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Fireside Chat with an R&D Veteran Dec 03, 2019

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Dr Jeffrey Chodakewitz, former EVP, Clinical Medicine and External Innovation, CMO at Vertex Pharmaceuticals, joins the Chief Medical Officer Summit for the first time to discuss his incredible journey as a CMO. Recorded at the 7th annual Chief Medical Officer Summit, Dr Chodakewitz sits down with Dr Julie Krop, AMAG Pharmaceuticals to discuss the following: The journeyPrioritizing resourcesSuccesses and failuresOvercoming hurdlesCareer decisionsTransitioning from large pharma to small biotechConsiderations for building your team in large and small companies Learn more at theconferenceforum.org

Designing Clinical Trials for Gene Therapy - A Paradigm Shift Dec 03, 2019

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This session, recorded at the 7th annual Chief Medical Officer Summit and moderated by Dr Martin Childers, Asklepios BioPharmaceutical, discusses designing clinical trials for gene therapy. Topics covered include: How to utilize adaptive trial design within the specific context of a gene therapy - are there any unique aspects of development conducive to this approach?How to ensure flexibility when pushing for an accelerated pathway?Communicating pros and cons of development options and your recommendation to your CEODe-risk identifying the primary efficacy endpoint without a proof of concept phaseHow to interpret the current FDA guidanceFactors to consider around in-vivo and ex-vivo regulatory guidanceHow to use the guidance to direct the path of your programGlobal regulatory considerations and how to overcome them Panelists include: Edward Conner, MD, Sangamo TherapeuticsKathleen Reape, MD, Spark Therapeutics Learn more at theconferenceforum.org

Case Study: Life of a Chief Medical Officer Pre and Post IPO Dec 02, 2019

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In this talk, first recorded at the 7th annual Chief Medical Officer Summit, Dr Tal Zaks, Chief Medical Officer, Moderna Therapeutics shares his experience and lessons learned through one of the biggest transitions a Chief Medical Officer can make in biotech: Expanding the role of the CMO to meet the requirements of a public companyInsights into the experienceManaging growthWhat role does the CMO have in articulating the data of clinical trials What role does the CMO have in business development opportunitiesWhat are the personal implications of being a CMO in a publicly traded companyLessons learned Learn more at theconferenceforum.org

How the CMO of Sage Therapeutics Positioned a New Indication for FDA Approval Dec 02, 2019

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In this session recorded at the 7th annual Chief Medical Officer Summit, Dr Steve Kanes, Chief Medical Officer, Sage Therapeutics, discusses how a company considered as an "up and comer" in the Cambridge biotech sector navigated the development and approval of the first treatment specifically designed for postpartum depression. Learn more at theconferenceforum.org

Addressing the Talent Gap in Biotech - Recruit and Retain Dec 02, 2019

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In an increasingly competitive market, there is a growing need for efficiency in attracting and retaining top talent. This session, recorded at the 7th annual Chief Medical Officer Summit, and moderated by Dr Julie Krop, AMAG Pharmaceuticals, addresses the following: How to source talent; pros and cons of recruiters versus word-of-mouthHow to make the work environment optimal to keep employees satisfiedHow to compete with the competition banging on the doorHow to ease or address relocation concerns of potential hiresWhen is a good time to have consultants or contractors filling the gapsHow to access the untapped talent in academia, do they know we exist?Benefit/risk of having non-MDs fill the gaps and guided by a physicianDoes the industry need to evolve to attract and retain talentHow do you decide whom to recruit firstHow to identify the right hire Panelists include: Kara Coluccio Bern, Perspective GroupJames Lewis, Barrington JamesChris Poshka, Govig Learn more at theconferenceforum.org

How to Navigate the Development Path from CMO to CEO Dec 01, 2019

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First recorded at the 7th annual Chief Medical Officer Summit, this session provides insight in what it takes and how to navigate and what to expect in the CEO role. Moderated by Dr Zain Kassam, Finch Therapeutics, this panel discusses: How can a CMO position themselves as a corporate leader?How to build a network of advisors and who should it include? Panelists include: Aoife Brennan, MB, BCh, BAO, MRCPI, SynlogicGreg Fiore, MD, Sollis Therapeutics Learn more at theconferenceforum.org

How do Patients Become Partners in the Sharing of Data to Advance Science? Nov 06, 2019

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In this podcast, hear a session from the 2019 Patients as Partners EU conference on How do Patients Become Partners in the Sharing of Data to Advance Science? How to encourage the sharing of suitably anonymized data to further medicines development for the benefit of patients?What are the barriers/issues? Public mistrust of pharma? Language, medical records versus coded data? Speakers: Natalie Banner, PhD, Understanding Patient Data Lead, Wellcome Trust Richard Stephens, Patient/Consumer Lead, Chair Consumer Forum, NCRI The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020 in London, UK. To learn more about the program and patient centricity in R&D, visit theconferenceforum.org.

Best Practices for Pharma - Patient Advocacy Partnerships Nov 05, 2019

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In this podcast, hear a panel discussion presented at the 2019 Patients as Partners EU conference on Best Practices for Pharma - Patient Advocacy Partnerships. Pharma and advocacy representatives discuss: • Advocacy point of view on is what pharma is doing in clinical trials and medicines development truly patient-centric? • How can advocacy groups work with the pharmaceutical industry to improve the clinical trial process? • How can advocacy get their foot in the door at pharma? Pharma’s advice. • How can pharma and advocacy better work together? • Explore the value of pharma reps spending time at an advocacy office to better understand what they do • How can this partnership impact patients and medicines development? Moderator: Chris Macdonald, Head of Research, Pancreatic Cancer UK Panelists: Vanessa Pott, Director, Patient Advocacy & Strategic Partnerships, Merck KGaA Natasha Ratcliffe, PhD, Research Involvement Manager, Parkinson’s UK The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020 in London, UK. To learn more about the conference and patient centricity in R&D, visit theconferenceforum.org.

Merck's Next Phase of Patient Centricity in R&D Nov 04, 2019

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In this podcast, hear a session from the 2019 Patients as Partners EU meeting where Merck's Vanessa Pott presented a case study on Innovative Medicines Development and Merck KGaA's next phase of Patient Centricity in R&D. The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020 in London, UK. To learn more about the program and patient centricity in R&D, visit theconferenceforum.org.

Clinical update on AMG 420, an anti-BCMA BiTE® Nov 01, 2019

Show notes

In this talk, recorded at the 5th annual IO360° Summit, Dr Alex Minella, Amgen, provides a clinical update on AMG 420, an anti-BCMA BiTE® This talk addresses the: Summary of IND enabling preclinical studiesFirst-in-human trial designFirst-in-human trial data (safety, efficacy) Save the date for the 6th annual Immuno-Oncology 360° Summit on February 26-28, 2020 at the Crowne Plaza Times Square in New York City. Learn more at www.io360summit.com

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