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Wednesday, February 16
3:00 PM
SPACs: Finding the Right Fit Between Teams

At least 50 biopharma companies have gone public via SPAC (special purpose acquisition company) deals in 2021. At least an additional 50 SPACs are actively searching for health care companies to acquire and bring to public markets within the next two years. For entrepreneurs seeking a SPAC deal, finding the right fit quickly between your company’s needs and a SPAC sponsor’s investment thesis is key to success. This panel will discuss which financial, scientific, and managerial characteristics are most appealing to SPAC sponsors and the critical factors biotech management teams should prioritize in reviewing SPACs as potential fundraising sources

Thank you to this session’s sponsors, Jonas Grossman, Managing Partner and President, Chardan, as well as Kristin Kraeger, Esq., Managing Director, Financial Services Group, Aon Risk Solutions, who is also acting as the moderator for this session.


  • Kristin Kraeger, Aon Risk Solutions, Managing Director, Moderator
  • Michael Byrnes, eFFECTOR Therapeutics, Chief Financial Officer
  • Maggie Cook, Renovacor, Inc, CEO
  • Michelle Doig, Omega Funds, Partner
  • Jonas Grossman, Chardan Capital Markets, President

“I think more and more institutional investors have come to understand the advantages of SPAC companies and recognize some of the advantages pursuing a SPAC transaction versus a traditional IPO transactions, which really haven’t seen a lot of innovation for decades. A SPAC really addresses a lot of the pain points that many companies go through on the pathway to going public, one of which is cycling up your capital before you launch and go public. The other pain point is finding a partner that can help the company raise capital along the way rather than only relying on an investment bank. The third pain point is flipping the costs around. Compared to an IPO, where cost is high at the beginning, with a SPAC you can line up your capital before really committing to the transaction.” - Jonas Grossman

“The advantage for Renovacor in pursuing a SPAC over the IPO route was the fact that there's capital already raised so then we could go down the path of pitching those investors in the SPAC, pitching investors, highlighting what the deal would look like, and having more confidence in what the valuation pricing would be. And then we could talk about how much capital would be raised and when going the SPAC route compared to a private financing or a more traditional IPO. So we had more confidence in being able to bring the money in in a certain amount of time at a certain valuation.” - Maggie Cook

“I think for the right company a SPAC is a very elegant way to combine the costs of an IPO and enabling the raising of larger quantities of capital all at once, as well as, importantly, bringing in a curated specialist investor group.” - Michelle Doig

“I think the key pain point for everyone in any investment scenario is how much capital is coming in, and are these investors going to be able to continue to support the company going forward? That's really where finding the right match for the SPAC matters. It is also important to find a team that understands your business and that has access to capital.” - Jonas Grossman

“Teams that match well with a SPAC are those that are interested in moving quickly. SPACs don’t work well in a slow environment. Investors are looking for someone who's super motivated and who really wants to move quickly and get them the information that the team needs quickly.” - Jonas Grossman

“Do your research. Make sure that you know you fit the criteria for the various different SPACs. There's lots of advisors out there that can be helpful in starting to engage with different SPACs. But really, it will be finding a good fit and a good match. Then you can engage directly with a banker on moving forward.” - Michelle Doig

“If you're a really early stage company, you’re probably not ready just yet. For a company like Omega Funds, we're looking for a little more critical validation before we invest.” - Michelle Doig

“With regard to the risk of redemptions, my recommendation to management teams is to have a different type of transaction that allows funding into your base case. Have a flexible Use of Proceeds model that delivers value to investors once you close the transaction and become a public company.” - Michael Byrnes

“One of the key positives of SPACs is that you can figure out pretty quickly if there's a deal within 60 days or so.” - Jonas Grossman

“When pursuing a SPAC you have to remember that you are doing three deals all at once. So you need to be prepared for a pretty intense workflow as you move from committing to the process and to closing. But the advantages are that you do have more confidence in closing with a certain amount of capital in a certain timeframe.” - Maggie Cook

“I'm very optimistic about biotech innovation and how we can turn capital into great returns for investors. I think that SPACs in particular within the biotech industry, versus other sectors, provide a really intriguing solution.” - Jonas Grossman

2:00 PM
Prioritizing Gene Therapies’ Approval & Commercialization Challenges

As of June 2021, the FDA has received more than 900 gene therapy applications for investigations – but only two heritable diseases currently have FDA-approved gene therapies.

