Leaders in Pharmaceutical Business Intelligence (LPBI) Group

LPBI Group will cover the event in Real Time

@pharma_BI

@AVIVA1950

Aviva Lev-Ari, PhD, RN will be in attendance

• e-Scientific Publishing: The Competitive Advantage of a Powerhouse for Curation of Scientific Findings and Methodology Development for e-Scientific Publishing – LPBI Group, A Case in Point – Updated on 4/2/2018
• Recollections: My days at Berkeley, 9/1978 – 12/1983 – About my doctoral advisor, Allan Pred, other Professors and other Peers
• Reflections on a Four-phase Career: Aviva Lev-Ari, PhD, RN, March 2018

Keynote Speaker: Michael J. Cima, Ph.D., Associate Dean of Innovation, MIT

1. Intraperiotneal Chemotherapy needed to remove the few cells left after surgery _ delivery of drugs to a single compartment
2. Hyperthermic Intraperiotneal Chemotherapy
3. Tumor burden – stage 3 women ovarian cancer
4. Extended IP drug exposure
5. device for drug delivery to the bladder (cancer): Inflammatory bladder disease, overactive Bladder, bladder (cancer); bladder removal (radical cystectomy – residual tumor size 3 cm tumor)
6. Local Drug delivery for stone disease in ureter
7. Change the pharmacology and change the lesion in the bladder – lesion disappeared in a single compartment
8. Mutation burden in Brain Cancer and in Ovarian Cancer much smaller than in Lung cancer
9. local drug delivery to one location in the brain and the drug will be carried to the entire body – pathology of the brain leads to different disease related to the Human Brain. Treatment of hemorrhage
10. Cervical cancer under MRI deliver drug to the tumor hypoxy of the tumor, guide the drug dosage using imaging MRI is Radiation therapy not drug therapy

• Maria Palasis, President and CEO, 480 Biomedical, Inc.
• Maria Berkman, MD, MBA, Director and Head of MedTech practice, Broadview Ventures
• Evan Sherr

Moderator: Harry Glorikian, General Partner, New Ventures Funds

• Paul Just, PharmD, Senior Principal, Medical Device Health Economics, ICON plc

1. VALUE (outcome achieved per $) is the currency for market ACCESS knock down barriers Care COST
2. Physician choose product that they wish to use while providing therapy as the lowest cost
3. Assessing Differentiating Value and Reimbursement
4. No guidance for combination products: New method of treating patients: Drug-Device
5. Value: Who benefits from the Value – Target stakeholders: 90 days vs 18-24 month, long term value

• Pamela J. Weagraff, Director, MedTech Regulatory, IQVIA [Quantile merged IMS]

1. MedTech meet BioPharma
2. Clinical data requirements for medical devices on the increase but not not necessarily in many cases
3. Combination Products: Microfluidics, micronization – not chemistry but features of the drug delivery device
4. Option 1,2,3 for Combination Product Pathways: Draft Guidance –>> FINAL immediately in effect

• Jessica Ballinger, Chief Operating Officer, Lyndra

1. Lyndra’s Ultra-long drug release – Extended Release Oral Capsule: 7 days
2. Dosage Form – Safety
3. Drug delivery – material manufacturing for long term resident inside the human body
4. Candidates: AD, Diabetes
5. Encapsulation automated – 3 partners assembly in several int’l locations in the supply chain: complications in making tablets – three years before the launch, freeze design 1st generation, 2nd generation

• Steven Rosenberg, Otsuka Pharmaceutical