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This talk was given at the Patients as Partners 2018 Meeting There are many frameworks and models that exist from various organizations on aspects of patient engagement and may be challenging to navigate through when applying to your own initiatives. In this session, Takeda will walk the audience through how they used multiple patient engagement frameworks to create an internal R&D Patient Engagement Guide tailored for their drug development teams from discovery through marketed products. The audience will learn how the guide has help build support and a cultural shift for Takeda’s internal patient engagement initiatives and how it has helped each team at various phases of development with the following: • Identifying what the patient engagement activities are at the different phases of development • How does patient engagement apply to the work I am doing? • Identifying who is relevant to talk to, how to go about it • What is the impact? • Mapping the patient advocacy landscape • Identifying what a

This talk was given at the Patients as Partners 2018 Meeting How Patient Research Advocates are Driving R&D: A Patient Case Study In this session, patient and research advocate, Geraldine Blavat will walk the audience through 10 steps on how patient input is integrated through the entire clinical development continuum including: Developing the Study Concept Secure Funding Preparing the Study Protocol Creating Study Procedure Implementing the Study Monitoring the Study Analyzing the Data and Interpreting Results Disseminating Study Information FDA Review and Approval Post Approval Studies This talk was given by Geraldine Blavat, Parkinson’s Foundation Research Advocate and Karlin Schroeder, Director, Community Engagement, Parkinson’s Foundation Join us this year at the 6th annual Patients as Partners US event, taking place March 11-12, 2019 in Philadelphia.

John Patton, PhD, Chief Executive Officer and Chairman with Dance Biopharma and Ann Daugherty, PhD, Senior Manager, Drug Delivery with Genentech present the closing talk at Drug Delivery West, held May 21-22, 2018 in San Francisco.  In this talk they discuss the lessons learned from drug delivery, what to be aware of in the future, and how to improve drug delivery methods.  The next conference in Drug Delivery is the 8th annual PODD: Partnership Opportunities in Drug Delivery on October 17-18, 2018 in Boston. For more information, visit www.theconferenceforum.org

Nanotechnology Keynote Address given by Omid Farokhzad, MD, Professor, Harvard Medical School and Director, Center for Nanomedicine, Brigham and Women's Hospital Omid Farokhzad is an inventor of more than 145 issued / pending patents. These for the launch of four biotechnology companies: BIND Therapeutics (acquired by Pfizer) Selecta Biosciences, Tarveda Therapeutics (formerly Blend Therapeutics) and Placon Therapeutics (spin-out from Tarveda), which are translating the aforementioned academic innovations toward commercialization and societal impact. Dr Farokhzad has served in various capacities on the Board of Directors and the Scientific Advisory Board of these companies.  In his lecture, Dr Farokhzad will be focusing on the emerging understanding of the nano-bio interactions and its implications for developing safer and more effective therapeutic and diagnostic modalities. Nanotechnology enabled drug delivery approaches for predictive and personalized medicines will be discussed with emphasis on the less

Panel: Utilizing a Device Platform Technology across Multiple Therapeutic Categories Most pharma and biotech companies realize the need and benefit of having a platform device technology. The challenge then becomes figuring out how to utilize the device to deliver different types of drugs for various indications such as rheumatoid arthritis, cancer, and rare diseases. Moderator: Paul Jansen Former Associate VP Sanofi and Board Member and Senior Advisor, Haselmeier Panelists: Donna French, PhD VP Drug Delivery and Device Development, MedImmune Michael Graffeo, MBA VP Business Development, Drug Delivery Insulet Rajan Patel CEO, io Life science Srini Sridharan, PhD Group Director, Materials Science and Engineering, BMS     

The Keynote was given at Partnerships Opportunities in Drug Delivery 2017 by Lars Rebein Sorensen Former President and CEO, Novo Nordisk with  Barbara Lueckel, PhD Global Business Development Director Roche Partnering Innovation, Roche  

The expert panel of scientific leaders from industry will discuss current formulation and delivery challenges for therapeutic areas (ophthalmology, immunology, oncology infectious disease, and neurodegenerative area disorders). Each panelist will address a specific disease area and discuss the role of drug delivery in the treatment of disease. The panel will also cover currently available delivery technologies and where improvement is needed. 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

The expert panel will address the scientific and business challenges and opportunities in this space. Panelists will discuss the difficult nature of providing therapies for diseases of the CNS, covering both device and chemistry-enabled technologies. They will also address questions such as:  Can devices take us where chemistry has not?What advances being made in the field of chemis conjugation technologies?Why is intrathecal, intracerebroventricular and intraparenchymal delivery relevant for CNS and other therapeutic categories? Finally the panel will talk about lessons learned, particularly with regard to scientific vs. business rationale. Introduction by: PJ Anand Founder President and CEO, Lifesciences Moderator: Lisa Shafer, PhD Senior Director New Devices and Bioelectronic Technologies Teva Pharmaceuticals Panelists: Dan Abrams, MD CEO, Cerebral Therapeutics, LLC  Krystof Bankiewicz, MD, PhD Director, Interventional Neuro Center UCSF Mikhail "Misha" Papisov, PhD Associate Professor Harv

