BIO 2014 Business Dev Fundamentals Course_Strategic Alliances_MWYoung 140620
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Strategic alliances have become increasingly important for pharmaceutical and biotech companies to fill pipelines, share risks and costs, and access new capabilities. The document discusses the shift toward more alliances and outsourcing in drug development. It also outlines best practices for forming alliances, including establishing governance committees and project teams to manage the collaboration. The role of alliance management is emphasized to build relationships, align objectives, and ensure alliances achieve their goals.
BIO 2014 Business Dev Fundamentals Course_Strategic Alliances_MWYoung 140620
- 1. Strategic Alliances Michael W. Young biomedwoRx: Life Sciences Consulting
- 2. Partnering in Life Sciences has many variations» Big Pharma Biotech Academia CRO We’re going to discuss issues and methods common to all of these types of collaboration and the role of Alliance Management as a DISCIPLINE in making these partnerships successful…
- 3. Commercialization Shift: Co-Development and Alliance Management • In 1970, 80% of US drug development was done in a FIPCO vertical (in- house). • By 2000, this had dropped to less than 40%. Client companies moving to FIPNET approach (e.g. Lilly) • Estimates are that in 2015, 60% + of the revenue generated by Big Pharma will come from licensed / alliance partner compounds.* • Outsource / Alliance Drivers: – Big Pharma seeking to fill pipelines quickly and with less cost exposure than previously – Availability of nearly ripe biotech fruit (diagnostic, drug, and technology) – Mitigating risk of product failure (shared-risk) *Source: InPharmaTechnologist.com, 02/08
- 4. Commercialization Shift: Co-Development and Alliance Management • Nearly 70% of industry drug entities fail at Phase II despite strong indicators for success. • Alliance development programs, well managed, can reduce the overall failure rate impact and associated costs. • Published data suggests in-licensed compounds / outsourced development have a higher POS in reaching the market than in-house gallenic programs.* • Alliance development, for instance with CROs, in areas outside of the company’s core competencies, allows in- house resources to remain focused. *Nature Reviews Drug Discovery, 06/06
- 5. Pharma / Biotech growth linked to Alliances • Over half of today's top-grossing drug products are the result of partnerships and outsourcing. • Companies across the industry annually spend hundreds of millions of dollars to utilize other firms' discovery, development and marketing capabilities to meet shareholder expectations for growth. • This pressure to maintain strong portfolios underscores the importance of alliance management. • Keen interest in strategic alliances from the Street • Alliance management has become a critical path capability in the deal-making process and assuring profits to a majority of pharma, biotech, and device enterprises.
- 6. Why Partner? • Cash • Development & Commercial Skills • External Validation • Risk Sharing or Increasing Shots on Goal • Technical Skills • Product Candidates • Speed • Innovation But this view oversimplifies some complexities… 6 “Pharma” “Biotech”
- 7. If the Objective is Sharing Risk Or Increasing Shots on Goal • Consider ways to retain economics, while off- loading some costs – Cost and Profit share in compound – Retain certain number of compounds/output resulting from collaboration – Retain certain geographies – Use financing vehicle to fund clinical development – Funding mechanisms from pharma partner 7
- 8. If the Objective is Access to Capabilities/Expertise/Validation • Valuing the partner’s contribution/capabilities – Increased Probabilities of Technical Success? – Shorter time to market? – Broader clinical program, larger number of indications? – Higher peak sales? – Increased valuation of company from “marquee” deal? 8
- 9. Partial Acquisitions Controlling >50% 100% Acquisitions Licensing (Non- Equity) Shared Resources & Competencies Through Collaboration Partial Acquisitions thru Equity <50% Joint Ventures Increasing Partner Commitment Increasing Degree of Integration Corporate Partnerships Traditional M&A Partnerships Come in a Variety of Forms Continuum of Transaction Types Contractual 9 Collaborative
- 10. Continuum of Transaction Requires Variable Levels of Relationship Management Alliance relationships: • range from simple customer/vendor transactions to true outsourcing partnerships • individual relationships vary over time. Degrees of interdependence between companies Acquisition Merger Joint Venture Strategic Alliance Franchise Alliance Joint Team Relationship Outsourcing Partnership Out / In License Customer / Vendor Transactions Need for Alliance Management Adapted from: “Managing Alliances for Business Results”, Weise, et.al. 2006
