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Live Notes, Real Time Conference Coverage 2020 AACR Virtual Meeting April 27, 2020 Opening Remarks and Clinical Session 11:45am-1:15pm Advances in Cancer Drug Discovery

SESSION VMS.CH01.01 – Advances in Cancer Drug Design and Discovery

April 27, 2020, 11:45 AM – 1:15 PM
Virtual Meeting: All Session Times Are U.S. EDT
DESCRIPTIONAll session times are U.S. Eastern Daylight Time (EDT).

Session Type
Virtual Minisymposium
Track(s)
Cancer Chemistry
14 Presentations
11:45 AM – 11:45 AM
– ChairpersonZoran Rankovic. St. Jude Children’s Research Hospital, Memphis, TN

11:45 AM – 11:45 AM
– ChairpersonChristopher G. Nasveschuk. C4 Therapeutics, Watertown, MA

11:45 AM – 11:50 AM
– IntroductionZoran Rankovic. St. Jude Children’s Research Hospital, Memphis, TN

11:50 AM – 12:00 PM
1036 – Discovery of a highly potent, efficacious and orally active small-molecule inhibitor of embryonic ectoderm development (EED)Changwei Wang, Rohan Kalyan Rej, Jianfeng Lu, Mi Wang, Kaitlin P. Harvey, Chao-Yie Yang, Ester Fernandez-Salas, Jeanne Stuckey, Elyse Petrunak, Caroline Foster, Yunlong Zhou, Rubin Zhou, Guozhi Tang, Jianyong Chen, Shaomeng Wang. Rogel Cancer Center and Departments of Internal Medicine, Pharmacology, and Medicinal Chemistry, Life Sciences Institute, University of Michigan, Ann Arbor, MI, Ascentage Pharma Group, Taizhou, Jiangsu, China

12:00 PM – 12:05 PM
– Discussion

12:05 PM – 12:15 PM
1037 – Orally available small molecule CD73 inhibitor reverses immunosuppression through blocking of adenosine productionXiaohui Du, Brian Blank, Brenda Chan, Xi Chen, Yuping Chen, Frank Duong, Lori Friedman, Tom Huang, Melissa R. Junttila, Wayne Kong, Todd Metzger, Jared Moore, Daqing Sun, Jessica Sun, Dena Sutimantanapi, Natalie Yuen, Tatiana Zavorotinskaya. ORIC Pharmaceuticals, South San Francisco, CA, ORIC Pharmaceuticals, South San Francisco, CA, ORIC Pharmaceuticals, South San Francisco, CA, ORIC Pharmaceuticals, South San Francisco, CA

12:15 PM – 12:20 PM
– Discussion

12:20 PM – 12:30 PM
1038 – A potent and selective PARP14 inhibitor decreases pro-tumor macrophage function and elicits inflammatory responses in tumor explantsLaurie Schenkel, Jennifer Molina, Kerren Swinger, Ryan Abo, Danielle Blackwell, Anne Cheung, William Church, Kristy Kuplast-Barr, Alvin Lu, Elena Minissale, Mario Niepel, Melissa Vasbinder, Tim Wigle, Victoria Richon, Heike Keilhack, Kevin Kuntz. Ribon Therapeutics, Cambridge, MA

12:30 PM – 12:35 PM
– Discussion

12:35 PM – 12:45 PM
1039 – Fragment-based drug discovery to identify small molecule allosteric inhibitors of SHP2. Philip J. Day, Valerio Berdini, Juan Castro, Gianni Chessari, Thomas G. Davies, James E. H. Day, Satoshi Fukaya, Chris Hamlett, Keisha Hearn, Steve Hiscock, Rhian Holvey, Satoru Ito, Yasuo Kodama, Kenichi Matsuo, Yoko Nakatsuru, Nick Palmer, Amanda Price, Tadashi Shimamura, Jeffrey D. St. Denis, Nicola G. Wallis, Glyn Williams, Christopher N. Johnson. Astex Pharmaceuticals, Inc., Cambridge, United Kingdom, Taiho Pharmaceutical Co., Ltd, Tsukuba, Japan

Abstract: The ubiquitously expressed protein tyrosine phosphatase SHP2 is required for signalling downstream of receptor tyrosine kinases (RTKs) and plays a role in regulating many cellular processes. Recent advances have shown that genetic knockdown and pharmacological inhibition of SHP2 suppresses RAS/MAPK signalling and inhibits proliferation of RTK-driven cancer cell lines. SHP2 is now understood to act upstream of RAS and plays a role in KRAS-driven cancers, an area of research which is rapidly growing. Considering that RTK deregulation often leads to a wide range of cancers and the newly appreciated role of SHP2 in KRAS-driven cancers, SHP2 inhibitors are therefore a promising therapeutic approach.
SHP2 contains two N-terminal tandem SH2 domains (N-SH2, C-SH2), a catalytic phosphatase domain and a C-terminal tail. SHP2 switches between “open” active and “closed” inactive forms due to autoinhibitory interactions between the N-SH2 domain and the phosphatase domain. Historically, phosphatases were deemed undruggable as there had been no advancements with active site inhibitors. We hypothesised that fragment screening would be highly applicable and amenable to this target to enable alternative means of inhibition through identification of allosteric binding sites. Here we describe the first reported fragment screen against SHP2.
Using our fragment-based PyramidTM approach, screening was carried out on two constructs of SHP2; a closed autoinhibited C-terminal truncated form (phosphatase and both SH2 domains), as well as the phosphatase-only domain. A combination of screening methods such as X-ray crystallography and NMR were employed to identify fragment hits at multiple sites on SHP2, including the tunnel-like allosteric site reported by Chen et al, 2016. Initial fragment hits had affinities for SHP2 in the range of 1mM as measured by ITC. Binding of these hits was improved using structure-guided design to generate compounds which inhibit SHP2 phosphatase activity and are promising starting points for further optimization.

  • anti estrogen receptor therapy: ER degraders is one class
  • AZ9833 enhances degradation of ER alpha
  • worked in preclinical mouse model (however very specific)
  • PK parameters were good for orally available in rodents;  also in vitro and in vivo correlation correlated in rats but not in dogs so they were not sure if good to go in humans
  • they were below Km in rats but already at saturated in dogs, dogs were high clearance
  • predicted human bioavailability at 40%

 

12:45 PM – 12:50 PM
– Discussion

12:50 PM – 1:00 PM
1042 – Preclinical pharmacokinetic and metabolic characterization of the next generation oral SERD AZD9833Eric T. Gangl, Roshini Markandu, Pradeep Sharma, Andy Sykes, Petar Pop-Damkov, Pablo Morentin Gutierrez, James S. Scott, Dermot F. McGinnity, Adrian J. Fretland, Teresa Klinowska. AstraZeneca, Waltham, MA

1:00 PM – 1:05 PM
– Discussion

1:05 PM – 1:15 PM
– Closing RemarksChristopher G. Nasveschuk. MA

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Live Notes, Real Time Conference Coverage 2020 AACR Virtual Meeting April 27, 2020 Opening Remarks and Clinical Session 9 am

Reporter: Stephen J. Williams, PhD.

9:00 AM Opening Session

9:00 AM – 9:05 AM
– Opening Video

9:05 AM – 9:15 AM
– AACR President: Opening Remarks Elaine R. Mardis. Nationwide Children’s Hospital, Columbus, OH

 

Dr. Mardis is the Robert E. and Louise F. Dunn Distinguished Professor of Medicine @GenomeInstitute at Washington University of St. Louis School of Medicine.

