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Product Development Strategy [clear filter]
Monday, October 28
 

1:00pm PDT

Track Chair Opening Remarks
Speakers
avatar for Natalia Borinshteyn, M.D., Ph.D.

Natalia Borinshteyn, M.D., Ph.D.

Former Vice President, Medical Affairs, HCV Launch Team, ABBVIE
Dr Natalia Borinshteyn, recognized industry leader with 20 years’ experience in Pharma and unique blend of Medical, Marketing and Research & Develooment expertise.  Dr. Borinshteyn is a founder and President of Life Science Excellence Inc a boutique strategic services company for... Read More →

Monday October 28, 2019 1:00pm - 1:15pm PDT
  Product Development Strategy

1:15pm PDT

Amgen’s Approach to Designing Clinical Trials That Can Improve the Rate of Success
  • Hear how adaptive design can enhance the odds of clinical success by correcting assumptions that may otherwise obscure a drug’s true potential
  • Weigh the benefits of finding out faster whether a drug works or doesn’t work and make quicker decisions to advance a program or terminate it
  • Explore how the optimization of clinical trial design is a key variable in reducing costs and driving the speed of trial that will ultimately serve patients better
Speakers
avatar for Elliott M. Levy

Elliott M. Levy

Senior Vice President, Global Development, AMGEN
Elliott M. Levy, M.D., is senior vice president, Global Development, responsible for the clinical development of Amgen’s pipeline. Before joining Amgen, Levy served as senior vice president and head of Specialty Development at Bristol-Myers Squibb (BMS). Prior to that role, he held... Read More →

Monday October 28, 2019 1:15pm - 2:00pm PDT
  Product Development Strategy

2:00pm PDT

Explore How AI and Machine Learning Can Be the Backbone to Building a Hypothesis for Drug Discovery
  • Highlight the major challenges, as well as misconceptions, to overcome in realizing the benefits of AI in drug discovery/pharma
  • Review some examples of successful implementation of AI methods in hypothesis generation in drug discovery
  • Explore some exciting areas for AI in drug discovery that are not quite ready for prime time, but are advancing quickly
  • Discuss how startups and pharma can work together to innovate in this space

Speakers
avatar for Roman Yelensky

Roman Yelensky

Executive Vice President and Chief Technology Officer, GRITSTONE ONCOLOGY
Roman Yelensky, Ph.D. has served as our Executive Vice President, Chief Technology Officer since October 2015. He joined Gritstone at its inception in October 2015 as executive vice president of sequencing and bioinformatics. Prior to Gritstone, from July 2010 to September 2015, Dr... Read More →
avatar for Nicolas Stransky

Nicolas Stransky

Senior Director, Head of Data Science, CELSIUS THERAPEUTICS
avatar for Dr. Josep Bassaganya-Riera

Dr. Josep Bassaganya-Riera

Chairman and CEO, LANDOS BIOPHARMA
Dr. Josep Bassaganya-Riera, Chairman and CEO of Landos Biopharma, is an innovator, serial entrepreneur & thought leader in biotech. He has published over 200 peer-reviewed publications & patents and has founded 3 award-winning companies, raising over $125 million in non-dilutive and... Read More →
avatar for Pat Walters

Pat Walters

Senior Vice President, Computation, RELAY THERAPEUTICS
Pat Walters heads the Computation & Informatics group at Relay Therapeutics. This group focuses on novel applications of computational methods that integrate computer simulations and experimental data to provide insights that drive drug discovery programs. Prior to joining Relay... Read More →
avatar for Ron Alfa

Ron Alfa

Vice President of Translational Research, RECURSION PHARMACEUTICALS
Ron is Senior Vice President, Translational Discovery at Recursion (recursionpharma.com), a technology-enabled drug discovery company combining machine learning with automated cell biology. At Recursion, his team manages commercial and translational strategy for Recursion’s portfolio... Read More →

Monday October 28, 2019 2:00pm - 2:45pm PDT
  Product Development Strategy

3:15pm PDT

New Indications in the Approval of Medicines
  • Consider how the FDA has begun to look at molecular pathway indications instead of indication by clinical diagnosis as treatment fields continue to evolve
  • Share opinions on whether the FDA should more formally consider when to utilize molecular pathway-based indications versus clinical diagnosis in the approval of medicines
  • Discuss the concerns of modifying a tried-and-true process versus the pros of change

Speakers
avatar for Bola Akinlade, M.D.

