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Archive for the ‘REAL TIME Conference Coverage Twitter’s Hashtags and Handles per Presentation/session’ Category


Real Time Coverage @BIOConvention #BIO2019: Genome Editing and Regulatory Harmonization: Progress and Challenges

Reporter: Stephen J Williams, PhD @StephenJWillia2

 

Genome editing offers the potential of new and effective treatments for genetic diseases. As companies work to develop these treatments, regulators are focused on ensuring that any such products meet applicable safety and efficacy requirements. This panel will discuss how European Union and United States regulators are approaching therapeutic use of genome editing, issues in harmonization between these two – and other – jurisdictions, challenges faced by industry as regulatory positions evolve, and steps that organizations and companies can take to facilitate approval and continued efforts at harmonization.

 

CBER:  because of the nature of these gene therapies, which are mainly orphan, there is expedited review.  Since they started this division in 2015, they have received over 1500 applications.

Spark: Most of the issues were issues with the primary disease not the gene therapy so they had to make new endpoint tests so had talks with FDA before they entered phase III.   There has been great collaboration with FDA,  now they partnered with Novartis to get approval outside US.  You should be willing to partner with EU pharmas to expedite the regulatory process outside US.  In China the process is new and Brazil is behind on their gene therapy guidance.  However there is the new issue of repeat testing of your manufacturing process, as manufacturing of gene therapies had been small scale before. However he notes that problems with expedited review is tough because you don’t have alot of time to get data together.  They were lucky that they had already done a randomized trial.

Sidley Austin:  EU regulatory you make application with advance therapy you don’t have a national option, the regulation body assesses a committee to see if has applicability. Then it goes to a safety committee.  EU has been quicker to approve these advance therapies. Twenty five percent of their applications are gene therapies.  Companies having issues with manufacturing.  There can be issues when the final application is formalized after discussions as problems may arise between discussions, preliminary applications, and final applications.

Sarepta: They have a robust gene therapy program.  Their lead is a therapy for DMD (Duchenne’s Muscular Dystrophy) where affected males die by 25. Japan and EU have different regulatory applications and although they are similar and data can be transferred there is more paperwork required by EU.  The US uses an IND for application. Global feedback is very challenging, they have had multiple meetings around the world and takes a long time preparing a briefing package….. putting a strain on the small biotechs.  No company wants to be either just EU centric or US centric they just want to get out to market as fast as possible.

 

Please follow LIVE on TWITTER using the following @ handles and # hashtags:

@Handles

@pharma_BI

@AVIVA1950

@BIOConvention

# Hashtags

#BIO2019 (official meeting hashtag)

 

 

 

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Real Time Coverage @BIOConvention #BIO2019: Precision Medicine Beyond Oncology June 5 Philadelphia PA

Reporter: Stephen J Williams PhD @StephenJWillia2

Precision Medicine has helped transform cancer care from one-size-fits-all chemotherapy to a new era, where patients’ tumors can be analyzed and therapy selected based on their genetic makeup. Until now, however, precision medicine’s impact has been far less in other therapeutic areas, many of which are ripe for transformation. Efforts are underway to bring the successes of precision medicine to neurology, immunology, ophthalmology, and other areas. This move raises key questions of how the lessons learned in oncology can be used to advance precision medicine in other fields, what types of data and tools will be important to personalizing treatment in these areas, and what sorts of partnerships and payer initiatives will be needed to support these approaches and their ultimate commercialization and use. The panel will also provide an in depth look at precision medicine approaches aimed at better understanding and improving patient care in highly complex disease areas like neurology.
Speaker panel:  The big issue now with precision medicine is there is so much data and hard to put experimental design and controls around randomly collected data.
  • The frontier is how to CURATE randomly collected data to make some sense of it
  • One speaker was at a cancer meeting and the oncologist had no idea what to make of genomic reports they were given.  Then there is a lack of action or worse a misdiagnosis.
  • So for e.g. with Artificial Intelligence algorithms to analyze image data you can see things you can’t see with naked eye but if data quality not good the algorithms are useless – if data not curated properly data is wasted
Data needs to be organized and curated. 
If relying of AI for big data analysis the big question still is: what are the rates of false negative and false positives?  Have to make sure so no misdiagnosis.

Please follow LIVE on TWITTER using the following @ handles and # hashtags:

@Handles

@pharma_BI

@AVIVA1950

@BIOConvention

# Hashtags

#BIO2019 (official meeting hashtag)

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Real Time Coverage @BIOConvention #BIO2019: Understanding the Voices of Patients: Unique Perspectives on Healthcare; June 4 11:00 AM

Reporter: Stephen J. Williams, PhD @StephenJWillia2

 

Description

The role of the patient has evolved dramatically over the past decade. Not only are patients increasingly more involved in their healthcare decision making, they are also passionate advocates who work tirelessly to advance drug development research and development and secure a public policy environment that is patient-centric. Join a discussion with patient advocates as they discuss their journeys to diagnosis and their viewpoints on our healthcare system. They will share their perspectives on what it means to be a patient and how they are advocating in their own unique ways to achieve a common goal: bringing new treatments to patients.

