios

1. Assemble epidemiological and market data (including the safety, efficacy, sales, share and cost of currently available products);

2. Outline current treatment algorithms and potential target patient populations;

3. Assess the status and projected performance of competitive agents (pipeline analysis);

4. Assess predicate licensing deals in the therapeutic space;

5. Develop preliminary market model.

6. Conduct primary market research as needed with Key Opinion Leaders define and prioritize target populations; define current approaches to treatment; define medical need; assess reactions to the product profile and to available preclinical and clinical data.

7. Develop risk adjusted Product and Licensing Income Statements in a format suitable for updating as additional information becomes available.

Matching Initiatives for Tech Transfer offices and Economic Development Authorities

1. Review portfolio companies and technologies

2. Help identify the most attractive candidates for given markets

3. Identify additional technical or market information needed to enhance potential for adoption

4. Develop high-impact confidential and non-confidential briefs and materials

5. Targeting and qualification of targets

6. Partner & channel strategy and approaches

7. Enabling meetings

Commercial Planning

1. Launches

2. Sales force make-vs.- buy

3. Launch readiness gap analysis

4. Support of out license / partner / launch decisions

Market Opportunity Identification for providers to the Life Sciences

1. Bringing a Market Perspective to technology driven companies

2. Using network of expert users from our business model o assemble real teams to

3. Review technologies

4. Ideate / Brainstorm applications and benefits based on problems they understand rather than simply what the company is trying to sell

5. Actionable approach to modeling markets and estimating potential for ill defined markets and established markets

6. Experience in commercial launches

Recent projects include technologies and services in the areas of catalysis technologies, anti-microbials, chemistry services, clean-room panels, diagnostics, serum & media, veterinary products and woundcare.

Optimization of service business models  

1. Leverage experts who have experience on “both sides of the desk” and have been successful fixing and running contract service business in the life sciences

2. Provide benchmarking data with respect to the relevant segments of the pharmaceutical contract manufacturing market (size of market, growth rate, pricing benchmarks, competitors)

3. Analyze the position of the client with respect to the overall market and provide recommendations with respect to business strategy, business objectives, pricing, positioning and advertising

4. Analyze the operations of the client and make recommendations with respect to policies, resources, business processes and organization structure to optimize the performance of the operation

5. Support implementation of effective processes, systems and approaches to improve sustainable revenue & profit

6. Leveraging databases of contract manufacturers by market segment, with location, capacity and capabilities information