Leaders in Pharmaceutical Business Intelligence (LPBI) Group

MONDAY, SEPTEMBER 19

PRE-CONFERENCE PROGRAM

1:30PM – 5:00PM

Registration

2:00PM – 5:00PM

Workshop 1: Drug Development Primer

Speaker: Simon Tulloch, MD | Chief Medical Officer | Faraday Pharmaceuticals

This 3-hour workshop focused on the regulatory considerations required to bring a drug successfully to market. The focus will be specifically on the safety studies necessary for IND filing and the clinical studies necessary for NDA/BLA approval. Discussion points feature both small molecule and biologic products. Learn what it takes to get a molecule from the bench into the marketplace by an industry expert who has received drug approvals in both the US and Europe.

Workshop 2: Financing a Cure

Speaker: Marc LeMaitre, PhD | Biotech Executive & Independent Consultant

This 3-hour workshop on the business acumen associated with the financial, IP, and life cycle management of a drug. Learn what it takes to successfully fund, protect, and price your molecule. Numerous personal accounts and war stories are used to illustrate the decision-making process companies use, giving participants a working knowledge of strategic development.

5:30PM – 6:30PM

Fierce 15 Awards Presentation & Networking Reception

The FierceBiotech Fierce 15 is a hunt for the biggest ideas in biotech, the most daring characters in biopharma, and entrepreneurs doing things that haven’t been done before. Fifteen privately held drug developers or platform biotechs with the potential to have a huge impact on the treatment of human diseases. The Fierce 15 celebrates the spirit of being “fierce”–championing innovation and creativity, even in the face of intense competition–and has recognized a number of distinguished biotechs over the years.

TUESDAY, SEPTEMBER 20

8:00AM – 5:00PM

Registration

 8:00AM – 8:45AM

Morning Coffee Networking

 8:45AM – 9:00AM

Chairperson’s Welcome

Speaker: Rebecca Willumson | Publisher | FierceBiotech

9:00AM – 9:50AM

KEYNOTE | Shire: Driving Growth by Building the Global Leader in Rare Diseases and Highly Specialized Conditions

Shire is striving for leadership positions in multiple, high-value franchises and to become the clear partner of choice in rare diseases and highly specialized conditions. 2015 saw the acquisition of NPS Pharmaceuticals and Dyax along with the integration of ViroPharma. 2016 was truly transformative for the Company following the successful combination with Baxalta earlier this year and the FDA approval of ophthalmics drug Xiidra.

The Baxalta deal gives Shire an impressive pipeline, with franchise operations that extend from hematology to immunology, neuroscience, lysosomal storage disorders and more. The combined company will generate 65% of its revenue from drugs that target rare diseases by 2020. Hear how Shire’s R&D head plans to forge strategic research collaborations and partnerships while reinvesting in targeted and innovative in-house R&D to drive its pipeline forward.

Phil Vickers | Global Head of Research & Development | Shire Pharmaceuticals

10:00AM – 10:50AM

GENERAL SESSION: Biotech IPOs in 2017

Moderator: Kimberly Ha | Senior Director, Strategic Communications | FTI Consulting

Panelists:
Bruce Booth | Partner | Atlas Venture
Wende Hutton | General Partner | Canaan
Dr. Carol Gallagher, PharmD | Partner | NEA
Simos Simeonidis, PhD | Managing Director – US Biotechnology Equity Research | RBC Capital Markets
Brian Hagerty | Senior Director, Head of Healthcare Capital Markets | New York Stock Exchange

It’s no secret that IPOs have been chilled by the bear market that ravaged biotech stock prices in Q1—but they weren’t eliminated from the scene. Our panel of IPO experts will size up the current market and look at the prospects for 2017. What are the factors that will determine a solid IPO? And when should companies stay away from an S-1?

