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2022 | Q4 Newsletter
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CONNECT
ADVOCATE
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ADVANCE
John Witkowski, President of DSM Biomedical joins hosts Chris and Rachael in the studio to record Being a Life Sciences Leader.
BEING A LIFE SCEINCES LEADER
PODCAST
Season 2 of Being a Life Sciences Leader launched in Q4 with a live recording of the podcast during LSPA’s signature Life Sciences Future - BioPharm conference. Hosts Chris Molineaux and Rachael Bushey interviewed Ron Philip, CEO of Spark Therapeutics in front of a live studio audience where they learned how his childhood as an immigrant to the U.S. shaped his view as a leader, and his desire to work in the life sciences. Other notable guests in Season 2 include Bruce Shook, Serial MedTech Entrepreneur, Peter Miller, CEO of OptiNose, John Witkowski, President of DSM Biomedical, and more!
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Stream the episodes to hear advice on leadership in the life sciences, key leadership traits, and how the Commonwealth’s top life sciences leaders continue to grow within the industry.
Tara Muzsi
Vice President, Immunology Sales and Marketing, Gastroenterology
Liam Kelly
Chairman, President & CEO
Valerie Asbury
President & CEO
Bryant Limm
S.V.P, General Counsel, & Secretary
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ADVOCACY
Election Leadership Update
Mid-term elections were held November 8. In Pennsylvania, two important statewide races were on the ballot – Governor and U.S. Senate. Both the gubernatorial and senate races garnered significant national attention, and winners were declared. Current Attorney General Josh Shapiro will be Pennsylvania’s next governor, and current Lieutenant Governor John Fetterman will be the next U.S. Senator from Pennsylvania, replacing the retiring Pat Toomey.
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 17 representatives in the House delegation rather than 18. Democrats won nine of Pennsylvania’s congressional seats and Republicans won eight. All congressional members are the same except for the two open seat races in the 12th and 17th, which were won by Summer Lee (D) and Christopher Deluzio (D), respectively.
The Pennsylvania State House and Senate districts all also went through the redistricting process. In the Pennsylvania Senate, Republicans held their majority by a count of 28-22. In the Pennsylvania House, where all 203 seats were up for election, it appears Democrats will have a one-seat majority, though due to several reasons it may take several weeks or months for that majority to materialize. We will have more than 50 new legislators in the Pennsylvania General Assembly.
For more information on Pennsylvania’s election outcomes, please visit the PA Department of State’s Election Returns website.
FEDERAL UPDATES
Government Funding
The U.S. Senate and U.S. House passed an omnibus spending bill, December 22 and December 23, respectively, which was then signed by President Biden December 29. The FY2023 budget comprises approximately $1.7 trillion in federal spending that funds the federal government through September 30, 2023. A topline summary of the 2023 Omnibus Appropriations package can be viewed here.
Specific to the life sciences, we are pleased to see the legislation include a $2.5 billion increase to the National Institutes of Health (NIH), and a $500 million increase for the second year of the Advance Research Projects Agency for Health (ARPA-H). The bill excludes ARPA-H from being located at the NIH and the Director will determine 3+ locations for it. The legislation also includes funding increases in the pandemic and biodefense space for programs such as the Biomedical Advanced Research and Development Authority (BARDA) and the Strategic National Stockpile. Life Sciences PA is pleased to see these investments in basic scientific research and public health and pandemic preparedness.
In addition to the funding outlined above, the omnibus package includes several other provisions germane to our industry:
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Reforms the FDA’s Accelerated Approval pathway
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Makes changes to increase diversity in clinical trials
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Includes most, if not all, of the PREVENT Pandemic Act introduced by Senators Burr and Murray earlier this year.
A summary of many of these changes can be found here.
ARPA-H Roundtable
Dr. Renee Wegrzyn was sworn in as the first director of the Advanced Research Projects Agency for Health (ARPA-H) by U.S. Department of Health and Human Services Secretary Xavier Becerra.
As the administration works with Congress to establish ARPA-H 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.
Additionally, Life Sciences PA President & CEO, Chris Molineaux, moderated a roundtable discussion at Spark Therapeutics with U.S. Senator Bob Casey, U.S. Health and Human Services Secretary Xavier Becerra, and life sciences leaders from southeastern Pennsylvania. Life Sciences PA continues to work with stakeholders throughout the Commonwealth to encourage ARPA-H to be headquartered in Pennsylvania.
New Executive Order on Drug Pricing
President Biden signed an Executive Order October 14 directing the Department of Health and Human Services (HHS) to explore additional actions it can take to lower prescription drug costs. This order is expected to build upon the drug pricing provisions contained in the Inflation Reduction Act passed in August.
The Executive Order will specifically leverage the Center for Medicare and Medicaid Innovation (CMMI), created by the Affordable Care Act. This entity, that previous administrations have used to try and establish “pilot” programs affecting reimbursement for our members, has authority to test new ways of paying for Medicare services.
Under the Executive Order, HHS will have 90 days to submit a formal report outlining its plans to use CMMI’s authorities to lower drug costs. Life Sciences Pennsylvania will work with its national partners to monitor the implementation of this Executive Order. Especially given the challenging financial markets, Life Sciences PA has significant concerns about how any new policy initiatives could further inhibit investment in biopharmaceutical research and development.
