Setting new standards in information exchange for the pharmaceutical and biotech industry

Pharma Talk Radio

PharmaTalkRadio is a non-profit, internet radio show organized and supported by the Conference Forum to give easy and free access to helpful information to all industry professionals and students in the life sciences. The program interviews industry insiders on the latest strategies, business models, leadership styles, technologies and innovations in clinical trials, patient centricity, drug development, drug delivery and emerging biotechs.

10/03/2018

From a Zimbabwean Village Kid to a PhD Regenerative Medicine Student

This amazing story is about a young Zimbabwean PhD student who lost his leg to a snake bite in a small African village which changed his entire voyage all the way to Wake Forest University.

Can you imagine coming from a family of 21 kids in a small remote village in Africa with no running water or electricity and one day a snake bite changes your entire future and you end up a PhD student in Winston-Salem, NC?  In this remarkable story, our guest Goodwell Nzou, PhD candidate in molecular medicine at the Institute at Wake Translation Science, tells Valerie Bowling, Executive Director, the Conference Forum, how he went from a village kid to an amputee to a band member that led him to a contest, a role in an Oscar winning documentary to a PhD candidate in a field that he hopes one day will allow him to grow back his own leg through regenerative medicine. 

Schools cited in the podcast include:

Jairos Jiri Association 

King George VI Centre

Wake Forest School of Medicine

Guest: Goodwell Nzou, PhD candidate in molecular medicine at the Institute at Wake Translation Science

Host: Valerie Bowling, Executive Director, PharmaTalk Radio and the Conference Forum


 

9/09/2018

Partnership Opportunities in Drug Delivery 2018: What to Expect 5 Min Podcast

The 8th Annual Partnership Opportunities in Drug Delivery (PODD) event will take place on October 18-19, 2018. PODD is designed with 3 purposes:

  1. To present a strategic level program for pharma and biotech biz development professionals with a thorough overview of the latest drug delivery technologies available along with an update on deals and opportunities.
  2. To provide drug delivery with a platform to present their technologies and get the latest insights on what the delivery and formulation needs are.
  3. To offer ample networking time, facilities and services for one-on-one meetings to establish new business contacts and enhance existing ones.

PODD is chaired by Dr Barbara Lueckel, Head of Research and Technologies Partnering at Roche. MIT’s Dr Robert Langer and Polaris’ Amy Schulman, two dynamic entrepreneurs in biotech are the opeining keynotes in a fireside chat. Justin Wright, PhD, Global Head of Innovation, Novartis will provide an industry keynote. Also, Jeffrey Karp, PhD keynotes with Stories from Bioinspiration to drug delivery. Choice of delivery tech tracks and includes partnering support.

For information, please visit, www.theconferenceforum.org.

Host: Valerie Bowling, Executive Director, Pharma Talk Radio and PODD Director


8/28/2018

All of Us Research Program, a Nation-wide Initiative from the NIH

Podcast guest, Elise Felicione, who is currently a Scientific Collaborator at the Scripps Translational Science Institute, is playing an integral role under the direction of Dr Eric Topol on a nation-wide initiative from the NIH. The initiative is called All Of Us, a US Precision Medicine program that aims to enroll a million Americans and follow them for 10 years, during which time participants will contribute biological, environmental, and lifestyle data. One-third of participants will participate virtually (not via a research site). The cohort will mirror the projected 2040 census. Individual pharma companies are never going to create cohorts like this, so the importance of this open source frame work that drug developers can tap into will be highly beneficial in serving the patient of the future.

Discussion points include:

  • – What is the All Of Us Research Program?
  • – Why does this matter to biopharmaceutical companies?
  • – How far along is the program and how to get invovled?
  • – What are your biggest challenges?
  • – How can biopharmaceutical companies get involved?

For more information on the All Of Us program, visit: https://allofus.nih.gov/

Elise will be speaking at DPharm on September 26th and will also have an exhibit booth to answer any questions are All of Us. For information on DPharm taking place September 25-26, 2018 in Boston. For information, please visit, www.theconferenceforum.org

Producer: Valerie Bowling, Executive Director, Pharma Talk Radio and DPharm


8/20/2018

Blockchain Opportunities for Patient Data Donation and Clinical Research

Patients are at the center of research and their data is the foundation for clinical innovation. However, significant barriers exist that inhibit the secure and efficient sharing of patient data. In this podcast, Craig Lipset, Head of Clinical Innovation, Pfizer, Munther Barra, Head of New Clinical Paradigm, Pfizer and Aditya Kudumala, Principal, Deloitte discuss blockchain as a catalyst to significantly change how we can access and use data to improve patient lives. Where is the patient data storm going?

Discussion points include, but not limited to:

  • – Who owns my data and where it’s going?
  • – What are the interoperability challenges and progress?
  • – How can data be shared?
  • – How you can pull in your own health data?
  • – Where does blockchain fit in and how can it secure patient data?
  • – How blockchain gives us authentication without identification?
  • – Next steps?

For more information on this topic and to get access to the Blockchain Opportunities for Patient Data Donation & Cinical Research, click here.

Craig will be leading an entire section on the democratization of patient data at DPharm on September 25-26 in Boston.

Producer: Valerie Bowling, Executive Director, Pharma Talk Radio and DPharm


8/17/2018

Reimagining Clinical Trials with Entrepreneur, Dr Ben Liu, CEO, Trialspark

During his graduate work, Dr Benjamine Liu observed the many bottlenecks that get in the way of clinical trials slowing the development of new treatments for patients. This challenge inspired him to launch 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 26 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 2018, visit www.theconferenceforum.org/conferences/disruptive-innovations-us/overview.

Producer: Valerie Bowling, Executive Director, Pharma Talk Radio and DPharm


8/16/2018

DPharm Podcast: What to Expect at the 2018 Event in 8 Minutes

This 8 1/2 minute podcast gives you an overview on what to expect from the 8th annual DPharm conference. DPharm is the annual event in the US to get the best access to innovative ideas, especially disruptive ones, to advance clinical trials with a view to reducing the burden to patients and investigators.

DPharm 2018 is dedicated to all things digital, data science, patient data ownership and new approaches to optimize clinical operation systems.

DPharm is September 25-26 at the Boston Marriott Copley Place.

Chaired by:

Sylke Poehling, PhD, SVP and Global Head, Strategy, Portfolio & Clinical Operations, Pharma Research & Early Development, Roche

Andreas Koester, MD, PhD, VP and Global Head, Janssen Clinical Innovation, Janssen

Craig Lipset, MBA, Head of Clinical Innovation, Pfizer

For more information about DPharm 2018, visit www.theconferenceforum.org/conferences/disruptive-innovations-us/overview.

Producer: Valerie Bowling, Executive Director, DPharm


8/15/2018

Mobile in Clinical Trials Podcast: 3 1/2 Minutes on What to Expect

Welcome to the 5th annual Mobile in Clinical Trials podcast. In this quick fire podcast, you will get a brief overview on what to expect. The conference takes place in Boston on Sept 24th, the day before DPharm. It is researched and produced by the Conference Forum and is chaired by:

Daniel Karlin, MD
Assistant Professor of Psychiatry, Tufts University and Former Head of Clinical, Informatics, and Regulatory Strategy, Digital Medicine, Pfizer Inc

Mobile and digital tools are the future of clinical trials and as the industry continues to transition into a data science industry with a responsibility to reduce patient burden, it is really important that we bring this conference to you to get the latest examples on what tools are available and who has used them and what are the lessons to engage patients?

For more information about Mobile in Clinical Trials, visit www.theconferenceforum.org/conferences/mobile-in-clinical-trials/overview.

Producers: Valerie Bowling, Executive Director, the Conference Forum and Jennifer Moran, Producer, the Conference Forum


7/19/2018

What to Expect at Rational Combinations 360° 2018 – 5 Min Overview

Rational Combinations 360° addresses business aspects, clinical advancements and scientific data in IO combination strategies. The rapid advancement in our understanding of human cancer immunity and immunotherapy combinations is nearly impossible for individual scientists to comprehend. Only together, as an engaged and interactive scientific community, can we hope to enable a patient’s immune system to eradicate cancer.

Rational Combinations 360° addresses the following plenary topics over the course of 2 days:

– Discovery and Preclinical Science
– Translational Science and Emerging Biomarkers
– Operationalizing IO Combinations
– Emerging Clinical Combinations
– Emerging Data Combinations in Clinical Trials
– Business Aspects

Dr Patrick Hwu, MD Anderson, Dr Axel Hoos, GSK and Dr Ian McCaffery, Janssen, together led the design of the 3rd annual program that includes more than 45 speakers and over 30 talks.

For more information about Rational Combinations 360°, visit www.theconferenceforum.org/conferences/rational-combinations-360/overview.

Be sure to use code TEML for a 10% discount. Thanks for listening.


6/15/2018

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: www.endpts.com.

This talk was given on Day 2 of the 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:
www.theconferenceforum.org/conferences/immuno-oncology-360/overview.


6/07/2018

Building Blocks of IO Clinical Trials – Part 2


In this episode of Pharma Talk Radio, we continue with Part 2 of the Building Blocks of IO Clinical Trials session led by Andy Lee, SVP and Head of Global Clinical Trial Operations and his team at Merck from the 5th annual IO360° conference.

In this final part of the recorded session, we continue to address clinical trial design and operations including:

– Supply Chain Management and Complexities of Biologics
– Data Management
– Project Management and Scaling up Resources

Save the Date: The 5th annual Immuno-Oncology 360° program will take place February 6-8, 2019 in NYC. For more information visit:
www.theconferenceforum.org/conferences/immuno-oncology-360/overview


6/06/2018

Building Blocks of IO Clinical Trials – Part 1


In this episode of Pharma Talk Radio, we feature Andy Lee, SVP and Head of Global Clinical Trial Operations and his team at Merck who spoke at IO360° in February 2018 on the Building Blocks of IO Clinical Trials. The Merck operations team detailed a day in the life of IO trial functions, how to work collaboratively and effectively, to advance the development of IO therapeutics. This is Part 1 of a 2 Part recording.

Part 1 delved into:

– A Patient Experience of an IO trial
– Site Management
– Clinical Oversight and Monitoring
– Operational Aspects of PDL1 Stratification and Biomarkers

Save the Date: The 5th annual Immuno-Oncology 360° program will take place February 6-8, 2019 in NYC. For more information visit:
www.theconferenceforum.org/conferences/immuno-oncology-360/overview


5/01/2018

Drug Delivery West – May 21-22: 4 minute Podcast Overview

The PODD presents Drug Delivery West, a partnering event May 21-22 in San Francisco. This inaugural program focuses on meeting the design and business needs of drug delivery systems from the perspectives of pharma, physicians, patients, investors, as well as KOLs in personalized medicine and digital.

There is an emphasis on how to reduce risk and advance drug delivery technologies for current and future needs. More specifically, we aim to cover the following:

– Where is the sector going?
– What are the key principles to reduce failures?
– What are the unknown, unknowns?
– How do we design for success and what are the guiding principles?