Speakers
Christopher Anselmo: affected by MS but did not understand why he should be involved in a study at the time or share your story but he saw others who benefited from both of these and now is fervent patient advocate. Each patient is worth their weight in gold as needed for other patient support.  The why needs to be asked of oneself before go out to other patients or into new trials. Might not see through to end if don’t have that discussion of why doing this.
Eve Bukowski:  she had stomach aches, went to hospital, and diagnosed with constipation, but had stage III colon cancer.  She was campaigning for Hillary Clinton but then started to campaign for her life.  She wound up having multiple therapies and even many I/O trials.  Fighting cancer is a mental challenge.   She has been fighting for eleven years but has an amazing strength and will.
Emily Kramer: cystic fibrosis patient.  Advocates for research as she has a mutant allele (nonsense mut) that is not targeted by the current new therapy against known mutants of CFTR.  So started Emily’s Entourage for this orphan of an orphan disease.  Funded $4 million in grants and helped develop a new startup and get early seed funding.  Noticed that the infrastructure to get these drugs to market was broken and also is investing to shore up these breaks in drug pipeline infrastructure for orphan diseases. For progressive diseases she would like drug developers to shift the timelines or speed with which they get to take a chance and try that new possibility. As a patient advocacy org, they want to partner every step of the way with biotech/pharma, they understand co’s and stakeholders can only do so much but let’s break out of convention.
Julie: many patient advocacy groups go person to person and make a support network.

Please follow LIVE on TWITTER using the following @ handles and # hashtags:

@Handles

@pharma_BI

@AVIVA1950

@BIOConvention

# Hashtags

#BIO2019 (official meeting hashtag)

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Real Time Coverage of BIO 2019 International Convention, June 3-6, 2019 Philadelphia Convention Center, Philadelphia PA

Reporter: Stephen J. Williams, PhD @StephenJWillia2

Please follow LIVE on TWITTER using the following @ handles and # hashtags:

@Handles

@pharma_BI

@AVIVA1950

@BIOConvention

# Hashtags

#BIO2019 (official meeting hashtag)

Please check daily on this OPEN ACCESS JOURNAL for updates on one of the most important BIO Conferences of the year for meeting notes, posts, as well as occasional PODCASTS.

 

The BIO International Convention is the largest global event for the biotechnology industry and attracts the biggest names in biotech, offers key networking and partnering opportunities, and provides insights and inspiration on the major trends affecting the industry. The event features keynotes and sessions from key policymakers, scientists, CEOs, and celebrities.  The Convention also features the BIO Business Forum (One-on-One Partnering), hundreds of sessions covering biotech trends, policy issues and technological innovations, and the world’s largest biotechnology exhibition – the BIO Exhibition.

The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO). BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

 

Keynote Speakers INCLUDE:

Fireside Chat with Margaret (Peggy) Hamburg, MD, Foreign Secretary, National Academy of Medicine; Chairman of the Board, American Association for the Advancement of Science

Tuesday Keynote: Siddhartha Mukherjee (Author of the bestsellers Emperor of All Maladies: A Biography of Cancer and  The Gene: An Intimate History)

Fireside Chat with Jeffrey Solomon, Chief Executive Officer, COWEN

Fireside Chat with Christi Shaw, Senior Vice President and President, Lilly BIO-Medicines, Eli Lilly and Company

Wednesday Keynote: Jamie Dimon (Chairman JP Morgan Chase)

Fireside Chat with Kenneth C. Frazier, Chairman of the Board and Chief Executive Officer, Merck & Co., Inc.

Fireside Chat: Understanding the Voices of Patients: Unique Perspectives on Healthcare

Fireside Chat: FDA Town Hall

 

ALSO SUPERSESSIONS including:

Super Session: What’s Next: The Landscape of Innovation in 2019 and Beyond

Super Session: Falling in Love with Science: Championing Science for Everyone, Everywhere

Super Session: Digital Health in Practice: A Conversation with Ameet Nathawani, Chief Digital Officer, Chief Medical Falling in Love with Science: Championing Science for Everyone, Everywhere

Super Session: Realizing the Promise of Gene Therapies for Patients Around the World

Super Session: Biotech’s Contribution to Innovation: Current and Future Drivers of Success

Super Session: The Art & Science of R&D Innovation and Productivity

Super Session: Dealmaker’s Intentions: 2019 Market Outlook

Super Session: The State of the Vaccine Industry: Stimulating Sustainable Growth

 

See here for full AGENDA

Link for Registration: https://convention.bio.org/register/

The BIO International Convention is literally where hundreds of deals and partnerships have been made over the years.

 

BIO performs many services for members, but none of them are more visible than the BIO International Convention. The BIO International Convention helps BIO fulfill its mission to help grow the global biotech industry. Profits from the BIO International Convention are returned to the biotechnology industry by supporting BIO programs and initiatives. BIO works throughout the year to create a policy environment that enables the industry to continue to fulfill its vision of bettering the world through biotechnology innovation.

The key benefits of attending the BIO International Convention are access to global biotech and pharma leaders via BIO One-on-One Partnering, exposure to industry though-leaders with over 1,500 education sessions at your fingertips, and unparalleled networking opportunities with 16,000+ attendees from 74 countries.

In addition, we produce BIOtechNOW, an online blog chronicling ‘innovations transforming our world’ and the BIO Newsletter, the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

 

Membership with the Biotechnology Innovation Organization (BIO)

BIO has a diverse membership that is comprised of  companies from all facets of biotechnology. Corporate R&D members range from entrepreneurial companies developing a first product to Fortune 100 multinationals. The majority of our members are small companies – 90 percent have annual revenues of $25 million or less, reflecting the broader biotechnology industry. Learn more about how you can save with BIO Membership.

BIO also represents academic centers, state and regional biotech associations and service providers to the industry, including financial and consulting firms.

