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PRESIDENT'S MESSAGE
Welcome to the 2023 Q2 Newsletter. Life Sciences Pennsylvania has been working tirelessly to advocate on your behalf and provide opportunities for you to connect within the life sciences industry. We hope this recap of the past quarter provides you the optimism we hold each day for the Association and the industry.
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ADVOCACY
IRA (Inflation Reduction Act) Implementation
President Biden is expanding IRA negotiations for Medicare drug price controls, doubling down on these bad policies ahead of the 2024 Presidential campaign which is already in full swing. This is likely to remain a popular political refrain for the Biden administration and Members of Congress. Regarding implementation, it is expected negotiation will begin in earnest this fall. Life Sciences PA is working closely with the Pennsylvania Congressional delegation, specifically House Republicans, to continue their role of oversight and accountability.
Meet and Greet with Congressman Deluzio
In June, members of the LSPA federal policy committee had the opportunity to meet with U.S. Representative Chris Deluzio. Congressman Deluzio was sworn-in to office earlier this year, and is one of three new legislators in the Pennsylvania Congressional Delegation. He represents Beaver and Allegheny Counties in western Pennsylvania. During the discussion, the Congressman spoke about his priorities since taking office and our members had a chance to share the important R&D work they’re conducting in the Commonwealth. Specifically, the importance of passing a bipartisan Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization by September 30, 2023. Working directly with our congressional delegation is a core accountability of LSPA and these events are an important opportunity to educate our legislators on incentivizing the Commonwealth innovation economy.
Transitional Coverage for Emerging Technologies (TCET)
Life Sciences PA supports the Ensuring Patient Access to Critical Breakthrough Products Act – H.R. 1691. This act would ensure FDA-approved breakthrough technologies are covered by CMS for several years during which time CMS would be required to make a permanent coverage determination. Life Sciences PA still awaits a final proposed rule from CMS and is working closely with its national partners to pursue a legislative fix. This issue was a focus of Life Sciences Pennsylvania’s in-person advocacy in Washington, DC this spring, and this bipartisan legislation has the co-sponsorship of many members of the PA delegation, second only to California.
Members of LSPA's Federal Policy Committee meet with Congressman Deluzio in Washington DC
Drug Pricing Legislation
The start of the 118th Congress brought closer looks at all actors in the drug pricing supply chain, most notably pharmacy benefit managers. There has been action in both the House of Representatives and in the Senate. Below are links to some of these high-profile hearings and committee sessions:
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Senate Finance Committee “Pharmacy Benefit Managers and the Prescription Drug Supply Chain: Impact on Patients and Taxpayers.”
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House Ways & Means Health Subcommittee Hearing—Why Health Care is Unaffordable: The Fallout of Democrats’ Inflation on Patients and Small Businesses
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The House Energy & Commerce Health Subcommittee held a two-panel, 5 ½-hour hearing, Lowering Unaffordable Costs Legislative Solutions to Increase Transparency and Competition in Health Care, on 17 bills on increasing competition and transparency while lowering costs throughout the health care system, pharmacy benefit managers (PBMs), general price transparency reforms, site-neutral payments, and more.
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The Senate HELP Committee held a hearing regarding the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization, “Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act”
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The House Energy & Commerce Oversight and Investigation subcommittee—Antimicrobial Resistance: Examining an Emerging Public Health Threat that focused on the AMR crisis and stressed urgency for reform.
Advanced Research Projects Agency-Health (ARPA-H)
LSPA is disappointed to share the Greater Philadelphia Hub and Spoke Consortium was not selected to continue into phase two of the Hub selection process by ARPA-H. We appreciate your engagement in this effort and will continue to work with the members of this broad and impressive coalition to recruit program manager applicants to “pursue health breakthroughs that cannot readily be accomplished through traditional research or commercial activity”. We encourage you to share the opportunity to become a program manager and the link to apply with relevant members of your network, including biomedical scientists, physicians, social and behavioral scientists, physical scientists, biostatisticians, data scientists, mathematicians, economists, and public health specialists.
R&D Amortization
The 2017 Tax Cuts and Jobs Act (TCJA) modified Section 174 of the US tax code. Starting in 2022, businesses could no longer deduct research and experimentation expenses in the same taxable year. Currently, businesses must amortize such deductions over five years for domestic expenditures or over 15 years for foreign expenditures. This mandatory amortization diverts much-needed funds away from small R&D-intensive companies, potentially jeopardizing the development of future treatments and negatively impacting the local economies where these companies are established. Life Sciences PA supports HR. 2673 as well as S. 866 (American Innovation and R&D Competitiveness Act of 2023) to restore the expensing of R&D expenditures to ensure the development of future treatments and cures. Pennsylvania is tied with Texas for the most co-sponsors of this legislation.
