Pipeline Insight: Molecular Targeted Cancer Therapies

More pipeline activity, less product differentiation

Publication Date	November 2008
Publisher	Datamonitor
Product Type	Report
Pages	431
ISBN Number	not applicable
Product Code	DAT14233

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Summary

Introduction

Approaches to cancer treatment continue to incorporate molecular targeted therapies into standard treatment regimens. With an increasing number of candidates gaining approval, and with a dynamic developmental pipeline, further clinical, commercial and strategic challenges are continuing to emerge.

Scope

*Research and analysis of the MTT pipeline with in-depth clinical and commercial assessment of Phase III candidates
*Seven major pharmaceutical market sales forecasts to 2017 for key pipeline candidates incorporating product specific assumptions and events
*Segmentation and examination of product pipeline by developmental phase, class, mode of action, indication and developer
*Insight and analysis of market potential including commercial opportunity, commonalities across cancers and discussion of unmet needs

Highlights

373 different pipeline candidates have been identified of which 38 are in late-phase development. These identified candidates have a forecast sales potential of up to $7.31 billion in the seven major pharmaceutical markets by 2017.
Agents holding the greatest commercial potential include Afinitor (everolimus; Novartis), Omnitarg (pertuzumab; Genentech/Roche), Brivanib (BMS-582664; Bristol-Myers Squibb) and aflibercept (VEGF-Trap; Sanofi-Aventis).
The 'big four' tumor typesnon-small cell lung cancer (NSCLC), breast cancer, colorectal cancer and prostate cancercontinue to attract the main attention from MTT developers. However, niche tumor types with lower bars to market entry can still offer high rewards for effective candidates.

Reasons to Purchase

*Acquire a detailed appreciation and impartial perspective of the entire molecular targeted therapies developmental pipeline
*Identify the key products in late-phase development based on sales forecasts to 2017 and Datamonitor's drug assessment methodology
*Assess the shifting oncology market dynamic and how future treatment of many cancers will incorporate pipeline products