Opening remarks:  Dr. Mardis gave her welcome from her office.  She expressed many thanks to healthcare workers and the hard work of scientists and researchers.  She also expressed some regret for the many scientists who had wonderful research to present and how hard it was to make the decision to go virtual however she feels there now more than ever still needs a venue to discuss scientific and clinical findings.  Some of the initiatives that she has had the opportunity to engage in the areas of groundbreaking discoveries and clinical trials.  606,000 lives will be lost in US this year from cancer.  AACR is being vigilant as also an advocacy platform and public policy platform in Congress and Washington.  The AACR has been at the front of public policy on electronic cigarettes.  Blood Cancer Discovery is their newest journal.  They are going to host joint conferences with engineers, mathematicians and physicists to discuss how they can help to transform oncology.  Cancer Health Disparity Annual Conference is one of the fastest growing conferences.  They will release a report later this year about the scope of the problem and policy steps needed to alleviate these disparities.  Lack of racial and ethnic minorities in cancer research had been identified an issue and the AACR is actively working to reduce the disparities within the ranks of cancer researchers.   Special thanks to Dr. Margaret Foti for making the AACR the amazing organization it is.

 

9:15 AM – 9:30 AM- AACR Annual Meeting Program Chair: Review of Program for AACR Virtual Annual Meeting Antoni Ribas. UCLA Medical Center, Los Angeles, CA

Antoni Ribas, MD PhD is Professor, Medicine, Surgery, Molecular and Medical Pharmacology; Director, Parker Institute for Cancer Immunotherapy Center at UCLA; Director, UCLA Jonsson Comprehensive Cancer Center Tumor Immunology Program aribas@mednet.ucla.edu

The AACR felt it was important to keep the discourse in the cancer research field as the Annual AACR meeting is the major way scientists and clinicians discuss the latest and most pertinent results.  A three day virtual meeting June 22-24 will focus more on the translational and basic research while this meeting is more focused on clinical trials.  There will be educational programs during the June virtual meeting.  The COVID in Cancer part of this virtual meeting was put in specially for this meeting and there will be a special meeting on this in July.  They have created an AACR COVID task force.  The AACR has just asked Congress and NIH to extend the grants due to the COVID induced shutdown of many labs.

9:30  Open Clinical Plenary Session (there are 17 sessions today but will only cover a few of these)

9:30 AM – 9:31 AM
– Chairperson Nilofer S. Azad. Johns Hopkins Sidney Kimmel Comp. Cancer Center, Baltimore, MD @noza512

9:30 AM – 9:31 AM
– Chairperson Manuel Hidalgo. Weill Cornell Medicine, New York, NY

9:30 AM – 9:35 AM
– Introduction Nilofer S. Azad. Johns Hopkins Sidney Kimmel Comp. Cancer Center, Baltimore, MD

9:35 AM – 9:45 AM
CT011 – Evaluation of durvalumab in combination with olaparib and paclitaxel in high-risk HER2 negative stage II/III breast cancer: Results from the I-SPY 2 TRIAL Lajos Pusztai, et al

see https://www.abstractsonline.com/pp8/#!/9045/presentation/10593

AbstractBackground: I-SPY2 is a multicenter, phase 2 trial using response-adaptive randomization within molecular subtypes defined by receptor status and MammaPrint risk to evaluate novel agents as neoadjuvant therapy for breast cancer. The primary endpoint is pathologic complete response (pCR, ypT0/is ypN0)). DNA repair deficiency in cancer cells can lead to immunogenic neoantigens, activation of the STING pathway, and PARP inhibition can also upregulate PD-L1 expression. Based on these rationales we tested the combination of durvalumab (anti-PDL1), olaparib (PARP inhibitor) and paclitaxel in I-SPY2.
Methods: Women with tumors ≥ 2.5 cm were eligible for screening. Only HER2 negative (HER2-) patients were eligible for this treatment, hormone receptor positive (HR+) patients had to have MammaPrint high molecular profile. Treatment included durvalumab 1500 mg every 4 weeks x 3, olaparib 100 mg twice daily through weeks 1-11 concurrent with paclitaxel 80 mg/m2 weekly x 12 (DOP) followed by doxorubicin/cyclophosphamide (AC) x 4. The control arm was weekly paclitaxel x 12 followed by AC x 4. All patients undergo serial MRI imaging and imaging response at 3 & 12 weeks combined with accumulating pCR data are used to estimate, and continuously update, predicted pCR rate for the trial arm. Regimens “graduation with success” when the Bayesian predictive probability of success in a 300-patient phase 3 neoadjuvant trial in the appropriate biomarker groups reaches > 85%.
Results: A total of 73 patients received DOP treatment including 21 HR- tumors (i.e. triple-negative breast cancer, TNBC) and 52 HR+ tumors between May 2018 – June 2019. The control group included 299 patients with HER2- tumors. The DOP arm graduated in June 2019, 13 months after enrollment had started, for all HER2- negative and the HR+/HER2- cohorts with > 0.85% predictive probabilities of success. 72 patient completed surgery and evaluable for pCR, the final predicted probabilities of success in a future phase III trial to demonstrate higher pCR rate with DOP compared to control are 81% for all HER2- cancers (estimated pCR rate 37%), 80% for TNBC (estimated pCR rate 47%) and 74.5% for HR+/HER2- patients (estimated pCR rate 28%). Association between pCR and germline BRCA status and immune gene expression including PDL1 will be presented at the meeting. No unexpected toxicities were seen, but 10 patients (14%) had possibly immune or olaparib related grade 2/3 AEs (3 pneumonitis, 2 adrenal insufficiency, 1 colitis, 1 pancreatitis, 2 elevated LFT, 1 skin toxicity, 2 hypothyroidism, 1 hyperthyroidism, 1 esophagitis).
Conclusion: I-SPY2 demonstrated a significant improvement in pCR with durvalumab and olaparib included with paclitaxel compared to chemotherapy alone in women with stage II/III high-risk, HER2-negative breast cancer, improvement was seen in both the HR+ and TNBC subsets.

  • This combination of durvalumab and olaparib is safe in triple negative breast cancer
  • expected synergy between PARP inhibitors and PDL1 inhibitors as olaparib inhibits DNA repair and would increase the mutational burden, which is in lung cancer shown to be a biomarker for efficacy of immune checkpoint inhibitors such as Opdivio
  • three subsets of breast cancers were studied: her2 negative, triple negative and ER+ tumors
  • MRI imaging tumor size was used as response
  • olaparib arm had elevation of liver enzymes and there was a pancreatitis
  • however paclitaxel was used within the combination as well as a chemo arm but the immuno arm alone may not be better than chemo alone but experimental arm with all combo definitely better than chemo alone
  • they did not look at BRCA1/2 status, followup talk showed that this is a select group that may see enhanced benefit; PARP inhibitors were seen to be effective only in BRCA1/2 mutant ovarian cancer previously

 

10:10 AM – 10:20 AM
CT012 – Evaluation of atezolizumab (A), cobimetinib (C), and vemurafenib (V) in previously untreated patients with BRAFV600 mutation-positive advanced melanoma: Primary results from the phase 3 IMspire150 trial Grant A. McArthur,

for abstract please see https://www.abstractsonline.com/pp8/#!/9045/presentation/10594

