@LSPA – The Life Sciences Center is open for member use! Join us for coffee and networking at our Open House in our offices.

About @LSPA – The Life Sciences Center : Our updated, 8,600 square foot center offers our members networking and educational events; happy hours; meeting space; Center-wide internet service; quiet, secluded rooms for phone calls, video-conferences or teleconferences; and conference and training rooms. To learn more about The Center, click here.

Time: 8:00 – 9:30 AM

Location: @LSPA – The Life Sciences Center
650 East Swedesford Road, Suite 190 | Wayne, PA

*When driving to Life Sciences PA, please look for building 656 on the signs bordering our complex. Building 650 (Life Sciences PA) is behind 656 in the same complex.

The 2019 CRO & CMO Summit is a half-day program designed specifically for those planning and conducting clinical trials or those who are seeking advice when selecting outsourced providers.

Location:  West Pharmaceutical Services, Inc. in Exton, PA
Date:        Friday November 22, 2019
Time:        8:00 – 11:30 AM

Who Should Attend:
· Individuals interested in becoming involved in a strategic partnership with a CRO or CMO in the next 12 to 18 months
·  Biotech, pharma, medical device or diagnostic companies planning a clinical trial
·  Individuals who have secured a CRO and CMO and the relationship has not been successful

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Agenda
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8 – 8:30 AM         Registration and networking
8:30 – 8:45 AM    Welcome
8:45 – 9:15 AM     Keynote – Potential of Next-Generation T Cell Immunotherapy
Usman “Oz” Azam, MD, President & CEO, Tmunity Therapeutics
9:15 – 9:30  AM    Break
9:30 – 10:30  AM  Panel Discussion – Expertise in Cell Therapy: Clinical Trials and Manufacturing
10:30 – 11:30 AM Networking and Lab Tour

Speaker Details
Keynote: Usman “Oz” Azam, MD, President & CEO, Tmunity Therapeutics

Dr. Azam is Tmunity’s President and CEO. Prior to joining Tmunity in 2016, he was the Head of the Cell & Gene Therapies Unit at Novartis Pharmaceuticals and was a member of the Pharmaceutical Executive Committee. Previous roles at Novartis included Head of Global Medical Affairs & HEOR General Medicines, Chief Scientific Officer and Head of US Clinical Development & Medical Affairs and Global Head Regulatory Affairs for the Neurosciences & Ophthalmic Franchise. Prior to Novartis, he was the CEO of Novaccel Therapeutics LLC, a company he founded focusing on accelerating translational medicine assets. Dr. Azam also held roles at Aspreva Pharmaceutics Inc and J&J. He started his life sciences career with Warner Lambert-Parke Davis in 1998. Dr. Azam is a member of the Board of Directors of the Alliance for Regenerative Medicine. Dr. Azam has a BSc and MD from the University of Liverpool.

Basics of Biotech is a comprehensive, two-day course meant to provide you with an overview of the development of biopharmaceuticals.  The course will start with foundational basics and give a detailed overview of the entire process from discovery to commercialization.  As an attendee, you will learn a bit of the science behind biotech products, the clinical research process, regulatory filings, and scale-up for manufacturing.  Different types of products such as biologic drugs, biosimilars, personalized medicine, stem cell, and regenerative medicine will be outlined.

This training will progress under the umbrella of the development timeline, from start to finish.

Learning Objectives:

Over two days, this interactive course will…

• Explain the biotech processes, what they are and how they work
• Explain the biotech lab, what it looks like and how it operates
• Explain the biotech product development process
• Examine how manufacturing facilities are built and operate
• Examine the evolution of biotech manufacturing
• Relate each step to the previous steps, and provide you with a seamless, consistent overview
• Provide you with an overview of basic science, terminology, and common areas of failure in product development
• Prepare you to improve in your current role, or be ready to enter the biotech field with some foundational knowledge

Who Should Attend?

This course will benefit anyone who is new to the biotech/biopharma industries, needs to know the process at a high-level, or those who need a refresher.  There is no level of prerequisite knowledge or understanding necessary to attend.  Additionally, this course will be of value to those who support any step within the development process, including outside vendors.

