Building on the successes of our events in Philadelphia and Jersey City, we are excited to be back where it all began – San Diego. Please join us for the most thought-provoking Precision Medicine event in the marketplace. Our speakers cover the panoply of leaders in the healthcare continuum, these include clinicians, industry experts, academics, regulators, payers, genetic counselors, bioinformaticians, and many more who are shaping the way Precision Medicine is implemented into healthcare systems on a global scale.
Join us for panel discussions, keynotes, “Meet the Expert”, roundtables, networking, exhibits, and opening reception to hear from thought leaders who are making the promise of Precision Medicine a reality.
Registration Rate:
Limited Time Offer $249 Expires September 30th
PLATINUM PARTNER
DIAMOND PARTNER
FLAGSHIP PARTNERS
AGENDA
THURSDAY OCTOBER 10th, 2019
7:00-8:20am
Registration & Breakfast Buffet
8:20-8:30am
Welcome and Opening Remarks
Dawn Barry, MBA, President & Co-Founder, LunaDNA – Chair – The Precision Medicine Leaders’ Summit – West
Nigel Russell, Founder & President, The Journal of Precision Medicine and the Precision Medicine Leaders Summits.
8:30-9:00am
Keynote – Precision Medicine: Complexity Beyond Simple Mutations
John Quackenbush, PhD, Henry Pickering Walcott Professor of Computational Biology and Bioinformatics, Chair, Department of Biostatistics, TH Chan School of Public Health, Harvard University
Early successes in precision medicine were driven by identifying, and targeting, single genetic variants exhibiting large biological effects. However, we are increasingly coming to recognize that disease phenotypes, including response to targeted therapies, involve a much more complex landscape of genetic and other factors. Embracing this complexity, and developing new predictive methods, is necessary if we are to make continued advances and extend effective predictive medicine beyond oncology.
9:05-9:55am
Standardizing Cancer Immunotherapy Diagnostic Assays: The Medical Imperative, the Challenges, and a Roadmap to Optimizing Delivery of Precision Medicine
Host: Karen Gutekunst, PhD, Vice President Regulatory Affairs, Illumina
Steven Averbuch, MD, Principal, S D Averbuch Consulting LLC
The application of Precision Medicine for the treatment of cancer is well established across multiple therapeutic classes including endocrine, targeted small-molecule, antibody-directed and immunotherapy. The benefit of Precision Medicine to identify an individual cancer patient that will likely respond to a selected cancer therapy is inextricably linked to a chain of events from specimen to in vitro diagnostic (IVD) to interpretation and a report that leads to an optimal therapeutic decision and action. Any error, deficiency, or even expected variance in the diagnostic chain of events may lead to an ambiguous or “wrong” result, with a subsequent inappropriate therapeutic choice and harm to the patient. The increasing number of cancer IVDs, the rapid advances in diagnostic technology, and the inherent biological heterogeneity of advanced cancer all contribute to an uncertain environment where the chance of getting it “wrong” for the patient is increased. Thus, there is a medical imperative to create the highest standards for cancer IVDs that are adopted and widely available to patients. This presentation will highlight immunohistochemistry and next generation sequencing IVDs for novel cancer immunotherapeutics to illustrate the challenges, recent efforts, and a future roadmap for providing consensus high standard Precision Medicine to cancer patients.
David Spetzler, MBA, MS, PhD, President and Chief Scientific Officer, Caris Life Sciences
We stand on the brink of a profound technological advancement that can deliver unprecedented improvements to humanity by enabling the treatment of malignancies that have historically proved fatal and untreatable. To achieve this lofty goal, we, the scientific community, must mandate and ensure that the data produced is of the highest quality and able to be compared across labs and providers. With the ability to measure unprecedented numbers of genomic and transcriptomic variables comes an enormous risk of false discovery and misinterpretation that can lead to improper treatment and suboptimal patient care. To guard against this, data must be comparable and consistent, requiring standardization of preanalytical variables, nomenclature, and metrics. The inherent complexity of NGS requires that assay metrics be monitored beginning with tissue procurement, ischemia time, fixation time and conditions, tumor percentage, gene coverage, input, hyb efficiency, q-scores, PCR dup rate, calling models and interpretation. There are no standards that exist today, and thus comparison of results across labs and assays is impaired to the detriment of patients. These deficiencies make comparison of univariate biomarkers challenging, but also impede the application of advanced machine learning modalities to find multivariate signatures that can improve and customize therapeutic strategies.
This session will consist of two presentations lasting 15-20 minutes followed by a fireside chat with Dr. Averbuch and Dr. Spetzler.
10:00-10:20am
Opportunities to Advance Precision Medicine with Blockchain Powered AI
David Houlding, MSc, CISSP, CIPP, Principal Healthcare Lead, Industry Experiences, Cloud + AI, Microsoft Corporation
AI is the powerhouse translating the growing tsunami of healthcare data near real-time into actionable insights, empowering healthcare professionals to improve patient outcomes, reduce healthcare costs, and even improve patient engagement and experiences. However, AI and ML are data hungry, and good models with low error rates, which are paramount in healthcare where patient lives are at stake, require hundreds of thousands if not millions of high quality patient data records to train precision medicine models from. Exacerbating this challenge is the fact that, while the required volumes of data do exist across the healthcare industry, data is mostly isolated across silos within healthcare organizations with little or no sharing, and as a result most AI initiatives draw data from just a single organization or silo with limited success, stunting the potential of AI in precision medicine. What if where was a way for a consortium of healthcare organizations to collaborate on AI for precision medicine, rather than each organization “going it alone”? Blockchain is designed to enable secure collaboration and sharing of data across a consortium. In this session we discuss opportunities for blockchain to enable collaboration and sharing across a consortium of healthcare organizations, of training data, provenance information, models, results, validation of results, audit trails and more to power AI to the next level in precision medicine.
10:20-11:00am
Coffee & Meet the Expert
11:00-11:50am
Precision Medicine in Complex Disease: Leveraging Polygenic Models to Define Genetic Risk and Stratification Towards Improving Prevention, Diagnosis, and Effective Treatment
Moderator: Christina Waters, PhD, MBA, President, CEO and Founder RARE Science, Inc
Panelists: Julie Collens, PhD, CEO & Founder, Vivid Genomics, Jessica Gibson CEO, Ariel Precision Medicine, Sally Howard, JD, Principal, Sally Howard Regulatory Resources, Jordi Serrats, PhD, Associate Director Neuroscience Drug Discovery Unit, External Neuroscience Innovation, Takeda
Thousands of variants, with varying effect, are responsible for the heritable variation we see in individuals. It is the highly polygenic nature of these complex traits that compound challenges of realizing the promise of precision medicine. In the field of oncology, stratification of patients based on polygenic risk scores (PRSs) is being used to improve screening and prevention. Our panel will discuss current use of PRSs for clinical decision support in prediction/prevention, treatment and new therapeutic development outside the field of Oncology. We will also delve into direct to consumer testing, regulation, reimbursement challenges and the future of PRSs in improving Precision Medicine for both common and rare disease.
11:55-12:45pm
The Health Economics of Companion Diagnostics and Laboratory Developed Tests
Moderator: Lori Anderson, XIFIN, Inc.
Panelists: Gabriel A. Bien-Willner, MD, PhD, FCAP, Medical Director, MolDX, Chief Medical Officer, Palmetto GBA, Trish Brown, Director; AMR Payer Partner and Field Market Access Lead, Illumina, Bruce Quinn MD PhD, Principal
Bruce Quinn Associates LLC, Rina Wolf, VP Commercialization Strategies, Consulting and Industry Affairs
XIFIN, Inc.