Gene therapies hold tremendous promise for patients, and technologies like CRISPR-Cas9 are poised to create a new wave of medicines ­– but how can we ensure they actually get to patients?

Luca Issi, Sr Biotech Research Analyst at RBC Capital Markets Wealth Management, moderated a discussion with experts including:

  • Will Chou, CEO of Aruvant Sciences, Inc.
  • Lawrence Klein, PhD, COO of CRISPR Therapeutics AG
  • Barbara Lavery, Chief Program Officer of Alliance for Cancer Gene Therapy
  • Guarav Shah, CEO of Rocket Pharma

Where are we in the innovation cycle and where are we going next?

“Overall, it’s still a young market,” said Aruvant Sciences’ Chou. “There are going to be more wins, and when those happen, there’s going to be a different psychology in the market.”

One challenge is human talent: “This is a people business, an expertise business,” he continued. “There will be more positions than experienced people, but with more time, people will get experience.”

“We’re really excited about the potential for gene editing to introduce a step change for what these gene therapies are able to achieve clinically,” said CRISPR Therapeutics’ Lawrence Klein. “CRISPR gene editing can usher in a new wave of therapeutics.”

Both a challenge and opportunity is the “sheer volume of new modalities, new approaches, and things coming out of academia that have great promise," said Alliance for Cancer Gene Therapy’s Barbara Lavery. "But how do you track those into the commercial setting and take them all the way to patients?”

There’s an “enormous amount of creativity and innovation coming down the pike,” but we have a lot of work to do to get to product approval," she added.

What about safety?

“Safety’s certainly on everyone’s mind,” especially with regards to some sickle cell therapies, said Chou.

“A really fantastic job has been done with the transparency of these investigations.”

“The number of patients treated with CRISPR-based therapies is in the hundreds,” with “zero side effects minor or major attributable to the gene editing process,” said Klein.

“There can be a tendency to think of the genome as this immutable, never-changing object,” but “no two cells in your body have the exact same genomic material,” he continued.

A sunburn would lead to “more DNA damage than we’ll ever produce with treating a patient with one of these CRISPR-based therapies that we’ve developed with the stringent require we adhere to.”

How should we think about durability and sustained efficacy?

The Alliance for Cancer Gene Therapy’s Lavery brought up the newly released 10-year data on the first CAR T patients treated, which showed that cells are still present 10 years later.

“In solid tumors, the biggest thing we’re lookin at is the tumor micro-environment,” she said. We’re “just at the beginning of the work in solid tumors.”

So, what’s next?

“In the next 10-12 years we’ll actually be able to apply it to more common, chronic conditions,” predicted Klein.

“For the first time in the history of our species, we’re talking about not therapies but cures and I think people don’t quite see that point yet,” said Rocket Pharma’s Guarav Shah.

Once, people didn’t believe this was possible, but “we are so far past that now, we’re going to see so many more new successes,” said Chou. Expect a “sea change.”

1:00 PM
Cures 2.0 Legislation and Patient-Focused Drug Development Opportunities

Moderator: Sarah Alwardt, PhD, Senior VP, Healthcare Transformation, Avalere Health


In November 2021, US Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) introduced Cures 2.0 legislation, to supplement and expand the 21st Century Cures Act that was signed into law in 2016. The new proposal seeks to accelerate biomedical development with increased roles for patient-provided data and real-world evidence, plus funding to launch an Advanced Research Projects Agency for Health (ARPA-H).

This panel will consider the opportunities and challenges of the proposed legislation’s approaches and the lessons learned about patient-centered drug development since the original Cures Act took effect.

Khushboo Sharma of BIO was asked to explain the history of how we got to this new bill. She said it started with the regular Prescription Drug User Fee Act (PDUFA) negotiatiaons that take place every five years and establish FDA fees and policies. In negotiations for PDUFA V around 2012 and then in Negotiations for PDUFA VI in 2017 there was discussion of the need to consider patient input in the process of drug development and approval. As Sharma explained, these considerations of the need to appreciate patient-centered data were included in the 21st Century Cures Act, called Cures 1.0, which will soon be updated with Cures 2.0.