STATE UPDATES
Pennsylvania Healthcare Supply Chain Leadership Alliance
Due in large part to the pandemic, supply chain disruptions have been top of mind for many Americans for more than two years. As we continue to recover and adapt to the healthcare and economic strains brought on by COVID-19, lawmakers, industries, and regulators, among others, are looking for ways to improve our supply chains, making them more resilient.
Life Sciences Pennsylvania participated in a panel discussion October 25 as part of the Pennsylvania Healthcare Supply Chain Leadership Alliance (PA-HSCLA). This coalition was formed to educate legislators about the function of the healthcare supply chain and open lines of communication among supply chain allies and government entities responsible for protecting the healthcare needs of Pennsylvanians. Life Sciences PA looks forward to participating in this alliance and increasing awareness of the critical research and development efforts being conducted by entities in the public health and pandemic preparedness sector.
SB 225 - Prior Authorization/Step Therapy
Life Sciences Pennsylvania was pleased to see SB 225 – legislation that amends the Insurance Company Law of 1921 and streamlines and standardizes the process for prior authorization of medical services in Pennsylvania – pass the House and Senate unanimously and then be signed by the Governor November 3.
Life Sciences Pennsylvania was proud to be part of the Patient Provider Coalition – a collection of health care providers, patient groups and other stakeholder organizations supporting SB 225. As part of that coalition, Life Sciences PA looks forward to the positive effect this legislation will have on helping patients access novel medicines and technologies.
Thank you to the American Cancer Society, Cancer Action Network and Pennsylvania Senator Kristen Phillips-Hill for their leadership in passing this legislation.
Patient Summit
Life Sciences PA hosted its 2022 Patient Summit virtually November 10 to provide patient advocacy groups and public officials the opportunity to learn about exciting developments in the life sciences ecosystem and better understand the interaction between payers, patients, innovators, and policy makers. The event brought together more than 90 attendees to hear from a variety of life sciences leaders on topics such as Innovation in Mental Health, Outcomes-Based Arrangements in Medicaid, and an update on various patient access policies.
The goal of this event is to empower patient groups to effectively share their stories and gain the necessary information and allies to influence change through the legislative process. We have the additional goal of educating and informing legislators on issues affecting patient groups, and how they too can work most effectively with them to provide better outcomes throughout the Commonwealth.
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EVENTS
LIFE SCIENCES FUTURE - BIOPHARM
October 6-7, 2022| In-Person & Virtual
A Life Sciences PA signature event, Life Sciences Future - BioPharm returned in-person in Philadelphia this past October. Biotech and Pharmaceutical leaders from across the Commonwealth attended a full day of Company and Investor Reverse Pitches, Keynote Sessions, Poster Presentations, One-on-One Partnering, and concluded with a networking cocktail hour. C-Suite members also attended a live recording of Being a Life Sciences Leader during Breakfast in the C-Suite. Attendees then had the opportunity to login the next day to attend virtual conference sessions and watch any on-demand recordings they may have missed on day one.
The conference covered a variety of timely topics including the state of the industry, market insights, academic and industry collaboration, real estate and development, investor relations, and more! Expert speakers from organizations like GSK, Merck, The University of Pennsylvania, BIO, and Pfizer addressed the crowd, as well as representatives from investment organizations like JPM Securities, BioAdvance, Xontogeny, Ben Franklin Technology Partners, and UPMC Enterprises. The in-person event concluded with a Patient Spotlight, highlighting a young boy who received life-altering gene therapy treatment at CHOP.
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 continued the Operator's Manual in quarter 4, a series of quarterly educational sessions to give advice to member companies on topics like fundraising, finance, operations and legal considerations. In October, LSPA introduced a new series to the manual, Phase-to-Phase: The Guide to Drug Development, to give insight on the drug development process and important 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.
Phase--to-Phase: The Guide to Drug Development features experts from FlowMetric, a KCAS Company, who guide attendees through the drug development process with important considerations for Discovery / Lead Optimization, Pre-clinical, Translational, and Clinical Trials.
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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. 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
CHIEF EXECUTIVE OFFICER DINNER
November 29, 2022 | Merion Golf Club
Life Sciences PA's most exclusive event of the year, the CEO Dinner welcomes leaders across hundreds of organizations for the opportunity to network, connect and hear from a high-level speaker. This year, Greg Deavens, President & CEO of Independence Health Group, addressed the crowd discussing hot topics such as health equity and insurance considerations around pharmaceuticals.
TELL ME ABOUT YOUR DE&I INITIATIVES
December 7, 2022| Hosted Virtually
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Life Sciences PA's popular DE&I series returned with more experts from organizations like MidAtlantic Employer's Association, Diversitas, and 20/20 Visual Media. Leaders discussed the importance of addressing personal and workplace bias to encourage diversity of hiring and thought.
The leaders also emphasized the responsibility of organizations to create a sense of belonging both in their culture and the work they are doing. Lastly, the experts discussed the diverse talent pool and understanding how the qualities of diverse candidates does not create a divide, but adds depth to the success of an organization. Additionally, not capitalizing on inclusivity can exclude potential business opportunities.
ULTIMATE NETWORKING DAY
To close the year, Life Sciences PA hosted the Ultimate Networking Day, an opportunity for different members to make valuable connections throughout the day, and end with a final holiday celebration in our new office space.
Four legends, one stage! Long-time experts in the life sciences gather to discuss how they stay active in the community at this leadership panel. Following the event, Life Sciences PA awarded panelist Bruce Peacock for his work as a transformer in the industry.