DENDREON PHARMACEUTICALS

Active Client Intelligence Report

Confidential — Active Client
Prepared by Agency Intelligence | February 2026

1. Report Methodology & Overview

Intelligence Framework

This Intelligence Report uses our proprietary CRAM™ Assessment Model to evaluate Dendreon Pharmaceuticals' commercial readiness, competitive positioning, and Agency expansion opportunities. CRAM™ measures:

  • Clinical Readiness — regulatory status, clinical data maturity, pipeline strength
  • Regulatory Access — market approval, coverage, reimbursement landscape
  • Actual Infrastructure — commercial capabilities, manufacturing, distribution, patient support
  • Market Maturity — competitive landscape, KOL engagement, HCP awareness, digital readiness

As an active Agency client, Dendreon currently receives Speaker Programs, KOL Management, and Marketing/Medical Education services for PROVENGE® (sipuleucel-T). This report identifies $1.2–2.0M in annual expansion opportunities across 4 unserved service areas and competitive defense initiatives to protect PROVENGE's market position against emerging threats.

Report Date: February 2026 | Prepared for: Agency Leadership & New Business Development | Classification: Confidential — Active Client

2. Executive Summary

Dendreon Pharmaceuticals is a commercial-stage biopharmaceutical company and pioneer in cellular immunotherapy, with its flagship product PROVENGE® (sipuleucel-T) being the first FDA-approved autologous cellular immunotherapy. As an active Agency client receiving Speaker Programs, KOL Management, and Marketing/Med Ed services for PROVENGE, Dendreon's partnership represents a foundation for significant expansion.

The competitive landscape is intensifying — Novartis's Pluvicto received an expanded FDA label in March 2025 for chemo-naïve mCRPC, directly threatening PROVENGE's positioning. Simultaneously, Dendreon's new CDMO business line creates an entirely new marketing and communications opportunity the Agency is not yet supporting.

This report identifies $1.2–2.0M in annual expansion opportunities across 4 unserved service areas and competitive defense initiatives for PROVENGE. Key recommendations include: (1) CDMO Services Marketing launch, (2) HCP Digital Platform development, (3) Enhanced Medical Education programming, and (4) Competitive intelligence/counter-campaign support for PROVENGE repositioning.

Key Findings

  • CRAM™ Score: 21/30 (70%) — Strong clinical foundation with critical gaps in Digital, Market Access defense, and HCP Education readiness
  • Active Investment Phase: SVP Commercial vacancy + MSL hiring (SE region) + manufacturing expansion signals aggressive growth phase
  • Competitive Threat: Pluvicto label expansion (March 2025) moves Novartis into chemo-naïve space; Xtandi/Apalutamide still dominant market share holders
  • Dual Revenue Streams: PROVENGE (~$237M est. annual) + emerging CDMO business (Shoreline partnership) creates two distinct GTM opportunities
  • KOL & Clinical Network: Established but under competitive poaching pressure; Agency-managed program is strong but limited to current PROVENGE services

Recommended Expansion Opportunities

Service Area Current Status Opportunity Size Strategic Priority Timeline
CDMO Services Marketing Not yet served $400–600K/yr HIGH Q2 2026
HCP Digital Platform Basic website only $300–500K/yr HIGH Q2 2026
Medical Education Program CME grants only $250–400K/yr MEDIUM Q3 2026
Competitive Intelligence/Congress Support Ad-hoc support $250–500K/yr HIGH Q1 2026 (immediate)

Total Addressable Expansion Opportunity: $1.2–2.0M annually

3. Company Snapshot

Overview

Founding & Stage

Founded 1992 | Commercial Biopharma + CDMO

Headquarters

Seal Beach, California

Employees

~710

Estimated Revenue

~$237M annually (private company)

Ownership

Nanjing Xinjiekou/Sanpower Group (private)

Profitability

Profitable since 2016; peak year 2017

Executive Leadership

Executive Title Name Focus Area
CEO/President Michael Pearson Overall company strategy
Chief Operating Officer Christina Yi Operations & manufacturing
Chief Financial Officer Chris Carr Financial strategy
Chief Medical Officer Bruce Brown Clinical & medical affairs
SVP Legal/General Counsel Kevin Helmbacher Legal & compliance
SVP Commercial & Marketing OPEN — GAP SIGNAL Commercial leadership (vacancy)

Manufacturing & Facilities

Seal Beach, CA (HQ)

180,000 sq ft manufacturing + corporate office | PROVENGE manufacturing site

Union City, GA

170,000 sq ft manufacturing | CDMO/cell therapy manufacturing (expansion phase)

Seattle, WA

R&D + Operations | Innovation & pipeline development

Key Financial Metrics

  • PROVENGE Sub-Brand Value: Estimated $250–350M range (per prior CEO commentary, "sub-$500M brand")
  • CDMO Business: Second revenue pillar in growth phase; partnerships with Shoreline Bioscience and others
  • Profitability Timeline: Profitable since 2016; 2017 was peak profitability year
  • Capital Structure: Stable private ownership under Sanpower/Nanjing Xinjiekou since 2017 (no recent M&A signals)

Current Hiring & Expansion Signals

Dendreon is actively hiring across multiple business units, signaling strategic expansion:

  • SVP Commercial & Marketing — VACANT (leadership gap, high-priority hire)
  • Medical Science Liaisons — Southeast regional expansion (medical education scale-up)
  • Manufacturing Operations — Union City GA expansion roles (CDMO/cell therapy growth)
  • Sr Manager Training & Development — Internal capability building (potential Agency training partnership)
  • Account Manager roles — NY, LA markets (PROVENGE sales force geographic coverage)

4. Product Portfolio Analysis

Current Product Portfolio

Product Indication Status Clinical Support Agency Services
PROVENGE® (sipuleucel-T) Metastatic Castration-Resistant Prostate Cancer (mCRPC) Commercial (2010) ASCO 2025; PROCEED registry; ongoing real-world evidence studies ✅ Speaker | ✅ KOL | ✅ Marketing
CDMO Services Cell Therapy Manufacturing Commercial (2021) Shoreline partnership; FDA-approved facilities ❌ None (Gap)
TRPM8 Small Molecule Multiple cancer types Preclinical Early development phase N/A

Product × Service Matrix (Current Agency Engagement)

✅ = Actively Served ❌ = Not Served (Opportunity) N/A = Not Applicable

Product Speaker Program KOL Management Marketing/DTC Medical Education Medical Affairs Congress Support Digital/Portal
PROVENGE (mCRPC) ✅ ✅ ✅ ❌ ❌ ❌ ❌
CDMO Services ❌ ❌ ❌ ❌ ❌ ❌ ❌
TRPM8 (pipeline) N/A N/A N/A N/A N/A N/A N/A

⚠️ Portfolio Gaps Identified

PROVENGE: Strong Speaker, KOL, and DTC/Marketing coverage, BUT medical education, medical affairs support, and digital channels remain unserved. CDMO Services: Complete portfolio gap — no Agency engagement despite commercial viability and strategic importance to Dendreon's growth pipeline.

PROVENGE® Clinical Highlights

  • Regulatory: FDA approved March 29, 2010; NCCN Category 1 recommendation for asymptomatic/minimally symptomatic mCRPC
  • IMPACT Trial (Pivotal): Phase 3, 512 patients, 4.1-month median overall survival (OS) benefit, HR 0.78 (p=0.021)
  • Mechanism: Autologous dendritic cell immunotherapy; unique personalized approach to mCRPC treatment
  • 15+ Years Real-World Evidence: PROCEED Registry + additional studies supporting durability and safety profile
  • 2020 Real-World Data: Adding PROVENGE to treatment regimen prolonged median survival by 14.5 months

5. CRAM™ Assessment Dashboard

PROVENGE CRAM™ Score: 21/30 (70%)

The CRAM™ model evaluates Dendreon's readiness across four dimensions. PROVENGE demonstrates strong clinical foundation (5/5) and commercial infrastructure (4/5), but critical gaps exist in Digital Readiness (2/5) and Market Access Defense (3/5) amid competitive pressure.