Drug Delivery Needs in Oncology Due to the increasing number of parenteral biologic therapies that are administered intravenously, the already high pressure on infusion capacity and healthcare resources is expected further increase. A change from intravenous to subcutaneous dosing has been shown to reduce dosing complexity and overall drug administration related costs. There is keen interest in technologies that facilitate subcutaneous administration and potentially enable drug administration in the home setting.  Led by: Beate Bittner, PhD  Portfolio Strategy Director, Roche  Panelists: Panel: H Janice Adkins, MBA Associate Director Marketing, BD Medical The exp Pharmaceutical Systems, North America EMEA Ulrich Bruggemann Head Academics and Innovation, Global Medical Devices of the Development, Sanofi US Shawn Davis, PhD Director, Technology Strategy and Innovation, Amgen Declan Reilly Section Head, Device Engineering, Device Development PTDE-D, Roche Andrew J Yee, MD Medical Oncologist, Massachusetts Gener

Track 2: Clinical Operations for IO Trials This section is designed for clinical trial operation executives who want to learn what it takes to execute an IO clinical trial. This is an excellent opportunity to walk through the building blocks of IO clinical trial operations and discuss pitfalls and lessons learned. Plenary Chair: Andy Lee, SVP, Head of Global Clinical Trial Operations, Merck   This discussion was presented at the 2018 Immuno-Oncology 360° Meeting. 

Building Blocks of IO Trials: This talk will consist of 7 perspectives that identify operational aspects of IO trials, including a patient perspective, site management, 3rd party component, clinical supply chain, a PI perspective, data management and project management. The collaborative talk concludes with a panel discussion and Q&A.   This Discussion was presented at the 2018 Immuno-Oncology 360° Meeting.

Endpoints News Industry Report on IO Collaborations and Trends In this episode of Pharma Talk Radio, John Carroll, Editor-in-Chief of Endpoints News, reviewed the build up of the immuno-oncology space over the past few years at the IO360° conference that took place February 2018. Mr Carroll discussed the impact the large amount of money and the extraordinary numbers that have been invested in the space, have had on collaborations. He also shed light on the natural limitations and boundaries that are going to impact IO R&D, along with exploring China as an upcoming major player in the IO space. About John Carroll: John Carroll is a biotech analyst with 38 years of prize-winning experience in journalism. For more information visit: https://endpts.com/ This talk was given at Day 2 of Immuno-Oncology 360° meeting  in 2018. Save the Date: The 5th annual Immuno-Oncology 360° program will take place February 6-8, 2019 in NYC. For more information visit: http://theconferenceforum.org/conferences/immuno-onco

Mobile Podcast Series #2 CTTI Findings are in from their Mobile Clinical Trials Program: Recommendations on Novel Endpoints CTTI's Mobile in Clinical Trials program was launched three years ago to propose recommendations that clarify the pathway for developing novel endpoints for use in clinical trials from data generated using mobile technology. Jennifer Goldsack shares recommendations and insights from their findings on: Developing an internal process for identifying endpointsStrategies for reducing friction throughout the processExecuting the processThe science required to validate an endpointA suite of tools developed in the process to help facilitate implementation The next Mobile in Clinical Trials conference is September 24 in Boston. Mobile is the annual update on not only the latest progress in applying mobile/digital tools to clinical trials, but how and when to do this and for what benefit.  Speaker: Jennifer Goldsack, MChem, MA, MBA, CPHQ, Clinical Project Manager, CTTI Producer: Valerie Bowli

Podcast on Mobile in Clinical Trials Series #1 How a Mobile App Can Offer Unique Value in Assessing Patient Reported Outcomes Crescendo Biosciences's CIO, Alex Bangs, reports on how a human-centered design approach was used to create MyRA, an award-winning app for patients living with RA. This podcast comes from the 2017 Mobile in Clinical Trials US event.  The next Mobile in Clinical Trials conference is May 15-16 in London and then September 24 in Boston. Mobile is the annual update on not only the latest progress in applying mobile/digital tools to clinical trials, but how and when to do this and for what benefit.  Speaker: Alex Bangs, Chief Information Officer, Crescendo Biosciences Producer: Kim Chin, Marketing Director, Mobile in Clinical Trials

