Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com
taking patient concerns and voices from anecdotal to data driven system
talked about patient accrual hearing patient voice not only in ease of access but reporting toxicities
at FDA he wants to remove barriers to trial access and accrual; also talk earlier to co’s on how they should conduct a trial
Digital tech
software as medical device
regulatory path is mixed like next gen sequencing
wearables are concern for FDA (they need to recruit scientists who know this tech
Opioids
must address the crisis but in a way that does not harm cancer pain patients
smaller pain packs “blister packs” would be good idea
Clinical trial modernization
for Alzheimers disease problem is science
for diabetes problem is regulatory
different diseases calls for different trial design
have regulatory problems with rare diseases as can’t form control or placebo group, inhumane. for example ras tumors trials for MEK inhibitors were narrowly focused on certain ras mutants
Lots of promise, timeline is progressing faster but we need more education on use of the gene therapy
Regulatory issues: Cell and directly delivered gene based therapies have been now approved. Some challenges will be the ultrarare disease trials and how we address manufacturing issues. Manufacturing is a big issue at CBER and scalability. If we want to have global impact of these products we need to address the manufacturing issues
of scalability.
Pfizer – clinical grade and scale is important.
Aventis – he knew manufacturing of biologics however gene therapy manufacturing has its separate issues and is more complicated especially for regulatory purposes for clinical grade as well as scalability. Strategic decision: focusing on the QC on manufacturing was so important. Had a major issue in manufacturing had to shut down and redesign the system.
Albert: Manufacturing is the most important topic even to the investors. Investors were really conservative especially seeing early problems but when academic centers figured out good efficacy then they investors felt better and market has exploded. Now you can see investment into preclinical and startups but still want mature companies to focus on manufacturing. About $10 billion investment in last 4 years.
Valuing early-stage opportunities is challenging. Modeling will often provide a false sense of accuracy but relying on comparable transactions is more art than science. With a long lead time to launch, even the most robust estimates can ultimately prove inaccurate. This interactive panel will feature venture capital investors and senior pharma and biotech executives who lead early-stage transactions as they discuss their approaches to valuing opportunities, and offer key learnings from both successful and not-so-successful experiences.
Dr. Schoenbeck, Pfizer:
global network of liaisons who are a dedicated team to research potential global startup partners or investments. Pfizer has a separate team to evaluate academic laboratories. In Most cases Pfizer does not initiate contact. It is important to initiate the first discussion with them in order to get noticed. Could be just a short chat or discussion on what their needs are for their portfolio.
Question: How early is too early?
Luc Marengere, TVM: His company has early stage focus, on 1st in class molecules. The sweet spot for their investment is a candidate selected compound, which should be 12-18 months from IND. They will want to bring to phase II in less than 4 years for $15-17 million. Their development model is bad for academic labs. During this process free to talk to other partners.
Dr. Chaudhary, Biogen: Never too early to initiate a conversation and sometimes that conversation has lasted 3+ years before a decision. They like build to buy models, will do convertible note deals, candidate compound selection should be entering in GLP/Tox phase (sweet spot)
Merck: have MRL Venture Fund for pre series A funding. Also reiterated it is never too early to have that initial discussion. It will not put you in a throw away bin. They will have suggestions and never like to throw out good ideas.
Michael Hostetler: Set expectations carefully ; data should be validated by a CRO. If have a platform, they will look at the team first to see if strong then will look at the platform to see how robust it is.
All noted that you should be completely honest at this phase. Do not overstate your results or data or overhype your compound(s). Show them everything and don’t have a bias toward compounds you think are the best in your portfolio. Sometimes the least developed are the ones they are interested in. Also one firm may reject you however you may fit in others portfolios better so have a broad range of conversations with multiple players.
Role of Informatics in Precision Medicine: Notes from Boston Healthcare Webinar: Can It Drive the Next Cost Efficiencies in Oncology Care? Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 1: Next Generation Sequencing (NGS)
Role of Informatics in Precision Medicine: Notes from Boston Healthcare Webinar: Can It Drive the Next Cost Efficiencies in Oncology Care?
Reporter: Stephen J. Williams, Ph.D.
Boston Healthcare sponsored a Webinar recently entitled ” Role of Informatics in Precision Medicine: Implications for Innovators”. The webinar focused on the different informatic needs along the Oncology Care value chain from drug discovery through clinicians, C-suite executives and payers. The presentation, by Joseph Ferrara and Mark Girardi, discussed the specific informatics needs and deficiencies experienced by all players in oncology care and how innovators in this space could create value. The final part of the webinar discussed artificial intelligence and the role in cancer informatics.