  • 66% R&D-Intensive Companies *Of those: 89% have annual revenues under $25 million,  4% have annual revenues between $25 million and $1 billion, 7% have annual revenues over $1 billion.
  • 16% Nonprofit/Academic
  • 11% Service Providers
  • 7% State/International Affiliate Organizations

Other posts on LIVE CONFERENCE COVERAGE using Social Media on this OPEN ACCESS JOURNAL and OTHER Conferences Covered please see the following link at https://pharmaceuticalintelligence.com/press-coverage/

 

Notable Conferences Covered THIS YEAR INCLUDE: (see full list from 2013 at this link)

  • Koch Institute 2019 Immune Engineering Symposium, January 28-29, 2019, Kresge Auditorium, MIT

https://calendar.mit.edu/event/immune_engineering_symposium_2019#.XBrIDc9Kgcg

http://kochinstituteevents.cvent.com/events/koch-institute-2019-immune-engineering-symposium/event-summary-8d2098bb601a4654991060d59e92d7fe.aspx?dvce=1

 

  • 2019 MassBio’s Annual Meeting, State of Possible Conference ​, March 27 – 28, 2019, Royal Sonesta, Cambridge

http://files.massbio.org/file/MassBio-State-Of-Possible-Conference-Agenda-Feb-22-2019.pdf

 

  • World Medical Innovation Forum, Partners Innovations, ARTIFICIAL INTELLIGENCE | APRIL 8–10, 2019 | Westin, BOSTON

https://worldmedicalinnovation.org/agenda-list/

https://worldmedicalinnovation.org/

 

  • 18th Annual 2019 BioIT, Conference & Expo, April 16-18, 2019, Boston, Seaport World Trade Center, Track 5 Next-Gen Sequencing Informatics – Advances in Large-Scale Computing

http://www.giiconference.com/chi653337/

https://pharmaceuticalintelligence.com/2019/04/22/18th-annual-2019-bioit-conference-expo-april-16-18-2019-boston-seaport-world-trade-center-track-5-next-gen-sequencing-informatics-advances-in-large-scale-computing/

 

  • Translating Genetics into Medicine, April 25, 2019, 8:30 AM – 6:00 PM, The New York Academy of Sciences, 7 World Trade Center, 250 Greenwich St Fl 40, New York

https://pharmaceuticalintelligence.com/2019/04/25/translating-genetics-into-medicine-april-25-2019-830-am-600-pm-the-new-york-academy-of-sciences-7-world-trade-center-250-greenwich-st-fl-40-new-york/

 

  • 13th Annual US-India BioPharma & Healthcare Summit, May 9, 2019, Marriott, Cambridge

https://pharmaceuticalintelligence.com/2019/04/30/13th-annual-biopharma-healthcare-summit-thursday-may-9-2019/

 

  • 2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies, May 17, 2019, Harvard Law School

http://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference

https://pharmaceuticalintelligence.com/2019/01/11/2019-petrie-flom-center-annual-conference-consuming-genetics-ethical-and-legal-considerations-of-new-technologies/

 

  • 2019 Koch Institute Symposium – Machine Learning and Cancer, June 14, 2019, 8:00 AM-5:00 PM  ET MIT Kresge Auditorium, 48 Massachusetts Ave, Cambridge, MA

https://pharmaceuticalintelligence.com/2019/03/12/2019-koch-institute-symposium-machine-learning-and-cancer-june-14-2019-800-am-500-pmet-mit-kresge-auditorium-48-massachusetts-ave-cambridge-ma/

 

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37th Annual J.P. Morgan HEALTHCARE CONFERENCE: News at #JPM2019 for Jan. 10, 2019: Deals and Announcements

Reporter: Stephen J. Williams, Ph.D.

From Biospace.com

 

JP Morgan Healthcare Conference Update: Sage, Mersana, Shutdown Woes and Babies

Speaker presenting to audience at a conference

With the J.P. Morgan Healthcare Conference winding down, companies remain busy striking deals and informing investors about pipeline advances. BioSpace snagged some of the interesting news bits to come out of the conference from Wednesday.

SAGE Therapeutics – Following a positive Phase III report that its postpartum depression treatment candidate SAGE-217 hit the mark in its late-stage clinical trial, Sage Therapeutics is eying the potential to have multiple treatment options available for patients. At the start of J.P. Morgan, Sage said that patients treated with SAGE-217 had a statistically significant improvement of 17.8 points in the Hamilton Rating Scale for Depression, compared to 13.6 for placebo. The company plans to seek approval for SAGE-2017, but before that, the FDA is expected to make a decision on Zulresso in March. Zulresso already passed muster from advisory committees in November, and if approved, would be the first drug specifically for postpartum depression. In an interview with the Business Journal, Chief Business Officer Mike Cloonan said the company believes there is room in the market for both medications, particularly since the medications address different patient populations.

 

Mersana Therapeutics – After a breakup with Takeda Pharmaceutical and the shelving of its lead product, Cambridge, Mass.-based Mersana is making a new path. Even though a partial clinical hold was lifted following the death of a patient the company opted to shelve development of XMT-1522. During a presentation at JPM, CEO Anna Protopapas noted that many other companies are developing therapies that target the HER2 protein, which led to the decision, according to the Boston Business Journal. Protopapas said the HER2 space is highly competitive and now the company will focus on its other asset, XMT-1536, an ADC targeting NaPi2b, an antigen highly expressed in the majority of non-squamous NSCLC and epithelial ovarian cancer. XMT-1536 is currently in Phase 1 clinical trials for NaPi2b-expressing cancers, including ovarian cancer, non-small cell lung cancer and other cancers. Data on XMT-1536 is expected in the first half of 2019.

Novavax – During a JPM presentation, Stan Erck, CEO of Novavax, pointed to the company’s RSV vaccine, which is in late-stage development. The vaccine is being developed for the mother, in order to protect an infant. The mother transfers the antibodies to the infant, which will provide the baby with protection from RSV in its first six months. Erck called the program historic. He said the Phase III program is in its fourth year and the company has vaccinated 4,636 women. He said they are tracking the women and the babies. Researchers call the mothers every week through the first six months of the baby’s life to acquire data. Erck said the company anticipates announcing trial data this quarter. If approved, Erck said the market for the vaccine could be a significant revenue driver.

