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Monday, October 28

7:30am PDT

Main Conference Registration and Continental Breakfast
Monday October 28, 2019 7:30am - 8:30am PDT

8:30am PDT

Chairperson’s Opening Remarks
avatar for Tara Nickerson Ph.D.

Tara Nickerson Ph.D.

Chief Business Officer, MAZE THERAPEUTICS
Dr. Tara Nickerson brings to Maze more than 20 years of experience building biotechnology businesses from startup to commercialization, serving in chief business officer and corporate board secretary roles. Known for leading company-building efforts, strategic partnering, corporate... Read More →
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 8:30am - 8:45am PDT

8:45am PDT

Keynote: Fireside Chat with Teresa Bitetti, President, Global Oncology, TAKEDA ONCOLOGY
avatar for Teresa Bitetti

Teresa Bitetti

President, Global Oncology, TAKEDA ONCOLOGY
avatar for Amirah Al Idrus

Amirah Al Idrus


Monday October 28, 2019 8:45am - 9:15am PDT

9:15am PDT

Prioritize, Consolidate, and Refine R&D Investment Through Strategic Portfolio/Pipeline Planning to Deliver the Greatest Overall Value to Your Company and Shareholders
  • Utilize portfolio management analytics to prioritize and optimize R&D spend within resource constraints
  • Hear how companies build business cases to support new product development and make major decisions affecting the capital allocation of the R&D budget
  • Examine lifecycle management considerations and the basis for sorting through multiple indication opportunities versus funding new research projects

avatar for Anirvan Ghosh, Ph.D.

Anirvan Ghosh, Ph.D.

Senior Vice President, Head of Research and Early Development, BIOGEN
avatar for Frederic Chereau

Frederic Chereau

avatar for Joanna Wolkowski

Joanna Wolkowski

Vice President, Portfolio & Decision Analysis, PFIZER
avatar for Pearl S. Huang

Pearl S. Huang

avatar for Sandy Macrae

Sandy Macrae


Monday October 28, 2019 9:15am - 10:00am PDT

10:00am PDT

Networking Break
Monday October 28, 2019 10:00am - 10:30am PDT

10:30am PDT

Build Vs. Buy: Key Considerations for Deciding Whether to Commercialize on Your Own or Find a Strategic Partner
  • Outline the risks of building a commercial organization and hear how to successfully transform from an R&D-oriented to fully integrated company during commercial scaleup while maintaining shareholder value 
  • Discuss selection criteria, hybrid models for working with partners while retaining commercialization rights, and what value means to different companies 
  • Determine the optimal timing to initiate commercialization planning versus partnering activities 
  • Hear best practices for taking a product to that value inflection point and effectively assess the opportunity 

avatar for Rich Daly

Rich Daly

Over the last 20 years Rich Daly has targeted his efforts on developing strategies and execution plans in two challenging areas: transforming R&D focused organizations into integrated R&D AND Commercial companies; and reinvigorating struggling commercial teams.Mr. Daly currently serves... Read More →
avatar for Molly Harper

Molly Harper

Senior Vice President and Global Franchise General Manager, AKCEA THERAPEUTICS
Molly Harper has extensive experience in all phases of pre-launch market development and global biopharmaceutical commercial operations, and leads Akcea’s global expansion strategies. Ms. Harper joined Akcea in April 2015 and serves as Vice President, Global Head and General Manager... Read More →
avatar for Marcio Souza

Marcio Souza

Chief Operating Officer, PTC THERAPEUTICS
After joining PTC as vice president of global marketing, Marcio Souza quickly moved into his current role as chief operating officer, where he is responsible for the integrated program teams and leading the global marketing, market access, and health economics areas. Prior to PTC... Read More →
avatar for Jeffrey Bova

Jeffrey Bova

Senior Vice President, Commercial, UROGEN PHARMA
Jeff is an experienced pharmaceutical industry executive with extensive leadership experience across key commercial functional areas, including national sales, marketing, and managed care. Jeff joined UroGen after 20 years at Bayer Healthcare, where he held multiple senior-level... Read More →
avatar for Amirah Al Idrus

