Rank #1: Immuno-Oncology Drug Development: Challenges & Next Steps
Ipilumumab/Nivo/Pembro challengesWhat can we learn from the development of sipuleucel-T that may be applicable for other therapeutic vaccines?Challenges with the following modalities: Checkpoints, Oncolytic Virus', Adoptive T-Cells, Cancer VaccinesBlinitumumabThe more interesting agents in late stage development now in immunotherapy and its promiseImmune related adverse eventsAdoptive cellular therapies, what is the most promising?Will IO become backbone therapies for cancer?What's the next set of assets that are going to come out?Promises in combination therapies?What can we expect next?
James Gulley, MD, PhD
Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute
Axel Hoos, MD, PhD, VP, Oncology R&D,GlaxoSmithKline
The Immuno-Oncology360° conference is scheduled for February 2-3, 2016 at the New York Academy of Medicine in NYC. For more information, please visit www.theconferenceforum.org.
Rank #2: Reimagining Clinical Trials with Entrepreneur, Dr Ben Liu, CEO, Trialspark
Trialspark partners with doctors to create FDA compliant trial sites within their existing practices (like Airbnb), unlocking the 98% of patients and doctors not involved in trials today and democratizing access to research treatments. In this podcast discussion with Ben, we discuss how to reimagine clinical trials, entrepreneurism, the rise of Trialspark and reducing the barriers for patients and investigators.
Ben will be speaking at DPharm on September 26th in Boston with Dr Ulo Palm, SVP Global Drug Development Operations, Allergan on a case study to scale more efficient clinical trials.
For more information about Trialspark, visit www.trialspark.com
For more information about DPharm visit www.theconferenceforum.org
Producer: Valerie Bowling, Executive Director, Pharma Talk Radio and DPharm
Rank #3: Alzheimer’s Studies: Exploring Registries to Improve Enrollment & Trial Design
A Patient Registry can be very useful in identifying patients. A registry can also address the original problem statement about failed trials. A robust, living registry becomes a data pool from which we can improve both drug discovery, using probabilistic statistics and AI/ML to identify new drug candidates, and drug development, using simulators to predict likelihood of success in Phase 2 or 3.
In this podcast, we discuss major challenges facing developers of Alzheimer’s therapies and address patient registries and how they can improve enrollment and trial design. In this podcast, we will hear some details about the HealthyMindsRegistry, Synexushmr.com and the Protect Study Registry, Protectstudy.org.uk registry. For US and UK citizens over 50 who have not been diagnosed with dementia can participate in the registry on-line.
Dr Clive Ballard, Pro-Vice Chancellor and Executive Dean, University of Exeter, External partner in the AES HealthyMinds Registry (HMR)
Dr Heather Bryson, Director, Operational and Strategic Solutions at Accelerated Enrollment Solutions, (AES)
Host: Dr Julie Adams, Psychiatrist and Regional Medical Officer, PPD Biotech
Producer: Valerie Bowling, Executive Director, the Conference Forum
Rank #4: Fireside Chat: Lessons Learned from a Drug Delivery Pioneer and Risk-Taker
Rank #5: Key Trends in Drug Delivery: Expert Perspective
Key Trends in Drug Delivery: Expert Perspective
Randall Mrsny, PhD
Professor's Chair, Department of Pharmacy and Pharmacology,
University of Bath
Rank #6: How GSK Implemented Pivotal End-to-End Engagement Initiatives at Different Stage
• Creation of a framework and toolkit that builds on existing infrastructure
• Networks of champions and project leads
• Project planning
• Emerging best practices being shared throughout the organization
Dr Metcalf will also be joining the 6th annual Patients as Partners US program on March 11-12 at the Wyndham Philadelphia Historic District Hotel in Philadelphia where she leads a panel with patients and advocacy on Mapping Out the Patient Decision Making Journey. Patients as Partners US is the only conference that demonstrates how to involve patients throughout the entire medicines development life cycle to drive greater efficiencies in clinical research. For more information visit www.theconferenceforum.org.
