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Wednesday, December 1
 

8:00am EST

Registration and Breakfast
Wednesday December 1, 2021 8:00am - 9:00am EST

9:00am EST

9:10am EST

Panel: Drive Alignment and Improve Dialogue Across Medical and Commercial Functions to Create a Unified Brand Strategy
  • Compare and contrast the motivations and objectives for medical and commercial functions
  • Examine some common pitfalls that lead to communication challenges between the two groups
  • Hear perspectives from both sides of the organization regarding how to successfully work together toward the creation of an effective brand strategy
  • Create strategic and tactical alignment between commercial and medical affairs while budgeting and goal building

Speakers
PR

Paul Rowe

Vice President, Head of Global Medical, Immunology, Sanofi Genzyme
avatar for Terri L. Phillips, M.D., F.A.A.P.

Terri L. Phillips, M.D., F.A.A.P.

Chief Medical Affairs Officer, Merz Aesthetics
Terri L. Phillips, M.D., F.A.A.P., is the Chief Medical Affairs Officer of Merz Aesthetics, where she provides oversight to all medical affairs functions for the business Dr. Phillips is a passionate advocate for increasing diversity and inclusion among leadership within the medical... Read More →
avatar for Blake Morrison, PharmD

Blake Morrison, PharmD

Vice President, Global Medical Affairs, Turning Point Therapeutics
Blake brings over 30 years of clinical practice and industry experience with a therapeutic area emphasis on hematology/oncology. Blake’s functional area of expertise is medical affairs and includes deep experience in strategic planning, evidence generation, thought leader engagements... Read More →


Wednesday December 1, 2021 9:10am - 9:45am EST

9:45am EST

Panel: Leadership Perspectives on Prioritizing R&D Investment Through Strategic Portfolio/Pipeline Planning
  • Understand the decision-making process behind funding development programs, which clinical indications to pursue and when to kill them
  • Discover how to allocate capital and determine what level of resources to invest to projects that are in different stages of development
  • Determine when to dedicate resources at different stages throughout the process
  • Enhance project prioritization and portfolio optimization activities

Speakers
avatar for Leonie Meima, MBA

Leonie Meima, MBA

Executive Director, Lifecycle Lead Immuno-Oncology; Portfolio and Corporate Strategy, Coherus BioSciences
Leonie is a biopharma industry veteran with 20+ years of experience in New Product Planning, Portfolio Planning, and Business Development gained at companies ranging in size from Roche Pharmaceuticals to two scientists and a molecule. Additionally, she spent many years in R&D at Genentech... Read More →
avatar for Sarah Kurz

Sarah Kurz

EVP, Chief Commercialization Officer & Head of Medical Affairs, Partner Therapeutics, Inc.
Sarah is passionate about great science and terrific teams.  She chairs the Executive Team of privately held Partner Therapeutics where she also leads the Commercial and Medical Affairs functions and oversees all corporate planning.  Prior to joining PTx, Sarah served as Vice President... Read More →


Wednesday December 1, 2021 9:45am - 10:30am EST

10:30am EST

Networking Break
Wednesday December 1, 2021 10:30am - 11:00am EST

11:00am EST

Modern Medical Grantmaking: Leveraging Technology to Reduce Complexity and Increase Transparency
  • How processing and tracking medical grants can be greatly simplified, while maintaining flexibility
  • Why fragmented solutions don't work, and how to coordinate efficiently
  • How to reduce friction across the grant lifecycle with automation
  • What true visibility and transparency can look like throughout the process
Hosted by Cyber Grants

Speakers
avatar for Zach Gendron

Zach Gendron

Senior Account Executive, CyberGrants
Zach GendronSenior Account ExecutiveResponsible for providing best practices and strategic guidance to both new and existing customers on industry trends and technologies.Architected and deployed numerous software solutions for Research Grants, Medical Education and Managed Access... Read More →


