2023 Agenda
7:50 am
Registration Opens, Tea/Coffee
8:20 am
Co-Chairs Opening Remarks
Nerissa Kreher, MD, MBA
CMO, Entrada Therapeutics
Ed Tucker, MD, MBA
Former CMO, Goldfinch Bio
8:30 am
🔑 Annual Keynote
Annual Clinical Development Landscape Keynote
- Overview of the changing drug development landscape
- Review of underlying trends and practices and their current and anticipated impact
- Discuss strategies and practices addressing challenges and pain points
- Highlight transformational opportunities to optimize drug development performance
Kenneth Getz, MBA
Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine/ Founder and Board Chair, CISCRP
9:00 am
🔑 CEO Keynote
Reflections on Alnylam and Biotech LeadershipThe CMO Summit is honored to have for the first time, bioentrepreneur, Dr John Maraganore, founding CEO, Alnylam Pharmaceuticals, as a keynote presenter. Dr Maraganore will share highlights and lessons learned from his 19 years as a CEO leading a team that conquered some very difficult drug development challenges.
John Maraganore, PhD
Founding CEO, Alnylam Pharmaceuticals
9:30 am
🔑 Keynote
Keynote Fireside Discussion with JP Morgan Executive Director of Healthcare Investment BankingIn this fireside discussion, Dr Elena Lovo shares her thoughts on:- Biotech investment trends in 2023
- What American biotechs should consider about the European biotech finance environment
- How CMOs can support the overarching process of a fundraising
- The hard and soft skills needed to succeed in investor interactions
Elena Lovo, PhD
Executive Director, Healthcare Investment Banking, JP Morganwith
Nerissa Kreher, MD, MBA
CMO, Entrada Therapeutics
10:00 am
Grand Opening of the CMO Summit 360˚ Cafe & Networking Break
- Breakfast
- Meet the Exhibitors
- Peer-to-Peer Meetings
10:45 am
An Update on Regulatory Trends and Best Practices in Navigating FDA Interactions
Moderated by:
Anna Berkenblit, MD, MMSc
VP, CMO, ImmunoGenPanelists:
Matteo Levisetti, MD
CMO, Cue Biopharma
Laurie Smaldone Alsup, MD
Chief Medical & Scientific Officer, NDA Group
Laura Williams, MD, MPH
CMO, Ardelyx
Scott Harris, MD
CMO, Altimmune
11:15 am
Leveraging Patient Advocacy Groups for Successful Trial Recruitment
- Provide an educational experience and build knowledge to help patients decide to enroll into clinical trials
- Overcoming lack of diversity in clinical trials by directly reaching out the patient communities
Andreas Reiff, MD
SVP, Immunology & Inflammation, Parexel
11:30 am
Regulatory Case Study: Getting FDA Approval in a Cell & Gene Therapy
Richard Colvin, MD, PhD
CMO, Bluebird Bio
11:50 am
When Novelty Is Not Enough: Assuring Adoption, Access, As Well As Approval Within The Clinical Development Process
- Healthcare is a complex, evolving and dynamic system of care – neither orderly nor always rational, diverse stakeholders impact the development pathway for product registration.
- Amongst the hierarchy of mandates, demonstrating the “value” of a novel chemical, or biological entity as well as its clinical efficacy/and safety is a prerequisite for patient access.
- Correspondingly, clinical development plans incorporate a mix of observational and interventional research to address divergent needs for data, tailored to phase of development
- Contract Research Organization role in facilitating this process provides an exceptional opportunity for organizational differentiation to facilitate adoption, access and approval
Michael Murphy, MD, PhD
Chief Medical & Scientific Officer, Worldwide Clinical Trials
12:05 pm
Prioritizing Development Programs and Pipelines that Align with Fundraising Catalysts
In this session, panelists discuss how they prioritize and optimize their development portfolios for success and make development decisions in the current resource-constrained environment. Should you prioritize assets with the best quality science? Lowest cost? Fastest? Biggest ROI?
