FierceBiotech 3rd Drug Development Forum: Full Schedule

1:00pm EDT

Workshop Day Registration

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

2:00pm EDT

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

Barbara Goodman

COO, CURES WITHIN REACH

Kevin Lynch

CBO, RECURSION PHARMACEUTICALS

Bobbie Mount

Program Officer, NIH

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

Workshop

2:00pm EDT

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

Sanuj Ravindran

CEO, PELLEPHARM

Neal Simon

CEO, AZEVAN PHARMACEUTICALS

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

Workshop

5:00pm EDT

Welcome Networking Reception

Monday October 1, 2018 5:00pm - 6:00pm EDT
Hilton Boston Logan Airport

Networking

8:00am EDT

Registration and Continental Breakfast

Tuesday October 2, 2018 8:00am - 8:25am EDT
Hilton Boston Logan Airport

8:25am EDT

Opening Remarks

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

General Session

8:30am EDT

KEYNOTE: Pursue Breakthrough Approvals in Multiple Global Markets

Moderators

Conor Hale

Associate Editor, FIERCEBIOTECH

Speakers

Roy Baynes

CMO, Senior Vice President, Head of Clinical Development, MERCK

Ramzi Dagher

Vice President, Worldwide Safety and Regulatory, and Regulatory Head, Europe and International, PFIZER

Maria Fardis

CEO, IOVANCE

Martine Zimmerman

Senior Vice President, Global Regulatory Affairs, ALEXION PHARMACEUTICALS

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

General Session

9:10am EDT

Networking Break

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

Networking

9:20am EDT

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

Judy Chuk

Vice President, Strategy & Operations, ENZYVANT

Speakers

Bruce Leicher

Senior Vice President and General Counsel, MOMENTA

Marc Schwabish

Senior Vice President, BD and US Operations, FUSION PHARMACEUTICALS

Stephen Webster

CFO, SPARK THERAPEUTICS

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

General Session

10:00am EDT

Networking Break

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

Networking

10:10am EDT

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

Amirah Al Idrus

Editor, FIERCEBIOTECH

Speakers

Karen Anderson

Senior Vice President, Chief Human Resources Officer, ALNYLAM PHARMACEUTICALS

Amri Johnson

Global Head, Diversity and Inclusion, NOVARTIS

Liz Lewis

Chief Counsel, Head of Patient Advocacy, TAKEDA

Lori Lyons-Williams

Chief Commercial Officer, DERMIRA

Brenda Sousa

Senior Vice President, Human Resources and Operations, CONSTELLATION PHARMACEUTICALS

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

General Session

11:10am EDT

Networking Break

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

Networking

11:40am EDT

Introduction From Breakthroughs in Guiding Early-Stage Research Track Chair

Speakers

Natalia Borinshteyn

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

Tuesday October 2, 2018 11:40am - 11:50am EDT
Hilton Boston Logan Airport

TRACK — Breakthroughs in Guiding Early-Stage Research

11:40am EDT

Introduction From Strategic Deal-Making and Partnering Track Chair

Speakers

Amit Hasija

CFO, FULCRUM THERAPEUTICS

Tuesday October 2, 2018 11:40am - 11:50am EDT
Hilton Boston Logan Airport

TRACK — Strategic Deal-Making & Partnering

11:50am EDT

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

Lauren Neighbours

Head, Regulatory Affairs, PSI-CRO

Speakers

Leslie Leahy

Vice President, Head of Medical Sciences, OVID THERAPEUTICS

Holly May

Vice President, Sales and Marketing, SOBI

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

TRACK — Breakthroughs in Guiding Early-Stage Research

11:50am EDT

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

Kate Haviland

CBO, BLUEPRINT MEDICINES

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 EDT
Hilton Boston Logan Airport