Content

about Datamonitor Healthcare
about The Oncology Pharmaceutical Analysis Team
Chapter 1 Executive Summary
- Scope of analysis
- Datamonitor insight into the molecular targeted therapies market
- Related reports
- Upcoming reports
Chapter 2 Pipeline Overview and Dynamics
- Pipeline overview
- Late-phase pipeline molecular targeted cancer therapies
- Phase II pipeline molecular targeted cancer therapies
- Phase I pipeline molecular targeted cancer therapies
- Pipeline by developmental phase and class of drug
- There are 373 different MTTs in clinical development
- The cell cycle and apoptosis targeted agents is the largest class of MTT in the pipeline
- Multi-targeted inhibitors account for the largest number of late-phase candidates while the single target agents will achieve higher level of sales
- Pipeline by indication
- Pipeline MTTs are being investigated in 42 different cancers
- The 'big four' tumor types remain the most popular indications for development
- Pipeline by mode of action
- Pipeline products are directed against a huge variety and combination of molecular targets
- Pipeline by company
- There are 183 different companies developing targeted therapies
- Top three companies in terms of number of pipeline MTT products are Pfizer, AstraZeneca and Novartis
- Pfizer - 21 MTT pipeline products
- AstraZeneca - 13 MTT pipeline products
- Novartis - 13 MTT pipeline products
- Key metrics
- Datamonitor pipeline assessment summary
Chapter 3 Current Market Status & Pipeline Classification
- Targeted therapies overview
- The development of molecular targeted therapies
- Current therapies are less cancer cell-specific
- The strategy is to target the specific survival factors of a tumor
- Key issue is the identification of targets unique to cancer cells
- Market definition
- L1X3 - Antineoplastic monoclonal antibodies
- L1X9 - All other antineoplastics
- Classification of pipeline products
- Angiogenesis inhibitors
- Angiogenesis as a normal biological process
- Angiogenesis is known to be aberrant in tumor cell proliferation
- Angiogenesis inhibitors as viable antitumor agents can target a number of pathways
- at present, only one angiogenesis inhibitor exists on the market
- Single-target signal transduction inhibitors
- A plethora of potential targets exist along the signaling cascade
- Several signal transduction inhibitors have reached the market, bringing with them their own sets of issues for consideration
- Multi-targeted inhibitors
- Multi-targeted inhibitors have certain advantages over single targeted agents
- Approval of three multi-targeted inhibitors
- Cell cycle and apoptosis targeted inhibitors
- Only one cell cycle inhibitor has entered Phase III
- Cell death can be induced via a number of different pathways
- to date, only one apoptosis stimulator has reached the market
- Immunomodulatory and immunoconjugated therapeutics
- Antibody-based technologies are an effective anticancer approach
- Epigenetic modulators
- despite relative immaturity of development in this class of drugs, the potential to enhance current therapies exists
- Oncology clinical trial design
- Patient selection
- Increasingly significant in the era of targeted treatment
- Clinical trial duration
- Sufficient follow-up is necessary to establish true clinical benefit
- The advent of novel therapies
- Diversity of targeted therapies will require an evolution in clinical trial design
- Clinical trial endpoints in oncology
- Most oncology clinical trials designate multiple endpoints
- Survival
- Quality of life
- Tumor response rates
- Toxicity
- Time to tumor progression
Chapter 4 Pipeline Angiogenesis Inhibitors Analysis & Forecasts
- Overview of angiogenesis inhibitors
- Pipeline summary
- Late-phase pipeline of angiogenesis inhibitors
- Phase II pipeline of angiogenesis inhibitors
- Phase I pipeline of angiogenesis inhibitors
- Comparative forecasts to 2017
- Drug assessment summary
- Definition of current comparator therapy - Avastin (Bevacizumab; Genentech/Roche/Chugai)
- Aflibercept (VEGF-Trap; Sanofi-Aventis/Regeneron)
- Drug overview
- Key historical events
- Clinical trial data
- Phase II results for aflibercept in advanced ovarian cancer
- Interim Phase II results for aflibercept in NSCLC
- Aflibercept demonstrates similar side effects to Avastin
- Datamonitor comments
- Fierce competition with Avastin in the wider cancer market
- Presence in oncology field will aid commercialization of aflibercept
- Armala (Pazopanib; GlaxoSmithKline)
- Drug overview
- Key historical events
- Clinical trial data
- Phase III trial evaluates Armala as a second-line monotherapy in metastatic RCC
- Second Phase III trial compares Armala with Sutent head-to-head in the first-line RCC setting
