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Monday, October 1
 

1:00pm

Workshop Day Registration
Monday October 1, 2018 1:00pm - 2:00pm
Hilton Boston Logan Airport

2:00pm

Workshop A — Improve Your Strategic Partnerships for Drug Repurposing
Data from previous clinical trials can be extremely useful for discovering new indications
and reducing overall R&D costs. Specialized skill sets are required to navigate the
partnerships for gathering and interpreting this data, especially for older drug candidates.
• Deploy open innovation partnerships for clinical validation success
• Partner with patient advocates and government agencies
• Build new economic incentives
• Update your computational strategy

Speakers
BG

Barbara Goodman

COO, CURES WITHIN REACH
avatar for Kevin Lynch

Kevin Lynch

CBO, RECURSION PHARMACEUTICALS
avatar for Bobbie Mount

Bobbie Mount

Program Officer, NIH


Monday October 1, 2018 2:00pm - 5:00pm
Hilton Boston Logan Airport

2:00pm

Workshop B — Add Orphan Indications to Accelerate Development
By demonstrating a new orphan indication for an existing therapeutic, you may be able to
lengthen the period of exclusivity. By comparing the orphan approvals for both older and
newer drugs, you can get a clearer picture of how viable this is as a business model.

• Target orphan drug indications to obtain extended periods of exclusivity for blockbuster
therapeutics
• Anticipate changes now that politicians and payers expect this
• Weigh the prospect of changes to the orphan drug program, either legislatively or at
the FDA level
• Review orphan strategies to build value

Speakers
avatar for Sanuj Ravindran

Sanuj Ravindran

CEO, PELLEPHARM
avatar for Neal Simon

Neal Simon

CEO, AZEVAN PHARMACEUTICALS


Monday October 1, 2018 2:00pm - 5:00pm
Hilton Boston Logan Airport

5:00pm

 
Tuesday, October 2
 

8:00am

8:25am

Opening Remarks
Tuesday October 2, 2018 8:25am - 8:30am
Hilton Boston Logan Airport

8:30am

KEYNOTE: Pursue Breakthrough Approvals in Multiple Global Markets
Moderators
CH

Conor Hale

Associate Editor, FIERCEBIOTECH

Speakers
avatar for Roy Baynes

Roy Baynes

CMO, Senior Vice President, Head of Clinical Development, MERCK
avatar for Ramzi Dagher

Ramzi Dagher

Vice President, Worldwide Safety and Regulatory, and Regulatory Head, Europe and International, PFIZER
avatar for Maria Fardis

Maria Fardis

CEO, IOVANCE
avatar for Martine Zimmerman

Martine Zimmerman

Senior Vice President, Global Regulatory Affairs, ALEXION PHARMACEUTICALS


Tuesday October 2, 2018 8:30am - 9:10am
Hilton Boston Logan Airport

9:10am

Networking Break
Tuesday October 2, 2018 9:10am - 9:20am
Hilton Boston Logan Airport

9:20am

Innovate Value-Based Pricing Models for Long-Lasting Therapies
• Map the data-gathering needs of multiyear therapeutics with undefined benefits, in a system that
is typically PAYGO
• Establish a timeline for value-based checks and rebates
• Find the best approach towards CMS Best Price Reporting and determine if rebates can become more
substantial
• Maintain dialogue with CMS and payers

Moderators
avatar for Judy Chuk

Judy Chuk

Vice President, Strategy & Operations, ENZYVANT

Speakers
avatar for Bruce Leicher

Bruce Leicher

Senior Vice President and General Counsel, MOMENTA
avatar for Marc Schwabish

Marc Schwabish

Senior Vice President, BD and US Operations, FUSION PHARMACEUTICALS
avatar for Stephen Webster

Stephen Webster

CFO, SPARK THERAPEUTICS


Tuesday October 2, 2018 9:20am - 10:00am
Hilton Boston Logan Airport

10:00am

Networking Break
Tuesday October 2, 2018 10:00am - 10:10am
Hilton Boston Logan Airport

10:10am

Fine-Tune Biotech Priorities for Improving Diversity
• Recall the employment and advancement patterns of biotech executives from previously
underrepresented groups
• Quantify the advances made in biotech leadership by women and people of color
• Discuss other kinds of diversity, such as nationality, industry background, and ideology

