CLINICAL OPERATIONS IN ONCOLOGY TRIALS 2021

Affordable Networking & Training
06/24/2021
Online
DAY 1|24th June 2021

10:00 am Keynote: Devising A Framework In Converting Your Clinical Pipeline Into Virtual Trials

  • Identifying the current tools at your disposal to convert current trials into
  • Assessing potential implications for oncology based trials and see the best approach in decentralizing it

Gurdayal Kalsi Kalsi

Chief Medical Officer

Asklepion Pharmaceuticals

10:30 am Risk Mitigation for Oncology Clinical Trials

  • Key risk areas of greatest concern in oncology clinical trials;
  • Strategies used to mitigate threats in 2020 for small and mid-size US oncology biotechs: what worked and what didn’t;
  • Cutting-edge small & mid-size oncology biotech trials: where to run them and which aspects may be different moving forward;
  • What decision factors are expected to most influence your choice of region(s) in 2021-2022, including speed of start-up, participant diversity and regional participation rates.

Julie Martin

Director of Clinical Operations

Scimega

11:00 am The Role of the ‘Virtual’ Patient In Oncology Trials

  • How to work with synthetic patients in trials and other AI trial design tools
  • Assessing the potential challenges in introducing virtual patient solutions
  • Analyzing the advantages synthetic patient trials have over conducting trial with physical patients
  • Specific challenges in cancer trials

Eric van der Putten

Modra Pharmaceuticals B.V.

11:30 am Reserved For Novotech

12:00 pm Networking Break

12:10 pm Reserved For Sponsor

12:40 pm Using clinical trial data and analytics to forecast the future oncology

Moderator: Fern Barkalow, Senior Director, Oncology and Hematology, GlobalData

1:20 pm Regulatory spotlight: pathways for expedited drug approvals in oncology

  • Focusing on the latest updates on expedited pathways for oncology programs and thinking strategically about how to deal with them from a regulatory point of view
  • Analysing how the FDA’s regulatory framework is evolving and what this means for trial sponsors
  • Outlining the FDA’s established and pilot programs and what different pathways are available for oncology companies
  • Providing advice on early planning and a solid regulatory strategy to get your drug to patients quicker

Sunni Miller

Executive Director, Regulatory Affairs

Gossamer Bio

1:50 pm Reserved For ERT

2:20 pm Assessing How Data Managers Should Review Their Data More Efficiently

Narayan Lebaka

Director of Clinical Data Management

Rgenix

2:50 pm Are digital tools and social media the future of patient recruitment and engagement?

  • Discussing how the Covid-19 pandemic has disrupted patient enrolment and if digital tools and remote onboarding systems are needed for the long-term
  • Exchanging best practices for patient recruitment in oncology and whether a one-size-fits-all approach for using technology works or if it varies by cancer indication
  • Exploring how valuable a resource physicians and oncology specialists are compared to CRO patient databases, social media, and digital tools for study recruitment
  • Sharing experiences of running patient recruitment campaigns on social media platforms and which patients groups are ideal targets for this

Sonja Heintz

Director Clinical Operations

Turning Point Therapeutics

2:50 pm Networking Break

3:00 pm Reserved For Genomoncology

3:30 pm Panel: Looking Towards The Future of Decentralising Oncology Trials

Join our panel experts, where they will discuss the prospect of virtual trials for Oncology Therapies and address the latest challenges and successes.

Len Rosenberg, Head Clinical Operations, BEAT AML

Reserved: Antonieta Sosa, Director Clinical Innovation, Janssen Research and Development

Ramon Mohanlal, Chief Medical Officer, Beyond Springs Pharmaceuticals

4:10 pm Reserved For DSG

4:40 pm Fireside Chat: Regulatory Considerations For Your Oncology Trial

Oliver Steinbach, Vice President Clinical and Regulatory Affairs, Imagion Biosystems

5:10 pm Patient Centricity Considerations and Challenges In Oncology Based Trials

  • Assessing in advance any concerns the patient may have to avoid potential drop outs
  • Identifying potential challenges in advance to avoid lack of patient diversity numbers in clinical trials
  • Evaluating how to make trials more patient centric and getting the numbers up
  • Understanding the impact of COVID and how the industry can evolve

Melaina Boyce

Director, Clinical Innovation

EMD Serono, a business of Merck KGaA

5:40 pm What does Covid-19 exposure mean for cancer patient health and clinical trials?

  • Uncovering the ways that the Covid-19 virus threatens patient safety and validity of clinical data and how to overcome this in your clinical trial strategy
  • Considering the scenario whereby a patient is exposed to coronavirus and whether that disrupts the validity of their drug response in an oncology trial
  • Looking ahead at the long-term implications of Covid-19 infection and if this could lead to an increase in cancer prevalence and other health conditions; will this shape the pharmaceutical industry and future of clinical trials?

Jason Litten

Chief Medical Officer

Artiva Biotherapeutics

6:10 pm Has Covid-19 accelerated the future of decentralized patient evaluation?

  • Discussing where we are now with patient evaluation in terms of site and clinic accessibility after the Covid-19 pandemic restrictions
  • Laying out the model to move from a site-centric trial to a decentralized approach when designing oncology trials
  • Putting the spotlight on emerging technology and systems to facilitate remote patient monitoring such as telehealth visits, electronic patients diaries, and e-consent Looking at remote monitoring options for CRAs to reduce travel to sites, cut costs, and be better prepared for new waves of coronavirus-related disruption

Devin Trejo

Director, Global Product Development

Pfizer

6:40 pm Keynote: Analyzing the Affect of COVID-19 Disease on Oncology Clinical Operations and How the Industry Responded

  • COVID-19: Disease overview, how the outbreak spread, and early impact on oncology trials
  • Public health and pharmaceutical industry responses to the outbreak
  • Future implications of the outbreak, what are the short- and long-term responses we can expect, and what will their impact be?

Ramon Mohanlal Mohanlal

Chief Medical Officer

Beyond Springs Pharmaceuticals

7:10 pm The State Of The Biopharmaceutical Industry

Bonnie Bain

Global Head and Executive Vice President of Healthcare Operations and Strategy

GlobalData Healthcare

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