- 11. Core Definitions 11 • Strategic Alliance • A strategic alliance is a structured strategic collaboration between two or more organizations, with the aim to achieve an agreed upon result neither of the partners can reasonably or easily achieve alone.* • Alliance Management • Alliance Management is a senior leadership-supported discipline through which specific relationship management skills, governance frameworks, and co-developed metrics are used to assure the continuing stability and growth of a collaborative partnership which wisely uses resources to create incremental value (develop solutions), build collaborative trust, and manage risk. * Doz & Hamel, Alliance Advantage: The Art of Creating Value Through Partnering
- 12. Value for the “Buyer” • New product candidates • New technologies (innovation) – Discovery – Development • IP/ Know-how • Catalyst for change – Challenge internal capabilities – Speed – Decision making 12
- 13. Value for the “Seller” 13 • Cash • Ability to advance technology platform • Ability to develop technology or therapeutic • Ability to commercialize technology or therapeutic • Underwrite development of infrastructure • Market “validation”
- 14. What Kind of Transaction? • Straight license agreement – Arm’s length – No collaboration (not really an alliance) • Research collaboration • Development collaboration • Promotion/Marketing collaboration • Royalties vs. Profit sharing • M&A (the ultimate alliance?) Varying degrees of all three? 14
- 15. Here’s how most see partnering… CEO/EXECS Finance IP and Legal Research and Development BUSINESS DEVELOPMENT BUSINESS DEVELOPMENT Internal Team 15 Partner
- 16. CEO/EXECS Finance IP and Legal Research and Development BUSINESS DEVELOPMENT BUSINESS DEVELOPMENT Internal Team Partner Senior Research Champion Senior Business Executive Here’s how it to make it successful A coordinated message backed up by relationship building will help close the deal 16 ALLIANCE MANAGEMENT ALLIANCE MANAGEMENT
- 17. Getting Started 17 • Define the objectives of the deal (corporate strategy) • Plan for timing – when does it need to be done? • Have an internal communication plan • Identify potential partners • Identify pre-deal, in-deal, and post-deal stakeholders • include Alliance Management • Prepare non-confidential package and confidential packages • Begin preparing due diligence materials
- 18. Launching the Operating Relationship • Joint Steering Committees • Project Teams • Work plans Research Development Commercialization 18
- 19. Joint Steering Committees 19 • Oversight for the collaboration • Typically equal numbers of appropriately senior representatives – Most often 3+3 – “Senior” most often means Directors and VPs • Responsibilities – General oversight – Resource allocation decisions/approvals – Setting of goals/Determination of success – Authorizing 3rd party engagements (e.g. academic labs, CROs, etc.) – Resolving disagreements / escalation management • Establish a mutually beneficial cadence (meet as often as seems mutually needed) • Consider alternating headquarters meetings or neutral zones
- 20. Company A – Company B Partnership Governance Executive Champions Division CEO President Quarterly Meetings Bi-Monthly Meetings Joint Steering Committee Company A Company B CIO SVP, Biometrics Client Services Principal SVP, Field Operations ED, Clinical Innovation VP, eClinical Client Services Principal VP, Implementation Services Alliance Management Alliance Management Program Dir. Program Dir.Program Dir. Services Lead Joint Clinical InnovationJoint Clinical Data Management Alliance Mgt. Alliance Mgt. Partnership & Customer Interface Product Dir.Program Dir. Program Dir. Weekly Meetings Partnerships Dir. Program Mgr. eClinical Arch. Ad-Hoc (Supporting Roles)
- 21. Escalation Pathways / Dispute Resolution 21 • The contract will usually say… – JSC to resolve disputes – Failing that, escalation to senior executives – Failing that, typically either of binding arbitration or the more powerful party has final say • The reality… – Should really be handled by the JSC with a goal of escalating the solution, not the issue. – If still not resolved then… you’ve probably got a major problem and the contract mechanism may not help – That’s why relationship-building is so important
- 22. Assuring Alliances Achieve Objectives Negotiation, Arbitration, And Creativity Two Sisters, One Orange… When compromise is making sure neither party gets what they need. And the alliance fails to achieve Its objectives. Acknowledgement to Stuart Kliman, Vantage Partners
- 23. Project Teams – Corporate communications (as needed) 88 • This is the where the real work gets done • Membership really depends on the stage of the program • Core members – Project leaders (one from each side) • Senior Scientist or Clinician – Research Scientists/Research Associates – DMPK/Toxicology – Clinical – Regulatory – Manufacturing – Program manager • Others? – Alliance Manager/Business Development (as needed) – Finance Manager