Amirah Al Idrus


Monday October 28, 2019 10:30am - 11:15am PDT

11:15am PDT

Uncertainty, Challenges, and Implications of Today’s Reimbursement Environment on the Deal-Making Landscape and Beyond
  • Consider the rising importance of a product’s commercial versus clinical success when evaluating a potential target 
  • Discuss the impact of payer consolidation and the evolving healthcare landscape 
  • Explore how pricing practices have drawn public and government scrutiny and how this close examination has impacted deal structuring 

avatar for Nayahmka McGriff-Lee

Nayahmka McGriff-Lee

Product and Portfolio Strategy Director, Early Pipeline and Portfolio Strategy, GSK
avatar for Peter Trybus

Peter Trybus

Senior Corporate Counsel, Healthcare Law, GENENTECH
avatar for Tim Mayleben

Tim Mayleben

avatar for Kia Motesharei, Ph.D.

Kia Motesharei, Ph.D.

Former Vice President, Global Head of Business Development, Neurology and Immunology, EMD SERONO
Kia Motesharei most recently has been Vice President, Global Head Licensing & Business Development, Neurology & Immunology at EMD Serono (Merck outside the US and Canada).  He was a member of Franchise Leadership Team and is responsible for all partnering and licensing transactions... Read More →

Monday October 28, 2019 11:15am - 12:00pm PDT

12:00pm PDT

Monday October 28, 2019 12:00pm - 1:00pm PDT

1:00pm PDT

Track Chair Opening Remarks
avatar for Tara Nickerson Ph.D.

Tara Nickerson Ph.D.

Chief Business Officer, MAZE THERAPEUTICS
Dr. Tara Nickerson brings to Maze more than 20 years of experience building biotechnology businesses from startup to commercialization, serving in chief business officer and corporate board secretary roles. Known for leading company-building efforts, strategic partnering, corporate... Read More →

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

1:00pm PDT

Track Chair Opening Remarks
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

1:15pm PDT

Key Questions Small Companies Should Ask When Evaluating Potential Partners
  • Consider common deal structures and requirements for the sellers to achieve milestones before receiving a full payout
  • Assess the sources of growth and where a potential partner stands in comparison to competitors
  • Analyze their core strengths and how to go about gathering detailed information about their finances and capabilities
  • Understand how to set up a successful integration using this process

avatar for Richard Brudnick

Richard Brudnick

Chief Business Officer and Head of Strategy, CODIAK BIOSCIENCES
avatar for Gil Labrucherie

Gil Labrucherie

Senior Vice President and Chief Financial Officer, NEKTAR THERAPEUTICS
avatar for Albert Hsia 

Albert Hsia 

Bussiness Development , MERCK & CO.
Albert Hsia focuses on partnership and M&A opportunities for Merck in immuno-oncology and immunology, as well as in new therapeutic modalities and platforms with potential across disease areas.  Merck builds strong partnerships with innovative biotechs globally, based on early-stage... Read More →
avatar for Robert Bagdorf

Robert Bagdorf

Group Lead, Search and Evaluation, Worldwide Business Development, PFIZER
avatar for Thomas Neenan

Thomas Neenan


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

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

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

2:00pm PDT

Buy-Side BD&L: Insights Into Process and Decision- Making at Big Pharma/Big Biotech
  • Gain insight on the inner workings of BD&L and the organizational structure at big pharma/big biotech
  • Understand buy-side motivators and general do’s and don’ts of interactions with your buy-side counterparts
  • Examine what it can mean if your counterpart goes silent and why it sometimes takes long to get feedback

avatar for Brendan Downey

Brendan Downey

Director, Center for External Innovation,, Takeda Pharmaceuticals 
avatar for Kleem Chaudhary

Kleem Chaudhary

avatar for Lance Ostrom

Lance Ostrom

Head, Boston Innovation Hub, ROCHE
avatar for Lizabeth Leveille

Lizabeth Leveille

Associate Vice President and Head, Boston Innovation Hub, MERCK & CO.

