Steven Nichtberger, MD Senior Fellow, Life Sciences &

Steven Nichtberger, MD Senior Fellow, Life Sciences &

Steven Nichtberger, MD Senior Fellow, Life Sciences & Management Program Adjunct Professor, Department of Healthcare Management L SM P 4 2 1 Sy l la b us : 20 1 7 - 2 0 18 Capstone Course LSMP 421 Vision Integration of business and science Transition from academic to real world Objectives 1. Develop & present integrated plan to finance a healthcare advance 2. Understand and develop individual leadership / teamwork behaviors Experiential and Practical Learning Process Groups of 6 students each form a management team o o o team diversity, trust, and transparency are key to success select an opportunity that you can get excited about develop and present an integrated plan to gain financing Organization and Staffing

Course Director: Steven Nichtberger, MD Assistant Course Director: Joan Lau, PhD Guest Lecturers: Leaders from healthcare industry Five teams, with substantial support: o TAs focused on leadership and teamwork Aya BenDavid, Serena Dasani, Louise Li, Andrea Park o Mentors LSM grads to guide on process Nada Boualam (+ Irenes), Neil Patel, Nuvid Bhiyan (Wills) o Scientific founders Founding scientists for each team o Board of Advisors Diverse group of experts offering continuity and advice to each team o

Strategic and functional advisors Dozens of pharma and biotech executives o VC, public investor, banker, and analyst advisors Atlas, Flagship, Deerfield, Adage, Bain, Jennison, Cowen, JPM Approach Lectures By accomplished experts in each functional area o o o o o o o o preclinical clinical regulatory marketing finance banking

investing partnering Team meetings immediately following lectures with experts rotating additional team meetings each week as needed Setting Expectations Substantial workload, but you get out of the class what you put into it Experiential learning with abundant resources to support teams Consultations with experts and advisors will be essential o networking is key to success Feedback may be conflicting as in the real world o teams will need to determine how to proceed Leadership / teamwork behaviors be honest, trusting, and vulnerable 1st semester understand expectations, self-assessment o 2nd semester 360 degree feedback and coaching o Process o

Individual emails to TAs from team members throughout the year Team 360 degree meetings with update to TAs 1:1 meetings in November and March with TAs and course director Learning process is iterative o Need to optimize and align strategic choices among functional areas Course Objectives (1 of 2) Understand scientific basis of product critically review literature Evaluate and understand clinical unmet need that product could fill Identify key attributes of product that can deliver relevant clinical advance Write target product profile, clinical indication, draft development strategies 5. Evaluate the market opportunity and make strategic choices 6. Evaluate pricing and reimbursement challenges and and key success factors 7. Create transparent assumption based revenue / expense projections (US and ex-US) 8. Create a sound development strategy (preclinical and clinical) 9. Create a detailed clinical development plan for each regulatory phase 10.Create a financial model and develop pro forma with key sensitivities April Dec 1.

2. 3. 4. Feb Oct Develop and present integrated plan to finance a healthcare advance 11. Create a milestone based operating plan that links directly with optimal recommended financing plan to minimize the cost of capital 12.Develop time based valuation and evaluate exit opportunities for investors Course Objectives (2 of 2) Understand and develop individual leadership / teamwork behaviors Coaching throughout semester o TAs are your direct manager Will attend Friday team meetings, other team meetings as needed, and will collect email impressions from each individual on a regular basis. Will meet with each of you individually each semester to discuss leadership and teamwork behaviors to provide feedback and guidance

o My office hours in McNeil 111 - by appointment Friday mornings; will schedule other days if necessary [email protected] In addition to encouraging you to schedule a meeting anytime, each student will schedule a 1:1 with me after your 1:1 meetings with your TA during November and March to discuss leadership and teamwork o Joan Lau, PhD, assistant course director Available to provide advice and guidance, meets with team as needed Course Overview September o 1 Steven Nichtberger, MD Introductions Course overview philosophy, objectives, approach, syllabus, grading o 8 Steven Nichtberger, MD

Leadership / teamwork behaviors and teamwork: foundational concepts Example of final presentation o 15 Steven Nichtberger, MD A sure thing is not o History of the industry: Project selection criteria o Project presentations and selection; team formation o 22 Robert Gould, PhD Merck R&D (retired); CEO Fulcrum Preclinical research targets, chemistry, PK, PD, assays, biologic effects, GLP safety and regulatory requirements to IND o 29 Laura Bessen, MD Head US Medical, BMS (retired) A problem well stated is half solved o How companies organize to develop a product o Developing a target product profile for a new product opportunity Course Overview October (Oct 6 - fall break) o

4 Assignments due 1 page summary and resume / CV Team problem statement and proposed questions to explore Each student sends a copy of your CV / resume to your TA o 13 Keith Gottesdiener, MD CEO, Rhythm Pharmaceuticals Clinical strategic choices, trial design key elements; Regulatory Team meetings initial plan, opportunities, challenges, and info gaps o 16 Assignment due 2 page summary Technology, unmet need, clinical / regulatory paths Detailed review of development strategy and specific plans Prof Lau will schedule time with each team to review o 20 Steven Nichtberger, MD / Dan Geffken, Managing Director, Danforth Developing revenue forecasts and expense models Team meetings revenue and expense model discussion o 27 Team Presentations (Due Wed Oct 25 by 5pm) 30 minutes presentation and 15 minutes Q/A

