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2018 Schedule of Events

Wednesday, October 17

9:00am - 4:15pm 

Company Presentations

8:30am - 9:25am

Therapeutic Panel
Navigating Checkpoint Inhibitors’ Clinical Results: Lessons for CEOs and Investors

9:30am - 10:25am

Business Session
Learning from Translational Research Successes to Attract Investment

10:45am - 11:40am

Therapeutic Panel
Using Microbiome-Based Therapies to Improve Patient Outcomes

12:00pm - 1:25pm

Fireside Chat and Plenary Luncheon
Speaker TBA

2:00pm - 2:55pm

Business Session
Reaching Chinese Investors: Considerations for an IPO in Hong Kong

3:15pm - 4:10pm

Business Session
Policy Outlook—Implications of the Trump Administration’s Healthcare Initiatives

4:15pm - 5:10pm

Business Session 
View from the Board: Responding to an Acquisition Offer 

 

Thursday, October 18

9:00am - 3:45pm

Company Presentations

8:30am - 9:40am

Therapeutic Panel
Expanding the Toolbox of Neurodegeneration Therapies

10:45am - 11:40am

Business Session
“Digiceuticals” as a New Class of FDA-Approved Therapeutics: Investment & Partnering Opportunities

12:00pm - 1:25pm

Fireside Chat and Plenary Luncheon
Speaker TBA

1:45pm - 2:55pm

Therapeutic Panel
How Real-World Evidence Can Improve Clinical Trial Productivity

3:00pm - 3:55pm

Business Session
Applying Artificial Intelligence to Improve Therapy Development Today

4:00pm - 4:55pm

Business Session
Market Outlook – IPOs Ascendant and Watching M&A Valuations


Navigating Checkpoint Inhibitors’ Clinical Results: Lessons for CEOs and Investors

Wednesday, October 17, 8:30-9:25 am

In the past three years, the number of U.S. clinical trials testing checkpoint inhibitors in combination immunotherapies has quintupled to nearly 1,300 trials. Two types of combination trials are attracting particular attention to their performance magnifying checkpoint inhibitors: IDO inhibitors and oncolytic viruses. The former combination has delivered initial disappointments in the past year, while combining oncolytic viruses with checkpoint inhibitors has seen promising clinical results. This panel reviews the current landscape of checkpoint inhibitor development, highlighting lessons that can be gained from recent achievements and setbacks in combination immunotherapies.

Learning from Translational Research Successes to Attract Investment

Wednesday, October 17, 9:30-10:25 am

As biomedical entrepreneurs seek to apply the newest biomedical research results to invest new treatment options that might help patients, a “valley of death” in funding availability continues to endure between the academic researcher and therapies ready to begin clinical trials.  Over the past decade, publicly-financed organizations designed to bridge this “valley” with development grants have created a track record with notable success stories.  Such non-dilutive funding sources reduce risks during the proof-of-concept stage and make investments more attractive to equity investors.  Panelists in this session will explore the characteristics of academic spinouts that continued past the grant stage to attract major and repeated investments from venture capital as well as that demonstrated therapeutic progress.

Using Microbiome-Based Therapies to Improve Patient Outcomes

Wednesday, October 17, 10:45-11:40 am

Investments in microbiome-related companies have accelerated across the past three years, demonstrating high investor expectations for results. As the first pioneering companies have pushed research into clinical development and started publishing results, those findings and new avenues beyond the gut and digestion-related therapies suggest diagnostic and treatment opportunities in inflammation, neurology, and dermatology, among others.  This panel will discuss a range of microbiome-based approaches for innovations to improve patient outcomes. Topics include microbiome transplants, bioengineered probiotics, next-generation antibiotics, and microbiome-based drug discovery platforms. 

Reaching Chinese Investors: Considerations for an IPO in Hong Kong

Wednesday, October 17, 2:00-2:55 pm

The Hong Kong Stock Exchange is capturing worldwide attention as it modifies listing rules to permit biotech companies, opening the door for Chinese firms seeking public market financing as well international firms eyeing the support of investors in China. In just the exchange’s first few weeks more than USD 1 billion in new offerings have generated funding that will be applied to accelerate clinical research on behalf of patients.  This session will examine cross-border perspectives on the appetite of China-based investors for biotechs and the criteria to determine the attractiveness of listing on the exchange for foreign entities as Hong Kong sets its sights at becoming a major biotech funding source.

