effectively running r&d in a resource constraint environment...2016/11/14 · therapeutics...

Organized by

Chris O’Brien, MD Neurocrine Biosciences

Mark Frohlich, MD Juno Therapeutics

Murray Aitken, MBA IMS Institute

CMO and R&D Summit WestEffectively Running R&D in a Resource Constraint Environment

November 14-15, 2016 Marines Memorial Club, San Francisco, CA

Pamela Palmer, MD, PhD AcelRx Pharmaceuticals

Susan Molineaux, PhD Calithera Biosciences

CO-CHAIR CO-CHAIR

KEYNOTE FIRESIDE: 30 TO 300

TECHNOLOGY KEYNOTE

CEO PERSPECTIVE

Donald Jones, MBA Scripps Translational

Science Institute

PRICING

Diego Miralles, MD Adaptive Therapeutics

KEYNOTE FIRESIDE: INNOVATION

Sara Radcliffe California Life Sciences

Association

LUNCH FIRESIDE: R&D LANDSCAPE

Anne-Marie Duliege, MD, MS Rigel Pharmaceuticals

FOSTERING INNOVATION

Pablo Cagnoni, MD Tizona Therapeutics

FIRESIDE CHAT: BIOTECH JOURNEY

Deirdre BeVard Nektar Therapeutics

OUTSOURCING

Mark Simon, MBA Torreya Partners

INVESTING IN BIOTECH

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Executive Sponsor

Associate Sponsors

Supporting Partner

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CMO AND R&D SUMMIT WEST OVERVIEW

Welcome to the annual San Francisco gathering of chief medical officers, investors and other R&D leadership, where we accomplish two goals:

1. To bring together a highly specialized population of R&D leadership in emerging biotechs to address the unique challenges associated with directing and managing all R&D functions with limited resources, while raising capital and strategizing for appropriate exits.

2. To create a network of R&D executives from emerging biotech/pharma companies to share ideas, solutions and support.

The Summit addresses a range of topics to help with decision making impacting risk/benefit, investment, outsourcing, new technologies and collaborations, factors and unlikely factors impacting R&D models, pricing, and responsible exit planning.

Moving molecules through the pipeline in the small and emerging bio/pharma space requires enormous resourcefulness, creativity and tenacity. This Summit is 100% dedicated to supporting the journey to do just that.

If you are interested in sharing ideas for our content or participating in the Summit, please contact Kate at [email protected]. We look forward to presenting the CMO and R&D Summit West on November 14-15 in San Francisco.

Sincerely,

Bridget MurphyConference Planner & Logistics

Meredith SandsExecutive Director, Business Development

Geeta BachaniBusiness Development Manager

Valerie BowlingExecutive Director

Kate WodaConference Director

Elizabeth BardBusiness Development Manager


mailto:[email protected]


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SPEAKING FACULTY

Sunil Agarwal, MD CMO, Ultragenyx Pharmaceuticals

Murray Aitken, MBA SVP & Executive Director, IMS Institute for Health Informatics

Lee Allen, MD, PhD CMO, Argos Therapeutics

Mark Bagarazzi, MD CMO, Inovio Pharmaceuticals

Jeffrey Bartlett, PhD SVP R&D & CSO, Calimmune

Karen Bernstein, PhD Co-Founder & Chairman, BioCentury

James (Jim) Bolognese Senior Director, Strategic Consulting, Cytel

Deirdre BeVard VP, Development Operations, Nektar Therapeutics

Laurie Burke, RPh, MPH Former Director, Study Endpoints and Labeling Development (SEALD), ONDIO, CDER, FDA and Founder, LORA Group

Pablo Cagnoni, MD Managing Director, MPM Capital and President & CEO, Tizona Therapeutics

Bharatt Chowrira, PhD, JD President, Synlogic

Anne-Marie Duliege, MD, MS EVP & CMO, Rigel Pharmaceuticals

Mark Frohlich, MD EVP, Development & Portfolio Strategy, Juno Therapeutics

Bruno Gagnon, BPharm, MSc Global Lead, Clinical Outsourcing, Raptor Pharmaceuticals

Carol Gallagher, PharmD Partner, New Enterprise Associates

Adam Hanina CEO, AiCure

Donald Jones, MBA Chief Digital Officer, Scripps Translational Science Institute

Thomas Lonngren, PhD (hc), MRPharmS, FRCP Former Head, EMA and Strategic Advisor, NDA Group

