DAY TWO | FRIDAY, MARCH 24TH
7:30 REGISTRATION & MORNING COFFEE
7:50 CHAIRPERSON’S OPENING REMARKS
Thad Bench, Chief Executive Officer, BENCHWORKS
Live Poll: What key factors are necessary to be an effective leader?
8:00 LEVERAGING PARTNERSHIPS FOR RESOURCES & EXPERTISE
In 2016, Xencor, a clinical-stage therapeutic antibody company, entered a third major strategic partnership with an established pharmaceutical company, highlighting the organization’s continued vision for advancing product development and commercialization by leveraging the resources and expertise provided by larger pharmaceutical organizations. Xencor has the ability to utilize immediate additional capital to push its products through clinical development, while also sharing ongoing expenditures and available resources to reach commercialization in the US and around the world. With each partnership formed, trade-offs exist to ensure a mutually beneficial partnership, and Xencor CEO Bassil Dahiyat has expertly negotiated agreements that protect IP and future revenue streams.
- Targeting the right partners to propel product candidates
- Addressing IP issues to protect assets in development
- Considerations for mutually beneficial partnership agreements
Bassil I. Dahiyat, PhD, President, Chief Executive Officer & Director, XENCOR
8:40 PANEL DISCUSSION: ASSESSING THE IMPACT OF PRICING PRESSURES ON THE PHARMACEUTICAL INDUSTRY
A principal issue affecting the pharmaceutical industry is the increased scrutiny of pricing, which has created major implications. Pending state legislations call for transparency in price increases and annual reporting of R&D investments to justify drug costs. California in particular has put forth a proposition to implement price controls on manufacturers, and the potential ripple effect of such legislature must be examined by CEOs. Through an assessment of the current state of pricing pressures, CEOs will have an opportunity to forecast the ongoing impact on market access, product revenue and a company’s public image.
- Various perspectives on drug pricing: payers, hospitals and industry
- Evaluating the current environment & scrutiny on pharmaceutical pricing
- Forecasting potential implications while preparing a product for success
Stephanie Trunk, Partner, ARENT FOX LLP
Leigh Purvis, Director, Health Services Research
AARP PUBLIC POLICY INSTITUTE
Joseph Fuhr, Lecturer, College of Population Health, THOMAS JEFFERSON UNIVERSITY
9:20 NETWORKING MEETINGS & COFFEE BREAK
10:20 PANEL DISCUSSION: BUSINESS MODELS & MEDICAL DEVICE CONTRACTING
As the healthcare industry progresses into a value-based system, medical device companies must find effective ways to partner with providers in meeting healthcare delivery objectives. In previous years, medical device manufacturers charged higher premiums to providers for innovative products; however, contracting and pricing models have evolved now that healthcare systems have access to more data regarding medical device performance, prompting the entrance of value-based negotiations and contracting. Through ongoing conversations with hospital leadership teams, CEOs of medical device organizations can successfully navigate through this increasingly complex healthcare environment to ensure optimal market access of new and existing medical devices.
- Novel contracting strategies for provider negotiations
- Communicating the value proposition of a new product
- Navigating value analysis committees for medical devices
Stephanie P. Hales, Partner, SIDLEY AUSTIN
Chase Hensel, Co-Founder & CEO, WELKIN HEALTH
Eric Steen, President & CEO, INFUSYSTEM HOLDINGS
Mary Alexander, Director, Supply Chain, FINANCIAL RESOURCE GROUP
11:00 REGULATORY CHALLENGES AND SOLUTIONS FOR VALUE-BASED PRICING
The Federal government and private payors have recently announced various “value-based pricing” initiatives for pharmaceutical products — essentially, paying more for a product when it works well and/or paying less when it does not. Some hope that these arrangements will spur the adoption of innovative products and help payors to manage their pharmaceutical spending. This session will help attendees to identify key regulatory challenges to adopting value-based pricing arrangements and solutions for meeting them, including in the areas of price reporting, discounting, and promotion.
John T. Gould, Partner, ARNOLD & PORTER LLP
11:40 DELIVERING ON THE PROMISE OF PRECISION MEDICINE
In his 2015 State of the Union address, President Obama announced the launch of the Precision Medicine Initiative – a program that will devote resources to revolutionizing healthcare through personalized treatment plans. Since then, the NIH and companies dedicated to precision medicine have united to deliver on the promise of improving the prevention and treatment of disease based on patient lifestyle, environment and genetics. Companies like Proove Bioscience, Illumina and Exagen Diagnostics are at the forefront of putting precision medicine into practice through innovative products that deliver better patient outcomes.
