Monday, October 1, 2018 // WORKSHOP DAY
1:00 Registration WORKSHOP A 2:00 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 Aris Persidis, President, BIOVISTA Chad Nivens, Director, Translational Sciences, ASTRAZENECA WORKSHOP B 2:00 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 Neal Simon, CEO, AZEVAN PHARMA Sanuj Ravindran, CEO, PELLEPHARM 5:00 Welcome Networking Reception
Aris Persidis Chad Nivens Neal Simon Sanuj Ravindran BIOVISTA ASTRAZENECA AZEVAN PHARMA PELLEPHARM
Scenes From the Drug Development Forum 2017
www.asdevents.com - www.asdevents.com/event.asp?id=18934 Tuesday, October 2, 2018 // Day One
8:00 Registration and Continental Breakfast 8:25 Opening Remarks
NEW REGULATORY AND MARKETPLACE CONCERNS
8:30 KEYNOTE: Pursue Breakthrough Approvals in Multiple Global Markets • Recognize and compare international regulators that emulate FDA’s accelerated approval programs • Outline the rewards for patient communities and the business of drug discovery • Reap the benefits of a more productive industry MODERATOR: Eric Palmer, Editor, FIERCEMARKETS Martine Zimmerman, Senior Vice President, Global Regulatory Affairs, ALEXION PHARMACEUTICALS Roy Baynes, CMO, Senior Vice President, Head of Clinical Development, MERCK Maria Fardis, CEO, IOVANCE Julian Adams, CEO, GAMIDA CELL 9:10 Networking Break 9:20 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 MODERATOR: Arlene Weintraub, Contributing Writer, FIERCEBIOTECH Stephen Webster, CFO, SPARK THERAPEUTICS Marc Schwabish, Senior Vice President, BD and U.S. Operations, FUSION PHARMACEUTICALS Bruce Leicher, Senior Vice President and General Counsel, MOMENTA Judy Chuk, Vice President, Strategy and Operations, ENZYVANT 10:00 Networking Break 10:10 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 MODERATOR: Amirah Al Idrus, Editor, FIERCEBIOTECH Liz Lewis, Chief Counsel, Head of Patient Advocacy, TAKEDA Lori Lyons-Williams, Chief Commercial Officer, DERMIRA Melissa McLaughlin, Chief People Officer, AGIOS PHARMACEUTICALS Amri Johnson, Global Head, Diversity and Inclusion, NOVARTIS Karen Anderson, Senior Vice President, Chief Human Resources Officer, ALNYLAM PHARMACEUTICALS Brenda Sousa, Senior Vice President, Human Resources and Operations, CONSTELLATION PHARMACEUTICALS
www.asdevents.com - www.asdevents.com/event.asp?id=18934 Tuesday, October 2, 2018 // Day One
11:10 Networking Break STRATEGIC DEAL-MAKING BREAKTHROUGHS IN AND PARTNERING GUIDING EARLY-STAGE RESEARCH 11:40 Introduction From Track Chair Introduction From Track Chair Robert Gould, CEO, FULCRUM THERAPEUTICS David Mack, CEO, PMV PHARMACEUTICALS 11:50 Meet and Beat Ambitious Growth Plans to Surpass Improve Orphan Drug Strategy so Your Company Can Grow Investor Expectations up With Your Patients • Clarify why some industry insiders are wrong to think • Review opportunities for biopharma companies to continue ambitious growth is impossible listening to patients long after a drug has launched, particularly • Understand the odds and obstacles to growth success as pediatric patients become adults and their needs evolve • Make the most of your assets during mergers and • Turn patient and physician insights into new formulations, new acquisitions doses, and new storage options Dan Wechsler, CEO, MELINTA THERAPEUTICS • Go beyond scientific innovation to address changing patient Jonathan Garen, CBO, UNIQURE needs through ambassador and other programs MODERATOR: Lauren Neighbours, Head, Regulatory Affairs, PSI-CRO Douglas Ingram, CEO, SAREPTA THERAPEUTICS Amit Rakhit, CMO, OVID THERAPEUTICS Holly May, Vice President, Sales and Marketing, SOBI 12:30 Update Collaboration Models Between Pharma and Determine “Best-in-Breed” Status to Realize Advances in Biotech Immuno-Oncology • Compare the performance of build-to-buy deals, company • See farther and discern signals in a very crowded, poorly creation, and option deals understood market • Review deal structures most attractive to all stakeholders • Tell a convincing story of clinical relevance out of the hundreds • Make sure teams can interface well enough for of immuno-oncology targets collaborations to move quickly • Win over investors about recruitment going well MODERATOR: Evan Smith, Managing Director, Strategic MODERATOR: Andrew Allen, CEO, GRITSTONE ONCOLOGY Communications, FTI CONSULTING Zhen Su, CMO, EMD SERONO Caroline Stark Beer, Vice President, Head of Business Sridhar Ramaswamy, Vice President, Translational R&D, TESARO Development, ALNYLAM PHARMACEUTICALS Barbara Dalton, Vice President, Venture Capital, PFIZER Aradhana Sarin, Senior Vice President, Head of Business Development and Strategy, ALEXION PHARMACEUTICALS Thomas Loeser, CFO, ORIGENIS Debanjan Ray, CFO, CYTOMX 