📊 Clinical Readiness 5/5
5/5
Status: FDA approved 2010; NCCN Category 1; IMPACT trial (NEJM 2011); 15+ years real-world evidence; PROCEED registry ongoing. PROVENGE has the strongest clinical foundation in its category with established superiority in overall survival.
🏢 Commercial Infrastructure 4/5
4/5
Status: Established sales force nationwide; established manufacturing across 3 FDA-approved facilities; ~710 employees. GAP SIGNAL: SVP Commercial role OPEN — indicates leadership transition/expansion. Grant Hill awareness campaign shows brand awareness investment.
💰 Market Access & Reimbursement 3/5
3/5
Status: Medicare coverage confirmed; PROvide copay assistance program established; ~$93K treatment cost covered under bundle codes. THREAT: Pluvicto label expansion (March 2025) creating formulary competition and potential reimbursement pressure. High cost scrutiny ongoing.
🎓 KOL Network Maturity 4/5
4/5
Status: Agency-managed KOL program active; strong investigator network from clinical trials; established advisory boards. RISK: Competitive KOL poaching from Novartis (Pluvicto), Pfizer (Xtandi), Bayer (nuances) creating retention pressure.
📚 HCP Education & Awareness 3/5
3/5
Status: Medical Affairs team supports CME grants + IITs. GAP: No formal Agency-managed Medical Education program. MSL team expanding (Southeast hiring) signals internal capability build but insufficient for full-scale HCP education platform.
🌐 Digital & HCP Channel 2/5
2/5
Status: Basic provenge.com + dendreon.com websites; dendreonmedicalaffairs.com for HCP information. CRITICAL GAP: NO HCP-exclusive portal; minimal digital engagement vs. competitors (Pfizer/Astellas Xtandi digital ecosystem significantly more mature); no app, no robust learning management system.

CRAM™ Summary Assessment

Overall Score: 21/30 (70%) — Above-average readiness with strong clinical and commercial backbone, but significant gaps in Digital, HCP Education, and Market Access Defense require immediate Agency support.

Key Strengths: Established clinical evidence, proven commercial model, FDA manufacturing infrastructure, NCCN positioning

Key Vulnerabilities: Digital readiness (2/5), HCP education infrastructure (3/5), market access pressure from Pluvicto (3/5), competitive KOL poaching risk

6. Financial Viability & Ownership

Revenue Profile

Dendreon operates as a privately held company with limited public financial disclosure. However, available market intelligence and company commentary provide the following snapshot:

Estimated Annual Revenue ~$237M (2024–2025 est.)
Primary Revenue Stream PROVENGE product sales (est. $200–220M)
Secondary Revenue Stream CDMO services (growing, est. $17–37M)
Profitability Status Profitable since 2016; peak 2017
Ownership Nanjing Xinjiekou / Sanpower Group

PROVENGE Product Economics

  • Brand Value Classification: "Sub-$500M brand" per prior CEO commentary; estimated $250–350M market size for mCRPC indication
  • Treatment Cost: ~$93,000 per treatment (estimated market price)
  • Unit Economics: Autologous cell therapy model with unique manufacturing requirements per patient
  • Annual Patient Volume: Estimated 2,000–3,000 new patients treated annually (U.S.); potential for expansion with enhanced marketing/KOL engagement

CDMO Business Pillar

The CDMO (Contract Development and Manufacturing Organization) business represents Dendreon's second growth pillar and strategic diversification beyond PROVENGE. Key facts:

  • Commercial Launch: 2021
  • Facility Capacity: 3 FDA-approved manufacturing sites (Seal Beach CA, Union City GA, Seattle WA)
  • Key Partnership: Shoreline Bioscience partnership for cell therapy manufacturing
  • Target Market: Biotech/pharma companies developing cell therapies (autologous and allogeneic)
  • Growth Signal: Manufacturing expansion hiring at Union City GA facility indicates scaling
  • Marketing Gap: Currently NO Agency marketing support for CDMO services — represents $400–600K/yr opportunity

Financial Stability Assessment

✅ Strong Fundamentals

  • Profitable operations since 2016; multiple revenue streams (PROVENGE + CDMO)
  • Stable private ownership (no M&A pressure or volatility)
  • Significant capital investment in 3 FDA-approved manufacturing facilities
  • Established market position with 15+ years of real-world evidence
  • Active hiring and expansion signals = confidence in growth

Conclusion: Dendreon demonstrates solid financial viability as a profitable, sustainable commercial biopharma company with stable ownership and diversified revenue streams. Financial risk to Agency partnership is LOW.

7. Therapeutic Focus & Development Pipeline

Pipeline Overview

Dendreon's R&D focus spans cellular immunotherapy (PROVENGE-based development) and CDMO platform expansion. The company is NOT pursuing an aggressive oncology pipeline outside of PROVENGE-related indications in the near term.

Pipeline Visualization

PROVENGE® (mCRPC) — Commercial Product APPROVED 2010
Commercial — Full Market
PROVENGE Combination Studies — Abiraterone + Prednisone PHASE 2
Phase 2 Active
TRPM8 Oral Small Molecule — Multiple Cancers PRECLINICAL
Preclinical Development
Dendreon CDMO Platform — Cell Therapy Manufacturing COMMERCIAL
Commercial Services — Growing

Clinical Program Details

1. PROVENGE® (sipuleucel-T) — Approved 2010

  • Indication: Metastatic castration-resistant prostate cancer (mCRPC)
  • Mechanism: Autologous dendritic cell immunotherapy; personalized ex vivo cell manipulation
  • Regulatory Status: FDA approved March 29, 2010 (first FDA-approved autologous cellular immunotherapy)
  • Clinical Efficacy: IMPACT trial (Phase 3, n=512) demonstrated 4.1-month median overall survival (OS) benefit, HR 0.78 (p=0.021)
  • Current Indication: NCCN Category 1 for asymptomatic or minimally symptomatic mCRPC

2. PROVENGE Combination Studies — Phase 2

  • Study Design: Evaluate concurrent vs. sequential PROVENGE dosing with abiraterone acetate + prednisone
  • Rationale: Explore synergy between immunotherapy and endocrine therapy
  • Status: Active recruitment; results expected 2026–2027
  • Clinical Significance: Potential label expansion to combination therapy positioning

3. TRPM8 Small Molecule Inhibitor — Preclinical

  • Target: TRPM8 ion channel (transient receptor potential melastatin 8)
  • Indication(s): Preclinical evaluation for multiple cancer types
  • Status: Early-stage preclinical development; no near-term clinical trials announced
  • Strategic Role: Diversification beyond cellular immunotherapy; potential synergy with dendreon manufacturing platform

4. CDMO Platform — Commercial

  • Service Offering: Contract development and manufacturing for cell therapies (autologous and allogeneic)
  • Facilities: 3 FDA-approved manufacturing sites with GMP capability
  • Current Partnerships: Shoreline Bioscience (cell therapy manufacturing)
  • Growth Trajectory: Rapid expansion phase; manufacturing capability expansion hiring ongoing
  • Market Opportunity: Cell therapy manufacturing capacity shortage in industry = strong CDMO demand

