Year in Review

What Do You Think Was The Single Most Consequential Event Or Result In Pharma/Biopharma In 2023?

Regulatory

What Do You See As The Most Significant Regulatory Decision Or Guidance On The Horizon For 2024 (Or Beyond)?

Sustainability

What is your plan to build a more sustainable business practice in the coming years?

Predictions

What key indicators do you look at to predict the future of this industry?

Unmet medical needs

In which orphan spaces or unmet medical needs do you think we will see the next treatment innovations?

Challenges

What do you consider the biggest challenge that the pharma/biopharma industry currently faces?

Milestones

What important company milestone do you anticipate reaching in 2022?

Leadership

What’s the key to being a leader in the industry?

Personalized and Precision Medicine

What do you see as the key innovations or technologies that will make personalized/precision medicine a reality?

Therapeutic Areas

For what therapeutic area do you think we will see the greatest progress in the coming years?

Innovation

What’s the next “big thing” on the horizon that will significantly alter the pharma/biopharma market, your operations, or the way you do business?

U.S. Market

What do you think most differentiates the U.S. pharma/biopharma industry or the market?

Evolving Technologies

How have evolving technologies like artificial intelligence (AI) and machine learning (ML) changed how you conduct research, manufacturing, or business?

Social Media Marketing

How is your organization using social media to extend your marketing efforts?

2021 Projections

Putting aside COVID-19 vaccines and therapeutics, what do you think will be the most significant development in the industry in 2021?

Virtual BD and Marketing

How are you growing your business development activities in the absence of conventional trade shows and other traditional business development/marketing activities?

Lessons from the Pandemic

What do you think is the greatest lesson learned from the COVID-19 pandemic, and what lasting impacts do you foresee over the next 5–10 years?

Dealing with a Crisis

How has your organization worked to become “crisis proof?”

Post-COVID-19 Supply Chain

How are you rethinking your supply chain and operational fitness in light of the COVID-19 pandemic?

Roundtable Topics

Year in Review

Regulatory

Sustainability

Predictions

Unmet medical needs

Challenges

Milestones

Leadership

Personalized and Precision Medicine

Therapeutic Areas

Innovation

U.S. Market

Evolving Technologies

Social Media Marketing

2021 Projections

Virtual BD and Marketing

Lessons from the Pandemic

Dealing with a Crisis

Post-COVID-19 Supply Chain

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In 2023, the FDA released the draft guidance titled: “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products.” This draft guidance provides insight into the FDA’s expectations for cell and gene therapy (CGT) developers regarding manufacturing changes and comparability assessments under chemistry, manufacturing, and control (CMC) requirements.

Jared Schuster
Senior Regulatory Affairs Associate

First-in-human phase 0 imaging studies are also known as microdosing proof-of-concept studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies.

Muctarr Sesay, Ph.D.
Chief Scientific Officer

2023 saw a downward shift and right-sizing of the biologics clinical pipeline. This led to reduced biologics clinical manufacturing capacity utilization, resulting in several CDMOs downsizing their assets.

Jean-Chrisophe Hyvert
President of Biologics

The rising global spotlight on upgraded obesity drugs may be one of the most noteworthy events highlighting the biopharmaceutical industry in 2023.

Minjee Kim
Market Intelligence Specialist

Limited availability of existing raw materials with the increased lead times. Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs).

Francisco Heredia
Director, Business Development

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The revision of EU GMP Annex 1, Manufacture of Sterile Medicinal Products, became effective in August 2023. This regulatory document provides general guidance for the manufacture of all sterile products using the principles of Quality Risk Management (QRM), to ensure that microbial, particulate, and pyrogen contamination is prevented in the final product.

Jean-Christophe Hyvert
President of Biologics

The EU Green Deal includes several strategies and action plans which directly impact the pharma and biotech industry: Chemicals Strategy for Sustainability (CSS) was adopted in October 2020 to realize Europe’s zero-pollution ambition.

Robert Nass
Head of Quality & Regulatory Management

Achieving greater patient representation in clinical research has been a focus area of regulatory agencies for years. However, there is a lack of consistency across the industry in terms of readiness and proactive efforts to promote diversity throughout the drug development process.