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

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

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

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

2:45pm PDT

Networking Break
Monday October 28, 2019 2:45pm - 3:15pm PDT

3:15pm PDT

Case Study: Key Considerations When Evaluating AI Capabilities and Non-Molecule Driven Targets for Acquisition
  • Hear about a strategic investment Paragon Biosciences made in an AI platform that will allow their new portfolio company to further develop the first FDA-cleared computer-aided diagnosis system in radiology for the evaluation of breast cancer
  • Understand why AI-enabled life sciences can be a key focus area for innovation and how to approach the valuation of these emerging technologies
  • Consider the risk/reward factors associated with the acquisition and implementation of the AI platform and how that impacts the commercial forecast

avatar for James Robinson

James Robinson

President and Chief Operating Officer, PARAGON BIOSCIENCES

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

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

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

4:00pm PDT

Consider the Risk Profile Associated With Different Sources and Mechanisms of Financing
  • Explore traditional, private, and alternative sources of investment
  • Outline the pros and cons for each finance mechanism and determine the best fit based on a company’s long-term goals
  • Gain insight on how each investor views risk and what makes them nervous when determining an investment opportunity

avatar for Rahul Dhanda

Rahul Dhanda

Rahul K Dhanda is a founder and is the president and chief executive officer of Sherlock Biosciences. He also serves on the company’s Board of Directors. Most recently, Mr. Dhanda spent 10 years at T2 Biosystems where he helped grow the company from an early-staged, venture-backed... Read More →
avatar for Neil Dhawan

Neil Dhawan

Neil is currently working on developing new chemical biology approaches to build small and large molecule oncology drugs. Neil previously co-founded Dual Therapeutics, a venture-backed biotechnology company creating novel multi-pathway inhibitors for cancer treatment. Neil co-invented... Read More →
avatar for Douglas M. Fambrough, III, Ph.D.

Douglas M. Fambrough, III, Ph.D.

Doug is co-Founder, President & CEO of Dicerna Pharmaceuticals, a second generation RNA interference company developing therapeutics for rare diseases and other liver diseases. Prior to taking the CEO role at Dicerna, Doug was a General Partner with the venture capital firm Oxford... Read More →
avatar for Roopom Banerjee

Roopom Banerjee

Chief Business Officer,, GLYMPSE BIO

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

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

avatar for Chris Garabedian

Chris Garabedian

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

4:45pm PDT

Case Study: Living with the Deal - Managing the Legend Biotech and Janssen Global CAR-T Collaboration
  • Overview of the transaction from each company’s perspective
  • How the companies align objectives and navigate pharma/biotech differences
  • The importance of proactive alliance management

avatar for Meeta Chatterjee, Ph.D.

Meeta Chatterjee, Ph.D.

Senior Vice President, Global Business Development, LEGEND BIOTECH
Meeta Chatterjee is SVP, Global Business Development for Legend Biotech. Legend Biotech is focused on CAR-T and Cell Therapies for oncology and infectious diseases. Meeta currently provides oversight for all business development activities including prioritizing opportunities, managing... Read More →
avatar for Debi Watson

Debi Watson

Vice President, Business Development, Oncology, JANSSEN BUSINESS DEVELOPMENT
Debi Watson is the head of the Oncology Business Development Group at Johnson & Johnson Innovation, Janssen Business Development, a position she has held since May 2013.  In this role she leads Business Development Strategy in coordination with Oncology R&D and Commercial leadership... Read More →

Monday October 28, 2019 4:45pm - 5:30pm PDT

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

avatar for Andrew DeMarco

Andrew DeMarco

avatar for Robert Weiland

Robert Weiland

Biotech Executive, Board Director and Strategist

Monday October 28, 2019 4:45pm - 5:30pm PDT

5:30pm PDT

Cocktail Networking Reception and Fierce15 Awards
Monday October 28, 2019 5:30pm - 6:30pm PDT

6:30pm PDT

Day One Concludes
Monday October 28, 2019 6:30pm - 6:30pm PDT
Tuesday, October 29

8:00am PDT

Continental Breakfast
Tuesday October 29, 2019 8:00am - 8:45am PDT

8:45am PDT

Recap of Day One
avatar for Tara Nickerson Ph.D.