“You have 3.9 million birth cohorts and we expect 80 percent to 90 percent of those mothers to be vaccinated as a pediatric vaccine and in the U.S. the market rate is somewhere between $750 million and a $1 billion and then double that for worldwide market. So it’s a large market and we will be first to market in this,” Erck said, according to a transcript of the presentation.

Denali Therapeutics – Denali forged a collaboration with Germany-based SIRION Biotech to develop gene therapies for central nervous disorders. The two companies plan to develop adeno-associated virus (AAV) vectors to enable therapeutics to cross the blood-brain barrier for clinical applications in neurodegenerative diseases including Parkinson’s, Alzheimer’s disease, ALS and certain other diseases of the CNS.

AstraZeneca – Pharma giant AstraZeneca reported that in 2019 net prices on average across the portfolio will decrease versus 2018. With a backdrop of intense public and government scrutiny over pricing, Market Access head Rick Suarez said the company is increasing its pricing transparency. Additionally, he said the company is looking at new ways to price drugs, such as value-based reimbursement agreements with payers, Pink Sheet reported.

Amarin Corporation – As the company eyes a potential label expansion approval for its cardiovascular disease treatment Vascepa, Amarin Corporation has been proactively hiring hundreds of sales reps. In the fourth quarter, the company hired 265 new sales reps, giving the company a sales team of more than 400, CEO John Thero said. Thero noted that is a label expansion is granted by the FDA, “revenues will increase at least 50 percent over what we did in the prior year, which would give us revenues of approximate $350 million in 2019.”

Government Woes – As the partial government shutdown in the United States continues into its third week, biotech leaders at JPM raised concern as the FDA’s carryover funds are dwindling. With no new funding coming in, reviews of New Drug Applications won’t be able to continue past February, Pink Sheet said. While reviews are currently ongoing, no New Drug Applications are being accepted by the FDA at this time. With the halt of NDA applications, that has also caused some companies to delay plans for an initial public offering. It’s hard to raise potential investor excitement without the regulatory support of a potential drug approval. During a panel discussion, Jonathan Leff, a partner at Deerfield Management, noted that the ongoing government shutdown is a reminder of how “overwhelmingly dependent the whole industry of biotech and drug development is on government,” Pink Sheet said.

Other posts on the JP Morgan 2019 Healthcare Conference on this Open Access Journal include:

#JPM19 Conference: Lilly Announces Agreement To Acquire Loxo Oncology

36th Annual J.P. Morgan HEALTHCARE CONFERENCE January 8 – 11, 2018

37th Annual J.P. Morgan HEALTHCARE CONFERENCE: #JPM2019 for Jan. 8, 2019; Opening Videos, Novartis expands Cell Therapies, January 7 – 10, 2019, Westin St. Francis Hotel | San Francisco, California

37th Annual J.P. Morgan HEALTHCARE CONFERENCE: News at #JPM2019 for Jan. 8, 2019: Deals and Announcements

 

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Live 12:00 – 1:00 P.M  Mediterranean Diet and Lifestyle: A Symposium on Diet and Human Health : October 19, 2018

Reporter: Stephen J. Williams, Ph.D.

12.00 The Italian Mediterranean Diet as a Model of Identity of a People with a Universal Good to Safeguard Health?

Prof. Antonino De Lorenzo, MD, PhD.

Director of the School of Specialization in Clinical Nutrition, University of Rome “Tor Vergata”

It is important to determine how our bodies interacts with the environment, such as absorption of nutrients.

Studies shown here show decrease in life expectancy of a high sugar diet, but the quality of the diet, not just the type of diet is important, especially the role of natural probiotics and phenolic compounds found in the Mediterranean diet.

The WHO report in 2005 discusses the unsustainability of nutrition deficiencies and suggest a proactive personalized and preventative/predictive approach of diet and health.

Most of the noncommunicable diseases like CV (46%) cancer 21% and 11% respiratory and 4% diabetes could be prevented and or cured with proper dietary approaches

Italy vs. the US diseases: in Italy most disease due to environmental contamination while US diet plays a major role

The issue we are facing in less than 10% of the Italian population (fruit, fibers, oils) are not getting the proper foods, diet and contributing to as we suggest 46% of the disease

The Food Paradox: 1.5 billion are obese; we notice we are eating less products of quality and most quality produce is going to waste;

  •  growing BMI and junk food: our studies are correlating the junk food (pre-prepared) and global BMI
  • modern diet and impact of human health (junk food high in additives, salt) has impact on microflora
  • Western Diet and Addiction: We show a link (using brain scans) showing correlation of junk food, sugar cravings, and other addictive behaviors by affecting the dopamine signaling in the substantia nigra
  • developed a junk food calculator and a Mediterranean diet calculator
  • the intersection of culture, food is embedded in the Mediterranean diet; this is supported by dietary studies of two distinct rural Italian populations (one of these in the US) show decrease in diet
  • Impact of diet: have model in Germany how this diet can increase health and life expectancy
  • from 1950 to present day 2.7 unit increase in the diet index can increase life expectancy by 26%
  • so there is an inverse relationship with our index and breast cancer

Environment and metal contamination and glyphosate: contribution to disease and impact of maintaining the healthy diet

  • huge problem with use of pesticides and increase in celiac disease

12:30 Environment and Health

Dr. Iris Maria Forte, PhD.

National Cancer Institute “Pascale” Foundation | IRCCS · Department of Research, Naples, Italy

Cancer as a disease of the environment.  Weinberg’s hallmarks of Cancer reveal how environment and epigenetics can impact any of these hallmarks.