10:50AM – 11:10AM

Networking & Refreshment Break

11:10AM – 12:00PM

R&D: Phase I/IIa: Early-stage Strategies and Phase III: The Pivotal Moment

Moderator: Amirah Al Idrus | Editor | FierceBiotech

Panelists:
Barry Ticho MD, PhD | Head of Development CVMD | Moderna Therapeutics
Susan Washer | CEO | Applied Genetic Technologies Corporation
Jim Roach MD, FACP, FCCP | SVP – Development and Chief Medical Officer | Momenta Pharmaceuticals, Inc.
Beatrice Setnik | Vice President of Clinical Pharmacology | INC Research

The standard trial path for drugs has been revolutionized in the past decade. These days, most developers design an early-stage program that can establish safety AND proof-of-concept data at an early stage. Recruit the right number of the right patients, and you can enhance your chances of getting the right partner for a pivotal program. In this session, experts will look at the impact of new technologies and FDA guidances on early-stage studies.

With the right late-stage development program, it’s possible to cut years out of a clinical pathway to an approval. The FDA has been helping with its new breakthrough program, just the latest in several agency designations aimed at speeding up approvals. And biopharma has responded with aggressive studies that can pinpoint the right surrogate endpoints and identify early signs of efficacy that can be further confirmed in post-marketing studies.

P&D: BioPharma M&A

Moderator: Carly Helfand | Senior Editor | FiercePharma & FiercePharmaMarketing

Panelists:
Mark G. Barrett | Vice President, Global Head of Strategy & Business Development | Genzyme
Luba Greenwood | Vice President, Global Business Development and Mergers & Acquisitions | Roche
Samantha Truex | Former CBO | Padlock Therapeutics
Alan Butcher | Head of Licensing & Business Development | Purdue Pharma

All the fundamentals are in place for a vibrant M&A market. But, Big Pharma still needs new assets for variable pipelines after years of weak productivity, yet Big Pharma CEOs have been leery about the prices they’re asked to pay. M&A advisers will discuss the art of the deal, and what lies ahead in deal terms.

C&O: New Tools for Patient Recruitment

Moderator: Beth Snyder Bulik | Contributing Writer | FiercePharmaMarketing

Panelists:
John Lewis | SVP – Policy & Public Affairs | Association of Clinical Research Organizations
Nathan Sanburn | Regional Director Medical-East Oncology, US Medical Affairs | Eli Lilly & Co.
Paulo Moreira | Vice President – Global Clinical Operations | EMD Serono

Matthew Howes | Executive Vice President, Strategy & Growth | PALIO, an inVentiv Health Company

Everyday new tools are being introduced to help companies identify, screen, and recruit patients in clinical trials. New mobile apps and social media networks like Facebook have helped revolutionize the way patients are recruited for clinical trials. The objective of using these approaches and tools is to expedite recruitment of eligible patients. Find out what’s new, and how it might help you.

12:00 PM – 1:00PM

Lunch & Sponsor Networking

1:00PM – 1:50PM

GENERAL SESSION: The Genomics Package

Moderator: Stacy Lawrence | Editor-in-Chief | FierceBiotech

Panelists:
Alex Parker, PhD | Vice President, Business Development | Foundation Medicine
Issi Rozen | Chief Business Officer | Broad Institute of MIT and Harvard
Murray Robinson, PhD | President | Molquant, Inc.
JC Gutierrez-Ramos | CEO | Synlogic

How are drugmakers working with top sequencing centers and companies? This session will take a look at accomplishments and challenges, with panelists from genomics institutes and drugmakers that are using their data in drug development. How will genomics change the way drugs are identified and developed? And how can small companies take advantage?

2:00PM – 2:50PM

R&D: Fine Tuning Remote Patient Monitoring in Clinical Trials

Moderator: Stacy Lawrence | Editor-in-Chief | FierceBiotech

Panelists:
Fred Cox | Senior Director – Patient Outcomes and Medical Economics | Sanofi Genzyme
Yury Rozenman | Director of Business Development | Qualcomm Life
David Van Sickle | Co-Founder & CEO | Propeller Health
Jane Rhodes | Senior Director – New Initiatives & Innovation Hub | Biogen

How are pharma companies using new monitoring technologies to generate trial data? Smart inhalers from a variety of respiratory developers, plus other testing and communications devices can keep track of adherence and patient results for real-time monitoring during clinical studies. What are the advantages and disadvantages of remote monitoring? Is it cost-effective? Find out the answers to these questions and more during this informative session.