Melissa Bartlett, an expert in the legislative process for Chamber Hill Strategies, said Cures 2.0 is being developed alongside the current PDUFA VII process, which must be passed by Congress in September, so legislators may try to make it easier to pass some of the planned reforms in Cures 2.0 by adding them in PDUFA. “The conversation will have to be, what are those things in Cures 2.0 that can be done easily on a bipartisan, bicameral basis that could be done in terms of PDUFA 7,” she said.

Michael Ward, Vice President of Public Policy at the Alliance for Aging Research, a patient advocacy group, spoke of how his organization has helped set up the patient meetings established by the FDA through Cures 1.0. “Once people started having those meetings, organizations found that hosting those meetings is only piece of the puzzle,” because it was not clear how the results were translated into action. The law has helped because it “provided a more systemic, scientific approach to gathering patient experience data.” But there is clearly more to do as far as ensuring that the FDA uses this data in its considerations. He said he hopes Cures 2.0 can address these issues.

Samantha Roberts of drug developer Genetech said that her company really focuses on a patient centric approach, because it allows them to make products that are of use to patients. She explained the many methods her company uses for collecting information from patients including advisory groups and interviews. “Once we understand what’s important to patients, we need to have valid tools to measure the impacts of our tools on those aspects, and so we’ve been very active in external applications, to drive consensus on the methodology to assess patient reported outcomes,” she said.

Pujita Vaidya of drug maker Amgen Inc. said her company also realizes how it helps them to get patient-centric data. “At the end of it all, patients are at the center of what we do,” she said. “Now I would say that the question is not should we collect patient experience data, it’s more how we should do it.” Her company’s methods include focus groups, interviews, and online patient communities, to extend their reach.

Asked to comment on the plans for Cures 2.0, several panelists said that the intention to include patients needs to be followed up with a real commitment. Sharma mentioned another concern, saying that the current draft of the bill “requires sponsors to collect standardized data on patient experience.” She noted that the practice of collecting patient-experience data is still too new to set standards, but added that she applauds any effort to increase use of patient-centered data and the patient experience in drug development and approval.

11:00 AM
Creating the Next Generation of Biotech Start-Ups through Incubators

Moderator: Chris Garabedian, CEO, Xontogeny


This panel provided an overview of the role of incubators in the biotech ecosystem, looking at how small companies can benefit from these innovative communities, and where to focus their efforts once they get the initial support of an incubator.

The panel recommended that start-ups seeking funding must understand how the incubators prioritize the research projects that will get the most attention and, in some cases, funding.

Regardless of the size and the type of incubator, and the services they offer (such as mentoring and guidance, securing necessary labs and equipment or seed investment), the relationship starts with an application process, panelists said. Start-ups therefore should have a clear picture of what they need as an entrepreneur and what the incubator they are applying to is looking for.

Dr. Glennis Mehra, Director of Biolabs@NYULangone, said her incubator evaluates the applicants “based on the scientific foundations, specific team execution plans, and clear milestones as well as the economic impact and ecosystem impact”.

Vivian Doelling, VP of Investments of North Carolina Biotechnology Center (NCBiotech), said her incubator is looking at “team technology, IP, market competition, etc.” when selecting 20-25 out of 80 applicants a year so “it’s a pretty deep dive and due diligence” into those individual companies.

She advised that start-ups “build an IP strategy, make sure to have sound advice and a strategy to move forward, and that they have the expertise to ensure their IP strategy matches their company’s long-term plans.”

As moderator Chris Garabedian, CEO of Xontogeny noted, when promoting access to capital, incubators also have an evaluation process that helps them determine which of the applicants are ready for a funding pitch and, in line with the services they offer, they mentor start-ups and lead and connect them with potential investors and investor hubs, syndicate parties, and VCs.

Sally Allain of Johnson & Johnson JLABS emphasized the possibilities offered by the public-private partnerships, mentioning J&J’s Blue Knight initiative in partnership with the Biomedical Advanced Research and Development Authority (BARDA) that not only offers mentorship to companies that are working on next technologies, but also expert programming and sponsored residencies for some QFCs.