- NIH update on the Precision Medicine Initiative & Cohort Program
- Industry perspectives on the future impact of precision medicine
- Collaboration opportunities to drive treatment improvements
Brian Meshkin, PROOVE BIOSCIENCE
Alex Dickinson, CHROMACODE
Brady Davis, DNANEXUS
Thierry Dervieux, EXAGEN DIAGNOSTICS
12:20 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS
During lunch, attendees are encouraged to continue networking and use this time for focused discussion. Friday’s Table Topics will be concentrated on the regulatory outlook.
- How has your company worked closely with FDA for product approval?
- What regulations are you most concerned with as a CEO?
Live Poll: What is your company’s ultimate goal/exit strategy?
1:20 PANEL DISCUSSION: PREPARING A LIFE SCIENCE COMPANY FOR ACQUISITION
Oftentimes, the exit strategy for small to mid-sized life science companies is acquisition by a larger manufacturer, which can be a dynamic and complex transaction to navigate. From the analysis of the right time to sell to ensuring an appropriate price is paid, CEOs must appreciate the intricacies of successfully negotiating an acquisition. This panel discussion will outline various factors to consider when preparing for a potential acquisition, including resources and expertise needed to execute a transaction, responsibilities as a company during the sale process and missteps to avoid that could result in a lower purchase price.
David Mills, DALLEN MEDICAL
Howard Root, VASCULAR SOLUTIONS
Susie Harborth, BIOINNOVATION CAPITAL
Sean Freeman, NUVASIVE
Byron S. Kalogerou, MCDERMOTT, WILL & EMERY
2:00 LESSONS LEARNED FROM A CEO’S FIGHT TO OVERCOME CRIMINAL PENALTIES
The vast amount of time and resources required to ensure regulatory compliance can often be a monumental undertaking for small to mid-sized life science companies; however, CEOs cannot afford to be anything but comprehensive in remaining compliant with regulatory expectations due to the increase in civil and criminal prosecution of senior leadership teams. Vascular Solutions, a medical device company based in Minneapolis, lives to tell the tale of a prosecution that ultimately resulted in no criminal penalties, which began with the false accusation of off-label promotion by a previous employee. After 5 years of a costly litigation, Chief Executive Officer Howard Root will share poignant and valuable insights from his experience and offer an alternative proposal for how the life science industry can collaborate on best practices for compliance policies.
- Case study: battling criminal charges for compliance infractions
- Improving compliance materials to avoid regulatory enforcement
- Banding together as an industry to share compliance policies on:
- Document retention
- False claims
- Impact of increased government scrutiny on senior leadership teams
Howard Root, Chief Executive Officer, VASCULAR SOLUTIONS
Mark DuVal, JD, President, DUVAL & ASSOCIATES
3:15 NETWORKING MEETINGS & COFFEE BREAK
Live Poll: What compliance issues are you most concerned with over the next year?
3:20 5 COMPLIANCE PITFALLS TO AVOID: INSIGHTS FROM AN EXPERIENCED LITIGATOR
In recent years, the life science industry has been under greater governmental scrutiny regarding its sales and marketing tactics along with product liability concerns, creating an increase in litigation of potential compliance violations. Government investigations can completely alter a company’s trajectory for revenue growth and expansion, and learning from recent litigation examples of pharmaceutical and medical device companies can serve as an opportunity to examine and improve current business practices. With his experience on the Johnson & Johnson talcum powder case and the Depuy Orthopedics multi-district hip litigation, Alexander Calfo, a partner with King & Spalding will deliver a powerful and insightful presentation on government enforcement trends and how emerging life science companies can avoid costly litigation through comprehensive compliance.
Alexander G. Calfo, Partner, KING & SPALDING
4:05 THE CONVERGENCE OF TECHNOLOGY & HEALTHCARE
As technology continues to evolve, the intersection of IT and healthcare progresses at a rapid rate with innovative products and solutions entering the life science industry on an annual basis. Pharmaceutial and medical device companies must pay attention to this growing sector and either partner with technology companies to continue product advancement or be left behind during this revolutionary time in developing novel therapies and medical devices in conjunction with powerful technologies. This panel discussion will provide attendees with an inside look on how digital health continues to disrupt the life science industry, supporting innovation in product development and healthcare delivery.
- State of the industry: current impact on the life science sector
- Entering the marketplace as a digital health company
- Down the pipeline: forecasting the future of digital health
Luke Lee, Principal, ASSET MANAGEMENT VENTURES
Felix Frueh, Chief Executive Officer, INTELLOS HEALTH
Brian Meshkin, President & Chief Executive Officer, PROOVE BIOSCIENCE
Stephanie Trunk, Partner, ARENT FOX LLP
Chase Hensel, Co-Founder & CEO, WELKIN HEALTH
4:45 CLOSING REMARKS & CONFERENCE CONCLUSION