DPHARM 2019 RECAP

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DPHARM 2019 RECAPDPharm: Disruptive Innovations to Advance Clinical Trials

Innnovating for PatientsDPharm had its most successful year yet, with attendee growth up 35%, sold-out exhibit rooms and more session choices from key trends to modernizing clinical

trials and preparing for the rise of the expert patient. Enjoy the recap of the 9th annual DPharm.

DPHARM 2019 RECAP

2 Save the Date - DPharm 2020 | September 22 - 23 | Boston, MA - theconferenceforum.org

DPHARM 2019 kicked off, literally, with veteran Radio City Rockette, breast cancer survivor and patient advocate keynote, Alyssa Epstein, leading conference-goers in a chorus line. In her keynote speech, Alyssa described the team she assembled to help her manage the cancer treatment process. In many ways, she said, it was similar to the network she relied on as a professional dancer. “I was building my own Rockette line of healthcare professionals.” Though the patient experience can feel solitary, Ms Epstein was grateful for the people who helped her. “My ‘I’ became a ‘We.’”

Opening Keynote: Patient Advocate Presentation

Keynote: Modernizing Clinical Trials, Frameworks and PrioritiesThe 23rd FDA Commissioner, Dr Scott Gottlieb, followed up on Ms Epstein’s presentation with a summary of the current state and future of clinical trials. Dr Gottlieb spoke on the ways the FDA has attempted to modernize their approach to clinical trials under his tenure, including allowing individual investigators in cell-based medicine to pool their resources and data under a common FDA application, introducing the concept of reverse accelerated approval for medicines with high, early impact, and advocating for master protocol groups for the testing of multiple drugs.

Dr Gottlieb encouraged the industry to pre-competitively pool resources for updating clinical trial tools, instead of only relying on old stand-bys such as patient-reported outcomes or periodic doctor visits, and highlighted the potential of validating methodologies for evaluating real-world evidence of drug and device safety.

DAY ONE

DPHARM 2019 RECAP

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Shwen Gwee of Novartis spoke about how, for true innovation, one must stop trying to innovate. Creating something new, he says, isn’t the same as creating something better. So, to actually innovate, Gwee advises companies to think like a start-up: understand the problems people have, incorporate a diversity of voices, and treat the end product not as something static but something iterative.

Actions to Embrace and Support Innovation for the Benefit of Patients

Good, Better...Balancing Innovation with Solid Common Sense to Deliver Innovative MedicinesAfter a portfolio shift into immuno-oncology with Keytruda, Merck had to face the change by operating under the mantra, “Standardization based on quality is the platform for innovation.”

To that end, Dr Mark Travers, Merck & Co, emphasized how Merck has undergone standardization across countries and trials, moved a lot of clinical trial operations in-house for better oversight, and made a change from CRO to FSP model. By incorporating TransCelerate’s SIP and investing in a mobile app for its CRAs, Merck was able to improve clinical trial monitoring visits and widen access while reducing duplication. Travers advised that disruption comes from understanding where companies stand solidly and innovating from there.

Keynote Dr Rod MacKenzie, Executive Vice President, Chief Development Officer, Pfizer was joined in a fireside chat with TrialSpark CEO and Founder Dr Benjamine Liu, where they evaluated the state of the modern clinical trial. The two agreed that the primary bottleneck facing their development is patient recruitment, and that while clinical trials and patient recruitment still lagged behind the drug discovery innovation, the bottleneck would only worsen.

To combat that, MacKenzie and Liu addressed how, from the ground up, they were attempting to diversify and innovate clinical trials: paying attention to the small details that can preclude someone from participating in a trial (everything from the overwhelming startup admin to the barrier of paying for parking), diversifying trials by bringing in local doctors and their patients, and tackling the standardization of data across trials.

