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2022 | Q3 Newsletter
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CONNECT
ADVOCATE
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ADVANCE
PRESIDENT'S MESSAGE
Welcome to the 2022 Q3 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 with the optimism we hold each day for the Association and the industry.
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2022 LIFE SCIENCES INDUSTRY ECONOMIC IMPACT REPORT
Life Sciences Pennsylvania released a new study on the economic impact of the life sciences in Pennsylvania. The study shows Pennsylvania’s life sciences ecosystem has made a sizable contribution to the growth and resilience of the Commonwealth’s economy during the COVID-19 pandemic.
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Review the report below:
Being a Life Sciences Leader Season 2 will debut with a LIVE recording October 6 at Life Sciences Future - BioPharm during Breakfast in the C-Suite. Tune in to the podcast to gain invaluable advice from the Commonwealth’s top industry leaders.
BEING A LIFE SCEINCES LEADER
PODCAST
Season 1 of Being a Life Sciences Leader concluded in quarter 3 with a final live recording of the podcast during LSPA’s signature Life Sciences Future - MedTech conference. Hosts Chris Molineaux and Rachael Bushey interviewed LifeScan President & CEO Valerie Asbury in front of a live studio audience, where they learned about her path to become CEO and how the pandemic presented a unique opportunity for her team to pivot. Other notable guests from the end of Season 1 include Ren Capocasale, Vice Chair & Founder at FlowMetric, a KCAS Company, Bryant Lim, S.V.P, General Counsel, & Secretary at Idera Pharmaceuticals, and Dr. Neal Walker, Founder, President & CEO at Aclaris Therapeutics.
Stream the episodes to hear advice on leadership in the life sciences, taking an organization public, and how the Commonwealth’s top life sciences leaders continue to grow within the industry.
Ren Capocasale
Vice Chair & Founder
Bryant Lim
S.V.P, General Counsel, & Secretary
Dr. Neal Walker
Founder, President, & CEO
Valerie Asbury
President, & CEO
ADVOCACY
FEDERAL UPDATES
Inflation Reduction Act
The U.S. House and Senate passed the Inflation Reduction Act of 2022 in early August. This legislative package included insurance subsidies, energy and tax policies and drug pricing reforms. In particular, the drug pricing provisions in the Inflation Reduction Act will:
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Direct the U.S. Health and Human Services Secretary to negotiate with manufacturers on the price of a set number of Part B and Part D medicines
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Institute a requirement for manufacturers to pay rebates to HHS if medicine prices increase over the rate of inflation – this provision applies to commercial insurers
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Reform Medicare Part D and includes a $2,000 out-of-pocket cap for beneficiaries
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Provide free vaccines for seniors in Medicare
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Cap out-of-pocket costs at $35/month for insulin copays in Medicare
The legislative text of the Inflation Reduction Act of 2022 can be found here. More information on the pricing policies can be found here.
Life Sciences PA and its many of its members contacted their Pennsylvania congressional delegation representatives to send a message that enacting government price-setting policies through direct negotiation only serve to hamper patient access to new medicines and inhibit investment – particularly for early-stage companies – in research and development. While the bill ultimately passed, Life Sciences PA will continue to work with its national partners and the Pennsylvania congressional delegation to find policy solutions that increase patient access and encourage investment in innovation.
Should you be interested in an overview of the policies contained in the Inflation Reduction Act, you can view an in-depth webinar hosted by BIO here.
Election Preview
On November 8, the United States will hold its mid-term elections. In Pennsylvania, two important statewide races are on the ballot this year – Governor and U.S. Senate. Both the gubernatorial and senate races have been garnering significant national attention.
Pennsylvania Governor:
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Republican Candidate – Doug Mastriano (current State Senator)
Democratic Candidate - Josh Shapiro (current Attorney General)
U.S. Senate:
Democratic Candidate – John Fetterman (current Lieutenant Governor)
Republican Candidate – Mehmet Oz, MD
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In addition to those two races, Pennsylvania went through a process of redistricting. The redistricting process saw the Commonwealth’s congressional delegation shrink by one U.S. House seat, so we’ll have 17 representatives in the House delegation rather than 18. More information on what those elections look like can be found here.
The Pennsylvania State House and Senate districts all also went through the redistricting process. In the Pennsylvania State House all 203 House seats are up for election. Republicans hold a majority of seats in the Pennsylvania House with 113 representatives, while Democrats hold 89 seats and 1 seat is currently vacant.
In the Pennsylvania State Senate 25 of the 50 Senate seats are up for election. As it stands Republicans hold a majority of seats in the Pennsylvania Senate with 28 seats to the Democrats 21 seats (1 seat is held by an Independent).
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Finally, Pennsylvania will also be electing its lieutenant governor. It is one of eighteen states that elects its lieutenant governor independent of its governor.