AbstractBackground: Approved systemic treatments for advanced melanoma include immune checkpoint inhibitor therapy (CIT) and targeted therapy with BRAF plus MEK inhibitors for BRAFV600E/K mutant melanoma. Response rates with CITs are typically lower than those observed with targeted therapy, but CIT responses are more durable. Preclinical and clinical data suggest a potential for synergy between CIT and BRAF plus MEK inhibitors. We therefore evaluated whether combining CIT with targeted therapy could improve efficacy vs targeted therapy alone. Methods: Treatment-naive patients with unresectable stage IIIc/IV melanoma (AJCC 7th ed), measurable disease by RECIST 1.1, and BRAFV600 mutations in their tumors were randomized to the anti­-programmed death-ligand 1 antibody A + C + V or placebo (Pbo) + C + V. A or Pbo were given on days 1 and 15 of each 28-day cycle. Treatment was continued until disease progression or unacceptable toxicity. The primary outcome was investigator-assessed progression-free survival (PFS). Results: 514 patients were enrolled (A + C + V = 256; Pbo + C + V = 258) and followed for a median of 18.9 months. Investigator-assessed PFS was significantly prolonged with A + C + V vs Pbo + C + V (15.1 vs 10.6 months, respectively; hazard ratio: 0.78; 95% confidence interval: 0.63-0.97; P=0.025), an effect seen in all prognostic subgroups. While objective response rates were similar in the A + C + V and Pbo + C + V groups, median duration of response was prolonged with A + C + V (21.0 months) vs Pbo + C + V (12.6 months). Overall survival data were not mature at the time of analysis. Common treatment-related adverse events (AEs; >30%) in the A + C + V and Pbo + C + V groups were blood creatinine phosphokinase (CPK) increase (51.3% vs 44.8%), diarrhea (42.2% vs 46.6%), rash (40.9% in both arms), arthralgia (39.1% vs 28.1%), pyrexia (38.7% vs 26.0%), alanine aminotransferase (ALT) increase (33.9% vs 22.8%), and lipase increase (32.2% vs 27.4%). Common treatment-related grade 3/4 AEs (>10%) that occurred in the A + C + V and Pbo + C + V groups were lipase increase (20.4% vs 20.6%), blood CPK increase (20.0% vs 14.9%), ALT increase (13.0% vs 8.9%), and maculopapular rash (12.6% vs 9.6%). The incidence of treatment-related serious AEs was similar between the A + C + V (33.5%) and Pbo + C + V (28.8%) groups. 12.6% of patients in the A + C + V group and 15.7% in the Pbo + C + V group stopped all treatment because of AEs. The safety profile of the A + C + V regimen was generally consistent with the known profiles of the individual components. Conclusion: Combination therapy with A + C + V was tolerable and manageable, produced durable responses, and significantly increased PFS vs Pbo + C + V. Thus, A + C + V represents a viable treatment option for BRAFV600 mutation-positive advanced melanoma. ClinicalTrials.gov ID: NCT02908672

 

 

10:25 AM – 10:35 AM
CT013 – SWOG S1320: Improved progression-free survival with continuous compared to intermittent dosing with dabrafenib and trametinib in patients with BRAF mutated melanoma Alain Algazi,

for abstract and more author information please see https://www.abstractsonline.com/pp8/#!/9045/presentation/10595

AbstractBackground: BRAF and MEK inhibitors yield objective responses in the majority of BRAFV600E/K mutant melanoma patients, but acquired resistance limits response durations. Preclinical data suggests that intermittent dosing of these agents may delay acquired resistance by deselecting tumor cells that grow optimally in the presence of these agents. S1320 is a randomized phase 2 clinical trial designed to determine whether intermittent versus continuous dosing of dabrafenib and trametinib improves progression-free survival (PFS) in patients with advanced BRAFV600E/K melanoma.
Methods: All patients received continuous dabrafenib and trametinib for 8-weeks after which non-progressing patients were randomized to receive either continuous treatment or intermittent dosing of both drugs on a 3-week-off, 5-week-on schedule. Unscheduled treatment interruptions of both drugs for > 14 days were not permitted. Responses were assessed using RECIST v1.1 at 8-week intervals scheduled to coincide with on-treatment periods for patients on the intermittent dosing arm. Adverse events were assessed using CTCAE v4 monthly. The design assumed exponential PFS with a median of 9.4 months using continuous dosing, 206 eligible patients and 156 PFS events. It had 90% power with a two-sided α = 0.2 to detect a change to a median with an a priori hypothesis that intermittent dosing would improve the median PFS to 14.1 months using a Cox model stratified by the randomization stratification factors.
Results: 242 patients were treated and 206 patients without disease progression after 8 weeks were randomized, 105 to continuous and 101 to intermittent treatment. 70% of patients had not previously received immune checkpoint inhibitors. There were no significant differences between groups in terms of baseline patient characteristics. The median PFS was statistically significantly longer, 9.0 months from randomization, with continuous dosing vs. 5.5 months from randomization with intermittent dosing (p = 0.064). There was no difference in overall survival between groups (median OS = 29.2 months in both arms p = 0.93) at a median follow up of 2 years. 77% of patient treated continuously discontinued treatment due to disease progression vs. 84% treated intermittently (p = 0.34).
Conclusions: Continuous dosing with the BRAF and MEK inhibitors dabrafenib and trametinib yields superior PFS compared with intermittent dosing.

  • combo of MEK and BRAF inhibitors can attract immune cells like TREGs so PDL1 inhibitor might help improve outcome
  • PFS was outcome endpoint
  • LDH was elevated in three patients (why are they seeing liver tox?  curious like previous study); are seeing these tox with the PDL1 inhibitors
  • there was marked survival over placebo group and PFS was statistically  with continuous dosing however intermittent dosing shows no improvement

Dr. Wafik el Diery gave a nice insight as follows

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Pfizer buys out Array BioPharma for $11.4 Billion to beef up its oncology offerings

Reporter: Stephen J. Williams, PhD

As reported in FiercePharma.com:

by Angus Liu |

Three years after purchasing Medivation for $14.3 billion, Pfizer is back with another hefty M&A deal. And once again, it’s betting on oncology.

In the first big M&A deal under new CEO Albert Bourla, Pfizer has agreed to buy oncology specialist Array BioPharma for a total value of about $11.4 billion, the two companies unveiled Monday. The $48-per-share offer represents a premium of about 62% to Array stock’s closing price on Friday.

With the acquisition, Pfizer will beef up its oncology offerings with two marketed drugs, MEK inhibitor Mektovi and BRAF inhibitor Braftovi, which are approved as a combo treatment for melanoma and recently turned up positive results in colon cancer.

The buy will enhance the Pfizer innovative drug business’ “long-term growth trajectory,” Bourla said in a Monday statement, dubbing Mektovi-Braftovi “a potentially industry-leading franchise for colorectal cancer.”

RELATED: Array’s ‘extremely compelling’ new colon cancer data spark blockbuster talk

In a recent interim analysis of a trial in BRAF-mutant metastatic colorectal cancer, the pair, used in tandem with Eli Lilly and Merck KGaA’s Erbitux, produced a benefit in 26% of patients, versus the 2% that chemotherapy helped. The combo also showed it could reduce the risk of death by 48%. SVB Leerink analysts at that time called the data “extremely compelling.”

