PDE10 report

Background and objectives

The head of Global Scientific Business Intelligence requested Lifescience Dynamics to carry out six to ten situation analyses on a yearly basis. They needed our help because of constraints on their internal resources and because the substantial syndicated information services they were purchasing neither covered all therapy areas nor were tailored to any specific needs the company required.

An analysis they requested was to write a report on PDE10A and its application in CNS indications. PDE10A is a newly discovered cyclic phosphodiesterase whose function either in health and disease is not known.

It is expressed at high levels in the striatal and adjoining regions of the brain, where the splice variant PDE10A2 appears to predominate. Its distribution in other tissues is unclear but there is some evidence of expression in the testis.

The aim of this study is to review scientific and commercial activity in the PDE10A field and to assess the therapeutic potential of this target, particularly its inhibitors. A separate, complementary study on drugs under development for schizophrenia was also delivered.

Approach

Secondary data were obtained from a wide variety of sources including research papers identified from Medline literature searches; IDdb and pharmaprojects databases, brokers' reports, company, professional association and patient websites. The views of a leading PDE expert were also obtained.

Results delivered

A detailed report of about 100 pages on the PDE10 family and PDA10A subfamily was delivered to the client.

A Report on Cardio-vascular diseases

Background and objectives

The overall objective of this project was to provide the marketing and new business development teams with a set of well-structured market analysis reports with deep market insights. The report needed to provide commercial attractiveness in each area which would give the commercial teams strategic guidance.

Approach

We organised a workshop with key stakeholders and agreed on the report content and developed shell as listed below:

• Disease burden
  • Epidemiology (prevalence, diagnosis rates, drug treated population, morbidity and mortality and economic cost)
• Medical background
  • Standard of care, treatment protocols and medical guidelines
  • Current gold standard treatment
  • Drug classes and their MOA
  • Delivery of care/pathways to care/patient flow
  • Key players making decisions - from gate keeper to final treatment
  • Diagnostic tools/kits used for diagnosis
  • Specialities in making initial diagnoses and maintaining patients
  • Treatment algorithms - 1st line, 2nd line, 3rd line and by severity
  • Unmet medical needs
  • Shortcomings of current therapies
• Market structures
  • Leading classes, leading products including gold standard, dosage forms/drug delivery
  • Product choice determinants/reasons for drug choice
  • Recent/current trends
• Market dynamics
  • Number of generic products and their efficacy
  • Pricing and reimbursement latitude
  • Regulatory, healthcare policy
• Evaluation of future therapies - Phases IIa and III
  • Pipeline drugs
  • Promising MOA class
  • Promising drug candidates
  • Key issues in clinical trial designs/clinical end points/size/comparators
• New medical  trends
  • Impact of pharmacogenomics
  • Preventative medicine rather than treatment of acute disease, coupled with use of new diagnostic techniques
• Potential value of a compound in this disease state

Results delivered

A detailed report of about 100 pages on major diseases in CV area, containing all references, was delivered to the client.

Brand communication via semiotic

Background and objectives

We undertook a simple semiotic desk analysis of five website homepages.
We selected five biological products sharing an indication for RA - as Lifescience Dynamics has a strong experience in this therapy area - and we analysed the European homepages of Remicade, Mabthera, Enbrel, Raptiva and Humira.

The main objective was to understand how each homepage communicates in terms of codes, themes, stories and values in order to map the competitive communicational environment.

This type of analysis could help companies improve graphic layout, contents, internal consistency and distinction of their website.

Approach

We applied a systematic analytical grid - "the generative path of signification" from Greimas & Floch theory - to examine texts, symbols, codes, cultural patterns, contexts, discourses, themes and values which structure and give sense to these five homepages. The grid covers four levels of analysis:

• Text and codes - what we see, listen, taste and touch at the surface of "texts"
• Themes - tone of voice, language style and how we express ourselves
• Stories - chains of meaning, narrations and the stories we tell
• Values - basic beliefs which shape meaning at a deeper level

Results delivered

• A map showing the positioning of each homepage on the semiotic square as a possible starting point for understanding communication/sensory codes and values related to this market/sector
• Detailed analysis of each homepage, including:
  • Assessment of the internal fit/consistency throughout the various levels where meaning is generated
  • Recommendations to make the page more effective, distinctive and internally consistent

Medical/scientific intelligence - Six-target competitive R&D assessment in diabetes

Background and objectives

Our client engaged us to support their efforts in a 6-target R&D assessment of the current and planned R&D diabetes treatment discovery landscape. KITs included:

• Current scientific development including status, approach and theories
• Clinical trial intelligence (phase 1 - phase 3)
• Product development road map
• Product lifecycle management strategy

Approach

A team of six research analysts was assembled to support the primary research efforts of the project.

