Register Here

Agenda

  • 8:30 am

  • Registration, Coffee & Tea

  • 9:00 am

  • Co-Chair’s Opening Remarks

    Julie Krop
    Julie Krop, MD

    CMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc

    Jim James Roach
    Jim Roach, MD

    CMO, Pulmatrix

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSaveSaveSave

    SaveSave

  • 9:15 am

  • Bloomberg Intelligence on Biotech Landscape

    • How the current pricing structure will impact the biotech industry
    • What can CMOs do to help inform the discussion of the future?
    • How is this affected by the evolving relationship between industry and academia?
    • We’re seeing many more companies focused on rare diseases and immuno-oncology than common diseases now. How is the shift in therapeutic areas affecting the industry?


    Asthika Goonewardene, MBA

    Senior Biotech Analyst, Bloomberg Intelligence

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSaveSaveSave

    SaveSave

  • 9:45 am

  • How is the Shifting Biotech Life-Cycle Changing Clinical Partnerships with Big Pharma and the Role of the CMO?

    • Why are many biotechs staying intact as opposed to looking for an exit strategy?
    • What is the CMO’s role with big pharma in the partnership?
    • What is big pharma’s role in the partnership? Do they have a say in trial design and operations?

    Moderator:


    Beth Trehu, MD

    CMO, Jounce Therapeutics

    Panelists:

    Christopher Heery
    Christopher Heery, MD
    CMO, Bavarian Nordic

    Robert Ross
    Robert Ross, MD

    CMO, Surface Oncology, Inc


    Marc Schwabish, PhD

    SVP, Business Development and US Operations, Fusion Pharmaceuticals

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSaveSaveSave

    SaveSave

  • 10:20 am

  • Networking Break

  • 11:00 am

  • Annual Keynote Address on the Changing Clinical Trial Landscape: Anticipating the Migration of Clinical Research Into Clinical Care and the Impact on Biotech

    Identifying, initiating and conducting clinical trials among traditional investigative sites remains highly inefficient and unpredictable. Several major trends are moving industry-funded clinical trials into large health systems. This session:

    • Reviews major trends and conditions driving this migration
    • Explores new clinical trial models and processes emerging in clinical care settings
    • Anticipates new and modified capabilities to best leverage health system advantages

    Getz_Ken-2018
    Ken Getz

    Director of Sponsored Research/Founder, Tufts CSDD/CISCRP

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSaveSaveSave

    SaveSave

  • 11:30 am

  • How can CMOs Ensure Strategic, Impactful, and Mutually Beneficial Patient Engagement?

    • How can CMOs promote compliant and impactful engagement to enhance objectives and meet goals for both their organizations and patient groups?
    • How can patient engagement can enhance trials? What is their contribution to benefit/risk? What about engaging patients/groups outside of trials?
    • What is the CMO’s role in patient engagement? What are best practices and how can we move the needle to prepare for the future?

    Moderator:

    Giuseppe Del Priore
    Giuseppe Del Priore, MD, MPH

    CMO, Tyme Technologies, Inc

    Panelists:


    Jodie Sherman Gillon

    Global Medical Lead, Patient Engagement Rare Diseases, Pfizer


    Jeff Sherman, MD, FACP

    CMO, EVP R&D, Horizon Pharmaceuticals

    Neil Solomons
    Neil Solomons, MD

    CMO, Aurinia Pharmaceuticals

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSaveSaveSave

    SaveSave

  • 12:00 pm

  • Fireside Chat: Taking a Strategic Approach to Global Regulatory and Market Access Challenges

    • Is a global regulatory and market access strategy the way to go?
    • Why isn’t EMA approval the same as market access in Europe
    • What is the difference between EMA and FDA in regulating and approving medicines?
    • When and how do you generate evidence that will satisfy regulators and payers?
    • What is the best strategy to interact with regulators and payers?
    • Early access schemes in EU and how to qualify
    • How will trends like Real World Evidence influence regulatory decision making?
    • Brexit and its consequences for the EU regulatory system and how will it affect pharmaceutical companies


    Thomas Lönngren, PhD (hc), MRPharmS, FRCP

    Strategic Advisor, NDA Group AB, Former Head of EMA


    Jeff Sherman, MD, FACP

    CMO, EVP R&D, Horizon Pharmaceuticals

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSaveSaveSave

    SaveSave

  • 12:30 pm

  • Lunch and Therapeutic Specific Round-Tables

    Take the first 25 minutes to get lunch and take a break. At 12:55 pm, you have the option of joining a Therapeutic Specific Round-Table where a leader is assigned to help facilitate discussion in your specific therapeutic area of interest.