- Armala shows applicability across a broad range of solid tumor types
- Datamonitor comments
- Armala will face intense competition in the RCC market
- Extensive parallel development program planned
- Tykerb may well enhance the success of Armala but at what price?
- Cilengitide (EMD-121974; Merck Serono)
- Drug overview
- Key historical events
- Clinical trial data
- Cilengitide may offer added benefit to standard treatment for glioblastoma multiforme
- Datamonitor comments
- Cilengitide is the only integrin antagonist in late-phase development...but is this enough?
- Recentin (Cediranib, AZD2171; AstraZeneca)
- Drug overview
- Key historical events
- Clinical trial data
- AstraZeneca targets first-line CRC
- Recentin's Phase II/III trial in advanced NSCLC does not progress into Phase III
- Phase III study planned for Recentin in glioma
- Datamonitor comments
- Recent NSCLC results may have created skepticism regarding Recentin's future
- Phase III studies in CRC are high-risk while development in glioma may offer a quicker route to market
- AstraZeneca's strength in the oncology market will be key in Recentin's success
- Ramucirumab (IMC-1121B; ImClone Systems)
- Drug overview
- Key historical events
- Clinical trial data
- Phase I data shows some evidence of antitumor activity
- Datamonitor comments
- A lack of clinical trial data makes it difficult to judge ramucirumab's potential
- Will ramucirumab be able to compete with Avastin in the HER-2-negative breast cancer market?
Chapter 5 Pipeline Single-Target Signal Transduction Inhibitors Analysis & Forecasts
- Overview of single-target signal transduction inhibitors
- Pipeline summary
- Late-phase pipeline of single-target signal transduction inhibitors
- Phase II pipeline of single-target signal transduction inhibitors
- Phase I pipeline of single-target signal transduction inhibitors
- Comparative forecasts to 2017
- Drug assessment summary
- Definition of current comparator therapy - Herceptin (Trastuzumab; Genentech/Roche/Chugai)
- Afinitor (Everolimus; Novartis)
- Drug overview
- Key historical events
- Clinical trial data
- Afinitor is the first drug to show a clinical benefit in tyrosine kinase inhibitor-refractory RCC patients
- Afinitor may be a promising addition to the treatment of neuroendocrine tumors
- Afinitor is showing applicability in variety of tumor types
- Datamonitor comments
- Targeting a niche population, Afinitor will face lower barriers to market entry
- Afinitor will have to significantly improve treatment outcomes in order to succeed in the neoadjuvant breast cancer setting
- Novartis is an ideal backer for the drug
- CP-751871 (Pfizer)
- Drug overview
- Key historical events
- Clinical trial data
- The combination of CP-751871 with chemotherapy is well-tolerated in a Phase II study
- Datamonitor comments
- Although costly, targeting multiple treatment settings in NSCLC may serve to maximize CP-751871's chances of approval
- Deforolimus (ARIAD Pharmaceuticals/Merck & Co)
- Drug overview
- Key historical events
- Clinical trial data
- Phase III sarcoma trial now underway based on modest Phase I data
- Datamonitor comments
- Sarcoma offers a quicker route to market for deforolimus but is a higher risk strategy
- Late-phase development of Avastin in sarcoma may pose a competitive threat for deforolimus
- Deforolimus will also need to compete with Afinitor and Torisel in other oncology indications
- Omnitarg (pertuzumab; Genentech/Roche/Chugai)
- Drug overview
- Key historical events
- Clinical trial data
- Phase II study suggests Herceptin-Omnitarg combination has activity in progressive metastatic breast cancer previously treated with Herceptin
- Omnitarg has limited activity as a single agent in metastatic breast cancer with low HER-2 expression
- The addition of Omnitarg to Gemzar produces no significant benefit over chemotherapy alone in platinum-resistant ovarian cancer
- Omnitarg's development as a monotherapy in HRPC may have been discontinued
- Datamonitor comments
- Clinical benefit will have to outweigh increased cost of adding Omnitarg to Herceptin
- Uncertainty as to whether Omnitarg will be developed for HER-2-negative population
- TheraCIM (Nimotuzumab; YM Bioscience)
- Drug overview
- Key historical events
- Clinical trial data
- Nimotuzumab shows favorable toxicity profile in a Phase III study in pediatric pontine glioma
- TheraCIM shows efficacy comparable to that of Erbitux in metastatic colorectal cancer
- Pivotal trials planned for TheraCIM in NSCLC and brain metastases from NSCLC
- Datamonitor comments
- TheraCIM expected to gain approval in pediatric glioma
- TheraCIM's potential in the oncology market can be greatly expanded
- Improved toxicity profile will support TheraCIM's uptake