Bola Akinlade, M.D.

Vice President, Head, General Medicine Therapeutic Area, REGENERON
Dr. Bola Akinlade is the Head and Vice President for Regeneron’s General Medicine Therapeutic Area. In his current role, he leads programs in pain, rheumatology, allergic disease and transplantation. Upon joining Regeneron in 2015, Dr. Akinlade led the immunology and inflammation... Read More →
avatar for Sabah Oney, Ph.D

Sabah Oney, Ph.D

Chief Business Officer, Alector
Sabah Oney, PhD, is Chief Business Officer at Alector, a clinical stage biotechnology company leveraging the immune system to cure neurodegeneration.Sabah joined Alector in 2016 and has been leading the company's fundraising, partnering, business development, finance, PR, and IT activities... Read More →
avatar for Craig L. Tendler, M.D.

Craig L. Tendler, M.D.

Vice President, Clinical Development and Global Medical Affairs, Oncology, JANSSEN RESEARCH AND DEVELOPMENT
Craig Tendler, M.D. is Vice President, Clinical Development and Global Medical Affairs for the Oncology Therapeutic Area at Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. In this position, he is responsible for creating robust... Read More →
avatar for Kyle Blankenship

Kyle Blankenship

Associate Editor, FIERCEPHARMA

Monday October 28, 2019 3:15pm - 4:00pm PDT
  Product Development Strategy

4:00pm PDT

Find Drivers for Development Success: IND Through Clinical Proof-of-Concept
  • Explore ways to garner success and generate significant value creation with optimization of development programs
  • Design early preclinical studies to generate definitive signals and prioritize next steps
  • Review the risks and hurdles to navigate the development pathway
  • Craft a robust and insightful POC trial to improve upon historical industry success rates

Speakers
avatar for Chris Garabedian

Chris Garabedian

Chairman and CEO, XONTOGENY LLC
Chris Garabedian is an industry pioneer with over two decades guiding and building early-stage biopharma companies ensuring development success.  Chris founded Xontogeny to support promising technologies from early development through clinical POC and formed a partnership with Perceptive... Read More →
avatar for Stefan Irion, M.D.

Stefan Irion, M.D.

Vice President, Translational Neuroscience, BLUEROCK THERAPEUTICS
Stefan Irion, M.D., joined BlueRock bringing deep knowledge of cell therapies from his research experience in both academia and industry. Dr. Irion has been working on the development team for BlueRock’s lead cellular therapeutic candidate targeting Parkinson’s disease since 2013... Read More →
avatar for Vangelis Vergetis

Vangelis Vergetis

Executive Director, INTELLIGENCIA
Vangelis has more than 13 years experience in healthcare and life sciences, including in clinical development – as a consultant at McKinsey and Hakluyt, and now at Intelligencia. Outside of Intelligencia, he is a board member and member of the Executive Committee at the Alliance... Read More →

Monday October 28, 2019 4:00pm - 4:45pm PDT
  Product Development Strategy

4:45pm PDT

Preparing for Commercialization and Transactional Success
  • Conquer the complexity of launching a product and a commercial enterprise
  • Model your asset’s unique commercial ecosystem: creating a “spinal cord” for decision-making
  • Boost launch readiness and preparing for the inevitable uncertainties
Speakers
avatar for Andrew DeMarco

Andrew DeMarco

Principal, SVA CONSULTING
avatar for Robert Weiland

Robert Weiland

Biotech Executive, Board Director and Strategist

Monday October 28, 2019 4:45pm - 5:30pm PDT
  Product Development Strategy
 
Tuesday, October 29
 

8:45am PDT

Recap of Day One
Speakers
avatar for Natalia Borinshteyn, M.D., Ph.D.

Natalia Borinshteyn, M.D., Ph.D.