Wednesday December 1, 2021 11:00am - 11:30am EST

11:30am EST

Never Too Early: Key Strategies for Successful Lifecycle Management Planning
  • Learn why lifecycle management (LCM) planning early in clinical development is an essential strategy for maximizing market potential and clinical reach
  • Discuss specific LCM strategies and tactics to consider for each stage of development, up to and beyond patent expiry
  • Identify key investment and trade-off considerations, market exploration needs and data implications inherent in the LCM planning process
  • Review case studies illustrating effective LCM planning and implementation that have yielded strong results

Speakers
TL

Tony Lanzone

Senior Managing Director, Value, Access & Medical, Syneos Health
AD

Aaron Davis

Senior Managing Director, Value, Access & Medical, Syneos Health


Wednesday December 1, 2021 11:30am - 12:15pm EST

12:15pm EST

Networking Lunch
Wednesday December 1, 2021 12:15pm - 1:15pm EST

1:15pm EST

Chairperson's Opening Remarks
Wednesday December 1, 2021 1:15pm - 1:30pm EST

1:15pm EST

Chairperson's Opening Remarks
Wednesday December 1, 2021 1:15pm - 1:30pm EST

1:30pm EST

Are you ready for takeoff? Preparing for a Successful Launch in Medical Affairs
  • Communicating the science and raising awareness: thinking strategically about scientific publications and congress planning
  • Building the relationships: engaging with thought leaders to critical gain insights
  • Executing your launch plan: where strategy meets operations

Speakers
avatar for Hannah Cummings

Hannah Cummings

Medical Director, Pipeline Lead (CNS and Oncology Franchises), Alkermes
Hannah Cummings serves as a Medical Director, Medical Strategy at Alkermes for the past 3.5 years where she lead the successful launch of LYBALVI and now leads early-stage pipeline in both CNS and oncology. Before joining Alkermes, Hannah was a Senior Director, Global Clinical and... Read More →


Wednesday December 1, 2021 1:30pm - 2:15pm EST

1:30pm EST

Maximizing Product Value with Robust Transitions from New Product Planning to Global Launch Teams
  • Building effective teams and robust frameworks to ensure global launch readiness across a portfolio of programs
  • Bridging R&D and Commercial to ensure early and effective customer-centric development and commercial strategy input into early pipeline programs
  • Creating an integrated approach across global and regional, affiliate teams to prepare for a global product launch

Speakers
avatar for Hani Houshyar

Hani Houshyar

VP, Head of Pipeline Product Development & Commercialization, Biogen
Hani Houshyar is Vice President, Head of Pipeline Product Development and Commercialization (PDC) at Biogen. In this role, she oversees the pipeline PDC and commercial teams accountable for driving Biogen’s pipeline assets toward global launches across all of Biogen’s disease... Read More →


Wednesday December 1, 2021 1:30pm - 2:15pm EST

2:15pm EST

Opportunities for MSLs to Deliver Value and Provide Key Insights to the Organization in the Pre-Launch Phase
  • Utilize MSLs when recruiting and enrolling patients in clinical trials to increase participation
  • Explore ways to meet doctors beyond the investigators at your trial sites and engage with KOLs reactively without having a product on the market
  • Gather and report insights that can drive the success of a product launch

Speakers
avatar for Sanaz Cardoza

Sanaz Cardoza

Senior Director, INOmax and Regenerative Medicine MSL Teams, Mallinckrodt Pharmaceuticals


Wednesday December 1, 2021 2:15pm - 3:00pm EST

2:15pm EST

Prioritizing your Product Pipeline by Analyzing Crucial Scientific and Commercial Variables
  • Starting with the end in mind: Goal setting for Pharma and Biotech
  • Learn how to establish critical outputs that inform portfolio prioritization
  • Review metrics and discuss decision making processes
  • Optimize your portfolio and pipeline by accounting for attrition rates