    Breakout Sessions Addressing Therapeutic Areas
    Join a discussion with other researchers in your therapeutic area for a collaborative session exchanging creative solutions, lessons learned, and creating new pathways.

    Table 1: Addressing CNS Disorders

    Table 2: Addressing Rare Disease

    Table 3: Addressing Oncology

    Table 4: Addressing Gene Therapy

  • 1:45 pm

  • How to Find the Right People and Build the A-Team

    The model of the recruiter has stayed the same, but the ability to successfully recruit the right people for your team has drastically changed.

    • How do you recruit for specific skill sets within your therapeutic area?
    • What is the best way to fill difficult positions?
    • If you’re based in an area full of talent, like Boston, how do you retain that talent?
    • If you’re based in an area without high recruiting potential, how do you attract talent?

    Moderator:

    Alan Roemer, MBA, MPH
    SVP, Corporate Development, Roivant Sciences, Inc

    Panelists:


    Kara Coluccio Bern

    Founder and Principal, Ivy Advisors, LLC


    Shawn Tang

    Head of R&D Talent Acquisition, Biogen

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSaveSaveSave

    SaveSave

  • 2:15 pm

  • Best Practices in Clinical Development and Outsourcing

    • How do you go about establishing clinically relevant endpoints?
    • When is it best to involve KOLs of your field? Expert researchers?
    • How do you involve KOLs in your communications with FDA/regulatory agencies?
    • Do you have a good measure on what the endpoints are? Including patient forward outcome measures?
    • How do you design a clinical trial where you get an early stage read out?
    • What is an example of accelerated clinical development pathways?
    • How can you create value as quickly as possible?

    Moderator:

    Ralf Rosskamp
    Ralf Rosskamp, MD

    CMO, Dicerna Pharmaceuticals

    Panelists:

    Zoran Antonijevic
    Zoran Antonijevic

    Chief Scientific Officer, MTEK Sciences


    David Clark, MD

    CMO, Aldeyra Therapeutics

    Dana Edwards
    Dana Edwards

    Head of Strategy and Development, Clinical Trial Optimization Solutions at IQVIA
     
    Jack Modell
    Jack Modell, MD

    VP and Senior Medical Officer, Rho, Inc


    Adrian Senderowicz, MD

    SVP, CMO, Constellation Pharmaceuticals

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSaveSaveSave

    SaveSave

  • 3:10 pm

  • Networking Break

  • 3:40 pm

  • Model-informed drug development? Why it matters especially to early stage and limited portfolio companies

    FDA Commissioner Scott Gottlieb has stated repeatedly that innovations in clinical research – specifically, adaptive trials and generally, more model-informed approaches, will speed the development process.  But what are the actual experiences among biotechs and special pharmas?  And what if your development goals stop short of filing for an NDA?

    Quantitative pharmacology, data science, adaptive designs, trial simulations and model-supported decision-making: Hear the real impact from the adopters.

    Moderator:

    Tom Falzareno
    Director, Clinical Research Services Business, Cytel

    Panelists:


    David Clark, MD

    CMO, Aldeyra Therapeutics


    Adrian Senderowicz, MD
    SVP, CMO, Constellation Pharmaceuticals

  • 4:00 pm

  • New Methods for Safety Signal Identification and Refinement, Including Machine Learning

    • How have patient safety measures evolved?
    • How do you prepare for the challenges of pharmacovigilance once your drug is approved?
    • How is the digitization of health data creating new pathways in pharmacovigilance?