Genomic testing is the fastest growing category of biomarker testing. Many laboratory developed genomic tests use next generation sequencing (NGS) as an approach to target numerous genomic variants with both proven and emerging evidence of clinical utility. However, the approach has resulted in uncertainty about appropriate use, interpretation, and value as health care providers and payors struggle to keep pace with the medical advances that NGS has enabled. The burden of evidentiary proof falls upon the test developers, but many labs do not have the resources, or the expertise required to perform the studies needed to establish clinical utility. This gap has created a conundrum for labs, providers, patients, and payors. This panel will discuss this important topic from the perspective of the test developer, laboratory, and payor.
12:45-1:40pm
LUNCH
1:40-2:00pm
Population-scale Human Genetics and Genomics for NASH Drug Target & Biomarker Discovery
Richard Williams, MBBS PhD, Global Head of Medicine, WuXi NextCODE
New drug targets & biomarkers are desperately needed for precision NASH therapy, monitoring & prevention.
In our global NASH discovery programs, we are (1) using whole genome sequencing (WGS) to compare thousands of patients with high fibrosis NASH, Low or No fibrosis NASH & NAFL, and population controls, and (2) interrogating hundreds of fresh liver biopsies from NASH & NAFL patients and control individuals with ‘bulk’ multi-omic genomic analysis (WGS, RNA-Seq, DNA methylation), single cell RNA-seq and fully-integrated AI to reveal novel disease biology, drug targets and biomarkers and enable precision medicine for liver disease.
2:05-2:55pm
Redefining The Role for the Precision Medicine Clinical Laboratory
Moderator: Steven M Anderson, PhD, CSO – Covance, SVP LabCorp
Panelists: Paul Billings, M.D., PhD, CMO & SVP, Medical Affairs, Natera, Sean Glenn, PhD, Vice President of Clinical and Research Development, OmniSeq, Palani Palanippan, PhD, CTO, Epic Sciences Roseanne Welcher, PhD, MBA, CSO, Companion Diagnostics, Agilent Technologies
2:55-3:30pm
Coffee & Networking
3:30-3:50pm
Precision 20 – Saudi Human Genome Program: Translating Discovery into Practice
Brian Meyer, PhD, Chairman, Department of Genetics Research Centre, KFSH&RC
The Saudi Human Genome Program (SHGP) has sequenced in excess of 40,000 samples, comprising approximately 25,000 gene panels targeting clinical categories of rare diseases and 15,000 whole exomes. Additionally, cohorts of samples have been processed for whole genome sequencing, tumor profiling and pharmacogenomics. The SHGP differentiated itself from mainstream genome projects around the world, by initially focusing on rare diseases which have a major impact in the healthcare of what is a highly consanguineous population. The SHGP targeted rapid translation of sequencing data to clinical practice and has demonstrated immediate impact for the diagnosis of rare diseases in a what was largely an unstudied population. The identification of more than 3,500 pathogenic alleles also provided immediate options for prevention of disease, through prenatal testing, pre-implantation genetic diagnosis and most importantly pre-marital screening. Validation of a custom microarray for pre-marital screening also highlighted opportunities within the Saudi population to apply this tool in newborn screening for early diagnosis and intervention in diseases such severe combined immunodeficiency, sickle cell disease, retinitis pigmentosa, some inborn errors of metabolism and others. In addition to the major impact of the SHGP in rare diseases, the knowledge database documenting normal variants and their frequency in the population has also facilitated tumor profiling and pharmacogenomics in the practice of precision medicine.
3:55-4:55pm
Alternative Non-Mutation Based Approach to the Early Detection of Cancer
Moderator: Nic Dracopoli, PhD, Chief Scientific Officer, Delfi Diagnostics, Inc.
Panelists: Anne-Renee Hartman, MD, Vice President of Clinical Development & Medical Affairs, GRAIL, Hakan Sakul, PhD, Vice President and Head of Diagnostics, Worldwide Research, Development & Medical, Pfizer
Liquid biopsies have the potential to improve outcome for cancer patients by guiding therapeutic intervention throughout the course of disease. These intervention’s range from early detection of cancer, following disease progression to monitoring treatment response and guiding subsequent cycles of therapy. The first liquid biopsy assays involved enumeration of circulating tumor cells (CTC) and of canonical cancer mutations in circulating tumor DNA (ctDNA). This session will focus on new approaches to liquid biopsies that, in addition to screening for cancer mutations, include analyses of RNA transcription and protein expression in CTCs as well as evaluation of epigenetic and nucleosome packaging of ctDNA isolated in liquid biopsies.
5:00-5:20pm
How Patient-Centricity Impacts Precision Medicine
Ardy Arianpour, MBA, CEO & Co-Founder, Seqster
We are finally entering the era of patient-centric precision medicine. Today’s patient engagement movement is born of patients who ever more frequently demand to be more active participants and final decision makers in their healthcare. Precision medicine combines elements of bioinformatics, biomarker research, genomics, epigenomics, nutrigenomics, pharmacogenomics, and proteomics, along with considerations involving environment, lifestyle, and traditional medical data. By putting patients at the center of their healthcare we are able to break down all the data silos and allow them to bring together all their EHR, DNA and Fitness health data in one place. In order to get the best outcomes for precision medicine we need to leverage a person-centric interoperability platform that engages not only the participants in clinical trials but also the researchers leading the discovery work with access to longitudinal data.
5:25-5:55pm
A Cancer Patient’s Perspective on Clinical Drug Trials
Laura Holmes Haddad, Best Selling Author & Patient Advocate
Drug investigators depend on them; oncologists turn to them when there are no other options; and patients fear them: this is the clinical trial in the U.S. healthcare system. But among the myriad players in this critical aspect of precision medicine, there is little understanding of what actually happens once the patient has enrolled.
Join me as I share my experience as a 37 year old, StIV inflammatory breast cancer patient in a Phase 1 extension trial. I’ll be discussing important details about patient life in a trial, including traveling by plane to access a trial; arranging childcare support for our two young children; and the complicated route to accessing the trial itself.
By sharing the highs and lows, and the financial and emotional toll of the trial experience itself, I hope to help move the needle for patients in clinical trials. This includes improving patient education and access to trials among cancer patients.
6:00-8:00pm
Networking Reception at The Alexandria – enjoy drinks and hors d’oeuvres with fellow attendees, speakers and sponsors.
FRIDAY OCTOBER 11th, 2019
7:15-8:00am
Breakfast Buffet
8:15-9:45am
Women on Boards of Directors Make Precision Medicine Companies Better
Co-Moderators: Tara Kochis-Stach, President, Slone Partners and Coco Brown, Founder, Athena Alliance
Panelists: Chris Cournoyer, MA, Consultant, Dawn Barry, MBA, President & Co-Founder LunaPBC, Mary Stutts, MHA, Chief Diversity, Inclusion & Health Equity Officer, Stanford Health Care, Gail Marcus, MBA, PhD, Professor, Massachusetts College of Pharmacy and Health Sciences.
An abundance of international evidence concludes that women propel organizations to outperform the competition. Presented and co-moderated by Slone Partners President Tara Kochis-Stach and Athena Alliance Founder Coco Brown, Women on Boards of Directors Make Precision Medicine Companies Better examines the benefits that gender diversity plays in organizational performance. Over 90 minutes, exceptional panelists who possess uncommon expertise in scientific healthcare executive management, finance, law, corporate governance, marketing, and ethics explore how precision medicine company boards populated by greater numbers of women can reap unique rewards.