Pennsylvania Lieutenant Governor:
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Democratic Candidate – Austin Davis (current State Representative)
Republican Candidate – Carrie DelRosso (current State Representative)
AMR Briefing
Life Sciences Pennsylvania held a multi-state congressional briefing July 18 on the importance of preparing for an emerging public health crisis – antimicrobial resistance. This was the third in a series of multi-state briefings held by a collection of state life sciences trade associations – such as the Healthcare Institute of New Jersey (HINJ), Biocom (California), MichBio, BioNJ, among many others. The previous two briefings focused on the Prescription Drug User Fee Agreement (PDUFA) and Cures 2.0.
This briefing educated attendees, particularly congressional staff, on the importance of incentivizing investment in novel antimicrobials. Additionally, it explained the unique scientific, regulatory, and economic challenges of antimicrobial innovation and stewardship.
Life Sciences PA President & CEO, Chris Molineaux, was pleased to moderate this discussion that also featured: Christopher Burns, Ph.D. – Founder, President, and CEO at Venatorx Pharmaceuticals; David Elin, MSW – Senior Director, Advocacy & Government Affairs at Cystic Fibrosis Foundation; and Tara Vijayan, MD – Medical Director, Antimicrobial Stewardship at UCLA Health.
Clockwise from top left: Tara Vijayan, UCLA Health; David Elin, Cystic Fibrosis Foundation; Christopher P. Molineaux, Life Sciences PA; and Christopher Burns, Venatorx Pharmaceuticals
User Fee Agreements and SBIR/STTR Reauthorization
As the federal fiscal year comes to an end September 30, several Life Sciences Pennsylvania federal advocacy priorities need reauthorization: the User Fee Acts and the Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) programs.
Timely reauthorization of the Prescription Drug User Fee Act, the Medical Device User Fee Act, and the Biosimilar User Fee Act are critical to ensure the Food and Drug Administration (FDA) can keep pace with the significant number of medicines and technologies entering the regulatory review pipeline.
Additionally, the SBIR/STTR programs are complementary programs that have been critical in providing small companies with early-stage capital funding. The funding provided through these programs is especially important for the life sciences, as it helps to de-risk the innovative products companies are pursuing and advances the development of new treatments for patients.
Life Sciences PA continues to urge its congressional delegation to include reauthorization of these program in any kind of bill – such as a continuing resolution – Congress must pass before the September 30 deadline to fund the government.
ARPA-H
The U.S. Department of Health and Human Services is working to establish the Advanced Research Projects Agency for Health (ARPA-H). In fact, President Biden announced September 12 his intent to appoint Dr. Renee Wegrzyn as the first director of ARPA-H.
As the administration works with Congress to establish ARPA-H, a process that continues to develop, many states and regions have begun advocating for ARPA-H to be headquartered in their respective geographies. Given Pennsylvania’s life sciences leadership, Life Sciences PA encouraged the administration to strongly consider Pennsylvania as that location and had more than 40 organizations sign on to that letter. Here is the letter urging the Secretary of Health and Human Services, Xavier Becerra, to strongly consider Pennsylvania for the ARPA-H headquarters. Life Sciences PA continues to work with stakeholders throughout the Commonwealth to encourage ARPA-H to be located in Pennsylvania.
Rally for Medical Research
Life Sciences Pennsylvania was honored to take part in the annual Rally for Medical Research in Washington, D.C. This event, spearheaded by the (Pennsylvania-based) American Association for Cancer Research (AACR) brings together national, state and local organizations to advocate for robust National Institutes of Health (NIH) funding – one of Life Sciences PA’s top federal priorities – and a bipartisan issue among the Pennsylvania delegation. These meetings ensure our congressional representatives understand the importance of medical research for patients, and for our life sciences economy.
Rally for Medical Research participants gather in Washington, D.C. before going to meetings on Capitol Hill
STATE UPDATES
Budget Passed
The Pennsylvania General Assembly passed a budget that was signed into law by Governor Wolf July 8. This budget represents Governor Wolf’s last budget in office as his second-term concludes at the end of the year. The final budget agreement includes $42.7 billion in General Fund expenditures, and more than $45.2 billion when supplemental spending and federal stimulus spending are included. This increase in spending can be credited to funds received from the Federal government’s American Rescue Plan Act (ARPA) and higher than expected revenues. Life Sciences PA was pleased this year’s budget provides for an annual phase-down of the Corporate Net Income Tax (CNIT) by 1% to 8.99% beginning in January 2023, with future reductions of 0.5% annually until the rate reaches 4.99% in 2031.
The final budget also includes two funding increases. The R&D Tax Credit Cap has been increased by $5 million to an expanded cap of $60 million with $12 million set aside for small business. The Ben Franklin Technology Partners received an increase of $2.5 million bringing their total funding to $17 million. It also contains the following items of interest to Pennsylvania’s life sciences community:
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$3 million to the three ($1 million each) Life Sciences Greenhouses
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Up to $15,000,000 in Keystone Innovation Zone (KIZ) tax credits
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13.6 percent of the state’s annual tobacco settlement payments for the Commonwealth Universal Research Enhancement (CURE) Program in the Department of Health to fund research projects conducted by Pennsylvania-based researchers, universities, medical schools and other institutions. This year’s budget continues allocations from the CURE dollars specifically for spinal injury research, pediatric cancer research and equipment grants for biotechnology research
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Department of Health funding for Bio-Technology Research is included at $10,600,000
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$5,000,000 in ARPA funding provided for grants to promote the growth or development of new and innovative technologies from biotechnology, life sciences, pharmaceutical and health fields.