Right now, one in every three new patients with mutated metastatic melanoma is getting the combo, despite its third-to-market behind combos from Roche and Novartis, Andy Schmeltz, Pfizer’s oncology global president, said during an investor briefing on Monday.

It is being studied in more than 30 clinical studies across several solid tumor indications. Moving forward, Pfizer believes the combo could potentially be used in the adjuvant setting to prevent tumor recurrence after surgery, Pfizer’s chief scientific officer, Mikael Dolsten, said on the call. The company is also keen to know how it could be paired up with Pfizer’s own investigational PD-1, he said, as the combo is already in studies with other PD-1/L1s.

But as Pfizer execs have previously said, the company’s current business development strategy no longer centers on adding revenues “now or soon,” but rather on strengthening Pfizer’s pipeline with earlier-stage assets. And Array can help there, too.

“We are very excited by Array’s impressive track record of successfully discovering and developing innovative small-molecules and targeted cancer therapies,” Dolsten said in a statement.

On top of Mektovi and Braftovi, Array has a long list of out-licensed drugs that could generate big royalties over time. For example, Vitrakvi, the first drug to get an initial FDA approval in tumors with a particular molecular feature regardless of their location, was initially licensed to Loxo Oncology—which was itself snapped up by Eli Lilly for $8 billion—but was taken over by pipeline-hungry Bayer. There are other drugs licensed to the likes of AstraZeneca, Roche, Celgene, Ono Pharmaceutical and Seattle Genetics, among others.

Those drugs are also a manifestation of Array’s strong research capabilities. To keep those Array scientists doing what they do best, Pfizer is keeping a 100-person team in Colorado as a standalone research unit alongside Pfizer’s existing hubs, Schmeltz said.

Pfizer is counting on Array to augment its leadership in breast cancer, an area championed by Ibrance, and prostate cancer, the pharma giant markets Astellas-partnered Xtandi. For 2018, revenues from the Pfizer oncology portfolio jumped to $7.20 billion—up from $6.06 billion in 2017—mainly thanks to those two drugs.

Source: https://www.fiercepharma.com/pharma/pfizer-never-say-never-m-a-buys-oncology-innovator-array-for-11-4b

 

About Array BioPharma

Array markets BRAFTOVI® (encorafenib) capsules in combination with MEKTOVI® (binimetinib)  tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K  mutation in the United States and with partners in other major worldwide markets.* Array’s lead clinical programs, encorafenib and binimetinib, are being investigated in over 30 clinical trials across a number of solid tumor indications, including a Phase 3 trial in BRAF-mutant metastatic colorectal cancer. Array’s pipeline includes several additional programs being advanced by Array or current license-holders, including the following programs currently in registration trials: selumetinib (partnered with AstraZeneca), LOXO-292 (partnered with Eli Lilly), ipatasertib (partnered with Genentech), tucatinib (partnered with Seattle Genetics) and ARRY-797. Vitrakvi® (larotrectinib, partnered with Bayer AG) is approved in the United States and Ganovo® (danoprevir, partnered with Roche) is approved in China.

 

Other Articles of Note of Pfizer Merger and Acquisition deals on this Open Access Journal Include:

From Thalidomide to Revlimid: Celgene to Bristol Myers to possibly Pfizer; A Curation of Deals, Discovery and the State of Pharma

Pfizer Near Allergan Buyout Deal But Will Fed Allow It?

Pfizer offers legal guarantees over AstraZeneca bid

Re-Creation of the Big Pharma Model via Transformational Deals for Accelerating Innovations: Licensing vs In-house inventions

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Live Conference Coverage Medcity Converge 2018 Philadelphia: Clinical Trials and Mega Health Mergers

Reporter: Stephen J. Williams, PhD

1:30 – 2:15 PM Clinical Trials 2.0

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?

Moderator: John Reites, Chief Product Officer, Thread @johnreites
Speakers:
Andrew Chapman M.D., Chief of Cancer Services , Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
Michelle Longmire, M.D., Founder, Medable @LongmireMD
Sameek Roychowdhury MD, PhD, Medical Oncologist and Researcher, Ohio State University Comprehensive Cancer Center @OSUCCC_James

 

Michele: Medable is creating a digital surrogate biomarker for short term end result for cardiology clinical trials as well as creating a virtual site clinical trial design (independent of geography)

Sameek:  OSU is developing RNASeq tests for oncogenic fusions that are actionable

John: ability to use various technologies to conduct telehealth and tele-trials.  So why are we talking about Clinical Trials 2.0?

Andrew: We are not meeting many patients needs.  The provider also have a workload that prevents from the efficient running of a clinical trial.

Michele:  Personalized medicine: what is the framework how we conduct clinical trials in this new paradigm?

Sameek: How do we find those rare patients outside of a health network?  A fragmented health system is hurting patient recruitment efforts.

Wout: The Christmas Tree paradigm: collecting data points based on previous studies may lead to unnecessary criteria for patient recruitment

Sameek:  OSU has a cancer network (Orion) that has 95% success rate of recruitment.  Over Orion network sequencing performed at $10,000 per patient, cost reimbursed through network.  Network helps pharma companies find patients and patients to find drugs

Wout: reaching out to different stakeholders

John: what he sees in 2.0 is use of tech.  They took 12 clinic business but they integrated these sites and was able to benefit patient experience… this helped in recruitment into trials.  Now after a patient is recruited, how 2.0 model works?

Sameek:  since we work with pharma companies, what if we bring in patients from all over the US.  how do we continue to take care of them?

Andrew: utilizing a technology is critically important for tele-health to work and for tele-clinical trials to work

Michele:  the utilization of tele-health by patients is rather low.

Wout:  We are looking for insights into the data.  So we are concentrated on collecting the data and not decision trees.

John: What is a barrier to driving Clinical Trial 2.0?

Andrew: The complexity is a barrier to the patient.  Need to show the simplicity of this.  Need to match trials within a system.

Saleem: Data sharing incentives might not be there or the value not recognized by all players.  And it is hard to figure out how to share the data in the most efficient way.

Wout: Key issue when think locally and act globally but healthcare is the inverse of this as there are so many stakeholders but that adoption by all stakeholders take time

Michele: accessibility of healthcare data by patients is revolutionary.  The medical training in US does not train doctors in communicating a value of a trial

John: we are in a value-driven economy.  You have to give alot to get something in this economy. Final comments?

Saleem: we need fundamental research on the validity of clinical trials 2.0.

Wout:  Use tools to mine manually but don’t do everything manually, not underlying tasks

Andrew: Show value to patient

2:20-3:00 PM 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 @IBX 

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

Comcast and Independence Blue Cross Blue Shield are teaming together to form an independent health firm to bring various players in healthcare onto a platform to give people a clear path to manage their healthcare.  Its not just about a payer and information system but an ecosystem within Philadelphia and over the nation.

Michael:  About 2015 at a health innovation conference they came together to produce a demo on how they envision the future of healthcare.

Marc: When we think of a customer we think of the household. So we thought about aggregating services to people in health.  How do people interact with their healthcare system?

What are the risks for bringing this vision to reality?

Michael: Key to experience is how to connect consumer to caregiver.

How do we aggregate the data, and present it in a way to consumer where it is actionable?

How do we help the patient to know where to go next?