Diego Miralles, MD President, Adaptive Therapeutics

Susan Molineaux, PhD Founder, President and CEO, Calithera Biosciences

Samuel Nussbaum, MD Former EVP, Clinical Health Policy and CMO, Anthem and Strategic Advisor, Epstein Becker Green

Chris O’Brien, MD CMO, Neurocrine Biosciences

Pamela Palmer, MD, PhD CMO & Co-founder, AcelRx Pharmaceuticals

Suyash Prasad, MD SVP & CMO, Audentes Therapeutics

Sara Radcliffe President and CEO, California Life Sciences Association

Allyson Rinderle, MBA Vice President, Longitude Capital

Camille Samuels, MBA Partner, Venrock

Mark Simon, MBA Managing Partner, Torreya Partners

Jamey Skillings, MD Former SVP & CMO / Clinical Advisor, Tocagen

Komathi Stem, MS Former Strategic Innovation Leader, Genentech/Roche

Barbara Troupin, MD Former SVP & CMO, Apricus Biosciences

John Varian CEO, Xoma

Mark Weinberg, MD Chief Medical Officer and Managing Director, Halloran Consulting Group

SPEAKING FACULTY CMO AND R&D SUMMIT WEST



CMO AND R&D SUMMIT WEST AGENDA

DAY ONE - MONDAY, NOVEMBER 14, 2016

8:00 amRegistration & Breakfast

8:30 am Co-Chair’s Opening Remarks



8:45 am Keynote Fireside Chat: Insights on Innovation and Building Impactful Therapeutic Programs from Adaptive Therapeutics President, Dr Diego Miralles Moving molecules through the pipeline in the small and emerging bio/pharma space requires enormous resourcefulness, creativity and tenacity. Dr Diego Miralles, President of Adaptive Therapeutics, joins us to share his experience with building impactful therapeutic programs including identifying the R&D challenges of moving a product through the development lifecycle, how he supports his team in overcoming those hurdles and how as President he fosters a culture of innovation.

Moderator: Lee Allen, MD, PhD CMO, Argos Therapeutics

Fireside Guest: Diego Miralles, MD President, Adaptive Therapeutics

9:25 am Fostering Creativity and Innovation in Small Biotech Panel This session examines culture, infrastructure, creativity, expertise, risk and tolerance. More specifically:

✤ How is the culture set up for accountability / innovation?

✤ How can we do a better job nurturing and supporting our most innovative people?

✤ How do we make room for disrupters?

✤ Paradigm shift in thinking from what can go wrong to what can go right?

✤ The issue of speed of decision-making and where it comes from?

✤ Thoughts on risks and incentives

Panelists: Sunil Agarwal, MD CMO, Ultragenyx Pharmaceuticals

Jeffrey Bartlett, PhD SVP R&D & CSO, Calimmune


10:05 am Unlikely Players and Disrupters are Evolving the R&D Model. Why Should Emerging Biotech Take Note? Despite exponential increase in new technologies, pharma is still developing drugs and associated evidence the same way we have done for over 60 years. New data sources are exploding in variety, volume and velocity. New players with new capabilities in big data, technology and consumer behavior are entering the drug development field. Unlikely partnerships are forming in drug development to re-imagine the model. Other industries have leveraged emerging technologies and unlikely partnerships to not only create new business models, but reinvent the ecosystem. In this session, we will examine:

✤ How could we rethink our R&D Business model?

✤ Why should pharma take note and react with a sense of urgency?

✤ What role do senior leaders play in transforming the industry?

Komathi Stem, MS Former Strategic Innovation Leader, Genentech/Roche

10:45 am Networking Break

11:15 am Morning Keynote: Disrupting 21st Century Drug Development In this session internationally recognized digital health expert, Donald Jones, will share his insights on the digital clinical trial landscape and the urgent need to pair digitization with drug products for patients. What does smaller pharmas have to be on the lookout for?

Donald Jones, MBA Chief Digital Officer, Scripps Translational Science Institute

11:55 am Disruptive Innovation Panel: Technologies Making a Difference in Clinical Trials This panel will explore companies that are creating and implementing innovative technologies to help better clinical trial design, development and patient experiences.