Epigenetic effects

  • gene gatekeepers (Rb and P53)
  • DNA repair and damage stabilization

Heavy Metals and Dioxins:( alterations of the immune system as well as epigenetic regulations)

Asbestos and Mesothelioma:  they have demonstrated that p53 can be involved in development of mesothelioma as reactivating p53 may be a suitable strategy for therapy

Diet, Tomato and Cancer

  • looked at tomato extract on p53 function in gastric cancer: tomato extract had a growth reduction effect and altered cell cycle regulation and results in apoptosis
  • RBL2 levels are increased in extract amount dependent manner so data shows effect of certain tomato extracts of the southern italian tomato (     )

Antonio Giordano: we tested whole extracts of almost 30 different varieties of tomato.  The tomato variety  with highest activity was near Ravela however black tomatoes have shown high antitumor activity.  We have done a followup studies showing that these varieties, if grow elsewhere lose their antitumor activity after two or three generations of breeding, even though there genetics are similar.  We are also studying the effects of different styles of cooking of these tomatoes and if it reduces antitumor effect

please see post https://news.temple.edu/news/2017-08-28/muse-cancer-fighting-tomatoes-study-italian-food

 

To follow or Tweet on Twitter please use the following handles (@) and hashtags (#):

@ handles


@S_H_R_O 

@SbarroHealth

@Pharma_BI 

@ItalyinPhilly

@WHO_Europe

@nutritionorg

# hashtags


#healthydiet

#MediterraneanDiet

#health

#nutrition

Please see related articles on Live Coverage of Previous Meetings on this Open Access Journal

Real Time Conference Coverage for Scientific and Business Media: Unique Twitter Hashtags and Handles per Conference Presentation/Session

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LIVE 2018 The 21st Gabay Award to LORENZ STUDER, Memorial Sloan Kettering Cancer Center, contributions in stem cell biology and patient-specific, cell-based therapy

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Synopsis for AI & Machine Learning in Clinical Trials, APRIL 12, 2018 PFIZER INNOVATION RESEARCH LAB – CAMBRIDGE, MA

 

Recap Book

http://viewer.zmags.com/publication/9d58c338#/9d58c338/30

 

Aviva Lev-Ari, PhD, RN, Director and Founder of  LPBI Group

will attend and cover in Real Time the Conference 

@pharma_BI

@AVIVA1950

  • Tweets for AI and Machine Learning in Clinical Trials April 12th, 2018 hosted at Pfizer’s Innovation Research Lab in Cambridge, MA @AVIVA1950 @pharma_BI

https://pharmaceuticalintelligence.com/2018/04/12/tweets-for-ai-and-machine-learning-in-clinical-trials-april-12th-2018-hosted-at-pfizers-innovation-research-lab-in-cambridge-ma-aviva1950-pharma_bi/

About Aviva Lev-Ari, PhD, RN and LPBI Group

 

 

AI and Machine Learning in Clinical Trials

April 12th, 2018 hosted at Pfizer’s Innovation Research Lab in Cambridge, MA

1 Portland St, Cambridge, MA 02139

With case studies from Pfizer, Novartis, Merck, AstraZeneca, MIT, Takeda, Sanofi & more, you will not
want to miss the latest in leveraging AI and Machine Learning in Clinical Trials.

#Pfizer #Merck #Sanofi #AstraZeneca #Novartis #Takeda #BMS #Biogen #GSK #MIT #Medable #Saama #RapidMiner

100+ innovators, data scientists, informatics, senior clinical trials execs & tech experts will convene to
discuss advances in artificial intelligence, machine learning, & clinical study data analytics.

Faculty of Advisors and Speakers:

Dan Karlin, Head of Digital Medical, Informatics, Regulatory Strategy, Pfizer
Joseph Lehar, Exec. Dir, Computational Biology, Merck
David Tester, Head, Data Sciences & Engineering, Chief Data Office, Sanofi
Bhaskar Dutta, Principal Scientist, Advanced Analytics Center, AstraZeneca
Jonas Dorn, Project Manager, Digital Health, Novartis
Jyoti Shah, Assoc. Dir, Data Development, Merck
Raj Bandaru, Sr. Director, Data Sciences Strategy, Sanofi
Ronald Dorenbos, Assoc. Dir, Materials Innovation, Takeda
Zeshan Farooqui, Sr. Clinical Site Manager, BMS
Shwen Gwee, Head, Digital Strategy, Global Clinical Ops, Biogen
Munther Baara, Head, New Clinical Paradigm, Pfizer
Shyamal Patel, Sr. Manager, PfIRe Lab, Pfizer
Bill Tobia, Lead Clinical Research Instructor, GSK
Regina Barzilay, Delta Electronics Professor, MIT
Amir Lahav, Digital Innovation Lead, Pfizer
Michelle Longmire, CEO, Medable
Karim Damji, SVP Product and Marketing, Saama
Malai Sankarasubbu, VP, AI Innovation, Saama
Ingo Mierswa, Founder/President, RapidMiner

You can take a look at the latest agenda here: http://panagorapharma.com/ai/schedule/

You can register at the following link using the promo code BOSTONBIOTECH25 for 25% off
registrations: https://panagorapharma.com/ai/registration/

If you have any other questions, you can reach out to the organizer:

Doug Lavender
CoFounder
PanAgora Pharma
Doug@panagoraconferences.com
Phone: 203-253- 6401

 

CORE THEMES:

1. An Exploration of Machine Learning for Clinical Study Data
2. Natural Language Processing (NLP) for Patient Voice Analysis via Social Channels
3. Machine Learning and Artificial Intelligence for Recruitment
4. The Potential of Machine Learning and AI for Adverse Event Identification
5. Real-time Patient Data Analysis

AGENDA for Thursday, April 12th, 2018

8:00 – 9:00 am Conference Registration Open in Pfizer Lobby – 1 Portland Street, Cambridge, MA

9:00 – 9:10 am Opening Remarks from Conference Chairman

Robert “Joe” Mather, Executive Director, Head of Digital Collaborations, Pfizer

9:10 – 9:50 am KEYNOTE PANEL: AI & ML to Support Clinical Trials – Where do we begin?
The internet of things, mHealth, wearable and sensor-enabled devices present an
unprecedented opportunity for accelerated data collection. What does it mean for life
sciences – are we prepared to handle the influx of data, and create valuable visibility to
accelerate trials? Where should we start? What are the best current applications? How can
we leverage AI and Machine Learning for Adverse Event Identification?