Tara Nickerson Ph.D.

Chief Business Officer, MAZE THERAPEUTICS
Dr. Tara Nickerson brings to Maze more than 20 years of experience building biotechnology businesses from startup to commercialization, serving in chief business officer and corporate board secretary roles. Known for leading company-building efforts, strategic partnering, corporate... Read More →

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

8:45am PDT

Recap of Day One
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

9:00am PDT

From Big to Small: How to Transition From Big Companies and Successfully Drive BD at a Start-Up Company
  • Consider the fundamental and unexpected challenges when jumping from a big pharma company to a startup
  • Understand how to leverage the power of a personal network
  • Share significant learnings when building business development capabilities at a new company

avatar for Lisa Beck

Lisa Beck

Vice President, Business Development and Alliance Management, BRII BIOSCIENCES
avatar for Matthew Batters, J.D.

Matthew Batters, J.D.

Vice President, Business Development and Counsel, ARVINAS
avatar for Zubin Bhagwagar, M.D., Ph.D.

Zubin Bhagwagar, M.D., Ph.D.

Global Program Lead, RALLYBIO
Zubin joined Rallybio in July 2018. He is a physician-scientist with more than 25 years of academic and industry experience as a scientist, manager, and R&D leadership team member in the areas of biopharmaceuticals, small molecule therapeutics, and research technologies. His expertise... Read More →

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

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

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.

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.

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

9:45am PDT

Explore Innovative Deal Constructs and Risk-Sharing Structures for Licensing and Acquisition Deals
  • Review the risks and hurdles to watch out for from an accounting point of view
  • Evaluate how robust your governance structure should be before you start to control the development of an options-based asset
  • Discuss the best ways to structure options agreements and how to minimize exposure to your P&L while ensuring the requisite controls needed

avatar for Emily Minkow

Emily Minkow

Chief Business Officer, PREVAIL THERAPEUTICS
Emily Minkow is the Chief Business Officer of Prevail Therapeutics. Prior to Prevail, Emily held positions of increasing responsibility at Celgene Corporation for seven years, most recently as Executive Director of Business Development. There, she led deal evaluation and execution... Read More →
avatar for Marc Schwabish

Marc Schwabish

Senior Vice President, Business Development and U.S. Operations, FUSION PHARMACEUTICALS
Marc Schwabish leads BD and US Operations at Fusion Pharmaceuticals. Fusion is developing radiotherapeutics with its proprietary Fast-ClearTM Linker Technology and was spun-out of a radiopharmaceutical manufacturer in 2017 with a $46M Series A. Dr. Schwabish’s background spans across... Read More →
avatar for Abbas Kazimi

Abbas Kazimi

Vice President, Head of Business Development, NIMBUS THERAPEUTICS
Abbas Kazimi is Vice President of Business Development at Nimbus where he is responsible for corporate and strategic development, establishing partnerships, and leading collaborations. Abbas joined Nimbus in 2014 and has driven key transactions at Nimbus as well as helped lead the... Read More →

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

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

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


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

10:30am PDT

Networking Break
Tuesday October 29, 2019 10:30am - 11:00am PDT

11:00am PDT

Compare and Contrast Different Operating Models for Search and Evaluation to Advance Innovation
  • Analyze new growth opportunities and how they should align favorably with your company’s growth culture and objectives
  • Discuss the various formal processes, metrics, and models for prioritization
  • Understand the broader goals of your business development strategy, such as geographic expansion, market share increases, and accelerated top-line growth
  • Weigh the pros and cons of R&D and innovation hubs as a way to partner with existing ecosystems

avatar for Milenko Cicmil, Ph.D.

Milenko Cicmil, Ph.D.

Vice President, Global Head of External Innovation and Partnering, IPSEN
avatar for Kim A. Seth, Ph.D.

