15th Annual Outsourcing in Clinical Trials East Coast 2024

Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget

21 - 22

May

2024
  • Valley Forge Casino Resort, King of Prussia, PA, USA
  • Complimentary
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Why attend?

WHAT TO EXPECT FOR 2024?

450+

Attendees

70+

Exhibitors

30+

Speakers

450+

Attendees

70+

Exhibitors

30+

Speakers

See What It's All About

Agenda

  • 21 May 2024
  • 22 May 2024
Expand All

Streams

Stream one

Clinical Operations and Outsourcing

Stream two

Clinical Technology and Innovation

10:30 AM

Morning Refreshments & Networking

11 AM

PANEL DISCUSSION: AI and digitalization in clinical trials

  • How AI can improve and streamline clinical operations: opportunities and real use cases
  • AI as a tool to support thinly stretched clinical operations teams: where can this be utilized to minimize workloads and increase overall output?
  • How are clinical trial sponsors implementing tools such as Generative AI and ChatGPT?
  • FDA perspectives on AI in clinical trials: are there limitations to its use?

MODERATOR:

Judyth Zahora, Senior Director, GCP Quality Risk Management and Process Improvement, Agenus

 

PANELLISTS:

Blake Edward Wilson, Partner (FDA Regulatory), Hogan Lovells

Derek Shannon, Director, Statistical Project Management, Madrigal Pharmaceuticals

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
Blake Edward Wilson
Partner (FDA Regulatory), Hogan Lovells
Derek Shannon
Director, Statistical Project Management, Madrigal Pharmaceuticals

11:30 AM

Reserved for Saama Technologies

12 PM

AI 101: the opportunities of AI for clinical trials

  • An overview of different types of AI and machine learning and where there are opportunities to use these in clinical trials
  • Assessing easy ways to incorporate and implement AI into your clinical study
  • Where is AI being utilized in other industries and how can this be applied to clinical trials?

Speakers

Derek Shannon
Director, Statistical Project Management, Madrigal Pharmaceuticals

12:30 PM

Reserved for eClinical Solutions

12:45 PM

Reserved for Acolad

1 PM

Lunch and networking

2 PM

CASE STUDY: Advancing therapeutics for rare diseases: innovative methods to ensure your trial is a success

  • An overview of developments in running a rare disease trial in the US
  • Using precision medicine in clinical trials: what new opportunities are unlocked?
  • Assessing clinical data with biomarker-correlated outcomes in Rett Syndrome

Speakers

Daniel Klamer
Vice President, Business Development & Scientific Strategy, Anavex Life Sciences

2:30 PM

Reserved for Clario

3 PM

The impact of high turnover of site staff on data collection and what sponsor companies can do to help

  • How to deal with high turnover of staff as a sponsor company: what issues are caused by this?
  • Assessing available technology and processes to alleviate pressure and workload on site staff
  • The importance of maintaining a strong relationship with sites when it comes to data entry and collection

Speakers

Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories

3:30 PM

Afternoon refreshments, networking and Apple prize draw

4 PM

Forecasting and budgeting for your clinical trial

  • Ensuring your trial is both cost-conscious and efficient without compromising on quality
  • Techniques, processes and technology to improve forecasting and budgeting
  • Avoiding common mistakes to keep your clinical trial budget on track

Speakers

Subs Tripathy
Head of Global Procurement, Seagen

4:30 PM

Reserved for session sponsor

5 PM

Critical to quality variables to drive risk assessment for functional plans and oversight

Speakers

Terry Katz
Senior Director, Biostatistics, Data Management Planning, Functional Excellence, Daiichi Sankyo

5:30 PM

Chairperson’s closing remarks

7:30 AM

Registration & Refreshments

8:20 AM

Chairperson’s opening remarks

Speakers

Peter O’Neill
Senior Director, Clinical Operations, Cellectis

8:30 AM

PATIENT ADVOCACY KEYNOTE: A caregiver’s story: supporting children participating in a clinical trial

  • What do patients and caregivers experience when participating in a clinical trial, from start to finish?
  • Understanding patients’ motivations for choosing and staying in a clinical trial
  • Hurdles and barriers to patients’ participation in pediatric clinical trials: what can pharma companies do to improve this and relieve burden on patients and caregivers?