Moderators
avatar for Amirah Al Idrus

Amirah Al Idrus

Editor, FIERCEBIOTECH

Speakers
avatar for Karen Anderson

Karen Anderson

Senior Vice President, Chief Human Resources Officer, ALNYLAM PHARMACEUTICALS
avatar for Amri Johnson

Amri Johnson

Global Head, Diversity and Inclusion, NOVARTIS
avatar for Liz Lewis

Liz Lewis

Chief Counsel, Head of Patient Advocacy, TAKEDA
avatar for Lori Lyons-Williams

Lori Lyons-Williams

Chief Commercial Officer, DERMIRA
avatar for Brenda Sousa

Brenda Sousa

Senior Vice President, Human Resources and Operations, CONSTELLATION PHARMACEUTICALS


Tuesday October 2, 2018 10:10am - 11:10am
Hilton Boston Logan Airport

11:10am

Networking Break
Tuesday October 2, 2018 11:10am - 11:40am
Hilton Boston Logan Airport

11:40am

11:40am

11:50am

Improve Orphan Drug Strategy so Your Company Can Grow up With Your Patients
• Review opportunities for biopharma companies to continue listening to patients long after a drug has launched, particularly as pediatric patients become adults and their needs evolve
• Turn patient and physician insights into new formulations, new doses, and new storage options
• Go beyond scientific innovation to address changing patient needs through ambassador and other programs

Moderators
LN

Lauren Neighbours

Head, Regulatory Affairs, PSI-CRO

Speakers
LL

Leslie Leahy

Vice President, Head of Medical Sciences, OVID THERAPEUTICS
avatar for Holly May

Holly May

Vice President, Sales and Marketing, SOBI


Tuesday October 2, 2018 11:50am - 12:30pm
Hilton Boston Logan Airport

11:50am

Meet and Beat Ambitious Growth Plans to Surpass Investor Expectations
• Clarify why some industry insiders are wrong to think
ambitious growth is impossible
• Understand the odds and obstacles to growth success
• Make the most of your assets during mergers and acquisitions

Speakers
avatar for Kate Haviland

Kate Haviland

CBO, BLUEPRINT MEDICINES
avatar for Kennen MacKay

Kennen MacKay

Managing Director, US Biotech Equity Research, RBC CAPITAL MARKETS
Dr. Kennen MacKay is Managing Director and Co-Head of RBC Capital Markets' Biotechnology Equity Research team. Kennen covers a range of Large & SMid-Cap biotechnology companies across a range of therapeutic indications & modalities: from small molecule precision medicines to antibody/protein... Read More →


Tuesday October 2, 2018 11:50am - 12:30pm
Hilton Boston Logan Airport

12:30pm

Determine “Best-in-Breed” Status to Realize Advances in Immuno-Oncology
  • See farther and discern signals in a very crowded, poorly understood market
  • Tell a convincing story of clinical relevance out of the hundreds of immuno-oncology targets
  • Win over investors about recruitment going well

Moderators
avatar for Andrew Allen

Andrew Allen

CEO, GRITSTONE ONCOLOGY

Speakers
avatar for Lawrence Bloch

Lawrence Bloch

President, INFINITY PHARMACEUTICALS
avatar for Sridhar Ramaswamy

Sridhar Ramaswamy

Vice President, Translational R&D, TESARO


Tuesday October 2, 2018 12:30pm - 1:10pm
Hilton Boston Logan Airport

12:30pm

Update Collaboration Models Between Pharma and Biotech
• Compare the performance of build-to-buy deals, company creation, and option deals
• Review deal structures most attractive to all stakeholders
• Make sure teams can interface well enough for collaborations to move quickly

Moderators
avatar for Robert Stanislaro

Robert Stanislaro

Managing Director, FTI CONSULTING

Speakers
avatar for Caroline Stark Beer

Caroline Stark Beer

Vice President, Head of Business Development, ALNYLAM PHARMACEUTICALS
TL

Thomas Loeser

CFO, ORIGENIS
avatar for Debanjan Ray

Debanjan Ray

CFO, CYTOMX
avatar for Joseph Zenkus

Joseph Zenkus

Senior Director, Worldwide Business Development, PFIZER


Tuesday October 2, 2018 12:30pm - 1:10pm
Hilton Boston Logan Airport

1:00pm

Luncheon
Tuesday October 2, 2018 1:00pm - 1:10pm
Hilton Boston Logan Airport

2:10pm

Develop Combination Therapies for Immuno-Oncology
  • Analyze where the field is going beyond the checkpoint blockade
  • Focus on challenges and opportunities for antibody therapeutics, bispecific and multivalent approaches in I-O
  • Optimize combination therapy regimens