In June, the House of Representatives Committee on Ways and Means passed out of committee a new tax package that will push the R&D amortization implementation to December of 2025. While this isn’t a complete repeal of Section 174, we are encouraged to see movement here in Congress addressing this issue.
MDMA Annual Meeting
Life Sciences PA attended the MDMA Annual meeting this spring in Washington, DC. This event is an important opportunity to hear from MedTech leaders in the public and private sectors, and strengthen relationships with one of our national partners. At the event, we heard directly from FDA Commissioner Dr. Robert Califf on several updates and priorities of importance to the medical technology community. There was also a panel discussion on the continued efforts of MDMA members on DE&I initiatives at all levels of R&D and manufacturing.
MDMA Annual Meeting in Washington DC (April 27 - 29, 2023)
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New Life Sciences Caucus Co-Chairs
As the new session of the General Assembly began the Pennsylvania House and Senate were each without a life sciences caucus co-chair after the 2022 retirements of Representative Mark Longietti (D-Mercer County) and Senator Bob Mensch (R-Montgomery County). While difficult to replace both of those individuals and their engagement and leadership with Pennsylvania’s life sciences community, Life Sciences PA is pleased to share the Life Sciences Caucus has selected two new caucus co-chairs: Representative Bridget Kosierowski (D-Lackawanna County) and Senator Frank Farry (R-Bucks County).
Representative Kosierowski was sworn into the Pennsylvania House in March 2019 following a special election in the 114th District. Before serving in the House, Rep. Kosierowski was a registered nurse with more than 25 years in the healthcare sector. She sits on the House Appropriations, Health and Insurance Committees among others.
Senator Farry was elected to the Senate of Pennsylvania in November 2022 to represent the 6th Senate District in Bucks County after serving seven terms in the House of Representatives. Senator Farry Chairs the Urban Affairs & Housing Committee, and is on the Appropriations, Health & Human Services and Consumer Protection & Professional Licensure (Vice Chair) committees.
Life Sciences PA looks forward to working closely with the two newest co-chairs of the Life Sciences Caucus.
Budget Update
he Pennsylvania House passed the General Appropriations Act July after the Pennsylvania Senate initially passed the bill Friday, June 30. This legislation serves as a spending plan for the commonwealth. Governor Shapiro is expected to sign it.
The overarching agreement includes approximately $45 billion in General Fund expenditures. This represents an increase of approximately $2.5 billion over last year’s General Fund expenditures.
A fiscal code bill will need to be passed by the Senate and sent to the House; however it is unclear when that will occur due to disagreements over an education funding component in the budget.
Based on the information available, several of Life Sciences Pennsylvania’s budget priorities are maintained at their current levels. A readout on the budget priorities and funding for additional programs of interest to the life sciences are as follows:
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The Ben Franklin Technology Partners maintain their total funding of $17 million.
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The budget continues to provide $3 million to the three ($1 million each) Life Sciences Greenhouses to fund early-stage, innovative life sciences companies.
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$33 million for the Pennsylvania First (PA First) program. PA First is a comprehensive funding tool to facilitate increased investment and job creation within the commonwealth.
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The budget funds the newly created Office of Transformation and Opportunity – a one-stop-shop for businesses looking to grow and an office that will work closely with Commonwealth agencies to facilitate economic growth, job creation and innovation
These budget items comprise several of our highest state legislative priorities and we are grateful to the new administration and General Assembly for continuing to invest in innovation and life sciences growth. We work closely with the Life Sciences Caucus Co-Chairs and with leadership in the Pennsylvania Legislature to secure, protect, and expand these critical incentives for the life sciences community. We will continue to monitor legislative developments for updates on additional programs such as the Research & Development Tax Credits, Keystone Innovation Zones, CURE Funding, and additional policy priorities.
Prescription Drug Affordability Board (PDAB) Legislation
LSPA President & CEO Chris Molineaux spoke at a Pennsylvania House Health Committee Informational Meeting on Prescription Drug Affordability Boards (PDAB). The meeting was comprised of four panels with varying perspectives on the issue and a board’s ability to lower the cost of prescription medicines. The meeting was chaired by Representative Dan Frankel, the Chair of the PA House Health Committee who previously introduced PDAB legislation in Pennsylvania. His previous bill is available HERE. He has not reintroduced this legislation yet.
While this legislation has taken a backseat to budget negotiations, Life Sciences PA members can contact their representatives in the State House let them know this bill will do little, if anything, to bring down the cost of prescription medicines borne by patients, and could establish price controls that inhibit innovation in the Commonwealth.
LSPA President & CEO Chris Molineaux speaks at a Pennsylvania House Health Committee Informational Meeting on Prescription Drug Affordability Boards.
Patient Access Legislation Update
With more than 50 patient advocacy group members, Life Sciences PA continues to support legislative proposals that increase patient access to novel medicines and technologies and oppose policies that interfere in the doctor-patient relationship.