Moderated by:
Bernard Ravina, MD, MS
Entrepreneur in Residence, Atlas VenturePanelists:
Albert Kim, MD, PhD
CMO, Cytel
Mustafa Noor, MD
CMO, Olatec Therapeutics
Mauro Avanzi, MD, PhD
CMO, Shoreline Biosciences
12:35 pm
Getting Hard Feasibility Data: How To Do It
This presentation offers key insights with answers that speak to the following:
- How do you access current, hard feasibility data?
- Does your CRO have a stable, permanent clinical team with trial legacy capability and expertise in your domain?
- Are your sites and vendors audit proof?
- Does your CRO act like a SMO with a dedicated site network?
- Are you confident your CRO has the capacity to achieve your study milestones on or before deadline?
- Is your CRO independent, and well-rounded in regard to systems, with a collaborative vendor team of specialized expertise to support your program?
Patrick Smith, MSc
Feasibility Manager & Clinical Trial Leader, Scimega Research
12:50 pm
CMO Summit Founding Advisor on the Biotech Landscape
Elizabeth Stoner, MD
Executive Partner, MPM Capital
1:00 pm
Lunch and Optional Roundtable Discussions
- Lunch
- Meet the Exhibitors
- Peer-to-Peer Meetings
Optional Roundtable Discussions
Roundtable #1: Challenges & Opportunities in CNS
Shaheen Lakhan, MD, PhD
CMO, Click Therapeutics
Richard Malamut, MD
CMO, MedinCell
Timothy Peters-Strickland, MD
VP, Global Medical Officer, Biotech Solutions, PPD, Part of Thermo Fisher Scientific
Roundtable #2: New Regulatory Initiative in Oncology
Alessandra Cesano, MD, PhD
CEO, ESSA Pharma
Kartik Krishnan, MD, PhD
CMO, OncoNano Medicine
Roundtable #3: Challenges & Opportunities in Cell & Gene Therapy
Todd Druley, MD, PhD
CMO, Mission Bio
Mohammed Asmal, MD, PhD
SVP, Head of Clinical, Prime Medicine
Roundtable #4: Challenges & Opportunities in Rare Disease
Ottavio Vitolo, MD
CMO, Cerevance
Raymond Urbanski, MD, PhD
SVP, Head of Clinical Development & Medical Affairs, PharmaEssentia
2:00 pm
Two Track Choices
TRACK A:
Early Stage Companies / Development
Track Chair:
Anna Frostegård, MD, PhD
Co-Founder, Chief Scientific & Medical Officer, Annexin Pharmaceuticals
2:00 pm
What CMOs Get Right and Get Wrong About Early Development
Barry Ticho, MD, PhD
CMO, Stoke Therapeutics
David Davidson, MD
Chief Medical & Development Officer, Tessera Therapeutics
2:20 pm
Intro to Finance & IPOs for CMOs
The financial side of leading a biotech can often seem like a different language to CMOs. In this session, panelists representing the CMO, CFO, investor and analyst perspectives explain what CMOs need to know about the IPO process from drafting an S-1 through bake-offs, TTWs, pitch deck drafting, the roadshow and stock issuance.