Registry & Real-World Evidence Studies

  • PROCEED Registry (NCT01306890): Multicenter, open-label, ongoing real-world safety and survival data collection for PROVENGE patients
  • Immune Boost Study: Open-label evaluation of single booster PROVENGE infusion after initial treatment cycle
  • Active Surveillance Study: PROVENGE in lower-risk non-metastatic prostate cancer (nmCRPC) — exploratory indication expansion
  • 2020 Real-World Evidence: Adding PROVENGE to treatment regimen prolonged median survival by 14.5 months vs. standard care

8. Clinical Development Status & Supporting Evidence

Pivotal Clinical Trial — IMPACT

Parameter Details
Trial Name IMPACT (Immunotherapy for Metastatic Prostate Cancer)
Study ID NCT00065442
Phase Phase 3 Pivotal
Enrollment 512 patients with asymptomatic or minimally symptomatic mCRPC
Design Randomized, double-blind, placebo-controlled
Primary Outcome Overall Survival (OS) — median OS benefit of 4.1 months
Hazard Ratio HR 0.78 (95% CI 0.61–0.98, p=0.021) — statistically significant
Publication NEJM (New England Journal of Medicine) — high-impact, widely cited
FDA Approval March 29, 2010 based on IMPACT data
Clinical Significance First FDA-approved autologous cellular immunotherapy; established precedent for cell-based cancer treatments

Real-World Evidence & Registry Data

PROCEED Registry (Post-Approval Registry)

Purpose: Ongoing collection of real-world safety, efficacy, and quality-of-life data from PROVENGE-treated patients

Design: Multicenter, open-label observational study

Current Status: Actively enrolling; 15+ years of follow-up data available

Clinical Value: Demonstrates sustained safety profile and supports long-term OS claims beyond controlled trial settings

2020 Real-World Data Analysis

A retrospective analysis of real-world treatment patterns found that adding PROVENGE to the treatment regimen prolonged median survival by 14.5 months compared to standard care alone. This study further supports PROVENGE's clinical value proposition and potential for therapeutic synergy with other mCRPC treatments.

Exploratory & Ongoing Studies

  • Immune Boost Study: Open-label evaluation of a single booster PROVENGE infusion administered after initial treatment regimen completion. Purpose: assess feasibility and safety of rechallenge in patient subpopulations.
  • Active Surveillance (Non-Metastatic mCRPC): Exploratory study evaluating PROVENGE utility in earlier disease stage (non-metastatic) prostate cancer with rising PSA. Strategic goal: indication expansion beyond current mCRPC label.
  • Combination Therapy Studies: Phase 2 evaluation of concurrent and sequential PROVENGE dosing with abiraterone acetate + prednisone. Rationale: optimize immunotherapy/endocrine therapy synergy.

Clinical Evidence Summary

✅ Strong Clinical Foundation

Strengths: NEJM publication, 15+ years post-approval evidence, Phase 3 pivotal data, NCCN Category 1 recommendation, real-world safety registry, potential combination study data (2026–2027)

Strategic Opportunity: Combination therapy data and early-stage indication expansion studies create ongoing clinical support opportunities for KOL engagement, Congress presentations, and medical education programming

Agency Impact: Clinical evidence is mature and well-established; future support should focus on communicating emerging combination data and exploratory indications (non-metastatic mCRPC)

9. Commercialization Readiness (Lifecycle Management Assessment)

Assessment Framework

For a 15-year commercial product (launched 2010), commercialization readiness focuses on lifecycle management, not market entry. This assessment evaluates Dendreon's capability to sustain, defend, and expand PROVENGE's market position against competitive threats and aging market perceptions.

🏭 Treatment Infrastructure & Manufacturing 5/5
5/5 Excellent
Assessment: 3 FDA-approved manufacturing facilities (Seal Beach CA, Union City GA, Seattle WA); established leukapheresis network nationwide; proven 15+ year supply chain. Manufacturing infrastructure is NOT a bottleneck. Opportunity: CDMO business demonstrates excess capacity available for commercial leverage.
🏥 Patient Pathway & Care Coordination 4/5
4/5 Strong
Assessment: Well-established patient ordering, HCP training, and logistics through ~15-year track record. Care coordination pathway is robust and mature. AGING RISK: Legacy systems and processes may feel antiquated vs. next-gen cell therapies (e.g., Novartis Pluvicto digital patient tools). Modernization opportunity: streamlined digital patient portal, telemedicine integration, simplified leukapheresis scheduling.
💼 Market Access & Formulary Positioning 3/5
3/5 Moderate
Assessment: Medicare coverage established; PROvide copay assistance program functional; ~$93K treatment cost bundled under established codes. THREAT LEVEL — HIGH: Pluvicto label expansion (March 2025) into chemo-naïve mCRPC creates direct formulary competition. Risk: payers may tier PROVENGE vs. oral competitors (Xtandi, Erleada, Nubeqa) due to cost and convenience factors. Agency support needed: Competitive market access defense strategy, payer health economics communication, formulary tier optimization.
🤝 Patient Support Services 4/5
4/5 Strong
Assessment: PROvide copay assistance program; patient navigator services; DTC campaign featuring Grant Hill (high-visibility athlete endorsement). Patient support ecosystem is mature and multi-channel. Opportunity: Digital patient engagement tools (app-based symptom tracking, treatment reminder, community forums) lag behind competitors.
🚚 Distribution & Logistics 5/5
5/5 Excellent
Assessment: Unique autologous cell therapy model with established leukapheresis → manufacturing → reinfusion pipeline. 3 IMF (Isolated Manufacturing Facility) sites provide redundancy and geographic coverage. Logistics chain is mission-critical and well-established. No distribution risks identified.

Lifecycle Management Roadmap

Current Stage: Mid-Lifecycle Maturity (Year 15)

PROVENGE is at peak maturity with established clinical evidence, commercial infrastructure, and payer relationships. However, competitive pressure is intensifying, and digital/patient experience modernization is critical to sustain market leadership.

Key Lifecycle Risks & Mitigation

Risk Factor Severity Mitigation Strategy Agency Role
Competitive Label Expansion (Pluvicto chemo-naïve) HIGH Differentiation strategy; formulary tier defense; positioning as combination therapy option Competitive intelligence; payer engagement; Congress support
Aging Brand Perception (15-year product) MEDIUM Modern messaging; HCP education on combination therapy potential; DTC refresh with contemporary positioning Brand strategy; KOL engagement; Marketing refresh
Digital/Patient Experience Gap MEDIUM HCP portal launch; patient app development; telemedicine integration; digital patient engagement Digital platform development; HCP portal marketing
Market Access Pressure (cost/payer scrutiny) MEDIUM Health economics data; real-world evidence communication; cost-effectiveness positioning Payer health economics support; RWE communication
KOL Retention/Poaching MEDIUM Enhanced KOL engagement; exclusive advisory board roles; ongoing education funding KOL program enhancement; Advisory board expansion

10. Market & Competitive Landscape

mCRPC Market Overview

Global Market Size $10–16B annually
U.S. Patient Population ~51,100 diagnosed with mCRPC annually
Market Growth CAGR ~4–6% (2024–2030)
Treatment Paradigm Multi-drug sequential/combination therapy standard of care
Key Competitive Drivers Efficacy, convenience (oral vs. infusion), safety, cost, real-world outcomes