- 24. Project Team Activities 24 • Draft the project work-plan and update as required – Align scientific reality with business objectives – Make clear assignments of roles and responsibilities – Are the resource allocations appropriate? – Is the timeframe appropriate? – Does plan account for expected timing of milestone events? – Have the parties agreed to success criteria so that you’ll know when the milestone has been met? • Meet regularly to review activities/data – Weekly is typical – Keep minutes/ track action items • Report to the JSC – Informal updates as often as warranted (“managing up”) – Formal presentations (at the quarterly meeting)
- 25. Critical Components of a Team Charter Component Purpose(s) 1 Overview of the Alliance Governance Structure Provide team members with the context necessary to fully understand how their team fits into and relates to alliance leadership, operations, and reporting / escalation structures 2 Committee Purposes and Membership Ensure members are aligned around their overarching mission and key responsibilities of the team and define its membership 3 Relevant Contractual Provisions Provide a reference to necessary contractual requirements (e.g., required activities, required number of meetings, etc.) 4 Key Committee Goals and Milestones Define and align team around key 6-18 month goals, timelines, and milestones 5 Key Committee Challenges and Related Mitigation Strategies Facilitate recognition of likely key cross-partner working together challenges and agree/document mitigation strategies 6 Decision-making Roles and Escalation Process Clarify roles, responsibilities, and decision-making authority within and across teams, including necessary pre-decisionmaking consultation needs and post-decision-making inform needs 7 Operating Norms and Standing Agenda Items Manage communications and meeting protocols regarding preparation, agenda creation, meeting distribution, etc. Defines the responsibilities of different team members and defines standing agenda items or agenda template for meetings
- 26. What Makes a Good Bus Dev Professional? • Selling skills – Generating as much interest as possible for the asset you are trying to market • People skills – Managing external discussions/relationships without ever closing the door – Internal decision making and consensus building • Negotiating Skills – Every interaction is an opportunity for negotiation • Analytical skills – Making data driven decisions in valuing and structuring a deal • Project management skills – Keeping the process moving smoothly – Very important to be responsive and timely to maintain momentum of a deal 96
- 27. What Makes a Good Alliance Manager? • Contextual Competencies: Certain skills are foundational elements to the Alliance Manager’s ability to effectively perform: – Strong Communication Skills (Inbound & Outbound) – Conflict Resolution Experience – Corporate Relationship Management – Change Management Capability – Global Understanding and Mindset – Demonstrated Team Management Skills – Demonstrated ability to influence others without authority / coaching leaders and department heads – Able to synthesize collaboration from disparate sources (i.e.. Vision to see how things might fit together – non-linear thinking) *Adapted from Association of Strategic Alliance Professionals @2010
- 28. Contextual Competencies (cont.) – Negotiation Skills (i.e.. Can they stand the heat?) – Financial management – Legal knowledge (e.g. Compliance) – Regulatory knowledge (e.g. FDA, DEA) – Time Management / Flexibility – Contract Development and Negotiation – Pharma / Biotech Industry knowledge (i.e. Need to know how their customers work and make their money) – Critical strategic thinking / proactive vision – Cultural sensitivity and management maturity – Leadership skills / C-suite qualities / Professionalism – Strong Networking capabilities / Social Media integration *Adapted from Association of Strategic Alliance Professionals @2010
- 29. After the Handshake… Foremost Identified Causes of Alliance Failure Percent of All Failed Alliances Adapted from: “Managing Alliance Relationships – Ten Key Corporate Capabilities, Ertel, et. al., 2001
- 30. Your Alliance Manager’s Responsibilities • To provide collaborative enterprise leadership to all alliance partners in order to achieve the corporate objectives every partnership. • To contribute in a measurable manner to the achievement of annual corporate revenue goals. • To assist in establishing new and improving existing alliance relationships with your partners. • To provide continuity and compliance with all contractual agreements with an eye toward profits. • To work in a collaborative fashion with internal stakeholders within the alliances. • To provide effective mediation in the event of contractual complications or alliance issues between partners.
- 31. Collaboration as a Lever to Drive Innovation & ProductivityCollaboration “working together to achieve a common goal…it is more than the intersection of common goals, but rather a deep, collective determination to reach an identical objective” Partnership “is formed between one or more businesses in which partners (owners) co-labor to achieve and share in success (profits) and failures (losses)”
- 32. 32 Build, Buy, or Ally? An alliance may be unique but its goals should be mutually useful and evident.