Julie Gilmore, COO of Business Development in Eli Lilly, recommends starting the initial dialogue regardless of how perfect you think your pitch might be, since “we do like engaging early, so take the lead.”

The advice that Christopher Jeffers, Managing Director of the funder Hibiscus BioVentures, offered to start-ups is to “reach out for help early and reach out to people that do development” since it’s a different world dealing with these venture communities. “It’s a lot harder to fix a company than to build it right,” he said, so the beginning is important.

10:00 AM
Fireside Chat: Shehnaaz Suliman, MD, MBA, MPhil, CEO, ReCode Therapeutics

“There couldn’t be a more exciting and relevant moment to be involved in non-viral delivery platforms,” said Dr Shehnaaz Suliman, continuing, “coupled with the vast potential of genetic medicines such as mRNA and gene editing.”

Dr. Suliman talked with BIO’s CEO about everything from the work being done at ReCode, to what biotech is doing to address market volatility through changes as a result of the COVID-19 pandemic, as well as diversification efforts. 

Speakers include:

  • Shehnaaz Suliman MD MBA MPhil, ReCode Therapeutics, Chief Executive Officer
  • Michelle McMurry-Heath MD PhD, Biotechnology Innovation Organization, President and CEO

“Primary ciliary dyskinesia is a great example of a severe genetic mutation that results in these patients having recurrent infections that lead to lung function decline and premature death. There are no treatments available at all for PCD. And historically it’s been understudied because it’s a very heterogeneous patient population and despite the genetic mutation, it can be hard to run clinical trials and determine what the best registrational path is. We’ve made it our mission to deliver genetic medicines to exactly these kinds of patients.” Said Dr. Suliman in response to how ReCode is addressing the needs of underserved patient populations.

When asked about the effects of the volatile capital market on biotech’s innovation, Dr. Suliman said, “I think we’re seeing the confluence of a correction in valuations that we’ve enjoyed… in addition to headwinds from the macro economy such as rising interest rates, which is resulting in all of this volatility. When I speak to some of the bankers and our folks on the capital markets side of the business they tell me that the industries have compressed by something like 25-30%. And the result of that is that the buy side has become a lot more discerning.” Continuing, “I think focusing on the fundamentals are always true, but I think in addition to that it’s really about focusing on execution and the delivery of really tangible and meaty milestones.”

“The bottom line is that COVID has blurred the lines between work and life and our employees are dealing with a lot - not just in biotech, but all around.” Dr. Suliman said in reflection about the importance of company culture in retaining and supporting employees, “There's COVID fatigue. There’s the realities of balancing personal and professional priorities. And there’s a cadence of constant change and uncertainty.” Continuing, “It demands that we lead differently with a certain kind of empathy… It can be a real differentiator if you work in a place where you have a strong affinity to a mission and where the emphasis is on community.” Ending that, “A sense of stability in a sea of uncertainty is what many of us crave. So I think the great leaders in this time will be those who have a steady hand, that lead with compassion, that coalesce around a mission, and that can create nurturing environments for people to succeed in.” 

When talking about the work she does with Women in Bio, as well as the Boardroom Ready Program, Dr. Suliman said, “There is this perspective that it is hard to find prospective (female) candidates - Well it’s not. In the last 5 years, we’ve graduated about 126 women in this program and we’ve had 125 board placements.” 

Continuing her discussion on the importance of diversity in the industry, Dr. Suliman explained that, “more diversity seems to drive business growth. There’s this triple bottom line concept of environmental responsibility, social responsibility, and stronger and more transparent governance practices that are all good for business. It’s no longer about the quota, but that some of these more hard and objective measures translate to the bottom line and overall better decision making.”

Dr. Suliman concluded the discussion by saying, “I’m so excited about the ReCode Platform. I think it represents a paradigm shift in the way that we think about rationally designing genetic medicine and its delivery. I fundamentally believe that this could be a breakthrough for mRNA and this next wave of genomic medicines.” Also saying that, “The pandemic has given us a unique opportunity to reshape public perceptions of the industry as innovators, as collaborators, and as a force for good. And what I would love to see is that we continue to use this momentum to establish what we do everyday in a much more positive light and to see ourselves as a positive force in other areas that matter as well, like patient access, and representation, and equity, and inclusion.”