Rose Blackburne, M.D., MBA
Vice President, Global Head, General Medicine/CVMet and Women’s Health, Medical Science and Strategy

Moving into 2024 amid the never-stagnant regulatory landscape, the biologics industry may face mounting difficulties in sufficiently supplying high-demand drugs to where they are needed the most on time.

Woosang Lee
Lead Regulatory Affairs Specialist

In the biopharma industry, there is a need for quality and regulatory standards to be harmonized for bioprocess ingredients used in cell culture media and upstream and downstream processes.

Andreas Nordheider, Ph.D.
Vice President Health Solutions

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Aceto will be focusing on the execution of its strategic plan with ambitious goals for sustainability in 2022 and beyond.

Anke Luxenburger
Attorney-at-Law, Vice President Legal & Regulatory, Europe, Actylis

Customers, investors, and employees all look for companies with a strong record and sound plans for sustainability.

Pete Williams
Vice-President of Global Environment, Health & Safety, and Sustainability, Catalent

ConcertAI was built to create greater contributions to societal, economic, and environmental benefits over time.

Jeff Elton, Ph.D.
Chief Executive Officer, ConcertAI

Evonik Health Care has adopted sustainability as a guiding business principle and has set the goal of becoming carbon neutral by 2030.

Jochen Becker, Ph.D.
Global Project Manager RD&I, Evonik Health Care

At PCI Pharma Services, we developed an Environmental Social Governance (ESG) committee about a year ago as the foundation for our sustainable business practices.

Craig LaMarca
General Manager, Boston Clinical Trial Services, PCI Pharma Services

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Keeping pace with the changing trends and fast proliferation of demands on businesses for environmental and social regulations is certainly the main challenge for most industries.

Anke Luxenburger
Attorney-at-Law, Vice President Legal & Regulatory, Europe, Actylis

Some people like to say that “the future is the in the stars.” In our scientific field, the appropriate version is “the future is in the pipeline!”

Alessandro Maselli
President and Chief Executive Officer, Catalent

Healthcare is an industry that is founded on innovation. Over the last 25 years, we have seen a percentage reduction in cancer deaths as a result of new medical innovations, such as immunotherapies.

Jeff Elton, Ph.D.
Chief Executive Officer, ConcertAI

Evonik Health Care

Jochen Becker, Ph.D.
Global Project Manager RD&I

One key indicator to predict the future of the biopharma industry, as it relates to ESG and the environment, is carbon emissions.

Craig LaMarca
General Manager, Boston Clinical Trial Services, PCI Pharma Services

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The next innovations in rare disease treatments will likely leverage investments into novel biologic drug modalities, such as oligonucleotide therapeutics and gene editing treatments.

Sergey Vlasenko, Ph.D.
Associate Vice President, Pharma and Biopharma End Markets, Agilent Technologies, Inc.

Biologics, which include recent innovations like cell and gene therapy, monoclonal antibody treatments, and mRNA-based treatments, have seen enormous growth in the past few years, and most notably in the past years alone.

Frank Romanski, Ph.D.
Director, Global Head of Marketing, BASF Pharma Solutions

There have been many advances (gene therapy, ASO, siRNA) in recent years to develop treatments and expand access to therapies for patients with unmet medical needs, particularly in patients living with rare genetic conditions, and, while the work is far from complete in that field, I predict that the next wave of innovations will focus on treating non-genetic illnesses.

David Fischer, Ph.D.
Chief Technology Officer (Early Discovery), Charles River Laboratories

There are two categories that I would highlight, an early-stage (gene therapy) and a maturing (CAR-T) one.

Jeff Elton, Ph.D.
Chief Executive Officer, ConcertAI

There is an exciting and growing clinical pipeline of rare disease drugs, with more than 700 candidates in development for a broad range of diseases, including rare cancers and autoimmune, infectious, and neurologic diseases, among many others.

Paula Ragan, Ph.D.
Chief Executive Officer and President, X4 Pharmaceuticals

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Decreasing the cost of bringing new biologic entities (NBEs) to market and improving R&D cycle times remain the biggest challenges in the industry.

Sergey Vlasenko, Ph.D.
Associate Vice President, Pharma and Biopharma End Markets, Agilent Technologies, Inc.