Speakers
avatar for Katja Wachtendonk

Katja Wachtendonk

Executive Director, Global New Products & Portfolio Strategy, Novartis


Wednesday December 1, 2021 2:15pm - 3:00pm EST

3:00pm EST

Networking Break
Wednesday December 1, 2021 3:00pm - 3:30pm EST

3:30pm EST

Understand the Role of Medical Affairs in the Changing Reimbursement Landscape
  • Analyze the payer landscape and explore the ways it has evolved during the pandemic
  • Gain a deeper understanding of how to assemble and lead field medical/HEOR teams when preparing for a launch
  • Outline the role of an MSL when engaging with payors and discussing pricing in the field
  • Compare best practices when working with the payer community and learn what they are looking for

Speakers
avatar for Andrew Shim, PharmD, JD, MAM

Andrew Shim, PharmD, JD, MAM

Executive Director, Head of Global HEOR, Medical Affairs, Turning Point Therapeutics
Andrew Shim, PharmD, JD, MAM - Medical Affairs, HEOR, and Payer/Access ExpertAndrew has over 20 years of clinical, payer, and industry experiences across broad therapeutics in medical affairs, clinical development, health economics & outcomes research, and formulary management. He... Read More →


Wednesday December 1, 2021 3:30pm - 4:15pm EST

3:30pm EST

Examining the Impact of COVID-19 on New Product Planning: Challenges and Opportunities
  • Highlight the disruptive challenges of COVID-19 on New Product Planning practices
  • Describe the opportunities and benefits that have emerged as a result of changed business practices under COVID-19
  • Discuss the short- and long-term impact of practice changes in New Product Planning

Wednesday December 1, 2021 3:30pm - 4:15pm EST

4:15pm EST

Future of Medical Affairs for Cell and Gene Therapies
• Devise ways to select, monitor and measure the right patients to develop the safest therapies
• Identify methods to interact with, engage and appeal to KOLs more effectively
• Establish a framework for education about the complexities of cell and gene therapies for HCPs, patients and caregivers


Speakers
avatar for Oscar Segurado, MD, PhD

Oscar Segurado, MD, PhD

Chief Medical Officer, ASC Therapeutics


Wednesday December 1, 2021 4:15pm - 5:00pm EST

4:15pm EST

Best Practices for New Product Planning Launch Strategy and Execution– Strategic, Behavioral & Cultural Considerations
  • Maximizing cross-functional planning and lessons learned from multiple product launches
  • Ensuring launches are not solely US-centric and success is planned for global markets
  • Evaluating primary strategic drivers that lead to launch success
  • How to effectively transform focus from development to commercialization to ensure an effective product launch

Speakers
avatar for Steven Closter

Steven Closter

VP, Worldwide Commercialization Planning and Launch Excellence, Sunovion


Wednesday December 1, 2021 4:15pm - 5:00pm EST

5:00pm EST

Networking Reception
Wednesday December 1, 2021 5:00pm - 6:00pm EST
 
Thursday, December 2
 

8:00am EST

Networking Breakfast
Thursday December 2, 2021 8:00am - 9:00am EST

9:00am EST

Chairperson's Opening Remarks
Thursday December 2, 2021 9:00am - 9:15am EST

9:15am EST

Learning how NPP Groups can Successfully Develop a Product and Advance the Critical Success Factor
  • Outline the core members of the team you should be working with
  • Examine the timeline and identify when to work with partners
  • Discover how to align with stakeholders on what will define a successful product launch

Speakers
avatar for Damon Harrell

Damon Harrell

Vice President Marketing, Psychiatry Franchise, Alkermes
Damon Harrell currently serves as Vice President of Marketing for the Psychiatry Franchise at Alkermes. With over 25 years of pharmaceutical experience, he has held a broad range of positions across multiple therapeutic areas, multiple geographies and product lifecycle responsibilities... Read More →


Thursday December 2, 2021 9:15am - 10:00am EST

10:00am EST

Integrating Market Access for the Launch of New Products: Changing the Focus from Registration to Patient Access
  • Determine when to consider reimbursement needs and challenges
  • Define the value proposition for payers and ways to communicate efficiently
  • Examine ways to effectively deal with new paradigms like gene therapy