Collaborating to Transform R&D

DPHARM 2019 RECAP

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DPHARM BY THE NUMBERS

85% 600+

32+ 300+

7 9

5X

Growth in Attendees since 2018

Innovators in 2019

Hours of Sessions

Reporting on Innovation

One-on-OneMeetings

Keynote Presentations

in 2019

Years of Reportingon the Latest in

Clinical Innovation

Growth in Speaking Faculty since founding event in 2011

DPHARM 2019 RECAP

5 Save the Date - DPharm 2020 | September 22 - 23 | Boston, MA - theconferenceforum.org

The World’s 50 Most Innovative Companies

Following his presentation, Mr Gwee was joined by Fast Company Deputy Editor David Lidsky, who puts together the magazine’s “50 Most Innovative Companies” issue every year. Lidsky highlighted two key features across industries of innovative companies: speed and the desire to understand the consumer better.

Innovation often comes in the wake of a competitor. Lidsky gave the example of Amazon: as the company became more automated, it opened a market space for competitor Target to provide a unique, in-store experience. When it came to the healthcare industry specifically, Lidsky spoke about the value of doing something impactful with collected data, and as outside industry giants, like Amazon, Apple and Google, move into the health space, it can provide the opportunity for pharmaceutical and biotech companies to form a more human connection.

Guest Keynote David Lidsky, JD, Deputy Editor, Fast Company with Shwen Gwee, Co-Founder, Novartis Biome, and General Manager, Head of Open Innovation, Novartis

Innovative Digital Solutions

Learning to Fish in an Industry Filled with Data Lakes with Jae Chung of Oracle Health Sciences, and Helen Yeardley of ICON plc.

The Move from EDC to eSource: Overcoming the Industry’s Data Crisis with CEO of Clinical Ink, Ed Seguine.

Follow the Science without Technology Limitations with Neta Bendelac of 4G Clinical, and Washington Alves of Gemini Therapeutics.

Bridging Socio-Economic Barriers in Important Maternal Health Research by snaploT’s Christian Knaus.

Why Respecting Site Agency is the Key to Site Success with Founder and CEO of Complion, Rick Arlow.

5 Years of Lessons Learned in Virtual Trials in 5 Minutes with Science 37’s CMO Dr Jonathan Cotliar.

Accelerating from Site-based to Real World Data-driven Clinical Development with Paul Bloom of UBC.

Observed Best Practices for Patient-Reported Outcomes with Danielle Chow and Walker Bradham both of IBM Watson Health.

Improving Patient Recruitment: Returning Genetic Results with Thermo Fisher Scientific’s Shantanu Kaushikkar.

Moderated by Dr Nikhil Kavimandan of Novartis. This track’s presentations focused on the unique challenges posed by the rapidly evolving use of technology in clinical trials:

DPHARM 2019 RECAP

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Innovative Patient SolutionsModerated by Sandra Freeman of Johnson & Johnson. This track consisted of presentations concerned with patient-centric approaches to difficulties in managing the patient resources of clinical trials:

Clinical Trial 2030: Pragmatic Predictions for the Next Evolution of Trials and What We Can Do Now to Prepare with Kelsey Jakee of PA Consulting.

The Myth: New Technology Inherently Equals Improved Outcomes with BBK Worldwide’s Aaron Fleishman and Matt Kibby.

The ROI of Providing Patient Travel Options: Exploring Cost Savings & Benefits for Sponsors & CROs with Al Peters of ClinEdge.

From Rideshare to Reservations: Improving the Patient Experience through Travel Innovation presented by Kyle Cunningham of Greenphire.

Improving Clinical Trial Performance through Effective Management of The Patient Journey with CEO of Clincierge, Scott Gray.

Increasing Patient Recruitment to Trials: Innovation in Predictive Analytics and Digitization Brings Clinical Trials into Clinical Care with Debra Kientop, VP of Life Sciences at Inteliquet.

AI-Based Digital Endpoints of Clinical Functioning: Increasing Sensitivity and Validity in Evaluating Clinical Efficacy with AiCure’s Isaac Galatzer-Levy.

Where Are They Now?Moderated by Dr Ülo Palm of Allergan. This track covered how to organically innovate around some of the more traditional challenges that can arise in clinical trials.

True Electronic Source: Why Elligo’s Approach Attains Real Source Data Collection in our Healthcare-Enabling Research Organization with Jacylyn Bodmer of Elligo Health Research.

Successful Integration of In-Home Visits with Mobile Technology presented by CEO of MRN, Dr Graham Wylie.