Below is the mp4 video and audio for this webinar. Notes on each of the slides with a few representative slides are also given below:
Please click below for the mp4 of the webinar:
worldwide oncology related care to increase by 40% in 2020
big movement to participatory care: moving decision making to the patient. Need for information
cost components focused on clinical action
use informatics before clinical stage might add value to cost chain
Key unmet needs from perspectives of different players in oncology care where informatics may help in decision making
Needs of Clinicians
– informatic needs for clinical enrollment
– informatic needs for obtaining drug access/newer therapies
2. Needs of C-suite/health system executives
– informatic needs to help focus of quality of care
– informatic needs to determine health outcomes/metrics
3. Needs of Payers
– informatic needs to determine quality metrics and managing costs
– informatics needs to form guidelines
– informatics needs to determine if biomarkers are used consistently and properly
– population level data analytics
What are the kind of value innovations that tech entrepreneurs need to create in this space? Two areas/problems need to be solved.
innovations in data depth and breadth
need to aggregate information to inform intervention
Different players in value chains have different data needs
Data Depth: Cumulative Understanding of disease
Data Depth: Cumulative number of oncology transactions
technology innovators rely on LEGACY businesses (those that already have technology) and these LEGACY businesses either have data breath or data depth BUT NOT BOTH; (IS THIS WHERE THE GREATEST VALUE CAN BE INNOVATED?)
NEED to provide ACTIONABLE as well as PHENOTYPIC/GENOTYPIC DATA
data depth more important in clinical setting as it drives solutions and cost effective interventions. For example Foundation Medicine, who supplies genotypic/phenotypic data for patient samples supplies high data depth
technologies are moving to data support
evidence will need to be tied to umbrella value propositions
Informatic solutions will have to prove outcome benefit
How will Machine Learning be involved in the healthcare value chain?
increased emphasis on real time datasets – CONSTANT UPDATES NEED TO OCCUR. THIS IS NOT HAPPENING BUT VALUED BY MANY PLAYERS IN THIS SPACE
Interoperability of DATABASES Important! Many Players in this space don’t understand the complexities integrating these datasets
Other Articles on this topic of healthcare informatics, value based oncology, and healthcare IT on this OPEN ACCESS JOURNAL include:
Medcity Converge 2018 Philadelphia: Live Coverage @pharma_BI
Stephen J. Williams: Reporter
3.3.3 Medcity Converge 2018 Philadelphia: Live Coverage @pharma_BI, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 2: CRISPR for Gene Editing and DNA Repair
MedCity CONVERGE is a two-day executive summit that gathers innovative thought leaders from across all healthcare sectors to provide actionable insight on where oncology innovation is heading.
On July 11-12, 2018 in Philadelphia, MedCity CONVERGE will gather technology disruptors, payers, providers, life science companies, venture capitalists and more to discuss how AI, Big Data and Precision Medicine are changing the game in cancer. See agenda.
The conference highlights innovation and best practices across the continuum—from research to technological innovation to transformations of treatment and care delivery, and most importantly, patient empowerment—from some of the country’s most innovative healthcare organizations managing the disease.
Meaningful networking opportunities abound, with executives driving the innovation from diverse entities: leading hospital systems, medical device firms, biotech, pharma, emerging technology startups and health IT, as well as the investment community.
Day 1: Wednesday, July 11, 2018
7:30 AM
2nd Floor – Paris Foyer
Registration + Breakfast
8:15 AM–8:30 AM
Paris Ballroom
Welcome Remarks: Arundhati Parmar, VP and Editor-in-Chief, MedCity News
8:30 AM–9:15 AM
Paris Ballroom
Practical Applications of AI in Cancer
We are far from machine learning dictating clinical decision making, but AI has important niche applications in oncology. Hear from a panel of innovative startups and established life science players about how machine learning and AI can transform different aspects in healthcare, be it in patient recruitment, data analysis, drug discovery or care delivery.
Opening Keynote: Dr. Joshua Brody, Medical Oncologist, Mount Sinai Health System
The Promise and Hype of Immunotherapy
Immunotherapy is revolutionizing oncology care across various types of cancers, but it is also necessary to sort the hype from the reality. In his keynote, Dr. Brody will delve into the history of this new therapy mode and how it has transformed the treatment of lymphoma and other diseases. He will address the hype surrounding it, why so many still don’t respond to the treatment regimen and chart the way forward—one that can lead to more elegant immunotherapy combination paths and better outcomes for patients.