Former Vice President, Medical Affairs, HCV Launch Team, ABBVIE
Dr Natalia Borinshteyn, recognized industry leader with 20 years’ experience in Pharma and unique blend of Medical, Marketing and Research & Develooment expertise.  Dr. Borinshteyn is a founder and President of Life Science Excellence Inc a boutique strategic services company for... Read More →

Tuesday October 29, 2019 8:45am - 9:00am PDT
  Product Development Strategy

9:00am PDT

How Small Companies Can Build and Leverage Outside Resources for Smarter Drug Development When Working With a Limited Budget
  • Outline key questions companies should always ask when evaluating potential outsourced firms
  • Understand the core differences between large CROs and emerging niche CROs and determine which type can most successfully match and integrate into your culture
  • Discuss strategies to maximize efficiencies and minimize costs when choosing an outsourced vendor
Speakers
avatar for Fabio Valentini, MSc, MBA

Fabio Valentini, MSc, MBA

Vice President, Head of Operations, New Businesses, EMD SERONO RESEARCH & DEVELOPMENT INSTITUTE
Fabio is currently the Head of Operations of the New Business Unit, a biotech incubator-like unit dedicated to the externalization, under various innovative partnership models, of selected R&D pipeline assets. He is accountable for the strategy, implementation and related clinical... Read More →
avatar for Christina Coughlin, M.D., Ph.D.

Christina Coughlin, M.D., Ph.D.

Chief Medical Officer, TMUNITY THERAPEUTICS
Prior to joining Tmunity, Dr. Coughlin was Chief Medical Officer at British biotechnology company, Immunocore Ltd., where she was responsible for leading the effort to develop novel bispecific T cell receptor-based biologics for cancer immunotherapy. Dr. Coughlin led the clinical... Read More →
avatar for Randall Owen, M.D.

Randall Owen, M.D.

Chief Medical Officer, NAVITOR PHARMACEUTICALS
J. Randall “Randy” Owen is Chief Medical Officer of Navitor Pharmaceuticals, the leader in the discovery and development of mTORC1-targeted therapeutics. Randy is responsible for the clinical and regulatory development of Navitor’s pipeline of product candidates across medical... Read More →
avatar for Lori Buckenmyer, PMP

Lori Buckenmyer, PMP

Head, Clinical Operations, INSEPTION GROUP
Lori is a senior executive leader with over 30 years of experience in biopharmaceutical research and development. She has a demonstrated track record of driving business growth, profitability, and quality by applying her passion and highly developed skills in the areas of organizational... Read More →

Tuesday October 29, 2019 9:00am - 9:45am PDT
  Product Development Strategy

9:45am PDT

Getting Real: The Changing Tide on Real-World Evidence in Drug Development
  • Consider how regulators are recognizing the need for a more flexible framework for evaluating treatments, helped along by the 21st Century Cures Act
  • Explore the growing ability to tap real-world data sources and analyze them using everything from the latest data-crunching technologies to natural language processing and artificial intelligence
  • Hear how companies are using RWE to identify biomarkers that can be used to select clinical trial patients, tapping patient records to help design and optimize trial protocols, and help identify optimal trial sites
  • Understand how RWE requires the right talent and technology in order to reduce trial duration and costs, tap new marketing and payer insights including long-term safety and outcomes, and the challenges of deploying it internally or with partners
Speakers
avatar for Danny Wiederkehr

Danny Wiederkehr

Senior Director, Global Health Economics and Outcomes Research Team Lead, PFIZER
avatar for Jennifer Lamppa, Ph.D.

Jennifer Lamppa, Ph.D.

Director, Real World Data Science, PAREXEL
Jennifer Lamppa is a Director of Data Sciences and Data Stewardship within Parexel’s Scientific Data Organization, a group focused on the identification and study of real-world healthcare data (RWD). Prior to joining Parexel, she worked at Health Advances, a healthcare strategy... Read More →
avatar for Jennifer Graff, Pharm.D.

Jennifer Graff, Pharm.D.

Vice President, Comparative Effectiveness Research, NATIONAL PHARMACEUTICAL COUNCIL
Jennifer Graff, PharmD, is vice president of comparative effectiveness research at the National Pharmaceutical Council (NPC). Since joining NPC in 2009, she has lead research and policy initiatives to advance the use of high-quality evidence to inform health care decision-making.Prior... Read More →
avatar for Kay Larholt, Sc.D.