The conference will dedicate the afternoon of day one for a wide variety of drug delivery presentations. Partnering meetings and networking will be available throughout the meeting.

The Inaugural Drug Delivery West 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 Drug Delivery West, visit www.theconferenceforum.org. Be sure to use code TEML for a 10% discount.


4/24/2018

Roche’s Dr Barbara Lueckel Reviews the 2017 Drug Delivery Industry

Chair of the Partnership Opportunities in Drug Delivery (PODD) event, Dr Barbara Lueckel, Head of Research and Technologies Partnering at Roche, presents an annual year-in-review of the drug delivery landscape from 2017. Dr Lueckel’s opening remarks are a highlight of PODD every year, and we’re excited to have her return as program chair for the 2018 event, coming up on October 17-18 in Boston.

About Dr Lueckel:
Since end of 2014, Barbara leads the Research & Technologies Partnering (RTP) team belonging to the Innovation Partnering group in Roche Partnering. RTP team members lead evaluations & negotiations with biotech companies in an effort to enhance the discovery efforts of Roche’s Research & Early Development organization (pRED) across all of its therapeutic areas – either applying technology platforms to targets or molecules of interest to pRED (including drug delivery), or collaborating on early stage molecules. RTP team members are also responsible for alliance management of the resulting license agreements. Barbara joined Roche in 2007 as a Global Drug Delivery Evaluator, and transitioned to the Research & Technologies Partnering team in 2012. She is trained as a pharmacist with a PhD from the University of Basel.


4/18/2018

Lessons Learned from the Journey of a CMO Leader, Michael Rosenblatt, MD

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


4/18/2018

Developing a Pathway for Compassionate Use Cases

 

 

 

 

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 Study
– How do you scale down for a biotech?
– Potential models
– Can 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, MPHAssistant Professor, Division of Medical EthicsNYU

Producer: Valerie BowlingExecutive Director, Chief Medical Officer Summit


4/17/2018

2018 Chief Medical Officer Summit Podcast Overview in a Nutshell

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, MDCMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc,  and Jim Roach, MD, FACP, FCCPCMO, 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 networking. To learn more about the event, visit www.theconferenceforum.org. Be sure to use code TEML for a 10% discount. Thanks for listening.


3/01/2018

Patients, a Seat at the Table in Clinical Trials with Pfizer’s Dr Roz Schneider

Dr Roslyn Schneider, Global Patient Affairs Lead at Pfizer, speaks with Valerie Bowling, Executive Director, Patients as Partners, in a podcast interview on patients at the center of clinical research. Dr Schneider, better known as Roz, helps drive patient centricity and the integration of the patiemt voice throughout the development of medicines at Pfizer. She gives us a brief history of the evolution of the involvement of patients in clinical research, next steps, and how patients and industry can collaborate.

Roz, together with Suzanne Schrandt, Director of Patient Engagement at the Arthritis Foundation, will co-chair the 5th annual Patients as Partners conference, March 15-16 at the Rittenhouse Hotel in Philadelphia. For more information, visit theconferenceforum.org.

 


3/04/2018

What to Expect at Clinical Trial Collaborations 2018 – 5 min. Podcast

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 9 – 11 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 patients and vice versa.

CTC is co-chaired by Ken Getz, Director of Sponsored Research, Tufts CSDD, Murray Abramson, MD, VP, Clinical Operations, BiogenJeff James, CEO, Wilmington Health and Katherine Vandebelt, Chief Ecosystem Officer, Reify Health.

Use code TEML for 10% off and for more information visit, www.theconferenceforum.org.


3/04/2018

Clinical Research as a Care Option, 2nd annual – 3 min. Podcast Overview

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, visitwww.theconferenceforum.org. Be sure to use code TEML for a 10% discount. Thanks for listening.


3/01/2018

Mobile in Clinical Trials Europe New for 2018 – 4 min. Podcast Overview

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’s Dr 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 life science industry research firm with veteran researchers, who carefully and meticulously present high quality programming. As with all Conference Forum events, you can expect networking activities and prominent networking.

To learn more, visit www.theconferenceforum.org. Be sure to use code TEML for a 10% discount. Thanks for listening.


2/17/2018

Wireless Remote Monitoring – DPharm Podcast Series #2

MIT Professor, Dina Katabi, PhD gave one of the best talks on in home non-intrusive patient monitoring at DPharm 2017 and provided a demo of technology that uses ambient radio signals to monitor a patient’s gait, falls, breathing, heart rate and even sleep, all without putting any sensor on the patient’s body. Find out how they have used the technology to redefine clinical endpoints and pushed clinical trials to the home. The next DPharm conference is September 25-26 in Boston. DPharm reports on innovation and disruptive innovation to advance clinical trials and supports the community behind the movement.

Speaker: Dina Katabi, PhD
MacArthur Fellow, Andrew & Erna Viterbi ProfessorMIT, and Director of MIT Center for Wireless Networks and Mobile Computing

ProducerValerie Bowling, Executive Director, DPharm


Aligning Incentives to Share Clinical Data: DPharm Podcast Series #1


Dr  Zak Kohane, Chair of the Department of Biomedical Informatics, Harvard Medical School spoke at the DPharm conference in 2017 where he talked about how to align incentives to share clinical data. He reports on the outcome of the SPRINT Challenge, which is like the “poster child” of data sharing. More specifically:

  • Why are we not sharing data from clinical trials?
  • What did the trialists say about data sharing?
  • Patients’ perspective?
  • Did having more people reviewing the data improve its quality and usefulness?
  • What did we learn about aligning incentives to share clinical data?
  • How can we create a proper framework for sharing data?
  • How can we promote opportunities to democratize access to data that can go beyond a trial’s primary outcome findings?

The next DPharm conference is September 25-26 in Boston.  DPharm is the annual event that reports on innovation and disruptive innovation to advance clinical trials. For more information, visit www.theconferenceforum.org.

Speaker: Isaac (Zak) Kohane, MD, PhD, Chair of the Department of Biomedical Informatics, Harvard Medical School

Producer: Valerie Bowling, Executive Director, DPharm


5th Annual Patients as Partners What to Expect Overview in 7 Minutes

Officially approved by Patients IncludedPatients as Partners is the only program in the US that truly demonstrates how to involve patients throughout the entire medicines development life cycle to drive greater efficiencies in clinical research. Taking place March 15-16 in Philadelphia, the focus of this year’s program is on turning discussion into action, and Kate Woda, the Conference Director has worked meticulously with the advisory board and members of the speaking faculty both in person and over the phone to make this happen. Valerie Bowling, Executive Director of the Conference Forum gives listeners an overview in a nutshell on what to expect.

Co Chairs:

Roslyn Schneider, MD
Global Patient Affairs Lead, Pfizer Medical

Suzanne Schrandt, JD (Newly confirmed!)
Director, Patient Engagement, Arthritis Foundation

Patient Keynote: Stefanie Joho, Cancer Survivor, Advocate and Consultant

For more information, visit www.theconferenceforum.org.


Immuno-Oncology Clinical Trial Operations 4-Minute Summary of What to Expect

The Conference Forum presents a 1 day meeting on Immuno-Oncology Clinical Trial Operations, February 8 at the Roosevelt hotel in NYC. It’s part of the IO360 conference, which runs over three days from February 7 through February 9. The OPERATIONS portion of this conference is offered as a stand alone program. This podcast gives a brief summary of what to expect.

The morning provides first hand reporting on new trends and emerging technologies. The afternoon goes through 7 components including: the patient perspective, site management, 3rd parties, clinical supply chain, a PI perspective, data management and project management.

Many thanks to Andy Lee, SVP, Head of Global Clinical Trial Operations at Merck for his guidance on the topic and for bringing his team to help us understand the building blocks, providing a really unique insight into obtaining the necessary precision IO trial operations require.

For information, go to www.theconferenceforum.org.


Challenges and Opportunities in Pursuing a New Therapeutic Modality


Adapted from the 2016 Chief Medical Officer Summit keynote address, Dr Akshay Vaishnaw, who serves as EVP of R&D and CMO at Alnylam Pharmaceuticals, tackles the challenges and opportunities in pursuing a new therapeutic modality from its inception.

The Chief Medical Officer Summit is designed for CMOs and R&D Leadership from small to mid-size life science companies. The 6th Annual CMO Summit will be held May 7-8, 2018, in Boston.

 


Partnering with Patient Organizations for Advancing Cures

In this multi-stakeholder session from the 4th annual Patients as Partners US meeting, patients, advocates, industry and nonprofit organizations come together to discuss how they partnered and the outcomes of those partnerships.

 

 

 

  • What’s the roadmap?
  • What are the ways you have partnered with industry?
  • What are some best practices or rules of engagement?
  • How can the pharma industry better serve patient advocacy organizations?
  • How are we creating and ruthlessly maintaining transparency and trust?
  • Addressing global models of patient engagement
  • Big companies are working in global environment and the Patient Engagement issues are quite different culturally, whether it’s China, Japan, Asia. What are the unique challenges and opportunities in countries outside US and EU?

Moderated by Lori Abrams, Director, Diversity and Patient Engagement, Bristol-Myers Squibb, panelists included: Stephanie Christopher, Program Manager, Patient Centered Benefit-Risk, Medical Device Innovation Consortium; Lauren McLaughlin, Associate Director, Research Partnerships, The Michael J Fox Foundation for Parkinson’s Research; Suzanne Schrandt, JD, Director, Patient Engagement, Arthritis Foundation; Nirmala Singh Steering Committee, Patient Focused Medicines Development and Former Patient Engagement Director, National Kidney Foundation.

The 5th annual Patients as Partners US will be held March 15-16, 2018 at The Rittenhouse, Philadelphia, PA, USA.


The Gap Between Clinical Care, Patient Involvement & What Patients Want

Originally recorded during the 4th annual Patients as Partners US event held in Philadelphia, March 2017, Bristol-Myers Squibb’s Mary Stober-Murray moderates this multi-stakeholder panel to discuss what patients truly want when it comes to clinical care and patient involvement. Patients John Creveling, a Parkinson’s Foundation Research Advocate, and Deb Maskens from the International Kidney Cancer Coalition, join her and representing the industry perspective are Paul Graves from Takeda Pharmaceuticals and Dr Michelle Vichnin from Merck.

Closing the gap between clinical care and patients wants/needs:

  • Ask patients what’s going on in their lives.
  • Ask patients what their goals are.
  • Because no one asks patients these questions, the result is they get care that’s aligned with what the doctor thinks is clinically relevant, even though it may be completely out of context to what is important to the patient.

What patients want and how pharma can help:

  • Identify what patients and industry want respectively in terms of patient involvement and why that is meaningful for each.
  • What can we do to enhance this across the development pipeline?
  • What is getting in the way? Identify hurdles.
  • How can we work through this collaboratively?

Initially developed out of the first DPharm event, the Patients as Partners US program seeks to understand and incorporate the patient’s voice in designing clinical trials and developing a clinical endpoint, as well as vastly improve the patient’s entire experience in a clinical trial. The 5th Annual Patients as Partners US will be March 15-16, 2018, in Philadelphia.