EDETEK’s CONFORM™ Clinical Informatics Platform is Revolutionizing How Clinical Data is Being Ingested Standardized, Transformed, Validated, Blinded and Mapped to Create Near Real Time Access to Decision Makers on Trial Executions presented by Mark Gee of EDETEK.

Decentralized / Hybrid Trials – Patient-Centric Services Facilitate Recruitment, Compliance and Retention with CEO of GlobalCare Clinical Trials, Gail Adinamis.

Case study: Impact of Lab Data on Phase 3 Study Planning, Site Selection and Recruitment with David Freeman of Quest Diagnostics.

First Year into Live Connection of EHR-to-EDC Clinical Pipe Application: Site Buy-in, Sponsor/CRO Adoption, Challenges and Solutions by Dr Hugh Levaux of Clinical Pipe.

Clinical Trials 2.0 The Era of Convenience for Patients, Efficiencies for Sponsors with Jodi Akin, Founder and CEO of Hawthorne Effect.

Sandra Freeman, Johnson & Johnson Dr Ülo Palm, Allergan

DPHARM 2019 RECAP

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Pharma Track A

The PD-FIDI: Developing a Digital Endpoint for Parkinson’s Disease by Sanofi’s Laura Kling.

Pfizer: The Validation Study - ePRO and Scrolling, presented by Elan Josielweski of ICON.

Digital Recruitment and Analog Issues: Goals, Metrics and Challenges in Evaluating Recruitment Tactics with VP of Allergan Sara Luijpers.

Structured Data and Corporate Structure: How a Centralized Data Platform Within a Decentralized Organization Unlocks Value with Roivant Sciences’ CIO Daniel Rothman.

Clinical Research as a Care Option into Direct to Patient Trials Leveraging Mobile Technologies with PRA Health Sciences’ Kent Thoelke, and Johnson & Johnson’s Dr John Wang.

Pharma Track B

The Evolution of Using Real World Data to Create Trial Readiness Cohorts with Johnson & Johnson’s Dr Martine Lewi.

Re-Thinking Clinical Development – Using Historical Data to Transform Clinical Trials by Genentech’s Aaron Mann.

The Novartis Biome: Helping the Digital Health Ecosystem Truly Impact Drug Development presented by Novartis Biome co-founder Robin Roberts.

The Value of Chasing Shiny Objects in Clinical Trials with Bayer’s Michelle Shogren and Merck’s Laura Galuchie.

Through a game of Kahoot!, Michelle and Laura tested the audience about the pros and cons of “shiny objects.” Whether that shiny object is a new technology, device or process, there’s value in researching it thoroughly without letting yourself get distracted. But, shiny objects aren’t always the solution; it has to be the proper fit.

Pharma Track C

How Bayer Leveraged the Patient Voice in the Redesign of their Clinical Trial Finder by Michelle Shogren of Bayer.

Eli Lilly: Tracing Patient Recruitment Effectiveness with Nicole Sheetz of Eli Lilly & Company.

Don’t Clinical Trial Participants Have a Right to their Data and Results? What is PDAI Doing About it? A panel moderated by Dr Jessica Scott of Takeda, with panelists David Leventhal of Pfizer, Sara Loud of ACP for MS, and Janssen’s Megan McBride.

Partnering with Patients: Retention and Engagement through Patient Data Return presented by IQVIA’s Dana Edwards and GSK’s Dr Judith Reece.

Sara Luijpers, Allergan Michelle Shogren, Bayer

Dana Edwards, IQVIA and Dr Judith Reece, GSK

Pharma Innovation Reporting from the Trenches

DPHARM 2019 RECAP

8 Save the Date - DPharm 2020 | September 22 - 23 | Boston, MA - theconferenceforum.org

Tech-Enabled Direct-to-Patient Return of Trial Results, was a discussion between 23andMe’s Shawn Tedman, Ken Getz of Tufts CSDD, and Paulo Moreira of Agenus. The three spoke on the rights of patients to get access to data generated by their engagement with clinical trials and the digital tools necessary to give them access to that data.

Enigmatic Exceptional Responders—What Can We Learn From These Miracle Patients? by Takeda’s Sunita Badola, who addressed registries for exceptional recipients of clinical study medicines.