9:50-10:20am
Accelerating Preventive Genomics: Risks, Rewards and Reality
Robert C. Green, MD, MPH, Associate Physician, Brigham and Women’s Hospital, Professor of Medicine, Harvard Medical School, Geneticist, Brigham and Women’s Hospital, Director, Genomes2People Research Program
When the Human Genome Project was completed in 2003, many believed that the dream of universal genomic evaluation and disease prevention was within reach. Yet 16 years later, the goal of integrating genomics with healthcare to identify disease risk, prevent morbidity and extend life within the healthcare system is still unfulfilled. In this presentation, recent data from the first rigorous clinical trials of comprehensive sequencing in healthy adults (the MedSeq Project) and in healthy newborn infants (the BabySeq Project) will be presented. These early data on the medical, behavioral and economic outcomes associated with the implementation of preventive genomics suggest that the medical benefits of such testing aggregate over a lifetime with modest risks and manageable downstream medical costs.
10:20-11:00am
Coffee & Meet The Expert
11:00-11:50am
Evolution of CAR-T Cell Therapy: Hype, Progress and Challenges
Moderator: Alessandra Cesano, MD, Chief Medical Officer, Essa Pharma
Panelists: Teresa Foy, PhD, Vice President, Immuno- Oncology and Cellular Therapy, Celgene, John Rossi, MS, Director, Translational Sciences, Kite, a Gilead Company
Chimeric antigen receptor (CAR) T cell therapy has shown to provide long lasting remission in a subset of patients with certain hematologic malignancies for whom chemotherapy had failed. With 2 FDA approved products commercially available for licensed indications in ALL and DLBCL, there is a fast-growing business in delivering CAR-T cells. While researchers, physicians, patients, and investors alike are seduced by such potential, there are still several major hurdles to overcome. Specifically, for the vast majority of patients with blood cancer, and all with solid cancers, CAR-T cells are not yet proven to be effective, are too toxic, or are not available due to expense or geography. This panel will focus on where the field is right now, and consider the issues that must be addressed as the field moves forward, in order to fulfill the promise of recent successes.
11:55-12:15pm
Moving Precision Medicine from Rhetoric to Reality
Roy Smythe, M.D, CEO, SomaLogic, Inc.
Despite many advances in the collection of human biologic and physiologic data, the vast majority of care delivery in the medically developed world is still focused at the “top of the triangle” of disease. In this stratum, patients have acute conditions, are expensive to care for and are relatively easy to identify. The problem is the “pipeline” of acute disease development is never interrupted – those at risk for acute exacerbations, occult existing diagnoses, pre-conditions and predispositions are often unidentified, and the possibility of lengthening “healthspan” is unfulfilled. While we tout the use of data to inform precision medicine, there is a difference between data, information, knowledge and wisdom – and perhaps wisdom is what is really required. What are the best sources of wisdom moving forward in precision medicine? Are they data from claims, EHRs, wearables and the genome, or something else?
12:20-12:50pm
Keynote – Precision Oncology: The Role of Genomic Profiling of Solid Tumors and Liquid Biopsies
Tim Triche, MD, PhD, Co-Director for the Children’s Hospital Los Angeles (CHLA) Center for Personalized Medicine
The era of ‘one size fits all’ chemotherapy based oncology is rapidly being replaced by various forms of targeted therapy based on unique patient tumor profiles generated that determine precise therapy. While the benefits on patient outcome are dramatic, the era of ‘Precision Oncology’ is still very much a work in progress. Among other issues, identification of multiple gene drivers in tumors at diagnosis is complicated by the presence of vast numbers of ‘variants of unknown significance’, tumor clonality, and lack of evidence that a given defect actually contributes to the oncogenic process in that tumor at that point in time. While multiple research publications have focused on the identification of new drivers using methods like whole genome sequencing and RNA expression profiling by RNA seq, clinical samples of sufficient quality to enable such studies are rarely available. Instead, technology that enables accurate, deep read DNA and RNA sequencing of routine clinical samples is rapidly entering clinical practice. For primary tumor material, cancer panels like Oncomine, and our pediatric cancer equivalent, OncoKids, have proved to be clinically invaluable. However, for patients that progress despite therapy, assays to detect tumor defects associated with treatment resistance are necessary. Since re-biopsy is rarely an option, attention has turned to liquid biopsy as a means of detecting these defects and avoiding ineffective therapies for patients with progressive disease. Prostate cancer is a common cancer that often progresses to metastatic disease where chemical castration is typically the first line of therapy. This so-called androgen deprivation therapy (ADT) is rarely curative. We are developing a specific liquid biopsy panel for the detection of clinically informative genomic alterations in both cell free tumor DNA and RNA and circulating tumors cells (CTCs). The benefits of integrated primary tumor profiling with longitudinal analysis of evolving tumors clones by liquid biopsy as a standard of care for cancer patients in the future is self evident. The choice of content for both is not, and requires extensive analysis of large numbers of patients at various stages of their disease to identify valid biologic and clinically relevant drivers. Centralized collection of both genomic and clinical data is thus a key priority going forward in efforts to develop meaningful ‘precision oncology’ tools for clinical use.
12:50-1:40pm
LUNCH
1:40-2:00pm
Lessons Learned from 20 Years in Precision Medicine
Kristine Ashcraft, MBA – Chief Executive Officer & Founder
This talk will examine the successes and stumbling blocks experienced in two decades of bringing precision medicine and pharmacogenomics to clinical care. I will present several key lessons and how to apply them to the current state of the industry and look at current opportunities ripe for disruption and positive change. From optimizing communication and outreach to providers and patients, to proving value to various stakeholders, to the importance of establishing success metrics we’ll take a look backwards so we can move the innovation flywheel faster in the next 20 years.
2:05-2:55pm
Re-imagining Health Science Education for a Genomics-First Future
Moderator: Barbara Kraatz Fortini, PhD, Assistant Professor of Genetics and MSGDA Program Coordinator, School of Pharmacy and Health Sciences, Keck Graduate Institute
Panelists: Karen A. Garman, EdD, MAPP, BCC, Director of Education and Engagement at Rady Children’s Institute for Genomic Medicine, Mark Kiel, MD, PhD, Founder and Chief Scientific Officer, Genomenon
With the clinical genomics industry advancing and expanding at a lightning speed, education programs for genetics and genomics must adapt to keep pace. The need for expertise in genetics and genomics throughout the healthcare system provides an opportunity for innovation in education models. Our panel will discuss the full spectrum of existing genomics educational programs from masters-level programs, MD and RN curriculums, to continuing education opportunities and discuss gaps that remain. Dr. Barbara Fortini will describe the development of two new master’s level programs at the Keck Graduate Institute in Genetic Counseling and Genomic Data Analytics. Dr. Karen Garman will discuss Rady Children’s Institute for Genomic Medicine’s educational programs for clinicians, NICU teams, healthcare payers, and legislators for implementing rapid whole genome sequencing for the diagnosis of acutely-ill children. Dr. Mark Kiel will speak about the role of industry in supporting educational initiatives.
2:55-3:15pm
Networking Break
3:15-4:05pm
Back to the Future: A look at the next generation technologies shaping Precision Medicine in Oncology.
Moderator: Marielena Mata, PhD, Director and Diagnostic Lead, Pfizer
Panelists: Sasha Akoulitchev, MBA, PhD, Chief Scientific Officer and Co-Founder, Oxford BioDynamics, Sean Downing, MBA, PhD, Director Customer Engagement, Ultivue, Leighton Howells, Vice President of Business Development, RareCyte
In this panel we explore how Precision Medicine is evolving and what are the technologies being developed today that will shape the future of Oncology treatments. We will highlight some of the biotech developing new platforms (Epigenetics, multiplexing, etc) but will also have the perspective of the customer, looking to answer some questions around the opportunities and challenges of bringing those technologies to fruition.
