SERVICES

Strategic Product Development Services

Scientific Commercialization LLC's Approach to Strategic Product Development

In today's competitive pharmaceutical and biotech market, the success of any new product depends on how well a company integrates a well-conceived strategic product development plan with the essential components of a sound regulatory strategy. Corporate success depends on integrating sound scientific, clinical, regulatory, and marketing approaches to the development and commercialization of pharmaceutical and biotechnology products. Such an integrated approach allows for the critical analysis of each new product, the monitoring of development time and resource utilization, and expedites effective "go/no go" decision-making.

Key Success Factors

• Creation of an Integrated Strategic Product Development Plan for each new product, managed within the context of an overall corporate (or unit) business plan. An Integrated Strategic Product Development Plan enables one to define and track critical success factors and decision points on a project-level and product-level basis.
• Recognition of the importance of a sound regulatory strategy guided by utilization of regulatory knowledge management, and effective interactions and communications with regulatory authorities.

The Scientific Commercialization LLC Approach

Integrated Strategic Product Development Planning Services

Utilizing information obtained from the activities listed below, Scientific Commercialization LLC can prepare an Integrated Strategic Product Development Plan. Scientific Commercialization's approach involves the integration of scientific and pharmaceutical/biopharmaceutical expertise and experience with sound market assessment techniques to enable our customers to make fast, informed decisions to maximize their commercial success. The activities involved in the planning process include:

• Conducting a regulatory and scientific review of available product data, including information on the pharmacology, toxicology, and pharmacokinetics in animals and (if available) humans, and any data relating to the safety and effectiveness in humans from prior clinical studies.
• Identifying key research in the field related to the product and target indications, including an extensive literature search of publications on the pharmacological activity and potential clinical efficacy and safety.
• Preparing concise regulatory and scientific opinions on the therapeutic potential of the product, and an assessment of the potential therapeutic indications from a pharmacological standpoint.
• Providing recommendations on the engagement of thought leaders to support the development strategy and key contributions to clinical program.
• Researching the FDA's (and other regulatory agencies) opinions and current guidance on development programs, clinical endpoints, and clinical designs in the potential indication(s).
• Formulating recommendations on regulatory strategy, including the applicability of any accelerated development and/or approval paths under current regulations.
• Evaluating specific regulatory requirements for achieving approval based on: prior product precedents; review of any relevant Advisory Committee opinions; current FDA policy and unique requirements in appropriate review divisions.
• Submitting recommendations on any additional nonclinical pharmacology and toxicology studies needed to support further clinical development.
• Evaluating the potential global market position and the relative market opportunities for use of a (novel) product in a particular pharmacological class.
• Providing a comparative assessment of the product and any relevant, approved comparative agent. Based on the results of the comparative assessment, provide recommendations for studies (both nonclinical and clinical) that will be useful in market differentiation.
• Conducting an assessment and development of the late phase and post-marketing strategy in order to accelerate physician experience, satisfy additional regulatory requirements post-approval, and support the life cycle management of a product.
• Conducting strategic market intelligence services including an overview of the U.S. market for treatments in the desired indication(s), primary research on physician preferences for new treatments in the desired indication(s), and a financial analysis of return on investment for the product.

Strategic Market Intelligence Services

To increase the utility of the Integrated Strategic Product Development Plan, Scientific Commercialization LLC can incorporate strategic market intelligence services including:

• An Overview of global markets
• Primary research on physician perceptions
• Financial analysis of return on investment

Each of these services may be pursued independently or initiated simultaneously as one engagement.

For all services, Scientific Commercialization LLC will summarize the results in an executive summary style document and, if desired, Scientific Commercialization LLC will present the results of the work via teleconference or in person.

Overview of Global Markets

The Overview of Global Markets provides a detailed overview of the U.S. and Global market for the desired indication(s). Based on the extensive amount of published clinical economic literature, secondary data sources, and interviews with clinical experts, Scientific Commercialization LLC will provide information (where available) on:

• Potential U.S. market size
• Current treatment approach
• Competitor agents (marketed and in development)
• Evidence tables of economic/quality-of-life studies and endpoints for consideration for inclusion in the Global Clinical Development Plan.

The results of the Market Overview are integral to the clinical development plan as it informs endpoint selection as well as potential demand for the product.

Primary Research on Physician Perceptions

The purpose of this component will be to collect more in-depth information on the targeted indication(s) market(s) and to assess physician perceptions of unmet treatment needs including:

• Diagnosis and treatment practices
• Unmet medical needs
• Evaluation of currently marketed products (e.g., likes/dislikes)
• Assessment of competing products in development (e.g., position in treatment)
• Reaction to product profile (i.e., "Product X" profile)
• Recommendations for clinical plan development

Our approach to collecting this information is to convene focus groups with clinicians involved in research and clinical practice (i.e., two groups per U.S. city). Our preferred approach is to conduct research in cities with differing managed care penetration rates as well as in markets with higher numbers of potential patients with the desired indication(s). This is due to differences in restrictions on referrals to specialists and other variations in health care access. Focus group sessions are typically 1.5 to 2 hours in duration.

To ensure that the output of these groups is best suited to your clinical development (and marketing) needs, our sponsor's staff is offered the opportunity to review the discussion guide as well as observe the focus group sessions. The sessions will also be videotaped and copies of the tapes will be provided. The findings and recommendations of the focus groups are incorporated into the clinical development briefing document, and can be used to help inform the clinical development plan to facilitate market acceptance of the product.

Financial Analysis of Return on Investment

The purpose of this service is to create a model to estimate the net present value of the product in the U.S. for the desired indication(s). This model would be constructed based on Monte Carlo simulation principles to allow for uncertainty and is likely to include the following parameters:

• Current market size
• Clinical development costs
• Anticipated launch date
• Patent expiration date
• Market share (i.e., vis-à-vis current and potential future competitors)
• Pricing

The output from the model is a range of net present value of the product's worth. Statistics will be run on the model results to present the expected value (i.e., mean) as well as potential variation in product worth (i.e., standard deviation).

The results of the model will help our customer understand product sales potential under varying assumptions. In the past, clients have found these models to be particularly useful in supporting the decision making process for a U.S. clinical development program.

Scientific Commercialization LLC Experience and Expertise

Scientific Commercialization LLC expertise derives from a core staff of individuals with diverse professional experience, obtained in both academic and pharmaceutical industry careers prior to joining the company. Together, these individuals provide our customers with extensive drug development experience in preclinical and clinical research, applied research in the pharmaceutical sciences, strategic regulatory affairs, pharmaceutical marketing, and strategic clinical development program design and management. As members of the Scientific Commercialization LLC Team, these experts have worked together with Customers to design, implement, and successfully complete numerous clinical development programs.

Scientific Commercialization LLC provides senior-level expertise and consultation services to customers for drug/product development and to produce the highest quality scientific and medical documents. Our partners have an average of over ten years of pharmaceutical industry and CRO experience, as well as significant academic research experience in neuroscience, psychopharmacology, cardiovascular pharmacology, pharmaceutical science, gerontology, and psychology.

Our consultants also provide international market research and financial analysis services to facilitate product development and ensure successful product commercialization. This integrative approach to strategic product development symbolizes Scientific Commercialization LLC's unique combination of high-caliber scientific expertise with in-depth knowledge of the commercialization process. The partners and consultants of Scientific Commercialization LLC offer their customers a proven track record of delivering market-relevant clinical development plans based on published scientific literature, expert opinion, market research, and expertise in clinical trial design.

< Back to SERVICES