To that end, Life Sciences PA is pleased to highlight the upcoming introduction of biomarker testing and non-medical switching legislation in the Senate. The biomarker bill will be introduced by Senator Devlin Robinson (R-Allegheny County) and you can view the co-sponsorship memo for the bill HERE. Representative Mullis (D-Lackawanna County) will be the prime sponsor in the State House. Under this legislation, state-regulated insurance plans, including Medicaid, will provide biomarker coverage to patients supported by clinical practice guidelines or peer-reviewed scientific evidence. Thanks to Donna Greco and the American Cancer Society Cancer Action Network for their leadership on this legislation.
Similarly, Senator Judy Ward (R-Blair, Fulton, Huntingdon, Juniata and Mifflin Counties) reintroduced her non-medical switching legislation, SB 348. This bill would amend the Unfair Insurance Practices Act to prohibit health insurers from altering the coverage or premiums included in an insured person’s health insurance policy during the policy term when an insured person has already received a specific treatment, service, or prescription drug. Thanks to the Community Liver Alliance for their leadership with the PA Non-Medical Switching Coalition on this legislation.
Qualified Manufacturing Innovation and Reinvestment Deduction (QMIRD)
As the Commonwealth looks to expand its toolbox for incentivizing innovative manufacturing projects – many of which are life sciences related – Life Sciences PA was pleased the Pennsylvania House Finance Committee voted in favor of HB 1219 (sponsored by Representative Tim Briggs). This bill standardizes and expands the Qualified Manufacturing Innovation and Reinvestment Deduction (QMIRD) program.
The life sciences industry is experiencing a significant uptick in biomanufacturing capital expenditure. The desire to locate more of the biopharmaceutical supply chain facilities within the United States is one of the many side effects of the COVID pandemic on our economy, and Life Sciences PA was proud to support this legislation during a House Finance Committee hearing held June 20.
BUS TOUR
April 14, 2023 | Montgomery County, PA
Life Sciences PA hosted a bus tour for state legislators in Montgomery County April 14. This three-hour tour provided public officials with first-hand visits and interactions with several life sciences entities including the Jefferson Institute for Bioprocessing; ActiveProtective, an early-stage medical technology company in Fort Washington, PA; and Janssen R&D in Spring House, PA. These visits are critical to helping legislators understand the complex and innovative ecosystem Life Sciences PA represents. LSPA was pleased to be joined by six legislators and staff from four additional offices during this tour.
ADVOCACY DAY
Life Sciences PA was honored to host its annual Advocacy Day April 25 in the Pennsylvania Capitol in Harrisburg. The day began with a conversation with Lieutenant Governor Austin Davis speaking with Advocacy Day attendees and was followed by close to 60 attendees in 6 groups taking part in 29 meetings throughout the day. This day is an important opportunity for Life Sciences PA member organizations to share their story with public officials, and ensure they understand the efforts of life sciences establishments to bring novel medicines and technologies to patients.
April 25, 2023 | Harrisburg, PA
SPECIAL EVENT ON ALZHEIMER'S
June 9, 2023 | Philadelphia, PA
June is Alzheimer’s and Brain Awareness Month, and currently more than 280,000 individuals in Pennsylvania are living with Alzheimer’s disease, and over 404,000 family members and friends are providing care to their loved ones. Life Sciences Pennsylvania was honored to host a discussion at the University City Science Center, in partnership with Eli Lilly and Company, on the economic impact of the disease, challenges, and opportunities for innovation to cure Alzheimer’s, and how policymakers can support continued neuroscience innovation in the region.
The event consisted of opening remarks from Mark Mintun, MD, the Group Vice President, Neuroscience R&D at Lilly Research Laboratories, and the President, Avid Radiopharmaceuticals and was followed by remarks from the Staff Director of the U.S. Senate Special Committee on Aging, Lizzy Letter. That committee is chaired by U.S. Senator Bob Casey. The event concluded with a comprehensive panel discussion on diagnosing, treating, and caring for Alzheimer’s patients and how we can improve those efforts moving forward.
CLICK BELOW TO VIEW OUR 2023
ADVOCACY PRIORITIES
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EVENTS
ANNUAL AWARDS DINNER
May 3, 2023 | Merion Cricket Club
Individuals and companies who have outstanding contributions to the industry during the past year and have dedicated their careers to achieving better outcomes for patients were honored at the intimate Annual Awards Dinner.
Congratulations to the 2023 Annual Awards Winners, and thank you for your dedication to the patients in our Commonwealth and our world.
President's Service Award
Federal Official of the Year Award
Hubert JP Schoemaker Leadership Award
President's Service Award
ANNUAL TAILGATE
May 9, 2023 | King of Prussia, PA
Over 700 members of the life sciences community joined us in King of Prussia for the Annual Tailgate. Attendees brought members of their team along to make new connections and exercise their creativity by decorating block parties. The lot was filled with games, food trucks, and other activities that individuals enjoyed while making new connections and strengthening relationships with their peers.