Kay Larholt, Sc.D.

Director of Integrated Knowledge Solutions, NEWDIGS, Center for Biomedical Innovation, MASSACHUSETTS INSTITUTE OF TECHNOLOGY
Kay M. Larholt ScD is Director of Integrated Knowledge Solutions, NEWDIGS at MIT Center for Biomedical Innovation.  Dr. Larholt is a seasoned statistical professional with 30 years of experience in the Pharmaceutical, Biotechnology, and Medical Device industry. She has global experience... Read More →
avatar for David Thompson, Ph.D.

David Thompson, Ph.D.

Senior Vice President, Real World Research, SYNEOS HEALTH
Dave is a health economist by training with 25+ years of experience conducting real-world research and consulting for clients in the biopharmaceutical sector. His work has been global in nature, with extensive experience in North American & European markets as well as the emerging... Read More →
avatar for Carly Helfand

Carly Helfand

Senior Editor, FIERCEPHARMA

Tuesday October 29, 2019 9:45am - 10:30am PDT
  Product Development Strategy

11:00am PDT

Leverage Innovative Regulatory Pathways to Expedite Drug Development
  • Outline major regulatory incentive programs available in the U.S., EU, and beyond, and how these pathways can be leveraged across the development life cycle
  • Understand the financial and commercial benefits for each of the different pathways
  • Consider how a regulatory strategy can align with a company’s corporate strategy to achieve future business success

Speakers
avatar for Kim Raymer

Kim Raymer

Vice President, Regulatory Affairs, HALLORAN CONSULTING GROUP
Kim Raymer has more than 24 years of professional experience in regulatory affairs, with deep expertise in chemistry, manufacturing, and controls (CMC). Kim has extensive experience with the regulatory CMC aspects of investigational and marketed drug products for both small molecules... Read More →
avatar for L. Mary Smith, Ph.D.

L. Mary Smith, Ph.D.

Senior Vice President, Clinical Research and Development, SPRINGWORKS THERAPEUTICS
Dr. Mary Smith is responsible for designing and running the clinical development programs. Prior to joining SpringWorks Therapeutics Mary was the executive vice president of gene therapy at Bamboo Therapeutics, a wholly owned subsidiary of Pfizer where she led several key gene transfer... Read More →
avatar for Matthew Boyd

Matthew Boyd

Vice President, Regulatory Affairs, North America, SOBI

Tuesday October 29, 2019 11:00am - 11:45am PDT
  Product Development Strategy

11:45am PDT

Develop a Go-To-Market and Launch Strategy That Successfully Differentiates Your Launch Providing the Best Possible Access for Patients
  • Determine the optimal timing in a product’s development cycle to begin launch preparations
  • Discuss key tactics to consider when developing a commercially and clinically viable differentiation strategy for a product
  • Hear how to build trust and interest, and ensure market development for your product ahead of a launch so you can hit the ground running
  • Leverage data-driven insights and analytics to identify the unique needs, preferences, and motivations of patient populations, and tailor key messaging to their expectations
Speakers
avatar for Randall Kaye, M.D.

Randall Kaye, M.D.

Chief Medical Officer, NEURANA PHARMACEUTICALS
avatar for Laura Saltonstall, M.D., MBA

Laura Saltonstall, M.D., MBA

Vice President, US and LATAM Medical Affairs, ALNYLAM PHARMACEUTICALS
Laura is Vice President, U.S. & LATAM Medical Affairs at Alnyalm where she is responsible for leading the U.S. and LATAM Medical Affairs organization across all therapeutic areas. Prior to joining Alnylam, Laura spent 14 years at Sanofi Genzyme where she was most recently Vice President... Read More →
avatar for Frank Sanders

Frank Sanders

Senior Vice President and General Manager, U.S. Commercial, SAGE THERAPEUTICS
avatar for Eric Warren

Eric Warren

Vice President, U.S. Cardiovascular (CV) Therapeutic Area Head, SANOFI

Tuesday October 29, 2019 11:45am - 12:30pm PDT
  Product Development Strategy
 
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