A clear challenge of the pharmaceutical industry has been highlighted by the recent pandemic, and that is the overreliance on single-sourced materials and vulnerabilities within the global supply chain.

Frank Romanski, Ph.D.
Director, Global Head of Marketing, BASF Pharma Solutions

Lower clinical trial access to patients, the pandemic further diminishing patient participation and new study starts, limited research infrastructure and budgets at healthcare providers, and rather burdensome legacy trial technologies have reduced the throughput potential for these biomedical innovations.

Jeff Elton, Ph.D.
Chief Executive Officer, ConcertAI

While emerging biotechs face their own set of challenges, contract development and manufacturing organizations (CDMOs) are challenged with standardizing production for novel modalities such as cell and gene therapies (CGT), improving yield and scalability, and ensuring that processes follow current good manufacturing practices (cGMP) and regulatory standards.

Andrew Bulpin
Head of Process Solutions, MilliporeSigma, the Life Science business of Merck KGaA, Darmstadt, Germany

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In 2022, the Pharma Business group will be putting more choices, solutions, and resources directly in the hands of customers through an innovative approach to our website.

Alen Guy, Ph.D.
Technical Director in the Pharmaceutical Business Group, IMCD

Arising from an increasing number of small and medium-sized pharmaceutical and biotech companies without their own production and/or testing facilities, heightened need for sterile injectable formulations, and growing demand for biopharma products, Alcami is undergoing significant growth.

Anna Dormady
Director of Laboratory Operation, Morrisville, NC, Alcami Corporation

This year, IFF’s Pharma Solutions is looking forward to the 60th anniversary of our flagship brand Avicel®, which pioneered the use of microcrystalline cellulose as a strategic excipient in the formulation of high-quality pharmaceutical products

Dago Caceres
Strategy Director, Pharma Solutions, IFF

We have several important milestones on the horizon. One is the continued release of new modules for our digital tools within our industry-leading Virtual Pharma Assistants (VPAs) platform.

David W. Freidinger
Vice President, Global Business Management, BASF Pharma Solutions

2022 is the first full year after the preliminary FDA guidance for real-world data (RWD) supporting real-world evidence (RWE) for regulatory decisions was released in the fourth quarter of 2021.

Jeff Elton
Chief Executive Officer, ConcertAI

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Perspective and agility. Being agile can mean flexible, but in a modern business setting it has more to do with a mindset that is adaptable through feedback.

Alen Guy, Ph.D.
Technical Director in the Pharmaceutical Business Group, IMCD

Alcami leads within the CDMO sector through convenience of offerings and reduction of complexity in processes offered to customers.

Anna Dormady
Director of Laboratory Operation, Morrisville, NC, Alcami Corporation

It’s about always being there for our customers. We help them with the answers that they need, using our unparalleled portfolio of solutions and unrivaled technical service in critical application areas, such as immediate and controlled release.

Dago Caceres
Strategy Director, Pharma Solutions, IFF

At BASF, we believe that true leadership involves more than innovation or a healthy bottom line.

David W. Freidinger
Vice President, Global Business Management, BASF Pharma Solutions

We are in an industry that is being transformed and transforming — and leadership is defined by how we respond, the new approaches we can provide, and the generation of evidence that the new approaches are working.

Jeff Elton
Chief Executive Officer, ConcertAI

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One of the major limitations of drug development efforts has been the lack of laboratory models that capture the complex biology of cells in our bodies.

Austin Mogen
Senior Field Application Scientist, Corning Life Sciences

Our understanding of the biological processes unfolding within our bodies continues to grow, and our ability to make use of this immense set of data through AI and advanced data analytics will be a driving force behind the development of personalized therapies.

Brian Graves
Global Business Manager, Grace Materials Technologies

Key innovations for personalized/precision medicine may come from advances in biomarker discovery and monitoring technologies.

Thaddeus Allen, Ph.D.
Vice President of Translational Biology and Business Development, San Francisco, Anticancer Bioscience

A prerequisite of personalized medicine is therefore being able to sequence a patient’s genome rapidly and affordably, which is becoming more of a reality every passing day.