Speakers

Kelly Franchetti
Senior Vice President And Global Head, Patient Insights And Strategy, YPrime

9 AM

Reserved for Medidata Solutions

Speakers

Alex Ireland
Associate Director Business Development, Novotech

9:30 AM

PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

  • Weighing up pros and cons of different outsourcing models: which is best for your trial?
  • When is mixing and matching better than fully outsourcing or keeping trials fully in house?
  • Developing an outsourcing strategy as a small to medium sized biotech with limited resources
  • Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?

 

MODERATOR:

John J. Seman, Chief Executive Officer, REVITALE Pharma

 

PANELLISTS:

Terry Katz, Senior Director, Biostatistics and Data Management Planning and Functional Excellence, Daiichi Sankyo

Jessica King, Head of Clinical Operations, Sonnest

Maria Metzger, Executive Director, Supplier Relationship Management and Performance, Clinical Development Operations, Eikon Therapeutics

Priya Marreddy, Vice President, Clinical Operations, Context Therapeutics

Speakers

John J. Seman
Chief Executive Officer, REVITALE Pharma
Terry Katz
Sr. Director, Biostatistics and Data Management Planning and Functional Excellence, Daiichi Sankyo, Inc.
Jessica King
Head of Clinical Operations, Sonnest
Maria Metzger
, Executive Director, Supplier Relationship Management and Performance, Clinical Development Operations, Eikon Therapeutics
Priya Marreddy
Vice President, Clinical Operations, OnCusp Therapeutics

10 AM

Reserved for ICON

Speakers

Kevin Collier
VP, Medidata

10:30 AM

Morning refreshments and networking break

11 AM

Site management: building a strong partnership with sites to ensure you are a sponsor of choice

  • Creating a partnership that is built on reciprocity and providing a voice for site feedback
  • Collaboration and training to ensure sites are confident and equipped to successfully complete trial
  • Reducing the burden on sites financially and operationally
  • Supporting sites individual needs from established clinics to naïve sites

Speakers

Suzy Montanye
Site Relationship Manager, Endo Pharmaceuticals

11:30 AM

Reserved for Worldwide Clinical Trials

12 PM

Insights into barriers to care in the rare disease community

  • Challenges and nuances of rare disease patients’ journey to receive a diagnosis
  • Recognizing the pivotal role insurance plays in accessing healthcare services
  • Assessing adequacy of healthcare coverage, affordability of services, and the extent to which patients utilize available healthcare resources
  • Exploring overall experiences individuals have had within the healthcare system: strengths and areas for improvement
  • Mental health and well-being: the emotional toll rare diseases take on patients and caregivers

Speakers

Jenifer Waldrop
Executive Director, Rare Disease Diversity Coalition

12:30 PM

Reserved for PCM Trials

1 PM

Lunch and networking

2 PM

Effective patient education to increase enrolment and retention

  • Making trial participation easy for patients: what is effective and what isn’t?
  • Ensuring communications with patients are pitched at the right level in order to maximize understanding and thus increase retention
  • Innovative ways to create resources for patients using new technology and digital content

Speakers

Susan Neal
Director, Clinical Operations, Novavax

2:30 PM

Reserved for session sponsor

3:30 PM

Afternoon refreshments, networking and Apple prize draw

3:50 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

4 PM

CASE STUDY: Practical challenges when running a rare disease trial in the US

  • The regulatory landscape for rare disease trials in the US: what do you need to be aware of?
  • Learnings and outcomes from running a rare disease trial: where were the main hurdles
  • Working with CROs and vendors in order to deliver a successful orphan drug clinical trial