Moderators
avatar for Amirah Al Idrus

Amirah Al Idrus

Editor, FIERCEBIOTECH

Speakers
avatar for Sean McCarthy

Sean McCarthy

CEO, CYTOMX
avatar for Thomas Schuetz

Thomas Schuetz

CEO, COMPASS THERAPEUTICS


Tuesday October 2, 2018 2:10pm - 2:50pm
Hilton Boston Logan Airport

2:10pm

Create Successful Biotech Financing Strategies
  • Match financing strategy to the company’s business model
  • Assemble syndicates that can go the distance from founding to exit (IPO or M&A)
  • Analyze the nuts and bolts of investor relationship management
  • Learn from case studies of successful and emerging biotechs

Speakers
avatar for Jason Rhodes

Jason Rhodes

Partner, ATLAS VENTURE
avatar for Ricky Sun

Ricky Sun

Principal, Life Science Fund, BAIN CAPITAL
BZ

Brett Zbar

Managing Director, FORESITE CAPITAL MANAGEMENT


Tuesday October 2, 2018 2:10pm - 2:50pm
Hilton Boston Logan Airport

2:50pm

Establish the Academic Partnerships Necessary for Success in Early Clinical Stages While Improving Trial Transparency
  • Navigate cultural divides between biotech and academia 
  • Work to make all partners equally aware of the need to protect and build IP 
  • Cut through the hype commonly found in early research
  • Discuss the pros and cons of an industrywide, open-data approach 
  • Envision the technical challenges of collating, storing, and sharing large volumes 


Moderators
CH

Conor Hale

Associate Editor, FIERCEBIOTECH

Speakers
avatar for Jim Doherty

Jim Doherty

Chief Research Officer, SAGE THERAPEUTICS
avatar for Lisa McKerracher

Lisa McKerracher

CEO, BIOAXONE BIOSCIENCES
avatar for Joseph Menetski

Joseph Menetski

Associate Vice President, FNIH BIOMARKERS CONSORTIUM
avatar for Chandra Ramanathan

Chandra Ramanathan

Vice President and Head, East Coast Innovation Center, BAYER


Tuesday October 2, 2018 2:50pm - 3:30pm
Hilton Boston Logan Airport

2:50pm

Evaluate the Impact of New, Non-Traditional Biotech Investors
  • Track the arrival and growth of new investor partners, including international capital (China, Russia)
  • Forecast what this will do to valuation, value-sensitivity, and price on public markets
  • Highlight factors that make biotech companies more attractive to unconventional investors


Moderators
avatar for Ravi Kiron

Ravi Kiron

Head, BioPharma External Innovation, EMD SERONO

Speakers
avatar for Kevin Lynch

Kevin Lynch

CBO, RECURSION PHARMACEUTICALS
avatar for Yaron Werber

Yaron Werber

CFO/CBO, OVID THERAPEUTICS


Tuesday October 2, 2018 2:50pm - 3:30pm
Hilton Boston Logan Airport

3:30pm

Select Ideal Animal Models for Early Research to Improve the Preclinical-to-Clinical Transition
  • Track a rapidly evolving field to find the most appropriate animal models 
  • Anticipate when data expectations will shift completely out of animals and into the clinic
  • Balance how much you spend on preclinical research with how hard you try to accelerate development to clinical stages



Moderators
avatar for Adrienne Takacs

Adrienne Takacs

former COO, Senior Director, R&D Operations, ELI LILLY

Speakers
avatar for Jean-Philippe Combal

Jean-Philippe Combal

CEO, VIVET THERAPEUTICS
avatar for Carol Robertson-Plouch

Carol Robertson-Plouch

Founder, CONVERGENCE BIOSCIENCE


Tuesday October 2, 2018 3:30pm - 4:10pm
Hilton Boston Logan Airport

3:30pm

Recognize When Novel Technologies Can Disrupt Standard Business Development
  • Understand precisely how the type of technology you have fits into the priorities of business development professionals 
  • Plan to work with more senior or creative groups when using very innovative technologies
  • Grasp whether your audience is correctly perceiving your technology
  • Show credibility for new solutions to old problems