Moderator: Donald Jones, MBA Chief Digital Officer, Scripps Translational Science Institute

Panelist: Adam Hanina CEO, AiCure



AGENDA CMO AND R&D SUMMIT WEST

12:15 pm Lunch & Fireside Chat

The Evolving R&D Landscape. How R&D Leadership in Emerging Biotech Can Do Even More? Karen Bernstein, Co-founder and Chairman of BioCentury and Sara Radcliffe, President and CEO of California Life Sciences Association, join us to discuss the R&D landscape specifically addressing the following questions:

✤ What is your organization working on to support the biotech industry?

✤ How do you prioritize what you are doing?

✤ How has R&D evolved over the past 5 years and where do you see it going?

✤ How can we keep improving on R&D?

✤ How can we continue increasing the return on R&D?

✤ What are you optimistic about for the industry?

✤ Where would you advise to be cautious?

✤ Thoughts on teams and culture to support innovation and success?

Moderator: Pamela Palmer, MD, PhD CMO & Co-founder, AcelRx Pharmaceuticals

Fireside Guests: Karen Bernstein, PhD Co-founder & Chairman, BioCentury

Sara Radcliffe President and CEO, California Life Sciences Association

1:35 pm CEO Panel: Perspectives on R&D Leadership This panel will bring together CEOs from biotech companies to delve into key components of R&D to get a better insight into concerns and priorities including:

✤ What are the challenges and pressures that keep CEOs up at night?

✤ What are CEOs looking for/expect from their heads of R&D/CMOs?

✤ CEOs experience/vision on moving products through the pipeline and how they can support their R&D/CMO management team to do so

✤ How do you determine when to outlicense a program or even terminate a program?

✤ How much do we need to work with payers in designing trials?

✤ When do we decide to go global with clinical trials?

Moderator: Chris O’Brien, MD CMO, Neurocrine Biosciences

Panelists: Susan Molineaux, PhD Founder, President & CEO, Calithera BiosciencesJohn Varian CEO, Xoma

2:15 pm The Process of Prioritizing Your R&D Dollars Case Study & Group Exercise Understanding what factors go into prioritizing the pipeline and how you choose to spend your limited dollars must derive from a sound strategy. Prioritizing your pipeline extends into a very multi-disciplinary/multi-stakeholder environment ( ie: commercial, financial, epidemiology, payer landscape, regulatory). For small lean companies, there might be more in your pipeline than you could ever assess and move forward in development. Having gone through the experience, Dr Troupin outlines the strategy and process for assessing a pipeline and will also provide a group exercise to give the audience an interactive experience to better understand how to allocate R&D dollars.Barbara Troupin, MD Former SVP/CMO, Apricus Biosciences

2:45 pm Building Your Intellectual Infrastructure Strategy: A Critical Investment In a perfect world, any organization would like to hire individuals to jump right in and get to work on current projects, but the reality is we need to invest in some level of training and provide continuous support. Balancing this with multiple responsibilities is hugely challenging, not to mention tapping into and managing external talent.R&D leadership knows all too well that time needs to be carved out to build an intellectual infrastructure so that people are aligned with the organizational goals and will support moving the product through the pipeline. This session will address current thinking on the following:

✤ How do you build a clinical infrastructure and how do your people fit into that?

✤ When workload exceeds the number of people employed, how do you overcome this challenge in a limited funding environment?

✤ When do you decide to keep something inhouse or outsource it? When do you decide to bring on full time employees?

✤ How do you incorporate talent that comes from a different therapeutic area into your current therapeutic area?

✤ How do you tap into talent networks for consultants, CROs and others servicing small companies?

✤ Best practice ideas to nurture current talent

Jamey Skillings, MD Former SVP & CMO / Clinical Advisor, Tocagen




3:15 pm Networking Break

3:45 pm The CMO/Biostatistician Connection: Driving Development Efficiency What are the advantages of a sound statistical strategy plan in early stage biopharma development? Jim Bolognese will be joined by biotech medical and business leaders in a dialog to challenge the status quo to evolve from utilitarian use of biostatistics and vintage methodologies to make more accurate and better clinical decisions. Topic highlights will include:

✤ Signal markers and how to improve them

✤ Pointers for investors funding proof-of-concept/Phase 1 trials

✤ What’s hot/what’s not in biostatistics: Calculating “Probability of Success” vs merely p-values

James “Jim” Bolognese Senior Director, Strategic Consulting, Cytel

4:05 pm CMO to CMO: Communicating Through the Good, the Bad and the Unexpected CMOs often have the job of being the voice of reason, injecting regulatory reality, and being the one to communicate bad news regarding regulatory feedback or study data to the board and investors. In this session, Halloran’s CMO, Dr Mark Weinberg will host a panel on:

✤ How do you communicate tough news inside and outside the company?