Kim A. Seth, Ph.D.

Executive Vice President, Head of Business and Corporate Development, REPARE THERAPEUTICS
avatar for Chandra Ramanathan

Chandra Ramanathan

Vice President and Head, East Coast Innovation Center, BAYER
avatar for Girish Aakalu

Girish Aakalu

Chief Business Officer, GENOCEA

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

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

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

11:45am PDT

Different Approaches to Retaining Key Talent Post- Transaction
  • Compare and contrast different corporate cultures and how they can impact the integration of new employees
  • Review traditional financial incentives to motivate key leadership
  • Explore innovative ways to manage acquired companies that can help retain essential talent

avatar for Daryn Lewis

Daryn Lewis

Head of People, CYCLERION
Daryn Lewis has over 13 years of experience in talent strategy and operations and has led organizational growth and transformation initiatives for STEM-centric businesses across the technology, energy, and management consulting industries. She began her career at high-growth energy... Read More →
avatar for Linea Aspesi

Linea Aspesi

Vice President, Human Resources, SOBI
Aspesi has served as Sobi North America’s vice president of human resources since January 2018. With more than 20 years of experience, Aspesi supports Sobi’s growth in North America by aligning talent priorities with business strategy. She is responsible for talent acquisition... Read More →

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

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

avatar for Randall Kaye, M.D.

Randall Kaye, M.D.

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

12:30pm PDT

Tuesday October 29, 2019 12:30pm - 1:30pm PDT

1:30pm PDT

Bringing a Novel Therapy to Market: Lessons from the Front Lines
Rare disease pioneer Rogerio Vivaldi, M.D., was the first to bring enzyme replacement therapies to Latin America as a senior vice president and head of the rare disease unit at Genzyme. Later, as chief commercial officer of Spark Therapeutics, he paved the way for the commercialization of Luxturna, the first gene therapy approved in the U.S. He also served as EVP and chief global therapeutic operations officer at Bioverativ. Now, as chief executive officer of Sigilon Therapeutics, he’s advancing a pipeline of novel cell therapies for chronic diseases, including hemophilia and diabetes. They are designed to be implanted in patients and function for years as biofactories, churning out the protein or factor they need to stabilize their health. In this address, Dr. Vivaldi will share lessons learned from his career on how to:
  • Lay the groundwork with regulators
  • Think about ex-U.S. opportunities
  • Prepare the market – payers, providers and patients – for the arrival of a new modality

avatar for Rogerio Vivaldi, M.D., MBA

Rogerio Vivaldi, M.D., MBA

President, Chief Executive Officer, SIGILON THERAPEUTICS
Rogerio Vivaldi, M.D., M.B.A. is the President and Chief Executive Officer of Sigilon Therapeutics. During his more than 25 years as a physician and an industry executive, Dr. Vivaldi has built a reputation as a devoted advocate for patients, particularly those with chronic diseases.Most... Read More →

Tuesday October 29, 2019 1:30pm - 1:45pm PDT

1:45pm PDT

Emerging Market Access to Affordable Medicine
  • Consider various therapeutic area models in the US and discuss their future viability
  • Understand the affordability challenges and pressures in emerging markets like China, Russia, India to effectively develop a framework that can be included in a global product development strategy
  • Explore innovative access models that will address product development models, commercial models and patient access to medicines
  • Leverage digital platforms and data capabilities to reallocate resources and fine-tune these operating models

avatar for Michelle M. Chen, Ph.D.

Michelle M. Chen, Ph.D.

Vice President, Head of Corporate Development, WUXI BIOLOGICS
avatar for Zhi Hong

Zhi Hong

Co-founder, President, and Chief Executive Officer, BRII BIOSCIENCES
avatar for Nikolay Savchuk, Ph.D.

Nikolay Savchuk, Ph.D.

Executive Chairman, VIRIOM

Tuesday October 29, 2019 1:45pm - 2:30pm PDT

2:30pm PDT

Conference Concludes
Tuesday October 29, 2019 2:30pm - 2:30pm PDT