David Tester, Head, Data Science & Engineering, Chief Data Office, Sanofi

  • Do exploratory AI & ML outside the context of Clinical Trials 1st

Joseph Lehar, Executive Director, Computational Biology, Merck

  • Oncology – images of response to treatment are complex, Pathology is assisted by AI
  • AI can assist in cell classification
  • Biggest opportunity of AI %& ML in Immunology, use non invasive medium even behavioral indicators
  • Informed Consent in Clinical Trials
  • Development of AI models to avoid bias
  • Monitoring the Trials identify signals

Bhaskar Dutta, Principal Scientist, Advanced Analytics Center, AstraZeneca

  • Structure exploration in first study, signals used in second study
  • Even in Informatics groups there can be and there is resistance to acceptance of AI and ML
  • 80%-90% clean the data holistic data view integration and Privacy
  • pooling data sets across companies for benefits of sampling: Parkinson Disease case
  • Patients Voice in a Biomarker study as partners vs Patients as Customers

Moderator: Robert “Joe” Mather, Exec. Dir, Head of Digital Collaborations, Pfizer

  • Data sharing across the organization
  • How the audience feel about sharing code not only data

 

9:50 – 10:20 am CASE STUDY: Making Sense of Sensor Data: A Case Study in Data Quality Evaluation

Bhaskar Dutta, Principal Scientist, Advanced Analytics Center, AstraZeneca

  • Making sense of sensor data – 40 clinical data scientists and expanding
  • Tactical impact, Strategic build, Horizon Scanning &evaluaiton capabilities, Quantitative Solutions
  • % of Healthcare spending of GDP: LOWER THE % BY DIGITAL TECHNOLOGIES
  • Improve adherence no need of new drugs
  • 70% of Patients are interested in Monitoring their Health digitally
  • wearable sensors – will increase the quality of monitoring
  • Burden of Chronic disease: i.e., Asthma (23Millions), Diabetes (29Million)
  • COst direct and Indirect
  • Patient Needs
  • Challenging in using digital solutions: Lack of integration,
  • Values: to Patients, to HCP, Pharma: Drug discovery, Drug Cost
  • Digital-solutions Lifecycle: Pharma perspective: Need characterization, device sensor characterization,
  • at AstraZeneca: Project – iPREDICT – individualize PREdiction of DIsease Control using digital sensor Technology
  • Device Brands and their Price to Consumer: ZephyrBioPatch, Garmin Vivosmart, MS Band 2, GoBe, HealthPatch MD, BodyGardian, BioPatch
  • Usability Survey: Ease of setting up, Ease of use, 1st impression, comfort, likely to recommend
  • Data capturing: Missing, quality of recording – data quality evaluation: signal to noise ratio
  • poor compliance
  • Data Privacy – GPS data is the most PRIVATE: de-identification of IDs, GPS can generate identifiable data
  • Integration with other data streams
  • Six different Groups: Patient cnetrality, Applications Usability,
  • They are hiring in the MD area

 

10:20 – 10:50 am Using AI and Machine Learning to Improve Clinical Trials

• Clinical trial dedicated mobile apps can improve patient experience in clinical trials and
increase data collection and yield,
• Advanced analytics on patient data
§ HIPAA compliance, data collection & analysis

Michelle Longmire, CEO, Medable

  • Enabling Direct personalized medicine
  • current process: 1-5 drugs >$2Bil, 12 years
  • Apply AI in a Case study on mild cognitive impairment:
  1. Recruitment,
  2. Trial (drug efficacy)
  3. Endpoint (crude assessment)
  • AI – From Engagement to Insight:
  1. Trial Process, – identify Patients in populations before onset of disease
  2. Discovery, – Adaptive Trials
  3. Transformation – Digitome, Digital Biomarkers
  • Input: Patient reported data – to measure daily progress
  • Probabilistic condition for algorithm development
  • Input: Smartphone sensors: 6-minute walk
  • Input: Contextual data – Location, air quality, weather, disease & crime
  • Input: VOICE: Google Home, Amazon Alexa, Apple: Siri
  • Input: Devices: fitbit, Tomtom, biovation – Swiss company – 6 paramenters per second: Cognition applications
  • Bayesian Nets: Conditional probabilities
  • Deep learning: Pathern in data : Problem/data
  • Partnering with other Medical Centers

MEDABLE INSIGHT: Signature of Digitome

  • AI platform
  • Choose form anumber of Neural Networks (NN) ‘pattern’ to allow
  • Train Multiple NN, Time series Data, Visualization: View Data
  • Cerebrum Demo: Correlate patterns

10:50 – 11:10 am NETWORKING COFFEE AND REFRESHMENT BREAK

11:10 – 11:40 am CASE STUDY: Machine Learning for Clinical Study Data

Shyamal Patel, Sr. Manager, PfIRe Lab, Pfizer

SEE Digital Biomarkers Journal

  • DIGITAL biomarkers: from algorithms to Endpoints
  • Algorithms (gait speed, HR)–>> Biomarkers (Change is stat is it change in Disease stage?)–>>> Endpoints (relevant for target)
  • Wearable devices are tight coupled on body for continuous monitoring
  • smartphone: Sensor
  • connect devices
  • iPhone – Sensor packed powerhouse: Movement, Location, Context, Emotion (Camera, microphone)
  • 70% of data is unstructured: Text, image, video  – SOURCE: IBM
  • Why use AI for building digital biomarkers: AI: Data _ Answers =Rules vs classic Programming: Data + rules = Answers
  • AI enables:
  1. Learn efficintly large data sets
  2. make updates when more data becomes available
  3. Deploy at scale across platforms