The Chief Medical Officer Summit is delighted to present a podcast featuring the Keynote Fireside Chat with Michael Rosenblatt, MD, on Lessons Learned from the Journey of a CMO Leader In this session, Dr Rosenblatt, former Merck CMO, will share his insights on career path decision-making and will compare the experiences and lessons learned from being the CMO on the drug development side versus the biotech investor side of the industry. Moderated by CEO of Evelo Biosciences, Simba Gill, MBA, PhD.  Join us at the 6th annual CMO Summit, the largest annual gathering for physicians to exchange best practices in clinical development within the confines of the emerging biotech space. We already have 50 CMOs confirmed to attend. You won't want to miss out on this event. Producer: Valerie Bowling, Executive Director, Chief Medical Officer Summit

The Chief Medical Officer Summit is delighted to share a podcast featuring a presentation prepared by Drs Alison Bateman-House and Arthur Caplan of NYU's Division of Medical Ethics on the topic of:   Developing a Pathway for Compassionate Use Cases What should the CMO do when they receive a request?What's the role of the CMO, the FDA and the IRB?Lessons learned from Janssen Case StudyHow do you scale down for a biotech?Potential modelsCan the process be accelerated? Join us at the 6th annual Chief Medical Officer Summit, the largest annual gathering for physicians to exchange best practices in clinical development and R&D within in the confines of the emerging biotech space. We already have 50 CMOs confirmed to attend, and you will not want to miss out on this event. Speaker: Alison Bateman-House, PhD, MPH,Assistant Professor, Division of Medical Ethics,NYU Producer: Valerie Bowling, Executive Director, Chief Medical Officer Summit

This podcasts gives you an overview on what to expect for the 2018 Chief Medical Officer Summit in a nutshell. The concept of the CMO Summit came from MPM Capital’s Dr Elizabeth Stoner, who told us that there is a deep need for a Summit that is designed for CMOs and heads of R&D in the emerging biotech space, specifically, where we can cover all the key issues affecting R&D decisions together with business development issues. The program takes place on May 7th and 8th at the Omni Parker House in Boston and we already have over 50 CMOs committed to attending. The program is co-chaired by Julie Krop, MD, CMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc,  and Jim Roach, MD, FACP, FCCP, CMO, Pulmatrix. The 6th Annual Chief Medical Officer Summit is produced by the Conference Forum. The Conference Forum is life science industry research firm that carefully and meticulously presents strategic level programming. As with all Conference Forum events, you can expect prominent

In this three minute podcast, you get an overview of one of the hottest topics we are covering in a full day 2nd annual event on Clinical Research as a Care Option. (CRAACO). Making clinical trials a care option is arguably the greatest challenge we can collaborate on in bringing patients closer to clinical trials. CRAACO takes place on April 11th at the Boston Marriott Cambridge. We look at how to integrate clinical research into the overall continuum of patient care and ask, how do we make clinical research a care option? The program is co-chaired by Jeff James CEO, Wilmington Health and Katherine Vandebelt, Chief Ecosystem Officer at Reify Health. The 2nd annual CRAACO event is produced by the Conference Forum. The Conference Forum is life science industry research firm with veteran researchers, who carefully and meticulously present strategic level programming. As with all Conference Forum events, you can expect networking activities and prominent networking. To learn more about CRAACO, visit www.thecon

This podcast gives you a five minute overview of the 3rd annual Clinical Trial Collaborations conference, otherwise known as CTC. CTC is a strategic level event focused on arguably the most important change in transforming drug development: How and who we collaborate with to drive better clinical trial outcomes? CTC is ideal for people working in clinical trial operations, who are involved with external relationships or need to be involved with external relationships and want to see examples of strategic and creative solutions to successful collaborations and who we need to be collaborating with next? The program takes place on April 9th – 11th at the Boston Marriott Cambridge and is divided into three parts, one on each day of the event. Part I deals with new advancements in clinical trial collaborations, current examples to challenge us, and progress. Part II focuses on strategic collaborations, virtual trials and next generation monitoring. Part III addresses how do we bring clinical research closer to

The Mobile in Clinical Trials conference comes to Europe for the first time on May 15th and 16th at the Millennium Gloucester Hotel in London. If you work or want to work with mobile and digital technologies to make clinical trials more efficient and reduce patient burden, we highly recommend this conference for you. Using our past four years of experience in the US, we are able to combine the best examples of mobile and digital optimization in clinical trials from the US with examples from the UK and other parts of Europe. Mobile in Clinical Trials Europe is chaired by Pfizer’sDr Daniel Karlin with a pharma speaking faculty of who’s who in leading mobile in clinical trials. VIP Guests include Verily Life Sciences’Dr Tushar Parlikar on how Verily’s studywatch is tackling scalability of wearables in clinical trials and Vodafone’s Dr Nuria Oliver, who gives a visionary keynote to address data-driven decision making. Mobile in Clinical Trials Europe is produced by the Conference Forum. The Conference Forum is