- Xinlay (Atrasentan; Abbott Laboratories)
- Drug overview
- Xinlay's target receptor plays a key role in cancer cell proliferation
- Key historical events
- Clinical trial data
- FDA does not approve Xinlay for prostate cancer
- SWOG runs second Phase III trial in prostate cancer
- Datamonitor comments
- despite its rejection by the FDA, Xinlay's future may still hold promise
- Abbott's favorable position in the prostate cancer market will be invaluable
- Zalutumumab (HuMax-EGFR; Genmab)
- Drug overview
- Key historical events
- Clinical trial data
- with Fast Track status granted, SCCHN offers promise as a lead indication for zalutumumab
- Datamonitor comments
- A head-to-head study against Erbitux could work in zalutumumab's favor
- Zalutumumab may have to compete with Tarceva and Iressa
- Zalutumumab may also have to compete with Tarceva and Iressa
- Zarnestra (Tipifarnib; Johnson & Johnson)
- Drug overview
- Key historical events
- Clinical trial data
- following rejection of NDA, the FDA requires Phase III data for Zarnestra in AML before regulatory approval can be considered
- Zarnestra fails to increase overall survival compared to BSC in a Phase III study
- Zarnestra has been evaluated in a number of Phase II studies
- Single-agent Zarnestra demonstrates antitumor activity in relapsed/refractory aggressive NHL
- Zarnestra holding promise in juvenile myelomonocytic leukemia
- Negative Phase III trial results cause termination of development in pancreatic and colorectal cancer
- Datamonitor comments
- Zarnestra's Phase III trial results raise more concerns regarding its future
Chapter 6 Pipeline Multi-Targeted Inhibitors Analysis & Forecasts
- Overview of multi-targeted inhibitors
- Pipeline summary
- Late-phase pipeline of multi-targeted inhibitors
- Phase II pipeline of multi-targeted inhibitors
- Phase I pipeline of multi-targeted inhibitors
- Comparative forecasts to 2017
- Drug assessment summary
- Definition of current comparator therapy - Gleevec (Imatinib; Novartis)
- Axitinib (AG-13736; Pfizer)
- Drug overview
- Key historical events
- Clinical trial data
- Phase III trial initiated in pancreatic cancer following a 26% reduction in the risk of death in a Phase II trial
- Activity in Nexavar-refractory RCC patients drives Phase III development in the second-line setting
- Axitinib demonstrates impressive activity in thyroid cancer but Phase III trial has yet to start
- Axitinib also making progress in other popular tumor types
- Datamonitor comments
- A similar response rate to Tarceva in pancreatic cancer suggests approval will be likely
- Head-to-head Phase III trial against Nexavar could maximize axitinib's potential
- Axitinib will enjoy Pfizer's global presence and unparalleled marketing strength
- Bosutinib (SKI-606; Wyeth)
- Drug overview
- Key historical events
- Clinical trial data
- Bosutinib Phase II results in Gleevec-resistant/intolerant chronic phase CML
- Bosutinib Phase II results in Gleevec-resistant/intolerant accelerated phase (AP) and blast crisis (BC) CML and Ph+ ALL
- Datamonitor comments
- The CML market is comparatively well served by Gleevec, Sprycel and Tasigna
- like the others, bosutinib appears ineffective in patients harboring the T315I mutation - a key driver of resistance
- Bosutinib trying to catch up with Sprycel and Tasigna in the race to replace Gleevec in the front-line setting
- Brivanib (BMS-582664; Bristol-Myers Squibb)
- Drug overview
- Key historical events
- Clinical trial data
- Brivanib and Erbitux competition shows early signs of clinical activity in a Phase I study
- Datamonitor comments
- Bristol-Myers Squibb offers ideal credentials to ensure brivanib's potential in CRC is maximized
- Economic evaluation is an encouraging inclusion as part of the Phase III trial endpoints
- Minimal threat from other FGFR/VEGFR TKIs...for the time being
- Ceflatonin (Myelostat; ChemGenex Pharmaceuticals)
- Drug overview
- Key historical events
- Clinical trial data
- Ceflatonin targeting Gleevec-resistant patients
- Datamonitor comments
- despite convincing clinical benefit, Ceflatonin will face strong competition from Bristol-Myers Squibb's Sprycel and Novartis's Tasigna
- Enzastaurin (LY317615; Eli Lilly)
- Drug overview
- Key historical events
- Clinical trial data
- Enzastaurin looking to make its mark in the B-cell lymphoma market
- Enzastaurin holding promise as a maintenance therapy in mantle cell lymphoma
- despite discontinuation of a Phase III trial in Glioma, Eli Lilly has initiated 20 additional clinical trials
- Datamonitor comments
- Eli Lilly continuing to pursue development in glioma
- Eli Lilly adopt a risky strategy for enzastaurin in DLBCL
- Lestaurtinib (CEP-701; Cephalon)
- Drug overview
- Key historical events