The Use of AI and Big Data to Increase Reproducibility and Greater Accuracy in Drug Development presented by Dr Arjun (Raj) Manrai of the Boston Children’s Hospital. Manrai spoke on methods of leveraging machine intelligence and mass information to improve the precision and design in drug development.

CEO of Unlearn.AI Dr Charles Fisher presented How Digital Twins will Revolutionize Clinical Trials, highlighting the coming value of virtual representation in the clinical trials space.

DPharm Idol Disrupt 2019

At the end of Day One, six young companies competed to be crowned winner of 2019’s DPharm Idol Disrupt: TrialScout, xCures, Shimmer Research, Intelligencia, Trials.ai and Tasso. Tasso took the gold for its innovative at-home blood-sampling kits, which draws blood from capillaries rather than veins for a painless approach.

Tasso demonstrated a commitment to easing patient burden by designing a patient-centric blood sampling kit that aims to eliminate the need for site visits when collecting blood samples. Judges were very impressed with their presentation, stating that Tasso “lays one more building block in the journey towards decentralizing clinical trials by enabling the collection of blood samples in an easy and seamless manner from the patient’s home.”

In celebrating the 10th Annual DPharm conference, we are seeking applications for DPharm Idol Disrupt 2020. If interested, please contact Meredith Sands at meredith@tcfllc.org.

Zeitgeist Talks

DPHARM 2019 RECAP

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The Collective Struggle to Evolve a Drug Development Organization’s Data and Analytics Culture andCapabilities

During his presentation, Zeitgeist Speaker on Big Data and AI for Drug Development, Milind Kamkolkar of Cellarity, said at its core, AI can have two functions: do things better, or do better things. Without good, usable data, good AI is useless.To avoid buying into the hype of artificial intelligence and machine learning, Kamkolkar spoke of using them as distinct tools for explicit goals. Data-driven companies are just companies that know how to leverage data and value it as much as drug delivery technologies, share prices and information assets.

Healthgrades Founder KerryHicks on Transparency and the Future of Patient Expectations

Across industries, ratings and surveys have become a pandemic that serve as a method of ranting. But within the healthcare space, consumers actually do the opposite: they are eager to share good experiences. However, with that comes added pressure: one bad rating or review could turn away potential patients. To combat that, Hicks advised that looking at the patient experience and solving for disproportionate negatives could serve to improve the overall experience, increase compliance and drive decision making.

.

“DPharm is truly a first class event and we are thrilled to have been a part of it.

We extracted tremendous value and look forward to expanding our role in future

events. Best event of the year.-Ryan Tubbs, Microsoft”

Pfizer’s former Head of Clinical Innovation, Craig Lipset, was joined by Healthgrades founder Kerry Hicks to examine measuring and evaluating the patient experience. During his time at Healthgrades, Hicks focused on three tenets: transparency, empowerment and accountability.

Today Show @DPharmHosted by Bayer’s Michelle Shogren, this section used an interview format to shine a spotlight on key innovating companies in the clinical trials space:

IQVIA’s Dana Edwards addressed What Innovative Technologies are Fundamentally Changing the Way Clinical Trials are Run? Edwards outlined how traditional challenges in clinical trials are being managed by digital tools that seek to lower patient burden and make collected data actionable.

Parexel’s Dr Sy Pretorius spoke on Putting Innovation into Practice. Within their interview, Shogren and Pretorius discussed his passion for patient-centricity, and several key practices within Parexel that seek to place the patient experience in the center of their clinical trial development.

DAY TWO

DPHARM 2019 RECAP

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ERT’s Andrea Valente spoke on the importance of emerging technologies and their intelligent use in Voice and AI plus Additional Support for Clinical Trials.

Starbucks: Innovation for theEnd User Experience

Robert Mercer, Design Director of Global Digital Products at Starbucks, sat down with Joseph Kim of Eli Lilly & Co. When Mercer was a part of the team responsible for launching the mobile order and payment app, it was largely to solve the growing problems of long lines in-stores. But that digitalization opened opportunities to understand their customers better.

Despite being vastly different industries, a lot can be learned about the implementation of technology in Starbucks stores for the clinical trial space. Starbucks’ attitude of dealing with problems as they came and being influenced by the on-the-ground feedback could be implemented for clinical trial sites.