Competitive Landscape — Direct Competitors in mCRPC

Drug Company Drug Class Approval Year Est. Price/Course Key Differentiator Threat Level
PROVENGE® Dendreon Cellular Immunotherapy 2010 ~$93K First FDA-approved autologous CT; unique OS benefit; personalized approach Reference
Xtandi
(enzalutamide)		 Pfizer / Astellas AR Inhibitor 2012 ~$156K/yr Oral; broad label in CRPC spectrum; dominant market share; mature data HIGH
Zytiga
(abiraterone)		 J&J CYP17 Inhibitor 2011 ~$96K/yr Oral; well-established; generic availability emerging; cost-effective MEDIUM
Erleada
(apalutamide)		 J&J AR Inhibitor 2018 ~$168K/yr Oral; strong nmCRPC label; growing share in chemo-naive space HIGH
Nubeqa
(darolutamide)		 Bayer AR Inhibitor 2019 ~$132K/yr Oral; favorable tolerability profile vs. Xtandi; growing adoption MEDIUM
Pluvicto®
(Lu-177 PSMA)		 Novartis Radioligand Therapy 2022 (approx) ~$42K/dose ⚠️ MARCH 2025: Label EXPANDED to chemo-naïve mCRPC — Novel mechanism; cost advantage; patient convenience 🔴 CRITICAL
Xofigo®
(radium-223)		 Bayer Alpha Emitter 2013 ~$70K Bone-targeting; established in symptomatic mCRPC; older mechanism LOW

🔴 CRITICAL COMPETITIVE THREAT: PLUVICTO LABEL EXPANSION (March 2025)

Novartis's Pluvicto (Lu-177 PSMA) received an expanded FDA label in March 2025 to include chemo-naïve metastatic castration-resistant prostate cancer (mCRPC). This is a direct competitive threat to PROVENGE's market positioning:

  • Mechanism Differentiation Loss: Pluvicto is now FDA-approved for the same early-disease population as PROVENGE (chemo-naïve mCRPC)
  • Convenience Advantage: Pluvicto is administered as infusions; patient convenience vs. PROVENGE's more intensive leukapheresis requirement
  • Cost Advantage: Pluvicto estimated at ~$42K per dose (~4 doses); lower than PROVENGE's ~$93K per treatment
  • Formulary Risk: Payers may prefer Pluvicto or oral competitors (Xtandi, Erleada) for cost and convenience reasons
  • KOL Migration Risk: Novartis aggressive KOL engagement and speaker support may recruit PROVENGE opinion leaders

Agency Response Required: Develop competitive differentiation strategy, payer market access defense, KOL retention program, positioning PROVENGE as combination therapy option vs. monotherapy sequencing.

Market Positioning Strategy

PROVENGE's Current Competitive Positioning

  • Clinical Advantage: Established NEJM data; longest follow-up evidence (15 years); personalized/immunotherapy approach
  • Mechanism Uniqueness: Only autologous cellular immunotherapy in mCRPC space (though Pluvicto now in same disease stage)
  • Market Share: Estimated ~5–8% of mCRPC treatment market (modest share vs. Xtandi dominance at ~30–40%)
  • Ideal Patient Profile: Asymptomatic/minimally symptomatic mCRPC; younger, higher-functioning patients; those seeking personalized/immunotherapy approach
  • Vulnerability: Convenience (multi-week leukapheresis process) vs. oral competitors; aging brand perception (15-year product)

Payer Landscape & Access Issues

  • Medicare: Coverage confirmed under existing CPT codes; no prior authorization barriers currently
  • Commercial Payers: Variable formulary positions; some tier PROVENGE as specialty tier or require prior auth; cost scrutiny ongoing
  • PROvide Copay Assistance: Dendreon's copay program covers out-of-pocket costs up to eligibility thresholds
  • Prior Auth/Formulary Trends: Increasing payer preference for oral agents (Xtandi, Erleada, Nubeqa) due to cost and patient convenience
  • Pluvicto Impact (Post-March 2025): Expected to increase formulary competition; some payers may tier PROVENGE less favorably vs. radioligand therapy as lower cost alternative

11. KOL Landscape & Engagement Ecosystem

KOL Segmentation Strategy

Prostate cancer KOLs span two primary specialties: urology and medical oncology. PROVENGE engagement strategy must address both, as patient treatment decisions often involve cross-specialty consultation. KOLs are segmented by geographic reach, institutional affiliation, and research/clinical focus.

Tier 1: National/Global Leaders (Highest Influence)

KOL Name Institution Specialty Key Focus Influence Area
Dr. Tomasz Beer Oregon Health & Science Univ (OHSU) Medical Oncology mCRPC; immunotherapy combinations National KOL; ASCO, ESMO speaker; clinical trial PI
Dr. Andrew Armstrong Duke University Medical Oncology mCRPC; biomarkers; treatment sequencing Leading clinical researcher; health economics expert; guideline author
Dr. Daniel Petrylak Yale University Medical Oncology Prostate cancer; combination therapies; clinical trials Senior opinion leader; ASCO/ESMO committee member
Dr. David Crawford University of Colorado Urology mCRPC; prostate cancer epidemiology Urology community leader; guideline influence

Tier 2: Regional Leaders (Strong Regional Influence)

  • Dr. Saby George (Roswell Park Comprehensive Cancer Center) — Medical Oncology
  • Dr. Neha Vapiwala (University of Pennsylvania) — Radiation Oncology
  • Dr. Michael Zelefsky (Memorial Sloan Kettering) — Radiation Oncology
  • Dr. Matthew Cooperberg (UCSF) — Urology; health economics focus
  • Dr. Christopher Evans (Stanford) — Medical Oncology; combination therapy research

Tier 3: Community KOLs (High-Volume Prescribers)

Regional high-volume prescribers of mCRPC treatments within community urology and oncology practices. These physicians directly influence patient treatment decisions and are critical to PROVENGE adoption. Estimated 200–300 community KOLs in U.S. across major metro areas.

Cross-Specialty Engagement Challenge

⚠️ Dual-Specialty Engagement Required

Prostate cancer treatment involves both urologists and medical oncologists. Patient pathways may originate in urology (initial diagnosis/prostatectomy) or medical oncology (metastatic disease management). PROVENGE KOL programs must engage BOTH specialties equally to maximize prescriber reach and avoid engagement gaps.

Competitive KOL Threats

KOL Poaching Risk (Post-Pluvicto Expansion)

Novartis, Pfizer, and Bayer are all actively recruiting mCRPC KOLs with speaker programs, advisory boards, and research support. Key threats:

  • Novartis (Pluvicto): Aggressive new-indication speaker program rollout; radioligand therapy education focus; targeting Tier 1 & 2 oncologists
  • Pfizer (Xtandi): Mature speaker program with competitive compensation; dominant market share provides leverage
  • Bayer (Nubeqa): Growing speaker program; tolerability positioning attractive to community practitioners
  • J&J (Erleada): Strong Tier 1/2 academic medical center relationships; health economics research partnerships

Current Agency-Managed KOL Program Status

The Agency currently manages KOL Management services for PROVENGE including speaker recruitment, advisory board management, and honoraria distribution. Key insights:

  • Program Maturity: Established with proven track record; active speakers and advisors engaged
  • Recruitment Pressure: Competitive poaching from Pluvicto/Xtandi programs increasing; retention focus critical
  • Expansion Opportunity: Enhanced KOL programs for emerging PROVENGE combination therapy data (Phase 2 abiraterone studies); speakers needed for ASCO 2026+ presentations
  • Digital Gap: No formalized HCP portal/learning platform for KOL-exclusive content; competitors have advantage in content distribution

KOL Program Recommendations

Initiative Focus Expected Impact Timeline
KOL Retention Program Enhanced speaker honoraria; advisory board expansion; research support Reduce competitive poaching; strengthen brand advocacy Q1 2026 (immediate)
Combination Therapy Speaker Track New speakers for abiraterone combination data; clinical trial investigator support Position PROVENGE as combination option; ASCO 2026+ presentations Q2 2026
Community KOL Expansion Geographic targeting (Southeast, Midwest); high-volume prescriber engagement Expand reach beyond Tier 1/2; drive prescriber adoption Q2 2026
Dual-Specialty Engagement Balance Ensure urology KOL representation equal to oncology; urology-focused advisory boards Strengthen urology community relationships; cross-specialty referral support Q2 2026

12. Internal Capability Assessment & Agency Expansion Signals

Dendreon's Current Organizational Capacity

Based on analysis of Dendreon's current job postings, hiring initiatives, and organizational structure, the company is in an active investment and expansion phase. This creates both opportunities and signals about internal capability gaps.