Rank #7: Managing the Role of Chief Medical Officer in a Biotech
From the Chief Medical Officer Summit, please join co-chairs Dr. Greg Fiore, CMO of the The Medicines Company and Dr. Steven Zelenkofske, CMO of Regado together with opening presenter Dr. Tyler Martin, CMO & Founder of Great Plains Biotechnology, to discuss the role of the CMO and how to best manage it.
What should a CMO be focused on? Functioning with restrictive capital Supporting a CEO who does not have experience in the therapeutic area you are in charge of The great balancing act
Rank #8: How Tesaro is Integrating the Patient in the Clinical Development Process
Other discussion points include:
How Tesaro is working to eliminate some of the burdens inherent in clinical trial participationWhat patient focus means to Tesaro and why/how they decided to jump in the deep endTesaro focus groups and what they learned from the experts
Join us this year at the 6th annual Patients as Partners US conference, taking place March 11-12, 2019 in Philadelphia.
Rank #9: What are the Regulatory and Ethical Concerns of Integrating Care and Research?
Research and care or treatment are separate spheres in the regulatory and ethical worlds. What happens when they are brought together?Are there ethical barriers that need to be overcome to allow clinical research to be offered as an option as part of clinical care?What are the ethical issues that surround offering a patient the opportunity to consider enrolling in a clinical trial?What current efforts are underway to address these issues?
This session was presented at the Clinical Research as a Care Option (CRAACO) meeting in April 2018 in Cambridge, MA.
The 2019 CRAACO conference will take place April 29-30, 2019 in Raleigh-Durham, NA. Learn more here.
Rank #10: Patient Perspectives on Drug Delivery Needs Present and Future
Valerie Bowling, Patient Advocate and Executive Director, Drug Delivery West
Sudeshna Dutta Ray, Senior Engineer, Advanced Device Technology and Innovation, Amgen
Cynthia Goldstein, Patient & Communications Specialist
Mikaela Saugstad, Patient, Co-Founder, Director of Customer Relations & Marketing, Gigil Precision LLC
Lily Stairs, Patient and Head of Patient Advocacy, Clara Health
To learn more about the 2019 Drug Delivery West conference taking place May 6-7, 2019 in San Francisco, CA, please click here.
Rank #11: Next Generation of Combination Immunotherapy with Dr Patrick Hwu of MD Anderson
Dr Hwu serves as a lead advisor for the 2nd annual Rational Combinations 360° meeting, which takes place June 28-29, 2017, at the The New York Academy of Medicine. Preview the program agenda, including Dr Hwu's plenary session on "DE-RISKING OF COMBINATION IMMUNOTHERAPIES."
Rank #12: 5 Minute Overview of DPharm (Disrupting Clinical Trials) Europe: What to Expect?
Real World Clinical Trial Strategies and ResultsNew Leadership in Driving Clinical Trial InnovationStrategies to Validate the Siteless TrialCommunity Outreach and Education in Clinical TrialsNew Financial ModelsPatient Involvement and EngagementBrexit Update and Potential Impact on R&DProtocol SimulationAdaptive Trial Model
DPharm EU takes place at the Millennium Hotel in London on February 8-9, 2017. For more information, visit www.theconferenceforum.org
Rank #13: How Digital Biomarker Innovation is Modernizing Clinical Endpoints
Understand what Digital Biomarker innovation means for the future of clinical development and potentially personalized healthcare.Be inspired to use mobile sensors technology in the context of clinical trials and beyond.Develop a detailed understanding of the underlying complexity to run such efforts and be able to plan for it.Understand how regulators are looking at these novel approaches.
Christian Gossens, PhD, MBA, Global Head Early Development Workflows, pRED, Informatics, Roche Pharmaceutical Research and Early Development (pRED)
The 9th annual DPharm conference with take place on September 17-18, 2019 in Boston, MA. Learn more at theconferenceforum.org.
