Agenda

  • 8:00 am

  • Registration Opens Tea/Coffee

    Masks are required indoors

  • 8:30 am

  • Co-Chairs Opening Remarks


    Zain Kassam, MD, MPH

    Co-Founder, CMO, Finch Therapeutics

    Julie Krop
    Julie Krop, MD

    CMO, PureTech Health


    Elizabeth Garner, MD, MPH

    CMO, ObsEva


  • 🔑 Keynote

  • 8:45 am

  • Keynote Fireside Chat with an R&D Veteran on Leading a Biotech through Founding, IPO and Acquisition

    Dr Viney joins the CMO Summit 360° to share her incredible journey in drug discovery and development, founding and leading Pandion Therapeutics and joining the advisory boards of multiple biotech companies. 


    Jo Viney, PhD

    President & CEO, Seismic Therapeutic

    with


    Zain Kassam, MD, MPH

    Co-Founder, CMO, Finch Therapeutics


  • 🔑 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

    with

    Ken Getz, MBA
    Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of MedicineFounder and Board Chair, CISCRP

  • 9:45 am

  • Walking Through Bayesian Methods in Drug Development

    In this session, Dr Muhlemann will present a walkthrough on the Bayesian framework and its advantages such as reduced sample size, increased power, reduced costs and ethical hazards. Bayesian methods can also be integrated into frequentist trials to improve dose selection and interim decision making, de-risking and increasing the efficiency of the entire clinical development program.


    Natalia “Natasha” Muhlemann, MD, MBA
    Vice President, Strategic Counseling, Cytel

  • 10:00 am

  • Grand Opening Break

    • Grab & Go Breakfast
    • Meet the Exhibitors
    • Peer-to-Peer Networking
    • Thank you for wearing your masks

     

  • 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.

    Moderated by:


    Elizabeth Garner, MD, MPH

    CMO, ObsEva

    Panelists:


    Seemi Khan, MD, MPH, MBA

    SVP, CMO, Reata Pharmaceuticals


    John Reites

    CEO, THREAD Research

     

  • 11:10 am

  • Enabling Digital Transformation in Clinical Research

    As we embrace the journey of transforming R&D digitally, we bring forward panelists to discuss various aspects of virtual trials, AI and data science including:
    • The value of designing a companion care app or or digital therapeutic with AI/ML algorithms to augment drug treatment and ensure proper administration and adherence
    • On-demand disease education to drive better outcomes that will get better pricing as well as new channels for better pharmacovigilance.

    Moderated by:


    Zain Kassam, MD, MPH

    Co-Founder, CMO, Finch Therapeutics

    Panelists:


    Mark Clements, MD, PhD, CPI, FAAP

    CMO, Glooko


    Anupam Agarwal, MD, MBA 

    Vice President & Global Head of Safety & PharmacovigilanceZogenix/ Member, Board of DirectorsThe Alliance for Artificial Intelligence in Healthcare


    MaryAnne Rizk, PhD

    Chief Strategy Officer, Medable

  • 11:40 am

  • The Value of Wearable Biosensors in Late Stage Clinical Development

    This session focuses on how biosensors enable innovative trial design, novel endpoints and support commercial strategies through case studies about how CMOs use wearable biosensors in their phase 3 clinical trials.

    Moderated by:


    Steve Steinhubl, MD
    CMO, PhysIQ

    Panelists:


    Luiz Belardinelli, MD
    CMO, InCarda Therapeutics


    Jan Komtebedde
    CMO, Corvia Medical

  • 12:10 pm

  • Lunch

  • 1:10 pm

  • Achieving an Effective Outsourcing Strategy 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.

    Moderated by:


    Elizabeth Garner, MD, MPH
    CMO, ObsEva

    Panelists:

    Lori Buckenmyer 
    Head of Clinical Operations & Project Management, InSeption Group
     
    Chelsey Ryan, PMP
    Associate Director, Clinical Operations and Pharmacovigilance, Prometrika
     
    Cadmus Rich
    Cadmus Rich, MD, MBA
    CMO, Aura Biosciences
     

    Timothy Peters-Strickland, MD
    Vice President, Regional Medical Officer, PPD Biotech
     
     
  • 1:50 pm

  • Essential Factors for Successful CRO Relationships from a 20 Year CMO Veteran

    During his 20 years serving as the chief medical officer at emerging and small biotech firms, Dr Skip Sands experienced first-hand how selecting the right development partner was one of the most important decisions they would make.

    In this session, Dr Sands shares his experiences evaluating and selecting CRO partners and provides advice to help you avoid the misalignments and misunderstandings that can cause these relationships to run off track.