Marc: Concept of ubiquity, not just the app, nor asking the provider to ask patient to download the app and use it but use our platform to expand it over all forms of media. They did a study with an insurer with metabolic syndrome and people’s viewing habits.  So when you can combine the expertise of IBX and the scale of a Comcast platform you can provide great amount of usable data.

Michael: Analytics will be a prime importance of the venture.

Tom:  We look at lots of companies that try to pitch technologies but they dont understand healthcare is a human problem not a tech problem.  What have you learned?

Marc: Adoption rate of new tech by doctors is very low as they are very busy.  Understanding the clinicians workflow is important and how to not disrupt their workflow was humbling for us.

Michael:  The speed at which big tech companies can integrate and innovate new technologies is very rapid, something we did not understand.  We want to get this off the ground locally but want to take this solution national and globally.

Marc:  We are not in competition with local startups but we are looking to work with them to build scale and operability so startups need to show how they can scale up.  This joint venture is designed to look at these ideas.  However this will take a while before we open up the ecosystem until we can see how they would add value. There are also challenges with small companies working with large organizations.

 

Please follow on Twitter using the following #hashtags and @pharma_BI

#MCConverge

#cancertreatment

#healthIT

#innovation

#precisionmedicine

#healthcaremodels

#personalizedmedicine

#healthcaredata

And at the following handles:

@pharma_BI

@medcitynews

 

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

LIVE – Real Time – 16th Annual Cancer Research Symposium, Koch Institute, Friday, June 16, 9AM – 5PM, Kresge Auditorium, MIT

Real Time Coverage and eProceedings of Presentations on 11/16 – 11/17, 2016, The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

Tweets Impression Analytics, Re-Tweets, Tweets and Likes by @AVIVA1950 and @pharma_BI for 2018 BioIT, Boston, 5/15 – 5/17, 2018

BIO 2018! June 4-7, 2018 at Boston Convention & Exhibition Center

https://pharmaceuticalintelligence.com/press-coverage/

 

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Allergan, Pfizer Deal Goes Through with Allergan Bigger Than Pfizer: But at What Cost to R&D?

Curator: Stephen J. Williams, Ph.D.

Just recently this site had a post entitled Pfizer Near Allergan Buyout Deal But Will Fed Allow It? 

Now, as Bloomberg reports the international deal between Allergan and Pfizer has gone through, resulting in a tax inversion and nary a discouraging word from the US Federal Government (their blessing for future tax inversions?).  And as Bloomberg Go guest speculate finally it may spark Congress to do something about it, or perhaps not.  For details see Bloomberg transcript below:

 

Pfizer Inc. and Allergan Plc agreed to combine in a record $160 billion deal, creating a drugmaking behemoth called Pfizer Plc with products from Viagra to Botox and a low-cost tax base.

QuickTake Tax Inversion

Pfizer will exchange 11.3 shares for each Allergan share, valuing the smaller drugmaker at $363.63 a share, according to a statement Monday. That’s a premium of about 27 percent above Allergan’s stock price on Oct. 28, before news of the companies’ discussions became public. Pfizer investors will be able to opt for cash instead of stock in the combined company in exchange for their shares, with as much as $12 billion to be paid out.

The transaction is structured so that Dublin-based Allergan is technically buying its much larger partner, a move that makes it easier for the company to locate its tax address in Ireland for tax purposes, though the drugmaker’s operational headquarters will be in New York. Pfizer Chief Executive Officer Ian Read will be chairman and CEO of the new company, with Allergan CEO Brent Saunders as president and chief operating officer, overseeing sales, manufacturing and strategy.

The deal will begin adding to Pfizer’s adjusted earnings starting in 2018 and will boost profit by 10 percent the following year, the companies said. Pfizer’s 11 board members will join four from Allergan, including Saunders and Executive Chairman Paul Bisaro.Pfizer dropped 2.1 percent to $31.51 at 9:34 a.m. in New York, while Allergan fell 2 percent to $306.17. The combined company will trade on the New York Stock Exchange.Pfizer said it will start a $5 billion accelerated share buyback program in the first half of 2016. The deal is expected to be completed by the end of next year.

Unprecedented Deal

Pfizer, based in New York, makes medications including Viagra, pain drug Lyrica and the Prevnar pneumococcal vaccine, and Allergan produces Botox and the Alzheimer’s drug Namenda. Together, barring any divestitures, the companies will be the biggest pharmaceutical company by annual sales, with about $60 billion. The deal will be unprecedented on many levels. It’s the largest acquisition so far this year. It’s the largest ever in the pharmaceutical world, eclipsing Pfizer’s purchase of Warner-Lambert Co. in 2000 for $116 billion. And if the new company is able to establish itself abroad for a lower tax rate, a controversial process called an inversion, it will be the largest such move in history. The U.S. Treasury Department has increasingly targeted such strategies, most recently announcing new guidance on how it will value assets owned by U.S. companies that undertake inversions. The U.S. has the highest tax rate for businesses in the world, at 35 percent, and is one of the only countries to tax corporate profits wherever they are earned. Previous moves by the U.S. Treasury have derailed other proposed inversions, including AbbVie Inc.’s plan to buy Ireland’s Shire Plc for an estimated $52 billion. Pfizer and Allergan’s deal appears structured to avoid the tax inversion rules.

Read has already reached out to lawmakers in both houses of Congress, including Senate Majority Leader Mitch McConnell, and is calling the White House Monday, according to a person with knowledge of the matter. His pitch is that that the deal will help the companies invest in more innovative drugs and that Pfizer Plc would have 40,000 U.S. employees at the close of the transaction.

Facilitate Split

An agreement may also facilitate the widely discussed potential for Pfizer to reconfigure itself by splitting the newly enlarged company into two: one focused on new drug development, the other on selling older medications. Pfizer said Monday it will decide on a potential separation by the end of 2018. Pfizer earlier this year bought Hospira Inc., the maker of generic drugs often administered in hospitals, in a transaction valued at about $17 billion. The deal bolstered Pfizer’s established-drugs business, which combines strong cash flow and slow growth. Allergan itself has been recently transformed, created through an acquisition by Actavis Plc that kept the Allergan name. The company agreed to sell its generics business to Israel’s Teva Pharmaceutical Industries Ltd. for about $40.5 billion and has been on a buying binge of its own. It now has more than 70 compounds in mid-to late-stage development.

But What About Pfizer R&D?  Will that be put on the Back Burner?

A little while ago this site posted a talk given by Pfizer on their foray into personalized medicine in

11/19/2015 8 a.m. Building a Personalized Medicine Company & Keynote: President, Worldwide R&D, Pfizer Inc. 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

Here Pfizer had emphasized its commitment to discoveries in the personalized medicine area however the emphasis on worldwide may have been a hint of what is to come.

Just a few days ago Allergan CEO wrote a guest post in Forbes  (edited by Matthew Herper)

Allergan CEO Brent Saunders: Here’s What I Really Think About R&D

There has been a lot of discussion about my views about pharmaceutical research and development. Let me cut to the chase. I’m pro-R&D, but I don’t believe that any single company can corner the market on innovation in even one therapeutic area. It doesn’t mean they shouldn’t do basic research where they have special insights, but even then they need to be open to the ideas of others. Innovation in healthcare is more important than ever. Other companies have had success with different models based on different capabilities, and we applaud every new drug approval. Here at Allergan, we’ve adopted a strategy we call “Open Science.” It is based on a simple concept: Sometimes great ideas come from places where they are least expected.