1:10 Luncheon 2:10 Understand Causes of Delay and Success When Nurturing Develop Combination Therapies for Immuno-Oncology Relationships With VCs and Planning Financial Strategy • Analyze where the field is going beyond the checkpoint • Assemble syndicates that can go the distance from founding blockade to IPO • Focus on challenges and opportunities for antibody • Build credibility through repeated reminders therapeutics, bispecific and multivalent approaches in I-O • Identify the right decision-makers and build strong bridges • Optimize combination therapy regimens • Realistically assess how much time a pipe financing scenario MODERATOR: Carly Helfand, Senior Editor, FIERCEMARKETS will require Thomas Schuetz, CEO, COMPASS THERAPEUTICS Ricky Sun, Principal, Life Science Fund, BAIN CAPITAL Jason Rhodes, Partner, ATLAS VENTURE Otello Stampacchia, Managing Director, OMEGA FUNDS
“Excellent perspectives!” —CEO, TRACON PHARMACEUTICALS “Beneficial information about deal types.” —V P, BEXION “Very important coverage of strategic partnerships.” —Senior Manager, SAMSUNG BIOEPIS
www.asdevents.com - www.asdevents.com/event.asp?id=18934 Tuesday, October 2, 2018 // Day One
STRATEGIC DEAL-MAKING AND PARTNERING BREAKTHROUGHS IN GUIDING EARLY-STAGE RESEARCH
2:50 Evaluate the Impact of New, Non-Traditional Biotech Establish the Academic Partnerships Necessary for Success Investors in Early Clinical Stages While Improving Trial Transparency • Track the arrival and growth of new investor partners, • Navigate cultural divides between biotech and academia including international capital (China, Russia) • Work to make all partners equally aware of the need to protect • Forecast what this will do to valuation, value-sensitivity, and and build IP price on public markets • Cut through the hype commonly found in early research • Highlight factors that make biotech companies more • Discuss the pros and cons of an industrywide, open-data attractive to unconventional investors approach Ravi Kiron, Head, BioPharma External Innovation, EMD SERONO • Envision the technical challenges of collating, storing, Yuval Cohen, CEO, CORBUS PHARMACEUTICALS and sharing large volumes Yaron Werber, CBO, OVID THERAPEUTICS MODERATOR: Conor Hale, Associate Editor, FIERCEBIOTECH Jim Doherty, Chief Research Officer, SAGE THERAPEUTICS Chandra Ramanathan, Vice President and Head, East Coast Innovation Center, BAYER Salim Mujais, Senior Vice President, Global Therapeutics Head, Specialty Pharma, ASTELLAS Paul Lammers, President and CEO, TRIUMVIRA IMMUNOLOGICS Lisa McKerracher, CEO, BIOAXONE BIOSCIENCES Joseph Menetski, Associate Vice President, FNIH BIOMARKERS CONSORTIUM 3:30 Recognize When Novel Technologies Can Disrupt Select Ideal Animal Models for Early Research to Improve Standard Business Development the Preclinical-to-Clinical Transition • Understand precisely how the type of technology you have • Track a rapidly evolving field to find the most appropriate fits into the priorities of business development professionals animal models • Plan to work with more senior or creative groups when using • Anticipate when data expectations will shift completely out of very innovative technologies animals and into the clinic • Grasp whether your audience is correctly perceiving your • Balance how much you spend on preclinical research with how technology hard you try to accelerate development to clinical stages • Show credibility for new solutions to old problems Cary Schockemoehl, Vice President, Business Development and MODERATOR: Carly Helfand, Senior Editor, FIERCEMARKETS Strategy, REALM THERAPEUTICS Dolores Baksh, Innovation Leader, GE HEALTHCARE Jean-Philippe Combal, CEO, VIVET THERAPEUTICS Nouhad Husseini, Vice President, Head of Business Development, REGENERON Steven Holtzman, CEO, DECIBEL THERAPEUTICS Praveen Tipirneni, CEO, MORPHIC THERAPEUTICS Kim Seth, Executive Vice President, Business and Corporate Development, REPARE THERAPEUTICS 4:10 Networking break 4:40 Use Shorter Timescales to Uncover Warning Signs of a Leverage 3DP Technologies to Accelerate Time to Market Failing Partnership • Use novel dosage forms to minimize R&D iterations of dosing • Give sufficient weight to whether prospective partners are frequency and dose size truly compatible • Provide real-time formulation support for adaptive • Provide more details on how deals will be executed, how to clinical trials leverage each organization, and how to deal with the cultural • Accommodate fragile molecules and particles to speed the and workplace norms of each company translation to final product scale • Lay the groundwork for broader partnerships by avoiding Timothy Tracy, CEO, APRECIA PHARMACEUTICALS confusing