    Anupam Agarwal
    Anupam Agarwal, MD, MPH

    Global Drug Safety and Pharmacovigilance, Zogenix, Inc

    Paul Beninger
    Paul Beninger, MD, MBA
    Assistant Professor, Tufts University School of Medicine and Director, MD/MBA Program 

  • 4:30 pm

  • Best Practices in Communication and PR Strategy

    • How can CMOs more effectively communicate with CEOs, CSOs, and Clinical Operations executives in order to provide a comprehensive summary of the science and business aspects of the company?
    • Learning to communicate to investors, analysts, board members, professional groups, investigators, patient advocacy using language they respond to
    • How can you help your CEO sell the accelerated clinical development path?
    • How can we better educate the public on expectations for clinical trial outcomes?
    • What can we be doing better to address negative press coverage?
    • How do you manage a crisis, like a death in your clinical trial, to the public?
    • How can we prepare for negative outcomes before they happen in real-time?

    Raju Joshi
    Raju Joshi, MS, CCRP

    Managing Partner, Clinical Partners Group


    Zain Kassam, MD, MPH

    CSO, Finch Therapeutics

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSave

    SaveSaveSaveSave

    SaveSave

  • 5:00 pm

  • Networking Reception

Agenda

  • 8:00 am

  • Coffee & Tea

  • 8:30 am

  • Co-Chair’s Opening Remarks

    Julie Krop
    Julie Krop, MD

    CMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc

    Jim James Roach
    Jim Roach, MD

    CMO, Pulmatrix

  • 8:45 am

  • Keynote Fireside Discussion: Lessons Learned from a Veteran Biotech and Investor MD

    Jim James Roach
    Jim Roach, MD

    CMO, Pulmatrix

    Elizabeth Stoner
    Elizabeth Stoner, MD, MS

    Managing Director, MPM Capital

  • 9:15 am

  • De-Risking a Failed Development Program

    In this session, we explore how expanding phase 2 programs, balancing development for both regulatory and marketing purposes, and de-risking a failed development program can further advance your clinical trial in the long term.

    Fran Brown
    Fran Brown, PhD

    SVP, Integrated Drug Development and Business Operations, Certara

    Richard Margolin
    Richard Margolin, MD

    Former Executive Director, Clinical Neuroscience and Interim Alzheimer’s Disease Group Head, Internal Medicine Research Unit, Pfizer, Inc

  • 9:45 am

  • Keynote: Best Practices for Biotechs to Collaborate with Large Pharma

    Azmi Nabulsi
    Azmi Nabulsi, MD

    Deputy Chief Medical & Scientific Officer, Head of R&D Strategic & Professional Affairs, Takeda

  • 10:05 am

  • CMO Exchange Between Small and Large Pharma: Addressing Mutual Challenges

    • What experiences can be translated across the industry divide?
    • What can large pharma learn from small pharma to increase efficiency?
    • What are the advantages of large pharma?
    • Lessons learned

    Moderator:

    Azmi Nabulsi
    Azmi Nabulsi, MD

    Deputy Chief Medical & Scientific Officer, Head of R&D Strategic & Professional Affairs, Takeda

    Panelists:

    Calvin Roberts
    Calvin W Roberts, MD

    CMO, Bausch + Lomb and Clinical Professor, Weill Cornell Medical College


    Barry Ticho, MD, PhD

    CMO, Stoke Therapeutics, Inc


    Steven Zelenkofske, DO

    CMO, UniQure

  • 10:30 am

  • Networking Break

  • 11:00 am

  • Case Study: Preparing for the Challenges of Late Stage Trials

    Case study from one company who lived to tell the tale.