Key Hiring Initiatives & Expansion Signals

Hiring Area Position/Role Implication Agency Opportunity
Commercial Leadership SVP Commercial & Marketing — VACANT (HIGH PRIORITY) Leadership gap indicates strategic transition or expansion phase; incoming exec may reshape commercial/marketing strategy HIGH: Influence incoming leader's strategy; present Agency capabilities during onboarding; capture expanded scope
Medical Education Medical Science Liaisons (MSLs) — Southeast Regional Hiring Field expansion signal; internal capability building in medical education/HCP outreach MEDIUM: Collaborate on MSL training; position Agency as Med Ed platform partner; avoid service overlap
Manufacturing Operations Operations roles (Union City GA manufacturing facility) CDMO business expansion underway; capacity investment signals growth confidence HIGH: Pitch CDMO marketing services (not yet Agency-engaged); manufacturing success requires customer/partner marketing
Training & Capability Sr Manager Training & Development Internal L&D program maturation; capability building in workforce training LOW-MEDIUM: Potential training services overlap; assess complementarity vs. competition
Sales Growth Account Manager roles (NY, LA markets) PROVENGE sales force geographic expansion/coverage increase MEDIUM: Sales force training/speaker support; regional market presence in key account manager locations

Internal Capability Gaps & Agency Opportunities

1. SVP Commercial & Marketing Vacancy — Leadership Gap

⚠️ CRITICAL SIGNAL: The open SVP Commercial & Marketing position is a major leadership gap in Dendreon's commercial organization. This vacancy likely indicates strategic transition (incoming executive may reshape commercial approach) or rapid growth requiring expanded leadership. Agency Recommendation: Prepare brief capabilities summary for incoming SVP; this leader will influence Agency scope and partnership strategy.

2. MSL Hiring (Southeast Regional Expansion)

  • Signal: Dendreon is building internal medical education and HCP engagement capability
  • Agency Opportunity: Avoid direct service overlap on MSL functions; instead position Agency as HCP platform/digital education partner to extend MSL reach. Medical Affairs should focus on clinical content; Agency can handle digital delivery, HCP portal development, educational technology.
  • Recommendation: Discuss regional MSL expansion with Dendreon; offer Agency support on physician engagement platform / digital medical education to complement MSL field work.

3. CDMO Business Expansion (Manufacturing Investment)

  • Signal: Manufacturing capacity expansion at Union City GA indicates confidence in CDMO business scaling
  • Current Gap: NO Agency marketing support for CDMO services (complete portfolio gap)
  • Agency Opportunity (HIGH PRIORITY): $400–600K/yr revenue opportunity:
    • CDMO customer marketing (biotech/pharma partners)
    • Industry conference presence/speaker support
    • Case study development (Shoreline partnership, customer testimonials)
    • Manufacturing capability communications
    • Business development marketing support
  • Timeline: Q2 2026 launch recommended

4. Sales Force Expansion (Account Manager Roles)

  • Signal: NY and LA account manager hiring indicates geographic market expansion/coverage increase for PROVENGE
  • Agency Opportunity: Sales force enablement, speaker program support in expanded markets, regional medical education coordination
  • Timeline: Ongoing; align with sales force onboarding calendar

Organizational Capacity Assessment Summary

✅ Current Capabilities (Internal):

  • Medical Affairs team (CME grants, IITs, clinical support)
  • MSL team (field expansion phase) — healthcare provider engagement
  • Manufacturing operations (3 FDA facilities, CDMO partnerships)
  • Patient support services (PROvide program)
  • DTC marketing (Grant Hill campaign)

❌ Gaps Identified (Expansion Opportunities):

  • Commercial/Marketing leadership (SVP role vacant) — strategy unclear
  • HCP Digital Platform (no portal, limited HCP engagement tools)
  • Medical Education Program (no formal Agency-managed structure)
  • CDMO Marketing (complete gap for second revenue pillar)
  • Competitive Intelligence/Market Access Defense (limited resources)

→ Agency Recommendation: Dendreon is hiring to fill gaps and expand capability. This creates window of opportunity to pitch integrated Agency solutions across 4 key areas (digital, med ed, CDMO, competitive defense). Incoming SVP Commercial will have significant influence; timing is critical for new business capture.

Recommended Agency Engagement Timeline

Quarter Action Target Contact Opportunity Size
Q1 2026 (NOW) Competitive intelligence brief; Pluvicto threat positioning; market access defense strategy CMO, CMO, SVP Commercial (pending hire) $250–500K/yr
Q2 2026 HCP Digital Platform RFP; Medical Education program design; CDMO marketing pitch Incoming SVP Commercial; Chief Medical Officer $700K–1.2M/yr
Q3 2026 Contract negotiation; project kickoffs; MSL collaboration framework SVP Commercial; Dendreon operations team Ongoing expansion
Q4 2026 Program execution; measurement/ROI reporting; renewal/expansion planning SVP Commercial; ongoing partnership Contract management

13. Client Relationship Value Map

Current Service Footprint: PROVENGE / mCRPC

Dendreon's PROVENGE business is supported across three core Agency service areas, but significant white space exists across the remaining service portfolio. The following table maps current service coverage against total available service areas:

Product Service Area Status Scope Details
PROVENGE / mCRPC Speaker Programs & P2P ✅ Active Speaker bureau management, peer-to-peer education programs
KOL Management ✅ Active KOL identification, tiering, advisory board management
Marketing Communications ✅ Active Brand messaging, competitive positioning materials
Medical Education ❌ Not Engaged Gap: No formal MSL training or CME strategy support
Value & Access ❌ Not Engaged Gap: No payer strategy or HEOR support
Congress & Events ❌ Not Engaged Gap: No ASCO/AUA/GU ASCO strategy support
Digital & Innovation ❌ Not Engaged Gap: No HCP portal, omnichannel strategy
CDMO Services All Services ❌ Not Engaged Gap: Entire CDMO business line unsupported

White Space Summary

Service Areas NOT Covered

4 of 7 service areas for PROVENGE

New Business Line Unsupported

CDMO business = entirely new engagement stream

Estimated Expansion

$1.2M–2.0M annually

Strategic Implication

Every ❌ cell represents revenue the Agency is leaving on the table

14. Pipeline Bridge Strategy

Leveraging PROVENGE Infrastructure to Support CDMO Marketing

The Agency's existing PROVENGE infrastructure is not a barrier to CDMO engagement—it's a bridge. Dendreon's PROVENGE success demonstrates operational excellence in cell therapy manufacturing, regulatory navigation, and commercialization. This expertise IS the CDMO pitch.