Moderators
CH

Carly Helfand

Senior Editor, FIERCEMARKETS

Speakers
avatar for Steven Holtzman

Steven Holtzman

CEO, DECIBEL THERAPEUTICS
avatar for Nouhad Husseini

Nouhad Husseini

Vice President, Head of Business Development, REGENERON
avatar for Kim Seth

Kim Seth

Executive Vice President, Head of Business and Corporate Development, REPARE THERAPEUTICS
TS

Trevor Smith

R&D Technology Lead, Cell & Gene Therapy, GE HEALTHCARE
avatar for Praveen Tipirneni

Praveen Tipirneni

CEO, MORPHIC THERAPEUTICS


Tuesday October 2, 2018 3:30pm - 4:10pm
Hilton Boston Logan Airport

4:10pm

Networking break
Tuesday October 2, 2018 4:10pm - 4:40pm
Hilton Boston Logan Airport

4:40pm

Leverage 3DP Technologies to Accelerate Time to Market
  • Use novel dosage forms to minimize R&D iterations of dosing frequency and dose size 
  • Provide real-time formulation support for adaptive clinical trials
  • Accommodate fragile molecules and particles to speed the translation to final product scale 



Speakers
avatar for Timothy Tracy

Timothy Tracy

CEO, APRECIA PHARMACEUTICALS


Tuesday October 2, 2018 4:40pm - 5:20pm
Hilton Boston Logan Airport

4:40pm

Sociology of Deal-Making: Ensure Stakeholder Compatibility while Monitoring Collaboration Health
  • Give sufficient weight to whether prospective partners are truly compatible 
  • Provide more details on how deals will be executed, how to leverage each organization, and how to deal with the cultural and workplace norms of each company
  • Lay the groundwork for broader partnerships by avoiding confusing pitfalls


Speakers
avatar for Christine Carberry

Christine Carberry

COO, KERYX BIOPHARMA
avatar for Paula Cobb

Paula Cobb

Executive Vice President, Corporate Development, DECIBEL THERAPEUTICS
avatar for Issi Rozen

Issi Rozen

CBO, BROAD INSTITUTE


Tuesday October 2, 2018 4:40pm - 5:20pm
Hilton Boston Logan Airport

5:20pm

Benefit From Strategic Advisors Pointing You Towards the Right Questions
  • Outline the function of innovation councils 
  • Improve competitive differentiation and research plans 
  • Gather multidisciplinary expertise to learn from new areas and avoid some biopharma assumptions

Speakers
DK

Darshan Kulkarni

Principal Attorney, KULKARNI LAW FIRM; Vice President, Regulatory Strategy and Policy, SYNCHROGENIX
avatar for Ana Maiques

Ana Maiques

CEO, NEUROELECTRICS
avatar for Thomas De Vlaam

Thomas De Vlaam

CEO, AMYLON THERAPEUTICS


Tuesday October 2, 2018 5:20pm - 6:00pm
Hilton Boston Logan Airport

6:00pm

7:00pm

Main Conference Day 1 Concludes
Tuesday October 2, 2018 7:00pm - 7:00pm
Hilton Boston Logan Airport
 
Wednesday, October 3
 

8:00am

Continental Breakfast
Wednesday October 3, 2018 8:00am - 8:50am
Hilton Boston Logan Airport

8:50am

8:50am

Introduction From Track Chair
Speakers
avatar for Richard Brudnick

Richard Brudnick

Chief Business Officer, Head of Strategy, CODIAK BIOSCIENCES


Wednesday October 3, 2018 8:50am - 9:00am
Hilton Boston Logan Airport

9:00am

Find New Drivers for Success After Prior Research Failures in CNS, Oncology, Rare Disease, and Gene Therapy
  • Learn from past over-reliance on soft or subjective endpoints and a shallow dynamic range 
  • Prioritize a clear mechanism, strong transitional biomarkers, and strong responders 
  • Get early signals around the PKPD relationship in phase I, prior to efficacy data 