4:05-4:55pm
What It Takes to Disrupt and Innovate in the Precision Medicine Space, When It Is Already Moving At 1000mph.
Panelists: Michael Heltzen, CEO, Cardea
4:55-5:00pm
Closing Remarks
SPEAKERS
Alexandre (Sasha) Akoulitchev, MA(Oxon), PhD(UCL), FRSM
Chief Scientific Officer & Co-Founder, Oxford Biodynamics
Alexandre read mathematics, physics, chemistry, biochemistry and biophysics at Moscow Institute of Physics and Technology. In 1989 he was selected by the George Soros Foundation for the Oxford Scholarship, associated with St. Antony’s College, along with 20 top Soviet graduate students from the USSR. He obtained his PhD in cell biology from University College, London, with his research based at the Imperial Cancer Research Fund. He spent six years at the Robert Wood Johnson Medical School-UMDNJ, NJ, as a research assistant funded by the Howard Hughes Medical Institute. Upon his return to England, he established his research laboratory at the Sir William Dunn School of Pathology, University of Oxford, becoming a University Academic Fellow and a Senior Fellow of Exeter College, sponsored by Cancer Research UK, the Wellcome Trust, The Medical Research Council UK. Alexandre has been elected a Fellow of the Royal Society of Medicine. He is now full-time dedicated CSO at Oxford Biodynamics.
Lori Anderson
Product Marketing Manager, XIFIN, Inc.
Lori Anderson is product marketing manager for precision medicine informatics at XIFIN, where she brings many years of experience in medical affairs and product portfolio management in the healthcare and life-sciences industries. Prior to joining XIFIN, Lori was the director of health economics and outcomes research at Quest Diagnostics where she defined the reimbursement strategy for numerous tests routinely used in precision medicine. As a laboratorian herself with a particular interest in hematological neoplasms and the role of platelets in cardiovascular disease, Lori has contributed to the publication of 10 book chapters, 20 peer reviewed publications and over 40 poster presentations and has presented on numerous topics in laboratory medicine and life sciences worldwide.
Ardy Arianpour, MBA
CEO & Co-Founder, Seqster
Ardy Arianpour is CEO & Co-Founder of Seqster, an award-winning SaaS healthcare platform that enables organizations to drive efficient healthcare via comprehensive medical records (EHR), individual genomic profiles (DNA), and personal health device data. For the first time, users create their own matched, longitudinal health data profile across all of their US-based healthcare data sources through person-centric interoperability. Ardy is a visionary health tech executive and serial entrepreneur in biotech and digital health.
Prior to starting Seqster, Ardy launched several clinical and consumer-based genetic tests as CCO of Pathway Genomics, and SVP of Ambry Genetics that sold to Konica for $1B in 2017. As a key player in the 2013 landmark SCOTUS decision scrapping gene patents, Ardy played an instrumental role in expanding genetic testing access with the launch of BRCA testing benefiting patients and family members across the country.
Ardy received his BS in Biological Sciences from UC Irvine and an MBA from Marshall Goldsmith School of Management. 2019 Recipient of Top 40 Healthcare Transformer and SDBJ 40 under 40.
Kristine Ashcraft, MBA
CEO & Founder, YouScript
Kristine Ashcraft, B.S., MBA is a molecular biologist by training and is CEO and founder of YouScript. She has worked in the precision medicine space since 2000 and was recently named one of the 25 leading voices in precision medicine. Kristine has authored multiple publications on the clinical and economic benefits of pharmacogenomic testing including one lauded as one of the most influential publications at an AMIA meeting. She has been interviewed by numerous media outlets including the New York Times, the Wall Street Journal, and NBC Nightly News and has spoken at SXSW, ASHG, and numerous precision medicine Conferences. She is committed to being a catalyst in the adoption of precision medicine.
Steven D. Averbuch, MD
Precision Medicine and Oncology Rx/Dx Development, S D Averbuch Consulting, LLC
Dr. Averbuch is a NCI trained academic medical oncologist with over 35 years in oncology drug development and over 10 years in biomarker and drug-diagnostic co development. In November, 2018 Dr. Averbuch retired as Vice President and Head, Precision Medicine within the Translational Medicine Division of R&D at Bristol-Myers Squibb. In this role, he led integrated biomarker and pharmacodiagnostic activities across the BMS R&D portfolio.
Dr. Averbuch joined Bristol-Myers Squibb in 2006. He created and led the Pharmacodiagnostics Center of Excellence since 2008 and he was promoted to Head, Precision Medicine in 2017. Contributions at Bristol-Myers Squibb include: leading the strategy and execution of external clinical collaborations for the company’s immuno-oncology pipeline; executive oversight for translational research activities for all late development and marketed oncology compounds; led corporate-wide strategic initiatives for Translational and Targeted Medicine; head of early global clinical research responsible for early asset development strategy and execution of all Phase 2 oncology programs and significant contributions to business development that led to multiple successful clinical and diagnostic collaboration agreements, licensing and acquisition deals.
Prior to 2006, Dr. Averbuch was at Merck Research Laboratories where he was the therapeutic area head for oncology clinical research, and at AstraZeneca, where he led oncology drug development. Prior to joining industry, Dr. Averbuch held academic appointments at the Mount Sinai School of Medicine and the U.S. Public Health Service (USPHS) School of Medicine. He received his M.D. and Internal Medicine training from the University of Illinois, Chicago and his Medical Oncology training at the National Cancer Institute in Bethesda, Maryland.
Dr. Averbuch has authored over 60 peer reviewed publications and book chapters and is a co-author on one patent. He is currently on the Personalized Medicine Coalition Board of Directors, the Steering Committee of the National Biomarker Development Alliance, the Advisory Board for the University of Kansas Institute for Advancing Medical Innovation, and he is a member of the American Society of Clinical Oncology and the American Association for Cancer Research having served on multiple committees for both organizations. Dr. Averbuch is the 2014 recipient of the University of Illinois College of Medicine Distinguished Alumnus Award.
Dawn Barry, MBA
President & Co-Founder, LunaPBC
Dawn Barry is the President and Co-Founder of public benefit corporation, LunaPBC, which launched, LunaDNA, in December 2018 following SEC-qualification. LunaDNA is a community-owned health data sharing platform where individuals are included in the value created through its data for ownership shares model. Prior to LunaDNA, Dawn served as the Vice President of Applied Genomics at Illumina, Inc. Dawn joined Illumina in 2005 as their first Market Development Specialist and grew to hold leadership roles in business units, sales, and marketing for the Company. Dawn was named San Diego Business Journal’s 2017 Business Woman of the Year, was a speaker at TEDxSanDiego 2016, and is a Board Chair of the Alzheimer’s Association San Diego/Imperial Chapter. She holds a BS in Biology from the University of Vermont and a MBA from the University of Connecticut School of Business.
Gabriel A. Bien-Willner, MD, PhD, FCAP
Medical Director, MolDx, Chief Medical Officer, Palmetto GBA
Dr. Bien-Willner is the Medical Director of the MolDX program at Palmetto GBA, a Medicare Administrative Contractor (MAC). MolDX seeks to understand the molecular testing landscape to implement payer controls, coverage, and to set policy for affiliated MACs, which currently cover 28 states. He is a leader in the Precision Medicine space and practices as a Board-certified Anatomic Pathologist and Molecular Genetic Pathologist. Throughout his career, he has been active in research, development, and advancement of molecular diagnostic services, specifically next generation sequencing. He has worked closely with clinicians to develop clear clinical diagnostic and treatment pathways directing Precision Medicine programs for community cancer centers. Dr. Bien-Willner received his MD and PhD degrees from Baylor College of Medicine, with a PhD in Human Molecular Genetics. He completed his residency, fellowship, and attained a faculty appointment at Washington University in St. Louis prior to leadership roles in laboratory and biotech companies before joining Palmetto GBA.