Moderated by:
Joanne Lager, MD
CMO, iTeos TherapeuticsPanelists:
Timothy Lu, MD, PhD
CMO, Dice Therapeutics
Josh Schimmer, MD, MBA
Senior Managing Director, Evercore ISI
Sanjay Subramanian, MS, MBA
CFO, Inozyme Pharma
Bernard Cooney, MBA
Senior Partner, Capital Formation, Flagship Pioneering
3:00 pm
Developing Internal and External Communication Strategies
In this panel, perspectives from corporate communications, regulatory and legal discuss best practices in effectively sharing your story with different audiences focusing on:
- Authentic messaging
- Press releases
- Sharing new data
- Social media
- Managing bad news
Moderated by:
Jodie Gillon, MPH
SVP, Corporate Affairs & Patient Advocacy, PeptilogicsPanelists:
Karla MacDonald
Chief Corporate Affairs Officer, Entrada Therapeutics
Austin Chiang, MD, MPH
CMO, Medtronic GI
Stephen Kanes, MD, PhD
CEO, EmbarkNeuro
Daniel Gold
President, Fairway Consulting Group
TRACK B:
Late Stage Development / Medical Affairs
Track Chair:
Ed Tucker, MD, MBA
Former CMO, Goldfinch Bio
2:00 pm
Preparing for Late-Stage Development
Seemi Khan, MD, MPH, MBA
SVP, CMO, Reata Therapeutics
2:20 pm
Interacting with Different Types of Investors as a CMO
In a constrained financial environment, presenting effectively to investors and analysts becomes paramount. In this session, panelists discuss how best to interact with specialist and generalist investors and analysts. Topics include:
- Tailoring your message to bulls and bears
- What do you do if they don’t believe in your company?
- What types of data are investors looking for?
- What exasperates investors and analysts about biotechs and how to rise above
Moderated by:
Alex Snyder, MD
CMO, Generate BiomedicinesPanelists:
Jatin Shah, MD
CMO, EVP and Global Head of Development, Sumitomo Pharma Oncology
Randall Stanicky
CFO, Click Therapeutics
Timothy Peters-Strickland, MD
VP, Global Medical Officer, Biotech Solutions, PPD, Part of Thermo Fisher Scientific
Stefan Vitorovic, MS, MBA
Co-Founder & Managing Director, Vida Ventures
3:00 pm
What CMOs Need to Know About Medical Affairs
- Publication management
- Internal interactions
- KOL interactions
- Working with MSL organizations
- When to officially kick off medical affairs
Moderated by:
John Yee, MD, MPH
CMO, Sobi – North AmericaPanelists:
Daniel Chung, DO, MA
CMO, SparingVision
Joseph Elassal, MD, MBA
CMO, Ankyra Therapeutics
Peg Crowley-Nowick, PhD, MBA
President, Medical Affairs Consulting and Head of Medical Affairs, Lumanity
3:30 pm
Afternoon Break & Networking
- Refreshments with Social Distance
- Meet the Exhibitors
- Peer-to-Peer Meetings
4:00 pm
Two Track Choices
TRACK A:
Innovations in Clinical Development & Remote WorkTrack Chair:
Anna Frostegård, MD, PhD
Co-Founder, Chief Scientific & Medical Officer, Annexin Pharmaceuticals
4:00 pm
Implementing Patient-Centricity Throughout Clinical Development and Preparing for Launch
This session provides CMOs with updated trends and best practices to avoid pitfalls and maximize collaboration throughout the development continuum to benefit patients and caregivers, the trial and the biotechs. Specifically:
- Protocol development, trial execution
- Preparing for reimbursement at launch
- Novel ways to engage patients and caregivers
- Patient fair market value
- Trial endpoint decisions
Moderated by:
Serena Hung, MD
CMO, Arkuda TherapeuticsPanelists:
Rolf Benirschke
Patient Advocate & Former NFL Player, Legacy Health Strategies
Sarah Gheuens, MD, PhD, MMSc
CMO, Head of R&D, Agios Pharmaceuticals
Amy Simon, MD
CMO, Beam Therapeutics
4:30 pm
Clinical Trials Outside the Office: DCTs and RWE in 2023 and Beyond
Panelists share experiences and best practices in designing and running decentralized clinical trials focusing on:
- Ensuring data integrity and patient safety
- Usability for sites & patients
- Changing regulatory implications
- Empowering patients
- Justifying the investment in these technologies and models
Jeffrey Bornstein, MD
CMO, Eledon Pharmaceuticals
Joseph Kim, MBA
Chief Strategy Officer, ProofPilot
Ali Hariri, MD
SVP, CMO, Eloxx Pharmaceuticals
Chelsey Ryan
Director of Clinical Operations and Pharmacovigilance, PROMETRIKA
5:00 pm
Leading & Managing Hybrid Teams
As companies have more time to thoughtfully explore evolving work environments, building and maintaining a corporate culture with an eye towards flexibility becomes both an opportunity to attract and retain talent and a challenge to manage geographically diverse teams. Panelists address:
- Different models of virtual and hybrid work
- Investing in corporate culture to ensure unity of mission
- Impacts on hiring practices, career development, retention and operations
- Lessons learned
Moderated by:
Simon Cooper, MBBS
CMO, Keros TherapeuticsPanelists:
Karen Ivester
Executive Director Operations, Cell & Gene Therapy Programs, inSeption Group
Nushmia Khokhar, MD
CMO, Pyramid Biosciences
TRACK B:
Outsourcing & Workforce Development
Track Chair:
Ed Tucker, MD, MBA
Former CMO, Goldfinch Bio
4:00 pm
CRO Selection & Assigning Accountability
Arguably the most important and expensive decision a biotech makes is around choosing a development partner. In this session, CMOs and CROs share how to navigate the RFP process in selecting a partner as well as how to avoid costly change orders and prevent common pitfalls.