Speakers

Emily Cook
Senior Vice President, Clinical Operations, Palvella Therapeutics

4:30 PM

Reserved for session sponsor

5 PM

CASE STUDY: Targeting Alzheimers: rationale and clinical trial plans at Neurotez

Speakers

Dr Nikolaos Tezapsidis
President and Chief Executive Officer, Neurotez

5:30 PM

Chairperson’s closing remarks

Speakers

Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

5:50 PM

END OF DAY 1 AND NETWORKING DRINKS

Streams

Stream one

Clinical Operations and Outsourcing

Stream two

Clinical Technology and Innovation

9 AM

Site selection for increased patient recruitment and retention

  • Highlighting discrepancies in the distance between clinical trial sites and the disease prevalent populations using case studies
  • Exploring the impact of appropriate and inappropriate site selection on a trial’s success through case studies
  • Showcasing how patient accrual has been affected in clinical trials utilizing virtual components

Speakers

Sonnika Lamont
Analyst, Clinical Trials Intelligence, GlobalData Plc

9:30 AM

Technology spotlight reserved for Diligent Pharma

Technology spotlight reserved for Diligent Pharma
Technology spotlight reserved for Egnyte

Speakers

Ted Kirby
Senior Director, Product Marketing, Saama

10 AM

Topic TBC

  • What is blockchain?
  • How can it be adapted in the Clinical Trial?
  • Why do we need to reach a consensus platform as soon as possible?  Who gets to decide this, will it be FDA or the Pharma industry?
  • What would be its cost impact on drug development?
  • Why does the C-suite need to engage in blockchain use immediately?

Speakers

Blake Edward Wilson
Partner (FDA Regulatory), Hogan Lovells

10:30 AM

Morning Refreshments & Networking

11 AM

PANEL DISCUSSION: Has DCT passed its peak in popularity?

  • Was DCT just a COVID buzzword or does it still have practical applications?
  • How can elements of decentralization be applied to clinical trials in order to maximize patient engagement?
  • Does DCT still have a future in a post-COVID world or has the clinical trial industry returned to ‘normal’?
  • Are there therapeutic areas where elements of decentralization or hybridization are essential to success?
  • Where are the main technological and practical hurdles to DCT taking off?

MODERATOR:

Judyth Zahora, Senior Director, GCP Quality Risk Management and Process Improvement, Agenus

 

PANELLISTS:

Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

Rosanne Petros, PMP, Associate Director, Clinical Research, Merck Research Laboratories

Kristen Olszyk, Senior Director, Clinical Scientist, Neuraptive Therapeutics

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
RAM RAJU
Former CEO, NYC Health & Hosptials Corporation
Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories
Kristen Olszyk
Senior Director, Clinical Scientist, Neuraptive Therapeutics

11:30 AM

Reserved for session sponsor

12 PM

FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

  • Training and inducting staff with technology and systems in order to ensure a smooth transition
  • The importance of your staff when it comes to clinical trial efficiency: why you need to avoid overlooking this
  • Ensuring your new staff training programs are as effective as possible: what should you consider?

Speakers

Carrie Lewis
Executive Director, Clinical Program Optimization, Endo Pharmaceuticals
Deanna Lutte
Senior Clinical Trial Manager, Clinical Operations, Endo Pharmaceuticals

8 AM

Registration and Refreshments

9 AM

PANEL DISCUSSION: Fostering a strong relationship with your CRO

  • Technology and new developments when it comes to managing CRO relationships
  • How to ensure your study is prioritized
  • Maintaining a strong relationship with vendors in remote and hybrid work settings
  • How to blend a CRO team with your internal team in order to foster communication and overall success of your trial

MODERATOR:

John J. Seman, Chief Executive Officer, REVITALE Pharma

 

PANELLISTS:

Hal J. Mann, Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions

Kathleen Cohen, Vice President, Clinical Development, Marinus Pharmaceuticals

Douglas Kling, Chief Operating Officer, NewAmsterdam Pharma

Patti O’Malley, Associate Director, Strategic Relationship Management, Incyte

Speakers

John J. Seman
Chief Executive Officer, REVITALE Pharma
Hal J. Mann
Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions
Kathleen Cohen
Head of Clinical Operations, Marinus Pharma
Douglas Kling
Chief Operating Officer, NewAmsterdam Pharma
Patti O’Malley
Associate Director, Strategic Relationship Management, Incyte

9:30 AM

Reserved for session sponsor

Speakers

Todd Rudo, MD
EVP & Chief Medical Officer, Clario

10 AM

Selecting vendors and CRO partners: what are the most important considerations?

  • Balancing cost alongside other considerations when selecting a CRO
  • Should trial partners always need expertise in your therapeutic area or are there other factors to consider?
  • Advantages and disadvantages of choosing a small CRO vs a global CRO for your trial

Speakers

Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

10:30 AM

Morning refreshments and networking

11 AM

CASE STUDY: Designing and running a trial for pediatric diseases: overcoming challenges when working with younger patients

  • Working with and supporting caregivers throughout the clinical trial process, and where sponsors can relieve burden
  • Additional considerations when designing a pediatric study: best practice when working with children and teenagers
  • Regulatory guidance in the USA around enrolling under 18s in a clinical trial and how to navigate this

Speakers

Gurdyal Kalsi
Chief Medical Officer, Asklepion Pharmaceuticals

11:30 AM

Reserved for session sponsor

Speakers

David Cutler
Director, Project Management, WCG

12 PM

PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

  • Advantages and disadvantages of regions including APAC, Latin America and Asia for running clinical trials
  • Regulatory hurdles to overcome when running trials outside of the USA
  • Key factors to consider in selection of sites and geographies for your clinical trials
  • Sourcing CROs, vendors and partners overseas
  • Analyzing cost and benefit of keeping your trial in the US vs taking it overseas

MODERATOR:

Judyth Zahora, Senior Director, GCP Quality Risk Management and Process Improvement, Agenus

 

PANELLISTS:

Susan Neal, Director, Clinical Operations, Novavax

Akihiro Ko, Chief Executive Officer, Co-Founder and Board Chairman, Elixirgen Therapeutics

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
Susan Neal
Director, Clinical Operations, Novavax
Akihiro Ko
Chief Executive Officer, Co-Founder and Board Chairman, Elixirgen Therapeutics

12:30 PM

Lunch and Networking

1:30 PM

Keynote presentation reserved for

Speakers

Craig Lipset
Advisor and Founder, Clinical Innovation Partners

2 PM

Developing a cell therapy for patients with telomere biology disorders: challenges and lessons learned

  • An overview of Elixirgen’s lead EXG-34217 program from a clinical operations perspective
  • Running a clinical trial with patients with a rare disease: what do you need to consider?
  • Key challenges faced during Phase I/II trials on EXG-34217 and future opportunities uncovered

Speakers

Akihiro Ko
Chief Executive Officer, Co-Founder and Board Chairman, Elixirgen Therapeutics

2:30 PM

CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

  • What more should sponsors, sites and CROs be doing in order to ensure clinical trials are as patient centric as possible?
  • Innovative strategies for working with patients and advocacy groups from early on in your trial design
  • Engaging groups and communities who would not typically participate in trials in order to achieve targets around diversity and inclusion
  • Reducing the burden on patients participating in clinical trials

MODERATOR:

Judyth Zahora, Senior Director, GCP Quality Risk Management and Process Improvement, Agenus

 

PANELLISTS:

Rosanne Petros, PMP, Associate Director, Clinical Research, Merck Research Laboratories

Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

Laurie Taraborrelli, Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

Kelly Franchetti, Patient Advocate

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories
Harsha K. Rajasimha
MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics
Kelly Franchetti
Senior Vice President And Global Head, Patient Insights And Strategy, YPrime

3 PM

Afternoon refreshments and networking

3:20 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

3:30 PM

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations.