Digital Solutions Impacting the Economic Efficacy of Clinical Trials

Internationally recognized digital health expert, Donald Jones, MBA, Chief Digital Officer at Scripps Translational Science Institute, shares his insights on the digital clinical trial landscape and the urgent need to pair digitization with drug products for patients during his keynote address from the 2016 CMO Summit.

The Chief Medical Officer Summit is designed for CMOs and R&D Leadership from small to mid-size life science companies. The 6th Annual CMO Summit will be held May 7-8, 2018, in Boston.

 


Partnering with Patients in the Development and Lifecycle of Medicines

At the 2017 Partners Europe event in London, Nicholas Brooke, Chief Executive, Patient Focused Medicines Development (PFMD) and Jan Geissler, Director, European Patients’ Academy on Therapeutic Innovation (EUPATI) call on industry to partner with patients in the development and lifecycle of medicines.

The Patients as Partners Europe program seeks to understand and incorporate the patient’s voice in designing clinical trials and developing a clinical endpoint, as well as vastly improve the patient’s entire experience in a clinical trial. The 2nd Annual Patients as Partners EU event will be held January 23-24, 2018 at Radisson Blu Portman Hotel, London, UK.


Trends and Collaborations in the IO Space

Dr Axel Hoos, GSK, leads a panel discussion on Trends and Collaborations in the Immuno-Oncology Space, featuring Dr Ramy Ibrahim, VP and Head of R&D, Parker Institute for Cancer Immunotherapy; Dr Jill O’Donnell-Tormey, CEO and Director of Scientific Affairs, Cancer Research Institute; Dr Daniel Chen, VP, Global Head of Cancer Immunotherapy Development, Genentech; and David Wholley, MPhil, Director, Research Partnerships Division, Foundation for the National Institutes of Health. The 4th Annual IO360° conference will take place February 7-9, 2018 in NYC.


From the Olympics to Clinical Research

Pan American Games Champion, Olympian and World Championship silver medalist, Jennifer Goldsack, became a world-class athlete while working and studying at the University of Oxford. How did she do it? She recently shared her story with DPharm Director, Valerie Bowling, discussing the lessons she learned from her Olympic experience and how she uses them in her professional life at the Clinical Trials Transformation Initiative (CTTI).

Ms Goldsack manages the development and implementation of Clinical Trials Transformation Initiative (CTTI) projects. In collaboration with team leaders, she creates project plans and budgets, and manages the implementation of those plans. She earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality.

Ms Goldsack spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, Ms Goldsack helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware.

Ms Goldsack recently presented at the Mobile in Clinical Trials conference organized by the Conference Forum.


Important Business Aspects of Immuno-Oncology: Issues and Controversies

Originally recorded during a panel session at the 2017’s Immuno-Oncology 360°, Mark Simon of Torreya Partners moderates the conversation around issues, controversies, and other important business aspects of IO. He’s joined by IO360° lead advisor and SVP at GSK, Dr Axel Hoos, Dr Robert Ang of Neon Therapeutics, Dr Jeffrey Bockman from Defined Health, Dr Jeffrey Legos from Novartis Pharmaceuticals, and Dr Chandra Ramanathan at Bayer Healthcare.

Save the date for the 4th Annual IO360° conference, taking place February 7-9, 2018 in New York City.


Roche’s Dr Barbara Lueckel Reviews the Drug Delivery Industry in 2016

If you are interested in hearing the 2017 drug delivery landscape year in review in 2017, please email service@tcfllc.org.

Chair of the Partnership Opportunities in Drug Delivery (PODD) event, Dr Barbara Lueckel, Head of Research and Technologies Partnering at Roche, presents an annual year-in-review of the drug delivery landscape from 2016. Dr Lueckel’s opening remarks are a highlight of PODD every year, and we’re excited to have her returning as program chair for 2017’s event, coming up on October 19 and 20 in Boston.

About Dr Lueckel:
Since end of 2014, Barbara leads the Research & Technologies Partnering (RTP) team belonging to the Innovation Partnering group in Roche Partnering. RTP team members lead evaluations & negotiations with biotech companies in an effort to enhance the discovery efforts of Roche’s Research & Early Development organization (pRED) across all of its therapeutic areas – either applying technology platforms to targets or molecules of interest to pRED (including drug delivery), or collaborating on early stage molecules. RTP team members are also responsible for alliance management of the resulting license agreements. Barbara joined Roche in 2007 as a Global Drug Delivery Evaluator, and transitioned to the Research & Technologies Partnering team in 2012.

Prior to Roche, Barbara worked at Novartis for ten years both on formulation development of poorly soluble molecules as well as on evaluation of reformulation opportunities as potential line extensions based on external drug delivery technologies. She is trained as a pharmacist with a PhD from the University of Basel.


What to Expect at Immuno-Oncology 360° 2018

 

 

 

 

 

 

Immuno-Oncology 360° is a comprehensive program providing exposure to the entire spectrum of R&D, addressing key aspects from all facets of IO including:

  • Discovery / Preclinical Science
  • Translational Science
  • Clinical Development
  • Business Aspects
  • Investor Relations
  • Emerging Technologies
  • Biomarkers / Diagnostics
  • Trends in the Field

Dr Axel Hoos, GSK and Dr James Gulley, NCI, together led the design of the 4th Annual Immuno-Oncology 360° program to include 45 speakers and over 30 talks. Save the date: February 7-9, 2018 in New York City.


Partnership Opportunities in Drug Delivery 2017: What to Expect?

The 7th Annual Partnership Opportunities in Drug Delivery (PODD) event will take place on October 19-20, 2017. This annual Boston-based conference is designed with three purposes:

1. To present a strategic level program for pharma and biotech business development professionals with a thorough overview of the latest drug delivery technologies available along with an update on deals and opportunities to improve therapies and extend the life cycle of a drug.

2. To provide drug delivery and specialty pharmas with a platform to present their technologies and get the latest insights on what the delivery and formulation needs are.

3. To offer ample networking time, facilities and services for one-on-one meetings to establish new business contacts and enhance existing ones.

The 7th annual event will be chaired by Dr Barbara Lueckel, Head of Research and Technologies Partnering at Roche. New to PODD this year, keynoting is Dr Jeffrey Karp, a bioengineer and world leader in drug delivery, stem cell therapeutics, and tissue adhesives. We are also delighted to welcome two additional keynote speakers: Lars Rebien Sørensen, former President and CEO of Novo Nordisk and Dr Omid Farokhzad, Associate Professor at Harvard Medical School and Director of the Center for Nanomedicine at BWH.


Immuno-Oncology 360°: Business Models for Complex Science by Dr Axel Hoos of GSK

Originally presented during the business aspects plenary session at Immuno-Oncology 360° 2017, Dr Axel Hoos of GSK discusses business models for complex science.

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.


Increasingly Critical Role of Predictive Biomarkers in Cancer Immunotherapy

Chief Medical Officer at nanoString Technologies, Dr Alessandra Cesano, brings to light the increasingly critical role of predictive biomarkers in cancer immunotherapy, originally presented during the translational science and new technologies session from 2017’s Immuno-Oncology 360° conference,

Save the date for the 4th Annual IO360° conference, taking place February 7-9, 2018 in New York City.

 

About Dr Cesano
Alessandra Cesano, MD, PhD has served as CMO at nanoString since July 2015. Prior to joining the company, Dr Cesano was Chief Medical Officer at Cleave Biosciences, Inc. From 2008 to 2014, she served as Chief Medical Officer and Chief Operations Officer at Nodality, Inc, where she built and led the R&D groups, while providing the overall clinical vision for the organization. In addition, Dr Cesano has held various management positions at Amgen, Biogen Idec and SmithKline Beecham Pharmaceuticals, where she helped to advance various oncology drugs through late stage development and FDA approvals. Dr Cesano spent 12 years researching tumor immunology, including nine years at the Wistar Institute, an NCI Basic Cancer Center at the University of Pennsylvania. She also holds membership in several professional and scientific societies, and has been an author on over 100 research publications.


Innovative Ways of Patient Involvement in Medicines Development


Originally recorded at the inaugural Patients as Partners Europe event, held in London in February 2017. Patient, industry, and regulatory perspectives are provided by Alastair Kent of Genetic Alliance UK, Dr Anton Hoos of Amgen Europe, and Isabelle Moulon of the EMD as they discuss on innovative ways of to include patient involvement in medicines development.

The Patients as Partners Europe program seeks to understand and incorporate the patient’s voice in designing clinical trials and developing a clinical endpoint, as well as vastly improve the patient’s entire experience in a clinical trial. The 2nd annual Patients as Partners EU event will be held January 23-24, 2018 at Radisson Blu Portman Hotel, London, UK.


Why Pharma R&D has to Start Thinking Like a Service Industry and How?


The Conference Forum is pleased to share a podcast featuring keynote speaker and world renowned customer service expert, Dr Chip Bell who spoke at the 6th annual DPharm: Disruptive Innovations to Advance Clinical Trials on the topic of service in clinical trials.

To truly service our patients, we need to understand service together with science. Can service be a disrupter in clinical research? In this keynote, Dr Bell tells us how to think like a service industry, why it’s worth it for R&D and how to get started. Dr Bell gives the listener practical insights on how to give patients a great experience. Although this podcast is primarily focused on serving patients in clinical research, you will find that hospitals and physician offices/medical groups will also benefit.

The 7th Annual DPharm conference will continue to cover service, but through a patient perspective. DPharm 2017 takes place September 7-8, 2017 in Boston. For more information, click here.

About Dr Chip Bell
Dr Bell is considered a world-renowned authority on customer loyalty and service innovation. He has authored eight national best-selling books. For more information visit, www.chipbell.com


Addressing Clinical Challenges in Immuno-Oncology


Originally recorded during the 3rd annual Immuno-Oncology 360° in February 2017, this panel discussion addresses clinical challenges within immuno-oncology. One of the IO360° lead advisors, Dr James Gulley of the National Cancer Institute, moderates the session between Merck’s Dr Roy Baynes, nanoString Technologies’ Dr Alessandra Cesano, MD Anderson’s Dr Patrick Hwu, and inVentiv Health’s Robert Millham.

Dr Hwu and Dr Baynes are also speaking on the 2nd annual Rational Combinations 360° program in June 2017, which is an exciting meeting dedicated to combination therapy in IO.

Save the date for the 4th annual IO360° conference, taking place February 7-9, 2018 in New York City.


Patients Influencing Policy in the EU


Alastair Kent, Director of the Genetic Alliance UK, talks about how patients can and are influencing policy within the EU.

The Patients as Partners Europe program seeks to understand and incorporate the patient’s voice in designing clinical trials and developing a clinical endpoint, as well as vastly improve the patient’s entire experience in a clinical trial. The 2nd annual Patients as Partners EU event will be held January 23-24, 2018 at Radisson Blu Portman Hotel, London, UK.