Edwin Rock, MD, PhD
CMO, GlycoMimetics
David Huang, MD, PhD
SVP & CMO, Peptilogics
Raul Lima, MBA
EVP, Strategic Clinical Operations, inSeption Group
4:30 pm
Best Practices in Building Out Your Clinical Development Team
This session addresses the following key issues:
- How do you incorporate FTEs, consultants and CROs as your company grows?
- What are the pivot points around which you hire in-house expertise?
- How do you think about partnering with boutique CROs versus the big box CROs?
- How do finances tie into these decisions?
Moderated by:
Vicki Goodman, MD
CMO, ExelixisPanelists:
Marcella Ruddy, MD
CMO, Tectonic Therapeutic
Hunter Smith
Executive Recruiter, Govig & Associates
Raul Lima, MBA
EVP, Strategic Clinical Operations, inSeption Group
5:00 pm
Navigating the Urgent Workforce Shortage and Turnover
With the growing trend of employees moving from company to company, the difficult financial environment and increased specialization of roles within biotech, effectively hiring and retaining staff is a top priority. Panelists discuss:
- Running operations effectively considering all the movement
- Hiring the right people quickly without selling yourself short
- Managing for title and salary creep
- Retaining talent through non-monetary incentives
Moderated by:
Patrick Burnett, MD, PhD
CMO, Arcutis BiotherapeuticsPanelists:
Barbara Day
Principal, Pharmaceutical Practice, Penfield Search Partners
Holly Schachner, MD
SVP, Clinical Development, NorthSea Therapeutics
James Lewis
Executive Director, Barrington James
Cliff Miras
Managing Partner, Miras Search Partners
5:30 pm
Networking Reception
6:30 pm
Day One Ends
2023 Agenda
7:50 am
Registration Opens, Tea/Coffee
8:20 am
Co-Chairs Opening Remarks
Nerissa Kreher, MD, MBA
CMO, Entrada Therapeutics
Ed Tucker, MD, MBA
Former CMO, Goldfinch Bio
8:30 am
🔑 Keynote Fireside Discussion
Keynote Fireside Discussion with Morgan Stanley’s Managing Director and Chair of Biotechnology Investment BankingIn this fireside chat, we are pleased to welcome back Jessica Chutter to share her thoughts on:- The current state of the biotech financial environment
- Future of biotech M&A
- Trends, opportunities
- Thoughts on evaluating companies
- Strategic transactions
- Examples of how investors evaluate companies
- Thoughts on sustaining publicly traded companies
- The importance of clinical trial design and readouts
- Thoughts on regulatory pathways, and primary endpoints
- Q&A
Jessica Chutter
Managing Director and Chair of Biotechnology Investment Banking, Morgan Stanleywith
Alise Reicin, MD
CEO & President, Tectonic Therapeutic
9:00 am
🔑 CMO Keynote
The Evolving CMO Role Through Moderna’s Rapid DevelopmentIn this session, Dr Zaks will share how he adapted his role as CMO at Moderna through rapid vaccine development from pre-clinical through commercialization in an unprecedented time. He will also discuss views on the future of biotech drug development.