“When a problem is evident, you don’t have to spend a lot of time to measure it”

- Robert Mercer

EHR eSource, RWD & the Rise of Voice TechModerated by Pfizer’s Michele Cherry. This section focused on novel uses of digital tools in the development of clinical trials, and effective practices to maximize the yields from these tools:

Operationalizing EHR eSource - Ruthless Separation of Hype from Reality with Dr Meredith Zozus, UT Health Science Center San Antonio, and Michele Cherry, Pfizer.

#WeHeartHackers: Why this is Vital to Clinical Trial Data Security with Andy Coravos of Elektra Labs and Nina Alli, Executive Director of BioHacking Village.

Using Real World Data to Plan Eligibility Criteria and Enhance Recruitment with CAPT Dianne Paraoan from The Center for Drug Evaluation and Research, and Dr Jack Sheehan of Janssen Scientific Affairs.

The Future Outlook on Voice Technologies and Their Possible Impact on Clinical Trials with CEO of Luminary Labs, Sara Holoubek.

Driving Patient Empowerment in Clinical Trial Recruitment: Case Study on Why Delivering Personalization at Scale is Not Only Necessary, but Possible! presented by Chief Business Officer of 83bar, Kate Hermans.

Maximizing the Value of RWD - Technology Challenges and Opportunities with the Co-Founder of the Clinical Research Innovation Hub at The Microsoft Corporation, Paul Slater.

DPHARM 2019 RECAP

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Enhancing Clinical Trial Communications Between Patients and Investigators presented by Janssen’s Suzann Johnson.

MAPs, Virtual Trials, Patient/Investigator Comm & Protocol ToolkitModerated by Merck’s Laura Galuchie this section covered innovative master protocol design, and patient-centric means of conducting virtual clinical trials:

Master Protocols as the Future of Clinical Research: Patient-Centric R&D and Transformational Efficiencies with Abby Bronson, Parent Project Muscular Dystrophy, and Daniel Millar of Janssen Research & Development.

Case Study: The ADAPTABLE Trial and Shared Learnings from a Virtual Trial with Michael Tucker of Medidata and Dr Holly Robertson of Duke Clinical Research Institute.

Direct-to-Patient Clinical Trials Next Milestones and Actions to Get There led by Craig Lipset, with Biogen’s Adama Ibrahim, Novartis’ Dr Jacob LaPorte, Vertex Pharmaceuticals’ Kelly McKee, and Target Health’s Dr Jules Mitchel.

The Launch of the Patient Protocol Engagement Toolkit (P-PET) presented by AstraZeneca’s Michele Tuefel.

Big Data, AI & Machine LearningModerated by Celgene’s Keith Koharski, this section had presentations centered on the use of machine intelligence in data analysis, and tools to automate the interpretation and accumulation of mass quantities of data:

Is Digital Science, Big Data, Machine Learning, and AI Going to Revolutionize Medical Research and Practice? Implications for Pharmaceutical R&D presented by Allergan’s own Dr Ülo Palm.

AI in Healthcare: Why Augmented Intelligence Is the Path Toward Success with Dr Elizabeth Milkovits of IQVIA.

An AI Powered Pragmatic Study: Mendel 3800 with Dr Karim Galil of Mendel.ai, and Matthew Michela of Life Image.

All the Insight at a Fraction of the Time and Effort: Using Deep Learning to Generate a Wearable Sensor-based Proxy for VO2max with Chris Economos of physIQ.

Managing Site and Study Performance in Clinical Trials with AI presented by Amit Gulwadi of Saama.

DPHARM 2019 RECAP

12 Save the Date - DPharm 2020 | September 22 - 23 | Boston, MA - theconferenceforum.org

AI Patterns in the Clinical Value Chain with Laszlo Vasko and Sudhi Rau of Janssen.

What Needs to be Assembled Among Teams and Infrastructure to Support AI Deployment? moderated by Parexel’s Michelle Hoiseth with panelists Milind Kamkolkar of Cellarity, and Allergan’s Dr Ülo Palm.