✤ How do you manage external expectations, maintain credibility and talk about it publicly?

✤ What does the press want to hear from you?

✤ How do venture investors and the Street typically react and how CMOs need to respond?

Moderator: Mark Weinberg, MD CMO and Managing Director, Halloran Consulting Group

Panelists: Bharatt Chowrira, PhD, JD President, Synlogic


4:25 pm Panel: How to Determine when/if a Service Provider is Right for your Organization? The reason why this topic gets discussed so often is because finding the right service provider is one of the most difficult decisions a biotech company makes. In this

session, clinical operations veteran, Deirdre BeVard leads a discussion to address the following:

✤ How do you decide to outsource?

✤ What external resources are available to you?

✤ What are the fundamentals of business that you look for in a provider?

✤ How to use consultants?

✤ How do you use a scientific advisory board/KOL?

Moderator: Deirdre BeVard VP, Development Operations, Nektar Therapeutics

Panelists: Lee Allen, MD, PhD CMO, Argos Therapeutics

Bruno Gagnon, BPharm, MSc Global Lead, Clinical Outsourcing, Raptor Pharmaceuticals


4:55 pm Panel: Whatever the Outsourcing Model, What’s the Best Way to Manage it? The reality with clinical outsourcing is that it’s extremely people dependent. Once relationships are sourced and pharma settles on governing and economics, the relationship moves down to different levels into the project teams. Roles and responsibilities in hand-offs become a challenge and often cause delays. This is where some of the biggest pressure points come from.

Everyone is under huge financial pressure and this tension can drive negative behavior, causing flare-ups. This session addresses the POV from clinical operation heads and CRO executives on what they really want from each other.

5:25 pm Networking Reception



DAY TWO - TUESDAY, NOVEMBER 15, 2016

8:00 amBreakfast

8:30 am Co-Chair’s Opening Remarks



8:45 am Keynote Fireside Chat: How Juno Therapeutics Went from 30 to 300 Mark Frohlich, EVP of Portfolio Strategy, Juno Therapeutics, sits down with us to talk about the progress they made as a small biotech company comprised of 30 people, now over 300, and the challenges they faced along the way including:

✤ Decision making with 30 people versus 300

✤ Leveraging outside resources as a small and emerging R&D company

✤ When moving into phase II or phase III, understanding how that affects your budget

✤ Determining when to explore a new disease area

Moderator: Mark Simon, MBA Partner, Torreya Partners

Fireside Guest: Mark Frohlich, MD EVP of Portfolio Strategy, Juno Therapeutics

9:25 am R&D Efforts That Translate to Approvals This session will examine what is important in the R&D process and advise what companies should do early in the drug development cycle to best position for regulatory approval in the US and Europe.

Laurie Burke, RPh, MPH Former Director, Study Endpoints and Labeling Development (SEALD), ONDIO, CDER, FDA and Founder, LORA Group

Thomas Lonngren, PhD (hc), MRPharmS, FRCP Former Head, EMA and Strategic Advisor, NDA Group

10:10 am R&D Best Practices on Interacting with Regulatory Authorities Panel In this session, heads of R&D and CMOs share their experiences and best practices on interacting with

regulatory authorities, including answering the following questions:

✤ How was your experience?

✤ What did you find with certain divisions?

✤ How did you interpret their words and actions?

✤ What were some of the challenges?

✤ What helped you get over this hurdle?

✤ What are some of the shortcuts or workarounds?