P&D: Partnerships in Immuno-Oncology

Moderator: Arlene Weintraub | Contributing Writer | FierceBiotech

Panelists:
David Sherris PhD | President & CEO | GenAdam Therapeutics, Inc.
Steven Tregay, PhD | President & CEO | Forma Therapeutics
Anne Altmeyer | VP – Business Development | Shire Pharmaceuticals
Jeff Albers | President & CEO | Blueprint Medicines
Etienne Drouet | Vice President Strategic Development | SynteractHCR

Immunotherapies for cancer are among the hottest drug candidates out there, and this trend has inspired a frenzy of collaborations among biotechs and pharma. In some cases, developers have begun to identify and pursue second-generation approaches before the first generation has even hit the market. How is this field likely to develop over the next 5 years, and what kind of natural boundaries will form as the leaders stake their claims to a share of a multibillion-dollar market?

C&O: Taking Maximum Advantage of Rare/Orphan Disease R&D Edge

Moderator: Markus Peters | Associate Partner | Alacrita

Panelists:
Stacy Coen | Head of Rare Disease Business Development & Licensing | Sanofi Genzyme
John Orloff | Biopharma R&D Executive
Mark Baglin | VP – Product Strategy | Shire Pharmaceuticals
Jeremy Springhorn | Partner – Corporate Development | Flagship Ventures
Karen Kaucic, MD | Vice President, Global Head | PPD® Consulting

One ideal approach in biotech is pursuing a new drug for rare/orphan diseases. Trials can be smaller and more affordable. It’s more realistic to blue print a marketing campaign. And Big Biopharma companies are ready and willing to buy in when the data is right. Our experts review some case studies on how this can be done right, and where the pitfalls are.

3:00PM – 3:50PM

R&D: Translational R&D Transformation

Moderator: Arlene Weintraub | Contributing Writer | FierceBiotech

Panelists:
Kenneth Kaitin, PhD | Professor & Director | Tuft Center for the Study of Drug Development / Tufts University School of Medicine
Lloyd Klickstein MD, PhD | Head of Translational Medicine, NIDU | Novartis Institutes for BioMedical Research, Inc.
Michael Kauffman | CEO | Karyopharm
John Quisel | SVP – Business Development and General Counsel | Acceleron

Harvard’s recent $20 million deal to out-license a preclinical drug to Merck & Co. underscores the transformation underway in translation research. While venture capital groups had already been cherry-picking some of the best academic research for the IP used to launch new companies, many academic investigators are now going the extra mile in candidate selection to enhance the value of their work, making it clinic-ready for development teams. How will this trend shape the next wave of new drug programs and upstart biotechs?

P&D: Early Research Analytics to Drive Precision Medicine and Increase PTRS

Speaker: Mike Mentasana | Pharmaceutical & Life Sciences R&D Advisory Leader, Partner | PwC

We are at the beginning of a “New Frontier” in biopharma research and development where advanced analytics are embedded into the discovery and development of products tailored to specific patient characteristics with increasing precision. The exponential growth in the volume and variety of medical information combined with recent advances in data storage and computing technology provide an incredibly rich data source and a cost-effective way to analyze it. Today, scientists across the industry are beginning to use these novel techniques to generate new insights about patients and underlying disease biology. Our panel of experts will discuss practical applications of advanced analytics being used today and share their vision for the future.

C&O: Innovative Drug Delivery Technologies

Moderator: Cornell Stamoran, Ph.D. | Vice President, Strategy | Catalent, Inc. | Founder and Co-Chair | Catalent Applied Drug Delivery Institute

Panelists:
Menashe Y. Levy PhD | VP & Chief Technology Officer – Global R&D | Teva
Ronald L. Smith | Scientific AVP – Pharmaceutical Sciences | Merck Research Laboratories
Keith Horspool | VP – Pharmaceutics | Boehringer Ingelheim
Robert Walsh, MD | Medical Director – Pharmacovigilance & Patient Safety | AbbVie

Better delivery can extend patent control and offer a new lease on life for many older drugs. These technologies are also key to hitting once undruggable targets. Learn what you need to know, now, in this informative session.