The 2020 Annual Dinner is the premier event of the season for the life sciences industry in Pennsylvania. On March 19, 2020 more than 1,400 attendees will convene for this can’t-miss event.  We look forward to hosting industry and community leaders for an evening spent celebrating the successes of the past year.

Sponsorship Opportunities are available. For any additional questions or information, please contact Melissa Callum at mcallum@lifesciencespa.org.

*Following your purchase, you will receive an email confirming your purchase and steps on how to send over your table attendees.

CANCELLATION POLICY: Table purchases are non-refundable.  For Individual Tickets, please contact LSPA to request a refund.  As of COB Friday February 28, 2020 LSPA will no longer refund ticket purchases.

LSPA Members receive a $100 discount by entering promotional code: STATE.

MDMA’s 22^nd Annual Coverage, Reimbursement and Health Policy Conference is being held in Washington, DC on November 13-14, 2019.

MDMA has assembled a dynamic group of speakers and informative sessions for this year’s conference that will share the latest approaches on how to demonstrate value for your medical technologies and what type of clinical data will ensure you secure fair and adequate reimbursement.

CMS’ Director of Coverage and Analysis Group, Tamara Syrek Jensen, is already confirmed to update attendees on the agency’s latest reform efforts and answer their questions.

Other sessions include:

• Working with Private Insurers – Best Practices
• CMS Ombudsman Listening Session
• Securing Local Coverage with MACS
• International Convergence: Aligning Evidence and Pricing Across the USA and Global Markets

REGISTER TODAY for the premier reimbursement conference for medical technology innovators.

The Nuts and Bolts of Early Clinical Research:
– Designing your First in Human Trial
– Assessing ADME and Absolute Bioavailability with Radiolabeled Drug
– Measuring Drug Interactions
– Evaluating Hepatic and Renal Insufficiency

About The Speaker
Space is limited. Please RSVP to Michelle Grundahl, Director of Business Development
at michelle.grundahl@celerion.com by Wednesday, November 6, 2019.
Mike Di Spirito, MSc | Director, Clinical Pharmacology & Pharmacometrics
– Master of Science degree in Rehabilitation Science in the Faculty of Medicine at McGill University in Montreal, Canada
– The Director of Clinical Pharmacology & Pharmacometrics at Celerion
– Over the last 20 years, Mike has worked on hundreds of NDA-enabling studies

About The Host
Celerion, a full-service, early clinical CRO, is the leader in accelerating development for Phase I-IIb. We enable our
clients to make timely decisions with expert advice and high-quality data through our unique combination of medical
expertise, clinical operations experience and scientific excellence. Celerion uses our experience, agility and innovation to
help clients get their drug to market faster so they can start making a difference in people’s lives.

Overview

Please join us for our exciting and updated PDE tradition, “State of the PDE” Cocktail Reception & Annual Business Meeting.

We look forward to an evening of networking with members and friends, an update on the future of the PDE, and a dynamic presentation on “Cannabis and The Law.”

Description

The PDE Member rate is only $30.00; Non-member rate is $50.00, payable by credit card or check. Checks may be mailed to: PDE, PO Box 1298, West Chester, PA 19380.

Speaker

Dr. Sara Jane Ward, PhD
Assistant Professor, Center for Substance Abuse Research, Department of Pharmacology at Temple University

Dress Code

Business / Business Casual

Agenda

5.00 pm Cocktail Reception (cash bar), networking, and heavy hors d’oeuvres
6.00 pm PDE Business Meeting
6:30 pm Keynote Presentation
7:30 pm Q&A Session

Contact

(484) 881-3147 or pdetrade@comcast.net

Travel Information

For directions, please copy & paste the link below.

Venue Information

Talamore Country Club offers the best amenities in the Philadelphia area for corporate meetings, business shows and golf outings. Pour over sales figures, enjoy dining in our historic clubhouse and tee it up on our amazing golf course. Talamore can host groups of almost any size providing all the necessary business services and equipment to make your event a smashing success..https://www.talamorepa.com/contact-us/