Sequencing of Combination Agents in Immuno-Oncology with Dr Charles Drake


During the preclinical science plenary session from 2017’s Immuno-Oncology 360° conference, Dr Charles Drake’s talks about “Sequencing of Combination Agents.”

Dr Drake is Director, Genitourinary Oncology and Co-Director Immunotherapy Associate Director, Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center. Previously, he was an associate professor of oncology, urology and immunology at the Johns Hopkins School of Medicine. He also serves as Co-Director of the Prostate Cancer Multidisciplinary Clinic. His areas of expertise include immunotherapy and the diagnosis and treatment of cancers of the prostate, kidney, bladder and testes.

Dr Drake graduated with a BS in electrical engineering and MS in biomedical engineering from Rutgers University in Piscataway, NJ. He then received a PhD in immunology from the National Jewish Center for Immunology, and in 1997 completed an MD at the University of Colorado Health Sciences Center. He conducted an internal medicine residency on the Osler Service at Johns Hopkins, and in 2002 he completed a fellowship in medical oncology, also at Johns Hopkins. He joined the Johns Hopkins faculty as an assistant professor in 2002.

Save the date for the 4th Annual IO360° conference, taking place February 7-9, 2018 in New York City.


Next Generation of Combination  Immunotherapy by Dr Patrick Hwu of MD Anderson


At 2016’s Rational Combinations 360° meeting, Dr Patrick Hwu of MD Anderson Cancer Center delivered a keynote address on the future outlook behind combination immunotherapy. Dr Hwu addressed innovations behind combination therapy, specifically focusing on what’s next after checkpoint combinations and whether combination of adoptive T-cell therapy and anti-checkpoint inhibitor therapies are the next wave.

 

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.”


Patients as Partners Europe 7 Minute Overview on What to Expect?


We are delighted to bring the Patients as Partners US event to Europe on February 6-7 in London. We would like to thank our European attendees at the US conference for challenging and encouraging us to bring the conference to Europe. The goal of creating patient centricity as the ecosystem within pharma can not be achieved without patient involvement.

Patients as Partners Europe is accredited by Patients Included and addresses what matters most to patients to enable them to engage in clinical research.

Patients as Partners EU is co-produced with patients, industry, academia, government and nonprofit organizations to establish a well-rounded program that addresses the needs of all stakeholders seeking to implement and advance patient involvement across the entire clinical development continuum.

Each session seeks to put ideas into action and must demonstrate the what, where, when and how behind the topic. This radio blog post provides a seven minute overview on what to expect at the conference. For more information about the conference, visit, www.theconferenceforum.org.


Unlocking the Power of Patient Engagement within Clinical and Commercial


At the inaugural Patients as Partners Europe event, Duncan Arbour from inVentiv Health explores the ‘how’ and ‘when’ for involving patients within clinical and commercial to enhance the development and delivery of innovative therapies.

The patient voice as a strategic driver is being included much earlier in the development process than ever before. In this session, pharmaceutical, biotech and device companies will gain insight into the value of smarter patient integration. Key focus areas include:
• The critical shift from drug-centric to patient-relevant
• Pivotal patient touch points throughout clinical development and launch planning that will maximize both clinical and commercial outcomes
• Positive impact of integration on efficiency and commercialization

The Patients as Partners Europe program seeks to understand and incorporate the patient’s voice in designing clinical trials and developing a clinical endpoint, as well as vastly improve the patient’s entire experience in a clinical trial. The 2nd annual Patients as Partners EU event will be held January 23-24, 2018 at Radisson Blu Portman Hotel, London, UK.


5 Minute Overview of DPharm (Disrupting Clinical Trials) Europe: What to Expect?

The 3rd annual DPharm Europe: Disruptive Innovations to Advance Clinical Trials event is led by Co-Chairs Dr Sue Collier (GSK) and Dr Jeff Kasher (Patients Can’t Wait).

 

 

 

 

This radio blogcast gives a five minute overview of the event, which presents global case studies on:

– Real World Clinical Trial Strategies and Results
– New Leadership in Driving Clinical Trial Innovation
– Strategies to Validate the Siteless Trial
– Community Outreach and Education in Clinical Trials
– New Financial Models
– Patient Involvement and Engagement
– Brexit Update and Potential Impact on R&D
– Protocol Simulation
– Adaptive Trial Model

DPharm EU takes place at the Millennium Hotel in London on February 8-9, 2017. For more information, visit www.theconferenceforum.org


Clinical Trials Collaborations & Clinical Trials as a Care Option in 7 Minutes


Get a 7 minute blogcast on the 2nd annual Clinical Trials Collaboration conference. This program takes place April 3-4 in Boston. Led by Katherine Vandebelt, Global Head of Clinical Innovation at Eli Lilly, the CTC conference is the only strategic-level event in the US entirely focused on collaborations needed for 21st century drug development.

Tufts CSDD, Ken Getz will kick off the event with “How the Clinical Collaborations Landscape Is Changing and Its Impact on R&D Operations.” The CTC conference also will feature 3 first-time keynotes:

  • Takeda on their Transformational Clinical Development and Marketed Product Partnership with PRA Health Sciences with Dr Andy Plump, Director, Chief Medical and Scientific Officer, Takeda.
  • Models for Exquisite Project Delivery with Internal and External Partners with Dr Andy Lee, SVP, Head of Global Clinical Trial Operations, Merck
  • Big Trends Impacting Clinical Development with Dr Steve Cutler, COO and CEO Designate, ICON

In addition, the CTC conference will feature:

Clinical Research as a Care Option: This collaborative session scheduled for the entire afternoon of April 4 shows us how clinical trial professionals can bring patients closer to clinical research and can find ways to make clinical trials a care option. Dr John McConnell, CEO, Wake Forest University Medical, is confirmed to keynote this section of the conference.


Immuno-Oncology 360 Conference in 5 Minutes: What to Expect?


The 3rd annual Immuno-Oncology 360° event takes place February 1-3, 2017 in NYC.  Lead advisors, Dr Axel Hoos (GSK) and Dr James Gulley (NCI) co-present a program that provides a  360-degree approach addressing the most-up-to-date information regarding business aspects, clinical advancements and scientific data that will help accelerate clinical trials and FDA approval, ultimately transforming the way cancer is treated. In this brief radio blog post, get a five minute overview on what to expect at IO360 2017! For more information on the entire event and speaking faculty, visit  www.theconferenceforum.org


PharmaTalkRadio: DPharm Team Discuss the 2016 Highlights


Members of the DPharm team engage in an informal conversation to highlight what’s happening in innovation and the latest thinking to disrupt clinical trials at the 6th annual event. Also discussed is a brief history of how this conference dedicated to applying disruptive thinking to clinical trials came to be. This conversation is well worth listening to if you plan to attend DPharm or want to get a sense of the quality and depth this program brings to clinical trial executives.

 

DPharm takes place September 20-21, 2016 at the Fairmont Copley Plaza Hotel in Boston. Also featured on September 19 is a full day on Mobile Applications to Enhancing Clinical Trials.

DPharm Link for more information or to register.

Host:
Valerie Bowling
Executive Director, DPharm

Guests:
Meredith Sands
Executive Director, Business Development, DPharm

Elizabeth Bard
Business Development Director, DPharm


Pfizer’s Blue Sky Approach to Help Transform Clinical Research


Pfizer’s “Blue Sky” approach to transforming clinical research in Parkinson’s disease is an inspiring example of patient-centric innovation. Conference Forum’s, Valerie Bowling welcomes co-host, Ed Miseta, Clinical Leader.com in a discussion with members of Pfizer’s “Blue Sky” team. Together they discuss the vision, goals and journey in taking a new approach to advancing drug development. More specifically, the Blue Sky team talks about their partnership with IBM, (first of its kind) decisions on how to use a device in a trial, real time data collection, an 1800s house for a 21st Century research and more.

Co-Hosts:
Valerie Bowling
Executive Director, The Conference Forum

Ed Miseta
Chief Editor, Clinical Leader and Contributing Writer, Life Science Leader

Guests:
Stephen Amato, PhD
Project Manager, BlueSky, Pfizer

David Caouette, MBA
Senior Director, Strategy and Operations Lead, BlueSky and Quantitative Medicine, Pfizer 

Daniel Karlin, MD
Senior Director, Quantitative Medicine, Clinical Lead, BlueSky, Pfizer

Both Drs David Caouette and Daniel Karlin are co-presenting at the DPharm conference on September 20th, 2016 in Boston. For more information, go here: DPharm.


Communicating the Good, Bad & Ugly for CMOs and R&D Leaders in Biotech

This discussion provides helpful approaches for Chief Medical Officers (CMOs) and other R&D leadership in biotech on how to communicate effectively in times of good, bad or unexpected news. Also discussed in this program are factors to evaluate for the discontinuation of a program. Dr Mark Weinberg, Chief Medical Officer and Managing Director of Halloran Consulting Group will be joined by Dr Lee Allen, CMO, Argos Therapeutics, to discuss strategic communication strategies CMOs/R&D leadership can utilize to effectively deliver unexpected or difficult news.

More specifically:

– How do you communicate successfully?
– How does a CMO manage an unexpected realization?
– Tips on being an advocate and skeptic for your programs
– Flexibility and decision making with data
– Scenario planning
– Tips on communicating to the public
– Evaluating factors for discontinuing a program
– Rationalizing your portfolio? Who decides?

Guests:
Lee Allen, MD, PhD
CMO, Argos Therapeutics

Mark Weinberg, MD, MBA
CMO and Managing DirectorHalloran Consulting Group

Producer:
Valerie Bowling
Executive Director, PharmaTalk Radio & The Conference Forum


Clinical Trial Opportunities in Puerto Rico

What is the quality, capacity and efficiency of running clinical trials in Puerto Rico? In this discussion we speak with Dr Myrto Lee, Director, PwC’s Strategy&, UK and Dr Kosmas Kretsos, Executive Director of the Puerto Rico Consortium for Clinical Investigation to learn about key initiatives and outcomes so far to make running clinical trials more attractive in Puerto Rico. For more information about conducting clinical trials in Puerto Rico, please visit www.PRCCI.org.

 

– Why consider Puerto Rico for clinical trials?
– Status of new sites to expand clinical trial networks
– Status of a central coordinator with sites to reduce bureaucracy e.g. central IRB, central invoicing
– Patient access and costs
– Patient engagement
– Access to new technologies
– Training

Guest Host:
Dr Myrto Lee
Director, PwC’s Strategy&, UK

Guest:
Dr Kosmas Kretsos
Executive Director, PRCCI (Puerto Rico Consortium for Clinical Investigation), Puerto Rico

Producer:
Valerie Bowling
Executive Director, The Conference Forum

 

Alternative Model to Transform a Funding Gap in Rare Disease Clinical Research


Frustrated that a promising therapy for a rare cancer was sitting in a freezer due to the lack of a relatively modest amount of funding, author Alexander Masters helped lead a campaign to crowd-fund a clinical trial: the result, iCancer.org.uk. The money required was indeed raised by a wealthy individual primarily, in return for being in the trial. At DPharm Europe, Pfizer’s Craig Lipset interviewed on stage Alexander to share his story. We are delighted to present the journey and latest updates on PharmaTalk Radio.

