Agenda

  • 8:00 am

  • Registration Opens Tea/Coffee

  • 8:30 am

  • Co-Chairs Opening Remarks


    Zain Kassam, MD, MPH

    Co-Founder, CMO, Finch Therapeutics

    Julie Krop
    Julie Krop, MD

    CMO, Freeline


    Beth Garner, MD, MPH

    CMO, ObsEva


  • 🔑 Annual Keynote

  • 8:45 am

  • The Impact of Innovation on Drug Development Operations: How We Become Agile to Remain Viable in a Post-Covid World

    Why did it take more than 20 years for EDC to become widely adopted? Why has the adoption of e-consent stagnated? Innovations supporting clinical trial operations follow a relatively similar, protracted and inefficient process. In this truly thought-provoking session, industry veteran Ken Getz will assess the typical innovation process in clinical development and identify opportunities to optimize the process. He will next discuss how we can modify the process to accommodate a variety of solutions that will be needed in a post-covid world. More specifically:

    • What it means to be an agile organization
    • How we can create cultural and operational alignment
    • Implications for infrastructure, collaboration effectiveness and workforce training
    • Comparisons with examples of the innovation process in other industries


    Ken Getz, MBA

    Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine / Founder and Board Chair, CISCRP


  • 🔑 Biotech CEO Keynote

  • 9:15 am

  • Building up a Company Through to Commercialization and Beyond

    In this session, hear from Dr Ron Cohen about his journey founding and building Acorda Therapeutics and leading the company as an MD CEO for 26 years. Dr Cohen will also share advice on how CMOs can best collaborate with their CEOs and add value to their companies.

    Ron Cohen
    Ron Cohen, MD

    Founder, President & CEO, Acorda Therapeutics

  • 9:45 am

  • Reserved Session

  • 10:00 am

  • Grand Opening Break

    • Breakfast
    • Meet the Exhibitors
    • Peer-to-Peer Networking

     

  • 10:40 am

  • The Realities of Transitioning from Brick-and-Mortar Trial Sites to DCTs and Finding the Balance

    In this session, our panelists bring forward the realities of what worked and hasn’t in decentralized clinical trials, finding the balance between brick-and-mortar and DCTs, how to prepare for DCTs and hybrid trials.

    Julie Krop
    Julie Krop, MD

    CMO, Freeline


    Seemi Khan, MD, MPH, MBA

    SVP, CMO, Reata Pharmaceuticals

     

  • 11:20 am

  • Enabling Digital Transformation

    As we embrace the journey of transforming R&D digitally, we bring forward a group of companies that each play a key role to enable various aspects of virtual trials, AI and data science. They will address the problem they aim to solve along with their thoughts on the value impact for patients.


    Zain Kassam, MD, MPH

    Co-Founder, CMO, Finch Therapeutics

  • 11:50 am

  • Achieve Effective Outsourcing that Truly Supports the Development Goals for Emerging Biotechs

    In this session, panelists will address how to decide what you need internally and when to outsource; outsourcing across the portfolio, from labs to market access to turnkey solutions with process development and CMC; and best practices in managing a relationship with outsourcing partners to ensure success.


    Beth Garner, MD, MPH

    CMO, ObsEva

    Chelsey Ryan, PMP
    Associate Director, Clinical Operations and Pharmacovigilance, Prometrika
     
    Barry Ticho
    Barry Ticho, MD, PhD
    CMO, Stoke Therapeutics
     
     
  • 12:35 pm

  • Lunch

  • 1:35 pm

  • Risk Mitigation for the 'Next Normal' in Oncology Clinical Trials

    This presentation explores post-2020 risks in clinical trial operations and proposes mitigating strategies & tactics to overcome them; with an eye to the emerging ‘next normal’ in the clinical research study landscape.

     
    Julie Martin

    CEO & Co-Owner, Scimega Research

  • 1:50 pm

  • Building a Long-Term and Global Regulatory Strategy

    This panel explores best practices in building global R&D projects and how different companies navigate policy changes, global regulatory engagement and development planning.

    Liz O'Brien Bergin
    Liz O’Brien Bergin, MB, MRCGP

    Global CMO, Besins Healthcare Ireland Ltd

    Oscar Segurado
    Oscar Segurado, MD, PhD
    CMO, ASC Therapeutics 

  • 2:30 pm

  • Reserved Session

  • 2:45 pm

  • Afternoon Break

  • 3:25 pm

  • Navigating the Rapidly Changing Regulatory Landscape

    What CMOs can learn about adaptability and engagement with KOLs and regulators from the experiences of biotechs regarding biomarkers, accelerated approvals, manufacturing GXP, safety and patient centricity.