R&D Leadership Keynote: KPIs that Support Innovation for Patient-Engagement

For the fireside keynote, Dr Andrew Plump and Dr Jessica Scott of Takeda covered the company’s commitment to patient-centric design in clinical trials through the use of novel KPIs for measuring and promoting patient engagement through patient-themed and patient-engagement activities.The guidelines for some of the patient-themed activities were left open-ended, promoting creativity and an attitude of creating a patient culture rather than jumping to an endpoint. Dr Scott’s team also produced a series of videosthat humanized diseases by bringing in patient perspectives on their own experiences living with chronic or rare diseases.

Workforce Innovation: Upskilling Site Stafffor 21st Century Clinical Trials

Choice #1 had Executive Director of the ACRP Jim Kremidas as its Workforce Innovation Chair. This session addresses the inequality of site workforce performance, and ways of ensuring skill levels and training of site staff. Including the following panels:

We Have a Problem with Workforce Performance at the Site Level and Here is What We Can Do Now with CEO of IACT Health Jeff Kingsley, Pfizer’s Chris Pitcherella, and HCA Healthcare’s David Vulcano.

How to Develop Career Paths and Build the Competency of the Clinical Research Workforce / Individuals via Organizational Level Changes with SCRS’ Deena Bernstein, Denise Snyder from the Duke University School of Medicine, and Dr Mark Travers of Merck & Co.

Collaborative Efforts for Workforce Efficiency and Productivity that are Disruptive by Javara’s Jennifer Byrne, Workforce Innovation Officer of the ACRP Beth Harper, and Dr Dave Morin of the Holston Medical Group.

DPHARM 2019 RECAP

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CRAACO @ DPharm: Clinical Research as a Care OptionIn Choice #2, Dr Murray Abramson of Biogen chaired the CRAACO section at DPharm where we addressed the barriers and presented case examples on bridging the gap between clinical research and clinical care.

Understanding the Goals of Care vs Research was moderated by Kent Thoelke of PRA Health Sciences, and included panelists Dr Murray Abramson of Biogen, CEO of Javara Jennifer Byrne, Dr Jonathan Jackson of the CARE Research Center at Massachusetts General Hospital, and Douglas Schantz of AstraZeneca.

How a CRAACO Approach Facilitates Diverse Recruitment and Especially Retention to Clinical Trial presented by Dr Jonathan Jackson from Massachusetts General Hospital.

Weighing Your Options in Considering Clinical Research from a Patient Perspective moderated by cancer veteran and patient advocate Cindy Geoghegan, with fellow patient advocates Dave Bjork and Danya Kaye.

“Wow! What a great event. So many interesting people and CRAACO is such a brilliant movement. I am inspired by so

many of the people and presentations that I saw. Congrats...Bringing together amazing

people at conferences with a mission”- Dave Bjork, Patient Advocate

Pfizer’s Collaborative Approach with Ochsner Healthcare System to Integrate Clinical Research into Clinical Care with Pfizer’s Tim Joy.

How Sanford Health Systems Integrated Clinical Care and Clinical Research – Going from 3% of Patients in Clinical Trials to 10% in 8 years: Case Study presented by Sanford Health’s Jennifer Weiss.

The Need for an Internal Advocate: How Can Clinical Research Professionals bring CRAACO into Clinical Operations with Kelly McKee, Head of Patient Recruitment at Vertex Pharmaceuticals.

Building a Site Network with Clinical Research as a Care Option with SCRS’ Deena Bernstein.

DPHARM 2019 RECAP

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September 22-23, 2020 Westin Copley Place

SAVE THE DATE!10th Annual

DPHARMDisruptive Innovations to Advance

Clinical Trials

for more information visit www.theconferenceforum.org

for inquiries, service@tcfllc.org

DPHARM 2019 RECAP

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MANY THANKS TO THE SPONSORS AND EXHIBITNG COMPANIESEXECUTIVE SPONSORS

ASSOCIATE SPONSORS

DPHARM 2019 RECAP

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MANY THANKS TO THE SPONSORS AND EXHIBITNG COMPANIESASSOCIATE SPONSORS

DPHARM 2019 RECAP

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MANY THANKS TO THE SPONSORS AND EXHIBITNG COMPANIESEXHIBITORS

SUPPORTING SPONSORS