Maaike Everts, Ph.D.
Director of Strategic Marketing, Parenteral Drug Delivery Solutions, Evonik

Right now, the frontrunner for cell and gene therapy treatments is CAR-T, which works well for hematological cancers, but to date has had limited success with solid tumors.

Andrew Bulpin, Ph.D.
Head of Process Solutions, MilliporeSigma, the U.S. and Canadian Life Science business of Merck KGaA, Darmstadt, Germany

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With the approval of Zolgensma in 2019, a gene therapy for treatment of spinal muscular atrophy that impacts infants, we are ushering in an age where many difficult-to-treat genetic disorders have the potential to be cured.

Austin Mogen
Senior Field Application Scientist, Corning Life Sciences

Perhaps the “therapeutic area” that could see the greatest progress will not be an existing area at all, but a convergence of the understanding of disease at a more fundamental level, allowing us to make advancements in many areas of therapeutic interest, all at the same time.

Brian Graves
Global Business Manager, Grace Materials Technologies

Given the enormous success of PARP inhibitors and thus the synthetic lethal approach in general, we expect many more synthetic lethal cancer drugs to emerge in the coming years.

Thaddeus Allen Ph.D.
Vice President of Translational Biology and Business Development, San Francisco, Anticancer Bioscience

The success of the COVID-19 vaccines has shown the potential of mRNA vaccines for prophylactic purposes. In coming years, I think that we will see rapid developments in mRNA to tackle other infectious diseases.

Maaike Everts, Ph.D.
Director of Strategic Marketing, Parenteral Drug Delivery Solutions, Evonik

Particularly for the treatment of cancer, both mRNA-based therapies and antibody–drug conjugates (ADCs) have potential for tremendous progress.

Andrew Bulpin, Ph.D.
Head of Process Solutions, MilliporeSigma, the U.S. and Canadian Life Science business of Merck KGaA, Darmstadt, Germany

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An important digital trend –– that has been exacerbated by the pandemic –– is using advanced tools to increase the resilience and predictability of the complex pharma supply chain.

Dago Caceres
Global Strategy Director, Pharma Solutions, IFF

From the perspective of some of our pharma customers, mRNA will be the biggest focus for the next generation vaccines for influenza, yellow fever, HIV, etc.; and new therapies for cystic fibrosis, multiple sclerosis, and different types of cancer.

Sandra Wisniewski
President, Materials Technologies and Reno Nguyen, Principal Scientist, W. R. Grace & Co.

Another “big thing” that is happing in the industry is the prioritization of investments into new drug modalities, focusing on disease prevention and curative therapies.

Sergey Vlasenko, Ph.D.
Associate Vice President Pharma and Biopharma End Markets, Agilent Technologies

I think the next big thing in healthcare is the integration of the normalization of digital tools to analyze and share ever increasing amounts of data.

Kurt Nielsen
President and CEO, Pharmaceutics International, Inc. (Pii)

One of the next big things which is pertinent to us is the increased momentum of inhaled or nasal drug development for delivery of vaccines and complex drugs, including peptides, monoclonal antibodies, oligonucleotides, mRNA, and gene therapies.

Mark Parry
Technical Director, Intertek Melbourn

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I think it's the incredible pace of incremental and breakthrough innovation.

Kurt Nielsen
President and CEO, Pharmaceutics International, Inc. (Pii)

Innovation, reliability, and transparency are some of the biggest differentiators when it comes to the U.S. pharma/biopharma industry.

Dave Short
Global Business & Technology Manager, Fine Chemicals, W. R. Grace & Co.

The United States has scale, which is a competitive edge in a highly globalized industry like pharma or biopharma.

Dago Caceres
Global Strategy Director, Pharma Solutions, IFF

What differentiates U.S.-based pharma/biopharma companies is their historically higher contribution to the worldwide R&D effort, which currently stands at approximately 45–50%.

Sergey Vlasenko, Ph.D.
Associate Vice President Pharma and Biopharma End Markets, Agilent Technologies

The two main differentiators of the U.S. pharma/biopharma industry are that the funding availability is much higher and there is a single drug supply across the entire United States, making trial design and packaging easier.