– The rstory of the formation of iCancer.org.uk and the Oncolytic Virus Fund
– An alternative way to make clinical trials more accessible
– Ethical and moral issues
– A possible disruptive and sustainable model for other neglected medicines

The next DPharm: Disruptive Innovations to Advance Clinical Trials event takes place September 20-21 in Boston. DPharm Europe is scheduled for February 8-9, 2017 in London. For more information about these events or our Immuno-Oncology events, visit, www.theconferenceforum.org.

Producer:
Valerie Bowling
Executive Director, Conference Forum & Pharma Talk Radio

Guest Host:
Craig Lipset, MBA
Head of Clinical Innovation, R&D, Pfizer

Guest:
Alexander Masters
Author, Medical Campaigner and Co-Founder, iCancer.org.uk

 


A New Economic Solution to Drive Cures to Patients


Generic drugs can be repurposed to create effective treatments in unsolved diseases. However, there is no economic incentive for industry to pay for a clinical validation and regulatory approval process for most generic drug repurposing because it will not achieve the necessary ROI. Cures Within Reach, FindaCure, Numbers For Good and the National Health Service in England are working together to the create a new economic solution to this problem by piloting the first ever Rare Disease Generic Drug Repurposing Social Impact Bond (SIB). This SIB would be a “pay for success” initiative, in which investors fund the proof of concept repurposing clinical trials and the government provides a payment to the SIB for any repurposed therapies that both improve patient outcomes and reduce healthcare costs. The government success payment would allow the SIB to repay the investors, and have additional funds for the next group of repurposing clinical trials, creating a sustainable funding source for generic drug repurposing.

Producer:
Valerie BowlingExecutive Director, The Conference Forum

Guest Host:
Bruce Bloom, JDPresident & CSO, Cures Within Reach

Panelists:
James PotterInvestment Director, Numbers for Good

Flóra RaffaiExecutive Director, Findacure

Dr Rick ThompsonScientific OfficerFindacure

Helpful Websites:

findacure.org.uk

numbersforgood.com


Partnering with Patients in the Development & Lifecycle of Medicines


Pharmatalk’s Valerie Bowling welcomes Anton (Tony)  Hoos, MD, PhD, Head of Medical, Amgen Europe and Marc Boutin, JD, Chief Executive Officer, National Health Council.  We address how industry and patients can work together to incorporate the patient voice in drug development and to improve patient’s experience in clinical trials. We examine the current challenges and barriers to patient involvement, progress and next steps.

 

Host:
Valerie Bowling, Executive Producer, PharmaTalk Radio

Guests:
Anton (Tony) Hoos, MD, PhD, Head of Medical, Amgen Europe  

Marc Boutin, JDChief Executive OfficerNational Health Council

Both Dr Hoos and Mr Boutin will be speaking at the Patients as Partners conference scheduled for March 14-15, 2016 in Philadelphia. For more information, visit www.theconferenceforum.org.


Immuno-Oncology Drug Development: Challenges & Next Steps

PharmaTalk Radio’s Valerie Bowling welcomes Immuno-Oncology 360° Co-Chair James Gulley, MD, PhD, National Cancer Institute as he leads a discussion with fellow Co-Chair, Axel Hoos, MD, PhD, GlaxoSmithKline. Together they discuss what’s currently happening in Immuno-Oncology and its impact on how cancer is being treated. They cover the latest challenges and next steps.

 

 

More specifically they also address:

– Ipilumumab/Nivo/Pembro challenges
– What 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 Vaccines
– Blinitumumab
– The more interesting agents in late stage development now in immunotherapy and its promise
– Immune related adverse events
– Adoptive 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?
– What can we expect within the next year or two?

Guests:
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-Oncology 360° 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.

 


Making Clinical Trials a Care Option for Patients

This talk demonstrates how an organized multi-specialty healthcare system, clinical research site network and pharma company uses clinical research as a tool and connector to help improve patient engagement in their overall healthcare management and compliance.
More specifically:

– Healthcare System: improving health and service to patients and advocators of clinical research participation
– Clinical Research Site Network: bringing the right patients to the right trials with increased quality of data and engagement of patients
– Pharma: expanding our reach to patients and getting trials done faster
– Shifting the paradigm: Applying a Value Based Health Care Delivery Framework to improve outcomes and reduce healthcare costs

Hosted by: Katherine Vandebelt Global Head, Clinical Innovation, Eli Lilly and Company

Guests:
Jeff James, MBA, CEO, Wilmington Health

Jennifer Byrne, CEO, PMG Research

Allen Buechler, MBA, Strategy and Operations, Eli Lilly and Company

Toyin Okanlawon, MD, MPH, Senior Health Care Researcher, Harvard Business School Health Care Team

For more information on cutting edge topics in clinical research/trials visit:

Dpharm US, visit www.theconferenceforum.org

Dpharm Europe, visit www.theconferenceforum.org

 


The Safety Elements of Immuno Cancer Therapies

In this episode of Pharma Talk Radio, we feature medical oncologist, Dr Anna Pavlick, Director of the Melanoma Program at the NYU Cancer Institute on Safety Elements of Cancer Immunotherapies. Dr Pavlick originally gave this presentation in June 2015 at the IO360 conference. Her talk focuses on immune related adverse affects of immuno therapy. More specifically, she covers:

– Identifying warning signs and low threshold for workup and treatment
– Understanding “pseudoprogression” before response, delayed toxicities
– Reporting and assessing adverse effects during clinical trial phases
– How to predict safety concerns when moving from animal models to human trials

 

We are pleased to bring this session to the public to help researchers, doctors, patients and care givers with some information on immune related adverse affects of immuno therapy. Please note that Dr Pavlick does occassionally refer to slides which are not included in the recording of this session.

Anna Pavlick, DO, MD is the Director of the NYU Cancer Institute Melanoma Research Program. After finishing her studies at University of Medicine & Dentistry of New Jersey, School of Osteopathic Medicine, Dr Pavlick completed her residency in internal medicine and her fellowship in hematology/oncology at Memorial Sloan Kettering Cancer Center. In 1999, she went on to become the Director of Clinical Oncology at UMDNJ in New Jersey before coming to NYU.

The next IO360 conference will take place February 2-3, 2016 at the New York Academy of Medicine in NYC. For more information, visit www.theconferenceforum.org.

PharmaTalkRadio is a non-profit program organized and supported by the Conference Forum to give easy and free access of helpful information to all industry professionals and students in the life sciences.

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


The Journey of a Physician CEO with David Schenkein, MD, CEO, Agios

At the Conference Forum’s 2015 Chief Medical Officer’s Summit in Boston, David Schenkein, MD, CEO, Agios provided a warm and personal keynote sharing his journey as a Physican CEO. In this recording of the session, gain an insight into Dr Schenkein’s views on leadership in running a biotech company and more specifically:

– The journey
– The people and mentorships
– Prioritizing resources
– Successes and failures
– Overcoming hurdles
– Strategic partnerships
– Business planning
– Audience Q&A

This is a great session for leadership and aspiring leadership in life sciences and beyond.

The Chief Medical Officer West Summit is this November 9-10 in the San Francisco area. See www.theconferenceforum.org for speaker line up and agenda information. The CMO West conference is dedicated to addressing the unique challenges faced by CMOs and their staff in managing R&D in emerging biotechs.

PharmaTalkRadio is a non-profit program organized and supported by the Conference Forum to give easy and free access of helpful information to all industry professionals and students in the life sciences.

 


Clinical Air Episode #14: Consumer Electronics in Clinical Research

Clinical Air Episode #14 is pleased to present a discussion on Consumer Electronics in Clinical Research. Craig Lipset, Head of Clinical Innovation R&D at Pfizer welcomes guests from Rebar Interactive and Eli Lilly to address and explore an update on what’s available, what’s capable and what’s working with consumer electronics in clinical research. We explore topics including, but not limited to:

-How to scale new tools
-The level of validation of different instruments
-The impact of tools like the Apple Research Kit
-What future apps will offer

 

 

Host:
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

Guests:
Rahlyn Gossen, Founder, Rebar Interactive

Michael Luker, Director, Clinical Innovation, Eli Lilly

Katherine Vandebelt, Senior Director, Clinical Development Innovation, Eli Lilly

*Please note this session has some background sound interference at the start of the program.

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Immuno-Oncology: Exploring the Challenges & Potential

Immuno-Oncology is arguably the most exciting area in the advancement of science and patient care today. However, with all research, there are plenty of challenges and to get a better understanding of this innovative approach to cancer research, we were pleased to welcome to Pharma Talk Radio, James Gulley, MD, PhD of the National Cancer Institute and Roy Baynes, MD, PhD at Merck Research Labs. Joining Drs Gulley and Baynes is Kate Woda, Director of the IO360 conference taking place at Columbia University Faculty House on June 29-30 in NYC.

Host:
Valerie Bowling, Producer, Pharma Talk Radio

Guests:
James Gulley, MD, PhD, Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute

Roy Baynes, MD, PhD, SVP, Global Clinical Development, Merck Research Labs

Kate Woda, Director, IO 360

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Design Thinking for Clinical Trials

Design Thinking is a human centered approach to innovation that helps uncover the sweet spot of opportunity where the needs of people, the possibilities of technology and the requirements for business success all converge. The application of the Design Thinking methodology (originating out of Stanford’s d.School) as a new approach to looking at solutions can lead to disruptive innovation in clinical trials for drug development. It allows for designing new ways of working, including the needs, challenges and insights about the complex world we work in.

In this discussion, we introduce the basic principals of Design Thinking and an understanding of how the methodology teaches empathy for the end user (the patients). We explore its ability to reframe questions and unleash innovative thinking as well as the “downside” of creative tension. Most importantly, we address how Design Thinking can drive more successful trials.

Host:
Valerie Bowling, Executive Director, The Conference Forum

Guests:
Kate Helber, Co-Founder, The Helber Group

Jen Reichuber, Co-Founder, The Helber Group

Komathi Stem, Strategic Innovation Leader, Genentech/Roche

Kate, Jen and Komathi will also be leading a hands-on program, May 11-12 in Boston. For more information, click here.

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode #13: TransCelerate & Industry Engagement

In September 2012, TransCelerate Biopharma launched with the aim of simplifying and accelerating the delivery of innovative medicines to patients. What progress has really been made and what are the realistic goals for 2015? In our 2015 kick off radio show, Clinical Air Episode #13, host Craig Lipset, Head of Clinical Innovation, R&D, Pfizer talks with Dalvir Gill, PhD, CEO of TransCelerate and Andy Lee, MD, SVP, Head of Global Clinical Trial Operations at Merck.

 

In this frank discussion, we learn:

– What’s working well and changes for 2015?
– Is TransCelerate performing better or differently from other collaborations?
– How have engagements with outside organizations advanced? Where do gaps remain?
– How are new areas selected and scope defined?
– Thoughts on implementing new ideas
– New role for CROs
– What deliverables does TransCelerate anticipate for 2015?