Tal Zaks, MD, PhD
Partner, Private Equity, OrbiMed
9:30 am
Visualizing Trade-Offs and Improving Decision-Making
This talk will discuss mitigation strategies to manage uncertainties improve decision-making in clinical development, with a focus on:
- Difficult choice of endpoints (multiple candidates) and study population
- Enabling better interim decisions
- Visualizing trade-offs to inform decisions
Natalia “Natasha” Mühlemann, MD, MBA
VP, Strategic Consulting, Cytel
9:50 am
Morning Break & Networking
- Breakfast
- Meet the Exhibitors
- Peer-to-Peer Meetings
10:30 am
- C-Suite Fireside ChatsFor the first time at the Summit, CMOs are joined by their C-Suite colleagues in fireside discussions to share how CMOs can best engage with their peers, overcome pain points, agree and disagree effectively and collaborate cross-functionally.
CMO – COO
Mark De Rosch, PhD
COO, Aura Biosciences
Cadmus Rich, MD
CMO & Head of R&D, Aura Biosciences
CMO – CFO
Richard Wanstall, MBA
CFO, Oncorus
John Goldberg, MD
CMO, Oncorus
CMO – CSO
May Orfali, MD, MBA
EVP, CMO, Sigilon Therapeutics
11:30 am
Skill Areas that CMOs can Benefit From
A Crash Course on What to Know about Patient Adherence, and Pharmacometrics
Moderated by:
Ed Tucker, MD, MBA
Former CMO, Goldfinch Bio
Lessons Learned in Implementing Digital Adherence Monitoring in a Late-Stage Drug Development Clinical Trial
- An introduction to the ramifications of poor adherence in clinical trials
- Tell-tale signs that poor adherence is present
- People, process, and tech involved in digital monitoring implementation
- Lessons Learned
Bernard Vrijens, PhD
CEO & Scientific Lead, AARDEX Group
Ning Yu, PhD, MBA
Director, Technical Development, Biogen
Multiregional Regulatory Strategies: Enabling Successful Early Drug Development
- Application of early regulatory engagement in Europe & UK
- Benefits of regulatory alignment across EMA, FDA & UK
- Building your PV, QA & REG teams at the right time
Peter Embley
Chief Regulatory Officer, Ariello
Establishing a Culture of Quality: What Every CMO Must Know
- Five Key Elements of a Culture of Quality
- Four Strategies for enabling a Culture of Quality
- Three Risks of not adopting a culture of Quality
- Positive Business Impact of a Culture of Quality
Sheila Gwizdak, MS
VP, Organizational and Quality Solutions,, Halloran Consulting Group
Exposure-Response Analysis to Find the Right Dose for the Right Patient
The key to successful drug development is finding the drug exposure that maximizes efficacy and minimizes side effects. Pharmacometrics integrates complex pharmacological and biological information from various sources into exposure-response models. This session will address how CMOs can leverage highly skilled pharmacometricians and clinical pharmacologists to create actionable insights for making informed dose decisions, including:
- Finding the right dose for the general patient population and special populations using exposure-response models
- Utilizing these regulatory compliant analyses at all stages of drug development.
- Leveraging these tools to improve the probability of success throughout the drug development process.