ROUNDTABLE 1: Topic TBC
Laurie Taraborrelli, Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

ROUNDTABLE 2: Working with patient advocacy groups to design a patient centric clinical trial 
Emily Cook, Senior Vice President, Clinical Operations, Palvella Therapeutics

ROUNDTABLE 3: Using an FSP model for your clinical outsourcing strategy
Hal J. Mann, Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions

ROUNDTABLE 4: Operational challenges when running a rare disease clinical trial
Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

ROUNDTABLE 5: Lessons from the pandemic: are there any DCT technologies which are here to stay?
Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

End of conference

END OF CONFERENCE – SEE YOU NEXT YEAR!

8:50 PM

Chairperson’s opening remarks

Speakers

Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

Speakers

Select a speaker to learn more

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Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus

Session Details:

PANEL DISCUSSION: AI and digitalization in clinical trials

2024-05-21, 11:00 AM

Session Details:

PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

2024-05-22, 12:00 PM

Session Details:

PANEL DISCUSSION: Has DCT passed its peak in popularity?

2024-05-22, 11:00 AM

Session Details:

CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:30 PM

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Daniel Klamer
Vice President, Business Development & Scientific Strategy, Anavex Life Sciences

Dr Daniel Klamer, Vice President of Business Development and Scientific Strategy of Anavex, has more than 15 years of experience in neuroscience and the orphan disease space, with acquisition, partnering and R&D experience in Europe and the USA. Prior to Anavex he worked at Retrophin and Neurosearch Sweden. At Neurosearch Sweden, Dr Klamer led and evaluated multiple discovery-phase neuropharmacological research products with an emphasis on strategic evaluation of preclinical and clinical development.

Dr. Klamer earned his PhD in Pharmacology at The Sahlgrenska Academy at University of Gothenburg, Sweden, his MBA at Fordham Gabelli School of Business, and his Post-Doctoral training at the Department of Psychiatry, Yale University School of Medicine. In addition, Dr. Klamer holds a position as an Associate Professor at the Department of Pharmacology at The Sahlgrenska Academy at the University of Gothenburg.

Session Details:

CASE STUDY: Advancing therapeutics for rare diseases: innovative methods to ensure your trial is a success

2024-05-21, 2:00 PM

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Next speaker
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Gurdyal Kalsi
Chief Medical Officer, Asklepion Pharmaceuticals

Session Details:

CASE STUDY: Designing and running a trial for pediatric diseases: overcoming challenges when working with younger patients

2024-05-22, 11:00 AM

View In Agenda
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Mohammed Ali
M&D Head of Reporting, Analytics and Insights, Astellas Pharma

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

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Craig Lipset
Advisor and Founder, Clinical Innovation Partners

Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors.  Craig is Co-Chair for the Decentralized Trials & Research Alliance and Vice President of the Foundation for Sarcoidosis.  He is Adjunct Assistant Professor in Health Informatics at Rutgers University, and serves on the Advisory Council for HL7 Project Vulcan and External Stakeholder Board for IMI Trials at Home.  Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures.

Next speaker
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Terry Katz
Senior Director, Biostatistics, Data Management Planning, Functional Excellence, Daiichi Sankyo

Session Details:

Critical to quality variables to drive risk assessment for functional plans and oversight

2024-05-21, 5:00 PM

View In Agenda
Next speaker
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Maria Metzger
, Executive Director, Supplier Relationship Management and Performance, Clinical Development Operations, Eikon Therapeutics

Session Details:

PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-05-21, 9:30 AM

View In Agenda
Next speaker
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Akihiro Ko
Chief Executive Officer, Co-Founder and Board Chairman, Elixirgen Therapeutics

Session Details:

Developing a cell therapy for patients with telomere biology disorders: challenges and lessons learned

2024-05-22, 2:00 PM

Session Details:

PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

2024-05-22, 12:00 PM

View In Agenda
Next speaker
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Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