Startups from diagnostics, biopharma, medtech, digital health and emerging tech will have 8 minutes to articulate their visions on how they aim to tame the beast.
Breakout: Biopharma Gets Its Feet Wet in Digital Health
In the last few years, biotech and pharma companies have been leveraging digital health tools in everything from oncology trials, medication adherence to patient engagement. What are the lessons learned?
Moderator:Anthony Green, Ph.D., Vice President, Technology Commercialization Group, Ben Franklin Technology Partners Speakers: Derek Bowen, VP of Business Development & Strategy, Blackfynn, Inc. Gyan Kapur, Vice President, Activate Venture Partners Tom Kottler, Co-Founder & CEO, HealthPrize Technologies @HealthPrize
11:00 AM–11:45 AM
Paris Ballroom
Breakout: How to Scale Precision Medicine
The potential for precision medicine is real, but is limited by access to patient datasets. How are government entities, hospitals and startups bringing the promise of precision medicine to the masses of oncology patients
Building a Precision Medicine Business from the Ground Up: An Operating and Venture Perspective
Dr. Pellini has spent more than 20 years working on the operating side of four companies, each of which has pushed the boundaries of the standard of care. He will describe his most recent experience at Foundation Medicine, at the forefront of precision medicine, and how that experience can be leveraged on the venture side, where he now evaluates new healthcare technologies.
The randomized, controlled clinical trial is the gold standard, but it may be time for a new model. How can patient networks and new technology be leveraged to boost clinical trial recruitment and manage clinical trials more efficiently?
CONVERGEnce on Steroids: Why Comcast and Independence Blue Cross?
This year has seen a great deal of convergence in health care. One of the most innovative collaborations announced was that of Cable and Media giant Comcast Corporation and health plan Independence Blue Cross. This fireside chat will explore what the joint venture is all about, the backstory of how this unlikely partnership came to be, and what it might mean for our industry.
sponsored by Independence Blue Cross
Moderator:Tom Olenzak, Managing Director Strategic Innovation Portfolio, Independence Blue Cross @IBX Speakers: Marc Siry, VP, Strategic Development, Comcast Michael Vennera, SVP, Chief Information Officer, Independence Blue Cross
3:00 PM–3:15 PM
Paris Foyer
Networking Break + Showcase
3:15 PM–4:00 PM
Montpellier – 3rd Floor
Breakout: Charting the Way Forward in Gene and Cell Therapy
There is a boom underway in cell and gene therapies that are being wielded to tackle cancer and other diseases at the cellular level. FDA has approved a few drugs in the space. These innovations raise important questions about patient access, patient safety, and personalized medicine. Hear from interesting startups and experts about the future of gene therapy.
Moderator:Alaric DeArment, Senior Reporter, MedCity News Speakers: Amy DuRoss, CEO, Vineti Andre Goy, M.D., Chairman and Director of John Theurer Cancer Center , Hackensack University Medical Center
3:15 PM–4:00 PM
Paris Ballroom
Breakout: What’s A Good Model for Value-Based Care in Oncology?
How do you implement a value-based care model in oncology? Medicare has created a bundled payment model in oncology and there are lessons to be learned from that and other programs. Listen to two presentations from experts in the field.
Breakout: What Patients Want and Need On Their Journey
Cancer patients are living with an existential threat every day. A panel of patients and experts in oncology care management will discuss what’s needed to make the journey for oncology patients a bit more bearable.
sponsored by CEO Council for Growth
Moderator:Amanda Woodworth, M.D., Director of Breast Health, Drexel University College of Medicine Speakers: Kezia Fitzgerald, Chief Innovation Officer & Co-Founder, CareAline® Products, LLC Sara Hayes, Senior Director of Community Development, Health Union @SaraHayes_HU Katrece Nolen, Cancer Survivor and Founder, Find Cancer Help @KatreceNolen John Simpkins, Administrative DirectorService Line Director of the Cancer Center, Children’s Hospital of Philadelphia
5:00 PM–5:45 PM
Paris Ballroom
Early Diagnosis Through Predictive Biomarkers, NonInvasive Testing
Diagnosing cancer early is often the difference between survival and death. Hear from experts regarding the new and emerging technologies that form the next generation of cancer diagnostics.
Opening Remarks: Arundhati Parmar, VP and Editor-in-Chief, MedCity News
8:40 AM–9:25 AM
Paris Ballroom
The Davids vs. the Cancer Goliath Part 2
Startups from diagnostics, biopharma, medtech, digital health and emerging tech will have 8 minutes to articulate their visions on how they aim to tame the beast.