Brian Keesee
Vice President & General Manager, Global Operations and Supply, Clinical Services, PCI Pharma Services

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The increasing manufacturing complexity of new medicines and the desire to reduce “time to market” are driving faster development and implementation of AI solutions in our activities.

Stephan Rosenberger, Ph.D.
Head of Digital Transformation, Lonza

With respect to research, which impacts manufacturing and the business operations generally, we have pursued machine learning (ML) to leverage data for optimizing process engineering and formulations to arrive at more robust solutions more efficiently for our clients.

David Vodak, Ph.D.
Senior Director, Head of Small Molecules R&D, Lonza

The application of evolving technologies like artificial intelligence (AI), machine learning (ML) and mixed reality (MR) is an important pillar of our digital agenda at Rentschler Biopharma.

Wolfram Schulze
Vice President Information Systems & Organization, Rentschler Biopharma SE

We are increasingly seeing opportunities to use high-quality data sets to predict outcomes, supplementing our use of theory-driven models.

Alan Stevens, Ph.D.
Senior Principal Scientist, CatSci Ltd.

Evolving technologies have transformed BASF’s ability to offer new services and solutions to our customers in the pharmaceutical industry.

Valerie Van Hulle
Global Strategic Marketing Manager, BASF Pharma Solutions

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Social media is an important channel to engage with customers, current and prospective employees, shareholders, and investors. During the COVID-19 pandemic, with in-person activities significantly curtailed, it has become more so.

Richard Harper
Vice President, Marketing, Vectura

Raising awareness for our sector’s contribution in simplifying the complexities of drug development, in the face of the pandemic and beyond, has been my personal mission in communication.

Cora Kaiser, Ph.D.
Senior Director Corporate Communication, Rentschler Biopharma SE

Social media is a key pillar of BASF Pharma Solution’s marketing communications strategy. Through LinkedIn, Twitter, and other platforms, we are able to reach a broad, global audience and develop a loyal follower base for our brand.

Valerie Van Hulle
Global Strategic Marketing Manager, BASF Pharma Solutions

Snapdragon Chemistry uses social media to celebrate corporate milestones, announce new capabilities and highlight news about the company that may be of interest to the chemistry community.

Matthew Bio, Ph.D.
President and Chief Executive Officer, Snapdragon Chemistry, Inc.

Social media is an important part of a wider digital marketing strategy for Sterling Pharma Solutions for both internal and external audiences for attracting new customers and to reinforce the decision-making process of existing ones.

Emma Greenwood
Marketing Director, Sterling Pharma Solutions

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I believe that the focus on the microbiome will significantly increase in 2021 and beyond. The pandemic hardly disrupted microbiome research, and 2020 saw an increasing level of investment and partnering in this area.

Isabelle de Cremoux
CEO and Managing Partner, Seventure Partners

I believe we will see an emphasis on precision medicine this year, as the industry focuses on a diagnostic and therapeutic approach that not only helps put each patient in the center of their medical care, but also helps physicians and payers make informed decisions in this unprecedented time.

Sidonie Golombowski-Daffner, Ph.D.
Chairperson and President, Advanced Accelerator Applications (AAA), a Novartis company

There’s no denying that the world has changed in the past 12 months. We’ve witnessed the almost miraculous development of new vaccines in timelines previously thought unattainable.

Phil Vanek
CTO, Gamma Biosciences

First, 2021 will see greater controls and regulation being brought in for the pharmaceutical supply chain due to the fragility that has been made evident in 2020.

Marrie Groeneveld
CCO, SkyCell

2021 will be unlike any other year in one clear way: digitalization. I believe the utilization of AI and machine learning will make big advances in 2021, particularly with respect to shortening development times for drug products

Alen Guy
Technical Director, the Pharmaceutical Business Group of IMCD

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While PCI must earn the right to serve, our customers are in need of services, and pharmaceutical companies need the value that integrated supply chain companies bring.

Tim Roberts
Vice President, Global Sales, Clinical Services | PCI Pharma Services

As the pandemic struck last year, Vectura was embarking on a path to change its business strategy and evolve from a development company into an inhalation-focused CDMO.