KOL Overlap: The Cell Therapy Expert Network

PROVENGE KOLs include academic cell therapy experts who regularly speak at industry conferences. These same individuals serve on advisory boards for CDMO industry events, manufacturing summits, and biotech partner forums. Agency speaker management infrastructure can be extended, not duplicated, to serve CDMO marketing.

Infrastructure Reuse: Avoiding Startup Costs

  • Speaker Management Platform: Database, compliance systems, scheduling tools already exist
  • HCP/Industry Database: Cell therapy KOL network transfers seamlessly to CDMO partner community
  • Compliance & Regulatory: PROVENGE pharma compliance framework adapts to B2B CDMO marketing
  • Reporting & Analytics: Agency reporting templates reusable across both portfolios

Manufacturing Success = CDMO Sales Pitch

Dendreon's PROVENGE manufacturing story—regulatory milestones, quality metrics, capacity expansion—IS the case study content that wins CDMO customers. Agency can develop case study materials, white papers, and success stories showcasing Dendreon's operational excellence.

Estimated Infrastructure Savings

$75K–125K in avoided startup costs by leveraging existing PROVENGE infrastructure for CDMO marketing launch. New CDMO program leverages 60–70% of existing Agency capabilities.

15. Proactive Opportunity Alerts

Six Key Opportunities for Agency Engagement

The following alerts represent immediate, medium-term, and strategic opportunities for Agency revenue expansion. Priorities are ranked by urgency and revenue impact.

🔴 URGENT — Pluvicto Competitive Threat

Threat: Novartis received FDA label expansion for Pluvicto (lutetium Lu-177 PSMA) in March 2025 for chemo-naïve mCRPC—directly overlapping PROVENGE's positioning. Pluvicto's Phase 3 PSMAfore trial showed 59% reduction in radiographic progression risk and doubled median PFS to 11.6 months. Novartis is investing heavily in speaker programs and KOL engagement.

Impact: PROVENGE requires immediate competitive defense response. Without strategic counter-positioning, Novartis will capture significant KOL mindshare and HCP awareness within 12–18 months.

Agency Action: Expand speaker bureau with competitive messaging, develop head-to-head clinical differentiation content

Revenue Opportunity: $300K–500K competitive defense campaign

Deadline: Immediate—Novartis is actively building share of voice

🔴 URGENT — SVP Commercial Vacancy

Opportunity: Dendreon is actively recruiting for SVP of Commercial and Marketing, reporting directly to CEO. This leadership transition creates a 60–90 day window to position Agency recommendations with the incoming executive.

Agency Action: Prepare comprehensive capabilities presentation for new SVP; schedule onboarding meeting to introduce expanded service portfolio

Revenue Opportunity: New SVP may expand agency scope; $200K–400K in additional services likely

Deadline: 30–60 days (before new hire sets vendor strategy)

🟡 PLANNING — ASCO 2025 Congress Strategy

Observation: Dendreon attending ASCO 2025 as exhibitor. Agency currently does NOT support congress strategy. This is a missed opportunity to demonstrate value and competitive presence.

Agency Action: Propose ASCO congress strategy and booth support package; develop multi-congress annual strategy

Revenue Opportunity: $80K–150K per major congress

Deadline: March 2026 (for ASCO 2026 planning)

🟡 PLANNING — CDMO Business Growth

Signal: Dendreon's CDMO division partnership with Shoreline Biosciences signals expansion. CDMO marketing, business development content, and industry presence are not currently Agency-supported.

Agency Action: Propose CDMO marketing communications and conference presence strategy; develop case study program

Revenue Opportunity: $200K–400K initial engagement

Deadline: Q3 2026 (as CDMO pipeline grows)

🟢 STRATEGIC — Grant Hill Campaign Refresh

Observation: The "Start Strong" campaign with NBA All-Star Grant Hill launched in 2021. Five years on, the campaign may benefit from refresh to maintain relevance and audience engagement.

Agency Action: Propose campaign evaluation and refresh strategy; update creative assets and messaging

Revenue Opportunity: $150K–250K campaign refresh

Deadline: H1 2027

🟢 STRATEGIC — TRPM8 Pipeline Monitoring

Development: Dendreon's preclinical TRPM8 small molecule oral compound could become a second therapeutic product. Too early for most services, but KOL mapping in target indications should begin 18–24 months before Phase 2.

Agency Action: Monitor development; propose KOL landscape assessment when Phase 1 initiates

Revenue Opportunity: $50K–100K near-term; $500K+ if progresses to Phase 3

Timeline: Monitor for Phase 1 initiation signal

16. Competitive Threat Monitoring Dashboard

PROVENGE Competitive Landscape: Threat Assessment

PROVENGE faces a multifaceted competitive landscape. The following dashboard tracks severity, market impact, and recommended Agency response for each threat category.

Threat Type Severity Details Agency Response
Pluvicto Label Expansion 🔴 HIGH March 2025 FDA expansion to chemo-naïve mCRPC; Novartis investing heavily in commercial Develop competitive defense messaging; expand speaker content; KOL engagement intensification
AR Inhibitor Dominance 🟡 MEDIUM Xtandi, Zytiga, Erleada, Nubeqa dominate mCRPC prescribing; PROVENGE positioned as complementary Reinforce PROVENGE OS benefit + sequencing data; develop physician education on combination therapy
Pipeline Vaccine Competition 🟢 LOW Prostvac, VTP-850, CAN-2409 all in trials; none near approval Monitor; no immediate action required
KOL Poaching Risk 🟡 MEDIUM Novartis and Pfizer actively recruiting prostate cancer KOLs for speaker programs Strengthen speaker engagement; improve retention programs; increase KOL event participation
Digital SOV Erosion 🟡 MEDIUM Competitor HCP portals more sophisticated; Dendreon digital presence weak (CRAM 2/5) Propose HCP digital platform for PROVENGE; develop omnichannel engagement strategy
Reimbursement Pressure 🟡 MEDIUM ~$93K cost under ongoing scrutiny; Pluvicto may offer cost-per-QALY advantage Develop HEOR evidence; support payer engagement strategy; build cost-effectiveness narrative

17. Contract Renewal Intelligence

Renewal Timeline & Strategic Positioning

The current Agency contract is 12+ months from renewal. Now is the optimal time to build the expansion case, demonstrate incremental value, and position the Agency for significant scope expansion.

Value Demonstration: Current Services Performance

Before building the renewal case, Agency should establish baseline metrics for each service area:

Speaker Programs

  • Programs delivered (YTD vs. plan)
  • HCPs reached and engagement depth
  • Speaker retention and satisfaction
  • Competitive positioning messaging penetration

KOL Management

  • Advisory boards conducted and attendance
  • KOL engagement depth and activity
  • Conference activations and speaking placements
  • KOL sentiment and advocacy tracking

Marketing Communications

  • Content deliverables (case studies, competitive materials, brand assets)
  • Competitive positioning materials adoption rate
  • Campaign performance (awareness lift, HCP engagement)

Expansion Pitch Strategy: Three-Tier Approach

The Agency should present renewal as a strategic opportunity to expand scope across three tiers, each representing incremental value:

Tier 1: Natural Extension (Highest Probability, $400K–650K)

Add Congress Strategy + Medical Education for PROVENGE (competitive defense package)

  • ASCO, GU ASCO, AUA, ESMO annual congress strategy
  • MSL training and sales force readiness for competitive defense
  • CME strategy support and grant management
  • Directly addresses Pluvicto competitive threat

Tier 2: Service Deepening ($350K–550K)

Add Value & Access + Digital & Innovation for PROVENGE (lifecycle management)

  • Payer engagement strategy and HEOR evidence program
  • HCP digital portal development and omnichannel engagement
  • Reimbursement defense strategy
  • Digital speaker program platform

Tier 3: New Business Line ($200K–400K)

CDMO Marketing Communications and Conference Presence

  • CDMO marketing communications strategy
  • Case study and manufacturing success story development
  • Industry conference presence and KOL speaker placements
  • Business development marketing support

Renewal Target

Current Contract + $950K–1.6M Expansion = 2–3x Growth

Tier 1 + Tier 2 + Tier 3 expansion offers significant revenue opportunity while positioning Agency as indispensable partner across PROVENGE lifecycle and new CDMO business.