pitfalls Christine Carberry, COO, KERYX BIOPHARMA 5:20 Benefit From Strategic Advisors Pointing You Towards the Revise Your CMO Engagement and Payment Strategies for Right Questions Immuno-Oncology • Outline the function of innovation councils • Work with multiple CMOs from early stages in order to develop • Improve competitive differentiation and research plans an entire therapeutic process • Gather multidisciplinary expertise to learn from new areas • Tighten up your performance prediction methods in order not and avoid some biopharma assumptions to waste non-refundable payments to CMOs Adriann Sax, Entrepreneur-in-Residence, FORTRESS BIOTECH • Strengthen your timelines and be willing to commit years of Thomas de Vlaam, CEO, AMYLON THERAPEUTICS advance funds at risk Anne Altmeyer, CBO, ADICET BIO 6:00 Cocktail Networking Reception and Fierce15 Awards 7:00 Day One Concludes www.asdevents.com - www.asdevents.com/event.asp?id=18934 Wednesday, October 3, 2018 // Day Two
8:00 Continental Breakfast STRATEGIC DEAL-MAKING BREAKTHROUGHS IN & PARTNERING GUIDING EARLY-STAGE RESEARCH 8:50 Introduction From Track Chair Introduction From Track Chair Richard Brudnick, Executive Vice President, Business Doug Fambrough, CEO, DICERNA PHARMACEUTICALS Development and Alliance Management, BIOVERATIV 9:00 Pinpoint the Crucial Data for Improving and Managing Find New Drivers for Success After Prior Research Failures Your Relationship With VCs in CNS, Oncology, Rare Disease, and Gene Therapy • Lead with the strongest, most experienced team members • Learn from past overreliance on soft or subjective endpoints • Learn from shift in VC preferences towards late-stage and a shallow dynamic range development • Prioritize a clear mechanism, strong transitional biomarkers, • Be able to explain why they should invest earlier – or how and strong responders you will get through the rest of development without their • Get early signals around the PKPD relationship in phase I, prior early-stage funds to efficacy data Randy Hubbell, CEO, CARMELL THERAPEUTICS MODERATOR: David Shoemaker, Senior Vice President, R&D, RHO Kevin McArdle, CFO, CHEETAH MEDICAL Augustin Melian, Senior Vice President, Global Medical Sciences, Nima Farzan, CEO, PAXVAX ALEXION PHARMACEUTICALS Ronit Simantov, CMO, GAMIDA CELL 9:40 Risk Management and Evidence-Based Management for Judge the Usefulness of Dedicated Innovation Groups Small Company Deals • Survey the success rates based on how many resources big • Make sure you have successes sufficient for milestone pharma has dedicated to this problem payments • Understand the key reasons why innovation groups may • Identify where key gaps and risks in modeling are not work • Build mitigation plans to minimize risk and make deals work • Map the development cycle for new venture and innovation Lixia Wang, Senior Vice President, Biometrics and HEOR, groups CTI BIOPHARMA Stephane Bancel, CEO, MODERNA THERAPEUTICS 10:20 Networking Break 10:50 Reach Agreement With Investor Community on Whether to A Dilemma in Immuno-Oncology: Unreliable Mice or Discover or Buy New Candidates Unaffordable People? • Recognize that investors can be suspicious of a deep • Explore whether you can escape inefficiencies in current drug commitment to discovery research due to challenging return development on capital • Quantify the time and resources being diverted towards steps • Augment a pipeline by buying external assets that may not be helpful to the overall development • Stay alert for overvalued assets that will shred your value • Shift the paradigm away from economical signaling pathways Anna Kazanchyan, CEO, SAGHMOS THERAPEUTICS 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 Samuel Blackman, Senior Vice President, Head of Clinical Development, SILVERBACK THERAPEUTICS 11:30 Move Into Specialty Arena to Achieve Higher Value Assets Fill Your Early-Stage Pipeline With Creative Approaches to • Follow unmet medical needs to find higher willingness to pay Search, Evaluation, and Partnership in specialty markets • Tailor your business model to outperform with emerging • Prepare for tremendous payer pressure opportunities • Recognize that the goal is to discover drugs with • Create business development and collaboration models unambiguously large effect size and societal importance specific to the early stages of R&D • Consider clinical and market development challenges for • Accelerate assets from the “eureka” moment to first-in-human NASH candidates trials Andrew Thompson, CEO, PROTEUS DIGITAL HEALTH Jake Reder, CEO, CELDARA MEDICAL Jigar Raythatha, CEO, CONSTELLATION PHARMACEUTICALS Richard Glickman, CEO, AURINIA
www.asdevents.com - www.asdevents.com/event.asp?id=18934 Wednesday, October 3, 2018 // Day Two