- 33. What is the Collaboration Goal / Deliverable? Task Oriented • Transactional • Tactical execution • Managing inputs • Accommodating issues • Many interfaces • Diffuse accountability Existing State Services, Technology, Market Presence Company A Company B Assets Desired State Partnering as One • Trust & relationship • Strategic plan & execution • Managing outcomes • Proposing solutions • Peer to peer points of contact • Common Goals & Systems An Integrated Asset Development Alliance With Seamless Accountability Integrated Partnership 33
- 34. Role of Alliance Management 34 • Elevate and strengthen the working relationship through strategic partnership • Align company strategy and direction with business goals, competencies, and focus areas • Considers a portfolio view of common projects to recommend best strategies • Focus is on enterprise and franchise level initiatives vs. project specific initiatives • Solutions-oriented strategies in response to high-priority shared problems vs. tactics in response to a prescribed solution • Build executive-level networks between company A and company B
- 35. Creating Value within an Alliance • Access to New Markets • Business Process Innovation • Development Risk Mitigation • Increased Brand Recognition • Improved Strategic Planning • Improved Partner Stability • Increased Customer Loyalty • Accelerated Knowledge Transfer • Reduction in Competitive Threat • Reduced Training Costs • Key Employee Retention • Improved Customer Satisfaction • Portfolio Diversification • Faster Time-to-Market • Increased Market Penetration • Reduced Development Oversight • Increased R&D Momentum • Higher development success rates • Reallocation of Cost-savings to priority projects 35 Beyond managed costs for development (procurement benefits), strategic alliances can drive significant long-term / intangible value:
- 36. People: Tactical Roles & Responsibilities 36 • Alliance team is responsible for the overall relationship with alliance partners • Build, foster relationships with designated alliance team members • Drive setting mutually beneficial strategic plans for the partnership • Contribute to product development roadmap to support strategic objectives • Serve as primary point of contact for the relationship; leverage resources as needed – Lead / Chair governance committees (ESC, JOC, etc.) as appropriate – Assist in development of relationship metrics, KPIs, alliance reports – Serve as conduit and interface with mutual sales groups to maximize new markets and revenue potential – Serve as conduit to subject matter expert (SME) on alliance product offerings, competition and product market – Serve as conduit to Marketing for partner communications; develop joint collateral; strategically manage joint commercial presence.
- 37. Process: Documents, Tools, Technology 37 • Development of core Alliance Agreements • Direct On-boarding process: charter, governance, etc. • Initiate Off-boarding process: risk management, soft landing • Design Value-add metrics • Oversee evolution and migration of Company B to partner B • Connect teams to related SOPs – i.e. biz continuity/affects on deliverables • Assure creation of communication tools, including internal, external, marketing campaigns, etc. • Manage alliance transition/hand-off process for internal stakeholders
- 38. 1. Building and maintaining internal stakeholder alignment 2. Evaluating and considering relationship fit with potential partners 3. Building strong working relationships while negotiating optimal deals 4. Establishing common ground rules and communication pathways for working together 5. Instituting dedicated alliance managers 6. Instilling collaboration skills in alliance-facing employees 7. Having a collaborative corporate mindset 8. Managing multiple relationships within the same partner 9. Monitoring, auditing and providing assessment of alliance relationships: Measurement of effectiveness, productivity, and profitability 10. Managing changes that affect alliances (M&A, asset failure, etc.) Managing Alliances for Business Results, Weiss @2006
- 39. After the Contract, the burden rests on Alliance Management personnel to keep relationships Healthy and Growing. Ensuring a productive collaboration is a daunting responsibility requiring many components: - Ample senior-level and organizational support - Efficient project coordination - Effective conflict resolution and intervention - And constant, open communication
- 40. Additional Alliance Management Resources • Strategic Alliances: Three Ways to Make Them Work, Steve Steinhilber (VP, Strategic Alliances, Cisco), Harvard Business Review, 2008. • The Association of Strategic Alliance Professionals (ASAP): http://www.strategic-alliances.org • Right from the Start: the Seven Virtues of a Successful Alliance Launch, Visioni, et.al., Int. J. Strategic Business Alliances, Vol. 1, No. 4, 2010 • Harvard Business Review on Strategic Alliances, HBR, 2002. • The New Successful Large Account Management, Miller, Heiman, et.al., 2005. • Managing Alliances for Business Results: Lessons Learned from Leading Companies, Weiss, et.al., Vantage Partners, LLC, 2006. • Michael W. Young, Principal, biomedwoRx: Life Sciences Consulting LLC, www.biomedwoRx.com