Moderator: Chris O’Brien, MD CMO, Neurocrine Biosciences

Panelists: Mark Bagarazzi, MD CMO, Inovio Pharmaceuticals


10:45 am Networking Break

11:15 am Late Stage Development Partnerships Case Study: Complex Transition from Biotech to Pharma For small discovery and early development stage companies, the transition of an asset or program from Phase 2 proof-of-concept into large scale Phase 3 studies is difficult. This is particularly true for indications requiring large sample sizes and long-duration studies for regulatory approval. Late stage development partnerships can address this challenge but finding an appropriate partner and reaching agreement on deal terms is only the beginning as multiple surprises can arise with technology transfer, research collaborations and communication within and outside the partnership. Observations and learnings from recent Neurocrine experiences will be shared along with recommendations for companies at this stage of development.


11:45 am Fireside Chat: Lessons Learned from the Journey of a Life Sciences Leader


Fireside Guest: Pablo Cagnoni, MD Managing Director, MPM Capital and President & CEO, Tizona Therapeutics

AGENDA CMO AND R&D SUMMIT WEST




12:15 pm Lunch (Grab and Go)

12:45 pm What Investors Look for from R&D Leadership in Emerging Biotech

✤ How investors gauge how R&D leadership is doing?

✤ Thoughts on structural gaps in R&D?

✤ How R&D can be providers to investors?

✤ How can R&D leadership work more collaboratively with investors?


Panelists: Pablo Cagnoni, MD Managing Director, MPM Capital and President & CEO, Tizona Therapeutics

Carol Gallagher, PharmD Partner, New Enterprise Associates

Allyson Rinderle, MBA Vice President, Longitude Capital

Camille Samuels, MBA Partner, Venrock

1:25 pm Panel: Pricing Trends and the Impact on R&D Strategies

✤ Understanding the ultimate value of pharmaceuticals in the healthcare ecosystem for managing illness and preventing progression of disease

✤ How R&D is interacting within the company as it relates to drug pricing?

✤ Will it be necessary to give into the pressure of pricing especially in the era of large scale partnering?

✤ Are we over pricing at the detriment of the patient to our own P&L?

✤ Approaching pricing in the US vs Europe

✤ Insight into strategies and policies of operating a global company, putting a research program together, provide the right data for regulatory approval and market access

✤ Price controls in the US?

✤ New ways of paying for medicines moving forward

Moderator: Pamela Palmer, MD, PhD CMO & Co-founder, AcelRx Pharmaceuticals

Panelists: Murray Aitken, MBA SVP & Executive Director, IMS Institute for Healthcare Informatics

Samuel Nussbaum, MD Former EVP, Clinical Health Policy and CMO, Anthem and Strategic Advisor, Epstein Becker Green

Mark Simon, MBA Partner, Torreya Partners

2:00 pm How Does a CMO Outline a Development Pathway in Rare Disease Trials? Given the increased interest and challenges in rare disease and patient centricity /interactions, there is no clear pathway for development. What must a CMO take into consideration? In this session we discuss:

✤ Developing a creative trial design to be more efficient with every patient and the data you obtain

✤ Benefits of a collaborative approach to protocol development

✤ Managing enrollment with limited research participants


2:30 pm Evaluating the Factors for Discontinuing a Program

✤ Balancing advocation vs. realistic stats

✤ Risk benefit of continuing when generating questionable data

✤ Rationalizing your portfolio? Who decides?

Lee Allen, MD, PhD CMO, Argos Therapeutics

3:00 pm Conference Concludes



VENUE Marines' Memorial Club & Hotel 609 Sutter StreetSan Francisco, CA 94102(415) 673-6672www.marineclub.com/index.php

Located in the Union Square neighborhood, the Marines’ Memorial Club & Hotel offers guests exclusive access to the excitement of downtown San Francisco. Just steps from the theater district and a variety of restaurants, galleries, museums, entertainment attractions and the cable cars. Moreover, Union Square, San Francisco shopping may offer some of the most unique opportunities in California.

We recommend that you book your room as soon as possible. To book a room, call: 415-673-6672 and ask for the R&D Biotech Leadership Summit 2016 rate.

REGISTRATION & PRICING Last Standard Early Bird thru 10/7 $1,395 Standard Ticket after 10/7 $1,495 Academic/Gvt. Late Early Bird thru 10/7 $697.50

Scholarships The Conference Forum has an Out-Reach Program to help start-up biotechs and pharma companies obtain partial and full scholarships to attend our events.

The mission behind the Out-Reach Program is to assist companies that can benefit from the information, but cannot afford the registration fee. Scholarships are limited so contact us early. For information on how to apply, please email us at [email protected].