Coco Brown
Founder, CEO, COO, Board Director and Advisor, The Athena Alliance
Coco Brown leads change and transformation, accelerating multimillion-dollar growth through vision, strategy, technology, and people leadership.
Coco has held leadership roles including CEO, COO, President, board member, and advisor, partnering with F1000 companies, start-ups, and nonprofits, delivering successful outcomes for Apple, Cisco, eBay, Facebook, Silicon Valley Bank and many others. Currently, Ms. Brown is the Founder, CEO, and board member of The Athena Alliance a game-changing executive firm helping to position top 10% of executive women for advancement and board opportunities while also transforming the board room towards a modern composition model. Since founding Athena in the Spring of 2016, Ms. Brown has led the organization to a network of over 1000 C-Level women, VCs, and CEOs from over 150 companies including Accenture, Cisco, Microsoft, Intuit, Autodesk, and Alphabet / Google. Within two years, Coco has overseen 20 board placements and secured $2 million in income through corporate and investor service offerings.
Trish Brown
Director; AMR Payor Partner and Field Market Access Lead, Illumina
Trish Brown is a board certified, licensed genetic counselor with over two decades of experience in clinical genetics. As a clinical genetic counselor she has worked in prenatal, craniofacial and general genetics clinics. After leaving the clinic to take on strategic business roles, she has worked at LabCorp, DNADirect/Medco, Fabric Genomics and BeaconLBS. She gained extensive experience in operations, commercialization, product development, bioinformatics, regulatory compliance and lab benefit management.
Alessandra Cesano, MD, PhD
Chief Medical Officer, ESSA
Alessandra Cesano, MD, PhD has recently joined ESSA as Chief Medical Officer.
Previously she has been the Chief Medical Officer of NanoString Inc from July 2015 until June 2019 where she focused in the development of translational and diagnostic multi-plexed assays for the characterization and measurement of mechanisms of immune response/resistance.
Prior to joining NanoString, Dr. Cesano was Chief Medical Officer at Cleave Biosciences, Inc. and before then she served as Chief Medical Officer and Chief Operations Officer at Nodality, Inc., where she built and led the R and D group, while providing the overall clinical vision for the organization. Between 1998 and 2008, Dr. Cesano held various management positions at Amgen, Biogen Idec and SmithKline Beecham Pharmaceuticals, where she helped to advance various oncology drugs through late stage development and FDA approvals.
Early in her professional career Dr. Cesano spent 12 years conducting research in tumor immunology, including nine years at the Wistar Institute, an NCI Basic Cancer Center connected with the University of Pennsylvania.
She also holds membership in several professional and scientific societies including ASCO, ESMO, ASH, EHA, AACR and SITC. In the latter she serves as co-chair in the SITC Industry Committee, Associate Editor for the Biomarker section of JITC and is an active member of the SITC Biomarker Working Group.
Over her careers she has been an author on over 100 publications.
Dr. Cesano received an MD summa cum laude, a Board Certification in Oncology and a PhD in Tumor Immunology from the University of Turin.
Julie Collens, PhD
CEO Vivid Genomics
Julie Collens, PhD, is CEO of Vivid Genomics. By applying machine learning to biology and genomics, Vivid Genomics is developing assays to help Alzheimer’s drug developers to identify patient variation that affects clinical trials, and to design and analyze more informed trials to increase the probability of identifying a drug response and getting a drug approved. Julie holds a BSc from the University of Calgary, and PhD in evolutionary population genetics from the University of Chicago. Her career has been motivated by the real-world application of genomics, as a sell-side equity analyst covering life science tools and molecular diagnostics companies at Robert W Baird, and in senior marketing strategy roles at Illumina to accelerate the clinical application of genomics in complex diseases. At Vivid Genomics, she is leveraging a combined experience in genomics, finance, business development, strategy, and commercialization to identify efficient approaches to implementing precision medicine and improving neurodegenerative disease drug development.
Chris Cournoyer, MA, MIT Executive Education Program
Strategic Advisor, Qiagen
Chris is an accomplished software executive who has a track record for successfully applying technology to create and transform businesses across industries including retail, healthcare IT and molecular diagnostics. Ms. Cournoyer has a broad range of strategic, technological, operational, financial and management experience in Software and Healthcare IT, with companies from $5m to $200b in annual revenue. Most recently, Chris served as the Chairperson for the Board of Directors for N-of-One, a privately held venture backed company in molecular diagnostics/genomics decision support. Chris has experience serving on the Finance, Audit, and Compensation Committees, and has chaired a Technology Committee for two of the boards and has also served on a nonprofit board as a member of the Emerson Hospital Board of Trustees. Leading teams with a focus on developing strategies for operational excellence, global partnerships, product direction and mergers and acquisitions, Chris has also successfully led the acquisition and integration of more than 15 companies. Ms. Cournoyer has strong functional knowledge of Information Technology, Healthcare, and Fulfillment Operations and has operated successfully in both large and small companies, publicly traded companies as well as privately venture backed companies. Chris has moved successfully across industries with software as the common thread across these companies. She has held executive general management roles in two publicly traded companies; was President and CEO in two venture backed companies and Vice President in two multi-billion companies. Ms. Cournoyer has raised venture capital, planned, acquired and integrated over 15 acquisitions, and successfully sold two companies. Chris is presently a Strategic Advisor to Qiagen.
Sean Downing, PhD, MBA
Director Customer Engagement, Ultivue
As the Director of Customer Engagement at Ultivue, Dr. Downing oversees the Services laboratory providing custom assays to Ultivue customers and the FAS team. Sean has implemented pathology workflows at several companies in work spanning both proteomics and genomics. Prior to Ultivue, he established and ran PerkinElmer’s CRO laboratory offering a menu of TSA-based staining services. Previously, Sean was one of the principal inventors of the first to market, pan-cancer NGS test at Foundation Medicine. He was a post-doc and junior faculty member at Harvard Medical School with appointments at Dana-Farber Cancer Institute and Boston Children’s Hospital.
Nicholas Dracopoli, PhD
Chief Scientific Officer, Delfi Diagnostics, Inc.
Nicholas (Nic) Dracopoli, Ph.D. is currently a consultant to the biopharma and diagnostics . Prior to starting his consultancy, Nic was Senior Vice President of Translation Science at Personal Genome Diagnostics (PGDx) after eighteen years working in oncology drug development at Bristol Myers-Squibb (BMS) and Janssen Research & Development. In these roles, he was responsible for building two new translational science teams whose work contributed to the approval of six new oncology drugs for BMS and Janssen. Prior to joining the pharmaceutical industry, he spent five years in the biotechnology industry at Sequana Therapeutics. Nic obtained his bachelor’s degree and doctorate from the University of London and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center in New York City and the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts. Subsequently, he served as an Assistant Director at the Whitehead/MIT Genome Center and as a Section Chief at the National Center for Human Genome Research at the National Institutes of Health, Bethesda, Maryland. Nic has authored more than 70 scientific publications and has extensive experience in the fields of genomics, molecular biology and cancer research.
Teresa Foy, PhD
Corporate Vice President, Head, Immuno-Oncology and Cellular Therapy, Thematic Center for Excellence, Celegene
Teresa (Teri) Foy is an immunologist with 25 years of experience in the biotechnology and pharmaceutical industry developing novel therapeutics in the areas of inflammation and immuno-oncology. Celgene’s IO CT TCoE is focused on development and translation of Celgene’s early IO and Cellular Therapy pipeline from discovery through human proof of concept.
