Life Sciences Pennsylvania launched a series called “Connect@” for members to network in a casual and relaxed atmosphere. Please join us for the opportunity to reconnect with life sciences colleagues from the region as well as to meet newcomers to the community.

*Although the event is complimentary you must register to attend.

When: Thursday, October 17, 2019
Where: 100 Delta Drive, Pittsburgh PA 15238
Time: 5:00 PM – 7:00 PM

Schedule:

• 5:00 – 5:45 PM Registration + Networking
• 5:45 – 5:48 PM Welcome from LSPA
• 5:48 – 5:52 PM Welcome from Ryan Pruchnic, Managing Vice President, Cook MyoSite
• 5:52 – 6:00 PM Brief remarks from your speaker
• 6:00 – 7:00 PM Networking

Click here to learn more about Cook MyoSite!

Cook MyoSite Incorporated was formed in 2002 as a wholly owned subsidiary of the Cook Group. Cook MyoSite was established to guide the organization into the expanding world of cellular technologies. Cook MyoSite aims to develop and commercialize technology related to the collection, selection, and expansion of human skeletal muscle cells. Through pioneering efforts, research involving the use of adult skeletal muscle-derived cells for tissue augmentation is being investigated as a potential treatment option for patients with a variety of muscle-related disorders.

In addition to clinical research, Cook MyoSite has been developing and commercializing high-quality primary muscle cells and associated reagents to assist researchers performing muscle-related research since 2008. Our brand is committed to providing the research community with products to research and develop cellular treatments for a variety of muscle-related disorders.

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.

@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.

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.

Join us for our Holiday Member Luncheon and the opportunity to gather with other Life Sciences Pennsylvania member companies – reconnect with life sciences colleagues from the region as well as meet newcomers to the community.

Date: Thursday, December 12, 2019
Location: Hofbräuhaus Pittsburgh – Southside Works 2705 South Water St Pittsburgh, Pa 15203
Timing: 12:00 – 1:30 PM

*This event is reserved for C-Level Executives of Core Life Sciences PA member companies.  Guests will include CEOs, CFOs, CBOs and CSOs from our R&D-based companies, research institutions and investment organizations.

Sponsorships are available: If you are interested in sponsorship, please contact Melissa Callum, Director, Programs, at mcallum@lifesciencespa.org or 610-947-6800 ext 208

Prizes valued at approximately $85,000!

Our two-stage business plan competition is open to anyone in the Pittsburgh region and beyond.

How it works:

Stage one

Entrants submit a short description of their business idea along with a two-minute video elevator pitch. $5,000 in cash prizes. Judges select finalists.

Stage two

Finalists submit an executive summary, business plan, PowerPoint presentation, and make a live presentation to a panel of judges followed by Q&A. $25,000 in cash prizes. Finalists are assigned mentors and receive free access to Palo Alto’s LivePlan software.

Submissions accepted from midnight on September 16 through noon on October 21, 2019.

Rules, Regulations and Policies

Finalists have access to the resources of our sponsors:

• Duquesne University School of Law
• Duquesne Small Business Development Center
• Center of Excellence in Entrepreneurship, including sophisticated equipment in our maker space-Bob’s Launch Pad.  Special thanks to judge Bob Mallet, Former Chairman, Mallet & Company, for making it happen!
• Palo Alto LivePlan software.

Our next workshop, which will be held in Philadelphia on October 16-18, 2019, is focused on understanding and correctly characterizing the 505(b)(2) pathway, while debunking the rampant misconceptions circulating in the pharmaceutical industry. Additionally, the agenda will look at how value-added medicines created through the 505(b)(2) pathway may, with focused upfront planning, satisfy other regulatory authorities, like EMA, allowing them to be parlayed into global marketing opportunities. For SAAMnow, this is a unique workshop in which we will extend our reach beyond just science by collaborating with a complimentary non-profit organization, The 505(b)(2) Platform with a synergistic remit. Our speakers, panelists, moderators and invited FDA will address the science, regulatory, legal, and financing components that are crucial to the successful development and launch of a 505(b)(2) product.

Join us in demystifying 505(b)(2) Development!

The Philadelphia 201
201 N 17th st
Philadelphia, PA 19103

If traveling by train, The 201 is a 4 minute walk from Suburban Station.

Agenda
Become A Sponsor

Similar to a game of chess, clinical development involves the strategic consideration of constantly moving elements, always keeping the end-game in mind, including but not limited to:

• Business goals
• Competitive landscape
• Clinical and regulatory precedent
• Guidance from regulatory interactions
• Advances in medical care
• New scientific / clinical discoveries
• New or changing regulatory guidance / issues

Please join us for an informative discussion on the benefits of clinical strategy, targeted to optimize results and de-risk drug development. 

Breakfast will be provided by PharmaLex and served prior to the event.

Our Subject Matter Experts will be available following the meeting for any individual questions.

Join Women In Bio-Philadelphia Metro chapter for cocktails and hors d’oeuvres as we expand our geographic reach and embrace one of the region’s most exciting life science companies: Rockland Immunochemicals. Come and network with fellow life science professionals, tour Rockland’s beautiful facility, and learn more about ways to get involved and support WIB-Philadelphia Metro.

Established in 1962, Rockland Immunochemicals, Inc. (Rockland) is a global biotechnology company manufacturing leading-edge research tools for basic, applied, and clinical research in functional genomics, gene therapy, and drug discovery markets. Rockland is a privately held company, which operates a manufacturing facility with antibody and protein production capabilities located near Philadelphia, Pennsylvania, USA. Global markets are supported by a highly specialized network of key distributors. Our laboratories consist of over 60,000 square feet, producing antibodies and antibody-based tools that are used to help define mechanisms underlying cell function and disease.

About this Event

Our eighth annual Blood, Sweat & Tears Five Miler & 5K will be bigger and better than ever. For 2019, do both the Five Mile course AND the 5K course and get a medal!  This is a timed event with police support on the roads for safety.  After the event, enjoy the post run festivities like food and drinks and visit the bake sale, gift basket stand, the prize drawing table and meet vendors. A bounce house and a rock climbing wall will be available for all ages. Our theme this year is “Let’s Make Pediatric Cancer Extinct” so consider doing our event as a fund raiser for the Emily Whitehead Foundation.

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.