Rank #14: Immuno-Oncology 360°: Business Models for Complex Science by Dr Axel Hoos of GSK
Save the date for the 4th annual IO360° conference, taking place February 7-9, 2018 in New York City. Dr Hoos returns as lead advisor, as well as moderating a talk called, "Investor Roundtable: The Role of IO within Large Pharma - Where Does it Stand?" with panelists from Citi, Atlas Venture, New Enterprise Associates, and SR One Ltd.
Rank #15: PODD: Partnership Opportunities in Drug Delivery 2019 Overview in 4 Minutes
Building a Company around a Transformative Drug Delivery Invention with MIT's Dr Robert Langer, Dr Sangeeta Bhati, Dr Giovanni Traverso and Harvard Medical School's Dr Jeffrey Karp.Modality Fluid Development: Tales of Evolving Pipelines and Drug Delivery Solutions with Merck's, VP, Pharmaceutical Sciences, Dr Allen TempletonGene Therapy Keynote with Spark Therapeutics, President and Head of R&D, Dr Katherine HighZeitgeist Presentation on Immune Targeting Nanomedicine by AstraZeneca’s, VP, External Innovation and Novel Product Technologies, Dr Anand SubramonyConference Chair opening remarks provided by AstraZeneca's, Dr Shawn Davis
Additional Featured Speakers:
Roche’s, Senior Portfolio Strategy Director, Dr Beate Bittner will moderate the Formulation & Device Lifecycle Management for Biotherapeutics – Clinical and Industry Perspectives on Subcutaneous Delivery panel.Drug Delivery Pipeline and Technologies, A Year in Review, with Pharmacircle’s, VP, Kurt SedoDelivering Flexible Dosage Forms with Pfizer's Dr Advait Badkar
The 9th annual PODD conference will take place on October 7-8, 2019 in Boston, MA. Learn more at theconferenceforum.org
Rank #16: Eli Lilly: How to Launch Multiple Mobile Devices in a Hybrid Setting
Considerations and lessons learned for:
• Connecting all the devices
• Implementation differences between traditional vs siteless
• Coordinating the equipment; challenges and successes
• Lessons learned
• What’s next?
Speaker: Joseph Kim, Sr Advisor, Clinical Operations and Digital Registry, Digital Health Office | Translational Technology & Innovation, Eli Lilly & Co
Rank #17: Keytruda in Combo with Chemo in NSCLC
This year, the University of Pennsylvania will be represented by Dr Marco Ruella, Assistant Professor and Scientific Director Lymphoma Program, Division of Hematology and Oncology, Department of Medicine and Center for Cellular Immunotherapies. Dr Ruella will be discussing the next steps for CAR-T therapy for cancer on day three during the Next Generation Cell Therapy Plenary
To join in on the discussion at the 5th annual IO360 conference taking place February 6-8, 2019 in New York, NY!
Rank #18: CAR-T Therapy: Optimization Through Engineering T-cells or Combinations
Save the date for IO Combinations 360° happening June 20-21, 2019 at the Wyndham Historic District Hotel, Philadelphia, PA and for IO360° happening February 26-28, 2020 at the Crowne Plaza Times Square in New York City.
Rank #19: Entrepreneur Data Scientist, Ben Liu on Solving Bottlenecks in Clinical Research
Rank #20: Addressing R&D Challenges using Drug Delivery Technologies
Moderator: Ann Daugherty, PhD
Senior Manager, Drug Delivery, Genentech
Panelists: Marianne Ashford, PhD
Senior Principal Scientist, Pharmaceutical Sciences, AstraZeneca
Advait Badkar, PhD
Senior Director Novel Delivery Technologies, Bio Therapeutics, Pfizer
Marian Gindy, PhD
Executive Director Pharmaceutical Sciences, Merck
Kapil Gupta, PhD
Associate Director, Protein Pharmaceutical Development, Biogen
Evan Thackaberry, PhD, DABT
Headm Preclinical Development, Ra Pharmaceuticals
This talk was given on Day 2 of the Partnership Opportunities in Drug Delivery (PODD) 2017 Meeting.