Mark Bridgewater
Chief Commercial Officer, Vectura

This year has brought many new challenges and opportunities across the healthcarelandscape. At Advanced Accelerator Applications (AAA), a Novartis company, data anddigital are some of our key strategic pillars.

Sidonie Golombowski-Daffner, Ph.D.,
Chairperson and President, Advanced Accelerator Applications (AAA)

Gamma Biosciences was intentionally built from the ground up to move quickly and purposefully to address the shortcomings in advanced therapy manufacturing.

Phil Vanek
Chief Technical Officer, Gamma Biosciences

As an established VC with a primary focus on the healthcare and life sciences sectors, we didn’t experience significant interruption in our business development activities.

Isabelle de Cremoux
CEO and Managing Partner, Seventure Partners

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Over the past three decades, the pharmaceutical supply chain has grown more complex and international to meet policies focused on aggressively decreasing drug prices.

Andrew Badrot
CEO, C² PHARMA

The greatest lesson we have learned is that cumulative ability, expertise, and knowledge offer the best path forward in developing new drugs and therapies.

Anthony Fitzpatrick
Executive Vice President Operations, Vectura

Preparedness for risks such as anthrax and smallpox are important because the threat remains high, but we never expected that the first significant pandemic since the flu pandemic was going to be an extreme version of the common cold.

Sean Kirk
EVP, Manufacturing & Technical Operations, Emergent BioSolutions

To me, the greatest lesson learned from the COVID-19 pandemic is resilience: the CDMO industry has proven to be capable of outstanding resilience over the past months.

Jean Bléhaut
President of the Synthesis Solutions Business Unit, Novasep

First, the importance of our industry: both the ability of biopharmaceutical companies to directly address the challenges of COVID-19 and the fact that our sector has remained so strong in such turbulent times.

Ben Zeskind, Ph.D.
CEO, Immuneering

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Because we’re a leading supplier for end-to-end bioprocessing products, our sector has been greatly impacted by COVID-19.

Amélie Boulais
Marketing Manager within the Vaccine Segment, Sartorius

Like every global organization, Catalent has crisis management plans in place for various scenarios. Surveillance and communication are key and help identify threats quickly to enable timely response.

Kay Schmidt
Senior Vice President, Technical Operations, Catalent

Obviously, the safety and well-being of trial participants and staff remains the top priority of any organization conducting clinical studies, but it is absolutely imperative that the quality and integrity of data from trials remains of the highest standard.

Nariné Baririan
PharmD, Clinical Pharmacology Expert, SGS

While the advent of the COVID-19 pandemic brought about a tumultuous period across industries, we demonstrated operational resilience and established ourselves as a “crisis-proof” organization.

Radek Špíšek, Ph.D.
Global CEO, Sotio

The key to overcoming any crisis is robust planning, eliminating single points of failure, adapting quickly, and building a culture of creative problem solving.

Dietrich Stephan, Ph.D.
CEO, Neubase Therapeutics

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Alcami’s simplified, entirely U.S.-based supply chain is one of our core strengths. At every phase of the product life cycle, risks are inevitable; this is especially true as supply chain complexities increase due to COVID-19.

Yadira Salamander
Director of Engineering Services, Alcami

The COVID-19 pandemic has highlighted the critical role that procurement plays in managing the supply of goods and services, especially in times of crisis. Business continuity planning has been used to great effect and has reinforced the need to keep plans live and...

David Duff
VP Procurement, Vectura

At BASF Nutrition and Health, global, regional, country, and site crisis-management teams are meeting regularly to further monitor the outbreak of COVID-19 and recommend the necessary mitigation measures.

David Freidinger
Vice President of Pharma Solutions Business Management, BASF

The COVID-19 pandemic has provided many lessons and inspiration for improvement related to areas from people to processes and systems.

Brian Albright
Global Manufacturing and Supply Chain Leader, Pharma Solutions, DuPont Nutrition & Biosciences

The continuous optimization of operational fitness has always been an integral part of Rentschler Biopharma’s strategy. We have been closely monitoring and improving our processes, business continuity, and digital maturity, even before the outbreak of the COVID-19 ...

Wolfram Schulze
Vice President Information Systems, Organization, & Digital Transformation and Head of Infection Prevention Task Force, Rentschler Biopharma

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