- Clinical trial data
- Lestaurtinib emerging as a promising agent for AML patients harboring Flt-3 activating mutations
- Datamonitor comments
- Lestaurtinib may be the first in its class to reach the market
- Cephalon's acquisition of Trisenox will provide valuable experience of the leukemia market
- Midostaurin (Novartis)
- Drug overview
- Key historical events
- Clinical trial data
- Amended midostaurin dose generates encouraging results in previously untreated AML
- Datamonitor comments
- Targeting the first-line AML setting seems to be the most reasonable strategy
- ...but the target population may not generate a high return on development costs
- Novartis's experience in the leukemia market will be very beneficial
- Motesanib (AMG706; Amgen/Takeda Pharmaceutical)
- Drug overview
- Key historical events
- Clinical trial data
- The combination of motesanib with chemotherapy is safe and shows preliminary evidence of clinical activity in NSCLC
- Datamonitor comments
- Can motesanib succeed where other tyrosine kinase inhibitors have failed?
- Amgen runs a high risk with the inclusion of squamous cell patients in motesanib's Phase III NSCLC trial
- Tovok (BIBW 2992; Boehringer Ingelheim)
- Drug overview
- Key historical events
- Clinical trial data
- Tovok shows promising activity in NSCLC patients harboring EGFR mutations
- Datamonitor comments
- Vargatef (BIBF 1120; Boehringer-Ingelheim)
- Drug overview
- Key historical events
- Clinical trial data
- Vargatef shows preliminary evidence of clinical activity in a Phase II trial in NSCLC
- Datamonitor comments
- Boehringer-Ingelheim's plans for Vargatef's development are unclear
- XL-184 (Exelixis)
- Drug overview
- Key historical events
- Clinical trial data
- Little information is available on XL-184's clinical activity
- Datamonitor comments
- XL-184 could satisfy an unmet need in the treatment of thyroid cancer
- Zactima (Vandetanib, ZD6474; AstraZeneca)
- Drug overview
- Key historical events
- Clinical trial data
- Zactima shows promising results in the treatment of thyroid cancer
- Multiple Phase III trials underway in NSCLC
- Zactima fails to demonstrate efficacy as a maintenance therapy for SCLC
- Datamonitor comments
- Zactima may achieve product differentiation through its unique multi-targeted characteristics
- Zactima is targeting a broad population of previously-treated, advanced NSCLC patients
- The head-to-head trial against Tarceva in NSCLC is a high-risk undertaking
- AstraZeneca's strength in the oncology market will be key to Zactima's success
Chapter 7 Pipeline Cell Cycle and Apoptosis Targeted Agents Analysis & Forecasts
- Overview of cell cycle and apoptosis targeted agents
- Pipeline summary
- Late-phase pipeline of cell cycle and apoptosis targeted agents
- Phase II pipeline of cell cycle and apoptosis targeted agents
- Phase I pipeline of cell cycle and apoptosis targeted agents
- Comparative forecasts to 2017
- Drug assessment summary
- Definition of current comparator therapy - Velcade (Bortezomib; Takeda; Johnson & Johnson)
- Elesclomol (Synta Pharmaceuticals/GlaxoSmithKline)
- Drug overview
- Key historical events
- Clinical trial data
- The combination of elesclomol with paclitaxel improves survival in metastatic melanoma
- Datamonitor comments
- Elesclomol's first-in-class nature and superior clinical activity could secure approval and uptake in metastatic melanoma
- Genasense (Oblimersen; Genta)
- Drug overview
- Key historical events
- Datamonitor comments
- Approval of Genasense is looking increasingly unlikely
- Termination of agreement with Sanofi-Aventis is a major setback for Genta
- Phenoxodiol (Marshall Edwards)
- Drug overview
- Key historical events
- Clinical trial data
- Marshall Edwards is hoping for a swift approval in ovarian cancer
- The combination of phenoxodiol and cisplatin is particularly effective in ovarian cancer
- Datamonitor comments
- Toxicity will be the key factor for phenoxodiol's success
- Securing a marketing partner will be crucial
- Marshall Edwards looking to expand phenoxodiol's potential
- Retaspimycin (Infinity Pharmaceuticals/AstraZeneca)
- Drug overview
- Key historical events
- Clinical trial data
- despite initiation of a Phase III trial, very limited data are available on retaspimycin's clinical activity
- Datamonitor comments
- Retaspimycin could satisfy a significant unmet need in GIST
- Tanespimycin (Bristol-Myers Squibb)
- Drug overview
- Key historical events
- Clinical trial data
- The combination of tanespimycin with Velcade shows manageable toxicity
- Tanespimycin is evaluated in combination with Herceptin in metastatic breast cancer
- Datamonitor comments
- Tanespimycin addresses a significant unmet need in MM