Allergan’s CEO goes on to stress innovation centers around academic centers such as in Boston and an emphasis on Alzheimer’s research and development but is this just shop talk or is there a agenda and strategy here?

It is known that Allergan has not felt that building big labs to support an R&D strategy was in their best interests but Derick Lowes Science blog In the Pipeline shows the changes in feeling about R&D, that Allergan is in fact pro-R&D they just don’t feel it is in their best interests to do it “in house”. (see Come to Think of It, Brent Saunders Likes R&D, Too! and the comments)

And check out CEO Saunder’s Twitter feed which gives some insight into his feeling on in house R&D.

Retweeted

on a R&D approach that can deliver big for patients.

This is all very interesting and might mean, with the size of this deal and that Allergan owns 40% of Pfizer, a massive sea-change in the way big pharma conducts R&D, possibly focusing on smaller “open-sourced” smaller players.

Our Open Science approach allows us to strategically invest in innovation and be more nimble so that we can increase our R&D efficiency. It has led to a robust pipeline of experimental medicines. We currently have 70 mid- to late-stage programs in the pipeline, and since 2009, we have successfully brought 13 new drugs and devices to the market.

It also allows us to invest in areas that other companies have abandoned, like central nervous system (CNS) treatments. In CNS, clinical development costs are higher, and market approval probability is lower. But treating these disorders can bring hope to patients of all ages. According to the Centers for Disease Control & Prevention, one in 68 children has autism spectrum disease. Alzheimer’s affects one in three people over the age of 85, based on data from the Chicago Health and Aging Project. Yet despite the 634 current open clinical trials for these diseases, there are no approved medicines for autism’s three core characteristics, nor drugs that treat Alzheimer’s underlying disease or delay its progression.

Other related articles published in this Open access Online Scientific Journal include the following:

On Allergan

https://pharmaceuticalintelligence.com/?s=Allergan

On Pfizer

https://pharmaceuticalintelligence.com/?s=Pfizer

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Pfizer Near Allergan Buyout Deal But Will Fed Allow It?

 pfizerallergan

 

Reporter: Stephen J. Williams, Ph.D.

From Bloomberg Business

Pfizer Inc. is in advanced talks to buy Allergan Plc for as much as $380 per share, according to people familiar with the matter, valuing the Botox maker at as high as $150 billion — if the U.S. government doesn’t get in the way of the drug industry’s largest-ever deal.

See Bloomberg’s QuickTake: Tax Inversion

There has been 51 US company tax-inversion based relocations since 1982 with the rate picking up in the last 3 years (from Bloomberg Data). Many of these inversions in recent years have involved large pharma companies.

The companies aim to announce an agreement as soon as Monday, the people said, asking not to be identified because the discussions are private. The price being discussed is $370 to $380 per share, two of the people said. However, the U.S. Treasury Department’s letter on tax inversion deals, released on Wednesday, could delay the final agreement and change the terms of any transaction, another person said.

Pfizer shares sank 1.5 percent to $32.80 and Allergan fell 1.4 percent to $306.37 at 9:57 a.m. in New York on speculation that the deal could be hampered by the Treasury’s letter, which said the department is reviewing ways to address overseas acquisitions and plans to issue guidance later this week.

Pfizer has tried but hadn’t succeeded, in the past, to complete a merger, supposedly for a tax inversion. The latest attempt was the failed attempt to buyout British based AstraZeneca in 2014 for $117 billion. When Pfizer makes a buyout employees of Pfizer and the purchased company generally acknowledge that layoffs will ensue (from FiercePharma UPDATED: Pfizer’s post-megamerger cost-cutting record? 51,500 jobs in 7 years).

More posts on Pharma Deals and Mergers on this Open Access site Include

Pfizer offers legal guarantees over AstraZeneca bid

Medical Devices Industry: Investment Facts and Industry Prospects

14:00PM – 10/1/2014: Conference Workshop “Conundrums and Conflicts in Licensing & M&A Deals” @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

Profits versus R and D: Shifts in the Research Culture – US vs Global Markets

 

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9:20AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

9:20 a.m. Panel Discussion – Genomic Technologies

Genomic Technologies

The greatest impetus for personalized medicine is the initial sequencing of the human genome at the beginning of this Century. As we began to recognize the importance of genetic factors in human health and disease, efforts to understand genetic variation and its impact on health have accelerated. It was estimated that it cost more than two billion dollars to sequence the first human genome and reduction in the cost of sequence became an imperative to apply this technology to many facets of risk assessment, diagnosis, prognosis and therapeutic intervention. This panel will take a brief historical look back at how the technologies have evolved over the last 15 years and what the future holds and how these technologies are being applied to patient care.

Genomic Technologies

Opening Speaker and Moderator:

George Church, Ph.D.
Professor of Genetics, Harvard Medical School; Director, Personal Genomics

Genomic Technologies and Sequencing

  • highly predictive, preventative
  • non predictive

Shareable Human Genomes Omics Standards

$800 Human Genome Sequence – Moore’s Law does not account for the rapid decrease in cost of Genome Sequencing

Genome Technologies and Applications

  • Genia nanopore – battery operated device
  • RNA & protein traffic
  • Molecular Stratification Methods – more than one read, sequence ties
  • Brain Atlas  – transcriptome of mouse brains
  • Multigenics – 700 genes: hGH therapies

Therapies

  • vaccine
  • hygiene
  • age

~1970 Gene Therapy in Clinical Trials

Is Omic technologies — a Commodity?

  • Some practices will have protocols
  • other will never become a commodity

 

Panelists:

Sam Hanash, M.D., Ph.D. @MDAndersonNews

Director, Red & Charline McCombs Institute for Early Detection & Treatment of Cancer MD Anderson Cancer Center

Heterogeneity among Cancer cells. Data analysis and interpretation is very difficult, back up technology

Proteins and Peptides before analysis with spectrometry:

  • PM  – Immunotherapy approaches need be combined with other techniques
  • How modification in protein type affects disease
  • amplification of an aberrant protein – when that happens cancer developed. Modeling on a CHip of peptide synthesizer

Mark Stevenson @servingscience

Executive Vice President and President, Life Sciences Solutions
Thermo Fisher Scientific

Issues of a Diagnostics Developer:

  • FDA regulation, need to test on several tissues
  • computational environment
  • PCR, qPCR – cost effective
  • BGI – competitiveness

Robert Green, MD @BrighamWomens

Partners, Health Care Personalized Medicine — >>Disclosure: Illumina and three Pharmas

Innovative Clinical Trial: Alzheimer’s Disease, integration of sequencing with drug development

  • Population based screening with diagnosis
  • Cancer predisposition: Cost, Value, BRCA
  • epigenomics technologies to be integrated
  • Real-time diagnostics
  • Screening makes assumption on Predisposition
  • Public Health view: Phenotypes in the Framingham Studies: 64% pathogenic genes were prevalent – complication based in sequencing.

Questions from the Podium:

  • Variants analysis
  • Metastasis different than solid tumor itself – Genomics will not answer issues related to tumor in special tissues variability

 

 

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

@HarvardPMConf

#PMConf

@SachsAssociates

 

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Track 9 Pharmaceutical R&D Informatics: Collaboration, Data Science and Biologics @ BioIT World, April 29 – May 1, 2014 Seaport World Trade Center, Boston, MA

Aviva Lev-Ari, PhD, RN

 

April 30, 2014

 

Big Data and Data Science in R&D and Translational Research

10:50 Chairperson’s Remarks

Ralph Haffner, Local Area Head, Research Informatics, F. Hoffmann-La Roche AG

11:00 Can Data Science Save Pharmaceutical R&D?