Policy Outlook—Implications of the Trump Administration’s Healthcare Initiatives

Wednesday, October 17, 3:15-4:10 pm

Across 2018 the U.S. federal government has launched multiple new initiatives regarding how new medicines will be authorized, commercialized, and reimbursed, including in such areas as genome editing, continuous manufacturing, and Medicare rebates.  This panel of people close to the policymaking process will share the latest data on FDA expectations, plus discuss the Trump Administration’s stances on healthcare spending, the opioid addiction crisis, trade tariffs, and tax policies that will affect biopharmas both immediately and in the years ahead. 

View from the Board: Responding to an Acquisition Offer

Wednesday, October 17, 4:15-5:10 pm

More than 60 biopharmaceutical acquisitions of private companies took place over the past four years. One of the greatest challenges faced by a leadership team is responding to an acquisition offer.  The inability to predict when such an offer is likely to be received and the deadline pressure to react quickly heighten the importance of preparing for such scenarios in advance within a board of directors.  Also, the inherent tension of boards including both venture investors and managers/founders may force difficult conversations regarding valuation and risk.  This panel will review how to structure those conversations and decisions to be as productive as possible.

Expanding the Toolbox of Neurodegeneration Therapies

Thursday, October 18, 8:30-9:40 am

Results of a Phase II clinical trial presented at the July 2018 Alzheimer’s Association International Conference suggest that an anti-beta amyloid antibody shows promise in slowing cognitive decline in Alzheimer’s patients, creating hope, but also refueling the debate regarding assumptions about the biology of neurodegeneration.  In a field historically focused on beta-amyloid plaques as primary targets but challenged to demonstrate new approvals, what are alterative hypotheses to neurodegenerative treatment development?  This panel brings together investors, scientists, and companies expanding the toolbox of neurodegeneration therapies.  Collectively, panelists will not only discuss the relevance of misfolded proteins, but also broaden the conversation to include the role of neuro-inflammation, alternative mechanisms of action, and other therapeutic targets for treating neurodegeneration.

“Digiceuticals” as a New Class of FDA-Approved Therapeutics: Investment & Partnering Opportunities

Thursday, October 18, 10:45-11:40 am

Within the past year, the FDA has launched a provider pre-certification program as a pilot to manage the expansion of “digiceuticals” or digital therapeutics that produce clinical benefits for patients via interaction with a software application or mobile app.  This innovative regulatory approach seeks to provide discipline around clinical utility with the iterative improvements enabled by software versus standard manufactured medicines.  Given the near-instant worldwide distribution platforms of mobile apps, the technology enables fundamental changes in managing interactions with patients to understand and treat disease, with clear collaboration benefits between biopharma and digital therapy providers.  This session will feature companies trying to expand this frontier, the investors distinguishing among the competing technologies, the therapeutic partners who might benefit from such apps, and experts on the most likely pathways innovations will take to reach patients.

How Real-World Evidence Can Improve Clinical Trial Productivity

Thursday, October 18, 1:45-2:55 pm

As a greater percentage of health care records are digitized, plus with the emergence of patient-provided data sets via wearables and other devices, therapy developers have much greater ability to distill insights from existing data rather than solely relying upon “started from scratch” clinical trials to learn about a disease.  Companies are combining new analytical techniques with careful human screening of real world data sources such as electronic health records, insurance billing records, and patients’ mobile devices to develop real-world evidence regarding which patient populations might respond best to a new treatment under development and which diagnostic markers might streamline clinical trial recruitment.  In the light of the FDA’s new guidance on real-world evidence this panel will explain how traditional approaches to clinical trial design may be enhanced to save time and money, while improving productivity and outcomes for patients.

Applying Artificial Intelligence to Improve Therapy Development Today

Thursday, October 18, 3:00-3:55 pm

As new techniques in artificial intelligence expand the functionality of software to find useful results from large data sets, progress companies are already folding such tools into their developments of new therapies to address unmet needs of patients.  For example, companies are using the “always-on” power of computers to filter existing molecular libraries and model new drug discovery techniques in ways never before possible.  This session will feature experts working at the intersection of information technology, therapy delivery, and new drug development, who can show the exponential power of machine learning and other artificial intelligence approaches to turn data into medicine.

Market Outlook – IPOs Ascendant and Watching M&A Valuations

Thursday, October 18, 4:00-4:55 pm

Despite heightened political discussion of the value of marketed medicines, the biopharma investor community continues to increase its support. As the industry has gained traction on new drug approvals through 2018, the financial dollars have followed with record public and private offerings. The attractive IPO market has however resulted in fewer M&A deals than prior years, with high pre-money IPO valuations for later-stage companies making it less enticing for them to accept early-exit offers. This has led to an M&A shift to focus on early-stage companies. The session will examine the current deals and market trends while highlighting the path forward.

*As of 8/14/2018.  Program sessions are subject to change.