Session Details:

Chairperson’s closing remarks

2024-05-21, 5:30 PM

Session Details:

Chairperson’s opening remarks

2024-05-22, 8:50 PM

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Carrie Lewis
Executive Director, Clinical Program Optimization, Endo Pharmaceuticals

Session Details:

FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

2024-05-22, 12:00 PM

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Suzy Montanye
Site Relationship Manager, Endo Pharmaceuticals

Session Details:

Site management: building a strong partnership with sites to ensure you are a sponsor of choice

2024-05-21, 11:00 AM

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Deanna Lutte
Senior Clinical Trial Manager, Clinical Operations, Endo Pharmaceuticals

Session Details:

FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

2024-05-22, 12:00 PM

View In Agenda
Next speaker
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Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

Session Details:

Selecting vendors and CRO partners: what are the most important considerations?

2024-05-22, 10:00 AM

Session Details:

CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:30 PM

View In Agenda
Next speaker
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Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc
Next speaker
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Sonnika Lamont
Analyst, Clinical Trials Intelligence, GlobalData Plc

Session Details:

Site selection for increased patient recruitment and retention

2024-05-22, 9:00 AM

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Blake Edward Wilson
Partner (FDA Regulatory), Hogan Lovells

Blake Wilson is a Partner in Hogan Lovells’ FDA Regulatory group.  He holds a juris doctorate from the University of Pennsylvania and a master’s degree in biostatistics from Columbia University.  Prior to becoming an attorney he managed Phase I and II pharmaceutical trials at Brown University.  His legal practice focuses on FDA’s premarket approval process for drugs/biologics/devices, oversight of clinical trials including BIMO audits, as well as navigating changes in laws or regulations that govern the life sciences industry.  He also guides sponsors through the special designation programs available at the premarket stage, like RMAT, accelerated approval, and breakthrough.  In this capacity, Blake advises extensively on novel products, study design considerations, and the use of clinical data in FDA-related matters.  By stress testing clinical materials through the lens of an FDA reviewer, Blake helps sponsors avoid pitfalls that can delay or derail a project.

Session Details:

PANEL DISCUSSION: AI and digitalization in clinical trials

2024-05-21, 11:00 AM

Session Details:

Topic TBC

2024-05-22, 10:00 AM

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Dija Atta
Senior Director, Clinical Operations, Incyte

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

View In Agenda
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Patti O’Malley
Associate Director, Strategic Relationship Management, Incyte

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

View In Agenda
Next speaker
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Harsha K. Rajasimha
MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

Session Details:

CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:30 PM

View In Agenda
Next speaker
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Derek Shannon
Director, Statistical Project Management, Madrigal Pharmaceuticals

Session Details:

PANEL DISCUSSION: AI and digitalization in clinical trials

2024-05-21, 11:00 AM

Session Details:

AI 101: the opportunities of AI for clinical trials

2024-05-21, 12:00 PM

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Kathleen Cohen
Vice President, Clinical Development, Marinus Pharmaceuticals
Next speaker
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Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories

Session Details:

The impact of high turnover of site staff on data collection and what sponsor companies can do to help

2024-05-21, 3:00 PM

Session Details:

PANEL DISCUSSION: Has DCT passed its peak in popularity?

2024-05-22, 11:00 AM

Session Details:

CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:30 PM

View In Agenda
Next speaker
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Kristen Olszyk
Senior Director, Clinical Scientist, Neuraptive Therapeutics

Session Details:

PANEL DISCUSSION: Has DCT passed its peak in popularity?