18. Relationship Health Indicators

Company-Level Health Assessment

Indicator Status Evidence
Pipeline Health 🟢 POSITIVE PROVENGE stable; CDMO growing; TRPM8 preclinical advancing
Financial Stability 🟢 POSITIVE Profitable since 2016; CDMO investment signals confidence; manufacturing expansion
Leadership Stability 🟡 WATCH SVP Commercial vacancy; CEO transition history suggests high turnover risk
Budget Outlook 🟢 POSITIVE CDMO growth + competitive defense spending likely to increase marketing investment
Competitive Pressure 🔴 ELEVATED Pluvicto label expansion; AR inhibitor dominance; KOL poaching risk
Agency Satisfaction ❓ ASSESS Recommend formal satisfaction survey with key contacts to establish baseline

Product-Level Health Assessment

Product Clinical Commercial Agency Coverage Competitive Overall Status
PROVENGE/mCRPC 🟢 Stable 🟢 Active 🟡 Partial (3/7 services) 🔴 Pressured (Pluvicto) 🟡 AT RISK
CDMO Services 🟢 Growing 🟡 Early 🔴 None 🟢 Low threat 🟡 OPPORTUNITY
TRPM8 🟡 Preclinical 🔴 N/A 🔴 None 🟢 Too early 🟢 MONITOR

19. Agency Service Opportunity Map

Seven Service Areas: Expansion Rating & Investment

For each service area, the following assessment provides expansion rating, evidence, Agency benchmark insights, and recommended investment. Services are ordered by priority and revenue impact.

1. Speaker Programs & P2P → EXPAND (Currently Active)

Rating: HIGH

Scoring: Base Need (Commercial product) = 4 | Competitive Intensity (+1, Pluvicto) = 5 | Internal Gap (-0, Agency managing) = 5 | FINAL = HIGH

Evidence: Pluvicto March 2025 label expansion creates urgent competitive defense need; current speaker bureau needs content refresh for competitive messaging; ~51,100 mCRPC patients annually = large target HCP universe

Agency Benchmark: "Post-launch competitive defense speaker programs typically require 40–60% content refresh and 20–30% speaker cohort expansion. Budget: $280K–420K annually for lifecycle management."

Opportunity: Expand speaker bureau by 20–30%, develop competitive differentiation content (PROVENGE OS benefit vs. Pluvicto PFS), add geographic coverage

Timing: Immediate (Pluvicto already in market)

Investment: $280K–420K/year (expansion of existing program)

2. KOL Management → EXPAND

Rating: HIGH

Scoring: Base Need = 4 | TA Complexity (+1) = 5 | Competitive KOL poaching = 5 | FINAL = HIGH

Evidence: Novartis/Pfizer actively recruiting prostate cancer KOLs; need to deepen advisory engagement; competitive positioning requires KOL validation

Agency Benchmark: "Competitive defense KOL programs require 2–3 additional advisory boards per year focused on differentiation messaging. Budget: $150K–250K annually."

Opportunity: Add competitive-focused advisory boards, expand KOL tiering for CDMO thought leaders, strengthen speaker retention

Timing: Q2 2026 (ahead of Pluvicto market penetration growth)

Investment: $150K–250K/year

3. Marketing Communications → EXPAND

Rating: HIGH

Scoring: Base Need = 5 | Competitive Intensity = 5 | Content Age = 5 | FINAL = HIGH

Evidence: Grant Hill campaign from 2021 needs refresh; Pluvicto competitive threat requires new differentiation messaging; CDMO business needs its own marketing materials

Agency Benchmark: "Competitive differentiation campaigns in crowded therapeutic areas require $600K–850K investment. For lifecycle brands: $250K–400K refresh cycle."

Opportunity: PROVENGE competitive positioning refresh; CDMO marketing launch; Grant Hill campaign evolution

Timing: Q2–Q3 2026

Investment: $350K–550K/year

4. Medical Education & Training → NEW

Rating: HIGH

Scoring: Base Need = 4 | MSL Team Growing (+1) = 5 | Internal Gap = 5 | FINAL = HIGH

Evidence: MSL hiring (Southeast region); Sr Manager Training role open; Medical Affairs supports CME grants but no formal Agency partnership for training design/delivery

Agency Benchmark: "MSL training programs for commercial oncology products: $150K–220K annually. Sales force readiness training: $280K–400K for major competitive events."

Opportunity: MSL training program design, sales force competitive readiness training, CME strategy development

Timing: Q3 2026 (aligned with MSL hiring timeline)

Investment: $200K–350K/year

5. Value & Access → NEW

Rating: MEDIUM–HIGH

Scoring: Base Need = 3 | Reimbursement Pressure (+1) = 4 | Pluvicto Price Competition (+1) = 5 | Internal = 4 | FINAL = MEDIUM–HIGH

Evidence: PROVENGE ~$93K cost under scrutiny; Pluvicto may offer cost-per-QALY advantage; PROvide copay program exists but HEOR evidence gaps remain

Agency Benchmark: "Payer defense strategy for established brands facing new competition: $180K–280K project-based. HEOR evidence generation: $250K–450K over 2–3 years."

Opportunity: Payer engagement strategy, HEOR real-world evidence program, cost-effectiveness narrative development

Timing: Q1–Q2 2027 (as Pluvicto market share data becomes available)

Investment: $180K–280K project

6. Congress & Event Strategy → NEW

Rating: HIGH

Scoring: Base Need = 5 | Conference Activity (+1) = 5 | Competitive Presence = 5 | FINAL = HIGH

Evidence: Dendreon attending ASCO 2025 as exhibitor but Agency NOT supporting congress strategy; competitors have significant congress presence; GU ASCO, AUA, ASCO are key conferences

Agency Benchmark: "Multi-congress annual strategy for commercial oncology: $300K–500K. Per-congress strategy: $80K–150K."

Opportunity: Develop annual congress strategy (ASCO, GU ASCO, AUA, ESMO), satellite symposia, booth strategy, KOL speaking placements, CDMO conference presence

Timing: Immediate (plan for ASCO 2026)

Investment: $250K–400K/year

7. Digital & Innovation → NEW

Rating: HIGH

Scoring: Base Need = 5 | Current Score (2/5 CRAM) = 5 | Competitor Digital = 5 | FINAL = HIGH

Evidence: CRAM Digital score 2/5; basic websites only; no HCP portal; competitors have sophisticated digital platforms; omnichannel engagement gap

Agency Benchmark: "HCP digital engagement platform buildout: $150K–280K Year 1. Omnichannel strategy integration: $100K–200K annually."