Jason M. Johnson, Ph.D., Associate Vice President,

Scientific Informatics & Early Development and Discovery Sciences IT, Merck

Although both premises – that the viability of pharmaceutical R&D is mortally threatened and that modern “data science” is a relevant superhero – are

suspect, it is clear that R&D productivity is progressively declining and many areas of R&D suboptimally use data in decision-making. We will discuss

some barriers to our overdue information revolution, and our strategy for overcoming them.

11:30 Enabling Data Science in Externalized Pharmaceutical R&D

Sándor Szalma, Ph.D., Head, External Innovation, R&D IT,

Janssen Research & Development, LLC

Pharmaceutical companies have historically been involved in many external partnerships. With recent proliferation of hosted solutions and the availability

of cost-effective, massive high-performance computing resources there is an opportunity and a requirement now to enable collaborative data science. We

discuss our experience in implementing robust solutions and pre-competitive approaches to further these goals.

12:00 pm Co-Presentation: Sponsored by

Collaborative Waveform Analytics: How New Approaches in Machine Learning and Enterprise Analytics will Extend Expert Knowledge and Improve Safety Assessment

  • Tim Carruthers, CEO, Neural ID
  • Scott Weiss, Director, Product Strategy, IDBS

Neural ID’s Intelligent Waveform Service (IWS) delivers the only enterprise biosignal analysis solution combining machine learning with human expertise. A collaborative platform supporting all phases of research and development, IWS addresses a significant unmet need, delivering scalable analytics and a single interoperable data format to transform productivity in life sciences. By enabling analysis from BioBook (IDBS) to original biosignals, IWS enables users of BioBook to evaluate cardio safety assessment across the R&D lifecycle.

12:15 Building a Life Sciences Data

Sponsored by

Lake: A Useful Approach to Big Data

Ben Szekely, Director & Founding Engineer,

Cambridge Semantics

The promise of Big Data is in its ability to give us technology that can cope with overwhelming volume and variety of information that pervades R&D informatics. But the challenges are in practical use of disconnected and poorly described data. We will discuss: Linking Big Data from diverse sources for easy understanding and reuse; Building R&D informatics applications on top of a Life Sciences Data Lake; and Applications of a Data Lake in Pharma.

12:40 Luncheon Presentation I:

Sponsored by

Chemical Data Visualization in Spotfire

Matthew Stahl, Ph.D., Senior Vice President,

OpenEye Scientific Software

Spotfire deftly facilitates the analysis and interrogation of data sets. Domain specific data, such as chemistry, presents a set of challenges that general data analysis tools have difficulty addressing directly. Fortunately, Spotfire is an extensible platform that can be augmented with domain specific abilities. Spotfire has been augmented to naturally handle cheminformatics and chemical data visualization through the integration of OpenEye toolkits. The OpenEye chemistry extensions for Spotfire will be presented.

1:10 Luncheon Presentation II 

1:50 Chairperson’s Remarks

Yuriy Gankin, Ph.D., Co. Founder and CSO, GGA Software Services

1:55 Enable Translational Science by Integrating Data across the R&D Organization

Christian Gossens, Ph.D., Global Head, pRED Development Informatics Team,

pRED Informatics, F. Hoffmann-La Roche Ltd.

Multi-national pharmaceutical companies face an amazingly complex information management environment. The presentation will show that

a systematic system landscaping approach is an effective tool to build a sustainable integrated data environment. Data integration is not mainly about

technology, but the use and implementation of it.

2:25 The Role of Collaboration in Enabling Great Science in the Digital Age: The BARD Data Science Case Study

Andrea DeSouza, Director, Informatics & Data Analysis,

Broad Institute

BARD (BioAssay Research Database) is a new, public web portal that uses a standard representation and common language for organizing chemical biology data. In this talk, I describe how data professionals and scientists collaborated to develop BARD, organize the NIH Molecular Libraries Program data, and create a new standard for bioassay data exchange.

May 1. 2014

BIG DATA AND DATA SCIENCE IN R&D AND TRANSLATIONAL RESEARCH

10:30 Chairperson’s Opening Remarks

John Koch, Director, Scientific Information Architecture & Search, Merck

10:35 The Role of a Data Scientist in Drug Discovery and Development

Anastasia (Khoury) Christianson, Ph.D., Head, Translational R&D IT, Bristol-

Myers Squibb

A major challenge in drug discovery and development is finding all the relevant data, information, and knowledge to ensure informed, evidencebased

decisions in drug projects, including meaningful correlations between preclinical observations and clinical outcomes. This presentation will describe

where and how data scientists can support pharma R&D.

11:05 Designing and Building a Data Sciences Capability to Support R&D and Corporate Big Data Needs

Shoibal Datta, Ph.D., Director, Data Sciences, Biogen Idec

To achieve Biogen Idec’s strategic goals, we have built a cross-disciplinary team to focus on key areas of interest and the required capabilities. To provide

a reusable set of IT services we have broken down our platform to focus on the Ingestion, Digestion, Extraction and Analysis of data. In this presentation, we will outline how we brought focus and prioritization to our data sciences needs, our data sciences architecture, lessons learned and our future direction.

11:35 Data Experts: Improving Sponsored by

Translational Drug-Development Efficiency

Jamie MacPherson, Ph.D., Consultant, Tessella

We report on a novel approach to translational informatics support: embedding Data Experts’ within drug-project teams. Data experts combine first-line

informatics support and Business Analysis. They help teams exploit data sources that are diverse in type, scale and quality; analyse user-requirements and prototype potential software solutions. We then explore scaling this approach from a specific drug development team to all.

 

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PLENARY KEYNOTE PRESENTATIONS: THURSDAY, MAY 1 | 8:00 – 10:00 AM @ BioIT World, April 29 – May 1, 2014 Seaport World Trade Center, Boston, MA

 

Reporter: Aviva Lev-Ari, PhD, RN

 

Keynote Introduction: Sponsored by Fred Lee, M.D., MPH, Director, Healthcare Strategy and Business Development, Oracle Health Sciences

Heather Dewey-Hagborg

Artist, Ph.D. Student, Rensselaer Polytechnic Institute

Heather Dewey-Hagborg is an interdisciplinary artist, programmer and educator who explores art as research and public inquiry. She recreates identity from strands of human hair in an entirely different way. Collecting hairs she finds in random public places – bathrooms, libraries, and subway seats – she uses a battery of newly developing technologies to create physical, life-sized portraits of the owners of these hairs. Her fixation with a single hair leads her to controversial art projects and the study of genetics. Traversing media ranging from algorithms to DNA, her work seeks to question fundamental assumptions underpinning perceptions of human nature, technology and the environment. Examining culture through the lens of information, Heather creates situations and objects embodying concepts, probes for reflection and discussion. Her work has been featured in print, television, radio, and online. Heather has a BA in Information Arts from Bennington College and a Masters degree from the Interactive Telecommunications Program at Tisch School of the Arts, New York University. She is currently a Ph.D. student in Electronic Arts at Rensselaer Polytechnic Institute.

 

Yaniv Erlich, Ph.D.