2024-05-22, 11:00 AM

View In Agenda
Next speaker
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Dr Nikolaos Tezapsidis
President and Chief Executive Officer, Neurotez

Session Details:

CASE STUDY: Targeting Alzheimers: rationale and clinical trial plans at Neurotez

2024-05-21, 5:00 PM

View In Agenda
Next speaker
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Douglas Kling
Chief Operating Officer, NewAmsterdam Pharma

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

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Next speaker
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Ram Raju
Senior Vice President and Community Health Investment Officer, Northwell Health

Dr. Ram Raju has a distinguished career over 40 years as a healthcare provider, teacher, researcher and community organizer. In his role at Northwell Health, Dr. Raju set the strategic vision to improve population health by finding ways to meet the needs of its most vulnerable communities, by examining the existing programs aimed at improving the health system's response to the community's needs and working with local organizations to address them. Northwell Health is the largest healthcare provider in the state of New York, is a system with 23 hospitals and 830 outpatient facilities that sees 2 million people every year in the New York metro area and beyond.

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

View In Agenda
Next speaker
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Susan Neal
Director, Clinical Operations, Novavax

Session Details:

Effective patient education to increase enrolment and retention

2024-05-21, 2:00 PM

Session Details:

PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

2024-05-22, 12:00 PM

View In Agenda
Next speaker
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Priya Marreddy
Vice President, Clinical Operations, OnCusp Therapeutics

Session Details:

PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-05-21, 9:30 AM

View In Agenda
Next speaker
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Emily Cook
Senior Vice President, Clinical Operations, Palvella Therapeutics

Session Details:

CASE STUDY: Practical challenges when running a rare disease trial in the US

2024-05-21, 4:00 PM

View In Agenda
Next speaker
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Kelly Franchetti
Senior Vice President And Global Head, Patient Insights And Strategy, YPrime

Kelly Franchetti is a Sr. Vice President and Global Head of Patient Insights and Strategy at YPrime. A highly experienced registered nurse who continues to spend time with patients directly, her diverse background comprises patient advocacy and clinical research. Kelly has over 25 years of experience in obtaining and discerning the patient and caregiver experience as well as developing strong relationships with advocacy groups on a global scale. She has extensive experience in multiple therapeutic areas such as oncology, cardiovascular, endocrinology, orthopedics, infectious disease, neurology, pediatrics, and critical care. This depth and breadth of experience translate into a keen understanding of how patients think regarding their treatment giving her a singular perspective on the best way to approach patients with their treatment options, and an understanding that proves invaluable to her pharmaceutical and clinical research stakeholders.

Session Details:

PATIENT ADVOCACY KEYNOTE: A caregiver’s story: supporting children participating in a clinical trial

2024-05-21, 8:30 AM

Session Details:

CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:30 PM

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Jenifer Waldrop
Executive Director, Rare Disease Diversity Coalition

Jenifer Ngo Waldrop joined the Black Women’s Health Imperative (BWHI) as Executive Director of the Rare Disease Diversity Coalition (RDDC) in October 2022. Before joining the leadership team of RDDC, she developed models and programs for diversity, equity, and inclusion initiatives to support multiple business units with Fortune 500 companies and organizations in Asia, Canada, and the US.

Jenifer has led initiatives at non-profit organizations where she recruited local community members to participate in numerous health-related fundraising events and developed programs to target disparities and underrepresented groups. In addition to facilitating development and fundraising, Jenifer developed a reputation for successful coalition building.

Jenifer received her undergraduate degree from Colby College and her Master of Human Resources Development from Villanova. As the Professional Development Director of the National Association of Asian-American Professionals (NAAAP) of Colorado, Jenifer continues her outreach in society. Through this organization, she mentors formally and informally.

Session Details:

Insights into barriers to care in the rare disease community

2024-05-21, 12:00 PM

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

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John J. Seman
Chief Executive Officer, REVITALE Pharma

Session Details:

PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-05-21, 9:30 AM

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

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Hal J. Mann
Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

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Subs Tripathy
Head of Global Procurement, Seagen

Session Details:

Forecasting and budgeting for your clinical trial

2024-05-21, 4:00 PM

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Jessica King
Head of Clinical Operations, Sonnest

Session Details:

PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-05-21, 9:30 AM

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+44 (0)20 766 10552