Moderators
avatar for David Shoemaker

David Shoemaker

Senior Vice President, R&D, RHO

Speakers
avatar for Neal Farber

Neal Farber

CEO, NEUROHEALING PHARMACEUTICALS
avatar for Agustin Melian

Agustin Melian

Senior Vice President, Global Medical Sciences, ALEXION PHARMACEUTICALS


Wednesday October 3, 2018 9:00am - 9:40am
Hilton Boston Logan Airport

9:00am

Pinpoint the Crucial Data for Improving and Managing Your Relationship with VCs and PEs
  • Lead with the strongest, most experienced team members 
  • Learn from shift in VC preferences towards late-stage development 
  • Be able to explain why they should invest earlier – or how you will get through the rest of development without their early-stage funds 

Moderators
avatar for Randy Hubbell

Randy Hubbell

CEO, CARMELL THERAPEUTICS

Speakers
avatar for Kevin McArdle

Kevin McArdle

CFO, CHEETAH MEDICAL


Wednesday October 3, 2018 9:00am - 9:40am
Hilton Boston Logan Airport

9:40am

Gene Editing: The Next Wave of Personalized Medicine
  •  Outline challenges of personalized medicine in hematological malignancies
  • Explore combination or sequencing of cell-based and molecular-directed therapy
  • Use gene editing alliances to tackle intrinsic complexity



Speakers
avatar for Stefan Scherer

Stefan Scherer

Senior Vice President, Clinical Development, Deputy CMO, CELLECTIS


Wednesday October 3, 2018 9:40am - 10:20am
Hilton Boston Logan Airport

9:40am

10:20am

Networking Break
Wednesday October 3, 2018 10:20am - 10:50am
Hilton Boston Logan Airport

10:50am

A Dilemma in Immuno-Oncology: Unreliable Mice or Unaffordable People?
  • Explore whether you can escape inefficiencies in current drug development 
  • Quantify the time and resources being diverted towards steps that may not be helpful to the overall development
  • Shift the paradigm away from economical signaling pathways highly conserved in mouse models
  • Conceptualize cheaper models that can kill off programs, molecules, and combinations that don’t work, before relying on clinical tests

Speakers
avatar for Samuel Blackman

Samuel Blackman

Senior Vice President, Head of Clinical Development, SILVERBACK THERAPEUTICS


Wednesday October 3, 2018 10:50am - 11:30am
Hilton Boston Logan Airport

10:50am

Tackle the Most Common Problems for Business Development Deal-Makers
  • Place more emphasis on results and add further endpoints in clinical trials 
  • Address concerns over reimbursement through early upfront conversations with payers
  • Cross the threshold of data where a purchase becomes worthwhile

Moderators
avatar for Robert Stanislaro

Robert Stanislaro

Managing Director, FTI CONSULTING

Speakers
avatar for Girish Aakalu

Girish Aakalu

VP, Global Head of External Innovation, IPSEN
avatar for Catherine Sohn

Catherine Sohn

Chairman, BIOECLIPSE THERAPEUTICS


Wednesday October 3, 2018 10:50am - 11:30am
Hilton Boston Logan Airport

11:30am

Fill Your Early-Stage Pipeline With Creative Approaches to Search, Evaluation, and Partnership
  • Tailor your business model to outperform with emerging opportunities
  • Create business development and collaboration models specific to the early stages of R&D
  • Accelerate assets from the “eureka” moment to first-in-human trials


Moderators
avatar for Adrienne Takacs

Adrienne Takacs

former COO, Senior Director, R&D Operations, ELI LILLY

Speakers
avatar for Jake Reder

Jake Reder

CEO, CELDARA MEDICAL


Wednesday October 3, 2018 11:30am - 12:10pm
Hilton Boston Logan Airport

11:30am

Move Into Specialty Arena to Achieve Higher Value Assets
  • Follow unmet medical needs to find higher willingness to pay in specialty markets 
  • Prepare for tremendous payer pressure
  • Recognize that the goal is to discover drugs with unambiguously large effect size and societal importance
  • Consider clinical and market development challenges for NASH candidates

Moderators
avatar for Natalia Borinshteyn

Natalia Borinshteyn

former Vice President, Medical Affairs, HCV Launch Team, ABBVIE

Speakers
avatar for Brad Dickerson

Brad Dickerson

General Manager Americas and Global Product Assessment, AURINIA PHARMACEUTICALS
avatar for Celia Economides