Discount Program Group Registration – Receive a 10% discount off each registration when three or more colleagues from the same company or organization register online. Group discount only applies to the standard rate.

Payment Policy Payment must be received in full by the event date. All discounts will be applied to the Conference Only fee (excluding add-ons)‚ cannot be combined with any other offer‚ and must be paid in full at the time of order.

Substitution and Cancellation Policy If you are unable to attend and would like to register a substitute, please email [email protected]. Please ask your substitute to provide identification on-site.

If you need to cancel your registration, please note the following policies based on the start date of the event:

Ten or more business days prior: A full refund less the administration fee of $295, or a pass to another event valid for two years from the date of issue.

Less than ten business days prior: A pass to a future event for either yourself or a colleague from the same company valid for two years from the date of issue.

If you need assistance with registering at any time, please email [email protected] or call 646-350-2580 ext. 1.

VENUE / REGISTRATION CMO AND R&D SUMMIT WEST


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CMO AND R&D SUMMIT WEST SPONSORS

EXECUTIVE SPONSOR

Our mission at Cytel is to improve success rates in the development of drugs, biologics and medical devices. We do this by improving clinical trials through innovative application of statistical science, operations research and data handling techniques. Leaders in adaptive trial design and implementation, the top 25 biopharma companies rely on our technology in their clinical studies. For more information, visit www.cytel.com.

ASSOCIATE SPONSORS

AiCure uses Artificial Intelligence to visually confirm medication ingestion on smartphones. Trials fail when subjects do not take their medication. Instead of capturing 10% of dosing data, AiCure provides detailed dosing patterns based on 100% of confirmed ingestions allowing sponsors to increase adherence, identify poor-performing subjects, and improve data quality. Visit www.aicure.com.

Halloran Consulting Group is a management consulting firm that partners with life science companies to guide them through today’s complex clinical, quality, and regulatory landscape. Halloran works with industry organizations of all types, including biotech, pharma, medical device, and life science service providers, to advance products, provide tailored solutions, streamline procedures, and maximize available resources. Visit www.hallorancg.com.

Europe’s leading regulatory drug development, pharmacovigilance and HTA consultancy. We support life science companies all over the world and across all phases of development, from pre-clinical to post marketing, to the needs and requirements of regulators and payers alike. We work together with our clients to address key strategic regulatory and reimbursement challenges. Our scientific expertise covers all major therapeutic areas. The advice you get from NDA is from real experts in the industry, many who have been involved in shaping today’s regulatory, HTA and pharmacovigilance environment. We have close to 100

employees across Europe. More than 25% are ex EU regulators. With our support, you can cut the time and associated cost it takes to get your products to market, and keep them there. NDA supported more than 38% of the new medicinal products that were approved in the EU in 2014. Visit www.ndareg.com

Veristat is a full-service clinical research organization (CRO) with over 20 years of experience supporting pharmaceutical, biotechnology and medical device companies throughout the clinical trial and regulatory approval process to bring novel therapies to market. We offer a consultative approach, providing you the personalized expertise and scientific knowledge to design and execute your clinical trials. For more information, visit: www.veristat.com.

SUPPORTING SPONSOR

Altasciences Clinical Research encompasses Algorithme Pharma in Montreal, QC, Vince & Associates Clinical Research in Overland Park, KS, and Algorithme Pharma USA in Fargo, ND, thereby making it one of the largest early phase clinical CROs in North America. Altasciences provides early phase clinical development services to biopharmaceutical and generic companies. To learn more, visit: www.altasciences.com.

SUPPORTING PARTNER

California Life Sciences Association (CLSA) is the leading voice for California’s life sciences sector. We work closely with industry, government, academia and other stakeholders to shape public policy, drive business solutions and grow California’s life sciences innovation ecosystem. CLSA serves over 750 biotechnology, pharmaceutical, medical device, and diagnostics companies, research universities and institutes, investors and service providers. CLSA was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged to create the state’s most influential life sciences advocacy and business leadership organization. Learn more at califesciences.org.



MEDIA PARTNERS CMO AND R&D SUMMIT WEST

MEDIA PARTNERS


effectively running r&d in a resource constraint environment...2016/11/14 · therapeutics...

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