    Mark Currie
    Mark Currie, PhD

    SVP, CSO, President of R&D, Ironwood Pharmaceuticals

  • 11:25 am

  • Adaptive Site Management: A Novel, Right the First Time and Quality by Design Approach to Managing Your Clinical Trials

    • Site-Focused: Using a proprietary technology to empower your sites and incorporate a high-performing study coordinator into the process
    • Increase quality, transparency and efficiencies while reducing your clinical trial costs by more than 35%
    • Case Study: How to run a Phase III trial with 250 patients and 50 sites monitored by only 1 CRA

    Daniel Perlman
    Daniel Perlman

    CEO, TPS

    Toby Vaughn
    Toby Vaughn

    Executive Director, Clinical Operations, Liquidia

  • 11:45 am

  • Pricing Trends and the Impact on R&D

    • How has pricing structure evolved for better or for worse?
    • How do we determine pricing of new drugs going to market?
    • Is the current pricing structure sustainable?
    • What are we doing to make drugs more affordable?

    Julia Gaebler
    Julia Gaebler, PhD

    Partner, Health Advances, LLC

  • 12:30 pm

  • Luncheon

  • 1:15 pm

  • Finding the Common Ground between CMOs and VCs

    • CMOs are looking for VCs who take a long term view at their science as an investment
    • Is it always important to be the quickest, cheapest option?
    • Are you looking for an exit strategy or a long-term strategy?

    Moderator:


    Barry Ticho, MD, PhD

    CMO, Stoke Therapeutics, Inc

    Panelists:

    Arjun Goyal
    Arjun Goyal, MD, MPhil, MBA

    Managing Director, Vida Ventures


    Vikas Goyal, MBA

    Principal, SR One


    Luba Greenwood

    Strategic Business Development and Corporate Ventures, Verily Life Sciences

  • 1:45 pm

  • Going from Big Pharma to Small Biotech Leadership: Challenges and Opportunities

    • Handling the false assumption that small pharma is less secure
    • Big pharma provides structured learning opportunities, but small pharma provides opportunities for exploration and collaboration
    • Dealing with potential lack of resources when looking for answers

    Moderator:

    Julie Krop
    Julie Krop, MD

    CMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc

    Panelists:

    Manu Chakravarthy
    Manu Chakravarthy, MD, PhD

    CMO, SVP Clinical Development, Axcella Health, Inc

    Keith Gottesdiener
    Keith Gottesdiener, MD

    CEO, Rhythm Pharmaceuticals

    Robert Wasserman
    Robert Wasserman, MD

    CMO, Northern Biologics
  • 2:15 pm

  • CMO Leadership Case Study: A Unique Approach to Registration in a Large Indication

    Hear from global and multicultural pharmaceutical executive, Christophe Arbet-Engels, about how Poxel decided in a very crowded market to go to a smaller country first, Japan, to start a Phase 3 registration program and find a commercial partner.

    Christophe Arbet-Engels
    Christophe Arbet-Engels, MD, PhD

    CMO, Poxel Pharmaceuticals

  • 2:45 pm

  • Networking Break

  • 3:15 pm

  • Should Patients Have the Right to Try?

    The debate of compassionate use and right to try has created a lot of controversy in the industry. In this discussion, we unpack the implications, both positive and negative, of opening up that door.


    Alison Bateman-House, PhD, MPH, MA

    Assistant Professor, Division of Medical Ethics, NYU Langone Health

  • 3:45 pm

  • What Could Be a CMO’s Career Trajectory?

    • Are all “CMO” roles equal?  Are there opportunities for career growth and development across different CMO roles?
    • What are the possibilities for CMOs to expand their horizons within biotech/pharma? Head of R&D?  CEO? Other?
    • What about other possibilities outside of a “company” environment? Consulting?  Venture Capital?  Board roles?
    • How can a CMO best position themselves to be considered for different types of leadership opportunities?
    • What are your individual/personal goals and ambitions and how should these influence your career choices?
    • How do you balance the difference between what you want to do vs what you (or others) think you should do?

    Moderated by:

    Jim James Roach
    Jim Roach, MD

    CMO, Pulmatrix

    Panelists:


    Mark Corrigan, MD

    Co-Founder, President R&D, Tremeau Pharmaceuticals

    Greg Fiore
    Gregory Fiore, MD

    President and CEO, Sollis Therapeutics


    Steven Zelenkofske, DO

    CMO, UniQure

  • 4:15 pm

  • Conference Concludes