Speakers
avatar for Debbie Drane

Debbie Drane

Senior Vice President Global Commercial Development and TA Strategy, CSL Behring
Debbie Drane is the SVP of Global Commercial Development & TA Strategy at CSL Behring based in the King of Prussia, PA office. In this role she is responsible for market development and go-to market strategies for new products, life cycle management of the current product portfolio... Read More →


Thursday December 2, 2021 10:00am - 10:30am EST

10:30am EST

Networking Break
Thursday December 2, 2021 10:30am - 11:00am EST

11:00am EST

Panel: The Changing Landscape of Evidence Generation
Speakers
IF

Isabel Firmino

Vice President, Head Global Medical Affairs Therapeutic Areas, Alexion, AstraZeneca Rare Disease
avatar for Oscar Segurado, MD, PhD

Oscar Segurado, MD, PhD

Chief Medical Officer, ASC Therapeutics
avatar for Zsuzanna Devecseri, MD, MBA

Zsuzanna Devecseri, MD, MBA

Vice President, Head of Global Oncology Medical Affairs, Sanofi


Thursday December 2, 2021 11:00am - 11:45am EST

11:45am EST

Astellas Global Cell Therapy – Planning for Commercialization
  • Overview of Astellas’ approach to building a cellular medicine platform
  • Capability building to create a learning organization
  • Ensuring early engagement and buy-in from cross functional teams - from the idea stage to product launch to achieve commercial viability

Speakers
avatar for Lorri Jones

Lorri Jones

Global Commercial Lead, Cell & Gene Therapies, Astellas Institute of Regenerative Medicine
Lorri Jones is the Global Commercial Lead for Regenerative Medicine & Ophthalmology at Astellas. Lorri joined Astellas in February 2020 and has extensive commercial experience in Global & US Marketing, Launch Excellence, and Strategic Planning.Lorri has an impressive track record... Read More →


Thursday December 2, 2021 11:45am - 12:15pm EST

12:15pm EST

Networking Lunch
Thursday December 2, 2021 12:15pm - 1:15pm EST

1:15pm EST

Chairperson's Opening Remarks
Speakers
KM

Khalid Mamlouk, Pharm.D, BCOP

Senior Vice President, Head of Medical Affairs, Mersana Therapeutics


Thursday December 2, 2021 1:15pm - 1:30pm EST

1:15pm EST

Chairperson's Opening Remarks
Thursday December 2, 2021 1:15pm - 1:30pm EST

1:30pm EST

Medical Affairs Journey to Digital Transformation
  • Develop a roadmap for the implementation of enterprise-wide systems to facilitate the push to digital
  • Streamline the processes, people and talent for digital transformation to ease the transition
  • Assess the needs of the business when preparing for launch based on the type of organization
  • Build a united team by establishing a global approach for the medical affairs team to reduce the silos within the department

Speakers
avatar for Francis Fitzgerald

Francis Fitzgerald

Senior Director - Digital, Commercial and Medical Affairs IT, Kyowa Kirin
Francis Fitzgerald is a biopharmaceutical IT leader with over 20 years of application development, system architecture and enterprise platform implementation experience across the R&D, Medical Affairs and Commercial areas. He has worked or consulted at several of the Top 20 pharmas... Read More →
avatar for Deborah Braccia, PhD, MPA

Deborah Braccia, PhD, MPA

Head of Global Medical Affairs Excellence, Kyowa Kirin
Dr. Braccia is a results-driven senior healthcare and biopharmaceutical leader with over 20 years of progressive experience and successes in pharmaceutical, biotech, clinical and academic settings. She is currently the Head of Global Medical Affairs Excellence at Kyowa Kirin. Extensive... Read More →


Thursday December 2, 2021 1:30pm - 2:15pm EST

1:30pm EST

Exercise: Attracting and Retaining Talent Post Covid-19
This interactive session will cover: 
  • Summarize relevant skill sets needed and how roles have evolved during the past 2 years 
  • Discuss ways to attract new talent and best practices for retaining the existing talent you have 
  • Discover methods to determine employees' next steps for growth 