    Christina Coughlin, MD, PhD
    CMO, Rubius Therapeutics

     

  • 3:55 pm

  • Creative Hiring Strategies with Remote Working and a Tight Job Market

    • Strategies for discovering talent
    • How remote work impacts where to look and what to look for in candidates
    • Working with recruiters to set them up for success
    • Understanding what candidates are looking for from a job post-COVID

    Zelenkofske
    Steven Zelenkofske, DO

    CMO, SwanBio Therapeutics

  • 3:55 pm

  • Remote Working: Structuring and Managing a Team Post-COVID

    After a year of working remotely, there is much thought being given to new organizational paradigms for biotechs. In this session, CMOs will share how they are organizing teams to support the balance of remote and in-person work to support company goals. Individual topics include:

    • Structuring and managing hybrid teams
    • Investing in IT infrastructure
    • Building a culture of trust
    • Determining a remote work strategy

    Nerissa Kreher
    Nerissa Kreher, MD

    CMO, Tiburio Therapeutics


    Timothy Peters-Strickland, MD
    Vice President, Regional Medical Officer, PPD Biotech

  • 4:25 pm

  • Reserved Session

  • 5:00 pm

  • Day One Concludes

  • 5:00 pm
    - 6:00 pm

  • Networking Reception

Agenda

  • 8:00 am

  • Tea/Coffee

  • 8:30 am

  • Co-Chairs Opening Remarks


    Zain Kassam, MD, MPH

    Co-Founder, CMO, Finch Therapeutics

    Julie Krop
    Julie Krop, MD

    CMO, Freeline


    Beth Garner, MD, MPH

    CMO, ObsEva


  • 🔑 Keynote

  • 8:45 am

  • Opening Morning Keynote

    TBA

  • 9:15 am

  • Having Influence with CEOs and Boards

    In this session, panelists discuss how to communicate with CEOs and Boards, what works and what doesn’t for different companies, CMO profiles and what separates the good from the great.

    Julie Krop
    Julie Krop, MD

    CMO, Freeline


    David Meeker, MD

    Chairman, President & CEO, Rhythm Pharmaceuticals

  • 10:00 am

  • Reserved Session

  • 10:15 am

  • Opening Morning Day Two Break

     

    • Breakfast
    • Meet the Exhibitors
    • Peer-to-Peer Networking

     

  • 10:45 am

  • The First 90 Days as a CMO

    • As each CMO role is different, it is critical for both first-time and seasoned CMOs to identify the role and develop a plan to ensure a successful transition. In this session, panelists will explore:
    • What to look for in a company
    • Identifying the position and taking your place
    • Prioritizing responsibilities and first hires


    Laurie Halloran, BSN, MS

    President & CEO, Halloran Consulting Group, Inc

     
    James “Terry” Ferguson, MD

    CMO, Matinas Biopharma

  • 11:15 am

  • CMO Preparation for Investor Interactions

    • In this session, panelists will explore best practices around:
    • How to strategize with your CEO, CFO and Head of IR for investor meetings
    • How to speak to investors about clinical trials
    • Regulatory affairs disclosures when interacting with investors
    • What works and what doesn’t from the investor perspective

    Christopher Heery, MD

    CMO, Precision BioSciences, Inc
     
    Anna Frostegård
    Anna Frostegård, MD, PhD
    Co-Founder, Chief Scientific and Medical Officer, Annexin Pharmaceuticals
  • 12:15 pm

  • Reserved Session

  • 12:30 pm

  • Lunch

  • 1:30 pm

  • Next-Generation Strategies to Optimize Diverse Patient Recruitment and Engagement in Clinical Research


    Beth Garner, MD, MPH

    CMO, ObsEva


    Rob Ianonne, MD, MSCE 
    EVP, R&D and CMO, Jazz Pharmaceuticals

  • 2:15 pm

  • Reserved Session

  • 3:00 pm

  • CMO Town Hall Hot Topics Audience Discussion

    In this town hall style session, the audience exchanges thoughts and suggestions on a number of hot topics including, but not limited to:

    • CMO Contract Pearls
    • CMO Professional Development


    Zain Kassam, MD, MPH

    Co-Founder, CMO, Finch Therapeutics

  • 3:45 pm

  • Conference Concludes