Klaas Prins, PhD
Head of Business Development & Partner, qPharmetra
12:30 pm
M&A From the CMO Perspective
In this session, panelists share their experiences as CMOs leading up to and during mergers. They specifically address:
- How to frame yourself for pharma and when to approach them
- Fostering a great relationship and balancing priorities
- Avoiding negative outcomes including delays and loss of knowledge
- What’s next for CMOs
Moderated by:
Barbara Klencke, MD
CMO, Sierra Oncology, a GSK CompanyPanelists:
Howard Rutman, MD, MBA
CMO & Head of Medical and Development, Xalud Therapeutics
Tadaaki Taniguchi, MD, PhD
CMO, Astellas Pharma
1:00 pm
Lunch and Optional Roundtable Discussions
- Lunch
- Meet the Exhibitors
- Peer-to-Peer Meetings
Roundtable #1: Adapting to the Role as a First-Time CMO
Raphaël Rousseau, MD, PhD
Former CMO, Neogene Therapeutics
Chin Lee, MD, MPH
CMO, Connect Biopharma
Roundtable #2: Compensation Contracting 101 for CMOs
Joseph Palumbo, MD, MACPsych
CMO, BioVie
Hunter Smith
Executive Recruiter, Govig & Associates
Donna Higgins
CEO, The Higgins Group
Roundtable #3: Career Coaching for CMOs
Roger Waltzman, MD, MBA
CMO, Molecular Templates
Debora Barton, MD
CMO, TScan Therapeutics
Roundtable #4: Making an Impact Through Storytelling
Effective storytelling is the key to attracting investors and motivating employees. In this roundtable discussion, presentation coach Donna Schwarz will provide a framework to quickly convey a compelling story that influences and inspires.
Donna Schwarz
Presentation Coach, Schwarz Consultants
2:00 pm
Unexpected Skill Sets Needed to Succeed as a CMO
CMOs share what skills they had, what they needed to learn and how they figured out the unknown unknowns based on their backgrounds in academia, pharma or biotech.
Moderated by:
James “Terry” Ferguson, MD
CMO, Matinas BiopharmaPanelists:
Sarah Grant, MD
CMO, Celsius Therapeutics
Arvin Yang, MD, PhD
CMO, Mersana Therapeutics
Deyaa Adib, MD
CMO, Triumvira Immunologics
Donna Higgins
CEO, The Higgins Group
2:30 pm
Navigating Board Interactions from Startup through Commercialization
In this session, CMOs and board members share how to best have influence and communicate simply and effectively with your Board around development, regulatory pathways, and justifying spending. Additionally, they discuss best practices around evolving boards, hiring/firing board members and independent board members.Moderated by:
Randall Kaye, MD, MPH
CMO, Longboard PharmaceuticalsPanelists:
Elliot Ehrich, MD
CMO, EVP, Translational Science, LifeMine Therapeutics
Iman El-Hariry, MD, PhD
CMO, Erytech
Michele Gerber, MD, MPH
CMO, Myeloid Therapeutics
Mary Spellman, MD
Principal, Panclarity
3:00 pm
Gathering Expertise in New Indications and Modalities
Over the course of one’s career as a CMO, there is inevitably exposure to new indications or modalities of treatment whether as one transitions from company to company or as a biotech expands its asset and study portfolio. In this session, panelists share how they achieved competence and expertise in new areas as well as best practices in leveraging external experts.
Moderated by:
Alessandra Cesano, MD, PhD
CMO, ESSA PharmaPanelists:
Samuel Falsetti, PhD
Global Chief Biotechnology & Innovative Solutions Officer, Inizio Biotech
Barbara Wirostko, MD
CMO & Co-Founder, Qlaris Bio
3:30 pm
The CMO’s Role as Mentor
In addition to the CMO’s responsibilities as an executive within their company, there is also a desire to provide mentorship and growth opportunities to both direct and indirect reports. In this session, panelists share how they think about and provide professional development to their teams.
Moderated by:
Barbara Troupin, MD
Independent Director, EquilliumPanelists:
Eslie Dennis, MD, MBChB
SVP, CMO & Head NA Medical Affairs, Kyowa Kirin
David Feltquate, MD, PhD
CMO, Palleon Pharmaceuticals
Oscar Segurado, MD, PhD
CMO, ASC Therapeutics
4:00 pm
Town Hall on CMO Career Development
Moderated by:
Steve Zelenkofske, DO
President/Principal, SLZ ConsultingPanelists:
Randall Moreadith, MD, PhD
President & CEO, Serina Therapeutics
4:30 pm
Conference Concludes