Teri joined Celgene in 2014 and established Celgene’s Seattle site. Early in her career Teri held scientific leadership positions at Corixa Corp. and Glaxo Smith Kline, both in Seattle WA. Teri served as the Chief Scientific Officer at VLST, developing therapeutics for autoimmune and inflammatory diseases.
She holds a Ph.D. in Immunology from the University of Iowa and completed a post-doctoral fellowship in Immunology at Dartmouth Medical School. Teri has an extensive publication record and holds close to a dozen patents for novel immune compositions.
Karen A. Garmen, EdD, MAPP, BCC
Director of Education and Engagement at Rady Children’s Institute for Genomic Medicine
Dr. Karen A. Garman is the Director of Education and Engagement for the Rady Children’s Institute for Genomic Medicine (RCIGM) where she is responsible for designing and executing educational programs to facilitate the awareness and implementation of rapid whole genome sequencing, along with the ethical, legal and social implications of precision medicine, to pediatric clinicians, researchers, patients’ families, and the public. The educational mission of RCIGM is to change the standard of care in the NICU/PICU environment through genomic sequencing at the institutional, national and international levels. Previous to joining the Institute in 2018, she was the regional director for physician education for Kaiser Permanente – Southern California and also the medical education consultant for the newly started Kaiser Permanente School of Medicine slated to open in Pasadena in September 2020. In 2007, she completed a masters in applied positive psychology degree (MAPP) from the University of Pennsylvania, and is currently one of 400 graduates in the world, and one of the few specialists in positive psychology and healthcare in the country, qualifying her to work as a board certified coach (BCC) and serve on the Clinician Well-being and Resilience Task Force for the National Academy of Medicine. Karen is unique in the healthcare field because, while she does not hold a medical degree, she has directed professional learning and development in both academic medicine and clinical healthcare practices for over 37 years.
Jessica Gibson, MBA
CEO & Co-Founder, Ariel Precision Medicine
Ms. Gibson is CEO and Co-Founder of Ariel Precision Medicine, a private health technology solutions company enabling the early diagnosis and targeted management of complex chronic disorders. Translating research and evidence based medical discoveries into real world health care solutions has always been a primary motivator for Ms. Gibson. Under her leadership, Ariel was awarded the 2018 Emerging Company of the Year award from Life Sciences PA. She lead the development, validation and commercial launch of Ariel’s proprietary Enterprise Software platform, ADVANCE®, and the first comprehensive genetics test for pancreatitis and CFTR related disorders, PancreasDx®. Ms. Gibson has focused on working with multiple stakeholders including establishing partnerships with National Pancreas Foundation, therapeutic discovery with Mission Cure and trials various pharmaceutical companies. She served as Chief Commercial Officer of Ariel Precision Medicine until 2016, leveraging a broad healthcare and Pharma experience, earning multiple national awards and recognition for her work in Sales, Training and Medical Marketing with Purdue and Shionogi Pharmaceuticals. Ms. Gibson gained early experience in complex genetics from her work in the biotechnology field with Gene Wiz Inc. prior to her work in the pharmaceutical industry. Before entering industry, she worked in emergency care and academic research at the University of Pittsburgh, developing a great appreciation for both the research and the practice of medicine. Early on in her career, she worked with the Center for Emergency Medicine in emergency care and was also a research assistant for projects both in Gastroenterology and with the Cancer Institute. Ms. Gibson received her Executive MBA from Liberty University after earning a Bachelor of Science in Emergency Medicine from the University of Pittsburgh.
Sean Glenn, PhD
Vice President of Clinical & Research Development, OmniSeq
Dr. Glenn is responsible for leadership of the OmniSeq clinical and R&D staff which is responsible for identifying and developing the next level of clinical tests needed to service the oncology field. Within this role he is responsible for maintaining the lab at the forefront of technological advances and is focused on developing the most state-of-the-art cost effective solution for clinical testing. This includes maintaining an up to date knowledge of all leading edge technologies and focusing on novel scientific findings which are continually evolving. The dual role Sean possesses as Director of RPCI’s Genomics Shared Resource and as OmniSeq’s VP of R&D proffers a unique ability to transition basic research concepts, findings, and technologies into translational practices with the development of new clinical tests that will be added to OmniSeq’s portfolio.
Sean received a PhD in Molecular and Cellular Biology from the Roswell Park Cancer Institute Division of the University of Buffalo where he developed a mouse model that mimics human metastatic pancreatic neuroendocrine carcinoma. This model, coupled with NGS technology, is a powerful tool for studying the cooperating mutations responsible for the evolution of metastatic disease including the identification and the role circulating tumor cells play in the progression of this process. This model also offers great promise for studying the pharmaceutical intervention of the metastatic phenotype.
Robert Green, MD, MPH
Associate Physician, Brigham and Women’s Hospital, Professor of Medicine, Harvard Medical School, Geneticist, Brigham and Women’s Hospital, Director, Genomes2People Research Program
Robert C. Green, MD, MPH, is a medical geneticist and physician-scientist who directs the G2P Research Program in translational genomics and health outcomes in the Division of Genetics at Brigham and Women’s Hospital and Harvard Medical School. Dr. Green is principal investigator of the MedSeq Project, the first NIH-funded randomized trial to explore the use of whole genome sequencing in the clinical practice of medicine.
Karen Gutekunst, PhD
Vice President Regulatory Affairs, Illumina
Karen Gutekunst is currently Vice President of Regulatory Affairs at Illumina. Karen holds a Ph. D. from the Georgia Institute of Technology and has over 25 years in the Diagnostic industry. Karen leads a team of regulatory specialists who are responsible for taking Illumina’s cutting edge sequencing technology and instrumentation through regulatory approval processes world-wide. Karen has held a variety of roles within Illumina and within the industry over the years including leading product development, project management and organizational efficiency programs. Karen has a passion for enabling technology to be used to improve healthcare. As part of the Illumina team, she is excited to see next generation sequencing transform the way we think about complex genetic diseases, particularly cancer. Karen also believes in developing our next generation of leaders who will continue to bring innovation into the healthcare space.
Anne-Renee Hartman, MD
Vice President of Clinical Development & Medical Affairs, GRAIL
Anne-Renee Hartman, MD, is Vice President of Clinical Development and Medical Affairs at GRAIL where she is leading the development of a multicancer blood test for early detection of cancer. Prior to GRAIL, Anne-Renee was the Senior Vice President of Clinical Development at Myriad Genetics, where she led the development of several commercialized diagnostics in oncology. Anne-Renee was previously an Assistant Professor of Medicine at The Dana Farber Cancer Institute. She completed her oncology fellowship at Stanford where she helped set up the cancer genetics clinic. Anne-Renee holds a BS in Molecular Biology from Princeton University, an MD from The University of Michigan, and completed her residency in Internal Medicine at The University of Chicago.
Michael Heltzen, MBA
Chief Executive Officer and Board Member,Cardea Bio
Michael is known for his leadership style based on the optimization of motivational factors and his trust in talented people. He sets up ambitious goals and long term strategies for all the talents and partnerships that make up Cardea Bio.
Michael has an extensive background in tech business building and development in Digital Biology, Next-Gen Sequencing, Genomics, and Intercellular Communication. He has also held leadership positions at CLC bio, BGI, EXO Incubator, Nanosens, and BlueSEQ before becoming the CEO of Cardea Bio.