Primary research efforts focused on KOLs, clinical trial partners and research scientists, as well as attendance at major medical conferences and symposiums. Project duration was three months.

Results delivered

• We were able to provide detailed intelligence concerning the development strategy for all six targets.
• We were able to provide detailed clinical trial data on five clinical trials.
• We were able to gain detailed insight from KOLs concerning the various development strategies of the targeted competitors.
• We provided a SWOT analysis of the client's development strategy in comparison to the targeted competitors.
• We provided a detailed development timeline for each competitor which provided the client with an effective and efficient benchmarking tool.

Market entry strategy

Background and objectives

Our client wished to build an oncology franchise based on their lead product, a novel minor-groove DNA binding agent. The first indication targeted was 'malignant soft tissue sarcoma'. This indication was to be followed up with these indications:

• Renal cell carcinoma
• Metastatic malignant melanoma
• Non-small lung cancer (NSCLC)
• Metastatic breast cancer
• Metastatic ovarian cancer

The primary objective was to evaluate in strategic and financial terms different market entry options, from total licensing-out of the asset to marketing the product themselves, with intermediate options of co-promotion partnerships with companies with established oncology franchises.

For the stand-alone approach a detailed European business plan was prepared which included forecasting and the valuation of different options, the most important of which was whether to employ a contract sales force.

Approach

We designed a three phase project:

• Business analysis
  • Secondary research - external data
  • Internal financial data
  • Internal interviews
  • Forecast modelling
• Financial modelling
  • Building free cash flow model and NPV models
  • Risk analysis
  • External interviews
• Solutions and recommendations
  • Evaluation of financial outputs
  • Recommendations and presentation

Results delivered

A complete going-to-market strategy based on a robust forecast and financial numbers. We evaluated seven strategic options and prioritised them based on ROI and the strategic implications and long term goals of the company.

• Greenfield - 100% organic effort
• Contract sales force
• Co-promo win-win
• Co-promo favourable-profit share
• Co-promo favourable-high milestones
• Licence-out
• Co-promotion with big pharma company

Product lifecycle management - Optimising the current and future ophthalmology franchise with a portfolio strategy in the face of impending generics

Background and objectives

The client, a top 10 pharmaceutical company, engaged us to undertake a strategy evaluation and formulation project taking into account pending generic threats facing ophthalmology franchises.

The key challenges facing our client were as follows:

• The optimal strategies for maximising short-term sales of the existing products may not be consistent with the long-term objectives of the portfolio.
• As market leading products in the X market, Z and Y will be important reference products for new products in development. This suggested that it is important to maintain the price of the brands as far as possible.
• However, it was also important to maintain a strong presence in the ophthalmology market as a platform for the new products. This necessitated targeted price reductions to maintain market share.
• In most markets, loss of patent is expected to occur at a similar time to the launch of the first new product. In some cases the exact timing of launch (following reimbursement negotiations where needed) relative to generic entry may be critical.
• The issue was more pressing in two European markets where generic entry could be significantly earlier than the launch of the new product.
• Price reductions in these two European markets in response to generic entry, may be optimal for those markets, but may have a knock-on effect through referencing pricing or parallel trade in other EU countries with longer patent life.
• In the US the client faced a particular challenge with the loss of patent of a competitor product in a different class but of a direct competitor. The possible implications for our client's product X and Y's volume, and to assess measures taken by ABC needed to be understood and strategies required to deal with these.

Approach

This was a large project lasting eight months with multiple phases, advance analytics, analogue modelling, competitive intelligence on generic companies, quantitative market research to measure brand equity, payer research to develop a pricing strategy for the follow-on product, and finally modelling of various strategies and tactics at country level as well as global ROI analysis.

• Intelligence about likely generics (Stages 1A, 1B 1C and 1D)
• Impact of generics on brand price and share based on country systems analysis and analogues (Stages 1C, 1D)
• Assessment of the pricing opportunity for new products (2C)
• Payer research: this tested the likely response from physicians in an environment where generic X and Y were available (2A).
• Primary intelligence: this tested the likely response from generic manufacturers; their interest and capabilities to manufacture and distribute copies or APIs of our client's product.
• Primary quantitative research: to provide the team with robust quantitative numbers for forecast modelling of revenue, and produce a market share simulations model for current products, and to measure brand equity of X and Y brands with ophthalmologists.

Results delivered

There were outputs from each activity, such as CI, which highlighted "intense" generic competition and MR "low" brand equity.

We delivered at each milestone, finally delivering global and regional strategic options of viable strategies, looking at all options, such as:

• Manufacturing
• Generics launches
• Reformulations
• Bridging
• Value enhancement

We also undertook a roadshow workshop for each of six markets and provided a template and guidance to co-ordinate strategies and tactics. All options were backed up by financial models.