9:00 AM
What is New in Cross–Pacific Deal Making and Investment


Anh Do, Partner Indus Capital Partners


This panel looked at international deals in the Asia-Pacific (APAC) region. PwC reports that the significant increase in M&A pharma and life sciences deal flow in APAC that began in Q3 2020 carried well into the first half of 2021 (totaling $26 billion), showcasing that R&D and innovation from the region continues to lead to valuable partnerships and investment opportunities.

The moderator of the panel, Anh Do, a partner with Indus Capital Partners and representative of the investor community, discussed this growing appetite for deals, noting that the accelerating number of cross–border deals came in waves.

“The first wave was for the Chinese biopharma to in-license the global drugs to China markets,” she said. “The second wave was out-licensing of Chinese discoveries to the global markets,” Do said.

Darren Ji, CEO of Elpiscience Biopharma, a Shanghai based biopharma company, said that they already established strong pipeline for out-licensing and have over 10 molecules for going to clinic in the next 24 months.

“Where did that come from? Besides the investment, I would say, is the capital efficiency and operational efficiency,” he said. “Now I see that the drive, the energy, the hunger for scientific innovation, both for industry and for academics, has been such a big uprise in China.”

China gets global

Angus Grant, Chief Business Executive of BeiGene, biotech company based in China, told the panel that that, for the huge investment into the Chinese biotech and biopharma industry it is important to recognize the tremendous advances in harmonization from a regulatory perspective.

“China joining the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) and influencing regulations that are much more consistent with other major sort of markets, has been very helpful.”, Grant said.

He said it is an exciting time for the Chinese biotech because they’ve now become much more global.

“The companies producing first-in-class and best-in-class molecules are partnering locally, regionally and globally in in-licensing and out-licensing. Obviously China is a huge marketplace. And to bring that into the global stage, I think is great for patients in China and worldwide.”

BeiGene is otherwise known for selling a 20.5% stake in U.S. biopharma giant Amgen for $ 2.7 billion in 2019.

Another Chinese biotech company that made significant transaction with major U.S. player from the sector is I-Mab, which made headlines in 2020 for its $1.9 billion deal licensing a CD47 drug to Illinois based AbbVie .

Neil Warma, General Manager of I-Mab US Limited, also participating at the panel, explained that although I-Mab is not very long in their development (founded in 2014), their whole vision was based on novel differentiated first /best – in class assets generated from their own internal R&D. He said the deal allowed his company to leapfrog past the development stage.

“To capture the whole development pipeline, we needed to jump on the initial wave, which we achieved, again based on in-licensing innovative distinctive assets,” he said.

Panelists agreed that the companies that will thrive are those that are adaptive, that have a global mindset, that understand  how to navigate the different regulatory pathways and how to develop drugs that make a difference to patients.

The panelists also agreed that local companies that have deep knowledge of the functioning of the China market, through strong relationships with the regulatory authorities making those the partners of choice.

7:55 AM
Watch: BIO's Dr. Michelle Questions CMS Coverage Decision

BIO President and CEO Dr. Michelle McMurry-Heath sat down yesterday with former CMS Administrator and FDA Commissioner Dr. Mark McClellan, where the conversation focused on the unprecedented decision to restrict coverage of the first disease-modifying Alzheimer's treatment. Here's a snippet:

BIO's Dr. Michelle McMurry-Heath and former CMS Administrator Dr. Mark McClellan
7:30 AM
Welcome to Day 3 of the CEO & Investor Conference

The fun and learning continues today online, with a full line-up of virtual sessions you don't want to miss. Here's what's on the agenda:

09:00 AM ET - What's New in Cross-Pacific Dealmaking and Investment

10:00 AM ET - Fireside Chat with Shehnaaz Suliman, MD, MBA, MPhil, CEO, ReCode Therapeutics

11:00 AM ET - Creating the Next Generation of Biotech Start-Ups through Incubators

12:00 PM ET - The Promise of Protein Degradation in Treating Undruggable Targets

1:00 PM ET - Cures 2.0 Legislation and Patient-Focused Drug Development Opportunities

2:00 PM ET - Prioritizing Gene Therapies’ Approval and Commercialization Challenges

3:00 PM ET - SPACs: Finding the Right Fit Between Teams

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