Liquid Biopsy and Gene Testing vs. Reimbursement Hurdles
Genetic testing, whether broad-scale or single gene-testing, is being ordered by an increasing number of oncologists, but in many cases, patients are left to pay for these expensive tests themselves. How can this dynamic be shifted? What can be learned from the success stories?
Moderator:Shoshannah Roth, Assistant Director of Health Technology Assessment and Information Services , ECRI Institute @Ecri_Institute Speakers: Rob Dumanois, Manager – reimbursement strategy, Thermo Fisher Scientific Eugean Jiwanmall, Senior Research Analyst for Medical Policy & Technology Evaluation , Independence Blue Cross @IBX Michael Nall, President and Chief Executive Officer, Biocept
10:15 AM–10:25 AM
Paris Foyer
Networking Break + Showcase
10:25 AM–11:10 AM
Paris Ballroom
Promising Drugs, Pricing and Access
The drug pricing debate rages on. What are the solutions to continuing to foster research and innovation, while ensuring access and affordability for patients? Can biosimilars and generics be able to expand market access in the U.S.?
Moderator:Bunny Ellerin, Director, Healthcare and Pharmaceutical Management Program, Columbia Business School Speakers: Patrick Davish, AVP, Global & US Pricing/Market Access, Merck Robert Dubois M.D., Chief Science Officer and Executive Vice President, National Pharmaceutical Council Gary Kurzman, M.D., Senior Vice President and Managing Director, Healthcare, Safeguard Scientifics Steven Lucio, Associate Vice President, Pharmacy Services, Vizient
11:10 AM–11:20 AM
Networking Break + Showcase
11:20 AM–12:05 PM
Paris Ballroom
Breaking Down Silos in Research
“Silo” is healthcare’s four-letter word. How are researchers, life science companies and others sharing information that can benefit patients more quickly? Hear from experts at institutions that are striving to tear down the walls that prevent data from flowing.
Moderator:Vini Jolly, Executive Director, Woodside Capital Partners Speakers: Ardy Arianpour, CEO & Co-Founder, Seqster @seqster Lauren Becnel, Ph.D., Real World Data Lead for Oncology, Pfizer Rakesh Mathew, Innovation, Research, & Development Lead, HealthShareExchange David Nace M.D., Chief Medical Officer, Innovaccer
12:10 PM–12:40 PM
Paris Ballroom
Closing Keynote: Anne Stockwell, Cancer Survivor, Founder, Well Again
Finding Your Well Again
Anne Stockwell discusses her mission to help cancer survivors heal their emotional trauma and regain their balance after treatment. A multi-skilled artist as well as a three-time cancer survivor, Anne learned through experience that the emotional impact of cancer often strikes after treatment, isolating a survivor rather than lighting the way forward. Anne realized that her well-trained imagination as an artist was key to her successful reentry after cancer. Now she helps other survivors develop their own creative tools to help them find their way forward with joy.
Oracle Health Sciences: Life Sciences & HealthCare — the Solutions for Big Data
Healthcare and life sciences organizations are facing unprecedented challenges to improve drug development and efficacy while driving toward more targeted and personalized drugs, devices, therapies, and care. Organizations are facing an urgent need to meet the unique demands of patients, regulators, and payers, necessitating a move toward a more patient-centric, value-driven, and personalized healthcare ecosystem.
Meeting these challenges requires redesigning clinical R&D processes, drug therapies, and care delivery through innovative software solutions, IT systems, data analysis, and bench-to-bedside knowledge. The core mission is to improve the health, well-being, and lives of people globally by:
Optimizing clinical research and development, speeding time to market, reducing costs, and mitigating risk
Accelerating efficiency by using business analytics, costing, and performance management technologies
Establishing a global infrastructure for collaborative clinical discovery and care delivery models
Scaling innovations with world-class, transformative technology solutions
Harnessing the power of big data to improve patient experience and outcomes
Oracle Life Sciences Data Hub. Better Insights, More Informed Decision-Making. Provides an integrated environment for clinical data, improving regulatory …
This Knowledge Zone was specifically developed for partners interested in reselling or specializing in Oracle Life Sciences solutions. To become a specialized …
Oracle Health Sciences Suite of. Life Sciences Solutions. Integrated Solutions for Global Clinical Trials. Oracle Health Sciences provides the world’s broadest set …
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