Host:
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

Guests:
Dalvir Gill, PhD, CEO, TransCelerate

Andy Lee, MD, SVP, Head of Global Clinical Trial Operations, Merck

Producer
Valerie Bowling, Executive Director, The Conference Forum

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Risk Based Monitoring: New Thinking on Clinical Oversight

Since the FDA and EMA published their current thinking on clinical oversight and risk-based monitoring (RBM) strategies, the topic has received a magnitude of attention, commanding column inches, webinar discussions and industry conferences. With so much discussion going on, it is unsurprising that many sponsors are feeling out in the cold when it comes to identifying how to practically implement RBM strategies within study designs. As data quality matters most in determining study success and ensuring patient safety, the latest recommendations have created growing demand for solutions that simplify the transition to risk-based techniques.

In this program, our guests discuss how emerging technologies and Central Statistical Monitoring (CSM) now present more practical means of implementing successful RBM strategies. Both Sanofi and Novartis will provide a large pharma perspective on making the move to RBM.

Host:
Valerie Bowling
Executive DirectorThe Conference Forum

Guests:
Marc Buyse
FounderInternational Drug Development Institute & CluePoints

Eric Genevois-Marlin
VP, Biostatistics & ProgrammingSanofi

Thomas Haag
Data Integrity Process Expert, eClinical Quality AssuranceNovartis Pharmaceuticals

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode # 12: Digital Startups & Applications for Clinical Research

In Clinical Air Episode #12, Craig Lipset, Head of Clinical Innovation, R&D, Pfizer talks with Marc Sluijs, Director Life Science Business Development at Oracle Health Sciences.

Marc shares his thoughts on the digital health space and where technology is heading in clinical trials. In this informal discussion, Craig and Marc also cover how digital technologies can better serve patients as well as tips on keeping tabs on this rapidly moving space and what can disrupt pharma?

Host:
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

Guest:
Marc Sluijs, Director Life Science Business Development, Oracle Health Sciences

Producer:
Valerie Bowling, Executive Director, The Conference Forum

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode # 11: How can Digital Complement and Disrupt Clinical Trials

Donald Jones, Chief Digital Officer, Scripps Translational Science Institute talks with host Craig Lipset, Head of Clinical Innovation, R&D, Pfizer on what’s happening with digital in drug development. Don discusses his thoughts on the evolution of new products with digital and the “digitazation” of tools for clinical trials. He also shares his thoughts on the biggest disruptors in pharma.

Don and Craig will be featured in an interview as well at DPharm: Disruptive Innovations to Advance Clinical Trials on September 11, 2014 in Boston.

Host:
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

Guest:
Donald Jones, Chief Digital Officer, Scripps Translational Science Institute & Founder & Chairman, Wireless Life Sciences Alliance

Producer:
Valerie Bowling, Executive DirectorThe Conference Forum

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode # 10: Patients as Partners in Clinical Trials

Join host, Craig Lipset,  Head of Clinical Innovation, R&D, Pfizer as he leads a discussion on what it really means to partner with patients in clinical trials.

Guests include:
Jeri Burtchell, Founder, Partners in Research

Regina Holliday, Artist and Medical Advocate

For more information on Jeri’s new launch, visit Healthivibe.com and for Regina walking gallery, google Regina Holliday, walking gallery.

For more information on the topic of Patients as Partners, visit www.theconferenceforum.org. The Conference Forum presented a program in March 2014 fully dedicated to understanding the journey a patient takes in clinical trials. Also take a look at Disruptive Innovations to Advance Clinical Trials scheduled for September 11-12, 2014 in Boston. This event addresses significant innovation to help improve a patients experience in a clinical trial.

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode # 9: Investing in the Future of Clinical Research

Join host, Craig Lipset,  Head of Clinical Innovation, R&D, Pfizer as he leads a discussion on Investing in the future of clinical research.

Guests include:

Todd Pietri, Co-Founder, Milestone Ventures

Jeremy Sohn, Managing Director, MPM Capital

 

 

 

 

VC views on:

-Disruption in the clinical trial space
-Entrepreneurs
-Finding opportunities (incubators and accelerators)
-Good sources of deal flows
-Investing in technology or people?
-Mobile
-Big data
-Beyond the pill
-and more….

Craig, Todd and Jeremy will also be speaking at Mobile@DPharm on September 10 at the Fairmont Copley Plaza hotel in Boston. This event helps drug developers get their arms around the mobile/digital clinical trial landscape and figure out:

-How mobile is innovating clinical trials
-What parts of clinical trials mobile/digital technology is currently impacting
-How mobile technology is making clinical trials cheaper, easier and more accurate
-How mobile/digital is increasing the efficacy of drugs
-What the true value is to clinical trials
-Opportunities

There is an opportunity to participate in creating a clinical trial app. Mobile@DPharm will also be of interest to investors and app developers. Following this one day event is DPharm: Disruptive Innovations to Advance Clinical Trials. For more information, visit www.theconferenceforum.org or call 646 350 2580.

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode # 8: Investigators as Partners in Clinical Research

In Clinical Air episode #8, Craig Lipset, Head of Clinical Innovation, R&D, Pfizer hosts a show discussing investigators as partners in clinical research. Guests include:

Christine Pierre, President, Society of Clinical Research

Jacalyn Kent, Director, Clinical Development Information & Optimization, Eli Lilly

 

 

 

 

Key topics include:

-Misunderstandings around Remote Based Monitoring
-Training and communication challenges for remote site managers
-Transcelerate update
-What are the real cost savings around RBM…are we just shifting costs?
-Real time data and how this should affect sites and payments
-Reducing burdens to the sites
-Investigator turn over rate, making sites sustainable

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode # 7: Engaging Patients by Sharing Electronic Clinical Data

In 2013 Pfizer launched the Pfizer Blue Button Project, a first-of-it’s-kind initiative enabling patients who have participated in clinical trials the opportunity to download their individual clinical data. Using the Blue Button standard launched by the White House, patients will be empowered to use the data to improve their overall health and wellness, from sharing with healthcare providers to powering clinical risk assessments. In this show, our host Craig Lipset, Head of Clinical Innovation, R&D, Pfizer speaks to the leaders behind these initiatives to find out why they launched, initial learnings, and where the projects may go if successful. Also joining Craig is Thomas Krohn, Business Lead for the Lilly Clinical Open Innovation Team.

Host:
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

Guests:
Adam Dole, Presidential Innovation Fellow, The White House

Thomas Krohn, Business Lead for the Lilly Clinical Open Innovation Team

Jennifer Wulff, Director, Clinical Innovation, Pfizer

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Barriers and Limitations in Engaging Patients in Clinical Trials

Join guests Kerri Weingard, ANP, COO, Verified Clinical Trials and Susan Salgado, PhD, Founder, Hospitality Quotient as they identify the barriers and limitations in engaging patients in clinical trials. What we can do about it through communication and service? Hosted by Valerie Bowling, Executive Director, the Conference Forum, this episode addresses one of the hottest topics at the Patients as Partners event scheduled for March 3-4, 2014 in Philadelphia. For more information, visit www.theconferenceforum.org.

About Our Guests:
Susan Reilly Salgado, PhD founded Hospitality Quotient with Danny Meyer in 2010. Hospitality Quotient offers customized advice and training to inspire, build and sustain a company culture of service in organizations across industries. In addition to her PhD, Susan holds a BS and an MBA from Lehigh University. Susan has also served as an instructor in organizational behavior and business strategy at NYU and as a guest lecturer at Lehigh.

Kerri Weingard is the chief operating officer at Verified Clinical Trials (VCT), a New York-based firm specializing in ensuring the integrity of medical studies and clinical trials by creating a database of research study participants trials. Ms. Weingard, who is a nurse practitioner, holds a master’s degree in science from Stony Brook University. She has conducted over 500 clinical trials as a research coordinator and sub-investigator.

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode #6: Clinical Trial Visits of the Future

How a patient experiences a clinical trial is changing. Access, ease, efficiencey, safety and better quality data collection are the target goals. This episode features some of the emerging technologies together with a discussion on the opportunities and challenges to include patient access, recruitment and retention. Predictions for 2014 are shared by our guests.

Host:
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

Guests:
Tomasz Sablinski, MD, PhD, Founder & CEO, Transparency Life Sciences

Komathi Stem, Senior Director, Product Development, Innovation Lead, Genentech, A Member of the Roche Group, United States

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode #5: Applications for Mobile/Sensors in Clinical Research

This episode provides a recap on what’s happening with mobile/sensors in clinical trials especially as they affect patients.

Host:
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

Guests:
Tim Davis, CEO & Co-Founder, Exco InTouch

Abbe Steel, Vice President of Patient & Physician Services, UBC

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode #4: Clinical Innovation Continuum

Eli Lilly and Quintiles entered into a co-investment partnership to develop a new solution using computer-assisted designs that emphasize the improvement of scientific and operational outcomes of clinical trials. The results were shared at the DPharm 2013 event and project leaders from both companies will talk to our host Craig Lipset on how this formation is doing a year later. Also joining Craig is Jeff Lee, CEO, Omniscience to discuss featured news and trends in clinical trial innovation and in particular mobile applications.

 

 

 

 

Host:
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

Guests:
Jeffrey Kasher, PhD, VP & COO, Eli Lilly & Company

Jeff Lee, CEO, Omniscience Mobile

Rick Sax, MD, SVP Clinical Design & Reporting Services, Quintiles

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode #3: DPharm & Beyond

A panel of executives from leading pharma and the venture capital community at the DPharm Disruptive Innovations conference recently awarded the 2013 Disruptive Innovator of the Year title to Medidata Solutions and Spaulding Clinical Research. They won for their collaboration on a novel study evaluating the impact of mobile and cloud-based technology on patient engagement for improved health outcomes in the diabetes community.

Host Craig Lipset, Head of Clinical Innovation, R&D at Pfizer speaks with Andrew Lee, MD, of Sanofi on key takeaways from the 2013 DPharm conference along with the CEOs of the winning companies to learn more about their collaboration.

 

Guests:
Andrew Lee, MD, SVP, Deputy Head of Clinical Sciences & Operations, Sanofi

Glen De Vries, President, Medidata Solutions

Randy Spaulding, Founder & CEO, Spaulding Clinical Research

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode #2: To Serve Patients in Clinical Trials

-Join us in a discussion on serving patients in clinical trials.
-Making clinical trials more accessible for patients
-Emerging technologies / iPads and informed consent
-Disruption
-Headlines in the news

Host:
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

Guests:
Andreas Koester, MD, PhD, VP, Clinical Innovation & External Alliances, Janssen

Anthony Costello, CEO, Mytrus

 

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Managing the Role of Chief Medical Officer in a Biotech

The CMO of a biotech is like no other job in the world. The CMO is not only responsible for delivering on clinical trials, but also is a key player in the company’s fundraising efforts.