DEEP Learning: automated driving, Object recognition, robotics, speech recognition

Case Study 1: Implement Heuristic algorithms (published in literature) Evaluate Performance (agreement with clinical ratings under controlled conditions) Train Machine Learning Models (Annotation as ground truth) to AI models

  • detect hand tremor – Quantify Tremor

Outcomes: 

  1. achieve significant reduction in false positive rate
  2. strong agreement with ratings provided by trained clinical raters

Case Study 2: Mining the sound signal for biomarkers

Outcomes:

  1. 85% accuracy in hackaton

Evaluating AI driven Digital Biomarkers:

Accuracy – Problem: Over fitting

Speed

Explainability – How does the model works? – understand the trade offfs

Scalability – do not be a hammer looking for a nail

 

11:40 – 12:10 pm Accelerating Clinical Trials using Natural Language Understanding

Pharma has a big text problem. Lots of useful information buried in unstructured data
formats that is difficult to use. Natural Language Understanding will help to turn what was
once unusable data into meaningful insights that can be applied to the clinical trial
development continuum. NLU engines also open up the possibility for users to have a more
interactive relationship with their vast data stores using speech or chat messaging in a
conversational experience
Come and see how we are using Natural Language Understanding to solve problems:
• Adverse events in the real world and clinical trials
• Better matched patients for on-going clinical trials
• Hidden associations from interactions between physiology, therapies, and clinical
outcomes

Karim Damji, SVP Product, Saama
Malai Sankarasubbu, VP of AI Research, Saama

  • Too many variations
  • ADE – Adverse Drug Event extraction from Biomedical Text

Data Manager: Delivers Clinical Data Analytics as a Service using Saama platform 

Implementation of dashboard: Smart Assistant for Clinical Operations:

  • Initiate a conversation over multiple natural channels of engagement
  • Identify intent and entity Need for NLU engine !!!!!
  1. Intent extractor
  2. Entity Extractor
  3. Conversation Experience (CX): One question per one answer – not a good CX

Saama: ChatBot Voice interaction

  • Rank studies on Pancreatic Cancer in ClinicalTrials.gov by Inclusion vs Exclusion Criteria
  • Entity extraction and Patinet matching for EHR Data
  1. Protein
  2. Chemical compound
  3. Organism
  4. Environment
  5. Tissue
  6. Disease/phenotype
  7. Gene Ontology Term

12:10 – 12:40 pm CASE STUDY: Bringing Digital Health and Artificial Intelligence to Merck

Merck is building up digital health capabilities to increase patient engagement, improve trial
performance, and develop clearer disease phenotypes. I will describe some efforts across
the organization in this area & provide examples of smart trials / AI collaborations underway.

Joseph Lehar, Executive Director, Computational Biology, Merck

  • Digital health innovations at Merck
  1. quantitative phyenotypes – clearer disease signals
  2. trial performance – more effective and more efficient
  3. Patient outcomes – Better ones
  4. Data analytics & Infrastructure – enabling 1,2,3
  • Smart trials: pacient-centric studies
  • Pilot studies: Smart dosing, sampling and analytics
  • at home vs at clinic
  • smart pill packs daily blood spot for PK/DNA, e-Diary
  • less expensive sampling
  • Key findings: More trials should have smart monitoring
  • Future expansion: Better, more relevant, wider: Less invasive , Apply to active clinical trials , scale up to larger populations
  • Collaborate with big Technology companies on AI
  • Flexible, scientific partnerships
  • Projects with like success sooner
  • Projects underway or being actively planned
  • Value-based models on Trials outcomes
  • Cross functional collaborations: Organizations, Projects: i.e., Oncology, Objectives

 

12:40 – 1:00 pm SINEQUA PRESENTATION

Jeff Evernham, Sinequa

evernham@sinequa.com

  • Content of the data: Expand, Link, Enrich, Improve
  • Data set Index
  • Row IndexStructured and Unstructured (Textual)
  • DIscovery: Common variables across all data sets
  • Cognitive Analytics: SEARCH, NLP, Integrated ML
  • Single study –>> Multiple Studies –> numerical variables –>> Enriched categorical variables Unstructured data

1:00 – 1:50 pm EXECUTIVE NETWORKING LUNCHEON

1:50 – 2:15 pm CASE STUDY: We want to teach a machine to think like a physician, but how do we tell how

a physician thinks?
Inter- and intra-rater variability can severely impact the data quality of our clinical trials. If we
could teach machine learning algorithms to assess patients like experienced physicians, we
would have every patient assessed the exact same way across all the sites in a clinical trial.
As a bonus, we could make these medical assessments available in underserved areas of the
world. However, how can we train a machine learning algorithm on data annotated by
humans, if we know that those human annotations are unreliable? We will present a
framework, and the journey that led us to it, that allows combining the judgments of
multiple human raters into one consensus scale and thus provide high quality ground truth,
an aspect of machine learning that doesn’t always get the attention it deserves.

Jonas Dorn, Digital Solutions Director, Novartis

  • Rater consistency is limited given by n-Raters to K-Patients – Human consistency is limited: Disease severity score assigned
  • ML –>> Scores are generated
  • What is ground truth to be considered GOOD?
  • Comparative video rating
  • Converting ranking into scores, “true Score”
  • True score + uncertainty + rater consistency – compare realization – compare realization to threshold, comes with uncertainty
  • Combine all rating by all doctores = continuous consensus score (with uncertainties) vs Coarse ratings (raw/consensus)
  • Create consistent score through comparisons
  • Conclusion: Humans are bad at absolute ratings but good at comparison
  • Comparison-based enable virtual rating

2:15 – 2:45 pm PANEL DISCUSSION: Hearing the Voice of the Patient – How Ambient Listening Devices and Artificial Intelligence Can Improve the Clinical Trial Experience

The healthcare industry, and in particular, the clinical research sector, has recently focused
its attention on achieving “patient-centricity”. Driven by the desire to better engage clinical
trial volunteers, coupled by the need to demonstrate value-added medical products, this
has become much more than the latest buzz word. However, once the trial begins, the
patient oftentimes may feel isolated in the process – quite simply, they need to ask
questions and receive answers that they can understand. Is this an opportunity to effectively & efficiently use ambient listening devices?