PA Rare Disease Advisory Council Summit
The PA Rare Disease Advisory Council (PARDAC) was created through legislation in July 2017. When it was formed, Pennsylvania was only one of four states with a rare disease advisory council – an entity formed to improve the quality of life for all those affected by rare disease.
PARDAC held its Stakeholder Summit September 22 in Harrisburg, and Life Sciences PA was proud to attend this event that provided an update and background on several issues important to Pennsylvania’s rare disease community. PA Rare Disease Caucus Co-Chairs: Senator Judy Ward, Representative Mark Longietti, Senator Maria Collett, Representative Barbara Gleim, and Acting Department of Human Services Secretary Meg Snead, were all in attendance. PARDAC provided an update on its PA Rare Disease Needs Assessment Survey and they continue to seek input from persons with a rare disease who reside in the Commonwealth.
B. Braun Ribbon Cutting
Life Sciences PA was honored to participate in a ribbon-cutting ceremony for B. Braun’s new, 310,000 square feet medical device manufacturing facility in Allentown. This facility – a state-of-the-art, $200 million expansion project – doubles the footprint of B.Braun’s current Allentown facility and will increase workforce there to more than 1,700. The investment will benefit healthcare providers and millions of patients across the country by adding capacity to manufacture critical life-sustaining medical equipment here in the U.S. The event was attended by company leadership and public officials from the Lehigh Valley and represents a significant investment in Pennsylvania’s life sciences community.
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EVENTS
LIFE SCIENCES FUTURE - MEDTECH
July 20-21, 2022| In-Person & Virtual
A Life Sciences PA signature event, Life Sciences Future - MedTech returned in-person for the first time since the pandemic. MedTech leaders from across the Commonwealth gathered in King of Prussia to hear the latest in technology, how patients have been impacted by their work, and network with those in their field. The following day, a virtual conference took place packed with Company and Investor Reverse Pitches, and top level speakers in the industry.
Notable speakers at this “hybrid” event include Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health at US Food and Drug Administration (FDA), who shared an update on the regulatory landscape for attendees. Bruce Stahlman, a patient of Novocure, spoke on the life altering device he uses each day to prolong his life living with brain cancer. The live audience also attended the season finale recording of Being a Life Sciences Leader, LSPA’s new podcast. LifeScan President & CEO Valerie Asbury joined hosts Chris Molineaux of Life Sciences PA and Rachael Bushey of Troutman Pepper to discuss her career path in the life sciences. Val gave the audience insight into how her team was able to pivot during the pandemic, and how challenges in her career have become great lessons when looking back. Investment experts addressed our virtual crowd on what products they are looking to invest in, the process of partnering, and answered questions about possible partnerships. The medical technology and device community continues to thrive in Pennsylvania thanks to our dedicated member organizations.
OPERATOR'S MANUAL - QUARTERLY SERIES
Life Sciences PA constantly evolves programming to meet the needs of members and help them reach their organizational goals. LSPA launched the Operator's Manual in quarter 3, a series of quarterly educational sessions to give advice to member companies on topics like fundraising, finance, operations, and legal considerations. Thanks to the generous support of the sponsors of these series, all sessions are free to members, giving them the insight into the areas of business operations they need.
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The Art of Fundraising launched in July with experts from Danforth Advisors who discussed real life scenarios and advice on topics such as preparing for the seed round and different stages of fundraising. Hundreds of LSPA members took advantage of this series to ask questions and get live feedback from the Danforth Advisors team.
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Attendees can have all their legal questions answered at the Legal Answers Workshop. Experts from Ballard Spahr discuss a variety of topics in this LAW series, including protecting your IP, licensing agreements and partnering.
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LSPA's first quarterly series, the Finance Operations Series has been assisting attendees with taking control of their financials for over a year. Experts at KPMG cover topics such as audits of financial statements, PA state budget considerations, and deferred compensation
FINANCE COMMUNITY RECEPTION
September 8, 2022 | Conshohocken Brewing Company
Finance leaders in the life sciences industry gathered at the Finance Community Reception for casual networking, festive brews, and a chance to see biotech in action during a tour of the Conshohocken Brewing Company. LSPA is thrilled to provide our members casual networking opportunities to enhance their network and grow their business.
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Start-Up Stadium: Advice from the All-Stars gives early-stage companies the opportunity to pitch their deck to experts before taking it to investors. These all-stars have been successful in raising capital, and give advice and feedback to the organizations looking to take the next step in their fundraising journey. Entrepreneurs are given the option to present their deck to experts in a "stadium" of viewers, or privately in our expert studios. The feedback is invaluable to organizations in preparing to pitch to investors.