From the Chief Medical Officer Summit, please join co-chairs Drs. Greg Fiore, CMO of the The Medicines Company and Steven Zelenkofske, CMO, 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.

 

 

 

Topics include:

-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
-The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Navigating the Complexities of Global Clinical Trials

Drs. Christopher Gallen, CEO at SK BioPharmaceuticals and Mitchell Katz, Executive Director, Medical Research Operations at Purdue Pharma, in a candid conversation on navigating the complexities of Global Clinical Trials and addressing topics including:

-Why global trials?
-Why are global trials so expensive?
-How are companies re-thinking global trials?
-What’s happening with global outsourcing?
-Thoughts on emerging markets and patient recruitment
-What can we do to help mitigate the risks of global trials?

The opinions shared by our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

 


Clinical Air Episode #1 Clinical Trial Calling

Join Clinical Air host Craig Lipset, Head of Clinical Innovation, R&D, Pfizer with guests Joe Kim, Clinical Operations Director, Shire and Dr Hugo Stevenson, physician and serial entrepreneur discuss innovation transforming the clinical trial space to include:

-Mobile technology and apps
-Clinical trials and diversity
-Google Glass for health
-Investigator database sharing
-Key motivations for innovators and more

The opinions shared by Craig and our guests are those of the speakers and do not necessarily reflect the opinions of their employers.

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  • September 13, 2018

  • Drug Delivery Highlights in 2017

    Dr Barbara Lueckel, Head of Research and Technologies Partnering at Roche, delivers a “Year in Review” presentation to kick off the annual Partnerships in Drug Delivery (PODD) conference. During the presentation, Lueckel discusses some of the year’s biggest innovations in the drug delivery market and provides a glimpse into the sector’s future. At PODD 2017, […]

    Dr Barbara Lueckel, Head of Research and Technologies Partnering at Roche, delivers a “Year in Review” presentation to kick off the annual Partnerships in Drug Delivery (PODD) conference. During the presentation, Lueckel discusses some of the year’s biggest innovations in the drug delivery market and provides a glimpse into the sector’s future.

    At PODD 2017, Lueckel highlighted a variety of drug delivery innovations in her Year in Review, such as:

    1. Small Molecules

    Small molecule drugs administered via immediate-release tablets or capsules are becoming exceedingly important for healthcare providers and their patients. Meanwhile, 2017 proved to be a landmark year for small molecule drugs, as several advancements were announced across the small molecule drug delivery market.

    Pfizer in August announced the U.S. Food and Drug Administration (FDA) approved Besponsa, a CD22-directed antibody-drug conjugate for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Additionally, the FDA approved Aliqopa, a kinase inhibitor that blocks several enzymes that promote cell growth and may be used to treat adults with relapsed follicular lymphoma.

    1. Peptides 

    Therapeutic peptides are available to treat rheumatoid arthritis, cancer and other medical issues. Last year, the FDA approved Trulance, a peptide-based treatment that stimulates the secretion of intestinal fluid and supports regular bowel function.

    The global peptide therapeutics market is projected to be worth more than $48 billion by 2025, according to industry analyst Grand View Research. As healthcare providers search for innovative ways to address patients’ medical problems, the demand for therapeutic peptides may increase in the years to come.

    1. Antibodies and Proteins

    2017 was “the year of subcutaneous administration” of antibodies and proteins, Lueckel said. Two key innovations highlighted the growing interest in antibodies and proteins for drug delivery: C1 esterase inhibitor and Benlysta treatments.

    The C1 esterase inhibitor treatment can be used to address systemic lupus erythematosus, and it can be administered by a patient on his or her own. Comparatively, Benlysta offers an FDA-approved prescription infusion or self-injectable medication to treat lupus symptoms.

    1. Connected Health 

    Technology constantly evolves. As such, healthcare providers are integrating technology into their drug delivery methods like never before.

    Several smart devices illustrate the link between connected health and drug delivery. For instance, a patch was developed last year that a patient can wear on his or her stomach; the patch includes a smart sensor that indicates if a patient has taken his or her daily medications. Furthermore, smart touch monitoring for the Symbicort inhalation aerosol is being evaluated as a potential way to enhance patient medication adherence.

    Ultimately, innovation is most impactful when it benefits the patient, Lueckel indicated. Healthcare providers remain on the lookout for innovation opportunities, and as a result, the future looks bright for the global drug delivery market.

    For those who want to learn more about the current state of the global drug delivery market, Lueckel will launch this year’s PODD event with a Year in Review. Read about to Lueckel’s 2016 Year in Review here or listen to it here. To find out more about PODD 2018, click here to view the conference agenda.

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  • September 10, 2018

  • Partnership Opportunities in Drug Delivery 2018: What to Expect 5 Min Podcast

    Listen to a five minute overview of the 8th Annual Partnership Opportunities in Drug Delivery (PODD) event which will take place on October 18-19, 2018 in Boston. PODD is designed with 3 purposes: To present a strategic level program for pharma and biotech biz development professionals with a thorough overview of the latest drug delivery technologies available along with an update on deals and […]

    Listen to a five minute overview of the 8th Annual Partnership Opportunities in Drug Delivery (PODD) event which will take place on October 18-19, 2018 in Boston.

    PODD is designed with 3 purposes:

    1. To present a strategic level program for pharma and biotech biz development professionals with a thorough overview of the latest drug delivery technologies available along with an update on deals and opportunities.
    2. To provide drug delivery with a platform to present their technologies and get the latest insights on what the delivery and formulation needs are.
    3. To offer ample networking time, facilities and services for one-on-one meetings to establish new business contacts and enhance existing ones.

    PODD is chaired by Dr Barbara Lueckel, Head of Research and Technologies Partnering at Roche. MIT’s Dr Robert Langer and Polaris’ Amy Schulman, two dynamic entrepreneurs in biotech are the opening keynotes in a fireside chat. Justin Wright, PhD, Global Head of Innovation, Novartis will provide an industry keynote.  Also, Jeffrey Karp, PhD keynotes with Stories from Bioinspiration to drug delivery. Choice of delivery tech tracks and includes partnering support.

    Host: Valerie Bowling, PODD Director

     

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  • September 4, 2018

  • All of Us Research Program, a Nation-wide Initiative from the NIH

    Podcast guest, Elise Felicione, who is currently a Scientific Collaborator at the Scripps Translational Science Institute, is playing an integral role under the direction of Dr Eric Topol on a nation-wide initiative from the NIH. The initiative is called All Of Us, a US Precision Medicine program that aims to enroll a million Americans and follow them for 10 […]

    Podcast guest, Elise Felicione, who is currently a Scientific Collaborator at the Scripps Translational Science Institute, is playing an integral role under the direction of Dr Eric Topol on a nation-wide initiative from the NIH. The initiative is called All Of Us, a US Precision Medicine program that aims to enroll a million Americans and follow them for 10 years, during which time participants will contribute biological, environmental, and lifestyle data. One-third of participants will participate virtually (not via a research site). The cohort will mirror the projected 2040 census. Individual pharma companies are never going to create cohorts like this, so the importance of this open source frame work that drug developers can tap into will be highly beneficial in serving the patient of the future.

    Discussion points include:

    • What is the All Of Us Research Program?
    • Why does this matter to biopharmaceutical companies?
    • How far along is the program and how to get involved?
    • What are your biggest challenges?
    • How can biopharmaceutical companies get involved?

    For more information on the All Of Us program, visit: https://allofus.nih.gov/

    Elise will be speaking at DPharm on September 26th and will also have an exhibit booth to answer any questions are All of Us. For information on DPharm taking place September 25-26, 2018 in Boston. For information, please visit, www.theconferenceforum.org

    Producer: Valerie BowlingExecutive Director, Pharma Talk Radio and DPharm

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  • August 27, 2018

  • Reimagining Clinical Trials with Entrepreneur, Dr Ben Liu, CEO, Trialspark

    During his graduate work, Dr Benjamine Liu observed the many bottlenecks that get in the way of clinical trials slowing the development of new treatments for patients. This challenge inspired him to launch 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 […]

    During his graduate work, Dr Benjamine Liu observed the many bottlenecks that get in the way of clinical trials slowing the development of new treatments for patients. This challenge inspired him to launch 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.

     

    RESERVE YOUR SPOT AT DPHARM

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  • August 20, 2018

  • Keynote from Bioinspirationalist Dr Jeffrey Karp, World Leader in Drug Delivery

    Hear the Bioinspirationalist Keynote given by Dr Jeffrey Karp given at Partnership Opportunities in Drug Delivery in 2017. Dr Jeff Karp is a world leader in drug delivery, stem cell therapeutics, and tissue adhesives. He is a Professor at Brigham and Women’s Hospital, Harvard Medical School, Principal Faculty at the Harvard Stem Cell Institute, and […]

    Hear the Bioinspirationalist Keynote given by Dr Jeffrey Karp given at Partnership Opportunities in Drug Delivery in 2017.

    Dr Jeff Karp is a world leader in drug delivery, stem cell therapeutics, and tissue adhesives. He is a Professor at Brigham and Women’s Hospital, Harvard Medical School, Principal Faculty at the Harvard Stem Cell Institute, and an affiliate faculty at the Broad Institute and at the Harvard-MIT Division of Health Sciences and Technology.

    Dr Karp’s bioinspirational keynote at the 2018 Partnership Opportunities in Drug Delivery (PODD) on October 17-18, 2018 will provide an update on multiple drug delivery technologies that he is developing including those highlighted in 2017 as well as other technologies developed in the KarpLab that are rapidly advancing to the clinic. Register for PODD 2018 here: http://theconferenceforum.org/conferences/partners-in-drug-delivery/overview/

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  • August 17, 2018

  • Blockchain Opportunities for Patient Data Donation and Clinical Research

    Patients are at the center of research and their data is the foundation for clinical innovation. However, significant barriers exist that inhibit the secure and efficient sharing of patient data. In this podcast, Craig Lipset, Head of Clinical Innovation, Pfizer, Munther Baara, Head of New Clinical Paradigm, Pfizer and Aditya Kudumala, Principal, Deloitte discuss blockchain as a catalyst to significantly change how […]

    Patients are at the center of research and their data is the foundation for clinical innovation. However, significant barriers exist that inhibit the secure and efficient sharing of patient data. In this podcast, Craig Lipset, Head of Clinical Innovation, Pfizer, Munther Baara, Head of New Clinical Paradigm, Pfizer and Aditya Kudumala, Principal, Deloitte discuss blockchain as a catalyst to significantly change how we can access and use data to improve patient lives. Where is the patient data storm going?

    Discussion points include, but not limited to:

    • Who owns my data and where it’s going?
    • What are the interoperability challenges and progress?
    • How can data be shared?
    • How you can pull in your own health data?
    • Where does blockchain fit in and how can it secure patient data?
    • How blockchain gives us authentication without identification?
    • Next steps?

    For more information on this topic and to get access to the Blockchain Opportunities for Patient Data Donation & Cinical Research, click here.

    Craig will be leading an entire section on the democratization of patient data at DPharm on September 25-26 in Boston.