STRATEGIC DEAL-MAKING & PARTNERING BREAKTHROUGHS IN GUIDING EARLY-STAGE RESEARCH
12:10 Manage Partnerships and Portfolios to Survive the Next Partnership and Pipeline Strategies for Digital Therapeutics Market Downturn • Improve the prescription and reimbursement rates • Evaluate whether the biotech sector is built up sufficiently to • Clarify the logistics from the patient and pharmacy side withstand the next downturn, and for how long • Address each partner’s concerns about reimbursement, market • Review who did and did not survive the 2000–2012 potential, and health outcomes downturn, and why • Build the mind-shift that the market needs from a scientific, • Take into account the effects of — and on — IPOs and VCs legal, IP, regulatory, technological, and organizational perspective • Discuss why IPOs were apparently able to resist bad clinical • Launch and maintain digital drugs while maintaining patient data this cycle privacy • Choose good investors with long-term views and the cash to MODERATOR: David Klein, CEO, CLICK THERAPEUTICS support you, who won’t allow for stockpiling excessive funds Alex Waldron, Chief Commercial Officer, PEAR THERAPEUTICS David Elmaleh, CEO, AZTHERAPIES Jeremy Sohn, Vice President, Global Head of Digital Business Development and Licensing, NOVARTIS Sameer Bansilal, Director, U.S. Medical Affairs, CV Pipeline, BAYER 12:50 Luncheon 1:50 Visualize the Full Economic Potential and Likely Longevity Innovate Biotech Business Models for Immuno-Oncology of the Improved IPO Market • Forecast the challenges of combination trial design • Track the past growth and downturn cycles of IPOs • Ensure access to complimentary mechanisms of action • Pinpoint where your pipeline best matches the indications / • Withstand the cost and complexity of development pathways disease areas most preferred by growing IPOs Lawrence Bloch, President, INFINITY PHARMACEUTICALS • Firm up the reasons why now might not be the best time to go public – and when would be instead Are you interested in sponsoring this session? Contact Andrew Sinetar at 212-400-6237 or [email protected]. 2:30 Grasp Deal-Making From a Sociology Perspective so All Strengthen Immuno-Oncology Portfolios Through Relevant Stakeholders Can Win Preclinical Models of Disease • Figure out functional counterparts at senior levels to sponsor • Gain access to patient-derived xenoblast models as deals translational tools • Navigate specific operating constraints between the • Develop faithful models that represent tumor biology and the organizations, particularly regarding how much of a time intersection of the immune microenvironment and system delay they each can withstand • Reach the next step in providing humanized mouse immune • Recognize the strategic operational dimension of post-deal systems alliances and project management Peter Smith, CSO, H3 BIOMEDICINE Paula Cobb, Executive Vice President, Corporate Development, Mike Burgess, President, R&D, TURNSTONE BIOLOGICS DECIBEL THERAPEUTICS 3:10 Tackle the Most Common Problems for Business Plan the Next Steps for a Renaissance in Women’s Health Development Deal-Makers • Reconstruct the recent history of drug R&D focused on • Place more emphasis on results and add further endpoints in women’s health clinical trials • Survey remaining areas of unmet needs • Address concerns over reimbursement through early upfront • Discuss the scientific potential for new biopharma growth in conversations with payers this space • Cross the threshold of data where a purchase becomes Julie Krop, CMO, AMAG PHARMACEUTICALS worthwhile MODERATOR: Evan Smith, Managing Director, Strategic Communications, FTI CONSULTING Catherine Sohn, Board of Directors, JAZZ PHARMACEUTICALS Girish Aakalu, Vice President, Head of Global Scientific Affairs and Scientific Intelligence, IPSEN 3:50 Critically Examine the M&A Mindset in Biotech and Pharma Specialize Your CRO Outreach for Early Research • Contrast recent growth in biotech purchases with high-profile • Maintain a productive atmosphere with a common philosophy departures of pharma execs for biotech companies • Share strategy for collaborative project development • Weigh the pros and cons of biotech independence vs. purchase • Determine milestone payment structures for successful • Analyze feedback from VCs who push towards selling development • Seek a balance between innovation potential and the new Andrea Gerken, Head of Business Development, resources of being subsumed H3 BIOMEDICINE MODERATOR: Jean-Philippe Combal, CEO, VIVET THERAPEUTICS Geeta Vemuri, Managing Partner, AGENT CAPITAL
4:30 Conference Concludes www.asdevents.com - www.asdevents.com/event.asp?id=18934