Celia Economides

Vice President, Corporate & Public Affairs, AURINIA PHARMACEUTICALS
avatar for Brad Prosek

Brad Prosek

Senior Vice President, Corporate Development, CONSTELLATION PHARMACEUTICALS


Wednesday October 3, 2018 11:30am - 12:10pm
Hilton Boston Logan Airport

12:10pm

Partnership and Pipeline Strategies for Digital Therapeutics
  • Improve the prescription and reimbursement rates 
  • Clarify the logistics from the patient and pharmacy side
  • Address each partner’s concerns about reimbursement, market potential, and health outcomes
  • Build the mind-shift that the market needs from a scientific, legal, IP, regulatory, technological, and organizational perspective
  • Launch and maintain digital drugs while maintaining patient privacy

Moderators
avatar for David Benshoof Klein

David Benshoof Klein

CEO, CLICK THERAPEUTICS

Speakers
avatar for Ruchita Sinha

Ruchita Sinha

Senior Director of Investments, SANOFI VENTURES
avatar for Jeremy Sohn

Jeremy Sohn

Vice President, Global Head of Digital Business Development & Licensing, NOVARTIS
avatar for Alex Waldron

Alex Waldron

Chief Commercial Officer, PEAR THERAPEUTICS


Wednesday October 3, 2018 12:10pm - 12:50pm
Hilton Boston Logan Airport

12:10pm

Manage Partnerships and Portfolios to Survive the Next Market Downturn
  • Evaluate whether the biotech sector is built up sufficiently to withstand the next downturn, and for how long 
  • Review who did and did not survive the 2000–2012 downturn, and why
  • Take into account the effects of — and on — IPOs and VCs
  • Discuss why IPOs were apparently able to resist bad clinical data this cycle
  • Choose good investors with long-term views and the cash to support you, who won’t allow for stockpiling excessive funds

Speakers
avatar for David Elmaleh

David Elmaleh

CEO, AZTHERAPIES


Wednesday October 3, 2018 12:10pm - 12:50pm
Hilton Boston Logan Airport

12:50pm

Luncheon
Wednesday October 3, 2018 12:50pm - 1:50pm
Hilton Boston Logan Airport

1:50pm

Explore New Modalities in Immuno-Oncology
  • Analyze latest advances in CAR-T and checkpoint inhibitors
  • Delve into breakthrough technology of pyroptosis
  • Weigh pros and cons of new technologies


Speakers
avatar for David Sherris

David Sherris

CEO, GENADAM THERAPEUTICS


Wednesday October 3, 2018 1:50pm - 2:30pm
Hilton Boston Logan Airport

1:50pm

Critically Examine the M&A Mindset in Biotech and Pharma
  • Contrast recent growth in biotech purchases with high-profile departures of pharma execs for biotech companies 
  • Weigh the pros and cons of biotech independence vs. purchase
  • Analyze feedback from VCs who push towards selling
  • Seek a balance between innovation potential and the new resources of being subsumed

Moderators
avatar for Jean-Philippe Combal

Jean-Philippe Combal

CEO, VIVET THERAPEUTICS

Speakers
GV

Geeta Vemuri

Managing Partner, AGENT CAPITAL


Wednesday October 3, 2018 1:50pm - 2:30pm
Hilton Boston Logan Airport

2:30pm

Strengthen Immuno-Oncology Portfolios Through Relevant Preclinical Models of Disease
  • Gain access to patient-derived xenoblast models as translational tools 
  • Develop faithful models that represent tumor biology and the intersection of the immune microenvironment and system
  • Reach the next step in providing humanized mouse immune systems

Moderators
avatar for David Sherris

David Sherris

CEO, GENADAM THERAPEUTICS

Speakers
avatar for Ronald Herbst

Ronald Herbst

Vice President, R&D, Head of Oncology Research, MEDIMMUNE
PS

Peter Smith

CSO, H3 BIOMEDICINE


Wednesday October 3, 2018 2:30pm - 3:10pm
Hilton Boston Logan Airport

3:10pm

Conference Concludes
Wednesday October 3, 2018 3:10pm - 3:10pm
TBA