Congratulations to the winners of the Best Block Party Contest, The O'Connor Group, Harmony Biosciences, Fisher Scientific, and Ally Construction Services, who all went home with prizes for their originality!
Click the right arrow to see some of the best moments from the Annual Tailgate!
LEADERSHIP PANEL ON TAP
April 20, 2023 | Pittsburgh, PA
Leadership Panel on Tap featured experts from Deloitte providing financial and accounting tips to attendees at The Assembly in Pittsburgh. Topics included an outlook on the life sciences industry, early-stage company financing, the Inflation Reducation Act, and more!
Afterwards, attendees networked with other members of the Pittsburgh life sciences community at the world-class life sciences development. A former Ford Model--T manufacturing plant, this space has been transformed into the future home of University of Pittsburgh researchers.
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OPERATOR'S MANUAL
Life Sciences PA continued it's quarterly education series - titled Operator's Manual, with sessions involving experts answering member's topical questions on fundraising and legal advice.
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The Art of Fundraising features experts from Danforth Advisors who discuss real life scenarios and advice on topics such as preparing for the seed round, different stages of fundraising, board topics, and more. On May 18, panelists shared their perspective on managing risk as well as insurance tools and strategies for early stage companies.
Experts from PPD present innovative strategies in outsourcing discovery in Phase-to-Phase: The Guide to Drug Development. In this edition, panelists focused on innovative strategies to discovery that allows small companies to focus on their core discovery needs and frees them up from both a capital and manpower investment.
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Attendees can have all their legal questions answered at the Legal Answers Workshop. In the June 22 edition, experts from Ballard Spahr discussed what life sciences companies need to know about the legal aspects of fundraising, including deal terms, prioritizing programs, licensing, and IP as an asset.
UPCOMING EVENTS
Q3 2023
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MEMBERSHIP
Welcome 2023 New Members!
20/20 Consulting |
Accelerated Biosciences |
Advant-Edge Solutions inc. |
Analytical Technologies Group |
ApiJect Systems |
Archer Insights, LLC |
Armstrong Teasdale LP |
Avancer |
Biologics Consulting Group |
Budd Bioworks |
CP Pathways LLC |
CRADL (Charles River Accelerator & Development Lab) |
Commonwealth University of PA |
Core Management Training |
CosciaMoos Architecture |
CytoEX Inc. |
Cytokinetics, Inc. |
Drug Information Association, Inc. (DIA) |
Eliassen Group |
Epic Insurance |
Evoke Medical, LLC dba DirectSync Surgical |
Exelixis |
FCA |
Faros Properties |
Genesis AEC |
Germfree |
Gilead Sciences |
Goodwin Procter |
J2 Solutions |
KOB Solutions, Inc. |
Keane Consulting |
Keystone Development & Investment |
MSIDE Solutions |
Malinoski Strategic Advisory Services |
Metaplan, LLC |
MetasTx |
Microsize |
Newfront |
PharmaBlock |
Pharmatech Solutions LLC |
Prelude Therapeutics |
Pression LLC |
Prevail Partners |
Prince Performance LLC |
Rebound |
Ren Bioscience |
SIA Partners |
SciSafe, Inc. |
Sentinel Process Systems, Inc. |
Senzo |
SoluStaff |
Stern Investor Relations, Inc. |
Syncro Technology Corporation |
Syridex Bio |
Team Clean Inc. |
The Leadership Edge |
TheracosBio, LLC |
US Specialty Formulations LLC |
Vector Lab Products |
aiaTranslations LLC |
Diamond Members
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BEING A LIFE SCEINCES LEADER
PODCAST
Life Sciences PA launched Season 3 of Being a Life Sciences Leader in April. Leaders throughout the Pennsylvania life sciences community, including those from biotech, pharma, medtech, and research institutions, gave their insights into leadership and provided actionable tips for new start-up CEOs.
Check out the first six episodes of Season 3 below, and stay turned for the rest of the season, while will run through July 26. Be sure to look out for the launch of Season 4 in September!
DOUG MANION
PRESIDENT & CEO
ACLARIS THERAPEUTICS
BRIAN HALAK
MANAGING PARTNER
MEDICAL EXCELLENCE CAPITAL
TOM ANDERSON
CEO & DIRECTOR
SWANBIO THERAPEUTICS
JOHN FUREY
CEO
IMVAX
JOE TRUITT
CEO
iECURE
PHIL JOHNSON
CEO
INTERIUS BIOTHERAPEUTICS
MAUREEN MULVIHILL
PRESIDENT & CEO
ACTUATED MEDICAL
STILL TO COME IN SEASON 3...