    Reserve Your Spot at DPharm

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  • August 16, 2018

  • Cambridge Design Partnership’s Uri Baruch on Innovation in the Drug Delivery Space

    At the 2018 Drug Delivery West Meeting, Uri Baruch, Head of Drug Delivery at Cambridge Design Partnership gave the talk “How to Innovate in the Drug Delivery Space” in which he explored: The Innovation Process The barriers to the innovation process and how to overcome them Summary of disease space Good design and engineering practices […]

    At the 2018 Drug Delivery West Meeting, Uri Baruch, Head of Drug Delivery at Cambridge Design Partnership gave the talk “How to Innovate in the Drug Delivery Space” in which he explored:

    • The Innovation Process
    • The barriers to the innovation process and how to overcome
      them
    • Summary of disease space
    • Good design and engineering practices
    • How to salvage something that goes wrong?
    • How do you find the unknown unknowns?
    • Does it feel right?

    Read More

  • August 16, 2018

  • Mobile in Clinical Trials Podcast: 3 1/2 Minutes on What to Expect

    Welcome to the 5th annual Mobile in Clinical Trials podcast. In this quick fire podcast, you will get a brief overview on what to expect. The conference takes place in Boston on Sept 24th, the day before DPharm. It is researched and produced by the Conference Forum and is chaired by: Daniel Karlin, MD Assistant Professor of Psychiatry, Tufts University and Former […]

    Welcome to the 5th annual Mobile in Clinical Trials podcast. In this quick fire podcast, you will get a brief overview on what to expect. The conference takes place in Boston on Sept 24th, the day before DPharm. It is researched and produced by the Conference Forum and is chaired by:

    Daniel Karlin, MD
    Assistant Professor of Psychiatry, Tufts University and Former Head of Clinical, Informatics, and Regulatory Strategy, Digital MedicinePfizer Inc

    Mobile and digital tools are the future of clinical trials and as the industry continues to transition into a data science industry with a responsibility to reduce patient burden, it is really important that we bring this conference to you to get the latest examples on what tools are available and who has used them and what are the lessons to engage patients?

    Producers: Valerie Bowling, Executive Director, the Conference Forum and Jennifer Moran, Producer, the Conference Forum

     

    Learn more about Mobile

    Reserve Your Spot for Mobile in Clinical Trials

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  • August 16, 2018

  • DPharm: Disruptive Innovations to Advance Clinical Trials 8 1/2 Minute Podcast

    This 8 1/2 minute podcast gives you an overview on what to expect from the 8th annual DPharm conference. DPharm is the annual event in the US to get the best access to innovative ideas, especially disruptive ones, to advance clinical trials with a view to reducing the burden to patients and investigators. DPharm 2018 is dedicated […]

    This 8 1/2 minute podcast gives you an overview on what to expect from the 8th annual DPharm conference. DPharm is the annual event in the US to get the best access to innovative ideas, especially disruptive ones, to advance clinical trials with a view to reducing the burden to patients and investigators.

    DPharm 2018 is dedicated to all things digital, data science, patient data ownership and new approaches to optimize clinical operation systems.

    DPharm is September 25-26 at the Boston Marriott Copley Place.

    Chaired by:

    Sylke Poehling, PhD, SVP and Global Head, Strategy, Portfolio & Clinical Operations, Pharma Research & Early DevelopmentRoche

    Andreas Koester, MD, PhD, VP and Global Head, Janssen Clinical Innovation, Janssen

    Craig Lipset, MBA, Head of Clinical Innovation, Pfizer

    Producer: Valerie Bowling, Executive Director, DPharm

     

     

    Learn more about DPharm

    Reserve Your Spot at DPharm

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  • July 18, 2018

  • What to Expect at Rational Combinations 360° 2018 – 5 Min Overview

    In this episode of Pharma Talk Radio, Kate Woda, producer of the Rational Combinations 360° conference, provides a 5 minute overview of what to expect this year. Rational Combinations 360° addresses business aspects, clinical advancements and scientific data in IO combination strategies. The rapid advancement in our understanding of human cancer immunity and immunotherapy combinations […]

    In this episode of Pharma Talk Radio, Kate Woda, producer of the Rational Combinations 360° conference, provides a 5 minute overview of what to expect this year.

    Rational Combinations 360° addresses business aspects, clinical advancements and scientific data in IO combination strategies. The rapid advancement in our understanding of human cancer immunity and immunotherapy combinations is nearly impossible for individual scientists to comprehend. Only together, as an engaged and interactive scientific community, can we hope to enable a patient’s immune system to eradicate cancer.

    Rational Combinations 360° addresses the following plenary topics over the course of 2 days:

    • Discovery and Preclinical Science
    • Translational Science and Emerging Biomarkers
    • Operationalizing IO Combinations
    • Emerging Clinical Combinations
    • Emerging Data Combinations in Clinical Trials
    • Business Aspects

    Dr Patrick Hwu, MD Anderson, Dr Axel Hoos, GSK and Dr Ian McCaffery, Janssen, together led the design of the 3rd annual program that includes more than 45 speakers and over 30 talks.

     

     

     

     

     

     

    Save the Date: The 3rd annual Rational Combinations 360° program will take place September 13-14, 2018 in Philadelphia. For more information visit www.theconferenceforum.org/conferences/rational-combinations-360/overview

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  • June 7, 2018

  • Building Blocks of IO Clinical Trials – Part 2

    In this episode of Pharma Talk Radio, we continue with Part 2 of the Building Blocks of IO Clinical Trials session led by Andy Lee, SVP and Head of Global Clinical Trial Operations and his team at Merck from the 5th annual IO360° conference. In this final part of the recorded session, we continue to […]

    In this episode of Pharma Talk Radio, we continue with Part 2 of the Building Blocks of IO Clinical Trials session led by Andy Lee, SVP and Head of Global Clinical Trial Operations and his team at Merck from the 5th annual IO360° conference.

    In this final part of the recorded session, we continue to address clinical trial design and operations including:

    – Supply Chain Management and Complexities of Biologics
    – Data Management
    – Project Management and Scaling up Resources

     

     

     

     

     

     

    Save the Date: The 5th annual Immuno-Oncology 360° program will take place February 6-8, 2019 in NYC. For more information visit: 
    www.theconferenceforum.org/conferences/immuno-oncology-360/overview

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  • June 6, 2018

  • Building Blocks of IO Clinical Trials – Part 1

    In this episode of Pharma Talk Radio, we feature Andy Lee, SVP and Head of Global Clinical Trial Operations and his team at Merck who spoke at IO360° in February 2018 on the Building Blocks of IO Clinical Trials. The Merck operations team detailed a day in the life of IO trial functions, how to […]

    In this episode of Pharma Talk Radio, we feature Andy Lee, SVP and Head of Global Clinical Trial Operations and his team at Merck who spoke at IO360° in February 2018 on the Building Blocks of IO Clinical Trials. The Merck operations team detailed a day in the life of IO trial functions, how to work collaboratively and effectively, to advance the development of IO therapeutics. This is Part 1 of a 2 Part recording.

    Part 1 delved into:

    – A Patient Experience of an IO trial
    – Site Management
    – Clinical Oversight and Monitoring
    – Operational Aspects of PDL1 Stratification and Biomarkers

     
     
     
     
     
     
     
     
     
     
    Save the Date: The 5th annual Immuno-Oncology 360° program will take place February 6-8, 2019 in NYC. For more information visit: 

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  • June 6, 2018

  • DPharm Podcast Series: Reducing the Burden of Type 1 Diabetes with Patient, Dana Lewis

    In this podcast, patient advocate star Dana Lewis, founder of OpenAPS, delivers a powerful session at DPharm on an idea to reduce the burden of type 1 diabetes with a smart system she created through open source. Learn how she drove the idea and creation of the “Self driving car for diabetes”. DPharm 2018 will be taking place September 25-26, 2018 […]

    In this podcast, patient advocate star Dana Lewis, founder of OpenAPS, delivers a powerful session at DPharm on an idea to reduce the burden of type 1 diabetes with a smart system she created through open source. Learn how she drove the idea and creation of the “Self driving car for diabetes”.

    DPharm 2018 will be taking place September 25-26, 2018 at the Boston Marriott Copley Place. Reserve your spot now. Never stop innovating!

    Listen to the podcast here.

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  • June 5, 2018

  • 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 […]

     

     

     

     

     

     

    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

    Save the Date: 
    The 5th annual Immuno-Oncology 360° program will take place February 6-8, 2019 in NYC. For more information visit: 
    www.theconferenceforum.org/conferences/immuno-oncology-360/overview

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  • September 5, 2017

  • Drug Delivery Market: Key Innovations in 2016

    In her 2016 PODD “Year in Review,” Dr Barbara Lueckel, Head of Research and Technologies Partnering at Roche discussed several innovations that transformed the drug delivery market at PODD 2016. These innovations included: 1. Miniature Magnetic Devices Researchers are exploring the use of miniature magnetic devices to treat diabetes, asthma and other diseases. Miniature magnetic […]

    In her 2016 PODD “Year in Review,” Dr Barbara Lueckel, Head of Research and Technologies Partnering at Roche discussed several innovations that transformed the drug delivery market at PODD 2016. These innovations included:

    1. Miniature Magnetic Devices

    Researchers are exploring the use of miniature magnetic devices to treat diabetes, asthma and other diseases. Miniature magnetic devices are designed to change the firing patterns of peripheral nerves that go to muscles and organs, according to Lueckel. They also may provide safe, effective alternatives for patients who are struggling with pills and intravenous injections.

    GSK and Verily launched Galvani Bioelectronics, a company dedicated to the development of bioelectronics medicines, in August 2016. Meanwhile, as researchers drive miniature magnetic device innovations, investments in this field could increase in the years to come.

    2. Diabetes

    Approximately 3 million Americans – or about 9% of the U.S. population – are diabetic, the American Diabetes Association (ADA) reports. Fortunately, researchers are using innovation to improve diabetes diagnosis and treatment.

    For example, the J&J OneTouch Via device was introduced in June 2016 and offers mealtime insulin delivery for diabetics. Other notable diabetes innovations in 2016 included Repatha, a PCSK9 inhibitor that offers monthly single-dose delivery, and a Bluetooth-enabled insulin pen that tracks insulin dosing and other patient data.

    3. Connected Devices for Chronic Respiratory Diseases

    Roughly 500 million individuals suffer from chronic respiratory diseases, Lueckel indicated. Yet the digital dose inhaler market is projected to grow from $1 billion in 2016 to $4 billion by 2024, thanks in large part to ongoing innovation across the field.

    Connected devices simultaneously enhance compliance and dosage tracking and promote connectivity between chronic respiratory disease patients and healthcare providers. As such, the market for connected devices for chronic respiratory diseases represents “a huge growth opportunity” for patients and healthcare providers alike, Lueckel said.

    The drug delivery market is constantly evolving, and Lueckel will provide the latest insights into the sector’s past, present and future during her “Year in Review” presentation at this year’s PODD conference. To find out more about PODD, click here.

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