TRACK — Strategic Deal-Making & Partnering

12:30pm EDT

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

Andrew Allen

CEO, GRITSTONE ONCOLOGY

Speakers

Lawrence Bloch

President, INFINITY PHARMACEUTICALS

Sridhar Ramaswamy

Vice President, Translational R&D, TESARO

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

TRACK — Breakthroughs in Guiding Early-Stage Research

12:30pm EDT

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

TRACK — Strategic Deal-Making & Partnering

1:00pm EDT

Luncheon

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

Networking

2:10pm EDT

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

TRACK — Breakthroughs in Guiding Early-Stage Research

2:10pm EDT

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

TRACK — Strategic Deal-Making & Partnering

2:50pm EDT

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

TRACK — Breakthroughs in Guiding Early-Stage Research

2:50pm EDT

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

TRACK — Strategic Deal-Making & Partnering

3:30pm EDT

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

TRACK — Breakthroughs in Guiding Early-Stage Research

3:30pm EDT

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

TRACK — Strategic Deal-Making & Partnering

4:10pm EDT

Networking break

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

Networking

4:40pm EDT

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

Timothy Tracy

CEO, APRECIA PHARMACEUTICALS

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

TRACK — Breakthroughs in Guiding Early-Stage Research

4:40pm EDT

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

TRACK — Strategic Deal-Making & Partnering

5:20pm EDT

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

TRACK — Strategic Deal-Making & Partnering

6:00pm EDT

Cocktail Networking Reception and Fierce15 Awards

Tuesday October 2, 2018 6:00pm - 7:00pm EDT
Hilton Boston Logan Airport

Networking

7:00pm EDT

Main Conference Day 1 Concludes

Tuesday October 2, 2018 7:00pm - 7:00pm EDT
Hilton Boston Logan Airport

8:00am EDT

Continental Breakfast

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

8:50am EDT

Introduction From Track Chair

Speakers

Doug Fambrough

CEO, DICERNA PHARMACEUTICALS

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

TRACK — Breakthroughs in Guiding Early-Stage Research

8:50am EDT

Introduction From Track Chair

Speakers

Richard Brudnick

Chief Business Officer, Head of Strategy, CODIAK BIOSCIENCES

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

TRACK — Strategic Deal-Making & Partnering

9:00am EDT

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

TRACK — Breakthroughs in Guiding Early-Stage Research

9:00am EDT

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

Randy Hubbell

CEO, CARMELL THERAPEUTICS

Speakers

Kevin McArdle

CFO, CHEETAH MEDICAL

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

TRACK — Strategic Deal-Making & Partnering

9:40am EDT

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

Stefan Scherer

Senior Vice President, Clinical Development, Deputy CMO, CELLECTIS

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

TRACK — Breakthroughs in Guiding Early-Stage Research

9:40am EDT

IP Strategy and Business Development: Transforming Ideas Into Value

Speakers

Jeffrey Ellison

Partner, CLARK ELBING LLP

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

TRACK — Strategic Deal-Making & Partnering

10:20am EDT

Networking Break

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

Networking

10:50am EDT

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

Samuel Blackman

Senior Vice President, Head of Clinical Development, SILVERBACK THERAPEUTICS

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

TRACK — Breakthroughs in Guiding Early-Stage Research

10:50am EDT

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

TRACK — Strategic Deal-Making & Partnering

11:30am EDT

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

Adrienne Takacs

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

Speakers

Jake Reder

CEO, CELDARA MEDICAL

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

TRACK — Breakthroughs in Guiding Early-Stage Research

11:30am EDT

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

TRACK — Strategic Deal-Making & Partnering

12:10pm EDT

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

TRACK — Breakthroughs in Guiding Early-Stage Research

12:10pm EDT

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

David Elmaleh

CEO, AZTHERAPIES

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

TRACK — Strategic Deal-Making & Partnering

12:50pm EDT

Luncheon

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

Networking

1:50pm EDT

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

David Sherris

CEO, GENADAM THERAPEUTICS

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

TRACK — Breakthroughs in Guiding Early-Stage Research

1:50pm EDT

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

Jean-Philippe Combal

CEO, VIVET THERAPEUTICS

Speakers

Geeta Vemuri

Managing Partner, AGENT CAPITAL

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

TRACK — Strategic Deal-Making & Partnering

2:30pm EDT

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

TRACK — Breakthroughs in Guiding Early-Stage Research

3:10pm EDT

Conference Concludes

Wednesday October 3, 2018 3:10pm - 3:10pm EDT
TBA