- Vadimezan (ASA-404; Antisoma/Novartis)
- Drug overview
- Key historical events
- Clinical trial data
- Vadimezan is effective and well tolerated in NSCLC patients with both squamous and non-squamous histology
- The addition of vadimezan to Taxotere does not have a significant impact on median survival in a Phase II study in HRPC
- Datamonitor comments
- Efficacy and safety in patients with squamous histology will be a considerable competitive advantage
- Vadimezan's combination with Taxotere will have to show very impressive results
Chapter 8 Pipeline Immunomodulatory and Immunoconjugated Therapeutics Analysis & Forecasts
- Overview of immunomodulatory and immunoconjugated therapeutics
- Pipeline summary
- Late-phase pipeline of immunomodulatory and immunoconjugated therapeutics
- Phase II pipeline of immunomodulatory and immunoconjugated therapeutics
- Phase I pipeline of immunomodulatory and immunoconjugated therapeutics
- Comparative forecasts to 2017
- Drug assessment summary
- Definition of current comparator therapy - Rituxan (Rituximab; Biogen Idec/Genentech/Roche)
- Galiximab (Anti-CD80 MAb; Biogen Idec)
- Drug overview
- Key historical events
- Clinical trial data
- Randomized Phase III trial will compare survival of galiximab plus Rituxan with Rituxan alone in relapsed/refractory follicular NHL patients
- Phase II results show galiximab and Rituxan can be safely combined and can produce promising response rates in follicular NHL patients
- Datamonitor comments
- Biogen Idec in a strong position to successfully market galiximab alone
- Biogen Idec will need to effectively demonstrate the value of a combination of galiximab and Rituxan to payers
- Lumiliximab (Anti-CD23 MAb; Biogen Idec)
- Drug overview
- Key historical events
- Clinical trial data
- The addition of lumiliximab to the FCR regimen may produce a higher response rate without additional toxicity
- Datamonitor comments
- Lumiliximab on course to become an established addition to the standard treatment for CLL
- Biogen Idec should look to investigate lumiliximab as a maintenance therapy
- Cluster of Differentiation (CD) drugs have become Biogen Idec's specialty
- Neuradiab (131I-81C6; Bradmer)
- Drug overview
- Key historical events
- Clinical trial data
- Neuradiab with radiotherapy and chemotherapy shows encouraging clinical activity in a Phase II trial
- Datamonitor comments
- Neuradiab's clinical benefit will have to justify the increase in cost
- Progression-free survival data may provide an early insight into Neuradiab's clinical benefit
- Ofatumumab (HuMax-CD20; Genmab/GlaxoSmithKline)
- Drug overview
- Genmab hoping ofatumumab will demonstrate a preferred efficacy profile over Rituxan in the clinic
- Key historical events
- Clinical trial data
- Ofatumumab receives Fast Track status for CLL and enters a Phase III trial
- Genmab initiates a pivotal Phase III trial in follicular NHL
- Genmab is investigating ofatumumab in the first-line follicular NHL setting
- Datamonitor comments
- Genmab's commercial strategy may improve ofatumumab's chances of success in the NHL market
- Targeting underserved CLL patients may enhance ofatumumab's uptake in the market
- Rencarex (WX-G250; Wilex)
- Drug overview
- MN/CA IX Antigen - A highly specific tumor target
- Mode of Action of Rencarex - ADCC
- Key historical events
- Clinical trial data
- Interim results from the ARISER trial expected in 2009
- in patients responding to treatment, Rencarex monotherapy improves survival
- The combination with IFN is well-tolerated and of clinical benefit in metastatic RCC
- Completed Phase I and II trials for metastatic RCC
- Additional trial initiated to investigate Rencarex in combination with Sutent
- Radiolabeled Rencarex in development as a molecular imaging tool
- Datamonitor comments
- The high recurrence rate for RCC creates a commercial opportunity
Chapter 9 Pipeline Epigenetic Modulators Analysis & Forecasts
- Overview of epigenetic modulators
- Pipeline summary
- Late-phase pipeline of epigenetic modulators
- Phase II pipeline of epigenetic modulators
- Phase I pipeline of epigenetic modulators
- Panobinostat (LBH589B; Novartis)
- Drug overview
- Key historical events
- Clinical trial data
- Panobinostat showing promise in pretreated CTCL patients
- Panobinostat's status of development in MM is unclear
- Datamonitor comments
- Novartis likely to evaluate panobinostat in other indications
Appendix
List of Tables
List of Figures
- Methodology
- Datamonitor forecast methodology
- Epidemiology forecasts
- Product forecasts
- Datamonitor drug assessment summary
- Abbreviations
- Contributing experts
- Bibliography
- about Datamonitor
- about Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- about the Disease analysis team
- Disclaimer