4:00PM – 5:00PM

GENERAL SESSION: 2016 Top Women in Biotech Panel

Moderator: Tracy Staton | Editor-in-Chief | FiercePharma

Panelists:
Anna Protopapas | President & CEO | Mersana Therapeutics
Cynthia Verst, PharmD | MS President – Clinical Operations | Quintiles
Susan B. Dillon, PhD | Global Therapeutic Area Head – Immunology Janssen Research & Development | Johnson & Johnson
Kathrin Jansen PhD | SVP & Head of Vaccine Research & Development | Pfizer

Over the past decade a group of extraordinary women has put the well-worn cliché that men dominate the top ranks of the biotech industry to the test! Along the way, they’ve learned some very important lessons. Join these top-notch women in the industry address the challenges they’ve faced in their careers and suggest ways companies can recruit talented women and create a working environment that’s friendlier to them.

5:00PM – 6:30PM

2016 Top Women in Biopharma Awards Presentation & Networking Reception

It’s a well-worn cliché that men dominate the top ranks of the biotech industry. But over the past decade a group of extraordinary women has put that cliché to the test. For each of the honorees, there are unique stories about how impressive women have gotten ahead in the competitive biotech field. The FierceBiotech Top Women in Biopharma is a celebration of women in the life sciences industry, academia and regulatory roles who are outstanding members of the field.

WEDNESDAY, SEPTEMBER 21

 8:00AM – 12:00PM

Registration

8:00AM – 8:45AM

Morning Coffee Networking

8:45AM – 9:00PM

Chairperson’s Welcome & Day 1 Review

Speaker: Rebecca Willumson | Publisher | FierceBiotech

9:00AM – 9:45AM

GENERAL SESSION: The Current State and Future of Big Data

Moderator: Stacy Lawrence | Editor-in-Chief | FierceBiotech

Panelists:
Steve Labkoff, MD | Executive Director – Medical Strategy & Medical Affairs | Purdue Pharma LP
Eric D. Perakslis PhD | Senior Vice President & Head – Takeda R&D Data Science Institute | Takeda Pharmaceuticals International Co.
Shuvayu Sen | Executive Director, Outcomes Research & Access | Merck & Co.
Chandra Ramanathan, PhD, MBA | Vice President and Head, East Coast Innovation Center | Bayer HealthCare LLC

Drugmakers, academic institutes, government-sponsored research programs and tech companies are pouring billions of dollars into big data-producing research and big data tech projects, counting on the investments to pay off—sometimes in ways that can’t even be imagined yet. But the industry has a long list of problems to work through as companies make big data their own. Attendees will hear from experts in the field talk about the state of big data in biopharma and what comes next.

9:45AM – 10:30AM

GENERAL SESSION: Jumping Onto the FDA’s Fast Track

Moderator: Diane M. Beatty, Ph.D. | Managing Director, Regulatory Affairs and Product Development | Cardinal Health

Panelists:
Robert Ashworth | VP – Regulatory Affairs | Advaxis, Inc.
Pam Swiggard | VP – Regulatory Affairs | Trevena
Donald L Raineri, PharmD | VP & Head – Regulatory Affairs-Americas | Astellas Pharma Global Development, Inc.

More than half of all cancer meds now approved have been on one of several FDA fast tracks. Breakthrough drug designations have shaved months and sometimes years off the research process. And investigators want to know how to get on the inside regulatory lane, and stay there. Our experts will provide some suggestions on what works with regulators, and take a close look at what’s at stake in the proposed 21st Century Cures Act.