Laura Holmes Haddad
Best Selling Author & Patient Advocate
Laura Holmes Haddad is a writer and speaker from California. A former cookbook editor, Laura’s career focus shifted when she was diagnosed with Stage IV inflammatory breast cancer at the age of 37. After completing three years of treatment– including a Phase I extension clinical trial–she remains NED (no evidence of disease) and is committed to healthcare policy and patient advocacy work. Her speaking engagements have included the ACS Cancer Action Network, Pillpack.com, Young Survival Coalition, and Blue Shield of California. She has also been a guest on numerous radio programs and podcasts.
In addition, Laura is the author of This is Cancer: Everything You Need to Know, from the Waiting Room to the Bedroom (Hachette, 2016). Follow her on Twitter (@HolmesHaddad) or at lauraholmeshaddad.com.
David Houlding, MSc, CISSP, CIPP
Principal Healthcare Lead, Microsoft
David Houlding is the Principal Healthcare Lead on the Microsoft Azure Industry Experiences Team. David has more than 24 years of experience in healthcare spanning provider, payer, pharmaceutical, and life sciences segments worldwide, and has deep experience and expertise in blockchain, cloud computing, privacy, security, compliance, and AI / ML. David currently serves as Chair of the HIMSS Blockchain in Healthcare Task Force, a group of ~100 leaders from across healthcare worldwide, collaborating to advance blockchain in healthcare. David also currently serves as an advisor to both the British Blockchain Association and Lifeboat Foundation. David has led the successful creation and deployment of a wide range of solutions to help reduce the cost of healthcare, improve patient outcomes, experiences, and engagement. Prior to joining Microsoft in 2018 David served for over 10 years at Intel Health & Life Sciences where he was the Director of Healthcare Privacy & Security, responsible for enabling healthcare organizations worldwide to achieve compliance with regulations and data protection laws, and implement effective privacy and security programs. In his current role at Microsoft, David works with key partners and industry influencers to enable healthcare organizations make use of cloud computing and related technologies to reduce healthcare costs, and enable new transformative healthcare use cases to improve patient outcomes, leveraging strategic technologies such as such as AI / ML, blockchain, IoMT (Internet of Medical Things), and others. David has a proven track record for innovation with 5 patents granted by the USPTO. David currently holds the CISSP (Certified Information Systems Security Professional), and CIPP (Certified Information Privacy Professional) credentials, and has a Master of Applied Science in Data Compression and Digital Signal Processing from Simon Fraser University, Canada.
Sally Howard, JD
Principal, Sally Howard Regulatory Resources
Sally Howard was formerly the Deputy General Counsel and then Chief of Staff at Health and Human Services, and Deputy Commissioner for Policy, Planning and Legislation at the FDA. In her role at the FDA, Sally worked with leadership to develop regulatory approaches for new technologies such as mobile medical health applications and biosimilar drugs. She also helped CDRH in its efforts to regulate Laboratory Developed Tests (LDTs). As part of President Obama’s Precision Medicine Initiative, she led the FDA’s efforts to develop a regulatory framework that could support the innovation and development of next generation sequencing tests, while ensuring the tests were analytically and clinically valid. Sally also helped guide the FDA’s consideration of direct to consumer genomic tests.
After leaving the FDA in 2015, Sally joined Human Longevity, Inc. as Vice President for Regulatory Affairs and Policy, where she developed the company’s global regulatory strategy, and oversaw FDA submissions for novel predictive modeling tests incorporating genomics and imaging. In her role at HLI, Sally also oversaw the Quality Department, and led the effort for the lab’s CAP accreditation. With her legal background, Sally also helped HLI develop its privacy and data use policy and oversaw legal compliance with HIPAA and GDPR.
After leaving HLI in 2018, she established Sally Howard Regulatory Resources, LLC, and is currently helping companies with FDA submission and CMS coverage strategies, as well as privacy and data use issues. Sally continues to focus her attention on the regulation and coverage of genomic tests and newer technologies including artificial intelligence, digital health, and targeted drugs and vaccines.
Leighton Howells
Vice President Business Development, RareCyte
Leighton has over 30 years of experience in developing, launching and commercializing new technology platforms for global markets. His technical and management career focused on the pioneer instrumentation and assays for High Throughput Screening, High Content Screening and highly multiplexed imaging to support pharmaceutical drug discover/development and diagnostics. With an extensive career at GE Healthcare in Life Sciences and Diagnostic business units, Leighton held leadership positions in R&D, Operations and Commercial organizations, additionally leading the acquisition and integration of several high-performance imaging companies. Most recently, Leighton was the Director of Operations, Pharma Services at NeoGenomics. Leighton holds a bachelor’s degree in biological sciences from the University of West England, Bristol.
Mark Kiel, MD, PhD
Founder and Chief Scientific Officer, Genomenon
Mark Kiel completed his MD, PhD and Molecular Genetic Pathology Fellowship at the University of Michigan, where his research focused on stem cell biology, genomic profiling of hematopoietic malignancies, and clinical bioinformatics. He is the Founder and Chief Scientific Officer of Genomenon, where he supervises the scientific direction of the Mastermind suite of software tools.
Barbara Kraatz Fortini, PhD
Assistant Professor of Genetics and MSGDA Program Coordinator, School of Pharmacy and Health Sciences, Keck Graduate Institute
Barbara Fortini is Assistant Professor of Genetics and Program Coordinator for the new Master of Science in Human Genetics and Genomic Data Analytics (MSGDA) Program in the School of Pharmacy and Health Sciences at the Keck Graduate Institute, one of the Claremont Colleges in Claremont, CA. Barbara completed her PhD at the California Institute of Technology where her thesis focused on the biochemistry and genetics of genome stability. Barbara undertook her postdoctoral training at the University of Southern California – Keck School of Medicine in the department of Preventive Medicine using post-GWAS functional genomics to understand colorectal cancer risk. Upon her appointment as Assistant Professor of Genetics in KGI’s School of Pharmacy and Health Sciences, she worked closely alongside Ashley Mills, Program Director of the MS in Genetic Counseling, to launch both genetics Masters programs in the Fall of 2018. Barbara currently teaches courses in Human Molecular Genetics, Human Genomics with NGS Lab, and Functional Genomics for both programs.
Tara Kochis-Stach
President, Slone Partners
Tara joined Slone Partners in 2004, bringing to the company over a decade of healthcare experience. Her successful sales career with industry leaders such as VERSYSS, American Medical Laboratories, and Quest Diagnostics covered a wide variety of healthcare segments, including information technology, medical records, and the diagnostic and laboratory testing industry.
Prior to healthcare, Tara recruited executive and management talent in the banking and finance sector. Tara’s executive abilities and business acumen have been instrumental in building Slone Partners into the successful and growing company it is today. Tara drives business development strategies, creating strong partnerships with new clients and strengthening relationships with existing clients. She is a tremendous resource for clients and prospects alike.
Through her partnership with Springboard Enterprises, she is an advisor to Blumio, a startup company focused on building sensors and systems to improve health and wellness, as well as a frequent panelist and speaker at industry conferences and a participant in select industry committees; activities that provide continuing opportunities to expand Slone Partners’ knowledge and expertise in the industries we serve.
Tara graduated cum laude from Boston College, receiving a Bachelor of Science with a concentration in Human Resources Management.