Technology, unmet need, target product profile, development strategy Course Overview November o 3 Rick Kuntz, MD Chief Scientific, Clin. & Reg. Officer Medtronic / Jeff Shuren, MD,JD, Center Director CDRH, FDA Device development and FDA approach to healthcare IT and emerging technologies o 10 Brian Daniels, MD - SVP Global Devel. BMS (retired); 5AM Partner Advanced discussion of clinical and regulatory project driven discussion in class Cross-fertilization team meetings (4-5pm) o 13 TAs schedule 1:1s week of November 13 for each student 1:1 meetings with course director week of November 27 th o 17 Jay Siegel, Chief Biotechnology Officer, JNJ (retired) 10am 2pm one hour meetings with each team Review development strategies and plans

o 17 Adam Schechter, President, Merck Marketing New product mkt assessment; Pricing / reimb; ex-US mkts Revenue model approach to development of pre-launch models Team meetings market framework, pricing / reimbursement needs Course Overview December o 1 Peter Kolchinsky, PhD Managing Partner, RA Capital Development of data driven environmental maps for therapeutic targets as a framework for decision making and strategic choices Team meetings discuss development of maps with each team o 8 Team Presentations Content of first presentation with expanded detail on preclinical and clinical strategies and design of specific studies planned, plus marketing strategy and choices, including preliminary sales forecast (expense model not yet included) 30 min presentation and 15 min Q&A Course Overview January o

12 Steven Nichtberger, MD Overview of semester; case study; feedback sessions with teams Assignment: Collection and submission of all references / articles o 19 Eric Schmidt, Senior Biotech Analyst, Cowen & Co. Financial modeling and valuation of early stage biotech companies Group discussions o 26 Volker Janssen, Simon Kucher Pricing and reimbursement opportunities and challenges Group discussions Course Overview February o 2 Jason Rhodes, General Partner, Atlas Ventures Biotech funding models for early stage biotech companies; VC view; Valuation Group discussions o

2 Assignment Due: 2 page summary before 2pm Technology, unmet need, clinical / regulatory plans, marketing choices; P&L Detailed review of development plans, budgets, and revenue forecasts Meetings will be scheduled to review with each team o 9 Adam Koppel, MD PhD, Bain Capital Life Sciences Fund Rick Solit, MD, Adage Capital Public investors perspective on early stage biotech companies Approach to valuation of a public healthcare company Group discussions o 16 Phil Ross, MD, Head Biotech Banking, JP Morgan Biotech IPOs; What needs to be true to succeed? Trends and expectations Group discussions o 23 Team Presentations Full presentation including detailed development plans & financials o Financing strategy and potential exits / partners not included 30 minutes each followed by 15 minutes each Q&A st

Course Overview March o 2 Roy Vagelos MD, PhD Perspectives on the past, present, and future state of the industry Followed by a reception and dinner o 9 no class (spring break) o 16 Henry Gosebruch, Chief Strategy Officer, AbbVie Strategic partner perspective, mergers & acquisitions Venture investing by strategic partners Group discussions o 19 TAs schedule 1:1s week of March 19th for each student 1:1 meetings with course director week of March 26th o 23 Arie Belldegrun, MD/PhD Founder Kite, serial entrepreneur

David Shulkin, MD, Secretary VA, Member, Presidents Cabinet Physician career paths and leadership discussions o 30 Jennifer Taubert, Company Group Chairman, JNJ The future of the healthcare industry access, affordability, and innovation Course Overview April o 6 Dry run final team presentations (2pm to 6pm) 60 min per team o 30 min presentation ( due on April 3 at 5pm) o Up to 30 min questions/discussion - LSM alumni reviewers o 11 (Tues 9-11pm) Leadership and Teamwork Class debriefing with dinner instead of April 13th class (Spring Fling) o 20 Final Team Presentations to LSM Advisory Board

9am 4pm (Final PPT and all excel models due April 17 at 5pm) 60 minutes per team o 30 min presentation o 30 min questions/discussion o No changes to actual presentations after submission o Jeremy will print copies for all attendees Capstone Course LSMP 421 Grading Team Presentations 66% o o o Quality of preparation and evaluation Persuasiveness of presentation in support of strategic choices Clarity and efficiency of presentation Individual Leadership / Teamwork Behaviors 34% o Grading will be influenced by how each student: Performs in each of four dimensions of emotional intelligence Embraces and acts upon feedback to improve their behaviors o

Four dimensions of emotional intelligence o o Self awareness Capstone Course LSMP 421 Additional logistics (1 of 2) Team presentations o Empowered leaders on teams for each functional area Expect team engagement and collaboration in each functional area o o Presenters may be assigned by professor prior to presentations Team brings 10 color copies with 2 slides per page for reviewers Background reading and pre-class preparation o o Reference materials and backgrounders will be provided as needed

If reading is required, invited speakers will expect you come prepared Projects and products selected from Penn Medicine and elsewhere o Non-disclosure / IP ownership agreements must be signed by all All classes JM Huntsman Hall 370 from 2:00-5:00pm, unless noted o Lunch with speakers can usually be arranged, based on interest TAs and LSM mentors invited to join o Each team will be assigned a GSR from 3:30-5:00 each week GSRs JMHH 368, 376, 377, 378; Each team in one room all semester; rotating order for week known in advance Capstone Course LSMP 421 Additional logistics (2 of 2) Class attendance is required and participation noted o o Must e-mail director in advance if absence unavoidable

Impact on team dynamics and grade Canvas Video o All classes recorded, including team presentations After presentations, LSM senior / staff gatherings o o Student organized, LSM budget covers costs Volunteers? Capstone Course LSMP 421 Questions?

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