10:30AM – 10:50AM

Networking & Refreshment Break

10:50AM – 11:30PM

GENERAL SESSION: How to Strike a $1 Billion Deal

Moderator: Steve Dickman | Founder & CEO | CBT Advisors

Panelists:
Tony Bower | President | BRG, LLC. / Former Vice President, Global Pricing, Reimbursement and Health Economics | Synageva
Jeb Keiper | Chief Business Officer | Nimbus Therapeutics
Caroline Stark Beer | Senior Director of Business Development | Alnylam
David Brush | Senior Director, Transactions | Johnson & Johnson Innovation

Let’s face it. Every upstart biotech wants to one day be in a position to strike a billion-dollar deal with plenty of that in up-front fees and near-term milestones. What are the key elements that make a billion-dollar deal possible, and how can you position your company to do the same? A group of executives who have been there and done that discuss successes and challenges of doing the deal.

11:30AM – 12:15PM

GENERAL SESSION: Navigating Global Logistics of Clinical Trials

Moderator: Amirah Al Idrus | Editor | FierceBiotech

Panelists:
Murray Alexander Abramson MD, MPH | Vice President, Global Clinical Operations | Biogen
Mike Collins | VP of Global R&D Vendor Management | Alexion Pharmaceuticals
Jonathan Edelman | Vice President – Clinical Development | Seqirus
Bardia Akbari | Vice President & Global Head of Product Global Development – Oncology | Genentech, Inc.

China and emerging markets present new opportunities to developers who are looking for more efficient studies and global approvals. Here we’ll discuss those opportunities and identify ways to navigate the challenges that come with global development plans.

12:15PM – 1:15PM

Lunch & Sponsor Networking

1:15PM – 2:00PM

GENERAL SESSION: The Next Wave in Biotech: How Are Funding Choices Changing?

Moderator: Eric J. McCafferty | Head of Biotech Client Solutions | PPD

Panelists:
Michal Preminger, PhD, MBA | Executive Director – Harvard University Office of Technology Development | Harvard Medical School
John Puziss | Director of Technology Licensing | Yale University
Deborah Dunsire MD | Principal | Southern Cross Biotech Consulting

Over the past few years a tidal wave of IPOs has helped transform the biotech industry, ushering in new venture funds that have been financing a host of startups. We’ll bring together some of the top academic investigators and serial entrepreneurs in the industry to look at what is happening in the biotech landscape and how funding sources are changing. How do you determine the right moment to set up a drive to create a commercial product? Who’s getting financing, and who isn’t?

2:00PM – 2:45PM

GENERAL SESSION: VCs: Creating Value in 2017 and Beyond

Moderator: Damian Garde | Reporter | STAT

Panelists:
Stephen Knight, MD | President & Managing Partner | F-Prime Capital Partners
Alan Crane | Partner | Polaris Partners
Todd Foley | Managing Director | MPM Capital
Marian T. Nakada, PhD | Vice President – Venture Investments | Johnson & Johnson Innovation – JJDC, Inc.

In the 8 years since the 2008 financial crisis, venture capital circles have tightened to a set of experienced, well financed players who like to back proven biotech execs with strong track records in value creation. But how do you create the ideal syndicate that can back your company all the way to a key catalyst? And what’s the outlook for venture capital in 2017? VCs discuss the fine points around how their world is changing-from how they view TAs, individual therapies vs. platform based technologies toward a variety of indications, deal structures, and ultimately how they drive value for their portfolio companies.

2:45PM – 3:30PM

GENERAL SESSION: Going Small Gets Big

Moderator: Chris Apolito | Partner | Triangle Insights Group, LLC

Panelists:
Jake Beverage | COO | Sirenas
Henry Rath| Vice President – Business Development & Strategy | Seres Therapeutics, Inc.
Nancy Thornberry | CEO | Kallyope
Steve Paul, M.D. | President & CEO | Voyager Therapeutics

When Briggs Morrison made the leap from top R&D exec at AstraZeneca to the helm of a much smaller biotech, it was just the latest in a whole series of such moves. As the IPO window stayed open for three long years, the appeal of running your own biotech grew more and more obvious, and the migration included some of the best known people in the business. That trend has been fostered by VCs anxious to put together seasoned teams of veteran drug developers, and even as the IPO window narrows, startups have remained strong. Some top execs who made the switch talk about the pros and cons of going small.