    Skip Sands, MD
    SVP, Senior Medical Officer, Parexel Biotech

  • 2:05 pm

  • Creative Hiring Strategies in a Tight Job Market and Remote Work Setting

    In this session, leading biotech recruitment firms come together to discuss new strategies for discovering talent, as well as:
    • 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

    Moderated by:

    Zelenkofske
    Steven Zelenkofske, DO

    CMO, SwanBio Therapeutics

    Panelists:


    Kara Coluccio 
    Partner, Perspective Group


    Donna Higgins
    CEO, The Higgins Group


    Cynthia Mason
    VP, Executive Recruiter, Govig

  • 2:45 pm

  • Structuring and Managing a Team to Succeed in a Remote or Hybrid Environment

    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
    • Building a remote talent strategy

    Moderated by:


    Ed Tucker, MD, MBA

    CMO, Mirum Pharmaceuticals

    Panelists:

    Debora Barton
    Debora Barton, MD
    CMO, Carisma Therapeutics, Inc


    Greg Fiore, MD
    CEO, Exacis Biotherapeutics 

     

  • 3:25 pm

  • Afternoon Ice Cream Break

    • Grab & Go Refreshments
    • Meet the Exhibitors
    • Peer-to-Peer Networking
    • Thank you for wearing your masks

    THREAD’s View on Best Practices for preparing Decentralized Clinical Trials and Hybrid Trials

    Virtual attendees will have the option to attend a virtual face-to-face round table to have a deeper interactive conversation with Q&A on the following topics:  
    • Build clinical trials with decentralization in mind
    • Prepare a pipeline to be technology enabled
    • How to integrate DCT elements to actualize increased inclusion and efficiency

     

  • 3:55 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.

    Moderated by:

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

    Global CMO, Besins Healthcare Ireland Ltd

    Panelists:

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

    Ramon Mohanlal
    Ramon Mohanlal, MD, PhD, MBA
    EVP, R&D and CMO, BeyondSpring Pharmaceuticals 


    Shefali Agarwal, MD 
    EVP, Chief Medical and Development Officer, Epizyme

  • 4:25 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

  • 4:40 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.

    Moderated by:


    Christina Coughlin, MD, PhD
    CMO, Rubius Therapeutics

    Panelists:


    Joanne Lager, MD 
    CMO, iTeos Therapeutics


    Dawn Niccum
    Head of Quality Assurance and Compliance, InSeption Group

     

  • 5:10 pm
    - 5:45 pm

  • Networking

  • 5:45 pm

  • Day One Concludes

Agenda

  • 8:00 am

  • Tea/Coffee

    Masks are required indoors

  • 8:30 am

  • Co-Chairs Opening Remarks


    Zain Kassam, MD, MPH

    Co-Founder, CMO, Finch Therapeutics

    Julie Krop
    Julie Krop, MD

    CMO, PureTech Health


    Elizabeth 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

  • 9:30 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.

    Moderated by:

    Julie Krop
    Julie Krop, MD

    CMO, PureTech Health

    Panelists:


    Thurein Htoo, MS, MBA 

    CEO and Co-Founder, Qlaris Bio


    David Meeker, MD

    Chairman, President & CEO, Rhythm Pharmaceuticals


    Asit Parikh, MD, PhD 
    President and CEO, MOMA Therapeutics


    Parisa Zamiri, MD, PhD  
    CMO, Graybug Vision

  • 10:15 am

  • Opening Morning Day Two Break

     

    • Breakfast
    • Meet the Exhibitors
    • Peer-to-Peer Networking
    • Thank you for wearing masks

     

  • 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

    Moderated by:


    Laurie Halloran, BSN, MS

    President & CEO, Halloran Consulting Group, Inc

    Panelists:


    James “Terry” Ferguson, MD

    CMO, Matinas Biopharma


    Becker Hewes, MD 
    CMO, Blueprint Medicines


    Roger Waltzman, MD, MBA 
    CMO, Molecular Templates

  • 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
    Moderated by:

    Christopher Heery, MD

    CMO, ArcellX
     
    Panelists:
     
    Cathryn Clary, MD, MBA
    SVP, Medical, SSI Strategy
    Anna Frostegård
    Anna Frostegård, MD, PhD
    Co-Founder, Chief Scientific and Medical Officer, Annexin Pharmaceuticals
     

    Natalia “Natasha” Muhlemann, MD, MBA
    Vice President, Strategic Counseling, Cytel
     

    Ted Myles, MBA
    CFO & Head of Business Operations, Scholar Rock, Inc
     
    Josh Schimmer, MD, MBA
    Senior Managing Director, Evercore ISI
  • 12:00 pm

  • Lunch

  • 1:00 pm

  • Communicating and Pivoting After a Failed Clinical Trial

    In this session, Drs Garner and Davis share their experiences and how their organizations handled CRLs and failed clinical trials. They also address:

    • The role of the CMO in communicating and interacting with investors and stakeholders
    • Planning for potential failure by creating a communication plan
    • Ensuring CEOs understand the risk of failure without appearing like a pessimist


    Elizabeth Garner, MD, MPH
    CMO, ObsEva

    with

    Tom Davis
    Thomas Davis, MD
    CMO, Genocea Biosciences

  • 1:30 pm

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

    This panel gives insight into improving diversity in clinical research and new strategies in patient engagement throughout the trial.

    • Barriers to diversity in clinical trials and potential solutions
    • Lessons learned during COVID that can address those barriers
    • Keeping patients engaged and motivated to remain in studies
    • Educational tools and post-trial communication

    Moderated by:

    Julie Krop
    Julie Krop, MD

    CMO, PureTech Health

    Panelists:


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


    Barbara Wirostko, MD
    CMO and Co-Founder, Qlaris Bio

  • 2:00 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
    • Growing within your role
    • Performance assessment and improvement
    • Possibilities for expanding horizons


    Zain Kassam, MD, MPH

    Co-Founder, CMO, Finch Therapeutics

    with


    Jim Roach, MD
    Manager/Principal, J Roach BioPharma Consulting

  • 2:30 pm

  • Conference Concludes