How can we leverage AI and Machine Learning for the detection of adverse events, using NLP and other strategies for analysis?
Amir Lahav, Digital Innovation Lead, Rare Disease Research Unit, Pfizer

  • speech technology – voice activated mechanism
  • voice recording for Ataxia Patients – for interaction with Patients
  • Accustic pattern recognition analysis of Human voice detects Asthman or CVD in Patient : voice for detection of disease: Stroke Patient,

Zeshan Farooqui, Sr. Clinical Site Manager, Bristol-Myers Squibb

Malai Sankarasubbu, VP of AI Research, Saama

  • Multiple Indexes

Moderated by: Bill Tobia, Lead Clinical Research Instructor, GSK

Voice of patient on audio technology

2:45 – 3:15 pm CASE STUDY: Clinical Data Integration from Translational Modeling Using Machine

Learning

Raj Bandaru, Sr. Director, Sr. Director, Translational Informatics, Sanofi

  • Clinical Data Integration for Translational Modeling
  • Challenges of Data Discovery Integration of Clinical Data
  • Automated Data Cataloging
  • Data DIscovery – 80% effort
  • Crawler – Bayesian machine learning – >> data Catalog (Index) –>>  Meta Data (Information) –>>> Elastic Data– >> synonyms and hierarchhical search –>. Ontologies and Access Management
  • Probabilistic model –>> no need for complete ontologies
  • self learning, self maintaining, meta data management, Data on demand, LOW of no IT support, cost a fraction of dat integration projects
  • GOAL: develop a classifier that predicts data class and relevnce to the question being asked
  • Metadata driven Risk-based De-Identification Strategy: Internal Use, External Use
  • Data Analytics Ask a question using Amazon Alexa
  • Data science and knowledge management Team

2:50 – 3:10PM Moving beyond Actigraphy: Using AI to make sense of multi-parameter wearable sensor data

Chris Economos, VP of Business Development, PhysIQ – AI for Personalized Anomaly Detection

  • Contnuous Biosensor Data +Deep Learning to Potentially DIagnose Heart Hailure Likelihood of Heart FAilure derived from Activity Alone: Heart Failure vs Normal Vs Cancer Treatment vs COPD
  • Activity + HR: Heart Failure vs Normal Vs Cancer Treatment vs COPD
  • “baseline” vs “estimates”
  • the difference is “Residuals”
  • Actual, RR, HR, Higher than Expected: Deterioration vs Improvement
  • Chris Economos, VP of Business Development, PhysIQ Case Study: Phase 3 Cardiovascular Clinical Trial: 600 patients, 97 sites, 14 countries, 9 languages 2 CROs
  • All Causes Hospitalization vs Worsening HF Hospitalization
  • Application of AI to data detection of exacerbation

3:15 – 3:35 pm NETWORKING COFFEE AND REFRESHMENT BREAK

3:35 – 4:05 pm Learning Disease Progression and Patient Stratification Models from Images and Text

 

Regina Barzilay, Delta Electronics Professor, MIT EECS, MIT Koch Institute for
Integrative Cancer Research

  • Predict recurrences, sensitivity to Treatment, LCIS – Lobar Carcinoma In-Situ
  • Enabling New Science – NLP Atypia – 7000 cases
  • Reducing Over-treatment – 87% excision are of benign tissue
  • 31% cancers were visible a year prior to cancer
  • Interpretable Neural Models
  • Multi-Task Representation Learning: Small sample size: Task “N” Tumor Size change GOALS: Correlate similar tasks

 

4:05 – 4:25 pm How AI will transform Clinical Trials

Ronald Dorenbos, Associate Director, Materials & Innovation, Takeda

  • Patient’s Perspective: AI can help patients to get better faster, present the disease
  • Future of clinical Trials: Personalization, Patients becoming the point-of-care, Adherence, Healthier Life Style
  • patient acceptance and adoption of digital health and AI are growing
  • In Pharma: SImulation Modeling, Predicting reaction to therapies Virtual Clinical Trials

 

4:25 – 5:00 pm PANEL DISCUSSION: How to make all the Data Machine Learnable?

Raj Bandaru, Sr. Director, Data Sciences Strategy, Sanofi

  • advises to use models that will signal noise vs clean the data upfront with endless effort

Jonas Dorn, Digital Solutions Director, Novartis

  • Cleaning data MUST be done before modeling
  • At present AI will not change the WOrld as fast, future of AI will move slowly

Ingo Mierswa, Founder and President, RapidMiner

  • missing data is not an excuse, it worth a chance
  • Data Engineering and Data modeling is separate in hands of two groups, optimal modeling requires one group, cooperation and validation both groups need be involved along the entire cycle
  • Support the RIGHT to own the data

Jyoti Shah, Associate Director, Data Development, Merck

  • A lot of data and high quality of Data
  • Digital technology – data collected by machine becomes part of the process
  • Patients Centers will disctate the pace of AI adoption, they want to own data

Moderated by: Munther Baara, Head, New Clinical Paradigm, Pfizer

5:00 – 6:30 pm Networking Drinks Reception / END OF CONFERENCE

SOURCE

http://panagorapharma.com/ai/schedule/

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