Speakers
avatar for Avi Kogan

Avi Kogan

Senior Director, New Product Commercialization, Alnylam Pharmaceuticals


Thursday December 2, 2021 1:30pm - 2:15pm EST

2:15pm EST

Product Launch Support from a Medical Affairs Family of Functions
  • Discuss how internally focused support functions can optimize launch preparedness (Scientific Development and Knowledge Management).
  • Review preparation steps for externally facing functions such as Medical Information, and Medical Promotional Review
  • Explore mechanisms to demonstrate the value of the functions and impact to launch efficiency

Speakers
avatar for Timothy Fish

Timothy Fish

Senior Director, Medical Information, Scientific Training, Knowledge Management, Alkermes
Dr. Fish is the Senior Director of Medical Information, Scientific Training & Development, and Knowledge Management Services at Alkermes; a Registered Nurse with over 25 years of experience, and a unique professional in healthcare systems leadership and worldwide process collaborations... Read More →
avatar for Todd Brackins

Todd Brackins

Director, Scientific Training and Development, Medical Affairs, Alkermes
Todd Brackins is the director of training and development in the Medical Affairs division at Alkermes.  In Todd’s career at Alkermes, he’s worked as a CNS Medical Science Liaison and as the Director, Field Medical Excellence, supporting the entire field MSL team at Alkermes with... Read More →


Thursday December 2, 2021 2:15pm - 3:00pm EST

2:15pm EST

The Use of Real-World Evidence to Enhance the Value Proposition of New Products
  • Review the shift in regulatory outlook on RWE and the industries view on RWE
  • Analyze the FDA’s framework for RWE and their approach to utilizing RWE for evidence generation
  • Define natural history of disease and explore the application of RWE in natural history studies
  • Examine how to make a successful use of Natural History of disease submission and the benefits of doing so

Speakers
avatar for Shoshana Reshef, PhD, MPH, MA

Shoshana Reshef, PhD, MPH, MA

Director, Global Epidemiology & RWE, Teva Pharmaceuticals
Shoshie Reshef is a Director of Epidemiology and Real World Evidence at Teva Pharmaceutical.She earned her PhD in Epidemiology and an MPH from the Johns Hopkins Bloomberg School of Public Health. She also has an MA in Logic and Political Philosophy from the University of Wisconsin-Madison.Shoshie... Read More →


Thursday December 2, 2021 2:15pm - 3:00pm EST

3:00pm EST

Networking Break
Thursday December 2, 2021 3:00pm - 3:30pm EST

3:30pm EST

Shaping Pipeline Efforts through Medical Affairs Strategy
  • Explain the role of medical affairs in mid-stage clinical development; when is early too early and what should the cross-functional priorities be
  • Discuss functional activation across different stages of development
  • Prioritize cross-functional and regional involvement and support while balancing for attrition


Speakers
avatar for Ioannis Petrakis

Ioannis Petrakis

Senior Director and Global Medical Unit Head, New Programs Gastrenterology, Takeda
Ioannis is a passionate advocate of transformative value for patients. Such breakthroughs come more easily when involving highly skilled and real-world oriented medical affairs teams early into the development phases. Ioannis is a Sr. Director and heads up Takeda’s Global Medical... Read More →


Thursday December 2, 2021 3:30pm - 4:15pm EST

3:30pm EST

Outlining how a TPP can Set up your Clinical Program and Commercial Model for Success
  • Outline the early stages of creating a TPP such as when to start and who owns the process
  • Compare how TPPs are developed in large, established companies versus emerging companies
  • Discover the benefits of a robust, evolving TPP document and the importance of cross-functional stakeholder involvement

Speakers
avatar for Avi Kogan

Avi Kogan

Senior Director, New Product Commercialization, Alnylam Pharmaceuticals


Thursday December 2, 2021 3:30pm - 4:15pm EST