Opportunity: Build HCP digital portal, omnichannel engagement strategy, virtual speaker program platform, digital KOL engagement

Timing: Q3–Q4 2026

Investment: $200K–350K/year

Service Opportunity Heatmap

Service Area Need Level Current Status Expansion Rating Investment Range Priority
Speaker Programs High Active HIGH $280K–420K 1 (Immediate)
KOL Management High Active HIGH $150K–250K 2 (Q2 2026)
Marketing Communications High Active HIGH $350K–550K 2 (Q2–Q3 2026)
Medical Education High Not Engaged HIGH $200K–350K 3 (Q3 2026)
Value & Access Medium–High Not Engaged MED-HIGH $180K–280K 4 (Q1–Q2 2027)
Congress & Events High Not Engaged HIGH $250K–400K 1 (Immediate)
Digital & Innovation High Not Engaged HIGH $200K–350K 3 (Q3–Q4 2026)

Service Crosswalk Table: How Recommendations Address Service Gaps

Recommendation Speaker KOL Marketing Med Ed V&A Congress Digital
R1: Pluvicto Defense ✓ ✓ ✓ — — — —
R2: CDMO Marketing — — ✓ — — ✓ ✓
R3: Congress Strategy — ✓ — — — ✓ —
R4: Digital Platform — — — — — — ✓
R5: Med Ed Program — — — ✓ — — —
R6: V&A Defense — — — — ✓ — —
R7: Campaign Refresh — — ✓ — — — ✓

20. Actionable Recommendations (7 Prioritized)

Strategic Recommendations for Agency Revenue Growth

The following seven recommendations are prioritized by urgency, impact, and strategic alignment. Each recommendation is actionable within defined timelines and revenue ranges.

R1: PROVENGE Competitive Defense Campaign (HIGHEST PRIORITY)

WHAT: Launch integrated competitive defense campaign against Pluvicto, including speaker content refresh, competitive messaging development, and expanded speaker deployment

WHY: Pluvicto March 2025 label expansion for chemo-naïve mCRPC directly threatens PROVENGE. Without response, PROVENGE risks significant market share erosion within 12–18 months.

HOW: Agency Competitive Intelligence & Rapid Response framework—competitive speaker analysis, differentiation messaging, speaker cohort expansion

WHEN: Immediate—begin within 30 days; fully deployed within 90 days

IMPACT: Maintain PROVENGE SOV; protect market share; 15–20% of target HCPs exposed to competitive differentiation messaging within 6 months

INVESTMENT: $300K–500K (immediate campaign)

TAGS: 🎤 Speaker Architecture 🏆 Competitive Intelligence 💊 Launch Excellence

R2: CDMO Marketing Communications Launch

WHAT: Develop comprehensive marketing communications program for Dendreon's CDMO business division

WHY: CDMO is Dendreon's second growth pillar but has zero Agency marketing support. First partnership (Shoreline Biosciences) signals scaling.

HOW: Agency Disease Education & Market Shaping framework adapted for B2B CDMO marketing

WHEN: Q3 2026 (aligned with CDMO growth trajectory)

IMPACT: Position Dendreon as top-tier CDMO; support new partnership acquisition

INVESTMENT: $200K–400K initial program

TAGS: 📋 Marketing Communications 🖥️ Digital Engagement

R3: Annual Congress Strategy

WHAT: Design and execute multi-congress annual strategy covering ASCO, GU ASCO, AUA, and ESMO

WHY: Dendreon attends ASCO as exhibitor without Agency support. Competitors have sophisticated congress programs.

HOW: Agency Multi-Congress Annual Strategy framework

WHEN: Begin planning Q2 2026 for ASCO 2026 + GU ASCO 2027

IMPACT: Establish congress presence; KOL speaking placements; satellite symposia

INVESTMENT: $250K–400K/year

TAGS: 🎤 Speaker Architecture 🧬 KOL Intelligence

R4: HCP Digital Engagement Platform

WHAT: Build and deploy PROVENGE HCP digital portal with clinical data, speaker program content, and peer engagement features

WHY: CRAM Digital score 2/5; competitors have sophisticated digital platforms; 40–50% of HCP touchpoints should be digital

HOW: Agency HCP Digital Engagement Platform Strategy framework

WHEN: Build Q3–Q4 2026; launch Q1 2027

IMPACT: 25–30% higher engagement frequency vs. rep-only strategy; measurable HCP digital engagement data

INVESTMENT: $200K–350K buildout + $75K–100K/year maintenance

TAGS: 🖥️ Digital Engagement 📊 Analytics

R5: Medical Education & MSL Training Program

WHAT: Design MSL training program and sales force competitive readiness curriculum for PROVENGE

WHY: Dendreon hiring MSLs (SE region) and Sr Manager Training; Medical Affairs active but no Agency training partnership

HOW: Agency MSL Training Program Design + Sales Force Readiness Training frameworks

WHEN: Q3 2026 (aligned with MSL onboarding)

IMPACT: 40–50% higher MSL effectiveness; 20–30% greater prescriber adoption from trained reps

INVESTMENT: $200K–350K/year

TAGS: 🏥 Medical Education 💊 Launch Excellence

R6: Value & Access Defense Strategy

WHAT: Develop payer defense strategy and HEOR evidence program to protect PROVENGE formulary position against Pluvicto

WHY: Pluvicto may offer cost-per-QALY advantage; PROVENGE ~$93K cost under scrutiny; HEOR evidence gaps exist

HOW: Agency Payer Strategy & Reimbursement Planning + HEOR Study Design frameworks

WHEN: Q1–Q2 2027 (as Pluvicto real-world data matures)

IMPACT: Protect favorable formulary position; develop cost-effectiveness narrative

INVESTMENT: $180K–280K project

TAGS: 📊 Market Access Strategy 🔬 Clinical-Commercial Bridge

R7: Grant Hill Campaign Evolution

WHAT: Evaluate and refresh the "Start Strong" campaign with Grant Hill for 2027

WHY: Campaign launched 2021; 5+ years old; racial disparities in prostate cancer remain critical issue; campaign needs refresh

HOW: Agency competitive differentiation + disease education frameworks

WHEN: Planning H2 2026; launch H1 2027

IMPACT: Refresh awareness campaign; maintain DTC presence; advance health equity positioning

INVESTMENT: $150K–250K campaign refresh

TAGS: 📋 Marketing Communications 🏥 Medical Education

21. Sources & References

Primary Research Sources

The following sources were consulted in preparation of this Active Client Intelligence Report. All data, clinical findings, and market observations are drawn from publicly available sources, industry databases, and regulatory filings.

  1. Dendreon.com corporate website (accessed Feb 2026)
  2. PROVENGE.com product website (accessed Feb 2026)
  3. DendreonMedicalAffairs.com (accessed Feb 2026)
  4. ClinicalTrials.gov—NCT00065442 (IMPACT trial)
  5. ClinicalTrials.gov—NCT01306890 (PROCEED registry)
  6. NEJM 2010; 363:411–22—Sipuleucel-T Immunotherapy for CRPC
  7. NCCN Clinical Practice Guidelines: Prostate Cancer v3.2026
  8. FDA.gov—PROVENGE (sipuleucel-T) Lead Page
  9. Novartis—Pluvicto (Lu-177 PSMA) FDA label expansion March 2025
  10. BioProcess International—"Life beyond Provenge: Dendreon enters CDMO world"
  11. Fierce Pharma—Dendreon cell therapy CDMO pivot
  12. BioSpace—Dendreon Invests in Contract Manufacturing
  13. Tracxn—Dendreon 2025 Company Profile
  14. Drugs.com—Provenge Price Guide
  15. DelveInsight—mCRPC Market Outlook
  16. Coherent Market Insights—CRPC Market Size 2032
  17. Comparably—Dendreon Executive Team
  18. Glassdoor—Dendreon Jobs & Careers
  19. LinkedIn—Dendreon Company Profile
  20. OncLive—Updated NCCN Guidelines for Prostate Cancer