Principal Investigator and Whitehead Fellow, Whitehead Institute for Biomedical Research

 

Dr. Yaniv Erlich is Andria and Paul Heafy Family Fellow and Principal Investigator at the Whitehead Institute for Biomedical Research. He received a bachelor’s degree from Tel-Aviv University, Israel and a PhD from the Watson School of Biological Sciences at Cold Spring Harbor Laboratory in 2010. Dr. Erlich’s research interests are computational human genetics. Dr. Erlich is the recipient of the Burroughs Wellcome Career Award (2013), Harold M. Weintraub award (2010), the IEEE/ACM-CS HPC award (2008), and he was selected as one of 2010 Tomorrow’s PIs team of Genome Technology.

 

Isaac Samuel Kohane, M.D., Ph.D.

Henderson Professor of Health Sciences and Technology, Children’s Hospital and Harvard Medical School;

Director, Countway Library of Medicine; Director, i2b2 National Center for Biomedical Computing;

Co-Director, HMS Center for Biomedical Informatics

 

Isaac Kohane, MD, PhD, co-directs the Center for Biomedical Informatics at Harvard Medical School. He applies computational techniques, whole genome analysis, and functional genomics to study human diseases through the developmental lens, and particularly through the use of animal model systems. Kohane has led the use of whole healthcare systems, notably in the i2b2 project, as “living laboratories” to drive discovery research in disease genomics (with a focus on autism) and pharmacovigilance

(including providing evidence for the cardiovascular risk of hypoglycemic agents which ultimately contributed to “black box”ing by the FDA) and comparative effectiveness with software and methods adopted in over 84 academic health centers internationally. Dr. Kohane has published over 200 papers in the medical literature and authored a widely used book on Microarrays for an Integrative Genomics. He has been elected to multiple honor societies including the American Society for Clinical Investigation, the American College of Medical Informatics, and the Institute of Medicine. He leads a doctoral program in genomics and bioinformatics within the Division of Medical Science at Harvard University. He is also an occasionally practicing pediatric endocrinologist.

 

#SachsBioinvestchat, #bioinvestchat

#Sachs14thBEF

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Track 5 Next-Gen Sequencing Informatics: Advances in Analysis and Interpretation of NGS Data @ BioIT World, April 29 – May 1, 2014 Seaport World Trade Center, Boston, MA

Reporter: Aviva Lev-Ari, PhD, RN

 

NGS Bioinformatics Marketplace: Emerging Trends and Predictions

10:50 Chairperson’s Remarks

Narges Baniasadi, Ph.D., Founder & CEO, Bina Technologies, Inc.

11:00 Global Next-Generation Sequencing Informatics Markets: Inflated Expectations in an Emerging Market

Greg Caressi, Senior Vice President, Healthcare and Life Sciences, Frost & Sullivan

This presentation evaluates the global next-generation sequencing (NGS) informatics markets from 2012 to 2018. Learn key market drivers and restraints,

key highlights for many of the leading NGS informatics services providers and vendors, revenue forecasts, and the important trends and predictions that

affect market growth.

Organizational Approaches to NGS Informatics

11:30 High-Performance Databases to Manage and Analyze NGS Data

Joseph Szustakowski, Ph.D., Head, Bioinformatics, Biomarker Development,

Novartis Institutes for Biomedical Research

The size, scale, and complexity of NGS data sets call for new data management and analysis strategies. High-performance database systems

combine the advantages of both established and cutting edge technologies. We are using high performance database systems to manage and analyze NGS, clinical, pathway, and phenotypic data with great success. We will describe our approach and concrete success stories that demonstrate its efficiency and effectiveness.

12:00 pm Taming Big Science Data Growth with Converged Infrastructure

Aaron D. Gardner, Senior Scientific Consultant,

BioTeam, Inc.

Many of the largest NGS sites have identified IO bottlenecks as their number one concern in growing their infrastructure to support current and projected

data growth rates. In this talk Aaron D. Gardner, Senior Scientific Consultant, BioTeam, Inc. will share real-world strategies and implementation details

for building converged storage infrastructure to support the performance, scalability and collaborative requirements of today’s NGS workflows.

12:15 Next Generation Sequencing:  Workflow Overview from a High-Performance Computing Point of View

Carlos P. Sosa, Ph.D., Applications Engineer, HPC Lead,

Cray, Inc.

Next Generation Sequencing (NGS) allows for the analysis of genetic material with unprecedented speed and efficiency. NGS increasingly shifts the burden

from chemistry done in a laboratory to a string manipulation problem, well suited to High- Performance Computing. We explore the impact of the NGS

workflow in the design of IT infrastructures. We also present Cray’s most recent solutions for NGS workflow.

SOSA in REAL TIME

Bioinformatics and BIG DATA – NGS @ CRAY i 2014

I/O moving, storage data – UNIFIED solution by Cray

  • Data access
  • Fast Access
  • Storage
  • manage high performance computinf; NGS work flow, multiple human genomes 61 then 240 sequentiallt, with high performance in 51 hours, 140 genomes in simultaneous

Architecture @Cray for Genomics

  • sequensors
  • Galaxy
  • servers for analysis
  •  workstation: Illumina, galaxy, CRAY does the integration of 3rd party SW using a workflow LEVERAGING the network, the fastest in the World, network useding NPI for scaling and i/O
  • Compute blades, reserves formI?O nodes, the Fastest interconnet in the industry
  • scale of capacity and capability, link interconnect in the file System: lustre
  • optimization of bottle neck: capability, capacity, file structure for super fast I/O

12:40 Luncheon Presentation I

Erasing the Data Analysis Bottleneck with BaseSpace

Jordan Stockton, Ph.D., Marketing Director,

Enterprise Informatics, Illumina, Inc.

Since the inception of next generation sequencing, great attention has been paid to challenges such as storage, alignment, and variant calling. We believe

that this narrow focus has distracted many biologists from higher-level scientific goals, and that simplifying this process will expedite the discovery

process in the field of applied genomics. In this talk we will show that applications in BaseSpace can empower a new class of researcher to go from

sample to answer quickly, and can allow software developers to make their tools accessible to a vast and receptive audience.

1:10 Luncheon Presentation II: Sponsored by

The Empowered Genome Community: First Insights from Shareable Joint Interpretation of Personal Genomes for Research

Nathan Pearson, Ph.D. Principal Genome Scientist,

QIAGEN

Genome sequencing is becoming prevalent however understanding each genome requires comparing many genomes. We launched the Empowered Genome Community, consisting of people from programs such as the Personal Genome Project (PGP) and Illumina’s Understand Your Genome. Using Ingenuity Variant Analysis, members have identified proof of principle insights on a common complex disease (here,myopia) derived by open collaborative analysis of PGP genomes.

Pearson in REAL TIME

One Genome vs. population of Genomes

IF one Genome:

  1. ancestry
  2. family health
  3. less about drug and mirrors
  4. health is complex

CHallenges

1. mine genome

2. what all genome swill do for Humanity not what my genome can do for me

3. Cohort analysis, rich for variance

4. Ingenuity Variant Analysis – secure environment

5. comparison of genomes, a sequence, reference matching

6. phynogenum, statistical analysis as Population geneticists do

Open, collabrative myopia analysis GENES rare leading to myuopia – 111 genomes

– first-pass finding highlight 12 plausibly myopia-relevant genes: variants in cases vs control

– refine finding and analysis, statistical association, common variance

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