Gail Marcus, MBA, MSE, PhD
Professor, Massachusetts College of Pharmacy & Health Sciences University
Ms. Marcus currently serves on two public company boards, Natera (NTRA) and Triple S (TSM) and two private company boards, Cambridge Epigentix and Binx Healthcare. She is a highly experienced healthcare executive with both domestic (U.S.) and international leadership assignments. She has worked in several healthcare sectors, including services, diagnostics, healthcare provision and managed care. She brings an in-depth understanding of the complex U.S. healthcare reimbursement environment and strong financial and operational leadership experience. Ms. Marcus has held leadership assignments in Fortune 100 healthcare companies, including United Healthcare and CIGNA, as well as small, private equity backed diagnostic organizations. She was named one of the top 100 women leaders in Massachusetts in 2014. Ms. Marcus serves on the CMS advisory committee on diagnostic testing. She has an academic appointment at Massachusetts College of Pharmacy and Health Sciences (MCPHS University), leading a cross section of programs in pharmaceutical business and administrative sciences. Ms. Marcus holds a B.A. from Wesleyan University, a M.B.A in Accounting and Decision Sciences from the Wharton School, a M.S.E in computer science from the University of Pennsylvania and a doctorate in healthcare administration from the Medical University of South Carolina. Ms. Marcus meets the requirements of a financial expert and achieved the Leadership Fellow designation from the National Association of Corporate Directors.
Marielena Mata, PhD
Director and Diagnostic Lead, Pfizer
Marielena Mata, Ph.D. is Director and Diagnostic Lead at Pfizer, where she is in charge of the development and commercialization efforts of companion diagnostics for Oncology assets from Early to late development.
Prior to Pfizer, Maty was Head of Personalized Medicine and Companion Diagnostics at GSK where she was responsible for implementation of the Precision Medicine strategy across the GSK portfolio encompassing technical, development, regulatory, commercial, IP and business development efforts. Previously, at Janssen R&D, Inc. Dr. Mata held several roles working in oncology biomarker efforts including development of Circulating Tumor Cell based assays and platforms, establishment of the Biomarkers biobank and evaluation of novel biomarker technologies. Dr. Mata obtained a B.A. in Biology at the University of North Carolina at Greensboro and her Ph.D. and postdoctoral training in Immunology at the University of Pennsylvania.
Brian Meyer, PhD
Chairman, Department of Genetics Research Centre, KFSH&RC
Dr. Brian Meyer is currently Chairman of the Department of Genetics in the Research Centre of King Faisal Specialist Hospital and Research Centre (KFSHRC). He is an Australian citizen and undertook his undergraduate and postgraduate studies at the University of Western Australia. He has worked at KFSHRC for 24 years studying primarily the genetic basis of recessive Mendelian diseases and has authored more than 150 related articles in peer reviewed journals. Results from many of these studies undertaken by scientists in the Department of Genetics have led to the development of molecular genetic testing specific to Arab populations. Dr. Meyer is the founding scientist of Saudi Diagnostic Laboratories and has introduced to the region cutting edge technologies in molecular diagnostics, carrier screening and preventative procedures such as prenatal testing. Prior to joining KFSHRC, Dr. Meyer was responsible for the Cytogenetics and Bone Marrow Transplant Laboratories in the hematology department at Royal Perth Hospital. During this time, he was actively involved in transplantation and molecular oncology research and developed several monoclonal antibodies for research purposes. Currently his role involves oversight of the Saudi Human Genome Program, a Clinical Genomics initiative for implementation of Precision Medicine at KFSHRC and a unique population based pre-marital screening program for the prevention of inherited diseases.
Chockalingam “Palani” Palaniappan, PhD
Chief Technology Officer, Epic Sciences
Chockalingam “Palani” Palaniappan is the chief technology officer at Epic Sciences. An accomplished global life sciences innovation executive with more than 20 years of global leadership experience across three multinational corporations, GE Healthcare, Life Technologies, and Terumo BCT, delivering over $500M in career revenue. Palani’s proven track record in managing products, people and process spans diverse fields from life science tool companies to the MedTech Industry. He has helped architect many transformative products at the interface of science and technology for scientific and clinical applications including genomics, proteomics, cell biology tools to patient connected engineering devices in health. Before joining Epic Sciences, Palani was the executive vice president of Innovation and Development and a board member of the Terumo Global Blood Management at Terumo BCT, a global leader in blood management, therapeutic apheresis, cell therapy and regenerative medicine. Prior to this role, he served as the vice president for Research and Development for Cellular Analysis at Life Technologies. Preceding that, he was the head of Molecular Diagnostics for the Amersham Life Sciences unit of GE Healthcare. Palani has a PhD in the field of biological sciences from Northern Illinois University, followed on by a post-doctoral fellowship at the University of Rochester in HIV biology.
John Rossi, MS
Director, Translational Medicine, Kite, A Gilead Company
John Rossi joined Kite in February 2015, after spending 12 years at Amgen. John is currently a Director in the Department of Translational Medicine and leads all biomarker activities related to clinical development of Kite’s CAR T-cell pipeline. At Amgen, John oversaw global biomarker development for a Phase III registrational trial in oncology (trebananib, AMG386). John also led biomarker development for other preclinical, first-in-human and Phase II clinical trials (AMG780, AMG224 and AMG176).
At Kite, John has led the development of a biomarker strategy and has also built an effective translational team to support the clinical development of axicabtagene ciloleucel/KTE-C19. During this time, John’s team has contributed directly to the US and European approval of axicabtagene ciloleucel through pharmacokinetic and pharmacodynamic evaluation of this product. Among many achievements at Kite, John has represented Kite through external scientific presentations and collaborative manuscripts with leading academic researchers such as Steven Rosenberg and James Kochenderfer at the National Cancer Institute. Scientific accomplishments include the discovery of novel metrics to characterize CAR T cells based on their functionality, novel biomarker knowledge of how CAR T cells work in the clinic, mechanistic information on CAR-related toxicities, novel insights into the biology of the tumor immune microenvironment, including immune checkpoints, and the pivotal role of IL-15 in the context of CAR T-cell function.
Hakan Sakul, PhD
Vice President and Head of Diagnostics, Worldwide Research, Development & Medical, Pfizer
As VP and Head of Diagnostics, Hakan leads Pfizer’s company-wide Diagnostics efforts. He worked with Pfizer’s Board and the Executive Leadership Team to develop Pfizer’s companion diagnostics (CDx) strategy in 2007, and later worked on its implementation which included founding of the Diagnostics Group. Under his leadership, companion diagnostics tests accompanied 4 Pfizer oncology drugs to global markets (3 in US and 1 in Japan), and a total of 21 global approvals obtained to date for these assets. There are over a dozen additional CDx programs currently in different phases of clinical development. These CDx tests on the market or in development collectively span over a dozen active collaborations with diagnostics companies which the Diagnostics Group oversees.
Hakan worked in the biotech industry in human genetics and statistical genetics fields early in his career before moving to Parke-Davis Pharmaceuticals to direct human genetics, statistical genetics and pharmacogenetics programs. Following the merger of Parke-Davis with Pfizer, he has held positions of increasing responsibility, including Director/Site Head for Clinical Pharmacogenomics, Senior Director in Molecular Profiling, and in Translational Oncology, and most recently as Executive Director of Diagnostics. One of his most significant professional accomplishments was to lead Pfizer’s flagship companion diagnostics program for Xalkori® (Crizotinib), resulting in simultaneous FDA approvals of the drug/diagnostic combination in 2011.
Hakan’s contributions to precision medicine and diagnostics have been widely recognized through both internal and external awards, frequent speaking engagements, and press coverage. He is a member of the Board of The Personalized Medicine Coalition and served on California Governor Brown’s Advisory Committee on Precision Medicine. After receiving BS and MSc degrees from Ankara University in Turkey, and PhD in Quantitative Genetics from the University of Minnesota as a Rotary Foundation Scholar, he conducted postdoctoral studies at the University of California-Davis. He is the author of over 30 refereed scientific articles as well as many other papers, abstracts and book chapters. Hakan is keenly interested in diagnostics and related medical technologies to advance Precision Medicine for the improvement of individualized healthcare.
